Pub - Food Plant Sanitation Food Science and Technology PDF

FOOD
PLANT
SANITATION
edited by
Y. H. Hui
Science Technology System
West Sacramento, California, U.S.A.
Bernard L. Bruinsma
Innovative Cereal Systems
Wilsonville, Oregon, U.S.A.
J. Richard Gorham
Consultant
Xenia, Ohio, U.S.A.
Wai-Kit Nip
University of Hawaii at Manoa
Honolulu, Hawaii, U.S.A.
Phillip S.Tong
California Polytechnic State University
San Luis Obispo, California, U.S.A.
Phil Ventresca
E.S.I. Qual International
Stoughton, Massachusetts, U.S.A.
Marcel Dekker, Inc. New York • Basel

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Preface
As food professionals, we have noticed the monumental increase in awareness of food

safety in the past decade. Professionally, this awareness manifests itself in many ways,
with educational materials (print, Internet, videos, etc.) heading the list. Reference books
on food safety are especially useful.
This book has three important goals: (1) to present the fundamental principles of
food plant sanitation and their applications in the food industry; (2) to provide profession-
als with basic, hands-on information for the day-to-day operations in a food processing
plant, (3) to review some of the industry’s most recent developments.
To achieve these goals, the book covers nine major areas: federal and state regula-
tions and guidelines, major biological and nonbiological contaminants, cleaning a food
plant, sanitation and worker safety, housekeeping, product quality, commodity processing,
retail food sanitation, and enforcement.
The book covers both basic sanitation practices and the latest information on the
Hazard Analysis Critical Control Point (HACCP) program. However, HACCP is discussed
as a peripheral consideration. Before one considers HACCP, one must make sure that
each food processing plant has put in place an acceptable sanitation program in principle
and in practice: Have the incoming raw materials been checked? Is there water (or debris)
on the floor of the operations room? Does every worker wear a hairnet when handling
food products or ingredients? Is the cold storage room maintained at the required tempera-
ture? Are there rat and bird droppings in the plant? There are these questions and more
to consider.
This book differs from other food sanitation books in that its presentation is a compi-
lation of multiple perspectives from more than 30 government, academia, and industry
food safety experts. They cover more than 40 topics in food plant sanitation and HACCP
and present the latest developments in retail food processing and sanitation. Last, but not
least, the book provides examples of the enforcement activities of the U.S. Food and Drug
Administration (FDA) in relation to food plant sanitation. The discussion is accompanied
by a reproduction of the FDA’s Handbook of Food Defect Action Levels in the appendix.
In sum, the approach for this book is unique and makes it an essential reference for the
food safety and quality professional.
The editorial team thanks all the contributors for sharing their experience in their
fields of expertise. They are the people who made this book possible. We hope you enjoy
and benefit from the fruits of their labor.
We know how hard it is to develop the content of a book. However, we believe
that the production of a professional book of this nature is even more difficult. We thank
the production team at Marcel Dekker, Inc., and express our appreciation to Ms. Theresa
Stockton, coordinator of the entire project.
Y. H. Hui
Bernard L. Bruinsma
J. Richard Gorham
Wai-Kit Nip
Phillip S. Tong
Phil Ventresca

Contents
Preface
PART I. PRINCIPLES OF FOOD PLANT SANITATION
1. An Overview of FDA’s Food Regulatory Responsibilities

Y. H. Hui
2. Foodborne Diseases in the United States

P. Michael Davidson
3. The FDA’s GMPs, HACCP, and the Food Code

Y. H. Hui, Wai-Kit Nip, and J. Richard Gorham
4. Food Plant Inspections

Alfred J. St. Cyr
PART II. FOOD CONTAMINANTS
5. Hard or Sharp Foreign Objects in Food

Alan R. Olsen and Michael L. Zimmerman

6. Filth and Extraneous Material in Food
Michael L. Zimmerman, Alan R. Olsen, and Sharon L. Friedman
7. Food Defect Action Levels

John S. Gecan
8. Analysis of Drug Residues in Food

Sherri B. Turnipseed
PART III. CLEANING A FOOD PLANT
9. Cleaning and Sanitizing a Food Plant

Peggy Stanfield
10. Water in Food Processing

Chun-Shi Wang, James Swi-Bea Wu, and Philip Cheng-Ming Chang
11. Water and HACCP Programs

Yu-Ping Wei, James Swi-Bea Wu, and Philip Cheng-Ming Chang
12. Water Use in the Beverage Industry

Daniel W. Bena
13. Sanitation of Food Processing Equipment

Peggy Stanfield
PART IV. WORKERS IN A FOOD PROCESSING PLANT
14. Workers’ Personal Hygiene

Tin Shing Chao
15. Worker Safety and Regulatory Requirements

Tin Shing Chao
16. Worker Training in Sanitation and Personal Safety

Tin Shing Chao
17. Worker Safety and Types of Food Establishments

Peggy Stanfield
PART V. HOUSEKEEPING IN A FOOD PROCESSING PLANT
18. Rodent Pest Management

Robert M. Corrigan
003 by Marcel Dekker, Inc.

19. Insects and Mites
Linda Mason
20. Pest Birds: Biology and Management at Food Processing Facilities

John B. Gingrich and Thomas E. Osterberg
21. Stored-Product Insect Pest Management and Control

Franklin Arthur and Thomas W. Phillips
PART VI. QUALITY ASSURANCE PROGRAMS
22. An Informal Look at Food Plant Sanitation Programs

Jerry W. Heaps
23. Sanitation and Warehousing

Y. H. Hui, Wai-Kit Nip, and J. Richard Gorham
24. Metal Detection

Andrew Lock
25. Packaging
Michael A. Mullen and Sharon V. Mowery
PART VII. HACCP AND PRODUCT PROCESSING
26. Beverage Plant Sanitation and HACCP

Henry C. Carsberg
27. Cereal Food Plant Sanitation

Gregory A. Umland, A. Jay Johnson, and Cheryl Santucci
28. Plant Sanitation and HACCP for Fruit Processing

Andi Shau-mei Ou, Wen-zhe Hwang, and Sheng-dun Lin
29. Sanitation in Grain Storage and Handling

Michael D. Toews and Bhadriraju Subramanyam
30. Sanitation and Safety for a Fats and Oils Processing Plant
Richard D. O’Brien
31. Poultry Processing, Product Sanitation, and HACCP

T. C. Chen and Ping-Lieh Thomas Wang
32. Seafood Processing: Basic Sanitation Practices

Peggy Stanfield
PART VIII. RETAIL FOOD SANITATION
33. Retail Foods Sanitation: Prerequisites to HACCP

Peggy Stanfield
34. Retail Food Processing: Reduced Oxygen Packaging, Smoking,

and Curing
Y. H. Hui
PART IX. FEDERAL ENFORCEMENT AND FOOD SAFETY PROGRAMS
35. FDA Enforcement and Food Plant Sanitation

Peggy Stanfield
36. A Review of U.S. Food Safety Policies and Programs

Tin Shing Chao
Appendix A: U.S. Food and Drug Administration Good Manufacturing Practices

Appendix B: Hazard Analysis and Critical Control Point Principles and
Application Guidelines
Appendix C: Food Code 2001 [Table of Contents]
Appendix D: The Handbook of Food Defect Action Levels

Contributors
Franklin Arthur Grain Marketing and Production Research Center, U.S. Department
of Agriculture, Manhattan, Kansas, U.S.A.
Daniel W. Bena PepsiCo Beverages International, Purchase, New York, U.S.A.
Henry C. Carsberg Henry C. Carsberg & Associates, Anacortes, Washington, U.S.A.
Philip Cheng-Ming Chang Department of Food Science, National Taiwan Ocean Uni-
versity, Keelung, Taiwan
Tin Shing Chao Hawaii Occupational Safety and Health Division, U.S. Department of
Labor, Honolulu, Hawaii, U.S.A.
T. C. Chen Poultry Science Department, Mississippi State University, Mississippi State,

Mississippi, U.S.A.
Robert M. Corrigan RMC Pest Management Consulting, Richmond, Indiana, U.S.A.
P. Michael Davidson Department of Food Science and Technology, University of Ten-

nessee, Knoxville, Tennessee, U.S.A.
Sharon L. Friedman Center for Veterinary Medicine, U.S. Food and Drug Administra-
tion, Laurel, Maryland, U.S.A.
John S. Gecan* Microanalytical Branch, U.S. Food and Drug Administration, Washing-
ton, D.C., U.S.A.
John B. Gingrich Department of Entomology and Applied Ecology, University of Dela-

ware, Newark, Delaware, U.S.A.
J. Richard Gorham Consultant, Xenia, Ohio, U.S.A.
Jerry W. Heaps General Mills, Minneapolis, Minnesota, U.S.A.
Y. H. Hui Science Technology System, West Sacramento, California, U.S.A.
Wen-zhe Hwang Department of Food Science, National Chung Hsing University, Tai-
chung, Taiwan
A. Jay Johnson Ringger Foods, Inc., Gridley, Illinois, U.S.A.
Sheng-dun Lin Department of Food and Nutrition, Hungkuang Institute of Technology,

Taichung, Taiwan
Andrew Lock Safeline, Inc., Tampa, Florida, U.S.A.
Linda Mason Department of Entomology, Purdue University, West Lafayette, Indiana,

U.S.A.
Sharon V. Mowery Department of Entomology, Kansas State University, Manhattan,

Kansas, U.S.A.
Michael A. Mullen Grain Marketing and Production Research Center, Agricultural Re-
search Service, U.S. Department of Agriculture, Manhattan, Kansas, U.S.A.
Wai-Kit Nip Department of Molecular Biosciences and Bioengineering, University of

Hawaii at Manoa, Honolulu, Hawaii, U.S.A.
Richard D. O’Brien Fats and Oils Consultant, Plano, Texas, U.S.A.
Alan R. Olsen Microanalytical Branch, U.S. Food and Drug Administration, Washing-
ton, D.C., U.S.A.
Thomas E. Osterberg General Mills, Golden Valley, Minnesota, U.S.A.
Andi Shau-mei Ou Department of Food Science, National Chung Hsing University,

Taichung, Taiwan
* Retired.

Thomas W. Phillips Department of Entomology and Plant Pathology, Oklahoma State
University, Stillwater, Oklahoma, U.S.A.
Alfred J. St. Cyr AIB International, Manhattan, Kansas, U.S.A.
Cheryl Santucci Ringger Foods, Inc., Gridley, Illinois, U.S.A.
Peggy Stanfield Dietetic Resources, Twin Falls, Idaho, U.S.A.
Bhadriraju Subramanyam Department of Grain Science and Industry, Kansas State

University, Manhattan, Kansas, U.S.A.
Michael D. Toews Department of Grain Science and Industry, Kansas State University,
Manhattan, Kansas, U.S.A.
Sherri B. Turnipseed Animal Drugs Research Center, U.S. Food and Drug Administra-
tion, Denver, Colorado, U.S.A.
Gregory A. Umland Ringger Foods, Inc., Gridley, Illinois, U.S.A.
Chun-Shi Wang Institute of Food Science and Technology, National Taiwan Univer-
sity, Taipei, Taiwan
Ping-Lieh Thomas Wang Fieldale Farms Corporation, Baldwin, Georgia, U.S.A.
Yu-Ping Wei Institute of Food Science and Technology, National Taiwan University,
Taipei, Taiwan
James Swi-Bea Wu Institute of Food Science and Technology, National Taiwan Uni-
versity, Taipei, Taiwan
Michael L. Zimmerman U.S. Food and Drug Administration, Albuquerque, New Mex-
ico, U.S.A.

1
An Overview of FDA’s Food
Regulatory Responsibilities
Y. H. HUI
Science Technology System, West Sacramento, California, U.S.A.
This chapter provides a summary of the legal requirements affecting manufacture and
distribution of food products within and those imported into the United States. The last
chapter in this book further expands the data. The United States Food and Drug Adminis-
tration (FDA) has provided a description of these requirements to the public at large. The
information has been translated into several languages and it is reproduced below with
some minor updating by the author.
The FDA regulates all food and food-related products, except commercially pro-
cessed egg products and meat and poultry products, including combination products (e.g.,
stew, pizza), containing 2% or more poultry or poultry products or 3% or more red meat
or red meat products, which are regulated by the United States Department of Agriculture’s
Food Safety and Inspection Service (FSIS). Fruits, vegetables, and other plants are regu-
lated by the that department’s Animal and Plant Health Inspection Service (APHIS) to
prevent the introduction of plant diseases and pests into the United States. The voluntary
grading of fruits and vegetables is carried out by the Agricultural Marketing Service
(AMS) of the USDA.
All nonalcoholic beverages and wine beverages containing less than 7% alcohol are
the responsibility of FDA. All alcoholic beverages, except wine beverages (i.e., fermented
fruit juices) containing less than 7% alcohol, are regulated by the Bureau of Alcohol,
Tobacco, and Firearms of the Department of Treasury.
In addition, the Environmental Protection Agency (EPA) regulates pesticides. The
EPA determines the safety of pesticide products, sets tolerance levels for pesticide residues
in food under a section of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and

publishes directions for the safe use of pesticides. It is the responsibility of FDA to enforce
the tolerances established by EPA.
Within the United States, compliance with the FD&C Act is secured through peri-
odic inspections of facilities and products, analyses of samples, educational activities,
and legal proceedings. A number of regulatory procedures or actions are available to
FDA to enforce the FD&C Act and thus help protect the public’s health, safety, and well-
being.
Adulterated or misbranded food products may be voluntarily destroyed or recalled
from the market by the shipper, or may be seized by U.S. marshals on orders obtained
by FDA from federal district courts. Persons or firms responsible for violation may be
prosecuted in the federal courts and if found guilty may be fined and/or imprisoned. Con-
tinued violations may be prohibited by federal court injunctions. The violation of an in-
junction is punishable as contempt of court. Any or all types of regulatory procedures
may be employed, depending upon the circumstances.
A recall may be voluntarily initiated by the manufacturer or shipper of the food
commodity or at the request of FDA. Special provisions on recalls of infant formulas are
in the FD&C Act. While the cooperation of the producer or shipper with FDA in a recall
may make court proceedings unnecessary, it does not relieve the person or firm from
liability for violations.
It is the responsibility of the owner of the food in interstate commerce to ensure
that the article complies with the provisions of the FD&C Act, the Fair Packaging and
Labeling Act (FPLA), and their implementing regulations. In general, these acts require
that the food product be a safe, clean, wholesome product and its labeling be honest and
informative.
The FD&C Act gives FDA the authority to establish and impose reasonable sanita-
tion standards on the production of food. The enclosed copy of Title 21, Code of Federal
Regulations, Part 110 (21 CFR 110) contains the current good manufacturing practice
(GMP) regulations for manufacturing, packing, and holding human food concerning per-
sonnel, buildings and facilities, equipment, and product process controls, which, if scrupu-
lously followed, may give manufacturers some assurance that their food is safe and sani-
tary. In 21 CFR 110.110, FDA recognizes that it is not possible to grow, harvest, and
process crops that are totally free of natural defects. Therefore, the agency has published
the defect actions for certain food products. These defect action levels are set on the basis
of no hazard to health. In the absence of a defect action level, regulatory decisions concern-
ing defects are made on a case-by-case basis.
The alternative to establishing natural defect levels in food would be to insist on
increased utilization of chemical substances to control insects, rodents, and other natural
contaminants. The FDA has published ‘‘action levels’’ for poisonous or deleterious sub-
stances to control levels of contaminants in human food and animal feed. However, a
court in the United States invalidated FDA’s action levels for poisonous or deleterious
substances on procedural grounds. In the interim we are using their ‘‘Action Levels for
Poisonous or Deleterious Substances in Human Food and Animal Feed’’ as guidelines
which do not have the force and effect of law. The Agency has made it clear that action
levels are procedural guidelines rather than substantive rules.
The FDA does not approve, license, or issue permits for domestic products shipped
in interstate commerce. However, all commercial processors, whether foreign or domestic,
of thermally processed low-acid canned foods (LACFs) packaged in hermetically sealed
containers, or of acidified foods (AF-), are required by regulations to register each pro-
cessing plant. In addition, each process for a LACF or AF must be submitted to FDA and
accepted for filing by FDA before the product can be distributed in interstate commerce.
A low-acid food is defined as any food, other than alcoholic beverages with a fin-
ished equilibrium pH greater than 4.6 and a water activity greater than 0.85. Many canned
food products are LACF products, and packers are therefore subject to the registration
and processing filing requirements. The only exceptions are tomatoes and tomato products
having a finished equilibrium pH less than 4.7. An acidified food is a low-acid food to
which acid(s) or acid food(s) are added resulting in a product having a finished equilibrium
pH of 4.6 or below.
The FDA’s LACF regulations require that each hermetically sealed container of a
low-acid processed food shall be marked with an identifying code that shall be perma-
nently visible to the naked eye. The required identification shall identify, in code, the
establishment where the product is packed, the product contained therein, the year and
day of the pack, and the period during the day when the product was packed [21 CFR
113.60(c)]. There is no requirement that a product be shipped from the United States
within a stipulated period of time from the date of manufacture. If a LACF or AF is
properly processed, it would not require any special shipping or storage conditions.
Regulations require that scheduled processes for LACFs shall be established by
qualified persons having expert knowledge of thermal processing requirements for low-
acid foods in hermetically sealed containers and having adequate facilities for making
such determinations (21 CFR 113.83). All factors critical to the process are required to
be specified by the processing authority in the scheduled process. The processor of the
food is required to control all critical factors within the limits specified in the scheduled
process.
The FDA has the responsibility to establish U.S. identity, quality, and fill of con-
tainer standards for a number of food commodities. Food standards, which essentially are
definitions of food content and quality, are established under provisions of the FD&C Act.
Standards have been established for a wide variety of products. These standards give
consumers some guarantee of the kind and amount of major ingredients in these products.
A food which purports to be a product for which a food standard has been promulgated
must meet that standard or it may be deemed to be out of compliance and, therefore,
subject to regulatory action.
Amendments to the FD&C Act establish nutrient requirements for infant formulas
and provide FDA authority to establish good manufacturing practices and requirements
for nutrient quantity, nutrient quality control, recordkeeping, and reporting. Under these
amendments, FDA factory inspection authority was expanded to manufacturer’s records,
quality control records, and test results necessary to determine compliance with the FD&
C Act.
The FDA has mandated Hazard Analysis Critical Control Point (HACCP) proce-
dures for several food categories including seafood and selected fruit and vegetable prod-
ucts. Such procedures assure safe processing, packaging, storage, and distribution of both
domestic and imported fish and fishery products and fruit and vegetable products. The
HACCP system allows food processors to evaluate the kinds of hazards that could affect
their products, institute controls necessary to keep hazards from occurring, monitor the
performance of the controls, and maintain records of this monitoring as a matter of routine
practice. The purpose is to establish mandatory preventative controls to ensure the safety
of the products sold commercially in the United States and exported abroad. The FDA will
review the adequacy of HACCP controls in addition to its traditional inspection activities.
The food labeling regulations found in 21 CFR 101 and 105 contain the requirements
which when followed result in honest and informative labeling of food. Mandatory label-
ing of food includes a statement of identity (common or usual name of the product—21
(CFR 101.3); a declaration of net quantity of contents (21 CFR 101.105); the name and
place of business of the manufacturer, packer, or distributor (21 CFR 101.5); and, if fabri-
cated from two or more ingredients, each ingredient must be listed in descending order
of predominance by its common or usual name (21 CFR 101.4 and 101.6). Spices, flavor-
ing, and some coloring, other than those sold as such, may be designated as spices, flavor-
ing, and coloring without naming each. However, food containing a color additive that
is subject to certification by FDA must be declared in the ingredients statement as con-
taining that color.
On January 6, 1993, the FDA issued final rules concerning food labeling as mandated
by the Nutrition Labeling and Education Act (NLEA). These rules, which are included
in the enclosed food labeling booklet, significantly revise many aspects of the existing
food labeling regulations, mainly nutrition labeling and related claims for food. The NLEA
regulations apply only to domestic food shipped in interstate commerce and to food prod-
ucts offered for import into the United States. The labeling of food products exported to
a foreign country must comply with the requirements of that country.
If the label on a food product fails to make all the statements required by the FD&
C Act, the FPLA, and the regulations promulgated under these acts, or if the label makes
unwarranted claims for the product, the food is deemed to be misbranded. The FD&C
Act provides for both civil and criminal action for misbranding. The FPLA provides for
seizure and injunction. The legal responsibility for full compliance with the terms of each
of these acts and their regulations, as applied to labels, rests with the manufacturer, packer,
or distributor when the goods are entered into interstate commerce. The label of a food
product may include the Universal Product Code (UPC) as well as a number of symbols
which signify that (1) the trademark is registered with the U.S. Patent Office; (2) the
literary and artistic content of the label is protected against infringement under the copy-
right laws of the United States; and (3) the food has been prepared and/or complies with
dietary laws of certain religious groups. It is important to note that neither the UPC nor
any of the symbols mentioned are required by, or are under the authority of, any of the
acts enforced by the U.S. Food and Drug Administration.
The FD&C Act requires premarket approval for food additives (substances whose
use results or may reasonably be expected to result, directly or indirectly, either in their
becoming a component of food or otherwise affecting the characteristics of food). The
approval process involves a very careful review of the additive’s safety for its intended
use. Following the approval of a food additive, a regulation describing its use is published
in the Code of Federal Regulations. As defined in the CFR, the term safe or safety ‘‘means
there is a reasonable certainty in the minds of competent scientists that the substance is
not harmful under the intended conditions of use. It is impossible in the present state of
scientific knowledge to establish with complete certainty the absolute harmlessness of the
use of any substance. Premarket clearance under the FD&C Act does assure that the risk
of adverse effects occurring due to a food additive is at an acceptably small level.
The FDA’s regulation of dietary supplements is under the authority of the Dietary
Supplements Health and Education Act of 1994. It ensures that the products are safe and
properly labeled and that any disease or health-related claims are scientifically supported.
The legal provisions governing the safety of dietary supplements depend on whether the

product is legally a food or a drug. In either instance the manufacturer is obligated to
produce a safe product. Premarket safety review by FDA is required for new drugs.
The label of a dietary supplement is to state what the product contains, how much
it contains, how it should be used, and precautions necessary to assure safe use with all
other information being truthful and not misleading. If the dietary supplement is a food,
a review of any disease or health-related claim is conducted under the NLEA health claim
provisions.
This book presents an important aspect of the stated requirements: the sanitation of
an establishment that manufactures and distributes processed food.

2
Foodborne Diseases in the United
States
P. MICHAEL DAVIDSON
University of Tennessee, Knoxville, Tennessee, U.S.A.
I. INTRODUCTION
While food is an indispensable source of nutrients for humans, it is also a source of micro-
organisms. Microorganisms in foods may be one of three types: beneficial, spoilage, or
pathogenic. Beneficial microorganisms include those that produce new foods or food in-
gredients through fermentations (e.g., lactic acid bacteria and yeasts) and probiotics. The
second type are those that cause spoilage of foods. Spoilage may be defined as an undesir-
able change in the flavor, odor, texture, or color of food caused by growth of microorgan-
isms and ultimately the action of their enzymes. The final group are those microorganisms
that cause disease. These microorganisms may grow in or be carried by foods. There are
two types of pathogenic, or disease-causing, microorganisms: those causing intoxications
and those causing infections. Intoxications are the result of a microorganism growing and
producing toxin in a food. It is the toxin that causes the illness. Infections are illnesses that
result from ingestion of a microorganism. Infectious microorganisms may cause illness by
production of enterotoxins in the gastrointestinal tract or adhesion and/or invasion of the
tissues. There are various types of pathogenic microorganisms that may be transmitted
by foods including bacteria, viruses, protozoa, and helminths (Table 1). Certain molds
(fungi) may also produce toxins (mycotoxins) in foods that are potentially toxic, carcino-
genic, mutagenic, or teratogenic to humans and animals. Sources of these pathogenic mi-
croorganisms include soil, water, air, animals, plants, and humans.
The U.S. Centers for Disease Control and Prevention (CDC) estimates that there
are 6.5 to 76 million cases of foodborne illness per year in the United States [1]. The
actual number of confirmed cases documented by CDC is much lower (Table 2). The
reason for the difference in estimated and confirmed cases is that foodborne illnesses are
Table 1 Primary Microbial Pathogens Associated with Food Products
Bacteria Protozoa Nematodes Viruses

Aeromonas hydrophila Cryptosporidium parvum Trichinella spiralis Hepatitis A
Bacillus cereus Cyclospora cayetanensis SRSV
Campylobacter jejuni Giardia lamblia Calicivirus
Clostridium botulinum Toxoplasma gondii Astrovirus
Clostridium perfringens
Escherichia coli
Listeria monocytogenes
Salmonella
Shigella
Vibrio cholerae
Vibrio parahaemolyticus
Vibrio vulnificus
Yersinia enterocolitica
often self-limited and non–life threatening. Therefore, affected persons often do not seek
medical attention and their illnesses are not documented. To improve foodborne illness
surveillance, CDC began a program in 1996 called FoodNet. Initially, surveillance in-
cluded laboratory-confirmed cases of Campylobacter, Escherichia coli O157, Listeria
monocytogenes, Salmonella, Shigella, Vibrio, and Yersinia enterocolitica infections by clin-
ical laboratories in Minnesota, Oregon, and selected counties in California, Connecticut,
and Georgia. In 1997, surveillance was expanded to include Cryptosporidium and Cyclo-
spora cayetanensis. By 2000, the surveillance area expanded to include all of Connecticut
and Georgia and counties in Maryland, New York, and Tennessee. The FoodNet surveil-
lance population is 29.5 million persons and represents 10.8% of the U.S. population.
Cases represent isolation of a pathogen from a person by a clinical laboratory and are not
necessarily linked to food sources. Data for the entire period of FoodNet surveillance are
shown in Table 3.
Disease incidence is related to susceptibility of the consuming population. Subpopu-
lations at increased risk for foodborne illness include individuals under 5 years of age,
Table 2 Confirmed Cases and Deaths in the United States as Reported by the
United States Centers for Disease Control and Prevention, 1973–1997
Bacteria Outbreaks Cases Deaths

Bacillus cereus 93 2,247 0
Campylobacter 106 2,821 5
Clostridium botulinum 304 683 59
Clostridium perfringens 287 18,807 13
Escherichia coli 103 4,691 12
Listeria monocytogenes — 323 70
Salmonella 1,696 109,651 139
Shigella 172 20,742 4
Staphylococcus aureus 459 20,339 5
Vibrio species 46 1,561 14
Source: Refs. 6, 7, 8.

Table 3 Illnesses per 100,000 Population Detected by the Centers for Disease Control
and Prevention’s Foodborne Active Surveillance Network (FoodNet) in the United States,
1996–2000
Microorganism 1996 1997 1998 1999 2000 Change

Campylobacter 23.5 25.2 21.4 17.5 20.1 ⫺3.4
Cryptosporidium NR 3.7 2.9 1.8 2.4 —
Cyclospora NR 0.4 0.1 0.1 0.1 —
Escherichia coli O157 2.7 2.3 2.8 2.1 2.9 ⫹0.2
Listeria monocytogenes 0.5 0.5 0.6 0.5 0.4 ⫺0.1
Salmonella 14.5 13.6 12.3 13.6 12.0 ⫺2.5
Shigella 8.9 7.5 8.5 5.0 11.6 ⫹2.7
Vibrio 0.2 0.3 0.3 0.2 0.3 ⫹0.1
Yersinia 1.0 0.9 1.0 0.8 0.5 ⫺0.5
Source: Ref. 12.
over 60 years of age, immunocompromised individuals, those with chronic diseases, AIDS
patients, and pregnant females. The immunocompromised include persons receiving im-
mune suppressive drug treatments or antibiotic therapies and organ transplant patients.
Chronic diseases predisposing persons to foodborne illness may include diabetes; asthma;
and heart, liver, and intestinal diseases [1].
II. BACTERIAL FOODBORNE DISEASES

A. Aeromonas hydrophila
This microorganism occurs widely in nature, especially in water. As a result of its occur-
rence in water, it is also found in foods. The microorganism has been isolated from raw
milk, cheese, ice cream, poultry, meats, fresh vegetables, finfish, oysters, and other sea-
foods [2]. Aeromonas hydrophila is a facultatively anaerobic, gram-negative rod that is
motile with a polar flagellum. The microorganism has a temperature range of 4–5°C up
to 42–43°C with an optimum of 28°C [2]. The pH range is 4.5–9.0 and the maximum
concentration of salt for growth is 4%. It is pathogenic to fish, turtles, frogs, snails, alliga-
tors, and humans. Evidence suggests that A. hydrophila causes gastroenteritis in humans
and infections in persons immunocompromised by treatment for cancer. Aeromonas hy-
drophila forms hemolysins, enterotoxins, and cytotoxins, all of which could be related to
its pathogenicity. The microorganism has a D48°C of 5.2 min in saline and 4.3 min in raw
milk with a z value of 6.21°C [2].
B. Bacillus cereus
Bacillus cereus is a gram-positive, aerobic, sporeforming, rod-shaped bacteria. Most
strains have an optimum temperature for growth of 30°C and a range of 15–55°C. Some
strains are psychrotrophic and able to grow at 4–6°C. The normal habitat and/or distribu-
tion for B. cereus is dust, water, and soil. The bacterium may be found in many foods
and food ingredients. Some other species of Bacillus have been associated with foodborne
illness, including B. thuringiensis, B. subtilis, B. licheniformis, and B. pumilis [3].
Because the microorganism is a sporeformer, it is heat resistant. Most spores are
of moderate heat resistance (D121°C of 0.3 min) but some have high heat resistance (D121°C
of 2.35) [3,4]. The pH range for the microorganism is 5.0–8.8 and the water activity
minimum is 0.93 depending upon acidulant and humectant, respectively.
Bacillus cereus produces two types of gastroenteritis: emetic and diarrheal. The
diarrheal syndrome (also called C. perfringens–like) is caused by an enterotoxin that is
a vegetative growth metabolite formed in the intestine. The toxin is a protein (50 kDa)
that is heat labile (56°C, 5 min) and trypsin sensitive. The illness onset for this syndrome
is 8–16 hr and it has a duration of 6–24 hr. The symptoms include nausea, abdominal
cramps, and diarrhea. Foods associated with the diarrheal syndrome include cereal dishes
(corn and corn starch), mashed potatoes, vegetables, minced meat, liver sausage, meat
loaf, milk and milk products, some rice dishes, puddings, and soups. The number of cells
required for outbreak of this type of syndrome is 5–7 log CFU (colony forming unit) per
gram of food [3].
The emetic syndrome (also called S. aureus–like) is caused by a cyclic polypeptide
toxin which is much smaller (5000 Da) and may be preformed in certain foods [3]. As
opposed to the diarrheal toxin, the emetic toxin is heat (⬎90 min at 121°C) and trypsin
stable. The illness onset is very short, from 1 to 6 hr and the duration is ⬍24 hr. Symptoms
include nausea and vomiting (more severe than diarrheal). The illness is not generally
fatal, although there was a report of liver failure associated with the illness [5]. Foods
associated with B. cereus emetic syndrome include primarily boiled or fried rice along
with pasta, noodles, mashed potatoes, and vegetable sprouts. The number of cells required
for an outbreak is ca. 8 log CFU/g.
From 1983 to 1997, there were 93 confirmed outbreaks and 2247 cases of B. cereus
foodborne illness [6–8] in the United States. Most outbreaks involved Chinese food or
fried rice.
C. Campylobacter
Campylobacter jejuni was first recognized in 1913 as a disease in sheep and cattle. It was
originally called Vibrio fetus. The human pathogens that are foodborne include C. jejuni,
C. coli, C. lari, and C. upsaliensis [9]. The most common foodborne pathogens (⬎90%
cases) are C. jejuni, C. coli, and C. lari. Campylobacter is a gram-negative, nonsporeform-
ing, vibroid (helical, S-shaped, gull wing–shaped) rod (0.2–0.5 µm ⫻ 1.5–5.0 µm). It is
motile by a single polar flagellum. The microorganism is microaerophilic requiring 5% O2
and 10% CO2 [9]. The temperature for growth ranges from 30 to 45.5°C and its optimum is
37–42°C. The microorganism is associated with warm-blooded animals, especially poul-
try, and can be found in raw milk, insects, and water.
Campylobacter jejuni is not extremely tolerant to environmental stresses. It survives
to a maximum sodium chloride level of ⬍3.5% and is inhibited by 2.0%. It has a very
low heat resistance. Heat injury occurs at 46°C and inactivation at 48°C. The microorgan-
ism has a D55°C of 0.64–1.09 min in 1% peptone and 2.12–2.25 min in chicken [4]. The
pH range for growth of the microorganism is 4.9–9.0. Campylobacter jejuni survives for
2 weeks in milk at 4°C or water and meat at ⫺25°C.
Campylobacter jejuni causes a gastroenteritis called campylobacteriosis that has an
onset time of 2–5 days and has primary symptoms of severe diarrhea and abdominal pain.
Fever and headache may also be present. The duration is ⬍1 week without treatment and
the mortality rate is very low. An infectious dose may be as low as 500 cells [9]. The
primary targets for C. jejuni are infants and young children under 5 years and those 20–
40 years old. Complications and sequelae of campylobacteriosis include relapse (5–10%),
bacteremia, acute appendicitis, meningitis, urinary tract infections, endocarditis (primarily
C. fetus), peritonitis, Reiter’s syndrome (see Sec. II.I) and Guillain–Barré Syndrome. The
latter occurs in 0.2–2 cases per 1000 cases of campylobacteriosis and involves paralysis
and demyelination of nerves [10]. The mechanism of pathogenicity is not entirely clear
but may involve attachment, invasion of intestinal epithelia, and/or enterotoxin formation.
Most cases of campylobacteriosis are sporadic, i.e., not associated with an outbreak.
There have been few outbreaks documented by CDC. From 1973–1987, there were 53
outbreaks, 1547 cases, and two deaths in the United States [6]. From 1988–1997, there
were also 53 outbreaks with 1274 cases and three deaths [7,8]. While there are a low
number of confirmed cases of campylobacteriosis, the epidemiological estimate of cases in
the United States is 2.5 million annually [11], making it the most prevalent food poisoning
microorganism. The FoodNet surveillance system revealed that campylobacteriosis occurs
at a rate similar to or higher than salmonellosis (see Table 3) [12]. Foods involved in
outbreaks of campylobacteriosis have primarily been raw milk. Up to 70% of sporadic
cases are associated with cross-contaminated or undercooked or raw poultry. Cross-
contamination occurs due to transfer of the microorganism to uncooked foods via contami-
nation of surfaces or food workers’ hands.
D. Clostridium botulinum
The illness botulism was first recognized around 900 AD. Emperor Leo VI of Byzantium
forbade consumption of blood sausage because of its relationship to illness [13]. Before
it was recognized as a microbial illness, botulism was termed ‘‘sausage poisoning’’ as
the illness and deaths were first associated with sausage. In fact, the term botulus is Latin
for sausage. The microorganism associated with the illness was first identified in 1897 by
E. Van Ermingem and named Bacillus botulinus.
The microorganism is a motile gram-positive rod that is a strict anaerobe. It is a
sporeforming bacterium with oval to cylindrical, terminal to subterminal spores. There
are four groups of C. botulinum (I, II, III, IV) based on physiological and phylogenetic
relationships containing seven strains that produce antigenically different types of toxins
(A through G) [14]. Groups I and II, types A, B, and E are most common in human
disease. The habitat of the microorganism is soil or water. Type A is often found in western
U.S. soils, while type B is more often found in the eastern United States. Type E is primar-
ily of marine origin.
The optimal temperature for growth of C. botulinum is 30–40°C. Temperature
ranges depend upon type, with A, B, and F at 10–50°C and type E at 3.3–45°C. The
spore heat resistance of C. botulinum is very high. Type A spores have a maximum identi-
fied D121°C of 0.21 min in phosphate buffer, pH 7. The heat resistance of type A C. botuli-
num spores in other heating media is shown in Table 4. Type B spores (proteolytic, group
I) have a D110°C of 1.19–2.0 min in phosphate buffer, pH 7.0, while nonproteolytic (group
II) strains have a D82.2°C of 1.49–73.61 min. Type E spores are the least resistant, with a
D80°C of 0.78 min in oyster homogenate and a D82.2°C of 0.49–0.74 min in crab meat [4].
The pH minima for types A, B, and E are within 4.7–4.8. The water activity minima are
0.94 for types A and B and 0.97 for type E.
The foodborne illness termed botulism is an intoxication. The onset time is 12–36
hr, and the symptoms are blurred or double vision, dysphagia (difficulty swallowing),
Table 4 Heat Resistance of Clostridium botulinum Strain 62A (Type A)
Spores at 110°C
Product D value (min) z value (°C)

Asparagus, canned, pH 5.04 1.22 8.8
Asparagus, canned, pH 5.42 0.61 7.9
Corn, canned 1.89 11.6
Macaroni creole, pH 7.0 2.48 8.8
Peas, puree 1.98 8.3
Peas, canned, pH 5.24 0.61 7.6
Peas, canned, pH 6.0 1.22 7.5
Spanish rice, pH 7.0 2.37 8.6
Spinach, canned, pH 5.37 0.61 8.4
Spinach, canned, pH 5.39 1.74 10.0
Squash 2.01 8.2
Tomato juice, pH 4.2 1.50–1.59a 9.43
Tomato juice, pH 4.2 0.92–0.98 —
Phosphate buffer, M/15, pH 7.0 0.88 7.6
1.74 10.0
1.34 9.8
1.6–1.9 8.1–9.2
1.01 9.1
Distilled water 1.79 8.5
a
Strain A16037
Source: Ref. 4.
general weakness, nausea, vomiting, dysphonia (confused speech), and dizziness. The
intoxication is due to a neurotoxin which first affects the neuromuscular junctions in the
head and neck. The toxin causes paralysis which progresses to the chest and extremities.
Death occurs when paralysis reaches the muscles of the diaphragm or heart. Duration of
the illness can be from 1 day to several months. A high proportion of patients require
respiratory therapy. Death occurs without treatment in 3–6 days. The mortality rate was
very high (30–65%) in the early part of the 20th century but has been reduced significantly
in recent years due to better detection and treatment. The treatment for botulism is adminis-
tration of an antitoxin. Its success depends upon timing since the toxin binds to myoneural
junctions irreversibly.
Clostridium botulinum toxins are proteins (150 kDa) produced by the cell as inactive
protoxins. These are activated to the toxic form by trypsin or bacterial proteases [14].
Clostridium botulinum toxin is one of the most toxic substances known; C. botulinum
type A produces 30,000,000 mouse LD50 /mg. The approximate human LD50 is 1 ng/kg.
The toxin is absorbed into bloodstream through respiratory mucous membranes or walls
of stomach or small intestine. It then enters the peripheral nervous system and attaches
at the myoneural junction blocking release of acetylcholine and causing paralysis of the
muscle. Heat resistance of the toxin is low, with 5 to 10 min at 80°C (type A) or 15 min
at 90°C (type B) required to inactivate.
Because of the seriousness of the illness, incidence statistics for the microorganism
have been kept for over 100 years. From 1899–1973, there were 274 outbreaks of botu-
lism, with the highest proportion of associated foods being vegetables, fish and fish prod-
ucts, and fruits. The same trend held in outbreaks from 1983–1992, with approximately
50% associated with vegetables and 19% fish and fish products. From 1988 to 1997, there
were 73 outbreaks involving 189 cases of C. botulinum food poisoning and 12 deaths
(6.3%) [7,8].
Foodborne botulism outbreaks have traditionally been associated with low-acid
canned vegetables and meats and vacuum-packaged fish and seafoods. Most outbreaks or
cases associated with low-acid foods are home-preserved. This is most likely due to insuf-
ficient heat processing during the home canning procedure. Recent outbreaks have been
associated with unique products that are primarily home-preserved products. Consumption
of home-canned jalapeno pepper hot sauce (type B toxin), baked potatoes, potato salad/
three bean salad, sauteed onions used to make patty melt sandwiches, garlic or roasted
vegetables in oil, home-pickled eggs, and uneviscerated fish have all led to outbreaks. The
outbreaks associated with potato salad and baked potato were due to baking the potatoes
in aluminum foil followed by severe temperature abuse. The aluminum foil caused the
atmosphere between the foil and potato to be anaerobic and allowed growth of the C.
botulinum. Two of the most famous commercial outbreaks involved underprocessed com-
mercially produced soup in 1971 which resulted in 1 death [15] and an outbreak of type
E C. botulinum in 1963 associated with smoked vacuum-packaged whitefish in Tennessee,
Kentucky, and Alabama that resulted in 17 cases and 5 deaths [13].
Infant botulism was first recognized in 1976 in California. Infants less than 1 year
old are susceptible to this illness. In adults, preformed C. botulinum toxin must be ingested.
In infants, if as few as 10–100 spores of C. botulinum are ingested, they may germinate
in the intestinal tract and produce toxin [14]. The illness occurs in infants most likely
because their intestinal microflora are not established enough to prevent C. botulinum
colonization. Types A and B are primarily involved. Symptoms of the illness are weakness,
loss of head control, and diminished gag reflex. Food sources for the illness are character-
ized by no terminal heat process and include honey and corn syrup.
E. Clostridium perfringens
Clostridium perfringens (formerly C. welchii) is a gram-positive, nonmotile, anaerobic
rod. Spores are present but difficult to demonstrate. The optimal temperature for growth
is 43–46°C (15–50°C range) [16]. Clostridium perfringens may be found in soil, water,
dust, air, and certain raw foods such as meats and spices. Clostridium perfringens spores
have a D90°C of 0.015–8.7 min in phosphate buffer, pH 7.0, and a D98.9°C of 31.4 min in
beef gravy [4]. The microorganism is not known to survive commercial sterilization for
low-acid canned foods. The pH range for growth of C. perfringens is 5–9, and the optimum
is 6–7. The minimum aw for growth is 0.95–0.97. The microorganism has a sodium chlo-
ride maximum of 7–8% and is inhibited by 5% [16]. Clostridium perfringens is relatively
sensitive to freezing. At ⫺15°C for 35 days, a greater than 99.9% kill occurs [17].
The gastroenteritis syndrome is an infection and is the result of an enterotoxin
formed in the intestine. Onset time is 8–24 hr and primary symptoms include diarrhea and
abdominal cramps. The duration is 12–24 hr and the mortality is low. The microorganism
produces a protein enterotoxin (35 kDa) during sporulation, and concentration of the toxin
is greatest immediately prior to cell lysis. Sporulation occurs at a high rate in the gut.
The number of cells to cause an illness is around 6–8 log CFU.
Clostridium perfringens accounts for approximately 10% of total food poisoning
outbreaks in the United States. From 1988–1997, the microorganism was associated with
97 CDC-confirmed outbreaks involving 6573 cases [7,8]. This number of cases was second
only to Salmonella. Foods associated with C. perfringens are primarily meat based. Beef,
turkey, and ethnic dishes with meat are all risks. A typical food poisoning outbreak sce-
nario would involve a meat dish, especially one with gravy or sauce, that is inadequately
heated to completely destroy spores. Inadequately cooling causes germination and out-
growth of the spores. Inadequate reheating (⬍75°C) allows survival of high numbers of
C. perfringens. A major problem locale is food service steam tables.
F. Escherichia coli
Escherichia coli was first described in 1885 by T. Escherich, who called it Bacterium coli
commune. Escherichia coli is a gram-negative, nonsporeforming rod which is motile with
peritrichous flagella. It is a facultative anaerobe. The temperature growth range is 15 to
45°C and the optimum is 37°C. One source of the pathogenic strains of the microorganism
is the gastrointestinal tract of warm-blooded animals. Tolerances are similar to generic E.
coli, with an optimum pH of 6.5–7 (with the exception of E. coli O157:H7; see following
discussion) and water activity minimum of 0.96.
Escherichia coli is classified by serotyping based upon the O antigen (heat stable
somatic; ⬎170 groups), K antigen (capsular; heat labile somatic; ⬎100 groups), and H
antigen (flagellar; 56 groups). There are at least five groups of pathogenic E. coli, including
enteropathogenic (EPEC), enterotoxigenic (ETEC), enteroinvasive (EIEC), enterohemor-
rhagic (EHEC), and enteroaggregative (EaggC). Disease manifestations vary with patho-
genic type.
Enteropathogenic E. coli involves primarily sporadic cases, and outbreaks are usu-
ally associated with neonatal or infantile diarrhea. The pathogenesis of neonatal and infan-
tile diarrhea involves colonization of the intestine, adherence, effacement, and invasion.
This probably causes most diarrhea. Some strains produce toxins and cytotoxins.
Enterotoxigenic E. coli causes traveler’s diarrhea. Onset time is 1–3 days and pri-
mary symptoms include abdominal cramps, diarrhea, headache, and moderate fever. The
duration is 24–72 hr and mortality rate is very low. The microorganism attaches to epithe-
lial cells and colonizes the epithelium. It produces heat-labile (LT) or heat-stable (ST)
enterotoxins that cause diarrhea. The heat labile enterotoxin (60°C, 30 min) has two sub-
units (A and B) and is an adenyl cyclase that increases cAMP. The heat stable enterotoxin
(100°C, 15 min) is a low molecular weight (2000 Da) peptide that is a guanylate cyclase.
Foods associated with ETEC outbreaks have included Brie cheese, turkey, salad vegeta-
bles, and seafood (Table 5) [18].
Enteroinvasive E. coli produces no enterotoxins but causes bloody diarrhea, cramps,
vomiting, fever, and chills. Onset time is 12–72 hours and the duration may be days to
weeks. The disease is similar to dysentery. The microorganism adheres and invades epithe-
lial tissue in the colon causing necrosis. One food involved in an outbreak was Brie cheese
contaminated by water used to clean cheesemaking equipment (Table 5).
Enterohemorrhagic E. coli includes various serotypes (O4:nonmotile, O11:NM,
O26:H11, O45:H2, O111:nonmotile, O111:H8, O104:H21, O145:nonmotile, O157:H7).
Primary symptoms of EHEC are diarrhea (often bloody) and abdominal cramps. The mi-
croorganism apparently originates in dairy cattle (healthy), deer, sheep, and water and is
also transmitted person to person. Escherichia coli O157:H7 is unique among the E. coli
in that it survives low pH very well. The optimal temperature for the microorganism is
30–42°C and it does not grow at 44.5°C. The minimal temperature for growth is 8–10°C.
The heat resistance of the microorganism is D64.3°C of 9.6 sec. It survives freezing well.
Table 5 Selected Outbreaks of Escherichia coli Associated Foodborne Illnesses
Date Location Cases Type Food Notes

1971 Several U.S. states 387 EIEC (O124:B17) Imported brie and camembert Source: contaminated water
cheese
1982 MI, OR 47 EHEC Ground beef Fast-food outlet
1983 DC, IL, WI, GA, CO 169 ETEC (O27:H20) Brie cheese
1984 NE 34 (4 deaths) EHEC (O157:H7) Ground beef Nursing home
1984 ME 42 ETEC Seafood
1990 ND 70 (2 HUS) EHEC Roast beef
1993 WA, ID, NV, CA 582 (5 deaths) EHEC Ground beef Undercooked, served at fast-
food outlet
1993 NH 8 ETEC Salad
1993 RI 47 ETEC Salad
1994 WA, CA 23 EHEC Salami
1994 Scotland 100 (1 death) EHEC Pasteurized milk
1995 TN, GA 10 EHEC Ground beef Undercooking or cross-contam-
ination
1996 Western U.S. EHEC Unpasteurized apple cider Dropped apples; Deer contami-
nation?
1996 Japan ⬎6,000 EHEC Radish sprouts
1996 Scotland 501 (21 deaths) EHEC Cooked meat, gravy
1997 MI, VA ⬃80 EHEC Alfalfa sprouts
1997 CO 15 EHEC Ground beef
Source: Refs. 18, 27, 44–49.

The illness caused by EHEC has an onset time of 12–60 hr. The duration of the illness
may be 2–9 days with an average of 4 days. A sequelae that occurs in 2–7% of patients
(most often younger age groups and the elderly) is development of hemolytic uremic
syndrome (HUS), characterized by hemolytic anemia, thrombocytopenia, and renal failure.
Damage to renal endothelial cells is caused by blood clotting in the capillaries of kidney
and accumulation of waste products in blood, which results in a need for dialysis. The
death rate associated with HUS is 3–5%. Thrombotic thrombocytopenic purpura is an
involvement of the central nervous system that occurs primarily in elderly adults. This
can lead to blood clots in the brain. The infectious dose of EHEC for susceptible persons
is estimated to be as low as 2 to 2000 cells [19]. The site of attack is the colon with
bloody diarrhea occurring due to attachment and effacement of cells. Enterohemorrhagic
E. coli produces Shiga toxin I (Stx I), also known as verocytotoxin or verotoxin (70 kDa),
and Shiga toxin II. The former is a protein with two subunits, A and B. Stx I A subunit
(32 kDa) cleaves a specific adenine residue from 28S subunit of rRNA and inhibits protein
synthesis. Stx I B subunit (5 per molecule, 7.7 kDa each) binds to galactose α-(1-4)-
galactose-β-(1-4)-glucose ceramide (Gb3) receptors [19]. Kidney endothelial cells and
colon endothelial cells are both high in these receptors. Foods implicated have included
ground beef, roast beef, raw milk, apple cider, meat sandwiches, mayonnaise, lettuce, dry
salami, as well as person-to-person transmission and from domestic animals to persons.
Enteroaggregative E. coli is a recognized agent of watery mucoid diarrhea, espe-
cially in children. It is associated with persistent diarrhea of ⬎14 days. The microorganism
is thought to adhere to the intestinal mucosa and produce enterotoxins and cytotoxins [20].
There have been numerous outbreaks of all types of pathogenic E. coli (Table 5).
Confirmed outbreaks, cases, and deaths associated with unspecified types of pathogenic
E. coli in 1973–1997 were 103, 4691, and 12, respectively [6–8]. The FoodNet surveil-
lance system has shown that E. coli O157 occurs in the United States at a rate of 2.9
cases per 100,000 population (Table 3) [12].
G. Listeria monocytogenes
That L. monocytogenes may infect humans and animals was recognized as early as the
1910s. However, the microorganism was only recognized as a food-transmitted pathogen
in 1981, possibly owing to difficulty in isolation and identification.
Listeria monocytogenes are nonsporeforming, gram-positive rods that are faculta-
tively anaerobic to microaerophilic (5–10% CO2). The microorganism is motile via peritri-
chous flagella at 20–25°C, but not at 37°C [21]. It has an optimal growth temperature of
30–37°C and a 3–45°C range. Because it can grow relatively well at low temperatures,
the microorganism is known as a psychrotroph. Listeria monocytogenes is truly ubiquitous
in that it can be found in many places. It occurs in human carriers (1–10% of the popula-
tion), healthy domestic animals, normal and mastitic milk, silage (especially improperly
fermented, i.e., high pH), soil, and leafy vegetables. The microorganism is very tolerant
to environmental stresses compared to other vegetative cells. Listeria monocytogenes has
a high vegetative cell heat resistance (Table 6), but is not known to survive pasteurization
of milk. It grows in ⬎10% salt and survives in saturated salt solutions. It has a pH range
for growth of 5–9. Human listeriosis may be caused by any of 13 serotypes of L. monocyto-
genes, but the majority of cases are due to 1/2a, 1/2b and 4b [21].
Listeriosis causes an estimated 2500 serious illnesses and 500 deaths in the United
States each year [22]. Listeria often may pass through the digestive systems of healthy
Table 6 Heat Resistance of Listeria monocytogenes
in Selected Products
Product D60°C value (min)

Ground meat 3.12
Ground meat, cured 16.7
Fermented sausage 9.2–11
Roast beef 3.5–4.5
Beef 3.8
Beef homogenate 6.27–8.32
Naturally contaminated beef 1.6
Weiner batter 2.3
Chicken leg 5.6
Chicken breast 8.7
Chicken homogenate 5.02–5.29
Carrot homogenate 5.02–7.76
Raw milk, raw skim milk, D52.2 ⫽ 24.08–52.8
raw whole milk, cream D57.8 ⫽ 3.97–8.17
D63.3 ⫽ 0.22–0.58
D66.1 ⫽ 0.10–0.29
Source: Ref. 4.
people, causing only mild, flulike symptoms or without causing any symptoms at all. The
main target populations for listeriosis include pregnant women (or more precisely their
fetuses), immunocompromised persons, persons with chronic illnesses, and elderly per-
sons. Antacids or laxatives may predispose persons to listeriosis if given in large doses
[21]. Most cases of listeriosis are sporadic.
Foodborne illness caused by L. monocytogenes in pregnant women can result in
miscarriage, fetal death, and severe illness or death of a newborn infant. Pregnant women
are most frequently infected in the third trimester [21]. The mother’s symptoms are
influenza-like (chills, fever, sore throat, headache, dizziness, low back pain, diarrhea).
During the illness the microorganism localizes in the uterus in the amniotic fluid resulting
in abortion, stillbirth, or delivery of an acutely ill baby. Once the fetus is aborted, the
mother becomes asymptomatic. In newborns infected with the microorganism, perinatal
septicemia involving the central nervous system, circulatory system, or respiratory system
or meningitis may occur. For other target groups, meningitis, meningoencephalitis, or
bacteremia are the most common outcomes [23]. It is not known why the microorganism
has an affinity for the central nervous system. In target populations the onset time for
listeriosis can be as short as 1 day or as long as 91 days. The illness has been successfully
treated with parenteral penicillin or ampicillin. In food-related human infections, L. mono-
cytogenes likely enters the host via intestinal epithelial cells or Peyer’s patches and are
phagocytized and transported to the liver where they cause infection. Several surface pro-
teins and enzymes, including internalin, listeriolysin O, and phosphatidylinositol phospho-
lipase C, are virulence factors.
The first recognized outbreak of foodborne listeriosis occurred in Nova Scotia in
1981. The outbreak was associated with coleslaw and resulted in 41 cases with 17 deaths,
primarily among infants. The cause of the outbreak was determined to be fertilizing cab-
bage with manure from sheep with listeriosis (circling disease). The cabbage was harvested
and placed in cold storage (4°C) for a long period, thereby selecting for L. monocytogenes.
In 1983, in Massachusetts, L. monocytogenes 4b in pasteurized milk was theorized to be
the source of an outbreak producing 49 cases (42 adults) and 14 deaths. The reason for
the outbreak was unknown as no defects were found in the pasteurization system, although
Listeria were present in a dairy herd supplying the milk processor. The largest outbreak
in the United States was in California in 1985 and implicated L. monocytogenes 4b in a
Mexican-style cheese called queso blanco. There were 142 cases and 48 deaths in the
outbreak. The cause was theorized to be due to use of raw milk in the cheese and/or
general contamination of the processing plant and workers. In 1997, there were 45 cases
of listeriosis due to contaminated chocolate milk [24]. In Switzerland, between 1983 and
1987, at least 122 cases and 34 deaths occurred due to consumption of Vacherin Mont
d’Or cheese. In France, in 1992, 279 cases, 22 abortions, and 63 deaths occurred because
of consumption of pork tongue in aspic contaminated with L. monocytogenes. Also in
France, in 1995, 17 cases, two stillbirths, and two abortions were associated with L. mono-
cytogenes contaminated Brie de Meaux soft cheese. In 1998–1999, at least 50 cases of
listeriosis were caused by consumption of hot dogs and/or deli meats contaminated with
L. monocytogenes 4b [25]. While there are few outbreaks of listeriosis, the illness occurs
at a rate of 0.4 cases per 100,000 population in the United States according to CDC
FoodNet (Table 3) [12].
Listeria monocytogenes accounted for the greatest number of food recalls in the
United States during the period 1993–1998 [26]. That is due to a zero tolerance policy
for the microorganism in many foods. Foods involved in the recalls have primarily in-
cluded dairy products (e.g., ice cream bars, soft cheeses), meats (hot dogs, etc.), shellfish,
and salads. In 2001, the FDA and the U.S. Department of Agriculture’s Food Safety and
Inspection Service released a draft risk assessment of the potential risks of listeriosis from
eating certain ready-to-eat foods and an action plan designed to reduce the risk of food-
borne illness caused by L. monocytogenes [22]. The agencies advised consumers to use
perishable precooked or ready-to-eat items as quickly as possible, clean refrigerators regu-
larly, and use a refrigerator thermometer to ensure that temperatures are 40°F to reduce
risk of listeriosis. For pregnant women, the elderly, and immunocompromised individuals,
they recommended avoidance of hot dogs or luncheon meats (unless heated until ‘‘steam-
ing hot’’), soft cheeses (e.g., feta, Brie or Camembert, blue-veined cheeses, queso blanco
fresco), refrigerated paté or meat spreads, refrigerated smoked seafood unless part of a
cooked dish, and raw milk.
H. Salmonella
Nontyphoid or foodborne illness associated Salmonella was first discovered in 1888 by
A. A. H. Gaertner in Germany. The microorganism caused an outbreak with 50 cases due
to consumption of raw ground beef (Salmonella serovar Enteritidis). Salmonella are gram-
negative, nonsporeforming rods that are motile by peritrichous flagella (except S. Pullorum
and S. Gallinarum, which are chicken pathogens). They are facultatively anaerobic. The
growth range for Salmonella is 5–47°C. Lowest growth temperatures observed were S.
Heidelberg at 5.3°C and S. Typhimurium at 6.2°C [27]. The optimal temperature for
growth of the microorganism is 37°C.
Salmonella are classified based upon biochemical characteristics, antigenic charac-
teristics, DNA homology, and electrophoretic patterns [28]. The latest classification
scheme recognizes two species: Salmonella bongori and Salmonella enterica. The latter
has six subspecies: arizonae, diarizonae, houteane, indica, salamae, and enterica. Salmo-
nella enterica ssp. enterica contains most of the serovars (1427) involved in foodborne
illness, including Dublin, Enteritidis, Heidelberg, London, Montevideo, Pullorum, Tennes-
see, Typhi, and Typhimurium [29].
Salmonella occur in the intestinal tract of animals such as birds, reptiles, farm ani-
mals, humans, and insects, in water, and in soil. They may also be found in animal feeds
and foods, including raw milk, poultry (up to 70%), raw meats, eggs, and raw seafood.
The pathogen generally has a pH range of 3.6–9.5 and an optimum of 6.5–7.5. The
minimum aw for growth is ca. 0.94. Salt concentrations of ⬎2% delay growth of the
microorganism. Salmonella is very tolerant of freezing and drying. The most heat resistant
serovar is S. Senftenberg with the following D values: D55°C ⫽ 24 min in microbiological
medium, D60°C ⫽ 6.25 min in 0.5% NaCl and 10.64 min in green pea soup, D65.5°C ⫽ 0.66
min in beef bouillon and 1.11 min in skim milk, D71.1°C ⫽ 1.2 sec in milk, and D90°C ⫽
30–42 min in milk chocolate [4]. Increased tolerance to various environmental stresses
has been demonstrated for Salmonella strains exposed to acid [30].
The nontyphoid foodborne illness caused by Salmonella is a gastroenteritis called
salmonellosis. It is classified as an infection. The onset time is 8–72 hr and duration is
ca. 5 days. The primary symptoms include nausea, vomiting, abdominal pain, headache,
chills, mild fever, and diarrhea. Salmonellosis may progress to septicemia or chronic se-
quelae such as ankylosing spondylitis, reactive arthritis, Reiter’s syndrome (see Sec. II.I)
or rheumatoid arthritis [28]. The mortality rate associated with the illness is low (⬍1%)
but is age dependent. The number of cells required to produce symptoms varies with
individual and strain and can be as low as 1 CFU/g of food or up to 7 log. It was estimated
that 6 cells per 65 g of ice cream caused a massive outbreak of salmonellosis in 1994
[31]. Populations at highest risk for Salmonella infections are infants, the elderly, and
those with chronic illnesses.
Salmonella cells attach to and invade gastrointestinal tissue in the small intestine.
Invasion of the intestinal epithelial cells triggers leukocyte influx and an inflammation.
Salmonella also produce an endotoxin, enterotoxin, and cytotoxin. The enterotoxin acti-
vates host adenyl cyclase resulting in diarrhea. Some serovars require plasmids for viru-
lence.
Epidemiological estimates suggest that there are 2 to 3 million cases of salmonellosis
annually in the United States [11]. Historically, salmonellosis has been associated with
the greatest number of confirmed foodborne illnesses, with 790 outbreaks and 55,864
cases from 1973 to 1987 [7]; 549 outbreaks, 21,177 cases, and 38 deaths from 1988–
1992 [6]; and 357 outbreaks, 32,610 cases, and 13 deaths from 1993–1997 [8]. The CDC’s
FoodNet has shown that salmonellosis is the second most prevalent foodborne illness (12–
14.5 cases per 100,000 population) behind campylobacteriosis (Table 3) [12]. Salmonella
Typhimurium and S. Enteritidis are the two serovars responsible for the greatest number
of cases.
Foods historically involved in salmonellosis outbreaks include eggs and egg prod-
ucts, poultry, meats, ice cream, and potato salad. The microorganism has recently been
involved in a number of outbreaks involving fruits and vegetables such as tomatoes, mel-
ons, and sprouts. The highest percentage of outbreaks occur in May, June, July, and August.
The largest outbreak of salmonellosis in U.S. history was in 1985 in the Chicago
area. The implicated food was pasteurized milk and the serovar isolated was Typhimurium.
There were an estimated 150,000 cases, ⬎16,000 culture-confirmed cases, 2777 hospital-
izations, and seven deaths. The suspected cause for the outbreak was a leaking valve
connecting the raw and pasteurized milk systems in a large milk processing operation.
Several outbreaks of salmonellosis have been associated with melon products, e.g. (year,
number of cases, causative agent, food): 1989, 295 cases, S. Chester, cantaloupe; 1991,
143 cases, S. Poona, cantaloupe; 1991, 39 cases, S. Javiana, watermelon. In each of these
cases it was suggested that the microorganism contaminated the outside of the melon and
the interior melon surface was inoculated when sliced. In some cases, these melons were
placed on salad bars in restaurants which had little or no temperature control. This allowed
the Salmonella to increase to infective levels over the course of the storage. In 1995, there
were 63 cases of salmonellosis in Florida caused by consumption of unpasteurized orange
juice contaminated with S. Hartford. A similar outbreak involving S. Muenchen in unpas-
teurized orange juice with over 200 cases occurred in Washington, Oregon, several other
U.S. states, and Canada in 1999 [32]. In 1994, another large outbreak with ca. 2000 docu-
mented cases (estimated ca. 224,000 cases nationwide) occurred involving S. Enteritidis
in commercially processed ice cream. The milk that was used to make the ice cream was
contaminated by raw eggs during transport in a tank truck [33]. Salmonella Enteritidis may
contaminate raw eggs in the ovaries of the hen. This is known as transovarian transmission.
Approximately 1 in 20,000 eggs is infected and the level of S. Enteritidis per egg is ca.
10–20 cells.
I. Shigella
Shigella are gram-negative, nonsporeforming rods that are weakly motile and lactose nega-
tive [34]. They are facultative anaerobes with a growth range of 6–48°C and an optimum
of 37°C. Four species of Shigella are grouped biochemically and on O antigens: S. dysen-
teriae (serogroup A), S. flexneri (serogroup B), S. boydii (serogroup C), and S. sonnei
(serogroup D). Shigella shares many similarities with EIEC. The microorganisms are pri-
marily of human origin and are spread to food by carriers and contaminated water. The
pH minimum for Shigella is 4.9 and its maximum is 9.3. The aw minimum for growth is
approximately 0.94 and the maximum salt concentration is ca. 4–5%. The microorganism
is not particularly heat resistant.
Shigella gastroenteritis, called shigellosis, or bacillary dysentery, is an infection with
an onset time of 1–4 days and a duration of 5–6 days. Primary symptoms are variable
but worst cases involve bloody diarrhea, mucus secretion, dehydration, fever, and chills.
The mortality rate is generally very low, but in susceptible populations (young, elderly,
immunocompromised) death may occur. Shigella dysenteriae causes the most and S. son-
nei the least severe symptoms. Shigella flexneri and S. boydii are intermediate in severity.
The number of cells to cause the illness is estimated at 10–100. A sequelae associated
with shigellosis is Reiter’s syndrome, also called reactive arthritis. Symptoms are swelling
of joints, conjunctivitis, and urethritis. It follows foodborne infection such as shigellosis,
salmonellosis, campylobacteriosis, or yersiniosis. Reiter’s patients have predisposition to
syndrome due to presence of histocompatibility antigen (HLA B27) [35]. In the sequelae,
bacteria attack the host cell causing production of antigen which reacts with HLA B27.
The site of Shigella attack is the colon. Cells attach to the epithelium, invade, and multiply
in the cells causing damage to the mucosal layer by inflammation and necrosis. Shigella
flexneri produces an enterotoxin (ShET1), while 80% of other Shigella produce another
enterotoxin (ShET2) [34]. Shiga toxin is an enterotoxin produced by S. dysenteriae Type I.
The estimate of annual cases of foodborne and waterborne shigellosis in the United
States is 90,000–150,000 [11]. Strains involved in U.S. cases are primarily S. sonnei (65%)
and S. flexneri (31%). Outbreaks, cases, and deaths associated with Shigella in the United
States have been as follows for the periods specified: 1961–1975, 72 outbreaks, 10,648
cases; 1973–1987, 104 outbreaks, 4488 cases, two deaths; 1988–1992, 25 outbreaks, 4788
cases, no deaths; and 1993–1997, 43 outbreaks, 1555 cases, no deaths [6–8,36]. According
to FoodNet, in 2000 there were 11.6 cases of Shigella foodborne illness per 100,000
population in the United States (Table 3) [12].
Foods most associated with shigellosis are those with a high degree of handling or
ones which could be contaminated by waterborne Shigella. The most implicated foods
are salads (potato, shrimp/tuna, chicken) and seafood/shellfish. Many outbreaks have oc-
curred in food service establishments such as hospital cafeterias and restaurants.
J. Staphylococcus aureus
Staphylococcus aureus was first shown to be associated with food in 1914 when M. A.
Barber implicated the microorganism in an illness associated with milk from a cow with
staphylococcal mastitis [37]. The microorganism presents as gram-positive cocci that grow
in clusters and is facultatively anaerobic. The growth range for S. aureus is 7–48°C, and
it has an optimal temperature of 37°C. A primary source for S. aureus in foods is humans.
The microorganism is carried in the nasal cavity, on the skin (arms, hands, face), and by
wounds (boils, carbuncles). Staphylococcus aureus may also be found in air and dust and
on clothing. It may be associated with mastitis infection in dairy cattle. The pH range for
S. aureus is 4.0–9.8 and its optimum is 6–7. It is uniquely tolerant to low water activities
with growth at a minimum of 0.86 and in the presence of ca. 20% salt [37].
Staphylococcus aureus gastroenteritis is an intoxication. It has a very short onset
time of around 4 hr (range 1–6 hr). Primary symptoms include nausea, vomiting, and
severe abdominal cramps (secondary symptoms: diarrhea, sweating, headache, prostration,
temperature drop). The duration is 24–48 hr and the mortality rate is very low.
Foods associated with S. aureus gastroenteritis are generally made by hand and
improperly refrigerated. The estimated cases per year are 1.1 to 1.5 million [11]. Docu-
mented numbers of cases are low owing to sporadic cases not being reported. From 1988–
1997, there were 92 CDC-confirmed outbreaks of S. aureus gastroenteritis involving 3091
cases and one death [7,8]. Foods involved in S. aureus outbreaks are shown in Table 7.
Table 7 Outbreaks of Staphylococcus aureus Foodborne Illness Associated

with Various Food Products
Food Product 1961–1973 1975–1981 1983–1992

Ham 137 57 16
Turkey 52 14 4
Chicken 50 10 1
Beef and pork 60 0 11
Dairy products 14 4 1
Baked goods 55 14 7
Eggs 17 0 1
Salads 31 34 10
Others 108 27 25
Total 578 194 76
Source: Refs. 6, 7.

Toxins produced by S. aureus are proteins of 26–30 kDa and are very resistant to
proteolytic enzymes (trypsin, chymotrypsin) and heat. Coagulase production and heat-
stable thermonuclease production by the microorganism are highly associated with toxin
production. There are ten serologically different forms of the toxin: staphylococcal entero-
toxin A (SEA), SEB, SEC1, SEC2, SEC3, SED, SEE, SEF, SEG, and SEH. The first named
is involved in more cases of foodborne illness than any of the other enterotoxins. The
toxins are extremely heat resistant. Over 27 min at 121°C are required to inactivate 5 µg/
mL SEA in beef bouillon and ⬎7 min at 121°C are required to inactivate an unspecified
amount in whole milk [4]. Relative thermal resistance of the enterotoxins is as follows:
SEA ⬎ SEB ⬎ SEC. In contrast to toxin heat resistance, the vegetative cells have a D65.5
of 2.0–15.08 min, depending upon suspending medium.
Production of toxin is favored by optimal growth conditions and the minimum water
activity for production is 0.90 (SEA). Production of SEA is less sensitive to pH than SEB.
The temperature range for production is 10–46°C and the optimum is 40°C. Minimal time
is 4–6 hr and sufficient production occurs during late log or stationary phases. The number
of cells necessary to produce enough toxin for symptoms (1 µg) is 1,000,000–10,000,000.
The maximal amount of toxin produced is 5–6 µg/mL. Toxin assay procedures are biologi-
cal methods (feeding to cats, rhesus monkeys, chimps), reversed passive latex agglutina-
tion (sensitivity of 1 ng/mL), and ELISA.
K. Vibrio
Several species of Vibrio are known foodborne pathogens, including V. parahaemolyticus,
V. cholerae, and V. vulnificus. This bacterium is a gram-negative, nonsporeforming,
straight to curved rod. Vibrio parahaemolyticus is motile by polar flagella, while V. chol-
erae and V. vulnificus may be nonmotile. All are facultative anaerobes. The growth range
for V. parahaemolyticus is 13–45°C and its optimum is 22–43°C. For V. cholerae the
temperature range is 10–43°C and the optimum is 37°C. The primary habitat for Vibrio
is seawater.
Vibrio parahaemolyticus has a pH range of 4.8–11 and an optimum of 7.8–8.6,
while the range and optimum for V. cholerae is 5–9.6 and 7.6 and for V. vulnificus is 5–
10 and 7.8. The water activity minima for each species are as follows: V. cholerae, 0.97;
V. parahaemolyticus, 0.94; and V. vulnificus, 0.96. Each species requires some amount
of NaCl. The optimum for each species is 0.5, 3, and 2.5%, respectively. The heat resis-
tance for each species depends upon heating medium. Vibrio cholerae has a D54°C of 1.04
min, 5.02 min, and 0.35 min in 1% peptone, crab meat homogenate, and oyster homoge-
nate, respectively [4]. Vibrio parahaemolyticus has a D55°C of 0.02–0.29 min and 2.5 min
in clam homogenate and crab homogenate, respectively. The heat sensitivity of V. vulnifi-
cus is similar to V. parahaemolyticus [4].
Vibrio parahaemolyticus gastroenteritis was first recognized in 1950. The onset time
is 8–72 hr with a median of 18 hr [38]. The primary symptoms include diarrhea and
abdominal cramps along with nausea, vomiting, and mild fever. The duration is 48–72
hr and the mortality rate is low. The number of cells required to initiate disease is around
5.0 to 7.0 log cells. More than 95% of stool isolates causing V. parahaemolyticus gastro-
enteritis produce a hemolysin to sheep or human red blood cells. Strains that produce the
hemolysin are termed kanagawa positive.
Vibrio cholerae has over 150 serogroups but only O1 and O139 have been linked

to epidemic cholera. The O1 serogroup has three serotypes and two biotypes. The sero-
types are known as Ogawa, Inaba, Hikojima. The O1 biotypes are classical and El Tor.
Classical has a negative Voges–Proskauer reaction, while El Tor’s is positive. In addition,
classical is nonhemolytic, while El Tor produces β-hemolysis on sheep blood [38]. Vibrio
cholerae O139 Bengal was first discovered in 1992 in India and Bangladesh and has a
biotype similar to O1 El Tor. Onset time for V. cholerae is 6 hr to 5 days. The primary
symptom is watery diarrhea (up to 1 L/hr), also called ‘‘rice water stools.’’ This condition
brings about severe dehydration, salt imbalance, and hypertension. Treatment is fluid and
electrolyte replacement. Antibiotic treatment may reduce volume and duration of diarrhea.
The infectious dose is 6 log depending upon the buffering capacity of the contaminated
food. The microorganism produces cholera enterotoxin (CT), a protein of 85 kDa which
has A and B subunits. The B subunits bind the cell membrane of the intestinal cells, and
the A subunit stimulates adenyl cyclase in the cells. This leads to increased cAMP in
the cell, increased chloride secretion, decreased NaCl absorption by the villus cells, and
electrolyte movement into the lumen of the intestine. The osmotic gradient produced re-
sults in water flow into the lumen and resultant diarrhea. Vibrio cholerae also has patho-
genic non-O1/O139 biotypes. These are nonepidemic and are associated with gastroenteri-
tis, soft tissue infections, and septicemia. The gastroenteritis syndrome has been highly
associated with consumption of contaminated raw oysters. The symptoms are diarrhea,
abdominal pain, and nausea.
Human illness caused by V. vulnificus has been associated primarily with consump-
tion of raw oysters. It may cause a soft tissue infection or septicemia, especially in immu-
nocompromised individuals. Individuals at risk for septicemia include persons with liver
or blood-related disorders such as alcoholic cirrhosis or hemochromatosis [38]. Other pre-
disposing conditions include use of immunosuppressive drugs and illnesses such as diabe-
tes, renal disease, and gastric diseases. The onset time is 7 hr to several days [38]. If
untreated, death can occur in 3–5 days and the mortality rate for the septicemia is 50%.
From 1973 to 1987, there were 31 confirmed outbreaks involving Vibrio (eight V.
cholerae, 23 V. parahaemolyticus) with 1462 cases and 12 deaths [6]. All deaths involved
V. cholerae. From 1988 to 1997, there were 15 outbreaks (five V. cholerae, nine V. para-
haemolyticus, one V. vulnificus), 99 cases and two deaths (one V. cholerae, one V. vulnifi-
cus) [7]. Vibrio parahaemolyticus is the leading cause of food poisoning in Japan. Foods
involved with confirmed outbreaks have been primarily fish and shellfish. Foods associated
with V. cholerae outbreaks have involved shrimp, raw oysters, crab, fish, and mussels.
L. Yersinia enterocolitica
Yersinia enterocolitica was first described in 1939 in New York and was named Bacterium
enterocoliticum. It is a gram-negative, nonsporeforming rod that is facultatively anaerobic.
Like L. monocytogenes, Y. enterocolitica is psychrotrophic with a growth range of ⫺2 to
45°C. Its optimal temperature range is 28–29°C. The microorganism may be found natu-
rally among swine, birds, cats, dogs, wild animals, raw milk, soil, and water. Pigs are
thought to be the primary source for serotypes pathogenic for humans. The bacterium has
a pH range of 4.2–9.6 and it tolerates high pH well. The bacterium has a D62.8°C of 0.01–
0.96 min in milk with a z value of 5.11–5.78°C [4].
The gastroenteritis caused by the microorganism is called yersiniosis. It has an onset
time of 3–7 days and a duration of 5–14 days. The symptoms include watery diarrhea,

vomiting, fever, and severe abdominal cramps. The illness mimics appendicitis and victims
may have appendectomies performed. The illness is rarely fatal. Reactive arthritis may
follow the primary illness. Clinical symptoms vary with age of the patient.
Pathogenic serotypes of Y. enterocolitica vary geographically. Serotype O8 is pre-
dominant in North America and is one of the more virulent strains. Its primary reservoir
is swine. Serotypes O3, O9, O5, and 27 are found in Japan, Europe, and Canada. A number
of avirulent strains exist. From 1973 to 1987 there were five CDC-documented outbreaks
of yersiniosis involving 767 cases and no deaths [6]. The FoodNet surveillance system
listed 0.5 cases of yersiniosis per 100,000 U.S. population in 2000, which was approxi-
mately 50% of the previous four years (Table 3) [12]. In a 1976 outbreak in New York,
222 children were made ill through consumption of chocolate milk. Eighteen unnecessary
appendectomies were performed on the children. Serotype O8 was implicated. In the out-
break, contaminated chocolate syrup was added to pasteurized milk. Eighty-seven cases
of yersiniosis occurred in 1982 in Washington state due to consumption of contaminated
tofu. Serotype O8 was implicated and the source of the microorganism was contaminated
water used in processing. In 1982, pasteurized milk was theorized to be the source of an
outbreak in Tennessee, Arkansas, and Mississippi. Serotype O13a,b was responsible for
172 cases and 17 appendectomies. It was suggested that pasteurized milk in plastic jugs
had become contaminated by plastic crates which had been stored on a hog farm and then
were used in a milk processing facility without washing.
III. MYCOTOXINS
Toxins may be produced by molds as secondary metabolites. They are formed when large
pools of primary metabolic precursors (e.g., amino acids, acetate, pyruvate, etc.) accumu-
late and are synthesized to remove primary precursors. Synthesis is initialized at the onset
of stationary phase and occurs with lipid synthesis.
Aflatoxins were the first mycotoxins discovered. In 1960, 100,000 turkey poults
died in England after eating peanut meal imported from Africa and South America. This
was called Turkey X disease. It was later determined that a toxin produced by Aspergillus
species was responsible for the turkey deaths. This toxin was named aflatoxin, from Asper-
gillus flavus toxin. The toxin is actually produced by A. flavus, A. parasiticus, and A.
nomius. The environmental conditions that influence production most appear to be temper-
ature and water activity. The optimal temperature for production is 24–28°C and the opti-
mal aw is 0.93–0.98.
There are several types of aflatoxins, including B1, B2, G1, G2, M1, and M2. The
mycotoxins are fluorescent under ultraviolet light and fluoresce blue (hence, B1 and B2),
green (G1 and G2) and blue, blue-violet (M1 and M2). The latter are produced in milk,
which is why they are designated by M. Toxicity of the aflatoxins is, in decreasing order,
B1 ⬎ M1 ⬎ G1 ⬎ B2 ⬎ G2, M2. Aflatoxins are hepatotoxic to birds, certain mammals,
and fish (trout) and are also carcinogenic to rats and trout. Aflatoxin B1 is acutely toxic
to humans and may be involved in liver cancer. The toxin is metabolized by animals to
the toxic dihydroxyaflatoxin and carcinogenic aflatoxin epoxide [39]. Foods in which afla-
toxin may be produced include peanuts, peanut butter, other nuts, fresh beef, ham, bacon,
milk, cheese (through contaminated feed to dairy cattle), beer, cocoa, raisins, soybean
meal, corn, rice, wheat, and cottonseed.
Many other mold genera produce mycotoxins in various foodstuffs (Table 8).

Table 8 Selected Mycotoxins, Mycotoxigenic Molds, Foods Associated with the Mycotoxin,
and Animals Affected and Illnesses
Toxin Mold Food Animal/illness

Fumonisins Fusarium moniliforme Corn Equine leucoencephalo-
malacia; porcine pul-
monary edema syn-
drome; lung edema
in pigs and horses;
poultry toxicity (im-
munosuppression),
human esophageal
cancer suspected
Ochratoxin A Aspergillus sp. (A. och- Grains, beans, peanuts, Pigs; humans (renal dis-
raceus), Penicillium citrus fruits, nuts, ease); nephrotoxic,
sp. (P. viridicatum, country-cured ham hepatotoxic, terato-
P. cyclopium, P. ver- genic, carcinogenic
rucosum)
Patulin Penicillium sp. (P. patu- Apples, apple products, Poultry; mammals (cat-
lum, P. claviforme, bread, sausage, other tle); fish; toxic, muta-
P. expansum), Asper- fruits, moldy feeds genic, carcinogenic,
gillus sp. (A. cla- teratogenic
vatus, A. terreus), By-
ssochlamys sp. (B.
fulva, B. nivea)
Sterigmatocystin Aspergillus versicolor, Cheese, wheat, oats, Hepatotoxic, carcino-
A. nidulans, A. rugu- coffee beans genic
losus
Zearalenone Fusarium grami- Corn, wheat, oats, bar- Reproductive and infer-
nearum, F. cul- ley, sesame tility problems in
morum poultry, swine, dairy
cattle, sheep
Source: Refs. 39, 50.
IV. VIRUSES
Diseases caused by foodborne viruses may be grouped as viral gastroenteritis or viral
hepatitis. The majority of viral gastroenteritis outbreaks are caused by small round struc-
tured viruses (SRSV), of which Norwalk/Norwalk-like virus, Snow Mountain, Montgom-
ery County, and Hawaii are members. To a lesser extent, astroviruses or caliciviruses may
be involved. Other enteric viruses, such as adenovirus and groups A and B rotaviruses
have not been fully demonstrated to be foodborne [40]. Viral hepatitis caused by hepatitis
A virus may also be carried by foods.
Illness caused by a Norwalk/Norwalk-like virus has an onset time of 1–2 days and
a duration of 1–6 days. Symptoms include severe nausea and vomiting. Secondary symp-
toms may be diarrhea, abdominal pain, headache, and low grade fever. Stools do not
contain blood, mucus, or white cells. The infectious dose is 10–100 virus particles [40].
Norwalk/Norwalk-like viruses are unaffected by low pH (ca. 3) and heat at 60°C for 30

min [4]. They are completely inactivated by free residual chlorine at 10 mg/L [4,40]. At
3.75 mg/L chlorine, the virus was only partially inactivated.
Calicivirus infection is characterized by diarrhea and vomiting following a 1–3 day
incubation period. Respiratory symptoms sometimes are evident. Infants and young chil-
dren are most commonly infected. Duration is ca. 4 days. Astrovirus infection has an onset
of 3–4 days. Primary symptoms include fever, diarrhea, headache, nausea, and malaise.
Neither calicivirus nor astrovirus is inactivated by low pH, but both are inactivated by 10
mg/L free residual chlorine [40].
Hepatitis A (infectious hepatitis) is characterized by a sudden onset of fever, nausea,
anorexia, and abdominal discomfort and is followed by jaundice. The onset is 1–7 weeks
with an average of 30 days. The illness is transmissible until 1 week after the appearance
of jaundice. The duration is 1–2 weeks up to months. All populations are susceptible but
the illness is more common in adults. Hepatitis is spread by infected food handlers or
fecal contamination of foods or food contact surfaces (fecal–oral route). Foods involved in
hepatitis A outbreaks include those that require significant handling, often in food service
situations, and those contaminated by polluted water. In 1997, an outbreak of hepatitis A
in Michigan was linked to consumption of strawberries imported from Mexico [41]. The
strawberries were thought to have been contaminated in the field. Other foods involved
in outbreaks are shellfish, salads, and deli foods. Hepatitis A virus is not inactivated by
low pH (ca. 3). At 60°C in buffer, the virus was reduced by 0.3 log (infective units) after
10 min, while at 80°C the reduction was 4.3 log [4]. It is inactivated by 70% ethanol and
10 mg/L free residual chlorine [40]. The virus showed a 90% decrease in viability in
mineral water at 4°C and room temperature after 519 days and 89 days, respectively [4].
V. PROTOZOA
Cryptosporidium parvum causes an illness known as cryptosporidiosis, which is transmit-
ted via fecal contamination of water or food. Onset time is 1–2 weeks and the duration
is 2 days to 4 weeks. The microorganism forms oocysts that are resistant to chlorine and
persist for long periods in the environment. Oocysts are susceptible to freezing, dehydra-
tion, high temperatures, and certain chemical sanitizers such as hydrogen peroxide, ozone,
and chlorine dioxide [42]. They may be removed from municipal drinking water supplies
by filtration. Symptoms include severe watery diarrhea, abdominal pain, and anorexia.
Surveillance for cases of cryptosporidiosis began in 1997 via the FoodNet surveillance
system of the CDC [12]. The incidence rate in 2000 for the illness was 2.4 cases per
100,000 population, which was down from a high of 3.7 cases in 1997 (Table 3).
Cyclosporiasis is caused by Cyclospora cayetanensis, a coccidian parasite that oc-
curs in tropical waters. The illness is characterized by watery diarrhea, abdominal cramps,
anorexia, weight loss, nausea, and vomiting. It has an onset of 1–11 days and lasts for
up to several weeks. The microorganism is carried by contaminated water and foodborne
outbreaks have been associated with raspberries, basil, and lettuce. According to CDC’s
FoodNet, cyclosporiasis occurs at a rate of 0.1 cases per 100,000 U.S. population and has
remained constant for three years (Table 3) [12].
Giardia lamblia, the causative agent of giardiasis, is one of the most common proto-
zoal infections of humans worldwide [42]. Several animal hosts may serve as reservoirs
for human infections. Human illnesses result from consumption of Giardia cysts through
poor hygiene (fecal–oral route), drinking contaminated water, or from infected food han-
dlers contaminating foods. High risk groups are infants, young children, and immunosup-
pressed individuals. Symptoms include diarrhea, cramps, and bloating. The onset is 5 to
24 days and the illness may last from several weeks to years.
Toxoplasma gondii is a protozoa that is the causative agent of toxoplasmosis. The
primary host for the microorganism is the cat. Humans may become infected by consuming
infected meat or water or contacting cat feces. Meat from lambs, poultry, and wild game
animals may serve as a source for the microorganism. In humans, the illness resembles
mononucleosis. Most infected newborns do not exhibit clinical symptoms, but mental
retardation may occur later in life [42]. Toxoplasmosis is sometimes seen in AIDS patients.
Temperatures of 61°C or higher for 3.6 min or freezing at ⫺13°C will inactivate oocysts
and cysts in meat [42].
VI. NEMATODES (ROUNDWORMS)

Trichinella spiralis is the organism that causes trichinosis. The illness is transmitted to
humans by consumption of infected meats of carnivores, including pork and wild game
such as bear and cougar. Dogs may also be infected. The majority of individuals infected
by Trichinella are asymptomatic [43]. Symptomatic illness begins with gastroenteritis
symptoms including nausea, vomiting, diarrhea, and fever. Onset is 72 hr and the infection
may last 2 weeks. Following initial symptoms, edema, muscle weakness, and pain occur
as the larvae migrate and encyst in the muscles. Respiratory and neurological manifesta-
tions may also occur. Without treatment, trichinosis may cause death. Prevention is
achieved by preventing contamination of meat or destroying the trichinae (encysted larvae)
in meat by cooking to 71°C, freezing meat less than 15 cm thick for 6 (⫺29°C) to 20
(⫺15°C) days, or applying irradiation [42].
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Science and Technology, 1989.

3
The FDA’s GMPs, HACCP, and the
Food Code
Y. H. HUI
WAI-KIT NIP
University of Hawaii at Manoa, Honolulu, Hawaii, U.S.A.
J. RICHARD GORHAM
Consultant, Xenia, Ohio, U.S.A.
I. INTRODUCTION
Nearly 25 years ago, the United States Food and Drug Administration (FDA) started the
approach of using umbrella regulations to help the food industries to produce wholesome
food as required by the Federal Food, Drug, and Cosmetic Act (the Act). In 1986, the
FDA promulgated the first umbrella regulations under the title of Good Manufacturing
Practice Regulations (GMPR). Since then, many aspects of the regulations have been
revised [1].
Traditionally, industry and regulators have depended on spot checks of manufactur-
ing conditions and random sampling of final products to ensure safe food. The current
good manufacturing practice regulations (CGMPR) form the basis on which the FDA will
inform the food manufacturer about deficiencies in its operations. This approach, however,
tends to be reactive rather than preventive and can definitely be improved.
For more than 30 years, FDA has been regulating the low-acid canned food (LACF)
industries with a special set of regulations, many of which are preventive in nature. This
action aims at preventing botulism. In the last 30 years, threats from other biological
pathogens have increased tremendously. Between 1980 and 1995, FDA has been studying

the approach of using hazard analysis and critical control points (HACCP). For this ap-
proach, FDA uses the LACF regulations as a partial guide. Since 1995, FDA has issued
HACCP regulations (HACCPR) [2] for the manufacture or production of several types
of food products. These include the processing of seafood and fruit/vegetable juices.
Since 1938, when the Act was first passed by Congress, FDA and state regulatory
agencies have worked hard to reach a uniform set of codes for the national regulation of
food manufacturing industries and state regulation of retail industries associated with food,
e.g., groceries, restaurants, caterers, and so on. In 1993, the first document, titled Food
Code, was issued jointly by the FDA and state agencies. It has been revised twice since
then. This chapter discusses CGMPR, HACCPR, and the Food Code. The appendices
present: (a) the FDA’s good manufacturing practice regulations (complete); (b) guidelines
for HACCP (complete); (c) the Food Code 2001 (Table of Contents only); and (d) an
excerpt of the Handbook of Food Defect Action Levels.
II. CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS

The current good manufacturing practice regulations cover the topics listed in Table 1.
These regulations are discussed in detail here. Please note that the word shall in a legal
document means mandatory and is used routinely in FDA regulations published in the
U.S. Code of Federal Regulations (CFR). In this chapter, the words should and must are
used to make for smoother reading. However, this in no way diminishes the legal impact
of the original regulations.
A. Definitions (21 CFR 110.3)

The FDA has provided the following definitions and interpretations for several important
terms.
1. Acid food or acidified food means foods that have an equilibrium pH of 4.6
or below.
2. Batter means a semifluid substance, usually composed of flour and other ingre-
dients, into which principal components of food are dipped or with which they
are coated, or which may be used directly to form bakery foods.
Table 1 Contents of the Current Good Manufacturing

Regulations
21 CFR 110.3 Definitions

21 CFR 110.5 Current good manufacturing practice
21 CFR 110.10 Personnel
21 CFR 110.19 Exclusions
21 CFR 110.20 Plant and grounds
21 CFR 110.35 Sanitary operations
21 CFR 110.37 Sanitary facilities and controls
21 CFR 110.40 Equipment and utensils
21 CFR 110.80 Processes and controls
21 CFR 110.93 Warehousing and distribution

3. Blanching, except for tree nuts and peanuts, means a prepackaging heat treat-
ment of foodstuffs for a sufficient time and at a sufficient temperature to par-
tially or completely inactivate the naturally occurring enzymes and to effect
other physical or biochemical changes in the food.
4. Critical control point means a point in a food process where there is a high
probability that improper control may cause a hazard or filth in the final food
or decomposition of the final food.
5. Food includes raw materials and ingredients.
6. Food-contact surfaces are those surfaces that contact human food and those
surfaces from which drainage onto the food or onto surfaces that contact the
food ordinarily occurs during the normal course of operations. Food-contact
surfaces include utensils and food-contact surfaces of equipment.
7. Lot means the food produced during a period of time indicated by a specific
code.
8. Microorganisms means yeasts, molds, bacteria, and viruses and includes, but is
not limited to, species having public health significance. The term undesirable
microorganisms includes those microorganisms that are of public health sig-
nificance, that promote decomposition of food, or that indicate that food is
contaminated with filth.
9. Pest refers to any objectionable animals or insects including, but not limited
to, birds, rodents, flies, and insect larvae.
10. Plant means the building or facility used for the manufacturing, packaging,
labeling, or holding of human food.
11. Quality control operation means a planned and systematic procedure for taking
all actions necessary to prevent food from being adulterated.
12. Rework means clean, unadulterated food that has been removed from pro-
cessing for reasons other than insanitary conditions or that has been success-
fully reconditioned by reprocessing and that is suitable for use as food.
13. Safe moisture level is a level of moisture low enough to prevent the growth
of undesirable microorganisms in the finished product under the intended con-
ditions of manufacturing, storage, and distribution. The maximum safe mois-
ture level for a food is based on its water activity, a w . An a w will be considered
safe for a food if adequate data are available that demonstrate that the food
at or below the given a w will not support the growth of undesirable microorgan-
isms.
14. Sanitize means to adequately treat food-contact surfaces by a process that is
effective in destroying vegetative cells of microorganisms of public health
significance and in substantially reducing numbers of other undesirable micro-
organisms, but without adversely affecting the product or its safety for the
consumer.
15. Water activity (a w) is a measure of the free moisture in a food and is the quo-
tient of the water vapor pressure of the substance divided by the vapor pressure
of pure water at the same temperature.
B. Personnel (21 CFR 110.10)

Plant management should take all reasonable measures and precautions to ensure compli-
ance with the following regulations.
1. Disease Control. Any person who, by medical examination or supervisory ob-
servation, is shown to have an illness, open lesion, including boils, sores, or
infected wounds, by which there is a reasonable possibility of food, food-contact
surfaces, or food-packaging materials becoming contaminated, should be ex-
cluded from any operations which may be expected to result in such contamina-
tion until the condition is corrected. Personnel should be instructed to report
such health conditions to their supervisors.
2. Cleanliness. All persons working in direct contact with food, food-contact sur-
faces, and food-packaging materials should conform to hygienic practices while
on duty. The methods for maintaining cleanliness include, but are not limited
to, the following:
a. Wearing outer garments suitable to the operation to protect against the con-
tamination of food, food-contact surfaces, or food-packaging materials.
b. Maintaining adequate personal cleanliness.
c. Washing hands thoroughly (and sanitizing if necessary to protect against
contamination with undesirable microorganisms) in an adequate hand-
washing facility before starting work, after each absence from the work
station, and at any other time when the hands may have become soiled or
contaminated.
d. Removing all unsecured jewelry and other objects that might fall into food,
equipment, or containers and removing hand jewelry that cannot be ade-
quately sanitized during periods in which food is manipulated by hand. If
such hand jewelry cannot be removed, it may be covered by material which
can be maintained in an intact, clean, and sanitary condition and which
effectively protects against their contamination of the food, food-contact
surfaces, or food-packaging materials.
e. Maintaining gloves, if they are used in food handling, in an intact, clean,
and sanitary condition. The gloves should be of an impermeable material.
f. Wearing, where appropriate, hairnets, headbands, caps, beard covers, or
other effective hair restraints.
g. Storing clothing or other personal belongings in areas other than where
food is exposed or where equipment or utensils are washed.
h. Confining the following personal practices to areas other than where food
may be exposed or where equipment or utensils are washed: eating food,
chewing gum, drinking beverages, or using tobacco.
i. Taking any other necessary precautions to protect against contamination of
food, food-contact surfaces, or food-packaging materials with microorgan-
isms or foreign substances including, but not limited to, perspiration, hair,
cosmetics, tobacco, chemicals, and medicines applied to the skin.
3. Education and Training. Personnel responsible for identifying sanitation fail-
ures or food contamination should have a background of education or experience
to provide a level of competency necessary for production of clean and safe
food. Food handlers and supervisors should receive appropriate training in
proper food handling techniques and food-protection principles and should be
informed of the danger of poor personal hygiene and insanitary practices.
4. Supervision. Responsibility for assuring compliance by all personnel with all
legal requirements should be clearly assigned to competent supervisory per-
sonnel.
C. Plant and Grounds (21 CFR 110.20)
1. Grounds. The grounds surrounding a food plant that are under the control of
the plant manager should be kept in a condition that will protect against the
contamination of food. The methods for adequate maintenance of grounds in-
clude, but are not limited to, the following:
a. Properly storing equipment, removing litter and waste, and cutting weeds
or grass within the immediate vicinity of the plant buildings or structures
that may constitute an attractant, breeding place, or harborage for pests.
b. Maintaining roads, yards, and parking lots so that they do not constitute a
source of contamination in areas where food is exposed.
c. Adequately draining areas that may contribute contamination to food by
seepage or foot-borne filth or by providing a breeding place for pests.
d. Operating systems for waste treatment and disposal in an adequate manner
so that they do not constitute a source of contamination in areas where food
is exposed. If the plant grounds are bordered by grounds not under the
operator’s control and not maintained in an acceptable manner, steps must
be taken to exclude pests, dirt, and filth that may be a source of food contam-
ination. Implement inspection, extermination, or other countermeasures.
2. Plant Construction and Design. Plant buildings and structures should be suit-
able in size, construction, and design to facilitate maintenance and sanitary oper-
ations for food-manufacturing purposes. The plant and facilities should
a. Provide sufficient space for such placement of equipment and storage of
materials as is necessary for the maintenance of sanitary operations and the
production of safe food.
b. Take proper precautions to reduce the potential for contamination of food,
food-contact surfaces, or food-packaging materials with microorganisms,
chemicals, filth, or other extraneous material. The potential for contamina-
tion may be reduced by adequate food safety controls and operating prac-
tices or effective design, including the separation of operations in which
contamination is likely to occur, by one or more of the following means:
location, time, partition, air flow, enclosed systems, or other effective
means.
c. Taking proper precautions to protect food in outdoor bulk fermentation ves-
sels by any effective means, including
Using protective coverings
Controlling areas over and around the vessels to eliminate harborages
for pests
Checking on a regular basis for pests and pest infestation
Skimming the fermentation vessels as necessary
d. Be constructed in such a manner that floors, walls, and ceilings may be
adequately cleaned and kept clean and kept in good repair; that drip or
condensate from fixtures, ducts, and pipes does not contaminate food, food-
contact surfaces, or food-packaging materials; and that aisles or working
spaces are provided between equipment and walls and are adequately unob-
structed and of adequate width to permit employees to perform their duties
and to protect against contaminating food or food-contact surfaces with
clothing or personal contact.
e. Provide adequate lighting in hand-washing areas, dressing and locker
rooms, and toilet rooms and in all areas where food is examined, processed,
or stored and where equipment or utensils are cleaned; and provide safety-
type light bulbs, fixtures, skylights, or other glass suspended over exposed
food in any step of preparation or otherwise protect against food contamina-
tion in case of glass breakage.
f. Provide adequate ventilation or control equipment to minimize odors and
vapors (including steam and noxious fumes) in areas where they may con-
taminate food; and locate and operate fans and other air-blowing equipment
in a manner that minimizes the potential for contaminating food, food-
packaging materials, and food-contact surfaces.
g. Provide, where necessary, adequate screening or other protection against
pests.
D. Sanitary Operations (21 CFR 110.35)

1. General Maintenance. Buildings, fixtures, and other physical facilities of the
plant should be maintained in a sanitary condition and should be kept in repair
sufficient to prevent food from becoming adulterated within the meaning of the
Act. Cleaning and sanitizing of utensils and equipment should be conducted in
a manner that protects against contamination of food, food-contact surfaces, or
food-packaging materials.
2. Substances used in cleaning and sanitizing and in storage of toxic materials:
a. Cleaning compounds and sanitizing agents used in cleaning and sanitizing
procedures should be free from undesirable microorganisms and should be
safe and adequate under the conditions of use. Compliance with this require-
ment may be verified by any effective means including purchase of these
substances under a supplier’s guarantee or certification or examination of
these substances for contamination. Only the following toxic materials may
be used or stored in a plant where food is processed or exposed:
Those required to maintain clean and sanitary conditions
Those necessary for use in laboratory testing procedures
Those necessary for plant and equipment maintenance and operation
Those necessary for use in the plant’s operations
b. Toxic cleaning compounds, sanitizing agents, and pesticide chemicals
should be identified, held, and stored in a manner that protects against con-
tamination of food, food-contact surfaces, or food-packaging materials.
3. Pest Control. No pests should be allowed in any area of a food plant. Guard
or guide dogs may be allowed in some areas of a plant if the presence of the
dogs is unlikely to result in contamination of food, food-contact surfaces, or
food-packaging materials. Effective measures should be taken to exclude pests
from the processing areas and to protect against the contamination of food on
the premises by pests. The use of insecticides or rodenticides is permitted only
under precautions and restrictions that will protect against the contamination of
food, food-contact surfaces, and food-packaging materials.
4. Sanitation of Food-Contact Surfaces. All food-contact surfaces, including
utensils and food-contact surfaces of equipment, should be cleaned as frequently
as necessary to protect against contamination of food.
a. Food-contact surfaces used for manufacturing or holding low-moisture food
should be in a dry, sanitary condition at the time of use. When the surfaces
are wet-cleaned, they should, when necessary, be sanitized and thoroughly
dried before subsequent use.
b. In wet processing, when cleaning is necessary to protect against the intro-
duction of microorganisms into food, all food-contact surfaces should be
cleaned and sanitized before use and after any interruption during which
the food-contact surfaces may have become contaminated. Where equip-
ment and utensils are used in a continuous production operation, the utensils
and food-contact surfaces of the equipment should be cleaned and sanitized
as necessary.
c. Non–food-contact surfaces of equipment used in the operation of food
plants should be cleaned as frequently as necessary to protect against con-
tamination of food.
d. Single-service articles (such as utensils intended for one-time use, paper
cups, and paper towels) should be stored in appropriate containers and
should be handled, dispensed, used, and disposed of in a manner that pro-
tects against contamination of food or food-contact surfaces.
e. Sanitizing agents should be adequate and safe under conditions of use. Any
facility, procedure, or machine is acceptable for cleaning and sanitizing
equipment and utensils if it is established that the facility, procedure, or
machine will routinely render equipment and utensils clean and provide
adequate cleaning and sanitizing treatment.
5. Storage and Handling of Cleaned Portable Equipment and Utensils. Cleaned
and sanitized portable equipment with food-contact surfaces and utensils should
be stored in a location and manner that protects food-contact surfaces from
contamination.
E. Sanitary Facilities and Controls (21 CFR 110.37)

Each plant should be equipped with adequate sanitary facilities and accommodations in-
cluding, but not limited to,
1. Water Supply. The water supply should be sufficient for the operations in-
tended and should be derived from an adequate source. Any water that contacts
food or food-contact surfaces should be safe and of adequate sanitary quality.
Running water at a suitable temperature, and under pressure as needed, should
be provided in all areas where required for the processing of food, for the clean-
ing of equipment, utensils, and food-packaging materials or for employee sani-
tary facilities.
2. Plumbing. Plumbing should be of adequate size and design and adequately
installed and maintained to
a. Carry sufficient quantities of water to required locations throughout the
plant
b. Properly convey sewage and liquid disposable waste from the plant
c. Avoid constituting a source of contamination to food, water supplies, equip-
ment, or utensils or creating an unsanitary condition
d. Provide adequate floor drainage in all areas where floors are subject to
flooding-type cleaning or where normal operations release or discharge wa-
ter or other liquid waste on the floor
e. Provide that there is no backflow from, or cross-connection between, piping
systems that discharge wastewater or sewage and piping systems that carry
water for food or food manufacturing
3. Sewage Disposal. Sewage disposal should be made into an adequate sewerage
system or disposed of through other adequate means.
4. Toilet Facilities. Each plant should provide its employees with adequate,
readily accessible toilet facilities. Compliance with this requirement may be
accomplished by
a. Maintaining the facilities in a sanitary condition
b. Keeping the facilities in good repair at all times
c. Providing self-closing doors
d. Providing doors that do not open into areas where food is exposed to air-
borne contamination, except where alternative means have been taken to
protect against such contamination (such as double doors or positive air-
flow systems).
5. Hand-Washing Facilities. Hand-washing facilities should be adequate and
convenient and be furnished with running water at a suitable temperature. Com-
pliance with this requirement may be accomplished by providing
a. Hand-washing and, where appropriate, hand-sanitizing facilities at each lo-
cation in the plant where good sanitary practices require employees to wash
and/or sanitize their hands
b. Effective hand-cleaning and sanitizing preparations
c. Sanitary towel service or suitable drying devices
d. Devices or fixtures, such as water control valves, so designed and con-
structed to protect against recontamination of clean, sanitized hands
e. Readily understandable signs directing employees handling unprotected
food, unprotected food-packaging materials, or food-contact surfaces to
wash and, where appropriate, sanitize their hands before they start work,
after each absence from post of duty, and when their hands may have be-
come soiled or contaminated. These signs may be posted in the processing
room(s) and in all other areas where employees may handle such food,
materials, or surfaces.
f. Refuse receptacles that are constructed and maintained in a manner that
protects against contamination of food.
6. Rubbish and Offal Disposal. Rubbish and any offal should be so conveyed,
stored, and disposed of as to minimize the development of odor, minimize the
potential for the waste becoming an attractant and harborage or breeding place
for pests, and protect against contamination of food, food-contact surfaces, wa-
ter supplies, and ground surfaces.
F. Equipment and Utensils (21 CFR 110.40)

1. All plant equipment and utensils should be so designed and of such material
and workmanship as to be adequately cleanable and should be properly main-
tained. The design, construction, and use of equipment and utensils should pre-
clude the adulteration of food with lubricants, fuel, metal fragments, contami-
nated water, or any other contaminants. All equipment should be so installed
and maintained as to facilitate the cleaning of the equipment and of all adjacent
spaces. Food-contact surfaces should be corrosion resistant when in contact with
food. They should be made of nontoxic materials and designed to withstand
the environment of their intended use and the action of food and, if applicable,
cleaning compounds and sanitizing agents. Food-contact surfaces should be
maintained to protect food from being contaminated by any source, including
unlawful indirect food additives.
2. Seams on food-contact surfaces should be smoothly bonded or maintained so
as to minimize accumulation of food particles, dirt, and organic matter and thus
minimize the opportunity for growth of microorganisms.
3. Equipment that is in the manufacturing or food-handling area and that does not
come into contact with food should be so constructed that it can be kept in a
clean condition.
4. Holding, conveying, and manufacturing systems, including gravimetric, pneu-
matic, closed, and automated systems, should be of a design and construction
that enables them to be maintained in an appropriate sanitary condition.
5. Each freezer and cold storage compartment used to store and hold food capable
of supporting growth of microorganisms should be fitted with an indicating
thermometer, temperature-measuring device, or temperature-recording device
so installed as to show the temperature accurately within the compartment and
should be fitted with an automatic control for regulating temperature or with
an automatic alarm system to indicate a significant temperature change in a
manual operation.
6. Instruments and controls used for measuring, regulating, or recording tempera-
ture, pH, acidity, water activity, or other conditions that control or prevent the
growth of undesirable microorganisms in food should be accurate and ade-
quately maintained and adequate in number for their designated uses.
7. Compressed air or other gases mechanically introduced into food or used to
clean food-contact surfaces or equipment should be treated in such a way that
food is not contaminated with unlawful indirect food additives.
G. Processes and Controls (21 CFR 110.80)

All operations in the receiving, inspecting, transporting, segregating, preparing, manufac-
turing, packaging, and storing of food should be conducted in accordance with adequate
sanitation principles. Appropriate quality control operations should be employed to ensure
that food is suitable for human consumption and that food-packaging materials are safe
and suitable. Overall sanitation of the plant should be under the supervision of one or more
competent individuals assigned responsibility for this function. All reasonable precautions
should be taken to ensure that production procedures do not contribute contamination
from any source. Chemical, microbial, or extraneous material testing procedures should
be used where necessary to identify sanitation failures or possible food contamination. All
food that has become contaminated to the extent that it is adulterated within the meaning
of the Act should be rejected, or if permissible, treated or processed to eliminate the
contamination.
1. Raw materials and other ingredients.
a. Raw materials and other ingredients should be inspected and segregated or
otherwise handled as necessary to ascertain that they are clean and suitable
for processing into food and should be stored under conditions that will
protect against contamination and minimize deterioration. Raw materials
should be washed or cleaned as necessary to remove soil or other contami-
nation. Water used for washing, rinsing, or conveying food should be safe
and of adequate sanitary quality. Water may be reused for washing, rinsing,
or conveying food if it does not increase the level of contamination of the
food. Containers and carriers of raw materials should be inspected on receipt
to ensure that their condition has not contributed to the contamination or
deterioration of food.
b. Raw materials and other ingredients should either not contain levels of mi-
croorganisms that may produce food poisoning or other disease in humans,
or they should be pasteurized or otherwise treated during manufacturing
operations so that they no longer contain levels that would cause the product
to be adulterated within the meaning of the act. Compliance with this re-
quirement may be verified by any effective means, including purchasing
raw materials and other ingredients under a supplier’s guarantee or certifi-
cation.
c. Raw materials and other ingredients susceptible to contamination with afla-
toxin or other natural toxins should comply with current FDA regulations,
guidelines, and action levels for poisonous or deleterious substances before
these materials or ingredients are incorporated into finished food. Compli-
ance with this requirement may be accomplished by purchasing raw materi-
als and other ingredients under a supplier’s guarantee or certification, or
may be verified by analyzing these materials and ingredients for aflatoxins
and other natural toxins.
d. Raw materials, other ingredients, and rework susceptible to contamination
with pests, undesirable microorganisms, or extraneous material should com-
ply with applicable FDA regulations, guidelines, and defect action levels
for natural or unavoidable defects if a manufacturer wishes to use the mate-
rials in manufacturing food. Compliance with this requirement may be veri-
fied by any effective means, including purchasing the materials under a
supplier’s guarantee or certification or examination of these materials for
contamination.
e. Raw materials, other ingredients, and rework should be held in bulk or in
containers designed and constructed so as to protect against contamination
and should be held at such temperature and relative humidity as to prevent
the food from becoming adulterated. Material scheduled for rework should
be identified as such.
f. Frozen raw materials and other ingredients should be kept frozen. If thaw-
ing is required prior to use, it should be done in a manner that prevents the
raw materials and other ingredients from becoming adulterated.
g. Liquid or dry raw materials and other ingredients received and stored in
bulk form should be held in a manner that protects against contamination.
2. Manufacturing operations.
a. Equipment and utensils and finished food containers should be maintained
in an acceptable condition through appropriate cleaning and sanitizing, as

necessary. Insofar as necessary, equipment should be taken apart for thor-
ough cleaning.
b. All food manufacturing, including packaging and storage, should be con-
ducted under such conditions and controls as are necessary to minimize the
potential for the growth of microorganisms or for the contamination of food.
One way to comply with this requirement is careful monitoring of physical
factors such as time, temperature, humidity, a w , pH, pressure, flow rate, and
manufacturing operations such as freezing, dehydration, heat processing,
acidification, and refrigeration to ensure that mechanical breakdowns, time
delays, temperature fluctuations, and other factors do not contribute to the
decomposition or contamination of food.
c. Food that can support the rapid growth of undesirable microorganisms, par-
ticularly those of public health significance, should be held in a manner
that prevents the food from becoming affected. Compliance with this re-
quirement may be accomplished by any effective means, including
Maintaining refrigerated foods at 45°F (7.2°C) or below as appropriate
for the particular food involved
Maintaining frozen foods in a frozen state
Maintaining hot foods at 140°F (60°C) or above
Heat treating acid or acidified foods to destroy mesophilic microorgan-
isms when those foods are to be held in hermetically sealed containers
at ambient temperatures
d. Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerat-
ing, controlling pH, or controlling a w that are taken to destroy or prevent the
growth of undesirable microorganisms, particularly those of public health
significance, should be adequate under the conditions of manufacture, han-
dling, and distribution to prevent food from being adulterated.
e. Work-in-process should be handled in a manner that protects against con-
tamination.
f. Effective measures should be taken to protect finished food from contami-
nation by raw materials, other ingredients, or refuse. When raw materials,
other ingredients, or refuse are unprotected, they should not be handled
simultaneously in a receiving, loading, or shipping area if that handling
could result in contaminated food. Food transported by conveyor should
be protected against contamination as necessary.
g. Equipment, containers, and utensils used to convey, hold, or store raw mate-
rials, work-in-process, rework, or food should be constructed, handled, and
maintained during manufacturing or storage in a manner that protects
against contamination.
h. Effective measures should be taken to protect against the inclusion of metal
or other extraneous material in food. Compliance with this requirement may
be accomplished by using sieves, traps, magnets, electronic metal detectors,
or other suitable effective means.
i. Food, raw materials, and other ingredients that are adulterated should be
disposed of in a manner that protects against the contamination of other
food. If the adulterated food is capable of being reconditioned, it should
be reconditioned using a method that has been proven to be effective or it

should be reexamined and found not to be adulterated before being incorpo-
rated into other food.
j. Mechanical manufacturing steps such as washing, peeling, trimming, cut-
ting, sorting and inspecting, mashing, dewatering, cooling, shredding, ex-
truding, drying, whipping, defatting, and forming should be performed so
as to protect food against contamination. Compliance with this requirement
may be accomplished by providing adequate physical protection of food
from contaminants that may drip, drain, or be drawn into the food. Protec-
tion may be provided by adequate cleaning and sanitizing of all food-con-
tact surfaces and by using time and temperature controls at and between
each manufacturing step.
k. Heat blanching, when required in the preparation of food, should be effected
by heating the food to the required temperature, holding it at this tempera-
ture for the required time, and then either rapidly cooling the food or passing
it to subsequent manufacturing without delay. Thermophilic growth and
contamination in blanchers should be minimized by the use of adequate
operating temperatures and by periodic cleaning. Where the blanched food
is washed prior to filling, water used should be safe and of adequate sanitary
quality.
l. Batters, breading, sauces, gravies, dressings, and other similar preparations
should be treated or maintained in such a manner that they are protected
against contamination. Compliance with this requirement may be accom-
plished by any effective means, including one or more of the following:
Using ingredients free of contamination
Employing adequate heat processes where applicable
Using adequate time and temperature controls
Providing adequate physical protection of components from contami-
nants that may drip, drain, or be drawn into them
Cooling to an adequate temperature during manufacturing
Disposing of batters at appropriate intervals to protect against the growth
of microorganisms
m. Filling, assembling, packaging, and other operations should be performed
in such a way that the food is protected against contamination. Compliance
with this requirement may be accomplished by any effective means, in-
cluding
Use of a quality control operation in which the critical control points are
identified and controlled during manufacturing
Adequate cleaning and sanitizing of all food-contact surfaces and food
containers
Using materials for food containers and food-packaging materials that
are safe and suitable
Providing physical protection from contamination, particularly airborne
contamination
Using sanitary handling procedures
n. Food such as, but not limited to, dry mixes, nuts, intermediate-moisture
food, and dehydrated food, which relies on the control of a w for preventing
the growth of undesirable microorganisms, should be processed to and

maintained at a safe moisture level. Compliance with this requirement may
be accomplished by any effective means, including employment of one or
more of the following practices:
Monitoring the a w of food
Controlling the soluble solids/water ratio in finished food
Protecting finished food from moisture pickup, by use of a moisture bar-
rier or by other means, so that the a w of the food does not increase to
an unsafe level
o. Food, such as, but not limited to, acid and acidified food, that relies princi-
pally on the control of pH for preventing the growth of undesirable micro-
organisms should be monitored and maintained at a pH of 4.6 or below.
Compliance with this requirement may be accomplished by any effective
means, including employment of one or more of the following practices:
Monitoring the pH of raw materials, food-in-process, and finished food.
Controlling the amount of acid or acidified food added to low-acid food.
p. When ice is used in contact with food, it should be made from water that
is safe and of adequate sanitary quality, and should be used only if it has
been manufactured in accordance with current good manufacturing prac-
tice.
q. Food-manufacturing areas and equipment used for manufacturing human
food should not be used to manufacture nonhuman food grade animal feed
or inedible products, unless there is no reasonable possibility for the con-
tamination of the human food.
H. Warehousing and Distribution (21 CFR 110.93)

Storage and transportation of finished food should be under conditions that will protect
food against physical, chemical, and microbial contamination as well as against deteriora-
tion of the food and the container.
I. Natural or Unavoidable Defects in Food for Human Use

that Present No Health Hazard (21 CFR 110.110)
1. Some foods, even when produced under current good manufacturing practice,
contain natural or unavoidable defects that at low levels are not hazardous to
health. The FDA establishes maximum levels for these defects in foods pro-
duced under current good manufacturing practice and uses these levels in decid-
ing whether to recommend regulatory action.
2. Defect action levels are established for foods whenever it is necessary and feasi-
ble to do so. These levels are subject to change upon the development of new
technology or the availability of new information.
3. The mixing of a food containing defects above the current defect action level
with another lot of food is not permitted and renders the final food adulterated
within the meaning of the Act, regardless of the defect level of the final food.
4. A compilation of the current defect action levels for natural or unavoidable
defects in food for human use that present no health hazard may be obtained
from the FDA in printed or electronic versions.

III. HAZARD ANALYSIS CRITICAL CONTROL
POINTS REGULATIONS
In 1997, FDA adopted a food safety program that was developed nearly 30 years ago for
astronauts and is now applying it to seafood and fruit and vegetable juices. The agency
intends to eventually use it for much of the U.S. food supply. The program for the astro-
nauts focuses on preventing hazards that could cause foodborne illnesses by applying
science-based controls, from raw material to finished products. The FDA’s new system
will do the same.
Many principles of this new system, now called hazard analysis and critical control
points, are already in place in the FDA-regulated low-acid canned food industry. Since
1997, FDA has mandated HACCP for the processing of seafood, fruit juices, and vegetable
juices. Also, FDA has incorporated HACCP into its Food Code, a document that gives
guidance to and serves as model legislation for state and territorial agencies that license
and inspect food service establishments, retail food stores, and food vending operations
in the United States.
The FDA now is considering developing regulations that would establish HACCP
as the food safety standard throughout other areas of the food industry, including both
domestic and imported food products. The National Academy of Sciences, the Codex
Alimentarius Commission (an international, standard-setting organization), and the Na-
tional Advisory Committee on Microbiological Criteria for Foods have endorsed HACCP.
Several U.S. food companies already use the system in their manufacturing processes,
and it is in use in other countries including Canada.
A. What is HACCP?
Hazard analysis and critical control points involves seven principles.
1. Analyze hazards. Potential hazards associated with a food and measures to

control those hazards are identified. The hazard could be biological, such as a
microbe; chemical, such as a toxin; or physical, such as ground glass or metal
fragments.
2. Identify critical control points. These are points in a food’s production—from
its raw state through processing and shipping to consumption by the con-
sumer—at which the potential hazard can be controlled or eliminated. Examples
are cooking, cooling, packaging, and metal detection.
3. Establish preventive measures with critical limits for each control point. For
a cooked food, for example, this might include setting the minimum cooking
temperature and time required to ensure the elimination of any harmful mi-
crobes.
4. Establish procedures to monitor the critical control points. Such procedures
might include determining how and by whom cooking time and temperature
should be monitored.
5. Establish corrective actions to be taken when monitoring shows that a critical
limit has not been met—for example, reprocessing or disposing of food if the
minimum cooking temperature is not met.
6. Establish procedures to verify that the system is working properly—for exam-
ple, testing time and temperature-recording devices to verify that a cooking unit
is working properly.
7. Establish effective recordkeeping to document the HACCP system. This
would include records of hazards and their control methods, the monitoring of
safety requirements and action taken to correct potential problems.
Each of these principles must be backed by sound scientific knowledge such as published
microbiological studies on time and temperature factors for controlling foodborne patho-
gens.
B. Need for HACCP

New challenges to the U.S. food supply have prompted FDA to consider adopting a
HACCP-based food safety system on a wider basis. One of the most important challenges
is the increasing number of new food pathogens. For example, between 1973 and 1988,
bacteria not previously recognized as important causes of foodborne illness (such as Esche-
richia coli O157:H7 and Salmonella enteritidis) became more widespread. There also is
increasing public health concern about chemical contamination of food, for example, the
effects of lead in food on the nervous system.
Another important factor is that the size of the food industry and the diversity of
products and processes have grown tremendously, in both the amount of domestic food
manufactured and the number and kinds of foods imported. At the same time, FDA and
state and local agencies have the same limited level of resources to ensure food safety.
The need for HACCP in the United States, particularly in the seafood industry, is further
fueled by the growing trend in international trade for worldwide equivalence of food prod-
ucts and the Codex Alimentarius Commission’s adoption of HACCP as the international
standard for food safety.
C. Advantages and Plans

The HACCP system offers a number of advantages over previous systems. Most impor-
tantly, HACCP
Focuses on identifying and preventing hazards from contaminating food
Is based on sound science
Permits more efficient and effective government oversight, primarily because the
recordkeeping allows investigators to see how well a firm is complying with food
safety laws over a period rather than how well it is doing on any given day
Places responsibility for ensuring food safety appropriately on the food manufacturer
or distributor
Helps food companies compete more effectively in the world market
Reduces barriers to international trade
Here are the seven steps used in HACCP plan development:
1. Preliminary steps.
a. General information.
b. Describe the food.
c. Describe the method of distribution and storage.
d. Identify the intended use and consumer.
e. Develop a flow diagram.
2. Hazard analysis worksheet.
a. Set up the Hazard Analysis Worksheet.
b. Identify the potential species-related hazards.
c. Identify the potential process-related hazards.
d. Complete the Hazard Analysis Worksheet.
e. Understand the potential hazard.
f. Determine if the potential hazard is significant.
g. Identify the critical control points (CCP).
3. HACCP Plan Form
a. Complete the HACCP Plan Form.
b. Set the critical limits (CL).
4. Establish monitoring procedures.
a. What?
b. How?
c. Frequency?
d. Who?
5. Establish corrective action procedures.
6. Establish a recordkeeping system.
7. Establish verification procedures.
It is important to remember that apart from HACCPR promulgated for seafood and
juices, the implementation of HACCP by other categories of food processing is voluntary.
However, the FDA and various types of food processors are working together so that
eventually HACCPR will become available for many other food processing systems under
FDA jurisdiction. Using the HACCPR for seafood processing as a guide, the following
discussion for a HACCP plan applies to all categories of food products being processed
in the United States.
D. Hazard Analysis
Every processor should conduct a hazard analysis to determine whether there are food
safety hazards that are reasonably likely to occur for each kind of product processed by
that processor and to identify the preventive measures that the processor can apply to
control those hazards. Such food safety hazards can be introduced both within and outside
the processing plant environment, including food safety hazards that can occur before,
during, and after harvest. A food safety hazard that is reasonably likely to occur is one
for which a prudent processor would establish controls because experience, illness data,
scientific reports, or other information provide a basis to conclude that there is a reasonable
possibility that it will occur in the particular type of product being processed in the absence
of those controls.
E. The HACCP Plan

Every processor should have and implement a written HACCP plan whenever a hazard
analysis reveals one or more food safety hazards that are reasonably likely to occur. A
HACCP plan should be specific to
Each location where products are processed by that processor
Each kind of product processed by the processor
The plan may group kinds of products together or group kinds of production methods
together if the food safety hazards, critical control points, critical limits, and procedures
required to be identified and performed are identical for all products so grouped or for
all production methods so grouped.
1. The Contents of the HACCP Plan

The HACCP plan should, at a minimum,
1. List the food safety hazards that are reasonably likely to occur, as identified,
and that thus must be controlled for each product. Consideration should be given
to whether any food safety hazards are reasonably likely to occur as a result of
the following: natural toxins; microbiological contamination; chemical contami-
nation; pesticides; drug residues; decomposition in products where a food safety
hazard has been associated with decomposition; parasites where the processor
has knowledge that the parasite-containing product will be consumed without
a process sufficient to kill the parasites; unapproved use of direct or indirect
food or color additives; and physical hazards.
2. List the critical control points for each of the identified food safety hazards,
including, as appropriate, critical control points designed to control food safety
hazards that could be introduced in the processing plant environment and critical
control points designed to control food safety hazards introduced outside the
processing plant environment, including food safety hazards that occur before,
during, and after harvest.
3. List the critical limits that must be met at each of the critical control points.
4. List the procedures, and frequency thereof, that will be used to monitor each
of the critical control points to ensure compliance with the critical limits.
5. Include any corrective action plans that have been developed to be followed in
response to deviations from critical limits at critical control points.
6. List the verification procedures, and frequency thereof, that the processor
will use.
7. Provide for a recordkeeping system that documents the monitoring of the critical
control points. The records should contain the actual values and observations
obtained during monitoring.
2. Signing and Dating the HACCP Plan

The HACCP plan should be signed and dated either by the most responsible individual
on site at the processing facility or by a higher-level official of the processor. This signature
should signify that the HACCP plan has been accepted for implementation by the firm
upon initial acceptance; upon any modification; and upon verification of the plan.
3. Sanitation
Sanitation controls [3] may be included in the HACCP plan. However, to the extent that
they are otherwise monitored, they need not be included in the HACCP plan.
4. Implementation
This book is not the proper forum to discuss in detail the implementation of HACCPR.
Readers interested in additional information on HACCP should visit the FDA HACCP
website http://vm.cfsan.fda.gov/, which lists all the currently available documents on the
subject.
IV. THE FDA FOOD CODE
The FDA Food Code (the Code) [4] is an essential reference that guides retail outlets
such as restaurants and grocery stores and institutions such as nursing homes on how to
prevent foodborne illness. Local, state, and federal regulators use the FDA Food Code as
a model to help develop or update their own food safety rules and to be consistent with
national food regulatory policy. Also, many of the over one million retail food establish-
ments apply Food Code provisions to their own operations. The Food Code is updated
every two years to coincide with the biennial meeting of the Conference for Food Protec-
tion. The conference is a group of representatives from regulatory agencies at all levels
of government, the food industry, academia, and consumer organizations that work to
improve food safety at the retail level [5]. A brief discussion of the Code is provided here.
Further information, including access to the Code, may be obtained from the Food Safety
Training and Education Alliance (www.fstea.org).
The Code establishes definitions; sets standards for management and personnel, food
operations, and equipment and facilities; and provides for food establishment plan review,
permit issuance, inspection, employee restriction, and permit suspension. The Code dis-
cusses the good manufacturing practices for equipment, utensils, linens, water, plumbing,
waste, physical facilities, poisonous or toxic materials, compliance, and enforcement. The
Code also provides guidelines on food establishment inspection, HACCP guidelines, food
processing criteria, model forms, guides, and other aids. A brief introduction to the Food
Code in this chapter is important for two reasons: First, at the end of this book, two
chapters cover retail food protection from the perspectives of food sanitation. The Food
Code forms the backbone of these chapters. Second, although this guide is designed for
retail food protection, more than half of the data included are directly applicable to food
processing plants, e.g., equipment design (cleanability), CIP system, detergents and sani-
tizers, refrigeration and freezing storage parameters, water requirements, precautions
against ‘‘backflow’’ (air, valve, etc.), personnel health and hygiene, rest rooms and acces-
sories, pest control, storage of toxic chemicals, inspection forms, inspection procedures,
and many more. Some of the data in the present book can be readily traced to the Code.
The Code consists of eight chapters and seven annexes. Some of the information
found in the Code will be further explored in two chapters at the end of this book. The
annex that covers inspection of a food establishment applies equally as well to both retail
food protection and to sanitation in food processing. According to the Code, the compo-
nents of an inspection would usually include the following elements:
Introduction
Program planning
Staff training
Conducting the inspection
Inspection documentation
Inspection report
Administrative procedures by the state/local authorities
Temperature measuring devices
Calibration procedures
HACCP inspection data form
Food establishment inspection report
FDA electronic inspection system
Establishment scoring
Details of these items will not be discussed here; some are further explored in various
chapters in this book (please consult the index for specific topics). Instead, the next two
sections trace the history and practices of food establishment inspection and how basic
sanitation controls are slowly evolving into the prerequisites for HACCP plans in both
retail food protection and food processing plants.
A. Purpose
A principal goal to be achieved by a food establishment inspection is to prevent foodborne
disease. Inspection is the primary tool a regulatory agency has for detecting procedures
and practices that may be hazardous and for taking actions to correct deficiencies. Food
Code–based laws and ordinances provide inspectors science-based rules for food safety.
The Food Code provides regulatory agencies with guidance on planning, scheduling, con-
ducting, and evaluating inspections. It supports programs by providing recommendations
for training and equipping the inspection staff, and attempts to enhance the effectiveness
of inspections by stressing the importance of communication and information exchange
during regulatory visits. Inspections aid the food service industry in the following ways:
1. They serve as educational sessions on specific Code requirements as they apply
to an establishment and its operation.
2. They convey new food safety information to establishment management and
provide an opportunity for management to ask questions about general food
safety matters.
3. They provide a written report to the establishment’s permit holder or person in
charge so that the responsible person can bring the establishment into confor-
mance with the Code.
B. Current Applications of HACCP

Inspections have been a part of food safety regulatory activities since the earliest days of
public health. Traditionally, inspections have focused primarily on sanitation. Each inspec-
tion is unique in terms of the establishment’s management, personnel, menu, recipes,
operations, size, population served, and many other considerations.
Changes to the traditional inspection process were first suggested in the 1970s. The
terms ‘‘traditional’’ or ‘‘routine’’ inspection have been used to describe periodic inspec-
tions conducted as part of an ongoing regulatory scheme. A full range of approaches was
tried and many were successful in managing a transition to a new inspection philosophy
and format. During the 1980s, many progressive jurisdictions started employing the
HACCP approach to refocus their inspections. The term ‘‘HACCP approach’’ inspection
is used to describe an inspection using the hazard analysis and critical control point con-
cept. Food safety is the primary focus of a HACCP approach inspection. One lesson
learned was that good communication skills on the part of the person conducting an inspec-
tion are essential.
The FDA has taught thousands of state and local inspectors the principles and appli-
cations of HACCP since the 1980s. The State Training Branch and the FDA Regional
Food Specialists have provided two-day to week-long courses on the scientific principles
on which HACCP is based, the practical application of these principles including field
exercises, and reviews of case studies. State and local jurisdictions have also offered many
training opportunities for HACCP.
A recent review of state and local retail food protection agencies shows that HACCP
is being applied in the following ways:
1. Formal Studies. Inspector is trained in HACCP and is using the concepts to
study food hazards in establishments. These studies actually follow foods from
delivery to service and involve the write-up of data obtained (flow charts, cool-
ing curves, etc.).
2. Routine Use. State has personnel trained in HACCP and is using the hazard
analysis concepts to more effectively discover hazards during routine inspec-
tions.
3. Consultation. HACCP-trained personnel are consulting with industry and as-
sisting them in designing and implementing internal HACCP systems and plans.
4. Alternative Use. Jurisdiction used HACCP to change inspection forms or reg-
ulations.
5. Risk-Based. Jurisdiction prioritized inventory of establishments and set in-
spection frequency using a hazard assessment.
6. Training. Jurisdiction is in the active process of training inspectors in the
HACCP concepts.
Personnel of every sort of food establishment should have one or several copies of
the Food Code readily available for frequent consultation.
V. APPLICATION TO FOOD PLANT SANITATION

The sanitary requirements in the CGMPR and the Food Code serve as the framework for
the chapters in this book. The HACCPR will be touched on when they help to clarify the
discussion. Essentially, this book shows how to implement the umbrella regulations pro-
vided under the CGMPR. Each chapter handles one aspect of these complicated regula-
tions. Most chapters discuss the regulations applicable to all types of food products being
processed. Several chapters concentrate on the sanitary requirements from the perspectives
of the processing of a specific category of food. The appendix of this book reproduces
the complete coverage of CGMPR in 21 CFR 110.
REFERENCES
1. FDA. Title 21, Code of Federal Regulations, Part 110, Current Good Manufacturing Practice in
Manufacturing, Packing, or Holding Human Food. Washington, DC: U.S. Government Printing
Office, 2001.
2. FDA. Title 21, Code of Federal Regulations, Part 120, Hazard Analysis and Critical Control
Point (HACCP) Systems. Washington, DC: U.S. Government Printing Office, 2001.
3. CM Nolan. Developing an integrated sanitation program using innovative techniques. Food
Safety Magazine 7(4):18,19,21,39,40,43,44, 2001.
4. FDA. Food Code. Washington, DC: U.S. Department of Health and Human Services, 2001.
5. G Lewis, PA Salisbury. Safe food at retail establishments. Food Safety Magazine 7(4):13–17,
2001.

4
Food Plant Inspections
ALFRED J. ST. CYR

AIB International, Manhattan, Kansas, U.S.A.
I. INTRODUCTION
Food manufacturing plants continue to increase in complexity, and the potential for issues
to develop that adversely affect the consumer increase accordingly. To avoid being in a
negative spotlight, food plants have developed numerous programs and policies designed
to meet their challenges. Good manufacturing practice (GMP) policies, hazard analysis
and critical control point (HACCP) programs, plant policies and practices, production
parameters, preventive maintenance programs, and sanitation/hygiene programs, along
with others, assist facilities in meeting their obligations. One critical program that must
be in place to verify that all objectives are being met on a consistent basis includes plant
inspections [1].
Plant inspections are used by several different entities to achieve the same goal.
Regulatory agencies utilize plant inspections for the enforcement of food laws. A com-
pany’s customers utilize inspections to determine the risks of doing business with a partic-
ular firm, using either their own resources or a third-party professional organization, to
conduct the inspection. Perhaps the most important aspect of the inspection program,
however, is the self-inspection program undertaken by a facility’s own personnel to moni-
tor the conditions in the plant. Personnel must identify potential food safety risks and take
actions to correct deficiencies that develop.
The internal inspection process should be conducted by a well-organized committee
dedicated to ensuring a high level of compliance with all the plant’s internal policies and
all external requirements (those of business partners, federal and state regulatory agencies,
etc.) [2]. The committee usually consists of management personnel from production, plant
sanitation and maintenance, as well as from the quality control and human resources de-
partments. More and more often, the committee includes hourly employees, who have an
equal commitment to the success of the plant. The mix of these various personnel offers
the committee the opportunity to view the plant from different perspectives and to evaluate
the programs using a more comprehensive approach. Often the plant manager will partici-
pate in the process to lend a higher visibility to the program as well as to accelerate the
corrective actions needed.
Once the committee members have been selected, their responsibility becomes one
of assessing what has been neglected and also compiling a report detailing solutions to
the food safety risks identified. Generally, these risks are beyond the capability or authority
of the individual responsible for the area of concern. This report, called a Corrective Action
Report, requires a specific action to be taken within a designated time frame. It also allows
for follow-up actions since the issue remains open until it has been corrected.
II. PLANT POLICIES

Food plants can expect regulatory agencies, customers, and even corporate personnel (both
in-house inspectors and inspectors from supplier companies) to conduct evaluations of
plant operations and conditions (see Chapter 21). This is often an inconvenience and some-
times a traumatic experience. The better prepared your facility is to meet these challenges,
the less likely your personnel will be tense and make costly mistakes by providing the
wrong information or behave in a manner that raises concerns. Each facility should be
prepared ahead of time by having a clearly written and understood policy concerning
inspections by outside personnel.
The policy should include and spell out clearly what actions are to be taken and by
whom when an inspector arrives at the facility. Policies concerning photographs, samples,
and records that can be reviewed with inspectors must be clear to give personnel the proper
guidance. Policies should indicate the member of the management team to accompany
the inspectors and answer the questions. The personnel assigned this responsibility should
be familiar with the policy and their responsibilities and should be able to outline the
firm’s policies for the inspectors during the initial meeting. Having clear policies that are
understood by all parties can help you avoid costly misunderstandings and controversy
during the inspections. Encountering a facility that is clearly in control of this aspect of
their operations sends a very positive message to any investigator regarding the commit-
ment and understanding of the obligation a firm has when manufacturing food. Rarely is
an inspection of your facility a pleasant experience; however, it can go relatively smoothly
if you take the time to be prepared.
III. REGULATORY INSPECTIONS

The Food, Drug, and Cosmetic Act of 1938 allows for the inspection of food manufactur-
ing plants by government investigators from various federal, state, and local health agen-
cies to determine if the facility complies with the current statutes. The authority to conduct
the inspections was further supported by the United States vs. Dotterweich decision (U.S.
Supreme Court 1943, 320 U.S. 277,64S.CT 134) rendered by the high court in 1948. The
federal inspection program is divided between the Food and Drug Administration (FDA)
and the U.S. Department of Agriculture (USDA). Though each is charged with different
responsibilities, they share the common goal of protecting the health and welfare of the
American consumer.
It is important to understand that a visit by an investigator from a government agency
such as the FDA is the beginning of a legal process—specific protocols must be followed.
Both parties have specific rights or privileges granted under the law that must be respected.
Since the FDA commonly inspects a variety of food manufacturing plants, we will review
the process commonly followed by that agency (the USDA programs are aimed mainly
at the meat and poultry industries).
The initial visit by an investigator from the FDA is likely to be an unannounced
event. The investigator (the number varies from one to several) will arrive at the facility
during what has been determined as reasonable business hours, which can mean that in-
spectors can arrive any time the business is open. However, since the visit will likely
require contact with senior management personnel, the investigator will normally arrive
at some point during typical business hours unless there is a significant urgency to the
issue.
Security personnel, if they are the first company personnel encountered, should di-
rect the investigator to the proper reception area. Though every effort should be made to
expedite the investigator meeting with the correct personnel, certain protocols should be
met. Every investigator should present his or her official identification credentials prior
to proceeding beyond this point. If not voluntarily provided, these should be requested.
Inquiries should be made concerning the reason behind the visit. This will likely produce
FDA form 482, ‘‘Notice of Inspection,’’ that will state that the investigator is there to
conduct an inspection of the facility and that this is the beginning of the process. The
form will not state whether the investigation is for routine GMP compliance or whether
a specific violation is being investigated. It is important to ask the investigator for this
information.
The vast majority of investigations conducted by the FDA are considered routine
as required by law. However, due to the complexities of food manufacturing in the United
States, conditions found in one distribution center or manufacturing facility may lead
investigators to your facility in their effort to determine the extent and/or source of a
particular risk to the public health. This may involve tracking an infestation or a contami-
nation issue introduced into interstate commerce. An excellent guide to help you under-
stand what inspectors are likely to evaluate in your facility is available in the manual
‘‘Inspectional Methods Taught by FDA: Inspections by Specific Food Categories’’ [3].
Regardless of the reason for the inspection conducted by outside personnel, it is
important to have only one spokesperson for your firm. This policy can reduce the potential
for confusion and misunderstanding between parties. In addition, if the spokesperson is
not familiar with the information requested, he or she should so state and then get back
to the inspector after obtaining the correct information.
At the conclusion of the FDA inspection, the investigator will issue a ‘‘List of Obser-
vations’’ (form 483) and present the observations to management prior to leaving the
facility. This form should be carefully reviewed and any points that appear unclear or
incorrect should be corrected with the investigator at that time. All corrections completed
during the visit should also be noted on this form. It is very important that management
take appropriate action to ensure that a repeat of the issues noted does not occur on subse-
quent inspections.
The inspectors may take samples of finished products, in-process ingredients, or
other sources of evidence such as insects or insect fragments, foreign matter, or rodent
evidence during an inspection. The FDA will provide you with a ‘‘Receipt for Samples’’
(form 484) for the samples taken during the course of the inspection. It is important that
you obtain a sample from the same source. The best option is to split the sample taken
by the FDA investigator. Find out what tests will be conducted on the samples and then
expedite having your samples tested by an independent laboratory using the same methods
outlined by the investigator.
IV. SELF-INSPECTION PROGRAM

The preceding section outlined the legal aspects of the inspection process. There is little
doubt that any person involved in any way with the production, storage, and distribution
of food items has a legal responsibility to comply with the established regulatory statutes.
Though important, the legal requirements cover only part of the issues. We cannot over-
look the moral obligation that we in the food industry have to those who purchase and
consume our products. All of us are dependent on other people to provide us with safe,
wholesome products. The impact of failing to meet the expectations of our customers and
putting their health and welfare at risk often results in a far more severe economic impact
on business than the fines imposed by regulatory agencies.
To avoid events that lead to failures, an effective food safety program should be
designed with attention to the interrelationships between all departments in the food plant
and between management and hourly employees. When you consider that the number of
employees represents the number of opportunities for program success or failure, it pays
to invest in each employee to ensure your success. Only when all employees personally
accept the responsibility for the products under their control and accept that they will be
held accountable for their actions can we truly succeed.
A. Preparing for Self-Inspections

One common excuse used to justify the failure of a viable self-inspection program is a
lack of time to do the inspection. Adequate preparation and notification of the members
of the committee designated to conduct the inspection can reduce the time required to
conduct the inspections and ensure that they are carried out with sufficient detail in order
to identify and correct potential food safety issues.
Since the self-inspection program is an extension of employee training programs
and is also used to assess the needs of the facility, the conduct of the inspection committee
members is critical to the success of the program. Having the tools (ladders, manlifts,
keys for access, etc.) available ahead of time and discussing issues identified with area
employees can only improve the acceptance of the program and participation by everyone.
Conducting a good inspection requires considerably more than collecting a long list
of issues for someone to correct. Far too often, without proper training of the inspectors,
the process becomes bogged down in personal conflicts. The task requires a person to
review a situation, identify the deficiency, determine a corrective action, and follow
through to its implementation.
Perhaps the two most important things a person can bring to the self-inspection
process are a blank mind and a blank notepad to document the findings. If you embark
on an inspection tour of the facility looking for specific issues, you will likely find those
issues. However, there may be other significant issues you overlook in your pursuit be-
cause your mind’s eye is closed to them. Since no one has perfect memory, the notepad
allows you to document the issues you identify and thus facilitate follow-up by the proper
personnel.
Proper note taking during inspections is a difficult task in itself. The inspection notes
are your primary method of conveying your concerns to others. You will, subsequently,
have to prioritize the corrective actions required to remedy the various defects observed.
At a minimum, the notes you take to document the findings should include what was
wrong, why you felt it was an issue, a suggestion for correction, and, perhaps most impor-
tant, the exact location in the facility where the observation was made. Understand very
clearly that the personnel reading your inspection report were likely not with you; so your
task is to create, through the least amount of words, an image that motivates them to
corrective action. Always provide the facts clearly. Poorly written inspection reports incor-
porating inaccurate or misleading comments may very well compromise the company’s
confidence in both the self-inspection program in the inspector conducting it.
Also useful during facility inspections are simple tools that permit you to make
clearer observations. Aside from dressing properly for conducting an inspection by includ-
ing safety shoes and safety equipment required by plant policy and having maintenance
resources available, other tools that may be useful to help identify opportunities include
Bright flashlight
Various spatulas
Screwdrivers
Extension inspection mirrors
Small adjustable wrench
Other specialized tools for the operation
Individual systems may require specific tools to obtain access. Regardless of the
plant or system you are inspecting, communication and following safety protocols are
imperative. Rely on the operators to provide access to equipment since they likely have
a very comprehensive knowledge of the system. Rely on them as a resource for information
to answer your questions. Since their participation is critical to the success of the programs,
involving them in the inspection process is an opportunity to provide instruction and solicit
their cooperation.
B. Inspecting the Plant

Though individual inspectors would appear to have their own unique techniques for in-
specting a food plant, close observation of their work will reveal that most of them pursue
a logical path, following the production process either from start to finish or vice versa.
Doing so can often make it easier for those reading the final report to better visualize the
flow the inspection took and improve their understanding of the issues noted.
Usually, inspectors will follow the flow of production from beginning to end. How-
ever, there are a few exceptions to this practice that you must consider. First, there may
be microbiological considerations in the process that would not allow you to start at the
beginning of a process. A facility such as a dairy would require that the raw milk receiving
area be inspected at the conclusion of the inspection to avoid the potential for transfer of
a microbiological contaminant from this area to the remainder of the facility. You may
encounter similar issues in other processes where beginning the inspection in the final
processing areas would be the most appropriate.
C. Raw Material Receiving

The raw material receiving area of the facility requires a thorough review of the materials
stored there and also close observation of the procedures followed to allow materials to
be accepted into the food plant. Each ingredient or material arriving from outside the plant
must be treated as suspect and treated as though each offers the potential for the introduc-
tion of a problem. Personnel in these receiving areas must become familiar with the poten-
tial problems they may encounter and be vigilant in their inspection of incoming materials
and the vehicles in which they arrived.
The inspection of raw materials in the storage warehouse provides an excellent op-
portunity to further identify issues with suppliers and must be paid the appropriate atten-
tion. By its design, this area of the plant houses all of the materials acquired from countless
‘‘unknown’’ sources. No other area of the plant provides a higher risk for hazards to
impact the plant.
Confirm that all of the programs the facility has developed to identify and correct
issues regarding receipt of raw materials from suppliers are in place and followed. Verify
proper dating or coding of materials and ensure that storage practices conform to the
requirements of the product and the facility. Particular attention should be paid to the
receipt documentation and pest control records for these areas to attempt to identify trends
that may have developed with a particular product or supplier. Insect monitoring devices
such as insect light traps and pheromone traps should certainly be regarded as valuable
sources of information.
Inspection of the area around the incoming products should be undertaken with a
three-dimensional approach. Too often we tend to limit ourselves to the easily accessible
areas or fail to fully identify the extent of an issue because the scope of the search was
equally limited. By making observations from an elevated vantage point that provides a
broad overview of a certain section of the facility, the inspector may be able to identify
a breakdown of a specific program or a potentially serious isolated issue that might go
unobserved at ground level. In a storage area for ingredients, for example, the observation
of dust and debris accumulations on numerous pallet stacks might signal a widespread
defect in stock rotation or cleaning programs. By spotting just one pallet stack that appears
to be out of sequence in the stock rotation system, the inspector is prompted to call atten-
tion to a specific issue that may have escaped the attention of the responsible plant per-
sonnel.
It is well worth the effort while you are in this area of the plant to inspect and
confirm the use of the product safety devices established to monitor incoming materials.
Sifters, strainers, magnets, metal detectors, filters, and other devices should be closely
examined and their documented records checked to determine if failures have occurred and
actions taken in response to these failures. This task is one that provides the opportunity to
involve the area personnel in the inspection process and enables them to demonstrate their
capabilities and participation in the overall product safety program.
D. Production Areas
The production areas of factories offer a variety of challenges and opportunities. Often
congested with equipment and in a state of haste, extra caution is required by the individual
inspecting these areas. Even the most knowledgeable employees have been known to
make simple errors of judgment that have caused serious injury. Always be aware of and
concerned about the effect your actions may have while working in busy areas of the
facility.
Though a human brain is indeed a marvelous tool, it has limitations. A limited

amount of data can be taken in, processed, analyzed, and interpreted. The volume of data
challenging the inspector in the production/processing area can be overwhelming. We
may believe we are making a comprehensive survey of an area when we attempt to scan
the entire area at one time, but in reality our mind’s eye tends to deceive us about how
little we actually see.
To overcome this, the inspector should break down (or cube) the area into small,
manageable parts to better evaluate conditions, with smaller volumes of data handled
individually rather than as a whole. To accomplish this, simply establish boundaries in a
given room and thoroughly evaluate that space before moving on to the adjacent space.
Use a piece of equipment or any solid object to help you focus on that object and the
surrounding space before moving on to the next piece of equipment.
A primary objective of the inspection conducted in processing areas is often to
establish that all of the policies and procedures in place are in fact being followed. Person-
nel given this responsibility need to recognize that their greatest asset is their ability to
observe and then to correlate the observations with the sum total of the processing opera-
tions. To do so, the auditor must have a comprehensive understanding not only of the
guidelines established within the organization, but also of the potential impacts of noncon-
formance with those guidelines.
This knowledge becomes increasingly relevant when the time for corrective action
requires the participation of the production area employees. Your ability to explain the
deficiency and what will be required for correction in a logical and meaningful way to
the personnel working in a given area will likely facilitate implementation of the correction
far more quickly than if it is perceived that you do not know what you are talking about.
When you can relate the need for change in such a way that the responsible employee
sees it as a personal advantage, then compliance with the change easily follows.
Recognize that the production facility changes throughout the day and that inspec-
tions conducted at various times will likely reveal different issues. This is partially dictated
by the access you have to the systems at various times. Realizing this, the plant inspection
program should be conducted during the different shifts in an attempt to obtain a varied
assessment of conditions in the operation.
E. Production Periods
Inspections conducted in production areas during production periods offer an opportunity
to observe personnel practices and the operational methods employed, as well as the over-
all state of repair of the facility, systems integrity, and policy compliance. Since personnel
are often a source of concern, time spent on the production floor during these periods is
extremely valuable. However, recognize the limitations you will encounter if your objec-
tive is to inspect the condition of the production equipment; access to critical elements
of the system will probably not be available for inspection except during production down-
time.
The inspection of the processing areas encompasses the GMP issues. Due to lack
of available time and scheduling constraints that do not allow for separate and distinct
evaluations, many companies combine both GMP and production/processing evaluations
in abbreviated formats to be conducted during the same visit to the facility. More detailed
audits can then be performed if the information collected warrants further action. This is
especially the case when there is a critical process control that also involves a food safety

risk. Verification that processes are being held within the critical limits established for
the product, as well as verifying the integrity of the system, is often incorporated into the
inspection process [4].
F. Packaging Areas
Special attention is required when inspecting the packaging area of any facility. This area
is the last point in the process where you have the opportunity to remove those products
not conforming to established specifications. Your inspection should focus on the ability
of the systems used to identify failures (magnets, metal detectors, sieves, etc.) and the
level of compliance by area personnel in the proper monitoring of these systems.
The inspection process should provide for a very thorough review to identify any
and all possible defects that might pass through the system and to ensure that they are
detected and corrected. It should be standard practice to test the metal detection equipment
and verify its effective operation by using the appropriate test blanks (see also Chapter
23). You should confirm that area personnel responsible for the validation procedures
follow the proper test protocols and, if necessary, then make sure that these same people
make the appropriate adjustments. In addition, the inspection procedures should include
a verification of code date systems and proper packaging for the products.
Packaging systems, ventilation systems, and electrical elements have become in-
creasingly complex and are often sensitive to the intrusion of untrained personnel per-
forming routine inspections. Due to these complexities, many plant managers are reluctant
to allow access to these systems frequently enough to insect infestations or other sources
of contamination to develop. To limit the potential for these unwanted outcomes to occur,
you must provide training to develop the skill level and competence of the personnel in
these areas.
G. Support Areas
Though often overlooked or de-emphasized during plant inspections, support areas can
have a significant impact on the rest of the facility. Many inspectors will gauge the level
of tolerance for policy compliance by the way the mechanical or utility areas are main-
tained. A general lack of GMP or plant policy compliance identified in these areas will
often raise suspicions in other areas as well. All plant policies should be uniformly applied
throughout the facility. Such areas should be checked closely for the presence of pest
activity or personnel practices that could lead to contamination by chemical, physical, or
microbiological means.
H. Exterior Areas
Failure to inspect the exterior areas of a food plant could lead to serious consequences.
Often, infestation issues can be traced directly to conditions that exist in these areas or
to a system failure. For example, a ventilation system that is in need of repair and no
longer provides the barrier protection it was designed for is a system failure. Ignoring
these areas can lead to serious food safety issues.
The inspection of the exterior should include the grounds along the immediate build-
ing exterior (see also Chapters 19 and 20). Also inspect the grounds as far out from the
building as necessary to identify unwanted conditions such as water sources, habitats con-
ducive to pest activity, or undesirable practices by personnel. Occasionally, the inspector
may have to consider surrounding properties as potential sources of hazards; a strategy
must be developed to reduce their impacts on the food plant.
The entire structure, including the roof, should receive close scrutiny to determine
if the proper barriers to exclude potential hazards are in place. Often, the roof is overlooked
as a contributor to rodent and insect activity experienced in the plant. Data collection
systems, such as mechanical rodent traps, will passively but efficiently monitor these areas.
These data then, when analyzed, will provide direction for the actions needed (see also
Chapter 17).
V. INSPECTION TIPS
Through experience, inspectors realize that regardless of how thorough they are, not every
issue will be identified during each inspection. More apparent issues often hide critical
issues. The hidden issues will not be identified until the less critical items have been
eliminated. No inspector, whether new or a seasoned veteran, should be discouraged when
this happens. Understand that the plant is in a constant state of change and issues do not
always present themselves in the same manner. The inspection becomes a means of discov-
ery and should be conducted frequently enough to allow you to improve and move forward.
The greatest asset an inspector can possess is knowledge. Whether your specialty
is microbiology, entomology, engineering, or even human resources, proper application
of your knowledge during the inspection will lead you to the significant issues. An accumu-
lation of wet debris may catch the interest of the microbiologist because of the microbio-
logical issues. An entomologist would regard the same issue as a potential pest harborage.
The individual from the human resources department may look at it as the failure of an
employee to follow standard procedures. Regardless of specialty, all would be drawn to
the issue and would, subsequently, make an effort to correct the basic problem. Use the
skills you possess and build on them.
Here are a few examples of how to expand your information sources during an
inspection.
Don’t be hesitant to ‘‘look up’’ when evaluating the possible location of the source
of insect activity found at floor level. Recent cleaning efforts in the area may
have dislodged a population of insects and, though they were found on the floor,
the source may be far more extensive than it first appears.
Repeated observations of insect activity along an area adjacent to a wall may require
you to access the interior of the wall to check the void space for product accumula-
tion and infestation. Your knowledge of the building structure will help with the
evaluation of this type of issue.
High microbe counts in a sensitive area would likely lead you to look for areas where
water is present. Closely inspect areas that would not normally be considered as
wet, such as ducting for ventilation or dust collection systems. Due to changes
in diameter or direction of the ductwork, product and/or moisture may collect
and cause problems.
Never overlook an opportunity to inspect a void space in the building or in equip-
ment. Void spaces, regardless of the size, often provide harborages for pests. They
may also serve as unauthorized storage areas for personnel. Examination of these
areas should become a routine practice during plant inspections.
Many inspectors routinely check the insect light traps for the source of insects found
in a certain area. In the absence of the traps, overhead lighting with shatterproof
globes or shields is another good area to check for insects. Insect activity found
in these units may lead to the discovery of ventilation filters in need of adjustment
or replacement or a recent opening created in an exterior wall.
Employee practices, such as the excessive use of tape or other materials to repair
equipment, should be recognized as an issue. In this case there are perhaps two
issues needing attention: a lack of adequate training and a need to improve the
overall maintenance program. Often, observing employee behavior and practices
provides insight into the status of these programs.
Take full advantage of all clues that come to you, directly or indirectly, from the
efforts of other plant personnel. For example, inspect the interior of vacuum clean-
ers and trash bags. The materials collected in these receptacles sometimes yield
evidence of GMP or sanitation issues, such as an insect infestation, that have
otherwise gone unobserved in a particular part of the facility. A vacuum cleaner
inspected after a cleanup period will give you an overview of the level of infesta-
tion in a general area based on the number of insects concentrated in the collection
reservoir.
When you are presented with an opportunity to take an issue at face value or to
investigate, choose to investigate. A thorough evaluation of any issue promotes
your credibility and, in most cases, confirms your first impression that an issue
was present and required attention.
As stated at the beginning of this chapter, the plant inspection is designed to provide
an overview of the condition of the facility. To do this effectively in the limited time
normally available to the inspector, the use of all disciplines and resources possessed by
the inspector are required. This book in its entirety provides an excellent source of informa-
tion for the various programs that should be in place in any food manufacturing facility.
Use the information as a guide and as a means to expand your abilities.
REFERENCES
1. American Institute of Baking. Basic Food Plant Sanitation Manual, 3rd Ed. Manhattan, KS:
American Institute of Baking, 1979.
2. JL Vetter. Food Laws and Regulations. Manhattan, KS: American Institute of Baking, 1996.
3. American Institute of Baking. Inspectional methods taught by FDA: inspections by specific food
groups [abstracted from FDA operational manual available at www.FDA.gov.ora.inspect ref].
Manhattan, KS: American Institute of Baking.
4. FDA. Title 21, Code of Federal Regulations, Part 110, Current Good Manufacturing Practice in
Manufacturing, Packing, or Holding Human Food. Washington, DC: U.S. Government Printing
Office, 2000, pp 208–217.

5
Hard or Sharp Foreign Objects in Food
ALAN R. OLSEN
U.S. Food and Drug Administration, Washington, D.C., U.S.A.
MICHAEL L. ZIMMERMAN
U.S. Food and Drug Administration, Albuquerque, New Mexico, U.S.A.
I. INTRODUCTION
A. Foreign Objects as Physical Hazards
Foreign objects in foods are considered adulteration under the provisions of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) [1]. Foreign objects can be broadly classified
as hazardous (e.g., glass) or nonhazardous (e.g., filth). Some hard or sharp objects in food
are physical hazards that may cause traumatic injury including laceration and perforation
of tissues of the mouth, tongue, throat, stomach, and intestine as well as damage to the
teeth and gums. A food that contains physically hazardous foreign objects is deemed
adulterated under Section 402(a)(1) of the FD&C Act in that ‘‘it bears or contains any
poisonous or deleterious substance which may render it injurious to health.’’
B. Naturally Occurring Hard Objects

Section 402(a)(1) of the FD&C Act applies only to ‘‘an added substance.’’ Hard or sharp
natural components of a food (e.g., bones in seafood, pits in whole olives) are unlikely
to cause injury because of awareness on the part of the consumer that the component is
a natural and intrinsic component of a particular product. The exception occurs when the
food’s label represents that the hard or sharp component has been removed from the food.
The presence of naturally occurring hard or sharp objects in those situations (e.g., pit
fragments in pitted olives) is unexpected and may cause injury. The U.S. Food and Drug
Administration (FDA) has established Defect Action Levels (DALs) [2] for many of these
types of unavoidable defects.
C. Foreign Objects as Nonhazardous Filth
Not all foreign objects are physical hazards. For example, tiny metal shavings sometimes
generated by opening cans with a can opener do not normally pose a physical hazard.
Other types of foreign objects that are not categorized as physical hazards include insects
and mites and their fragments, evidence of rodents and birds such as their excreta, hairs
and feathers, and molds and rots associated with decomposition and dirty machinery parts.
Foods containing these types of nonhazardous foreign matter may be deemed adulterated
under Section 402(a)(3) of the FD&C Act in that ‘‘it consists in whole or in part of any
filthy, putrid, or decomposed substance’’ or ‘‘it is otherwise unfit for food.’’
II. HAZARDOUS FOREIGN OBJECTS

A. FDA Definition of a Physical Hazard
A foreign object in food is categorized as a physical hazard if it meets all of the following
criteria:
There is clinical evidence of physical trauma or injury from ingestion.
Medical authorities recognize the type of object as a potential ingestion hazard.
Subsequent processing or intended use of the product does not eliminate or neutral-
ize the hazard.
These criteria apply to all types of physical hazards, including hazards from hard foreign
objects, from sharp foreign objects, and from objects that pose a choking hazard.
B. Hard or Sharp Foreign Objects

The most common type of physical hazard from foreign objects that are encountered in
food products is the injury or trauma hazard from hard or sharp foreign objects [3]. Ac-
cording to FDA Compliance Policy Guide 555.425, any hard or sharp foreign object that
is 7 mm or larger is a potential physical hazard in food [4]. This guideline does not apply
to the naturally occurring hard foreign objects as described under Sec. I.B. Two additional
conditions are included in the Compliance Policy Guide. The first condition provides that
a foreign object is not a physical hazard if the processing or intended use of the food
would remove the hazard (e.g., filtration). Intended use and processing steps that would
remove or neutralize a hazard are important considerations when evaluating the likelihood
of a hazard occurring. The second condition provides that if a product is intended for use
by a special risk group (e.g., elderly, infants), then foreign objects as tiny as 2 mm, or
even smaller, could be a potential physical hazard.
C. Choking Hazards
There are no clear science-based parameters for what constitutes a choking hazard from
foreign objects in food. Research in the area of choking hazards is mainly concerned with
establishing size criteria above which an object is unlikely to be mouthed or swallowed
by small children [5]. The Consumer Product Safety Commission (CPSC) has established
a safety standard for small parts in toys that may serve as a general standard for comparison
when dealing with foreign objects that are larger than the 25-mm CPSC standard [6]. The
CPSC standard defines what size of an object is too large to be accidentally swallowed
by small children but does not address the question of how small an object must be in
order to be considered nonhazardous in this regard.
D. Other Agencies
The FDA criteria and guidance regarding physical hazards from hard or sharp foreign
objects in food are consistent with guidance from other government agencies that are
concerned with food safety. The United States Department of Agriculture (USDA) catego-
rizes hard or sharp objects over 7 mm in length as potentially hazardous, while objects
that measure between 2 and 7 mm are normally considered a nonhazardous defect [7].
Health Canada recognizes foreign objects 2 mm or greater as being a potential physical
hazard.
E. Potential Sources of Physical Hazards

Three major sources of physical hazards involving foreign objects are (1) foreign objects
in raw materials, (2) objects that break off containers, processing machinery, or other
equipment in the plant, and (3) objects associated with maintenance operations (e.g., glass
from unshielded light bulbs). Food manufacturers and processors must be aware of these
possible sources of physical hazards and be prepared to take proactive measures to prevent
the hazards from occurring.
F. Analytical Considerations
The analytical techniques for detecting potentially hazardous foreign objects in food rely
on visual examination of product samples [8] and on sedimentation methods that separate
food components from heavier or denser foreign objects [9]. A special protocol for the
analysis of infant food for glass has been established by FDA to deal with this highly
sensitive issue [10].
III. HAZARD ANALYSIS AND CRITICAL CONTROL POINTS

A. Definition
Hazard analysis and critical control points (HACCP) is a preventive system of hazard
control that is designed to identify hazards, establish controls, and monitor the controls.
Hazards can be harmful microorganisms, toxic chemical contaminants, or physically haz-
ardous foreign objects [11]. The FDA requires formal written HACCP plans for members
of the seafood industry. The FDA-mandated seafood HACCP plans [12] must follow the
seven principles of HACCP, as listed in Table 1. Recently, the FDA proposed a rule that
would require similar HACCP plans for establishments that manufacture or import fruit
juice [13].
B. Application
The first HACCP principle requires an establishment to conduct a hazard analysis to iden-
tify any potential hazards, including physical hazards, and to identify preventive measures
[14]. Table 2 is an example of the application of the first HACCP principle to the identifi-
cation of potential physical hazards. The HACCP planners use aids such as Table 2 to
identify which potential hazards are reasonably likely to occur in their manufacturing
Table 1 National Advisory Committee on Microbiological Criteria for Foods’
Seven Principles of Seafood HACCP
1. Conduct hazard analysis and identify preventive measures.

2. Identify critical control points.
3. Establish critical limits.
4. Monitor each critical control point.
5. Establish corrective action to be taken when a critical limit deviation occurs.
7. Establish verification procedures.
Source: Ref. 10.
Table 2 Examples of Potential HACCP Physical Hazards from Foreign Objects in Food
Foreign objects Potential hazard Possible source
Bone (sliver/chip) Trauma Processing (hard/sharp pieces)
Burr Trauma/dental Raw materials
Button Dental Personal effects
Coin Dental Personal effects
Glass Trauma Processing (e.g., lights, containers)
Hand tool Dental Maintenance
Hard plastic Trauma Processing (e.g., tote bin, packaging), personal ef-
fects (e.g., false fingernail)
Hard shell Trauma/dental Raw materials (crustaceans)
Hook Trauma Raw materials (fish hook)
Insect Trauma Raw materials (e.g., sharp spine), processing
(e.g., dermestid setae)
Insulation Trauma Maintenance (e.g., asbestos)
Jewelry Trauma/dental Personal effects
Key Dental Personal effects
Lead weight/shot Dental Raw materials
Loose solder/weld Dental Maintenance
Machinery part Dental Processing
Metal shaving Trauma Maintenance (e.g., plumbing repair)
Metal sliver Trauma Processing (e.g., container strap)
Nail Trauma Maintenance
Puncture vine Trauma Raw materials
Stainless steel Dental Processing
Staple Trauma Personal effects
Stone Dental Raw materials
Thorn Trauma/dental Raw materials
Thumb tack Trauma Personal effects
Wire Trauma Raw materials (e.g., twist tie), processing (e.g.,
screen/sieve)
Wood splinter Trauma Raw materials (e.g., crate), processing (e.g., table,
tool handle)
Source: Ref. 4.

process and to locate the possible sources of likely hazards so that appropriate controls
can be designed and implemented.
The HACCP planner’s goal is to prevent the hazard from occurring and to have a
preplanned corrective action ready in the event that the HACCP control fails. The USDA
also requires HACCP systems for many of the firms regulated by that agency. Although
HACCP plans are not required for all segments of the food industry, many food manufac-
turers and processors recognize the value of a voluntary HACCP system and are applying
HACCP principles to their businesses.
IV. NONHAZARDOUS FOREIGN OBJECTS

A. Filth and Extraneous Material
Foreign objects that do not qualify as a physical hazard according to the definition in Sec.
II.A may still be considered to be filth adulterants, as defined in Section 402(a)(3) of the
FD&C Act. Filth adulterants are fully discussed in Chapter 6 of this book.
B. Naturally Occurring Components

Normally, naturally occurring components of a product (e.g., pits in dates) are not consid-
ered hazardous because the consumer is aware of the components. However, if a product’s
label indicates that the component has been removed (e.g., pitted dates), then the failure
to completely remove the component could be construed as adulteration and evaluated
according to the physical hazard definition in Sec. II.A.
C. Defect Action Levels

Many nonhazardous, naturally occurring hard objects are considered natural defects, which
are to a certain extent unavoidable. The FDA establishes maximum levels for these harm-
less defects (e.g., pit fragments in pitted dates). The FDA maximum levels are called
defect action levels. Defect action levels represent levels of natural, harmless defects that
are attainable when a product is produced under current good manufacturing practices
(CGMPs). Compliance with DALs does not excuse adulteration resulting from unsanitary
conditions [12].
D. Other Considerations
The intentional addition of a foreign object to a food is subject to criminal prosecution
under the Federal Anti-Tampering Act if the intent is fraud or sabotage [15]. The lead
enforcement agency for the Federal Anti-Tampering Act, the Federal Bureau of Investiga-
tion, often coordinates with the FDA to investigate incidents of tampering. The FD&C
Act, Section 402(d)(1), specifically prohibits imbedding objects in confectionery products.
Even though the intent is not malicious, the law specifically forbids this type of novelty
confection.
V. THE FDA COMPLAINT REPORTING SYSTEM

During a 12-month period (October 1988 to September 1989), Hyman et al. [16] compiled
data on 10,923 complaints about food registered with the U.S. Food and Drug Administra-
tion. Of these complaints, 25% (2726 cases) involved foreign objects in food or drink,
and 14% (387 cases) of these involved illness or injury associated with foreign objects
ingested in beverages or food. Most of the injuries/illnesses, as might be expected, in-
volved cuts or abrasions in the mouth and throat, damage to teeth or dental prostheses,
or gastrointestinal distress. The foreign objects were ranked, ordered from most to least
common: glass, slime or scum, metal, plastic, stones/rocks, crystals/capsules, shells/pits,
wood, and paper.
Foreign object complaints involving injury or illness were associated most often
with soft drinks, followed in descending order by baby foods, bakery products, cocoa/
chocolate products, fruits, cereals, vegetables, and seafoods. The study by Hyman et al.
revealed that health professionals rarely reported cases if injury or illness was attributed
to foreign objects in beverages and foods. Most often (82% of the cases), it was the con-
sumer who registered the complaint. Hyman et al. also note that the FDA Complaint
Reporting System is a much underused early warning system that, if properly utilized,
could benefit greatly both consumers and producers of foods and beverages in the United
States.
REFERENCES
1. FDA. Federal Food, Drug, and Cosmetic Act, as Amended February 1998. Rockville, MD:
Division of Compliance Policy, Office of Enforcement, Food and Drug Administration, 1998,
pp. 37–38.
2. FDA. Food Defect Action Levels. Washington, DC: Center for Food Safety and Applied Nutri-
tion, Food and Drug Administration, 1995.
3. AR Olsen. Regulatory action criteria for filth and other extraneous materials: I. Review of
hard or sharp foreign objects as physical hazards in food. Regul Toxicol Pharmacol 28:181–
189, 1998.
4. FDA. Compliance Policy Guides: Section 555.425, Foods—Adulteration Involving Hard or
Sharp Foreign Objects. Rockville, MD: Division of Compliance Policy, Office of Enforcement,
Food and Drug Administration, 2000, pp 326–328.
5. G Rider, CL Wilson. Small parts aspiration, ingestion and choking in small children: findings
of the Small Parts Research Project. Risk Anal 16:321–330, 1996.
6. Consumer Product Safety Commission. Title 16, Code of Federal Regulations, Part 1501,
Method for Identifying Toys and Other Articles Intended for Use by Children Under 3 Years
of Age, Which Present Choking, Aspiration, or Ingestion Hazards Because of Small Parts.
Washington, DC: U.S. Government Printing Office, 1997, pp 464–467.
7. JR Rhodeheaver. Inspection Procedures for Foreign Materials. U.S. Department of Agriculture
File Code 172-A-1, 1996, pp 1–18.
8. AR Olsen, SA Knight, GC Ziobro (eds.). Macroanalytical Procedures Manual, Revised Edi-
tion. FDA Technical Bulletin Number 5. Washington, DC: Food and Drug Administration,
1998.
9. JL Boese, SM Cichowicz. Extraneous materials isolation. In: P Cunniff, ed. Official Methods
of Analysis of AOAC International. Arlington, VA: AOAC International, 2000, chap. 16, pp.
1–69.
10. JS Gecan, SM Cichowicz, PM Brickey Jr. Analytical techniques for glass contamination of
food: a guide for administrators and analysts. J Food Prot 53:895–899, 1990.
11. National Seafood HACCP Alliance. HACCP: Hazard Analysis and Critical Control Point
Training Curriculum, 2nd Ed. Raleigh, NC: North Carolina Sea Grant, North Carolina State
University, 1997.
12. FDA. Title 21, Code of Federal Regulations, Part 110, Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Human Food. Washington, DC: U.S. Government
Printing Office, 2000, pp 208–217.

13. FDA. Hazard analysis and critical control point (HACCP) procedures for the safe and sanitary
processing and importing of juice: final rule. Fed Reg 66(13):6137–6202, 2001.
14. FDA. Fish and Fishery Products Hazards and Control Guide, Chapter 20—Metal inclusion.
Washington, DC: Center for Food Safety and Applied Nutrition, Food and Drug Administra-
tion, 1998.
15. U.S. Department of Justice. Federal Code and Rules, Title 18, Code of Federal Regulations,
Chapter 65, Section 1365, Tampering with Consumer Products. St. Paul, MN: West Group,
1997, pp 702–704.
16. FN Hyman, KC Klontz, L Tollefson. Food and Drug Administration surveillance of the role
of foreign objects in foodborne injuries. Public Health Reports 108(1):54–59, 1993.

6
Filth and Extraneous Material in Food
MICHAEL L. ZIMMERMAN
U.S. Food and Drug Administration, Albuquerque, New Mexico, U.S.A.
ALAN R. OLSEN
SHARON L. FRIEDMAN
U.S. Food and Drug Administration, Laurel, Maryland, U.S.A.
I. INTRODUCTION
A. The Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act (FD&C Act) [1] contains three paragraphs
that apply to extraneous material in food. The first, Section 402(a)(1), states that ‘‘a food
shall be deemed to be adulterated if it bears or contains any poisonous or deleterious
substance which may render it injurious to health.’’ The second, Section 402(a)(3), states
that ‘‘a food shall be deemed to be adulterated if it consists in whole or in part of any
filthy, putrid, or decomposed substance, or if it is otherwise unfit for food.’’ Finally,
402(a)(4) states that ‘‘a food shall be deemed to be adulterated if it has been prepared,
packed, or held under insanitary conditions whereby it may have become contaminated
with filth, or whereby it may have been rendered injurious to health.’’
B. Definitions
The courts have always defined filth in its ordinary sense (i.e., the dictionary definition)
rather than giving the term any specialized, technical meaning [2]. The same can be said
for extraneous material, that is, things that do not belong in food, such as filth or any
foreign matter in a product as a result of objectionable conditions or practices in produc-
tion, storage, or distribution of food. Included within the meaning of extraneous material
(or matter) are filth (any objectionable matter contributed by animal contamination such
as rodent, insect, or bird matter); decomposed material (decayed tissues due to parasitic
or nonparasitic causes); and miscellaneous matter such as sand, soil, glass, rust, or other
foreign substances (bacteria excluded) [3].
C. AOAC International
In the course of enforcing the FD&C Act, the Food and Drug Administration (FDA)
relies upon official compendia for definitions and analytical methodology for detecting
and categorizing filth and extraneous material in foods. These methods include flotation
and sieving extraction procedures for light and heavy filth recoveries, both microscopic
and macroscopic; visual examination procedures for macroscopic filth; and chemical tech-
niques for detecting residues of urine and excrement. The reliance upon official compendia
is required under Part 2, Section 2.19, ‘‘Methods of Analysis,’’ in Title 21 of the Code
of Federal Regulations (21 CFR) [4]. Two official compendia commonly used for filth
and extraneous materials are the AOAC International (formerly known as Association of
Official Analytical Chemists) Official Methods of Analysis [3] and the FDA ‘‘Macroanaly-
tical Procedures Manual’’ [5].
II. CATEGORIES OF FILTH AND EXTRANEOUS MATERIAL

The science relating to filth and extraneous material has developed in recent years to the
point that scientists now recognize three major categories of filth and extraneous material.
The categories are (1) potentially hazardous, (2) indicators of insanitation, and (3) aesthetic
defects [6–8]. These categories focus on the issues of food safety and wholesomeness of
foods. The purpose of organizing filth and extraneous material into these three categories
is to provide an objective and uniform framework for evaluating whether or not there are
any health risks associated with a particular type of filth element. This framework is espe-
cially important for the development of modern food safety programs that rely upon risk
management and/or hazard analysis and critical control point (HACCP) principles to en-
sure the safety and wholesomeness of the food supply [9].
A. Potentially Hazardous Extraneous Material

1. Criteria
The criteria for categorizing foreign/extraneous material as potentially hazardous include:
Clinical evidence of injury from ingestion.
Recognized as a hazard by medical or scientific authorities.
Hazard is not removed or neutralized by subsequent process or intended use of the
product.
2. Examples of Potentially Hazardous Extraneous Material
Hazards from extraneous material include physical hazards such as hard or sharp foreign
objects (see Chapter 5) and chemical hazards from allergenic pests such as mites and
cockroaches [7]. Table 1 lists examples of potentially hazardous allergenic mites that have
caused allergic reactions in people when ingested in mite-infested food [7]. Examples of
physical hazards are included in Chapter 5.
Table 1 Examples of Allergenic Mites that Infest
Food Products
Species References
Dermatophagoides farinae 16, 17, 18
Suidasia sp. prob. pontifica 17
Thyreophagus entomophagus 18
Tyrophagus putrescentiae 19
Source: Adapted from Ref. 7.
3. Vectors
There is also an indirect health hazard from insects and other pests that are known vectors
of foodborne diseases. These disease vectors include certain species of flies, cockroaches,
ants, and rodents that are contributing factors to the spread of foodborne pathogens such
as pathogenic types of Salmonella, Shigella, and Escherichia coli. Table 2 lists the species
of pests that meet the following criteria for categorizing a pest as a vector of foodborne
pathogens [10]:
Synanthropy (living around human settlements)
Endophily (found inside buildings)
Communicative behavior (moves back and forth between food and pathogen reser-
voir)
Attracted to food and filth
History of pathogens in wild populations
It is important to recognize that the actual hazard is the foodborne pathogen, not
the pest that carries the pathogen, and that the effective elimination or neutralization of
the pathogen hazard, through subsequent processing or intended use of the product, may
render the vector species less dangerous as a contributing factor to the spread of the patho-
gen (see Sec. III for further discussion of this concept).
B. Indicators of Insanitation
Regardless of whether a health hazard has been demonstrated, pest activity and/or the
presence of foreign matter in food are indications of insanitation.
1. Criteria
The basis for categorizing filth and extraneous material as indicators of insanitation is
found in the FDA current good manufacturing practices (21 CFR 110) [11]. The current
good manufacturing practices, or food CGMPs, address the need for hygienic personnel
practices; adequate maintenance of facilities, production, and process controls; hygienic
warehousing and distribution practices; and exclusion of pests. The food CGMPs are used
to determine whether or not a food is adulterated within the meaning of Sections 402(a)(3)
and/or 402(a)(4) of the FD&C Act [1].
2. Examples of Indicators of Insanitation
Often, the first indications of insanitation consist of on-site observations by inspectors or
quality control personnel. Examples include observations of potential routes of entry for
Table 2 Examples of Pests that Are Vectors of Foodborne Pathogens
Common name Scientific name
German cockroach Blattella germanica (L.) (Dictyoptera: Blattellidae)
Brownbanded cockroach Supella longipalpa (Fabricius) (Dictyoptera: Blattellidae)
Oriental cockroach Blatta orientalis L. (Dictyoptera: Blattidae)
American cockroach Periplaneta americana (L.) (Dictyoptera: Blattidae)
Pharaoh ant Monomorium pharaonis (L.) (Hymenoptera: Formicidae)
Thief ant Solenopsis molesta (Say) (Hymenoptera: Formicidae)
Housefly Musca domestica L. (Diptera: Muscidae)
Stable fly Stomoxys calcitrans (L.) (Diptera: Muscidae)
Little housefly Fannia canicularis (L.) (Diptera: Muscidae)
Latrine fly Fannia scalaris (Fabricius) (Diptera: Muscidae)
Cosmopolitan bluebottle fly Calliphora vicina Robineau-Desvoidy (Diptera: Calliphoridae)
Holarctic bluebottle fly Calliphora vomitoria (L.) (Diptera: Calliphoridae)
Oriental latrine fly Chrysomya megacephala (Fabricius) (Diptera: Calliphoridae)
Secondary screwworm Cochliomyia macellaria (Fabricius) (Diptera: Calliphoridae)
Bluebottle fly Cynomyopsis cadaverina Robineau-Desvoidy (Diptera: Callipho-
ridae)
Green bottle fly Lucilia (Phaenicia) sericata (Meigen) (Diptera: Calliphoridae)
Black blow fly Phormia regina (Meigen) (Diptera: Calliphoridae)
Redtailed flesh fly Sarcophaga haemorrhoidalis (Fallén) (Diptera: Sarcophagidae)
House mouse Mus musculus (Mammalia: Muridae)
Polynesian rat Rattus exulans (Mammalia: Muridae)
Norway rat Rattus norvegicus (Mammalia: Muridae)
Roof rat Rattus rattus (Mammalia: Muridae)
pests; potential harborage for pests; poor maintenance of equipment or buildings that may
lead to contamination; failure of employees to wear appropriate protective garments in
food processing areas to prevent contamination; failure to inspect raw materials for con-
taminants; and discovery of live pest infestations or other evidence of commensal pest
activity (e.g., excreta, gnawing, nests) [12]. The presence of filth from a commensal pest
in a food product is, in and of itself, an indication of insanitation. Identification of filth
from insects or other pests in food is mandatory in order to differentiate between pest
contaminants that are indicators of insanitation and contaminants that are harmless and
unavoidable [13]. The precise identification of insects fragments in food, for example,
allows access to information about the insect’s biology and distribution, which in turn
allows the understanding of the history of the contamination and the etiology or origins
of the contaminants [14].
3. Commensal Pests
Within the animal community, there are certain species that are considered commensal
pests because of their ability to adapt to manmade environments. Evidence of commensal
pest activity in a food-processing or storage facility is a strong indicator of insanitation.
These pests are synanthropic, endophilic, and attracted to human food. They tend to flour-
ish under the types of insanitary conditions and neglect associated with poor CGMPs and
the spread of foodborne disease. There are over 600 species of commensal pests that could
infest food and food handling facilities [13]. There are four major categories of commensal
pests that may contaminate processed food products [10]. The categories are opportunistic
pests, adventive pests, obligatory stored-product pests, and parasitoids/predators of the
first three categories.
1. Opportunistic pests. Opportunistic pests are synanthropic, endophilic, at-
tracted to human food, and communicative in behavior. Unlike stored-product
pests, they are rarely found living in the products they contaminate. Examples
of opportunistic pests include commensal flies, cockroaches, ants, rats, and
mice. Many opportunistic pests are also carriers of disease. If the circumstances
indicate a reasonable likelihood that a particular opportunistic pest could trans-
mit pathogens to humans via the food product, then the pest is categorized as
a vector. If, under different circumstances, the situation is such that there is
little chance that the same pest could actually transmit viable pathogens to the
consumer via the food, then the pest is categorized as an opportunistic pest and
indicator of insanitation. Thus, a house fly, for example, could be either a patho-
gen vector or an indicator of insanitation, depending on the circumstances.
2. Adventive pests. Adventive pests are those that are synanthropic and some-
what endophilic but lack communicative behavior and are not particularly at-
tracted to human food. These include bird, bat, and insect pests that may enter
food processing facilities in order to nest, roost, or conduct some other activity
not closely concerned with the human food located in the facility.
3. Obligatory pests. Obligatory pests are the typical storage pests. They are syn-
anthropic, endophilic, attracted to human food, and normally live and breed in
the food product under storage conditions. Obligatory storage insects are rarely
associated with the transmission of foodborne pathogens.
4. Parasitoids. Finally, predators and parasitoids (tiny parasitic wasps in this
scenario) associated with the other three categories of commensal pests are also
encountered as contaminants because they are attracted to their hosts or prey
in or near the food product.
C. Aesthetic Defects
1. Criteria
Filth that does not meet the criteria for hazardous filth or for indicators of insanitation is
nonetheless objectionable to the consumers and excessive levels of these defects are sub-
ject to regulatory action. This includes aesthetic defects, incidental and field pests, and
microscopic filth elements that are not derived from vectors or indicators of insanitation.
The presence of these types of filth often indicates inadequate cleaning of raw materials.
2. Examples of Aesthetic Defects
Examples of types of filth and extraneous material that meet the criteria for aesthetic
defects include agricultural and incidental pests; residues from agricultural fields such as
sand, grit, and stems; and gross contamination that, although essentially harmless, would
still be highly objectionable to the consumer.
3. Defect Action Levels
Title 21, Code of Federal Regulations, Section 110.110, allows FDA to establish maximum
levels of natural or unavoidable defects in foods for human use that present no health
hazard [11] (see Chapter 7). These food defect action levels (DALs) are set on the premise
that they pose no inherent hazard to health. Poor manufacturing practices may result in
FDA enforcement action without regard to defect action levels. Likewise, the mixing or
blending of food with a defect at or above the current DAL with another lot of the same
or another food is not permitted. That practice renders the food unlawful regardless of
the defect level of the finished food.
The FDA set these action levels because it is economically impractical to grow,
harvest, or process raw products that are totally free of nonhazardous, naturally occurring
defects. Products harmful to the consumer, however, are subject to FDA regulatory action
whether or not they exceed the action levels. It is incorrect to assume that because FDA
has established DALs for a food commodity, the food manufacturer need only stay just
below that level. The defect levels do not represent an average of the defects that occur
in any of the products—the averages are actually much lower. The levels represent limits
at which FDA will regard the food product adulterated and subject to enforcement action
under section 402(a)(3) of the FD&C Act [15].
III. APPLICATION
Figure 1 presents a sequential procedure for evaluating various types of filth and extrane-
ous material using the categories described in Sec. II.A–C. The decisionmaking process
described in Fig. 1 is a model that reflects the decisionmaking process used by FDA
Figure 1 Flow chart for evaluating hazardous and nonhazardous filth and extraneous materials
(SSOP, sanitation standard operating procedures). (Adapted from Ref. 10.)

and other regulatory officials to determine the significance of adulteration from filth and
extraneous material and to decide on an appropriate course of action [10]. A key feature
of the process involves the consideration of whether a potentially hazardous contaminant
would be rendered harmless or neutralized by subsequent processing or intended use by
the consumer. This process allows triage of incidents of insanitation based on the health
hazard urgency of the incidents.
For example, an infestation of disease-carrying flies in a processing plant requires
immediate corrective action if there is no biocidal barrier to pathogen growth. However,
if there is a biocidal processing step downline from the fly infestation (and the flies do
not circumvent the biocidal step), then the urgency of that fly infestation is reduced from
an immediate hazard of pathogen transmission to an indication of insanitation. Even
though the flies belong to a disease-carrying species, if their capacity to actually transmit
pathogens is neutralized, then the same flies are considered indicators of insanitation.
Indicators of insanitation also require corrective action, albeit not of the same urgency
that would be appropriate in the absence of a downline biocidal processing step.
REFERENCES
1. FDA. Federal Food, Drug, and Cosmetic Act, as Amended February 1998. Rockville, MD:
Division of Compliance Policy, Office of Enforcement, Food and Drug Administration, 1998,
pp 37–38.
2. PM Brickey Jr. The Food and Drug Administration and the regulation of food sanitation. In:
JR Gorham, ed. Ecology and Management of Food-Industry Pests. Arlington, VA: Association
of Official Analytical Chemists, 1991, pp 491–495.
of Analysis of AOAC International. Arlington, VA: AOAC International, 2000, chap. 16,
pp 1–69.
4. FDA. Title 21, Code of Federal Regulations, Part 2, Subpart 2.19, Methods of Analysis. Wash-
ington, DC: U.S. Government Printing Office, 2000, p 16.
5. AR Olsen, SA Knight, GC Ziobro (eds.). Macroanalytical Procedures Manual, Revised Edi-
tion. FDA Technical Bulletin No. 5. Washington, DC: Food and Drug Administration, 1998,
pp VI–117.
6. AR Olsen. Regulatory action criteria for filth and other extraneous materials. I. Review of
189, 1998.
7. AR Olsen. Regulatory action criteria for filth and other extraneous materials. Allergenic mites:
an emerging food safety issue. Regul Toxicol Pharmacol 28:190–198, 1998.
8. AR Olsen. Regulatory action criteria for filth and other extraneous materials. Review of flies
and foodborne enteric disease. Regul Toxicol Pharmacol 28:199–211, 1998.
9. AR Olsen. Discussion Paper on Proposed Draft Guidelines for Evaluating Objectionable Mat-
ter in Food. Codex Alimentarius Commission CCFH/CX/FH 00/13, 2000, pp 1–6.
10. AR Olsen, JS Gecan, GC Ziobro, JR Bryce. Regulatory action criteria for filth and other
extraneous materials. V. Strategy for evaluating hazardous and nonhazardous filth. Regul Tox-
icol Pharmacol 33 (in press), 2001.
11. FDA. Title 21, Code of Federal Regulations, Part 110, Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Human Food. Washington, DC: U.S. Government
12. ML Zimmerman, SL Friedman. Identification of rodent filth exhibits. J Food Sci 65(8):1391–
1394, 2000.
13. AR Olsen, TH Sidebottom, SA Knight (eds.). Fundamentals of Microanalytical Entomology:

A Practical Guide to Detecting and Identifying Filth in Foods. Boca Raton, FL: CRC Press,
1996.
14. OL Kurtz, KL Harris. Micro-analytical Entomology for Food Sanitation Control. Washington,
DC: Association of Official Agricultural Chemists, 1962.
15. FDA. Food Defect Action Levels. Washington, DC: Center for Food Safety and Applied Nutri-
tion, Food and Drug Administration, 1995.
16. AM Erban, JL Rodriguez, J McCullough, DR Ownby. Anaphylaxis after ingestion of beignets
contaminated with Dermatophagoides farinae. J Allergy Clin Immunol 92:846–849, 1993.
17. M Sanchez-Borges, A Capriles-Hulett, E Fernandez-Caldas, R Suarez-Chacon, F Caballero,
F Castillo, E Sotillo. Mite-contaminated food as a cause of anaphylaxis. J Allergy Clin Immu-
nol 99:739–743, 1997.
18. C Blanco, J Quiralte, R Castillo, J Delgado, C Arteaga, D Barber, T Carillo. Anaphylaxis
after ingestion of wheat flour contaminated with mites. J Allergy Clin Immunol 99:308–313,
1997.
19. T Matsumoto, T Hisano, M Hamaguchi, T Miike. Systemic anaphylaxis after eating storage
mite–contaminated food. Int Arch Allergy Immunol 109:197–200, 1996.

7
Food Defect Action Levels
JOHN S. GECAN*
I. INTRODUCTION
The sections of the federal Food, Drug, and Cosmetic Act (FD&C Act) [1] that are relevant
to regulating filth, decomposition, and extraneous matter are sections 402(a)(1), (a)(3),
and (a)(4). Section 402(a)(1) states that a food is adulterated when it bears or contains
any poisonous substance which may render it injurious to health. In the area of filth and
extraneous matter, this section generally applies to direct hazards such as contamination
by hard or sharp objects such as glass or metal that might cause injury.
Section 402(a)(3) states that a food is adulterated if it consists in whole or in part
of a filthy, putrid, or decomposed substance. This section applies specifically to contami-
nants found in the food product. An example might be rodent excreta pellets in wheat.
Section 402(a)(4) states that a food is adulterated when it is prepared, packed, or
held under insanitary conditions whereby the product may have become contaminated
with filth, or whereby it may have been rendered injurious to health. This section applies
to insanitary conditions that are reasonably likely to result in contamination of the prod-
ucts, even if adulteration of the food itself cannot be demonstrated. A good example would
be unshielded lighting over a production line which could result in product contamination
if a bulb were to shatter. This is a condition that would render the likelihood of contamina-
tion [2].
This chapter is intended to provide an overview of the food defect action levels
(DALs) [3], with respect to the FD&C Act, from their earliest beginnings to their future
* Retired.

role in the Food and Drug Administration’s new enforcement strategy for contamination
of foods by animal filth, decomposition, and extraneous matter. (See Appendix D.)
A. What Do We Mean by Filth?

A layman’s definition of filth in food would probably focus on some aspect of the food
that would make it so repulsive to look at, to smell, or to taste that the food would not
be eaten under normal circumstances. Filth can be a health hazard, but even if no hazard
can be shown, its mere presence in a product will render that product adulterated. The
following sections describe examples of contaminants from the three major contaminant
categories of filth.
1. Rodent Adulteration
Rodent contamination comes in many shapes, sizes, and forms. The most repulsive form
of contamination by rodents or other mammals is the presence of a whole or partial animal
in a product, such as a rabbit’s foot in frozen green beans or a mangled mouse in a custard
pie. Rodents commonly cause damage by gnawing on cardboard cartons containing pack-
aged foods. Sometimes the gnawing penetrates the inner packages, exposing the food.
Rodents also leave behind their urine and excreta pellets along with the attached
rodent hairs. These partially digested hairs, having passed through the rodent’s gut and
having emerged embedded or stuck to the fecal pellets, are frequently found as contami-
nants of foods. Rodent urine stains on foods indicate rodent visitation to the stored product.
2. Bird Adulteration
Evidence of bird activity includes everything from birds roosting above stored products
in a warehouse to excreta and feathers on product packaging. The open weave of a burlap
bag would permit the liquid excreta components, particularly at the time of deposition,
to pass through the weave and contact any food inside the sack. As the excreta dries out
and the bag is handled, the particles of the bird droppings will break up and pass through
the weave into the product. Birds also contaminate foods with microscopic feather frag-
ments such as barbs and barbules.
3. Insect Adulteration
Insects may also occasionally be found in consumer products. These insects can generally
be separated into field and storage types. The unavoidable aesthetic contaminants of field
origin fall under the DAL regulatory area, while the avoidable storage contaminants repre-
sent a lapse of good manufacturing practice (GMP).
Examples of insect contaminants of field origin include bruchid weevils (e.g., Acan-
thoscelides obtectus) on beans, corn earworm (Helicoverpa zea) larvae on an ear of corn,
and coffee beans that have been bored by the coffee berry borer (Hypothenemus hampei).
Examples of storage contamination include Indianmeal moth (Plodia interpunc-
tella) larvae infesting peanuts, flour beetles (Tribolium spp.) in bread, and cigarette beetles
(Lasioderma serricorne) in spices.
4. Mold Adulterants
Mold contaminants can generally be separated into two groups, avoidable and unavoid-
able. Avoidable molds on tomatoes as they arrive from the field are generally removed
from the lot before they enter the processing line. If some of the rotted tomatoes get into
the processing line, whether through error or carelessness, this fact can be brought to
light by analytical techniques that demonstrate mold particles in finished products such
as catsup.
Geotrichum spp., one of the avoidable molds, also known as machinery mold or
slime mold, grows on food contact surfaces of processing lines, especially in those envi-
ronments that are warm and moist, as in fruit and vegetable canning factories. In-process
food products passing over contaminated processing lines can dislodge pieces of this mold.
Upon analysis, clumps of the Geotrichum mold that had been growing on the food contact
surfaces of the processing line can be demonstrated in the finished product.
5. Adulteration by Extraneous Matter
Examples of extraneous material include glass shards, sand and pebbles, pits in pitted
olives, and shell fragments in canned clams and oysters.
B. What Are Defect Action Levels?

Title 21, Part 110.110 of the Code of Federal Regulations [4] allows the Food and Drug
Administration (FDA) to establish maximum levels of natural or unavoidable defects in
foods for human use that present no health hazard. Defect action levels represent levels
of natural or unavoidable defects or contaminants that can be found in a food product
produced from acceptable quality raw materials using current processing technologies and
sanitation practices. The levels represent limits at which FDA regards food products to
be adulterated and subject to regulatory action under Section 402(a)(3) of the FD&C Act.
C. Where Did DALs Come From?

For purposes of perspective, it is important to understand how filth, decomposition, and
extraneous matter have been regulated up to this point in time. The early regulation of
aesthetic filth relied primarily upon the FDA’s scientific knowledge and regulatory case
precedents that were generally not available to the public.
1. Action Criteria
Defect action levels had their origins with the FDA’s ‘‘action criteria’’ for filth and decom-
position defects and contaminants beginning in the early 1900s as ‘‘tolerances,’’ followed
by ‘‘field legal action guides’’ in the 1950s, ‘‘administrative guidelines’’ in the early
1960s, and finally the ‘‘compliance policy guides’’ (CPGs) (5) of the late 1960s.
2. Howard Mold Count
One of FDA’s earliest action criteria was established in 1911 as a tolerance for mold in
tomato pulp. That action limit, called a tolerance, was based on the Howard mold count
method (a count of mold mycelial fragments observed under a microscope) [6] that esti-
mated the amount of moldy raw tomatoes present in the finished product pulp.
3. Confidential Action Levels
Over the years since the first established mold tolerance, as analytical methods became
available, other action levels have been developed for other defects, such as insect and
rodent contaminants. These action levels went through several name changes but remained
essentially the same action criteria. Prior to 1972, all the action criteria, regardless of what
Table 1 Published Defect Action Level Contamination Profile Studies
Product Contaminant Reference
Chocolate, unsweetened Insect, bird, rodent 7
Cranberry sauce, whole and jellied Mold 8
Wheat Insect, rodent 9
Walnuts Insect, mold, decomposition 10
Pecans
Brazil nuts
Tomato juice Mold, rot, fly eggs, maggots 11
Tomato paste
Tomato puree
Tomato sauce
Tomato soup
Apricot nectar Mold 12
Peach nectar
Pear nectar
Apricot puree
Peach puree
Pear puree
Wheat flour Insect, rodent 13
Oregano, ground and unground Insect, rodent, bird 14
Cinnamon, ground
Nutmeg, ground
Macaroni Insect, rodent 15
Noodles
Marjoram, ground and unground Insect, rodent, bird 16
Sage, ground and unground
Thyme, ground and unground
Allspice, ground
Black pepper, ground
Paprika, ground
Coffee beans, green Insect, mold, mammalian excreta 17
Crabmeat, canned Insect, rodent, bird 18
Sardines, canned
Tuna, canned
Creecy greens, canned Insect 19
Collard greens, canned
Kale greens, canned
Mustard greens, canned
Turnip greens, canned
Shrimp, fresh and frozen Insect, rodent, Listeria spp., Sal- 20
monella spp., decomposition
they were called, were generally regarded as confidential and were available only to a
select group of FDA regulatory officials.
4. Action Levels Made Public
In 1972, FDA Commissioner Charles Edwards made the Agency’s action criteria for filth,
decomposition, and extraneous matter available to both consumers and manufacturers.
The commissioner directed that the action criteria, now known as CPGs, should be released
to the public as ‘‘defect action levels,’’ an abbreviated, condensed version of the CPGs.
When work was initiated to comply with the commissioner’s directive, the existing
action levels were extracted from the CPGs. Some remain the same today, while others
have been updated to reflect improved agricultural and manufacturing technologies. Addi-
tionally, new action levels were established for a number of foods based on identified
needs.
D. About the DAL Booklet

The Food Defect Action Levels booklet is available in hard copy from the Industry Activi-
ties Staff (HFS-565), Center for Food Safety and Applied Nutrition, Food and Drug Ad-
ministration, 5100 Paint Branch Parkway, College Park, MD 20740, or on the Internet at
http://first.fda.gov/infosr.htm. The most recent issuance is May 1998. The booklet consists
of a preface, glossary, and a listing of action levels by product.
1. The preface. The preface cites the Code of Federal Regulations section that
authorizes the FDA to establish DALs, the significance of contaminants re-
sulting from a failure to adhere to GMP, a brief discussion of why DALs exist,
what the levels mean, and the FDA’s regulatory position relative to products
lacking DALs.
2. The glossary. The glossary defines the terminology used in the action levels
section of the booklet.
3. The action levels section. The action levels section is an alphabetical listing
of defect action levels, with each DAL linked to a specific analytical method
used in the database development for that product. It is incumbent upon the
users of this booklet to be aware that different analytical methods may yield
different analytical results for a particular product and that the FDA uses the
cited analytical method to determine contamination profiles for a product lot in
order to apply the published action levels. The DAL booklet also provides ‘‘de-
fect source’’ and ‘‘defect significance’’ information for each product listed.
After an existing DAL was updated or a new DAL established and published in the
DAL booklet, the details of the update or establishment studies were published as a series
of research notes detailing the contamination profiles of significant contaminants for each
product studied. All of the contamination profile studies were published, as research notes
in the Journal of Food Protection from 1978–1994. Table 1 lists the products and contami-
nants for which contamination profile studies were published.
II. SIGNIFICANCE OF DEFECT ACTION LEVELS

A. About DAL Contaminants
The DALs are set because it is economically impractical to grow, harvest, or process raw
agricultural products that are totally free of nonhazardous, naturally occurring, unavoid-
able defects. It is therefore incumbent upon the food processing industry to process the
best quality raw materials under the best sanitary conditions using current processing
technologies in order to produce the high quality products that U.S. consumers have
learned to expect.
Industry should never strive to just meet the DAL by manipulating the manufactur-
ing process or by the illegal act of blending. The mixing of high quality products with
poor quality products just to meet the DAL is not only unethical, but is illegal under
current FDA regulations [21]. This practice renders the blended food product unlawful,
regardless of the level of defects or contaminants in the finished product.
Poor manufacturing practices may cause a food product to contain levels of filth,
decomposition, and extraneous matter contaminants that do not exceed the published DAL;
however, these products are still subject to enforcement action under current FDA regula-
tions because the insanitary processing conditions that contributed to the contamination
were avoidable.
Likewise, a food product containing filth, decomposition, or extraneous matter con-
taminants determined to be hazardous to consumers [22], regardless of levels or sources
of contamination, is subject to regulatory action within the meaning of 402(a)(1), in that
the food bears or contains a deleterious substance which may render it injurious to health
[1].
B. Impacts on Users
Defect action levels provide food regulatory agencies with the action limits they need to
distinguish between legal and illegal food products as defined under Section 402(a)(3) of
the FD&C Act. The DALs ensure uniformity of regulatory actions between food regulatory
agencies at local, state, and federal levels, and also internationally.
Defect action levels provide food processors with the action criteria, used by regula-
tory authorities, that define the minimal acceptable quality achievable when raw agricul-
tural materials are handled and processed under good manufacturing practice. DALs allow
in-plant quality control analyses to distinguish between acceptable and unacceptable fin-
ished products.
III. SO YOU NEED A DAL

Don’t even consider asking the FDA to develop a DAL for a particular product. The
agency’s DAL development program operated at full capacity for at least a dozen years
after the FDA commissioner mandated the public release and updating of the DALs in
1972. After more than a decade of data development studies to update existing and estab-
lish new DALs, the commissioner’s mandated goal was considered to have been achieved.
Because of the high cost of sample collections and analyses associated with the
development of databases necessary to update or establish DALs, and because of the recent
reprioritization of DALs for aesthetic filth, decomposition, and extraneous matter, the
DAL development program has been placed in abeyance.
A. Should I Develop My Own DAL?

One solution to the absence of a DAL is for you to undertake the development of a DAL
for your product. Before you decide to proceed with this endeavor, you must consider the
magnitude and cost of the effort required to accomplish the job.
Once you have identified the appropriate defects or contaminants of a specific prod-
uct, a validated method of analysis is essential. If a method exists, you are ready to consider
the sampling requirements. If not, the method development research and validation process
must be undertaken. This phase of the study can require several years or more of effort,
depending upon the difficulty of the methods research and the outcome of the interlabora-
tory collaborative study (a system used to determine the reliability and accuracy of any
new method).
With the method phase completed, a sampling plan that considers geographic, sea-
sonal, and environmental factors affecting contaminants or defects must be developed.
These considerations will determine the collection sites—retail market place, ports of
entry, or both. Will the sampling be conducted in a single year or multiple years in order
to ensure consideration of the seasonal and environmental fluctuations of the occurrence
of the contaminants? Sample collection is no small undertaking. A minimum of 1500
production lots is required for the establishment of a new DAL. Who will carry out the
collection and who will pay for all these samples?
With a validated method and representative product samples in hand, one must find
a qualified laboratory to perform the analyses. My experience in this phase of the develop-
ment process has shown that many laboratories are ready and willing to reap the financial
benefits associated with the analysis of 1500 samples, but finding a laboratory that is
technically qualified to perform the sample extraction and quantify the selected contami-
nants is problematic. One cannot assume that all laboratory personnel are qualified to
perform analyses for filth, decomposition, or extraneous matter, even if they claim to be.
A careful examination of both company and analyst qualifications, along with a
judiciously monitored analytical audit program, is essential to getting the results you will
be paying for. Once valid product contamination profiles have been obtained, it would be
advisable to contact the FDA analysts or other knowledgeable individuals to obtain guid-
ance with the data analysis and the action level setting process. When all is said and done,
the development of a DAL for a single product can require five years or more at a minimum
cost of $200,000.
B. Use Existing Action Levels

Considering the foregoing discussion of DAL development, a more appealing alternative
is to use an existing DAL for a similar product, if one exists. To do this, one must still
consider the applicability issues such as identifying appropriate contaminants and the geo-
graphical and seasonal influences on their occurrence in the subject product. There is no
cheap, easy answer.
IV. THE FUTURE OF DEFECT ACTION LEVELS

In keeping with a pattern set during the past century, the action criteria for filth, decomposi-
tion, and extraneous matter have undergone still another change. This current change,
while keeping the DALs intact conceptually, places the DALs within the context of the
recently revised enforcement strategy for filth, decomposition, and extraneous matter.
A. The Revised Strategy

The revised enforcement strategy was a joint effort of the FDA’s Office of Regulatory
Affairs and the Center for Food Safety and Applied Nutrition (CFSAN). In June 1999,
the strategy was presented to the FDA’s Food Advisory Committee [23]. This is a technical
and scientific committee that advises the agency on emerging food safety, food science,
and nutrition issues. The committee consists of 18 standing members with expertise in
the physical and life sciences, food science, risk assessment, and other relevant scientific
and technical disciplines. Most members are drawn from academia, government, and pro-
fessional societies, with some technically qualified members also representing consumer
and industry interests. The Food Advisory Committee unanimously endorsed the revised
enforcement strategy [24].
The strategy has its foundations in published scientific literature [25–28] that defines
scientific criteria for the objective evaluation of health hazards, GMP violations, and aes-
thetic contaminants associated with filth, decomposition, and foreign matter in foods. The
scientific criteria are components of a transparent process (readily accessible to all inter-
ested persons) for reviewing regulatory actions and making enforcement decisions based
on end-product analyses of finished product samples.
The strategy is suitable for evaluating analytical results from end-product surveil-
lance sampling by FDA and from samples analyzed by private testing laboratories and food
processors quality control laboratories. The criteria are organized into three prioritized
categories associated with filth, decomposition, and extraneous matter contaminants: (1)
health hazards, (2) good manufacturing practice violations, and (3) aesthetic contaminants
(as identified in the DAL booklet).
B. DALs and the Revised Strategy

Incorporation of the DALs into the FDA’s revised enforcement strategy has effectively
changed the regulatory significance of these action criteria. This current change has appro-
priately placed the DALs for aesthetic filth, decomposition, and extraneous matter in the
proper perspective with the other two identified contaminant categories of the new enforce-
ment strategy—health hazards and GMP violations.
The evaluation process for analytical findings starts with the first priority action
criteria, that is, for health hazards. If none is found, the evaluation next considers the
second priority action criteria, for GMP violations. Again, if evidence of poor manufactur-
ing practice is not found, the evaluation proceeds to the final stage where analytical results
are compared with relevant CPGs or other precedents regarding acceptable levels of harm-
less or aesthetic filth, decomposition, and extraneous matter, i.e., the DALs.
It must be emphasized that while DALs have been reprioritized to a lower regulatory
enforcement category, the FDA continues to take regulatory actions against aesthetic
(DAL) filth as well as sanitation-related GMP violations and food safety issues involving
filth and extraneous matter (e.g., hard foreign objects, toxic mushroom contaminants, etc.).
Fiscal year 2000 filth case referral figures provided by FDA show 450 actions for aesthetic
(DAL) filth, 20 actions for sanitation-related GMP violations, and five filth and extraneous
matter food safety actions.
This revised enforcement strategy provides broad-ranging benefits. The FDA will
operate more efficiently, with reduced case referrals from the field to headquarters. The
agency receives hundreds of case referrals every year from FDA field offices for subject
matter review, with generally a one- to five-day turnaround time. Once the enforcement
strategy is formalized and in the hands of the FDA field compliance offices, many of those
decisions will be made on-site in the district offices and will not require subject matter
expert review at headquarters.
To consumers, it provides increased protection from genuine foodborne hazards
associated with filth, decomposition, and extraneous matter, while providing a reasonable
level of emphasis on the purely aesthetic contaminants.

To the regulated industry, it provides a level playing field of action criteria for both
imported and domestic products and predicted cost savings through faster regulatory re-
view turnaround, reduced storage time for seized or detained goods, and fewer recondi-
tionings. Everyone will benefit from clearly defined action criteria that will result in uni-
form regulatory decisions worldwide. Transparency of both the action criteria and the
science base will enable industry, both here and abroad, to fully understand FDA’s ap-
proach to regulating filth, decomposition, and foreign matter.
While maintaining the sanitation safeguards of the federal FD&C Act, the revised
strategy preserves the wholesomeness role of the defect action levels in the proper perspec-
tive with regard to GMP violations and the genuine food safety hazards from filth, decom-
position, and extraneous matter.
REFERENCES
1. FDA. Requirements of Laws and Regulations Enforced by the U.S. Food and Drug Adminis-
tration. Washington, DC: U.S. Department of Health and Human Services, 1984.
2. PM Brickey Jr. Concepts of food protection. In: JR Gorham, ed. Principles of Food Analysis
for Filth, Decomposition, and Foreign Matter, 2nd Ed. Washington, DC: Food and Drug Ad-
ministration, 1981, pp 3–5.
3. Industry Activities Staff. The Food Defect Action Levels. Washington, DC: Food and Drug
Administration, 1998.
4. FDA. Title 21, Code of Federal Regulations, Part 110.110, Natural or Unavoidable Defects
in Food for Human Use that Present no Health Hazard. Washington, DC: U.S. Government
5. DL Michels, A Schroff, eds. FDA Compliance Policy Guides. Rockville, MD: Food and Drug
Administration, 1996.
of Analysis of AOAC International. Arlington, VA: AOAC International, 2000, pp 1–69.
7. JS Gecan, JE Kvenberg, JC Atkinson. Microanalytical quality of unsweetened chocolate. J
Food Prot 41:696–698, 1978.
8. JS Gecan, AE Schulze, SM Cichowicz, JC Atkinson. Mold in jellied and whole-berry styles
of cranberry sauce. J Food Prot 42:328–329, 1979.
9. JS Gecan, JJ Thrasher, WV Eisenberg, PM Brickey. Rodent excreta contamination and insect
damage of wheat. J Food Prot 43:203–204, 1980.
10. JS Gecan, PM Brickey, JC Atkinson. Defects of inshell walnuts, pecans and Brazil nuts. J
Food Prot 45:547–548, 1982.
11. SM Cichowicz, JS Gecan, JC Atkinson, JE Kvenberg. Microanalytical quality of tomato prod-
ucts: juice, paste, puree, sauce and soup. J Food Prot 45:627–631, 1982.
12. R Bandler, JS Gecan, JC Atkinson. Mold in fruit nectars and infant fruit purees. J Food Prot
45:634–635, 1982.
13. JS Gecan, JC Atkinson. Microanalytical quality of wheat flour. J Food Prot 46:582–584, 1983.
14. JS Gecan, R Bandler, LE Glaze, JC Atkinson. Microanalytical quality of ground and unground
oregano, ground cinnamon and ground nutmeg. J Food Prot 46:387–390, 1983.
15. JS Gecan, JC Atkinson. Microanalytical quality of macaroni and noodles. J Food Prot 48:
400–402, 1985.
16. JS Gecan, R Bandler, LE Glaze, JC Atkinson. Microanalytical quality of ground and unground
marjoram, sage and thyme, ground allspice, black pepper and paprika. J Food Prot 49:216–
221, 1986.
17. JS Gecan, R Bandler, JC Atkinson. Microanalytical quality of imported green coffee beans.
J Food Prot 51:569–570, 1988.

18. JS Gecan, R Bandler, JC Atkinson. Microanalytical quality of canned crabmeat, sardines, and
tuna. J Food Prot 51:979–981, 1988.
19. JS Gecan, R Bandler. Microanalytical quality of canned collard, creecy, kale, mustard, and
turnip greens. J Food Prot 53:511–512, 1990.
20. JS Gecan, R Bandler, WF Staruszkiewicz. Fresh and frozen shrimp: a profile of filth, microbio-
logical contamination, and decomposition. J Food Prot 57:154–158, 1994.
21. FDA. Title 21, Code of Federal Regulations, Part 110.110(d) Natural or Unavoidable Defects
in Food for Human Use that Present no Health Hazard. Washington, DC: U.S. Government
Printing Office, 1998, p 223.
22. FDA. Foods—adulteration involving hard or sharp foreign objects. FDA Compliance Policy
Guide. Fed Reg 64(62), 15774–15775, 1999.
23. FDA. Food Advisory Committee: notice of meeting. Fed Reg 64(110), 31005–31006, 1999.
24. JS Gecan, AR Olsen. Enforcement of Filth and Extraneous Materials. Transcript of FDA Food
Advisory Committee Meeting, Arlington, VA, 1999. Available at http:/ /www.fda.gov/ohrms/
dockets/ac/cfsan99.htm (click on 3524t1.rtf).
25. AR Olsen. Regulatory action criteria for filth and other extraneous materials. I. Review of
189, 1998.
26. AR Olsen. Regulatory action criteria for filth and other extraneous materials. II. Allergenic
mites: an emerging food safety issue. Regul Toxicol Pharmacol 28:190–198, 1998.
27. AR Olsen. Regulatory action criteria for filth and other extraneous materials. III. Review of
flies and foodborne enteric disease. Regul Toxicol Pharmacol 28:199–211, 1998.
extraneous materials. IV. Regulatory action criteria profiles and regulatory action categories.
Regul Toxicol Pharmacol 33:362–392, 2001.

8
Analysis of Drug Residues in Food
SHERRI B. TURNIPSEED
U.S. Food and Drug Administration, Denver, Colorado, U.S.A.
I. INTRODUCTION
The use of antibiotics or other medications is common in modern agriculture because
animals are held together in dense populations where the potential for disease outbreak
is high. Drugs can be used therapeutically, to cure existing disease, or prophylatically, to
minimize the potential for disease threat across a population. Often, however, they are
used subtherapeutically as growth promotants to increase feed conversion. The possibility
of drug residues remaining in the edible product and the potential human health problems
associated with exposure to these residues is a concern because of the widespread drug
use in food animals. The actual public health significance of drug use in animal agriculture
and of their residues in food of animal origin is an area of much debate. Recently the
National Research Council convened a group to evaluate the benefits and risks of using
drugs in the animal food industry (National Research Council, 1999). They identified
antimicrobial resistance of disease-causing bacteria as the most serious risk associated
with the continued use of drugs in food animals. Animals fed low (subtherapeutic) levels
of antibiotics may develop bacterial infections that evolve to be impervious to these drugs.
Humans may be exposed to these bacterial populations in the environment or during prepa-
ration or consumption of food. A task force consisting of several U.S. government agencies
has formulated a public health plan to combat antimicrobial resistance, including ways to
limit the spread of drug resistance due to agricultural applications (Center for Disease
Control, 2001). In addition, some animal drugs may cause an immediate adverse reaction,
such as allergic response, in susceptible human populations. Therefore, it is important to
regulate the improper use of animal drugs by monitoring animal tissues or the resulting
food products for drug residues.

The occurrence of drug residues is possible in any food of animal origin. This in-
cludes, but is not limited to, tissue (muscle, liver, kidney) or fat from bovine, swine,
poultry, fish, shrimp, or minor species (such as ratites, rabbits) in addition to animal prod-
ucts such as milk, eggs, and honey. Because this is such a diverse list, the procedures for
food processing, and therefore the sanitation guidelines as well as the regulations covering
these commodities, are also quite varied.
The governmental responsibility for reducing the incidence of animal drug residues
in the nation’s food supply is primarily shared between the United States Department of
Agriculture (USDA) and the Food and Drug Administration (FDA). The FDA regulates
animal drug residues in milk, eggs, and aquaculture products. The USDA is responsible for
monitoring meat and poultry products for animal drug residues. The Food Safety Inspection
Service (FSIS) of the USDA conducts the National Residue Program (NRP) to prevent
animals containing violative amounts of drug residues from being marketed (Food Safety
Inspection Service, 1998). The FDA is also responsible for approving new animal drugs,
setting tolerances, and conducting enforcement actions as a result of any FSIS findings.
In many cases the introduction of illegal residues occurs at the original producer or
farmer and not at the food processing establishment. In fact the most common causes for
the presence of illegal residues include not following proper withdrawal times, administra-
tion of improper dosage, etc. However, a recent review illustrates how contamination can
also be a cause of illegal animal drug residues (Kennedy et al., 2000). One possible source
of contamination includes mixing of nonmedicated feed with medicated feed during manu-
facturing, compounding, or transporting. In addition, these authors provide examples of
wild fish or other aquatic species harvested near aquaculture pens being contaminated
with drug residues from that facility. Another study cited in this review illustrates how
pigs held in the same housing structure as a previous population that had been given
sulfamethazine were found to be positive for this residue by immunoanalysis of their
kidney tissue (McCaughey et al., 1990). All of these possible sources of drug residue
contamination relate directly to food/feed sanitation procedures.
Even if the causes of illegal drug residues are more likely to originate with the food
producer, the introduction of hazard analysis critical control point (HACCP) programs
holds food processing plants responsible for minimizing this source of contamination. The
use of HAACP as a tool to ensure food safety extends to residue monitoring. Under the
HAACP system food processing plants must have systems in place to prevent hazards in
their products. These hazards include not only pathogenic organisms and physical hazards,
but also chemical residues such as illegal drugs or pesticides. The rule indicates that the
industry must evaluate significant residue hazards and develop a HAACP plan for control-
ling residues. An example of a HAACP plan designed to minimize the risk of drug residues
at the producer level is the Milk and Dairy Beef Residue Prevention Protocol (Boekman
and Carlson, 2000). Aspects of a HAACP plan for a food processing plant designed to
reduce the risk of illegal drug residues might include avoiding buying animals from prob-
lem producers and implementing live animal tracking and residue testing (Dey, 2001).
Monitoring the food supply for residues is important because of the potential health
risk from exposure to some animal drugs. However, the low levels and complex matrices
involved can make residue monitoring a real analytical challenge. Several broad types
of analytical methods for drug residues in food can be described, including screening,
determinative, and confirmatory procedures. These all play a role in monitoring the food
supply for chemical residues due to improper use of animal drugs.

II. ANALYTICAL METHODS FOR DRUG RESIDUES
A. Screening Methods
Screening methods are designed to be rapid, easy-to-use tests which provide a positive
or negative response for a drug at a given concentration level in a matrix. Samples
taken at food processing plants are often analyzed initially using a screening test to de-
termine if there may be a problem with drug residues. Traditionally, microbial inhibi-
tion tests (MITs) have been used to screen large numbers of samples for antimicrobials,
and these tests are still widely used. All MITs are based on the inhibition of bacterial
growth by antibacterial residues present in a matrix that results in zones of inhibition on
bacterial plates. These tests are relatively simple to use and detect many classes of anti-
bacterial compounds. Selective sensitivity for specific classes of antibacterials can be
obtained by changes in the culture medium, indicator bacteria, or pH. However, these
methods often lack the specificity and sensitivity required for residue detection at maxi-
mum residue limits. They may be affected by nonspecific inhibitors and do not detect
microbiologically inactive metabolites. In addition, they often require a 20–24 hr incu-
bation period.
Microbial inhibition tests that have been used by the FSIS for screening red
meat and poultry tissues for antibacterial residues include the Swab Test On Premises
(STOP) and the Calf Antibiotic and Sulfa Test (CAST) (Sundlof, 1989). The Fast Antibi-
otic Screen Test (FAST) is a test used by FSIS that provides results within 6 hr. There
are several other MITs used globally, including the New Dutch Kidney Test, the German
Three Plate Assay, the European Four Plate Test, and the Charm Farm Test.
Although MITs can be very useful, there are some inherent problems with these
tests, including the FAST test. Imprecision occurs as a result of zone of inhibition size
differences between replicate plates. Zone size may vary as a result of differences in agar
layer thickness, agar quality, uneven seeding of bacterial spores on the agar surface, or
incubator temperature variation (Brady and Katz, 1987). Additionally, bacteriostatic drugs
such as sulfonamides may result in a diffuse zone, while bactericidal drugs provide a
sharply defined zone of inhibition, and this may complicate the interpretation. In fact,
studies indicate that the sensitivity to the FAST test for different classes of drugs can vary
widely (Korsrud et al., 1998).
In addition to MITs, new rapid test kits, generally based on bacterial cell recep-
tor or enzyme immunoassay, are being used to screen samples for specific drugs. The
Charm II test is a proprietary competitive microbial receptor binding assay that can de-
tect residues of seven classes of antibiotics. Although this test can detect a number of
drugs within a class, the relative sensitivity of the test to individual drugs varies. It is
commonly used for monitoring antibiotics in milk, but has also been tested for use in
bovine muscle and kidney samples (Korsrud et al., 1994). Immunoassays are widely used
on dairy farms and processing plants to screen milk samples for veterinary drug residues.
With appropriate extraction methodology many of these assays may also be used for
residue analysis of food animal tissues. Recent examples of the use of immunoassays in
meat analysis include the analysis of aminoglycosides in porcine kidney (Haasnoot et al.,
1999) and tetracyclines in pork and chicken meat (De Wasch et al., 1998). These rapid
tests are well suited for in-plant use due to the limited amount of sample manipulation,
simple analytical equipment and procedures required, and the relatively fast analysis
time.

B. Determinative Methods
These screening tests, however, are not always accurate at or below the test threshold. They
are often class, not compound, specific, and may or may not give quantitative information.
Therefore, additional analytical tests may be needed to determine if a sample is actually
violative for an animal drug residue. Determinative methods are designed to separate,
quantitate, and perhaps provide some qualitative information on the analyte of interest.
These tests may require more specialized laboratory equipment and experienced personnel
to perform than the screening tests discussed previously.
A determinative method involves several stages including sample preparation, ex-
traction of the analyte from the food matrix, separation of the drug residue from any
remaining matrix components, and detecting (measuring) the amount of residue present.
Sample preparation, isolation, and cleanup are major rate-limiting factors in sample analy-
sis. The classical approach to isolation of drugs from tissues involves tissue homogeniza-
tion followed by liquid–liquid partitioning of the homogenate, with or without additional
cleanup or concentration steps. These methods may provide adequate separation of the
drug from the matrix but are often expensive in terms of time, labor, material use, and
organic solvent disposal costs. Such approaches also tend to be highly nonspecific in their
isolation of the target drug(s).
Recent advances in the field of residue analysis offer several promising techniques
as possible solutions to the problems caused by outmoded and complex analytical methods.
Three techniques—solid-phase extraction (SPE), matrix solid-phase dispersion (MSPD),
and immunoaffinity—are receiving particular attention because they have the potential to
greatly reduce analytical costs and reduce analysis-generated waste and pollution. The
SPE process is a type of chromatographic separation designed to isolate the analyte of
interest from the rest of the food matrix. Before SPE can be used with solid tissue (e.g.,
muscle and liver), a separate homogenization step and often additional steps are required.
The most common use of SPE is to develop conditions whereby the analyte adheres to
the solid-phase material while the other components are washed through, then the solvent
system is changed to elute the analyte separately. Because selection of the SPE column
depends on the matrix and on the particular compound of interest, a wide range of solid-
phase extraction columns of differing polarities have been used for drug extraction from
tissue and include silica, alumina, C 18 , NH 2 , and ion exchange resins.
Matrix solid-phase dispersion (MSPD) is a variation of the SPE isolation technique.
In general terms, MSPD involves blending a tissue sample (0.1–1.0 g) with lipophilic
polymer-derivatized silica particles, which simultaneously disrupts and disperses the sam-
ple. The resulting slurry is then packed as a ‘‘column’’ which can be eluted with appro-
priate solvent to give an extract containing the residue of interest. Matrix solid-phase
dispersion has been used in the analysis of furazolidone (Long et al. 1990), penicillins
(McGrane et al., 1998), and sulfamethazine (Shearan et al., 1994) in swine tissue. This
technique has also been used to analyze milk samples for chemical residues (Schenck and
Wagner, 1995).
The simplest methods of extraction, however, require minimal or no sample manipu-
lation. These are the methods that extract the drug directly from the sample matrix by
means of specific or selective antibodies or receptors. Immunoaffinity isolation techniques
can be used for sample cleanup. Recent examples where immunoaffinity techniques have
been used in animal drug residue analysis include the determination of 19-nortestosterone

and trenbolone in animal tissue (Stubbings et al., 1998) and avermectins in cattle meat
(Li and Qian, 1996).
Once a drug residue has been extracted from the food matrix, the amount of residue
can be measured using the physical characteristics of the molecule after separation from
any remaining food components. Many of the drugs used in animal agriculture can be
separated from any remaining food matrix using liquid chromatography (LC). In LC,
separation occurs when a compound is isolated from a liquid sample based on its relative
solubility in the liquid mobile phase compared to its solubility in a solid support-bound
liquid stationary phase or its affinity to a solid support stationary phase. Reverse-phase
LC chromatography columns generally consist of a liquid phase (C 18 , C 8 , phenyl, etc.)
covalently bound to a spherical (particle size 3–10 µm) silica support. The degree of free
silanol groups remaining unbound can greatly affect the selectivity of the column for any
given analyte. There is a great variety of LC columns commercially available based on
principles of polymer chemistry, chiral selection, ion exchange, and size exclusion, as
well as the traditional reverse-phase chemistry. Ideally the compound of interest can be
eluted from the chromatographic column isolated from any other material and then intro-
duced into a detector to measure the amount of compound present. For LC the most com-
mon detector is a UV/VIS spectrophotometer using a variable wavelength or diode array.
Liquid chromatographs using fluorescence, chemiluminescence, or postcolumn reaction
detectors are also available and have been successfully used to determine drug residues
in animal tissue.
Gas chromatography (GC), in which separation is based on the relative partitioning
of an analyte into a liquid coated onto a fused silica capillary as it travels through the
column in the gas phase, can also be used to analyze drug residues in food matrices. GC
is very suitable to volatile analytes such as organophosphates. Many animal drugs have
a large molecular weight and are relatively nonvolatile and thermally labile. To overcome
these characteristics, chemical derivatization is generally required to obtain sufficient
volatility and stability for GC analysis. Detection for GC is generally done using flame
ionization or electron capture techniques. More selective detectors for nitrogen-, phospho-
rus- and sulfur-containing compounds are also available, and mass spectrometry (MS)
detection is commonly used as a detector for GC.
Several reviews have been written on the determinative methods in use today (Oka
et al., 1995; Turnipseed and Long, 1998). In addition, the European Union has established
a database of veterinary drug determinative methods (Van Eeckhout et al., 1998). Section
III of this chapter lists the common types of animal drugs that might be found in food,
typical extraction and analytical parameters, as well as some references for more recent
specific procedures or reviews.
C. Confirmatory Methods
Confirmatory methods are meant to provide absolute identification of the drug residue in
question. Because of its sensitivity and specificity, mass spectrometry is the preferred
method for confirmation. Guidelines as to what should constitute a positive identification
with mass spectral data have been discussed (Sphon, 1978; FDA, 2001). In most cases,
confirmation is achieved using an instrument that interfaces the MS with a chromatograph
(GC or LC). There are many examples in the reference section of this chapter of methods

that contain not only determinative procedures, but also give information on qualitative
confirmatory analysis.
III. SUMMARY OF ANALYTICAL METHODS FOR DRUG RESIDUES

IN FOOD
A. Sulfonamides
Uses: pneumonia and other respiratory diseases, mastitis, diphtheria, diarrhea
Examples: sulfamethazine, sulfadimethoxine, sulfamerazine, sulfathiazole
Foods of concern: milk; bovine, swine, and poultry tissue (muscle, liver, kidney);
fish tissue
Typical extraction: liquid–liquid extraction and/or SPE isolation
Typical detection: reverse-phase (RP) LC with UV (270 nm) or LC/fluorescence
after derivatization
Alternative methods: LC/MS/MS, supercritical extraction
Comments: multiresidue methods available
References: Parks and Maxwell (1994), Tsai and Kondo (1995), Gehring et al.
(1997), Stoev and Michailova (2000), Van Eeckhout et al. (2000a)
B. Beta-Lactams
Uses: colibacillosis, bacterial enteritis, salmonellsis, etc.
Examples: penicillin, ampicillin, amoxicillin, cloxacillin, cephapirin, ceftioflur
Foods of concern: milk; bovine, swine, and fish tissue
Typical extraction: liquid–liquid extraction (sometimes using tungstic or trichloro-
acetic acid) with SPE (usually C 18) cleanup
Typical detection: RPLC/UV penicillins: 210–230 nm; cephalsosporins: 260–295 nm
Alternative methods: derivatization to penicellenic acid mercuric mercaptide, deri-
vatization with fluorescamine, LC fractionation, LC/MS
Comments: difficult to analyze for all types simultaneously
References: Boison and Keng (1998), Moats and Romanowski (1998), Luo and Ang
(2000), Hong and Kondo (2000)
C. Aminoglycosides
Uses: used as broad-spectrum antibiotics, also to enhance growth efficiency
Examples: streptomycin, apramycin, dihydrostreptomycin, gentamicin, neomycin
Foods of concern: milk; bovine, poultry, and swine tissue (especially kidney)
Typical extraction: liquid extraction with aqueous buffers, ion exchange columns
Typical detection: RPLC/fluorescence with derivatization or GC/electron capture
Alternative methods: LC/MS
Comments: usually need ion pair reagents for LC separation
References: Heller et al. (2000), Isoherranen and Soback (1999)
D. Tetracyclines
Uses: to treat enteritis, pneumonia, and anaplasmosis, also to promote weight gain
and increase feed efficiency
Examples: tetracycline, oxytetracycline, chlortetracycline
Foods of concern: milk; bovine, poultry, and swine tissue; shrimp; eggs; honey
Typical extraction: mild acid with chelating agents, metal chelate affinity columns
Typical detection: RPLC or ion exchange with UV at 270–350 nm
Alternative methods: LC/MS/MS, LC/fluorescence of metal complexes
Comments: oxalic acid or chelating agent used in LC mobile phase to avoid com-
plexing with metals and adsorbing on silanol sites of column
References: Oka et al. (2000), Moats (2000), Van Eeckhout et al. (2000b), Posyniak
et al. (1999)
E. Macrolides
Uses: to treat gram positive organisms and some strains of Listeria and Mycoplasma,
promote growth efficiency
Examples: erythromycin, tylosin, oleandomycin, spiramycin, tilmicosin
Foods of concern: milk; bovine, poultry, swine, and fish tissue; eggs
Typical detection: RPLC with UV or LC/fluorescence after derivatization
Comments: many have weak UV chromophores
References: Kiehl and Kennington (1995), Chan et al. (1994), Leal et al. (2001),
Stobba-Wiley et al. (2000)
F. Quinolones
Uses: broad-spectrum effective against gram positive, gram negative (fluoroquino-
lones) and mycoplasma
Examples: oxolinic acid, naladixic acid, sarafloxacin, enrofloxacin, ciprofloxacin,
flumequine
Foods of concern: milk; bovine, poultry, swine, and fish tissue; eggs
Typical extraction: liquid–liquid extraction and/or SPE cleanup using C 18 or cation
exchange
Typical detection: RPLC with fluorescence and/or UV detection
Alternative methods: on-line dialysis, LC/MS
Comments: high level of concern regarding antibiotic resistance to these drugs
References: Munns et al. (1995), Maxwell et al. (1999), Roybal et al. (1997), Rose
et al. (1998)
G. Phenicols
Uses: infections, bovine respiratory disease
Examples: chloramphenicol, florfenicol, thiamphenicol
Foods of concern: milk; bovine, poultry, swine, and fish (including shrimp) tissue;
eggs
Typical detection: RPLC with UV or GC/electron capture after derivatization
Alternative methods: GC/MS or supercritical fluid extraction
Comments: multiresidue methods available, florfenicol metabolized to amine
References: Pfenning et al. (2000), Pensabene et al. (1999)
H. Ionophores
Uses: coccidiostats, growth efficiency
Examples: monensin, lasalocid, salinomycin
Foods of concern: poultry, eggs, beef tissue
Typical extraction: liquid–liquid extraction and/or SPE cleanup
Typical detection: RPLC with visible or fluorescence detection after derivatization
Comments: present as sodium salts, weak chromophore
References: Matabudul et al. (2000), Gerhardt et al. (1995)
I. Benzimidazoles
Uses: anthelmintics; growth efficiency
Examples: albendazole, fenbendazole, oxfendazole, thiabendazole
Foods of concern: bovine and swine tissue, milk (also fruits and vegetables)
Typical extraction: liquid–liquid extraction and/or SPE isolation, MSPD
Typical detection: RPLC with UV (290 nm)
Alternative methods: LC/MS/MS
References: Long et al. (1990), Sorensen and Hansen (1998), Balizs (1999)
J. Avermectins
Uses: anthelmintics
Examples: ivermectin, eprinomectin, doramectin, moxidectin
Foods of concern: milk; bovine, swine, and fish tissue
Typical detection: RPLC/fluorescence after derivatization
Alternative methods: LC/MS, postcolumn photochemical reaction
References: Rupp et al. (1998). Roybal et al. (2000), Schenck and Lagman (1999),
Danaher et al. (2001)
K. Hormones
Uses: increasing weight gain
Examples: estradiol, progesterone, and testosterone melengestrol acetate, trenbolone
acetate, zeranol, and diethylstilbestrol (DES)
Foods of concern: bovine and swine tissue
Typical extraction: liquid–liquid extraction and/or SPE, LC fractionation
Typical detection: GC/MS after derivatization
Comments: approval for these drugs varies, DES banned worldwide
References: Marques et al. (1998), Daeseleire et al. (1992, 1998). Hori and Naka-
zawa (2000)
L. Corticosteroids
Uses: anti-inflammatory and gluconeogenic agents
Examples: dexamethasone, prednisolone, betamethazone, flumethasone, prednisone,
triamcinolone
Foods of concern: bovine and swine tissue
Typical extraction: liquid–liquid extraction (sometimes with the addition of NaOH),
SPE
Typical detection: GC/MS after derivatization, LC/UV (240 nm)
Alternative methods: LC/MS, LC/chemiluminescence
References: Mallinson et al. (1995), Stolker et al. (2000), Iglesias et al. (1999), Van
Den Hauwe (2001)
IV. FUTURE TRENDS

The most significant trend in drug residue analysis is to increase the numbers of samples,
residues, and matrices that can be monitored simultaneously. A higher throughput of sam-
ples being analyzed for more types of residues obviously increases the efficiency of moni-
toring. In addition to the rapid screening methods already discussed, there has also been
an emphasis in developing determinative methods that will monitor more compounds more
rapidly. For example, the development of generic, universal extraction methods that will
extract many classes of drugs from a single sample (Rose et al., 1998; Heller and Cui,
2001). High throughput processing of samples using arrays of SPE columns developed
for combinatorial chemistry applications in drug discovery may have relevance to the
analysis of animal drug residues as well (Harrison and Walker, 1998).
As mass spectrometry, particularly modern LC/MS, becomes more practical and
affordable it has also been used to screen and perform quantitative analyses as well as
just provide qualitative confirmation. There are now several examples of methods where
MS is used for multiresidue screening and analyses (Volmer, 1996; Heller and Cui, 2001;
Stolker et al., 2000; Tarbin et al., 1998)
Technological advances made in other areas of analytical, process, and food chemis-
try will have an effect on the analysis of drug residues in animal tissues. For example,
the Biocore company in Switzerland has developed optical biosensors which have been
used for the analysis of animal drug residues including the detection of sulfonamides in
meat (Crooks et al., 1998; Bjurling et al., 1999). This technology has been used on-site at
a slaughterhouse. Biochip array technology using immunoassay with chemiluminescence
detection has been developed for the detection of growth promoters and sulfonamides
(McConnell et al., 2000). All of these new technologies will have an impact on how animal
drug residues are monitored and regulated in the future.
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9
Cleaning and Sanitizing a Food Plant
PEGGY STANFIELD
Dietetic Resources, Twin Falls, Idaho, U.S.A.
I. INTRODUCTION AND DEFINITIONS

A. Introduction
Cleaning a food processing plant is one way to make sure that there is no contamination
from the raw ingredients to a final product. To implement the cleaning process, the good
manufacture practice (GMP) regulations issued by the U.S. Food and Drug Administration
(FDA) serve as a frame of reference. The sources of information in this chapter include
FDA current good manufacturing practice regulations
FDA inspection operation manual
FDA/state food codes
FDA miscellaneous documents relating to the sanitation of a food processing plant
and/or a foodservice establishment
B. Definition of Terms
Three definitions are germane to our discussion:
1. Cleaning. A process which will remove soil and prevent accumulation of food
residues which may decompose or support the growth of disease-causing organ-
isms or the production of toxins.
2. Sanitizing. A process which destroys disease causing organisms which may
be present on equipment and utensils after cleaning. Chemical sanitizer used
shall meet the requirements of 21 CFR 178.1010.
3. Soil. Soil has been appropriately defined as ‘‘matter out of place’’; grease on
a gear, for example, is a lubricant, but that same grease on a table top becomes
soil.
II. GENERAL CONSIDERATIONS IN SANITATION AND CLEANING
Overall sanitation of the plant should be under the supervision of one or more competent
individuals assigned responsibility for this function. All reasonable precautions should be
taken to ensure that the entire process, from raw ingredients to a finished product, does not
contribute contamination from any source, including chemical, microbial, or extraneous
material. Basic mechanical manufacturing steps include, among others, washing, peeling,
trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, ex-
truding, drying, whipping, defatting, and forming.
Note the following principles:
Assure that all operations in the receiving, inspecting, transporting, segregating, pre-
paring, manufacturing, packaging, and storing of food will comply with basic
sanitation and cleaning principles.
Provide adequate physical protection of food from contaminants that may drip, drain,
or be drawn into the food. Protection may be provided by adequate cleaning and
sanitizing of all food-contact surfaces, and by using time and temperature controls
at and between each manufacturing step. If applicable, clean and remove any
contaminants.
Require that all holding, conveying, and manufacturing systems, including gravimet-
ric, pneumatic, closed, and automated systems, are of a design and construction
that enables them to be maintained in an appropriate sanitary condition.
Treat compressed air or other gases mechanically introduced into food or used to
clean food-contact surfaces or equipment in such a way that food is not contami-
nated with unlawful indirect food additives.
A. Plants and Grounds

Keep the grounds about a food plant in a condition that will protect against the contamina-
tion of food. For example,
Provide appropriate equipment storage, remove litter and waste, and cut weeds or
grass within the immediate vicinity of the plant buildings or structures so that it
will not become an attractant, breeding place, or harborage for pests.
Maintain roads, yards, and parking lots so that they do not constitute a source of
contamination in areas where food is exposed.
Drain areas that may contribute contamination to food by seepage or foot-borne filth
or that provide a breeding place for pests.
Provide sufficient space for placement of equipment and storage of materials to
permit sanitary operations and the production of safe food.
Protect food in outdoor bulk fermentation vessels:
Use protective coverings.
Clean areas over and around the vessels to eliminate harborages for pests.
Check on a regular basis for pests and pest infestation.
Skim the fermentation vessels, as necessary.
Inside a plant, some general considerations in cleaning are
Clean and repair floors, walls, and ceilings.
Eliminate drip or condensate from fixtures, ducts, and pipes to avoid the contamina-
tion of food, food-contact surfaces, or food-packaging materials.
Provide adequate floor drainage in all areas where floors are subject to flooding-
type cleaning or where normal operations release or discharge water or other
liquid waste on the floor.
Assure that aisles or working spaces are provided between equipment and walls and
are adequately unobstructed and of adequate width to permit employees to per-
form their duties and to protect against contaminating food or food-contact sur-
faces with clothing or personal contact. For example, to clean a wall, the worker
must have enough space to move around.
In order to clean properly, one must be able to see. Provide adequate lighting in
hand-washing areas, dressing and locker rooms, and toilet rooms and in all areas
where food is examined, processed, or stored and where equipment or utensils
are cleaned. Provide safety-type light bulbs, fixtures, skylights, or other glass
suspended over exposed food in any step of preparation or otherwise protect
against food contamination in case of glass breakage.
Maintain buildings, fixtures, and other physical facilities of the plant in a sanitary
condition, with regular repair and cleaning, all aimed at preventing food from
becoming adulterated.
Maintain the toilet facilities in a sanitary condition and keep them in good repair
at all times.
B. Equipment Cleaning and Maintenance

1. Procedures
Written procedures should be established and followed for cleaning and maintaining
equipment, including utensils and storage vessels, used in the manufacture, processing,
packing, and holding of food or food ingredients.
Procedures should, at a minimum, include
Assigning responsibility for cleaning and maintaining equipment

Establishing maintenance and cleaning schedules, including,where appropriate, sani-
tizing schedules
Developing a complete description of the methods and materials used to clean and
maintain equipment and, when necessary, instructions for disassembling and reas-
sembling each article of equipment to ensure proper cleaning and maintenance
Protecting clean equipment from contamination prior to use
Inspecting equipment for cleanliness immediately before use, if practical
Establishing the maximum time that may elapse between the completion of pro-
cessing and equipment cleaning
2. Basic Requirements
The minimal considerations in cleaning and sanitizing include
All cleaning and sanitizing of utensils and equipment should be done properly to
avoid contamination of food, food-contact surfaces, or food-packaging materials.
Sanitizing agents should be adequate and safe. Any facility, procedure, or machine
is acceptable for cleaning and sanitizing equipment and utensils if it is known to
be effective and in compliance with voluntary or mandatory requirements.
Cleaned and sanitized portable equipment with food-contact surfaces and utensils
should be properly stored in a location that protects food-contact surfaces from
contamination.
All plant equipment and utensils should be so designed and of such material and
workmanship as to be adequately cleanable and should be properly maintained.
The design, construction, and use of equipment and utensils should preclude the
adulteration of food with lubricants, fuel, metal fragments, contaminated water,
or any other contaminants.
All equipment should be so installed and maintained as to facilitate the cleaning of
the equipment and of all adjacent spaces. Food-contact surfaces should be corro-
sion resistant when in contact with food. They should be made of nontoxic materi-
als and designed to withstand the processing environment, the action of food,
and, if applicable, cleaning compounds and sanitizing agents.
Equipment that is in the manufacturing or food-handling area and that does not
come into contact with food should be so constructed that it can be kept in a
clean condition.
Equipment and utensils and finished food containers should be maintained in an
acceptable condition through appropriate cleaning and sanitizing, as necessary.
Insofar as necessary, equipment should be taken apart for thorough cleaning.
Equipment, containers, and utensils used to convey, hold, or store raw materials,
work-in-process, rework, or food should be constructed, handled, and maintained
during manufacturing or storage in a manner that protects against contamination.
3. Cleaning Methods
Observe the following guidelines in the basics of cleaning methods:
Equipment and utensils should be cleaned, held, and, where necessary, sanitized at
appropriate intervals to prevent contamination or cross-contamination.
Dedicated equipment should be cleaned at appropriate intervals to prevent the build-
up of objectionable material or microbial growth.
Nondedicated equipment should be thoroughly cleaned between different products
and, if necessary, after each use to prevent contamination and cross-contamina-
tion. If cleaning a specific type of equipment is difficult, the equipment may need
to be dedicated to a particular operation or one operation only.
The choice of cleaning methods, cleaning agents, and levels of cleaning should be
established and justified. When selecting cleaning agents (e.g., solvents) the following
should be considered:
The cleaning agent’s ability to remove residues of raw materials, precursors, byprod-
ucts, and intermediates
Whether the cleaning agent leaves a residue itself
Compatibility with equipment construction materials
For certain types of food processing, especially those requiring sampling for contam-
ination, e.g., fermented food products, equipment cleaning methods should be validated,
where appropriate. In general, cleaning validation efforts should be directed to situations
or process steps where contamination or incidental carryover of residues poses the greatest
risk to food safety.
The cleaning validation protocol should describe the equipment to be cleaned, meth-
ods, materials, and extent of cleaning, parameters to be monitored and controlled, and
analytical methods. The protocol should also indicate the type of samples (rinse, swabs)
to be obtained, and how they are collected, labeled, and transported to the analyzing labora-
tory.
Sampling should include swabbing, rinsing, or alternative methods (e.g., direct ex-
traction), as appropriate, to detect residues (both insoluble and soluble) and microorgan-
isms. For example, the sampling methods used should be capable of quantitatively measur-
ing levels of residues remaining on the equipment surfaces after cleaning. Swab sampling
may be impractical when product contact surfaces are not easily accessible due to equip-
ment design and/or process limitations (e.g., inner surfaces of hoses, transfer pipes, reactor
tanks with small ports).
Equipment cleaning and sanitization studies should address microbiological and en-
dotoxin contamination for those processes intended or purported to reduce bioburden or
endotoxins in the other processes where such contamination may be of concern.
Cleaning procedures should be checked by appropriate methods after validation to
ensure these procedures remain effective when used during routine production. Where
feasible, equipment should be examined visually for cleanliness. This may allow detection
of gross contamination concentrated in small areas that could go undetected by analytical
verification methods.
4. Clean in Place
Where feasible, clean-in-place (CIP) methods should be used to clean process equipment
and storage vessels. Clean-in-place equipment should be designed and constructed so that
Cleaning and sanitizing solutions circulate throughout a fixed system and contact
all interior food-contact surfaces.
The system is self-draining or capable of being completely drained of cleaning and
sanitizing solutions.
CIP equipment that is not designed to be disassembled for cleaning should be de-
signed with inspection access points to ensure that all interior food-contact sur-
faces throughout the fixed system are being effectively cleaned.
Clean-in-place methods might include fill and soak/agitate systems, solvent reflux-
ing, high impact spray cleaning, spray cleaning by sheeting action, or turbulent flow sys-
tems.
Clean-in-place systems should be subjected to cleaning validation studies to ensure
that they provide consistent and reproducible results. When practical, equipment in CIP
systems should be disassembled during cleaning validation to facilitate inspection and
sampling of inner product surfaces for residues or contamination, even though the equip-
ment is not normally disassembled during routine use. Once CIP systems are validated,
appropriate documentation should be maintained to show that critical parameters (e.g.,
time, temperature, turbulence, cleaning agent concentration, rinse cycles) are achieved
with each cleaning cycle.
C. Contact Surfaces
All food-contact surfaces, including utensils and food-contact surfaces of equipment,
should be cleaned as frequently as necessary to avoid contamination. Note the following:
Food-contact surfaces used for manufacturing or holding low-moisture food should
be in a dry, sanitary condition at the time of use. When the surfaces are wet-
cleaned, they should, when necessary, be sanitized and thoroughly dried before
subsequent use.
In wet processing, when cleaning is necessary to protect against the introduction of
microorganisms into food, all food-contact surfaces should be cleaned and sani-
tized before use and after any interruption during which the food-contact surfaces
may have become contaminated. Where equipment and utensils are used in a
continuous production operation, the utensils and food-contact surfaces of the
equipment should be cleaned and sanitized as necessary.
Non–food-contact surfaces of equipment used in the operation of food plants should
be cleaned as frequently as necessary to protect against contamination of food.
Food-contact surfaces should be maintained to protect food from being contaminated
by any source, including unlawful indirect food additives.
Seams on food-contact surfaces should be smoothly bonded or maintained so as to
minimize accumulation of food particles, dirt, and organic matter and thus mini-
mize the opportunity for growth of microorganisms.
D. Water
The primary constituent of all food processing plant cleaners is water. Basic water require-
ments common to all food processing operations are that it must be free from disease-
producing organisms, toxic metal ions, and objectionable odors and taste. Pure water
presents no problems, but no food processing establishment has an ideal water supply.
Therefore, the cleaning compounds must be tailored to the individual water supply and
type of operation.
Water used for washing, rinsing, or conveying food should be safe and of adequate
sanitary quality. Water may be reused for washing, rinsing, or conveying food if it does
not increase the level of contamination of the food.
The water supply should be sufficient for the operations intended and should derive
from an adequate source. Any water that contacts food or food-contact surfaces should
be safe and of adequate sanitary quality. If needed, running water at a suitable temperature
and under pressure should be provided in all areas where required for the processing of
food; for the cleaning of equipment, utensils, and food-packaging materials; and for em-
ployee sanitary facilities.
1. Water Impurities and Cleaning

Three groups of impurities in water can affect cleaning:
1. Suspended matter must be kept to a minimum to avoid deposits on clean equip-

ment surfaces.
2. Soluble iron and manganese salts (concentrations above 0.3 ppm) will cause
colored deposits on equipment surfaces. Suspended matter and soluble iron and
manganese can be removed only by treatment.
3. Water hardness.
2. Water Hardness
Water hardness due to salts of calcium and magnesium presents a major problem in the
use of cleaners by reducing effectiveness and by forming surface deposits.
Types of hardness include
Carbonate hardness (formerly called temporary hardness) due to calcium and magne-
sium carbonates and bicarbonates, which can be removed by heating
Noncarbonate hardness (formerly called permanent hardness) due to calcium sul-
fates, calcium chloride, magnesium sulfate, and magnesium chloride, which can-
not be removed by heating
The hardness of waters varies considerably from place to place. In general, surface
waters are softer than ground waters.
Water hardness is classified as follows:
Class Grains per gallon ppm per gallon

Soft 0–3.5 0–59.85
Moderately hard 3.5–7.0 59.85–119.70
Hard 7.0–10.5 119.70–179.55
Very Hard Over 10.5 Over 179.55
In terms of savings and effectiveness, the ideal water for general food plant cleaning
purposes is completely softened water. However, a degree of hardness is often preferable
in some food processing such as canning of certain vegetables.
III. FUNDAMENTALS OF CLEANING

The basics of cleaning include four parts:
1. To bring a cleaning agent into intimate contact with the soil

2. To displace the soil from the surface to be cleaned
3. To disperse the soil in the solvent
4. To prevent redepositing of the dispersed soil back onto the clean surface
A. Definition of Functions Performed by Cleaning Agents

The following provides a glossary of functions performed by cleaning agents:
Deflocculation (or dispersion). The action in which groups or clumps of particles

are broken up into individual particles and spread out suspended in the solution.
Dissolving. The reaction which produces water-soluble materials from the water-
insoluble soil.
Emulsification. A process where fats are broken up into tiny globules and are sus-
pended in the cleaning solution.
Penetration. The action of liquids entering porous materials through cracks, pin
holes, or small channels.
Peptization. Physical formation of colloidal solutions from partially soluble mate-
rials.
Saponification. Action of alkali on fats resulting in the formation of soap.
Suspension. The action in which insoluble particles are held in solution and not
allowed to settle out onto the utensils.
Rinsability. The action which breaks the surface tension of the water in the solution
and permits the utensil to drain dry.
Water softening. Water softening is accomplished by three chemical processes:
1. Precipitation. Softens-water by precipitating out the hardness
2. Sequestration. The action of an inorganic compound attaching itself to the
water hardness particles and inactivates them so they will not combine with
other material in the water and precipitate out
3. Chelation. The same as sequestration except that an organic compound is
used
Wetting. Action of water in contacting all soil; helps to reduce surface tension
(wetting agents usually do a good job of emulsification).
Synergism. A chemical used as a builder with a soap or detergent, which results
in a detergency that is greater than the total detergency of the chemical and the
soap if they were used independently.
B. Factors Affecting Cleaning Efficiency

The proper selection of the cleaner to do the job, the concentration of cleaner, the time
in contact with the surface, and the force, velocity, and temperature used are all important
to effective cleaning. Each of these can be varied independently to adjust a cleaning opera-
tion to a particular problem or plant operating practice. These factors will vary from hand
cleaning to circulation cleaning and will depend upon the type and condition of soil to
be removed.
The functions of various factors are
The cleaner.
Temperature. Increasing temperature (1) decreases the strength of bond between
soil and surface, (2) decreases viscosity, (3) increases solubility of soluble materi-
als, and (4) increases chemical reaction rate.
Velocity or force. In hand cleaning, force is applied by ‘‘elbow grease,’’ where
fluid flow is used to apply cleaning force in CIP systems. Increased turbulence
provides more effective removal of film from surfaces. However, efficiency is
less effected by turbulence as the physical–chemical effectiveness of the detergent
increases. A CIP cleaning velocity of 5 ft/sec is recommended to ensure adequate
turbulence.
Time. All other factors remaining constant, cleaning efficiency can be increased
by utilizing longer times.
Concentration. Increased concentration increases the reaction rate. It is the least
effective of the five variables to change in cleaning.
C. Desirable Properties of Good Cleaners

The following lists the most desirable properties of a good cleaner for a food processing
plant:
Quick and complete solubility
Good wetting or penetrating action
Dissolving action on food solids
Emulsifying action on fat

Deflocculating, dispersing, or suspending action
Good rinsing properties
Complete water softening power
Noncorrosive on metal surfaces
Germicidal action
Economy in use
IV. CLEANING METHODS

A. Cleaning Methods
1. Removal of Gross Food Particles
Loose material should be removed before the application of cleaning solutions. This may
be accomplished by flushing the equipment surface with cold or warm water under moder-
ate pressure. Very hot water or steam should not be used because it may make cleaning
more difficult.
2. Application of Cleaning Compounds

There are many methods of subjecting the surfaces of equipment to cleaning compounds
and solutions. Effectiveness and the economy of the method generally dictate its use:
Soaking. Small equipment or fittings or valves may be immersed in cleaning solu-

tions in a sink, while larger vessels such as vats and tanks may be partially filled
with a predissolved cleaning solution. The cleaning solution should be hot (125°F;
52°C) and the equipment permitted to soak for 15–30 min before being manually
or mechanically scrubbed. One relatively recent approach is the ultrasonic clean-
ing tanks in which equipment is immersed in a cleaning solution and cleaned by
the scrubbing action of microscopic bubbles caused by high frequency vibrations
(20,000–40,000 cycles per second).
Spray methods. Cleaning solutions may be sprayed on equipment surfaces by use
of either fixed or portable spraying units using either hot water or steam. These
methods are extensively used in the food industry.
Clean in place systems. This method is an automated cleaning system generally
used in conjunction with permanent-welded pipeline systems. In CIP cleaning,
fluid turbulence in pipelines is considered to be the major source of energy re-
quired for soil removal.
Abrasive cleaning. Abrasive-type powders and pastes are still available and used
for removing difficult soil. Complete rinsing is necessary and care should be taken
to avoid scratching stainless steel surfaces. Scouring pads should not be used on
food-contact surfaces because small metal pieces from the pads may serve as
focal points for corrosion or may be picked up in the food.
Cleaning compounds and sanitizing agents used in cleaning and sanitizing proce-
dures should be free from undesirable microorganisms and should be safe and appropriate
for the intended objectives, i.e., used in cleanings. Identify, hold, and store toxic cleaning
compounds, sanitizing agents, and pesticide chemicals to protect food-contact surfaces
and food-packaging materials.

3. Rinsing
All equipment surfaces should be thoroughly rinsed with clean potable water immediately
after being cleaned in order to remove all traces of the cleaning solution. Very hot water
may be desirable to decrease drying times.
V. SANITIZING
The primary reason for the application of effective sanitizing procedures is to destroy
those disease organisms which may be present on equipment or utensils after cleaning,
and thus prevent the transfer of such organisms to the ultimate consumer. In addition,
sanitizing procedures may prevent spoilage of foods or prevent the interference of microor-
ganisms in various industrial processes which depend on pure cultures. The FDA has
provided a list of those agents it has approved for sanitizing equipment (178 CFR 1010).
A. Chemical Sanitizing Agents

There are a wide variety of known chemicals whose properties destroy or inhibit the
growth of microorganisms. Many of these chemicals, however, are not suitable for use
on food-contact surfaces because they may corrode, stain, or leave a film on the surface.
Others may be highly toxic or too expensive for practical use. Therefore, the discussion
on chemical sanitizing agents will be restricted to those agents in common use in the food
industry.
1. Chlorine
Chlorine and its compounds combine indiscriminately with any and all protein and proto-
plasms. The mode of bactericidal action is thought to be the reaction of chlorine with
certain oxidizable groups in vital enzyme systems.
a. Inorganic Chlorine Products. Types in common use include
Calcium hypochlorite—generally in powder form of 70% available chlorine

Sodium hypochlorites—generally in aqueous solution of 2–15% available chlorine
Characteristics and limitations are as follows:
Effective sanitizer if high enough residual used

Organic matter may cause a substantial reduction in bactericidal effectiveness.
Temperature and pH may exert marked influence upon the bactericidal effectiveness.
Relatively unaffected by water hardness.
No film left on surface but may leave odor or taste.
Bactericidal activity if (is?) good against a wide variety of microorganisms.
b. Organic Chlorine Products. Types include
Chloramine-T—in powdered form of 25% available chlorine

Dichlorocyanuric and trichlorocyanuric acids—in powdered form of 70–90% avail-
able chlorine
Characteristics and limitations include
Slower bactericidal action than hypochlorites.
Factors affecting hypochlorites similarly affect organic chlorine compounds.
Relatively nonirritating to skin.
2. Iodophors
Iodophors are soluble complexes of iodine combined usually with nonionic surface-active
agents, loosely bound. Characteristics and limitations are as follows:
Rapid bactericidal action in acid pH range in cold or hard water
Less affected by organic matter than hypochlorites
Nontoxic in ordinary concentration
Noncorrosive, nonirritating to skin
Yellow or amber color of solution is proportional to concentration
Less effective against bacterial spores than hypochlorites
Does not stain; only minimal taste and odor
3. Quaternary Ammonium Compounds
Quaternary ammonium compounds (QACs) compounds are synthetic surface-action
agents. The most common ones are the cationic detergents, which are poor detergents but
excellent germicides. In these compounds, the organic radical is the cation, and the anion
is usually chlorine. The mechanisms of germicidal action is not completely understood,
but is associated with enzyme inhibition and leakage of cell constituents.
Types of compounds include
Alkyl dimethyl benzyl ammonium chloride; alkyl dimethyl ethylbenzyl ammonium
chloride. These compounds are effective in water ranging from 500 to 1100 ppm
hardness without added sequestering agents.
Diisobutyl phenoxy ethoxy ethyl dimethyl benzyl ammonium chloride; methyl dode-
cyl benzyl trimethyl ammonium chloride. These compounds require sodium tripo-
lyphosphate to raise hard water levels to a minimum of 500 ppm.
Characteristics and limitations are as follows:
Require high dilution for germicidal or bacteriostatic action
Very selective in destruction or inhibition of various types of organisms
Form bacteriostatic film on surface after treatment
Noncorrosive and nonirritating to skin
No taste or odor in used dilutions
More stable in presence of organic matter than some other chemical sanitizers
Incompatible with soap, anionic detergents, and inorganic polyphosphate
Difficult to accurately measure residual
4. Factors Affecting Action of Chemical Sanitizers
In order for a chemical to react with microorganisms. It must achieve intimate contact.
a. Concentration of Sanitizer. In general, the more concentrated a sanitizer, the more
rapid and certain its actions. Increases in concentration are usually related to exponential
increases in effectiveness until a certain point when it accomplished less noticeable effec-
tiveness. Minimum concentrations are as follows:
Minimum
Chemical agent concentration (ppm)
Hypochlorites 50
Chloramine-T 200
QACs 200
Iodophors 12.5
For sanitization of assembled equipment, the solution strength should be checked at the
outlet end. When it is in excess of the minimum concentrations, the solution should be
pumped through the entire equipment for at least 1 min.
b. Temperature of Solution. All of the common sanitizers increase in activity as the

solution temperature increases. This is partly based on the principle that chemical reactions
in general are speeded up by raising the temperature. However, a higher temperature also
generally lowers surface tension, increases pH, decreases viscosity, and effects other
changes which may enhance germicidal action. It should be noted that chlorine compounds
are more corrosive at high temperatures and iodine tends to sublime at temperatures above
120°F (49°C).
c. pH of Solution. The pH of the solution exerts a very pronounced influence on most

sanitizers. Quaternary compounds present a varied reaction to pH depending on the type
of organism being destroyed. Chlorine and iodophors generally decrease in effectiveness
with an increase in pH.
d. Time of Exposure. Sufficient time must be allowed for whatever chemical reactions
that occur to destroy the microorganism. The required time will not only depend on the
preceding factors, but on microorganism populations and the populations of cells having
varied susceptibility to the sanitizer due to cell age, spore formation, and other physiologi-
cal factors of the microorganisms.
B. Physical Sanitizing Agents

1. Heat
a. Moist Heat.
hot water. An effective, nonselective sanitization method for food-contact sur-
faces;however, spores may remain alive even after an hour of boiling temperatures. The
microbicidal action is thought to be the coagulation of some protein molecules in the cell.
The use of hot water has several advantages in that it is readily available, inexpensive, and
nontoxic. Sanitizing can be accomplished by either pumping the water through assembled
equipment or immersing equipment into the water. When pumping it through equipment,
the temperature should be maintained to at least 170°F (77°C) for at least 5 min as checked
at the outlet end of the equipment. When immersing equipment the water should be main-
tained at a temperature of at least 170°F for 1–5 min depending on the size of the equip-
ment.
steam. Steam is an excellent agent for treating food equipment. Treatment on
heavily contaminated surfaces may cake on the organic residues and prevent lethal heat
to penetrate to the microorganism. Steam flow in cabinets should be maintained long
enough to keep the thermometer reading above 170°F for at least 15 min or above 200°F
(93.3°C) for at least 5 min. When steam is used on assembled equipment, the temperature
should be maintained at 200°F for at least 5 min as checked at the outlet end of the
assemble equipment.
b. Dry Heat. Hot air ovens and chambers are not generally used because the method
requires longer times and higher temperatures. When such equipment are used, the temper-
ature must be at least 180°F (82.2°C) for a holding period of at least 20 min.
2. Ultraviolet Radiation and New Technology

Low pressure mercury vapor lamps, which produce effective bactericidal action by the
emission of radiation at a wavelength of around 2500 Å, have had limited use in the food
industry. Major application has been with disinfection of air. However, installations of
lamps have been reported on bread-slicing machines, over open vats in breweries, and in
chill rooms for meats. Bacterial resistance will highly influence the lethal exposure time.
Moreover, the light rays must actually strike the microorganisms because the rays are
absorbed by dust, thin films of grease, and opaque or turbid solutions.
In the last few years, many new technologies for cleaning a food processing plant
began to emerge. This book is not designed to go into details on such topics. Standard
reference sources should be consulted.
VI. EXAMPLES OF INSANITARY CONDITIONS IN A FOOD

PROCESSING PLANT
The FDA has various methods of enforcing its laws and regulations. Inspecting a food
plant is one of them. For some companies, the deficiencies in sanitary conditions may
elicit a warning letter from the FDA. The following are some examples (from warning
letters) of such deficiencies from a failure in doing an adequate job in cleaning a food
plant.
A. Pests
Live and dead insects (i.e., cockroaches, flies, apparent weevils, and gnats) on, in,
and around raw materials, in-process food, finished product, and equipment
B. Equipment and Residues
Equipment encrusted/covered with old apparent product residue or extraneous mate-

rials used in the manufacture of food products.
The interior surface of the ice-making machine had old food residues and the ice-
dispensing scoop was stored on top of a soiled measuring scale.
The surfaces of the mixer-blender, meat slicer, and can opener all had a build-up
of old food residues.
The food cart shelves in the food preparation area and the refrigerator racks had a
build-up of old food residues.
C. Washing and Sanitizing
There was no sanitizing solution available to sanitize utensils and equipment.

There was no three-compartment sink available to wash, rinse, and sanitize utensils
and equipment.
There was no chemical test kit or other device available to measure the concentration
of the sanitizing solution.
The chemical concentrations of iodine at four sanitizer stations were measured and
found to be too low to adequately sanitize the utensils and equipment.
D. Garbage and Waste
Three 50-gallon trash cans in the food preparation area were overfilled with garbage,
and garbage was spilling onto the floor. Trash was not disposed of on a regular
schedule.
The ground surfaces under both the trash compactor and the container holding soda
cans for recycling had a strong foul odor. The ground surface in the loading dock
area had a pool of standing murky water and a build-up of trash and garbage.
E. Floors
The floor drains in the food preparation area were clogged with old food residue.
The floor areas throughout the facility and along the walls were not clean, i.e., areas
around the dish washer, food preparation, and refrigerator.
The floors in the three refrigerators were cracked, soiled with food debris, and worn
from deterioration and disrepair.
ACKNOWLEDGMENT
Data in this chapter have been modified with permission from publications prepared by
Science Technology System, West Sacramento, CA.

10
Water in Food Processing
CHUN-SHI WANG and JAMES SWI-BEA WU

National Taiwan University, Taipei, Taiwan
PHILIP CHENG-MING CHANG
National Taiwan Ocean University, Keelung, Taiwan
I. INTRODUCTION
Water is an essential element for the existence of life. Many physiological reactions have
to occur in water solution. Where water is present, life is possible. Where it is absent,
life can not sustain. Water is one of the most abundant substances on earth. However, the
quantity of water that is available for human beings to use without laborious treatment is
very limited; for example, only 1% of the world’s total is freshwater [1]. Therefore, it is
important to make the best utilization of water.
Water can be the most crucial component in the processing of most food products.
It is often used as the medium for washing, heating, and cooling as well as for the cleaning
and sanitation of equipment and facilities. Water is a food ingredient itself and also the
vehicle that carries other ingredients such as sodium chloride during formulation. The
demand for water in the food industry keeps increasing because (1) more food is being
produced; (2) foods are more apt to be intensively processed; (3) there is increased empha-
sis on cleanliness and good sanitation; (4) mechanical harvesting leads to more dirt and
debris on produce that must be washed off; and (5) the use of water for conveying food
in the processing plant is increasingly common [2]. To cope with the ever-growing de-
mand, food processors ought to use water more efficiently, either by developing processing
operations that utilize less water or by reconditioning and recycling a higher percentage
of water within the food plant.

II. SOURCES AND PROPERTIES OF WATER
Water from different sources may have different physical, chemical, and biological proper-
ties. It may require different treatments to meet the same quality standards for a specific
usage. Some plants may have an alternative water supply to make up the deficiency in
quantity or quality of their own source. For example, they may purchase municipal water
and treat it for sanitary utilization, while relying on their own source of water only for
nonsanitary operations because of its lack of cleanliness.
A. Surface Water
Surface water is defined as all the water open to the atmosphere and subjected to surface
runoff. Water in streams, rivers, brooks, lakes, and reservoirs is included in this category.
The quality of surface water is influenced by the location of the collection point where
water is diverted for treatment. Quiescent water bodies, whether natural or human-made,
are living ecosystems. Their specific properties may change from time to time, often accel-
erated by human activities. The major sources of pollution for surface water are fertilizers
and other agricultural chemicals that have been applied to the field, industrial wastes,
sewage, and decayed materials of animal or plant origin.
The quality of streams, rivers, and brooks may also vary with seasons. Rapid changes
in quality including turbidity may occur right after heavy precipitation and accidental
spills [3]. In these occasions, much greater capacity in treatment and closer attention
among operators than that in normal operation conditions are required. Lakes and im-
pounding reservoirs also have seasonal variations in water quality, but these variations
usually occur at a slower rate than those of streams and rivers [4]. Generally speaking,
water from lakes and reservoirs contains less precipitable solids, primarily because there
is sufficient retention time to permit settling [2]. As a result, water from reservoirs and
lakes is often easier to filter and purify, although it may be inherently less pure than river
water due to the greater impact from microbiological activity.
B. Ground Water
All water beneath the land surface is referred to as underground, or subsurface water [5].
Underground water occurs in two different zones. One is right beneath the land surface,
called the unsaturated zone, while the other is at greater depths where all the empty spaces
are completely filled with water, and it is therefore called the saturated zone, with the
water table being the upper surface [6]. The term ground water refers only to the water
in the saturated zone. Ground water originates from either springs or wells, and the sanitary
conditions are much the same as long as it is properly protected during and after rising
to the surface.
The contaminants in ground water may be from surface water and sewage. Springs,
infiltration galleries, shallow wells, and other collectors in subsurface aquifers may be
hydraulically connected to nearby surface water sources, depending on local geology [7].
Floods may also allow surface water to enter the well and produce contamination [8].
Sewage can enter wells if they flood or are located too close to cesspools, septic tanks,
or associated drainage fields. A small quantity of contaminated ground water may enter
a well without sufficient natural filtration and percolation to remove impurities and con-
taminate a much large quantity of clean ground water [2].
Ground water quality is usually superior to that of surface water with respect to
microbial content, turbidity, and total organic concentrations [4]. However, the mineral
content (hardness, iron, manganese, etc.) of ground water may be so high that a softening
treatment is required. The quality, especially the concentrations of chemicals such as pesti-
cides, herbicides, and solvents, is of great concern for the safe use of ground water in
food processing [9].
C. Seawater
Seawater is usually drawn up from deep sea at some distance from shore for conveying
and cleaning fish on fishing boats and in seafood processing operations [10]. This water
is simply filtered to remove debris of large size, and further purification is not considered
necessary for the purposes intended [2]. There is an inherited freshwater shortage problem
in some countries, especially in the Middle East. Desalination of seawater to create a
water source of good quality is an adequate solution for these countries [11].
D. Public Water Systems

Potable water, commonly known as ‘‘drinking water,’’ means water that meets the U.S.
‘‘National Primary Drinking Water Regulations’’ (40 CFR 141), the World Health Organi-
zation’s ‘‘International Standards for Drinking Water,’’ or other recognized equivalent
standards. A public water system is an approved water source and is convenient for the
food industry to use.
E. Reuse of Water
The need to conserve water through reuse is crucial given the finite nature of this resource
and increasing demands for its use in domestic, agricultural, and manufacturing activities.
There is 5–10 m 3 of wastewater produced for each ton of food product processed in Ger-
many [12]. Water having an organic concentration, measured as total organic carbon
(TOC), below 300 mg/L and an inorganic concentration below 2200 µS/cm is defined as
low-contaminated water that is reusable in the food industry. It constitutes up to 30% of
the total wastewater quantity in a food plant [13]. Food processors can make a prudent
reuse of wastewater through proper treatments to recondition it. The reconditioning in-
cludes reduction in the total suspended solids content (TSS), biological oxygen demand
(BOD), and chemical oxygen demand (COD). Reusing water saves not only the initial
water cost, but also the cost of disposing of the liquid waste because sewage charges are
usually based on volume as well as TSS, BOD, and COD of the effluent. Table 1 shows
some examples of water reuse in food plants.
Table 1 Occurrence of Water Reconditioning in Different Food Processing Sectors
Application Treatment Reference

Egg washing water Addition of sanitizer 14
Pickling brine Addition of sodium chloride 15
Surimi processing brine Removal of proteins 16
Hydrocooling water Addition of chlorine dioxide 17
Chiller shower water Membrane and UV 13

Recycled water obtained from a food manufacturing operation, reconditioned if nec-
essary, may be reused in the same or another food manufacturing operation. Reuse water
shall not jeopardize the safety of the product through the introduction of chemical, micro-
biological or physical contaminants in amounts that represent a health risk to the consumer.
Therefore, water from sources that are in contact with or include human or agricultural
sewage should not be upgraded for reuse [18]. Also, unless reconditioned to potable qual-
ity, distribution of reuse water should be in systems separated from the distribution lines
for potable water. Nor shall reuse water jeopardize the organoleptic property of the
product.
Recirculated water is water reused repeatedly in a closed loop for the same manufac-
turing operation. It can be untreated, treated to remove particulate matters, or added with
a disinfectant if the period of recirculation is long.
III. WATER UTILIZATION FOR FOOD PROCESSING

There is no standard quantity of water utilization in the processing of food. Few food
plants use no water at all, while many of them consume very large quantities. Food pro-
cessing sectors vary in their major purposes for using water. For instance, 60% of the
water used by meat processors is for cooling purposes, 62% of the water used by sauce
manufacturers is for cleaning; while starch millers use 55% of water for granule separation.
Water serves multiple functions in the processing of food, including cleaning, conveying,
steam generation, heat exchange, and as an ingredient, etc.
A. Cleaning
The use of water for cleaning involves washing plant structures and surfaces, equipment,
raw materials, and in some cases, the finished products. The purposes of cleaning the
plant and equipment are sanitation and removing undesirable residues from a processing
line. Raw materials such as fruits and vegetables also require cleaning because modern
mechanized harvesting leaves extensive soil residue on their surfaces. Hard water is a
problem in households and manufacturing facilities when it hinders the ability for soaps
and detergents to form lather. For this reason, hard water is often softened to remove
calcium and magnesium ions. The hot water supply shall be sufficient to satisfy the peak
demands of the establishment. Hot water for handwashing shall be at a temperature no
lower than 55°C (110°F), while for mechanical dishwashing shall be 66–74°C (150–
165°F) in the washing stage and 74–82°C (165–180°F) for sanitizing. The temperature
of the wash solution in spray-type warewashers that contain chemical sanitizers ought not
to be lower than 49°C (120°F). The temperature for manual hot water sanitization needs
to be no lower than 77°C (171°F) [19].
B. Conveying
Water is widely used for conveying in the fruit and vegetable processing industry. In many
cases, cleaning and conveying are done at the same time. Wherever practical, conveying
water is reused after reconditioning. Fluming in a water pumping system is a common
method of transporting product from one corner of the factory to another, and, as men-
tioned, the water used often is recycled. The proper diameter of pipes used for this purpose
depends on the size of the product to be conveyed. One of the major difficulties with
transportation by fluming is the tendency for the food product to contact and adhere to
the inner surface of the conveying duct, thus becoming a focus for microbial growth [20].
When this happens, such pipes shall be disassembled periodically, depending on the build-
up rate, and scrubbed thoroughly to remove the deposit.
C. Steam Generation
Steam is used to heat, peel, humidify, and clean in the food industry. As a result, the
water for steam generation is considered a food ingredient that ought to meet the regulatory
requirements for potable water. For alleviating the corrosion problem in boilers and steam
ducts, corrosion inhibitors and water-conditioning compounds may be added to water be-
fore it is fed into a boiler to generate steam. These materials are regarded as food additives
by regulatory authorities and their use in process steam generation is controlled accord-
ingly [21].
D. Heat Exchange
It is common to use water or a water solution to heat or to cool in the food industry. In
fact, more water is used for cooling than for any other process [22]. There are two types
of cooling system in food plants. One is a closed-loop cooling system where water does
not contact with food; the other is a cooling canal system where water contacts with
food directly. The closed-loop system involves equipment such as a cooling tower for the
liberation of heat to the atmosphere. In the cooling canal system the velocity of water
should be adequate to agitate and float off loose particles in an overflow and meanwhile
to keep the raw materials submerged. Water may also be frozen to ice and then used as
a cooling medium, in contact with the produce directly or mixed with water to form slush
in a cooling canal. Ice bank formation in the closed-loop system becomes common in
modern industry as a way of utilizing cheap off-peak energy.
When fruits and vegetables are heated in water, the amount of calcium ions in the
medium may influence the texture of the product. For example, calcium ions may crosslink
with low-methoxyl pectin that is beneficial for maintaining firmness in cooked fruits and
vegetables [23]. However, cooking in water containing excessive amounts of calcium ions
may result in a product with unacceptably tough texture. Peas and beans that are cooked
in high-calcium water and then dried will be difficult to rehydrate [24].
E. Ingredient
This occurs when the water eventually becomes a constituent of the food. It should be of
the highest purity and potability. A good example of water as a food ingredient is in the
making of soft drinks. Water is mixed directly with syrup, then is carbonated, bottled,
and pasteurized. The water needs to be softened before use because hard water can cause
unwanted cloudiness in the soft drink [25]. In a jam-producing plant, if alginate is used
for jelling, the calcium ion content in water has to be controlled; if κ-carrageenan is used,
the potassium ion content in water has to be controlled instead [26]. Chlorinated water
may sometimes be an unsatisfactory ingredient because chlorine can cause taste and odor
problems [27].
IV. WATER PURIFICATION OPERATIONS

As water travels over the land’s surface or through the ground or is reused in the food
plant, it may pick up various kinds of contaminants including microbials, such as viruses
Table 2 Water Purification Treatments and Their Functions
Nature
of treatment Function Treatment
Physical Removal of solids and some microorganisms Absorption
Bubble separation
Centrifugation
Coagulation
Filtration
Sedimentation
Biological Reduction of BOD, COD, TSS, and TOC Aerobic biodegradation
Anaerobic biodegradation
Chemical Removal of organic and inorganic materials, re- Chemical precipitation
moval of ions and dissolved solids, or reduction Disinfection
of microorganisms Ion exchange
and bacteria; inorganic substances, such as salts and metals; pesticides and herbicides;
organic compounds from industrial processes; radioactive contaminants; etc. Certain puri-
fication treatments are required to ensure the water is suitable for processing and safe for
the public to use or drink. A treatment can be physical, biological, or chemical in nature
(Table 2).
The purpose of a treatment can be clarifying, deodorizing, softening, or disinfecting,
as described in the following sections.
A. Clarification
Clarification reduces the amount of suspended solids. Many pollutants of concern to hu-
man health are solid particles themselves (e.g., pathogenic organisms) or are associated
with solid particles (e.g., certain toxic metals) [28]. Clarification involves, but is not lim-
ited to, the following treatments.
1. Coagulation
Coagulation is a treatment to promote aggregation of small particles into large particles
that can be removed by subsequent sedimentation and/or filtration processes. Coagulation
destabilizes particulate suspensions in water. Particulate suspensions that are commonly
removed with coagulation include clay- and silt-based turbidity, natural organic matters,
and other associated constituents, such as microbial contaminants, toxic metals, synthetic
organic chemicals, iron, and manganese. The associated contaminants often adsorb to or
combine with turbidity and natural organic suspensions, thus enabling their removal by
coagulation treatments [4].
Coagulation usually proceeds in three steps, namely, coagulant formation, particle
destabilization, and particle aggregation. In the rapid-mixing stage of a coagulation treat-
ment coagulant forms and particles destabilize as a response to the hydrolization and
dispersion of the chemical additive. Particle aggregation is then promoted in a flocculation
stage, where interparticle collisions create larger particles amenable to separation from
the treated water [28].
Alum and iron salts are the most common chemical additives used in the coagulation
treatment of water. The most common rapid-mixing equipment used in the treatment is
a back-mix mechanical reactor. Other rapid-mixing equipment includes in-line blenders,
hydraulic jumps, motionless static mixers, and diffuser injection devices. Flocculation is
typically performed in a basin baffled into three or more compartments, with mechanical
mixing provided in each stage to promote interparticle collisions and aggregation [4].
2. Sedimentation
Sedimentation and flotation are solid–liquid gravity separation treatments to reduce the
quantity of suspended solids in water. A sedimentation treatment promotes gravity settling
of solid particles to the bottom of the water column, where they are accumulated and
removed. Flotation treatments introduce gas bubbles into water that attach to solid particles
and create bubble/solid agglomerates. The agglomerates then float to the top of the water
column to be removed [4].
Sedimentation is particularly necessary for high-turbidity water, which may release
a substantial quantity of solids during coagulation or flocculation treatments. Sedimenta-
tion may also be employed at the head of a water treatment in a so-called presedimentation
basin to allow gravity settling of dense solids that do not require any coagulation or floccu-
lation treatment to be separated from water. Flocculation is used ahead of sedimentation
for algal-laden, low-turbidity, low-alkalinity, or colored water that contains low-density
particles [4].
3. Filtration
Filtration is a major treatment that removes suspended particulate materials from water.
Among the materials usually removed are clay and silt, colloidal and precipitated natural
organic matters, metal salt precipitates from coagulation, lime-softening precipitates, iron
and manganese precipitates, and microorganisms.
Granular media filters are the most common types of filter used in the treatment for
potable water. The pore volume, pore size, and pore tortuosity of the filter affect its solids-
holding capacity, head loss characteristics, filtrate quality, and backwash flow require-
ments. The filter is usually made of sand, crushed anthracite coal, garnet, ilmenite, or
granular activated carbon. Filters can be specified by the rate of filtration, that is, the flow
rate per unit area. They can also be classified as depth filtration filters if the solids are
removed within the granular material or cake filtration filters if the solids are removed
on the entering face of the granular material. Rapid granular-bed filters are among the
former group, while precoated and slow sand filters are among the latter group.
Cartridge filters are available for various point-of-use filtration applications. They
are usually pressure filters with a medium comprised of membrane, fabric, or string. The
medium is supported by a filter element and housed in a pressure vessel. The cartridge
is generally disposed of after a single filter cycle. Cartridge filters are usually rated by
their manufacturers as to the particle size to be retained, with the smallest being about
0.2 µm and the largest going up to about 10 µm. Smaller retained particle sizes result
in lower flow rates, higher pressure requirements, and a shorter operating period before
replacement [29].
4. Membrane Processes
Membrane processes include reverse osmosis (RO), ultrafiltration (UF), and nanofiltration
(NF). They are emerging as viable potable water treatment processes for removing particu-
lates, color, trihalomethane precursors, and some inorganic substances. The common com-
ponent shared among the various membrane processes is a membrane able to reject or
select passage of certain dissolved species based on size, shape, and/or charge. The perfor-
mance and limitations of membrane processes depend on several factors. The specific
quality of the feed water and desired quality of the product water shall be considered in
the selection of system [30]. Generally, the more contaminated the feed water and the
higher the desired product water quality, the greater the likelihood of membrane fouling
caused by particulate matter, scaling, and biofouling [31]. Common practices to overcome
the fouling problem include pH control, addition of antiscalants and compatible biocides
that can also prevent membrane decomposition [32].
5. Biological Treatment
Water containing nonnegligible concentrations of biodegradable materials is described as
biologically instable. Biologically instable water may allow pronounced bacterial growth
in subsequent processes. In the distribution system, biodegradation of the instable materi-
als can create undesirable odors or taste and increase turbidity and the rate of corrosion
[33]. Water from which nearly all of the biodegradable materials have been removed is
called biologically stable [34]. Placing biological treatment as one of the initial processes
is most advantageous because early removal of biodegradable materials guards against
slime build-up during coagulation and filtration and eliminates the need for chlorination
beyond that required for pathogen destruction. Biofilm formation is a method to prepare
biologically stable water [35]. The bacteria are attached as a naturally occurring film on
solid media such as small rocks, stones of pozzolana, particles of expanded clay, fluidized
particles of sand or slit, or plastic media. In biofilm reactors, water usually flows by
quickly, with a detention time of only a few minutes. An important design criterion for
a successful biofilm process is to obtain a high specific surface area to maximize the
volumetric reaction rate [36].
B. Deodorization
Treated water can be very safe to drink yet still have an unpleasant taste and odor because
of the activity of some microscopic organisms such as algae [37], especially during hot
summer months. The purpose of deodorization is to remove the taste and odor in water.
1. Air Stripping and Aeration
Air stripping and aeration can be defined as a treatment to bring water into contact with
air in order to expedite the transfer of a gas between the two phases. Historical applications
of aeration include the removal of hydrogen sulfide that causes off-taste and smelly odors,
carbon dioxide to reduce the demand of lime in the subsequent softening treatment, and
trace volatile organic contaminants. Packed tower, diffused aeration, spray nozzles, and
tray aerators are the common equipment used [38].
2. Adsorption
Adsorption of a substance involves its accumulation at the interface between two phases,
such as a liquid and a solid or a gas and a solid. The molecule species that accumulates,
or adsorbs, at the interface is called an adsorbate, and the solid on which adsorption
occurs is the adsorbent. Adsorbents of interest in water treatment include activated carbon;
adsorbent resins; metal oxides, hydroxides, and carbonates; activated alumina; clays; and
other solids that are suspended in or are in contact with water. Powdered activated carbon
(PAC) is commonly used for controlling seasonal taste and odor problems experienced
in surface water supplies. Typical dosage ranges from 1 to 50 mg/L, and the effectiveness
is water-source specific and difficult to predict without performing bench, pilot, or full-
scale tests. Granular activated carbon (GAC) is far more effective than PAC as an adsor-
bent. The retention time of water in the treatment, given a feed water quality and desired
finished water quality, determines the size of the GAC contactor and the activated carbon
usage rate [39].
C. Softening
Softening is used to remove the cation contaminants such as calcium, magnesium, barium,
strontium, and radium ions and anion contaminates such as fluoride, nitrate, fulvates, hu-
mates, arsenate, selenate, chromate ions, and anionic complexes of uranium. The technol-
ogy of chemical precipitation or ion exchange may soften water to prevent texture and
color changes in certain foods, improve the effectiveness of bottle-washing operations,
and lessen the accumulation of mineral deposits within pipes, ducts, and equipment.
1. Chemical Precipitation
Chemical precipitation is one of the most common treatments for water softening as well
as iron and manganese removal. The effectiveness of removing substances from water by
precipitation depends primarily on the solubility of the complexes formed after the addi-
tion of chemicals. Lime, lime/soda ash, and caustic soda are the chemicals usually used
in water precipitation treatment. During the process, calcium is removed in the form of
calcium carbonate (CaCO 3), while magnesium is removed as magnesium hydroxide
[Mg(OH) 2]. Concentrations of various carbonic species and pH play an important role.
Water right after the precipitation treatment usually has a pH of 10 or greater that may
easily cause the deposition of hard carbonate scale on filter sand and distribution piping.
Therefore, carbon dioxide in sufficient quantity is often added to the water to bring the
pH down to the range of 8.4 to 8.6 [40].
2. Ion Exchange
Ion exchange with synthetic resins is generally applied in circumstances where mineral
quality of the product water necessitates a treatment more powerful than conventional
ones. An ion exchanger is typically comprised of a bed packed with resin beads presatu-
rated with exchangeable ions. Ion exchange media need to be reactivated with a regenerant
solution and rinsed with water in preparation for another treatment cycle [41].
D. Disinfection
The purpose of disinfection is to reduce the total bacterial concentration and eliminate
the pathogenic bacteria in water. Potable water supply requires zero or very low bacterial
concentration to avoid disease transmission. The total number of coliform groups of organ-
isms, instead of the presence of specific pathogens, is often used as an indicator for sanitary
quality and the efficiency of disinfection. There are many chemical disinfectants and physi-
cal methods that can be used for disinfection.
1. Chemical Disinfectant
Addition of the chemical disinfectant to water provides a maximal time of contact between
the chemical and organisms, assuring efficient bactericidal action. A variety of chemical
disinfectants is available for use in water treatment. Chlorine, iodine, bromine, quaternary
ammonium, and ozone are examples. Chlorine, as gaseous chlorine or solid compounds
such as calcium or sodium hypochlorite, is the most common chemical used for disinfec-
tion due to low cost, high efficiency, and ease of application. Prechlorination, or source
water chlorination, is designed to minimize operational problems associated with biologi-
cal slime formation on filters, pipes, and tanks and to lessen potential taste and odor
problems as well. Postchlorination, or terminal disinfection, is the primary exercise for
microbial reduction in product water. Addition of chlorine either immediately before the
clear well or immediately before the sand filter is most common [42].
2. Ultraviolet Radiation
Ultraviolet (UV) radiation at a wavelength of approximately 254 nm is an effective biocide
and provides no residual for distribution. The inactivation of microorganisms upon expo-
sure to UV is based on the specific deleterious changes in nucleic acid. Yip and Konosew-
ich [43] suggested that the dose of UV to kill pathogens is more comparable to the dose
necessary to kill indicator bacteria than in the case of chlorine. Thus, the UV levels neces-
sary to meet coliform standards may be relatively more effective than chlorination in
killing pathogens. However, UV has not been widely used due to its inability to control
biofilm formation in distribution systems [44] and high operation cost. Ultraviolet disinfec-
tion is generally more practical for smaller-capacity usage because of the capital and op-
erating expense necessary to ensure adequate water contact with lamp surface. An effective
cleaning program must be established to ensure that biological and/or chemical foulants
do not block UV transmission into the water.
E. Desalination
Conversion of saline water can be experimentally approached from either of two direc-
tions: (1) removal of salts from water by ion exchange or electrodialysis or (2) the removal
of pure water from the raw liquid through unit operations such as vaporization (distilla-
tion), crystallization (freezing concentration), or membrane processes (reverse osmosis).
The main desalination methods used in industry are distillation and membrane processes.
Multistage flash distillation (MSF) and RO have been found to be cost effective [11].
Multistage flash has an extra advantage of the cogeneration of electricity.
V. WATER DISTRIBUTION SYSTEM

The purpose of a water distribution system is to deliver water in adequate quantity and
acceptable quality in its application. The system includes water pumps, pipes, hoses, con-
nections, other appurtenances, water transport vehicles, and reservoirs. Water contamina-
tion is a serious threat to the food industry. There has to be a system in place to ensure
the use of safe potable water in food production and processing continuously.
Where nonmunicipal water supply and sewage disposal are utilized, the location of
these facilities shall be noted on the factory construction plans, and certification of compli-
ance with state and local regulations shall be acquired. The pumping and storage capaci-
ties, as well as the frequency of testing, of a nonmunicipal water supply must be specified.
All sewage including liquid waste shall be disposed by a public sewage system or by a
sewage disposal system constructed and operated following local laws and located for
easy cleaning.
A. Reservoir
A reservoir that is used to supply water to a device such as a produce fogger shall be
maintained in accordance with manufacturer’s specifications and cleaned in accordance
with manufacturer’s specifications or according to the procedures specified in the FDA’s
Food Code, whichever is more stringent [19]. The reservoirs of product water should be
covered whenever possible to avoid recontamination from bird excrement, air contami-
nants, and surface water runoff. The water should be visually examined for color and
clarity and checked for flavor and odor before it is pumped into the holding tank [2].
Reuse water storage vessels, if used, should be properly constructed of material that will
not contaminate the water and should allow for periodic cleaning.
B. Plumbing Systems
A plumbing system refers to a receptacle or device that is permanently or temporarily
connected to the water distribution system of the premises. It is assembled of water supply
and distribution pipes, traps, vent pipes, sanitary and storm sewers, and building drains.
Plumbing systems and hoses conveying water must be made of approved materials, which
are smooth, durable, nonabsorbent, and corrosion resistant, sized and installed according
to applicable codes. The piping of any nonpotable water system shall be durably identified
and distinguishable from differently colored piping that carries potable water. There shall
be no cross-connections between potable water supply and any nonpotable or questionable
water supply. Filters, screens, and other water conditioning devices; backflow prevention
devices; and legal air gaps are sometimes installed in the plumbing system to prevent
contamination of clean water with potentially contaminated water.
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drought period. Sci Total Environ 171:69–76, 1995.
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and Hall, 1992, pp 371–466.
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14. K Leclair, M Heggart, M Oggel, FM Barlett, RC McKellar. Modeling the inactivation of
Listeria monocytogenes and Salmonella typhimurium in simulated eggwash water. J Food Mi-
crobiol 11:345–353, 1995.
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40:1311–1315, 1975.
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commercial washing and fluming practices. Am Potato J 61(8):495–507, 1982.
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cowpea (Vigna unguiculata L. Walp) seeds. Int J Food Sci Technol 27(1):49–55, 1992.
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11
Water and HACCP Programs
YU-PING WEI and JAMES SWI-BEA WU

National Taiwan University, Taipei, Taiwan
PHILIP CHENG-MING CHANG
National Taiwan Ocean University, Keelung, Taiwan
I. INTRODUCTION
Water is used to produce, process, and under certain conditions store food. Water is also
used as an ingredient in many processed foods. Contaminants can find their way into food
products via water as a carrier. Therefore, the quality of water influences the quality of
food greatly. Only potable water should be used in food handling, formulation, and pro-
cessing, except for steam production, operations where water is not in contact with food,
and in certain processes provided that direct contact between water and food does not
constitute a hazard to safety, e.g., chilling with clean seawater [1]. Potable water should
meet the specifications in World Health Organization (WHO) or U.S. Environmental Pro-
tection Agency (EPA) guidelines for drinking water quality. Some of the key values are
listed in Table 1.
Natural water must be properly treated to meet drinking water standards. Water can
also be recontaminated during storage and distribution. It is necessary to implement a
sanitation standard operating procedure for water management in every food processing
plant. Control should be established to prevent contamination from water to food products.
The hazard analysis and critical control point (HACCP) system is often applied for this
purpose.
II. WATER AS A HAZARD SOURCE

There are three major sources of contaminants in water used in food plants: contaminants
in water source; residues of additives or contaminants formed during water treatment,
Table 1 Some Key Values for Drinking Water Guidelines
Parameter WHO EPA
Color point/color scale 15 15
Turbidity, nephelometric turbidity unit (NTU) 5 5
Total dissolved solids, mg/L 1000 500
pH 6.5–8.5 6.5–8.5
Magnesium (as Mg), mg/L — 0.05
Sodium (as Na), mg/L 200 —
Iron (as Fe), mg/L 0.3 0.3
Manganese (as Mn), mg/L 0.1 —
Chloride (as Cl), mg/L 250 250
Fluoride (as F), mg/L 1.5 2.0
Sulfate (as SO 4), mg/L 250 250
Nitrate (as NO 3), mg/L 50 10
Copper (as Cu), mg/L 1.0 1.0
Cadmium (as Cd), mg/L 0.003 0.005
Selenium (as Se), mg/L 0.01 0.05
Mercury (as Hg), mg/L 0.001 0.002
Arsenic (as As), mg/L 0.01 0.005
Lead (as Pb), mg/L 0.01 0.015
Zinc (as Zn), mg/L 3 5
Chromium (as Cr), mg/L — 0.1
Cyanide (as CN), mg/L 0.07 0.2
Aluminum, mg/L 0.2 —
Boron, mg/L 0.5 —
Alpha emitters, Bq/L 0.1 0
Beta emitters, Bq/L 1.0 0
Fecal coliform, counts/mL 0 0
Source: Adapted from Refs. 4 and 40.
storage, or distribution of drinking water [2]; and cross-contamination during processing

especially in reused or recycled water [3]. Water for food processing should be routinely
analyzed for its quality. The elements of the analysis of water are listed in Table 2. Many
of the listed items are used as a sanitary index or a measure of potential hazards.
A. Chemical Hazards
Chemical components in drinking water to be assessed for health risk include inorganic
and organic compounds, pesticides, disinfectants, and disinfectant byproducts [4]. Natu-
rally occurring contaminants are predominantly inorganic compounds such as arsenic and
manganese, which are derived from natural mineral formations. Organic compounds, like
pesticides, disinfectants, and disinfectant byproducts are usually introduced by human
activity [2].
Several of the inorganic contaminants have beneficial as well as adverse effects.
Trace elements like copper, iron, manganese, molybdenum, selenium, and zinc are exam-
ples. On the other hand, lead from lead piping and plumbing and nitrate from intensive
agricultural activities are usually harmful [2].
Table 2 Elements of the Analysis of Water
Water Physical–chemical Undesirable Toxic
characteristics properties components components Hazardous organisms
Scent PH Nitrate Arsenic Salmonella spp.
Color Conductivity Nitrite Cadmium Escherichia coli
Turbidity Chloride Ammonia Cyanide Pseudomonas aeruginosa
Sulfate Oxidation Chromium Streptococcus D
Calcium Iron Mercury Coliforms
Aluminum Magnesium Nickel Aerobic mesophiles
Hardness Copper Lead
Dry residuum Zinc Antimony
Phosphorus Pesticides
Suspended Aromatic
particles hydrocarbons
Pesticides can reach ground or surface water by leaching or run-off following normal
agricultural practices or by accidental spills [5]. Conventional drinking water treatment
cannot remove many of these agricultural chemicals adequately because it was not spe-
cifically designed for this purpose [2]. Disinfection of drinking water often involves the
use of very reactive chemicals such as chlorine, which has been the most important disin-
fectant for decades, or ozone, which is becoming more popular now. These compounds
may react with many organic micropollutants in drinking water and thus give rise to disin-
fection byproducts.
Food products may be contaminated by disinfectants that are used in cleaning but
not thoroughly removed afterward. Or they may be contaminated from cooling water if
the water is not properly treated. The metals that came from piping, plumbing, and equip-
ment may also contaminate food [6].
B. Biological Hazards
Freshwater carries indigenous microorganisms, including bacteria, fungi, protozoa, and
algae. A few among them are known to produce toxins and cause or transmit diseases.
The pathogenic microorganisms include Salmonella spp., Vibrio cholerae, Shigella spp.,
Cryptosporidium parvum, Giardia lamblia, Cyclospora cayetanensis, Toxiplasma gondii,
some strains of Escherichia coli, etc., and the viruses such as Norwalk and hepatitis A
viruses [7].
Water in distribution system may be contaminated by pathogenic bacteria, fungi,
yeasts, protozoa, etc., that come from back-siphonage or have grown in dead ends [8,9].
Iron bacteria, whose sheaths contain ferric hydroxide, may gum up an entire water supply
and are difficult to eliminate. Efficient filtration greatly reduces the microbial load, but
filters themselves may sometimes be a source of bacterial contamination of the water. For
instance, filters in the treatment of water for making soft drinks have occasionally been
found to contribute large numbers of coliform bacteria [10,11]. The two main sources of
bacteria in drinking water distribution systems are bacteria grown in and sheared from
the biofilm and those carried over from the water treatment process [9].
Water may be in contact with food products after heat treatment. The microbiologi-
cal quality of this water, especially if the foods are ready-to-eat types, should not only
be free from pathogens (like drinking water), but also be low in (if not free from) spoilage
bacteria, such as Pseudomonas, Alcaligenes, and Flavobacterium [7]. This is particularly
important for foods to be kept at low temperatures. When water is used as one of the
ingredients or as a process aide, there will be certain specific microorganisms that deserve
concern. Anaerobic gas formers may enter foods from soil-laden water. The gas-forming
coliform bacteria may enter milk via cooling tank water and cause trouble in cheese mak-
ing. Bacteria that cause ripeness of milk, e.g., Alcaligenes viscolactis and Enterobacter
aerogenes, usually come from water, as do slime-forming species of Achromobacter, Al-
caligenes, and Pseudomonas, which sometimes cause trouble in cottage cheese. Cannery
cooling water often contains coliform and other spoilage bacteria that may enter canned
foods during cooling through minute defects in the seams or seals of the cans. This water
commonly is chlorinated, but there have been reports that chlorine-resistant flora can build
up over a certain time period. Insufficient cooling could result in thermophilic spoilage;
excessive cooling could result in postprocess contamination due to leakage of corroded
cans. The bacterium causing the surface taint of butter, Pseudomonas putrefaciens, comes
primarily from water. The bacterial flora of crushed ice to be applied to fish or other foods
consist mostly of Corynebacterium, Alcaligenes, Flavobacterium, Pseudomonas, and
cocci [6].
The ice or water used for chilling products, such as chicken at the final stage of
processing, can be a source of cross-contamination of a large number of birds from a
single bird contaminated with an enteric pathogen [12,13]. Similarly, the warm water used
in defeathering chickens can be a source of thermoduric bacteria [7]. Furthermore, reuse
of water to cool continuous loads of produce increases the risk of cross-contamination.
For example, contaminated produce from a single container going through a cooling pro-
cess may result in the build-up of pathogens over time in the cooling water supply [3].
C. Physical Hazards
A suspended particle in water generates at least two types of problems: first, it can carry
bacteria adhered on its surface and protects them from disinfection [13a,14]; second, it
contributes to the formation of loose deposits in reservoirs and pipework, which are resus-
pended into the water phase when a change occurs in the hydraulic properties of the
system (direction, velocity, water hammer, etc.) [15]. In distributed water, the number of
suspended particles is usually quite low [16]. The composition of loose deposits has been
determined and shown varying proportions of iron and manganese oxides, sand, zinc floc,
algae siliceous skeleton, detrital organic particles, and micropollutants [15,17,18].
Sand, stone, and dirt resulting from washing vegetable or fruit and debris from
equipment corrosion or breakage are the most commonly found physical hazards in process
water [19]. However, a properly designed water treatment procedure is usually sufficient
to remove or detect harmful physical materials by means of sedimentation, screening,
centrifugation, or metal detection devices. Therefore, potential physical hazards presented
in water are usually not significant enough to be dealt with individually.
III. WATER HAZARD MANAGEMENT

The aim of water management is to develop and maintain healthy water systems that
guarantee sustained use. Proper equipment design and software management is a good
way to control water safety. Through built-in antipollution features and a user-friendly
self-diagnostic software interface, ideal water treatment equipment can avoid unplanned
contaminations to occur from careless human handling errors. Hardware itself can never be
error-free. It depends on properly designed standard operation procedures and monitoring
routines to prevent any error from happening.
Water contaminants from various sources are discussed in the following sections.
A. Water Source
Food plants should have an easy access to water supplies in good quality and sufficient
quantity. Criteria for choosing water supply vary with the geographic location and cost
considerations. Potable, underground, and surface water are three common water sources
for food production. Each source has its own hazardous characteristics.
Potable water, which has previously been treated to meet drinking water standards,
does not need to go through further treatment for amending its quality except to be used
in the production of some special products such as carbonated beverages, which usually
requires the water to softer. The quantity of water available to a food plant depends on
the capacity of piping systems and other variables such as water pressure or pipe leakage.
Most food companies are equipped with their own water storage facilities for emergent
needs [20].
When using underground water for food production, the supply is usually sufficient,
and large storage tanks are not needed. The quality of underground water is mainly deter-
mined by the location and the depth of the well. Underground water generally goes through
some natural filtration processes that result in less contaminants and higher mineral con-
tent. Intended use determines if a demineralization treatment is necessary. In recent years,
the concern over the contamination from industrial dumps, agricultural pesticides, and
human activities has limited the use of underground water without cautious purification
treatments followed by constant monitoring of the quality [21].
Surface water from rivers or lakes is the most convenient source of water, while at
the same time the most unstable one in terms of the variation in quality and quantity, as
affected by season, climate, and the environment. Because of the direct exposure of surface
water to biological and chemical pollutants, hazards from this origin should be watched
for carefully. Therefore, surface water should never come into contact with foods unless
it has been adequately purified.
The supply of water should be planned to meet the peak water demand of the food
processing facility. In practice, two sets of parallel water treatment systems, or a set of
a backup system in addition to the main system, are suggested to keep the supply of water
uninterrupted while maintenance or repairing work is undertaken [20].
B. Water Treatment and Distribution Systems

Though it is designed to remove impurities and safeguard the water supply, water treat-
ment systems without proper maintenance can be a potential source of contamination
[22,23]. Modern water treatment equipment also includes sensors, detectors, or controllers
that continuously monitor the water quality. These automated devices can detect or control
water pressure, water flow velocity, alkalinity, as well as the residual disinfectant content
in a piping system. In a computer-aided automatic water treatment system, accurate in-
line monitoring and controlling of water quality can be achieved and the chance for water
safety failure from human error is greatly reduced. However, scheduling for inspection and
maintenance service, including calibration of sensors, timers, or feeding pumps, becomes
necessary to prevent the occurrence of failures of the system. Moreover, the person in
charge should keep complete records of service and inspection.
Plumbing systems and hoses conveying water should be made of approved corro-
sive-, alkaline-, and acid-resistant materials. Cross-connection between drinking water and
non–drinking water systems should be prohibited. It is advisable that non–drinking water
piping systems shall be durably identified to be readily distinguishable from drinking water
systems. A backflow prevention design should be installed to prevent reverse contamina-
tion of water reservoirs or tanks from handwashing or service sinks. These devices include
air gap or backflow (back-siphonage) prevention valves or altitude control design.
Devices such as water treatment equipment or backflow preventers shall be sched-
uled for inspection and service in accordance with manufacturer’s instructions and as
necessary to prevent device failure based on local water conditions. Routine inspection
of microbial, alkalinity, and residual chlorine of the water supply is important. A routine
microbial check of potable water every six months is normally adequate, but should be
more frequent, such as once per month, for water from other sources. Alkalinity and
residual chlorine are easier to be measured, and more frequent inspections are recom-
mended [20].
C. Water for Food Processing

Included in this category are washing water, rising water, chilling water, cooling water,
etc. The required quality of water may vary depending on where along the chain of pro-
cesses the water is used. While water quality management may vary throughout all opera-
tions, packers should follow good manufacturing practice (GMP) to minimize the potential
for the introduction or spread of pathogens via processing water. Water that meets the
microbial standards for drinking water is considered safe and sanitary.
The use of chemical disinfectants ought to be in accordance with national or regional
laws or regulations. Operators should carefully read antimicrobial chemical labels, regula-
tions, and other relevant information. Operators should follow manufacturers’ directions
for correct mixing of antimicrobial chemicals to obtain efficient concentrations and to
minimize safety hazards. Operators should not add antimicrobial chemicals in wash water
to reach a concentration higher than the allowable level. Antimicrobial chemical levels
should be routinely monitored and recorded to ensure that they are maintained at appro-
priate concentrations. Other parameters, such as pH, temperature, and oxidation–reduction
potential, which indicate level of active agents or those factors affecting the effectiveness
of the antimicrobial agents, should also be monitored and recorded. Surfactant treatments
with some antimicrobial chemicals may need to be followed by a clean water rinse to
remove any residues.
If hot water is used for cleaning purposes, temperature should be monitored. Periodic
changing or cleaning of screens and filter assembles is important to maintain sanitary
conditions for the reconditioning of washing water.
The benefits of chilling to remove field heat and the temperature requirements for
optimal keeping quality vary for different types of produce. Maintaining temperatures
that promote optimal product quality may reduce the risk of microbial hazards. Chilling
equipment, such as hydrocoolers, and containers holding produce during chilling opera-
tions, should be clean and sanitary. Field soil should be removed as much as possible
from produce and containers prior to chilling [24].

D. Reused or Recycled Water
Washing water recycled for food product usage is generally not acceptable because of its
highly polluted nature. If its utilization is inevitable, complete removal of impurities and
pathogens by means of filtration, disinfection, or heating is necessary.
In any case, reused water should be subjected to reconditioning to meet certain
microbiological as well as chemical and physical criteria on drinking water specifications
before its use. It is recommended for the processor to adopt performance parameters for
monitoring and testing programs to assure that the water is reconditioned and maintained
free of pathogens. Appropriate performance parameters may include temperature control
and microbiological tests. Visible solids should be removed before reuse. No sanitary
nuisance should be allowed. Testing for total bacterial counts, total coliforms, fecal coli-
forms, coagulase, Staphylococcus aureus, Listeria monocytogenes, Legionella spp., and
other related pathogens should be considered for validation purposes. Testing for chemical
oxygen demand (COD) or similar tests may also be performed. During storage, there
should be no microbiological carryover of reused water from one day to the next unless
the temperature is maintained at or above 63°C (145°F) by automated means. The intended
use of the water determines the chemical quality required. For instance, if the water is
reused for disinfecting or cleaning, it should not contain substances in amounts that affect
the efficiency. Recycled water should have a separate distribution system that is readily
identifiable [25].
E. Steam Supply
Steam coming into direct contact with food or food-contact surfaces should be generated
from potable water with no harmful substances added. Steam supply should be sufficient
for operational requirements. The use of boiler treatment chemicals ought to be in accor-
dance with national or regional laws or regulations.
F. Ice Supply
Ice as an ingredient or in direct contact with food should be made from potable water
and be properly manufactured, handled, and stored to avoid contamination. Microbial
testing of water for ice making ought to be performed periodically to ensure its clean and
sanitary condition. If the ice is purchased from a supplier, the food plant operator should
ask the supplier for information about the ice-making plant and the routine inspection
records of this product. It is advisable to keep these records on file. Equipment for the
manufacture, transportation, and storage of ice should be in sanitary condition. Water in
hydrocoolers should be changed as needed to maintain the quality. Interiors of hydrocool-
ers should routinely be cleaned and sanitized [20].
IV. CONTROL OF WATER HAZARDS

A. Critical Control Point
As mentioned, water used for culinary purposes or in direct contact with food materials
should meet drinking water standards. As a common practice in the food industry, the
quality of processing water is constantly monitored and controlled by sanitation standard
operation procedure (SSOP) or GMP programs. An operation that may affect the shelf-

life of a food product is regarded as a critical control point (CCP). Water may be involved
at a CCP either by acting as the means for reducing the microbial load of a raw material
in such treatments as washing or cleaning in the processing for fresh or minimum pro-
cessed foods or by acting as a heat exchange medium in contact with an in-process or
final product. The water used in these instances should receive especially stringent quality
control. Examples are the washing water in the processing of fresh-cut vegetables, fruits,
poultry, and red meat [26–29] and the cooling water in canneries [30].
B. Critical Control Limits

Critical control limits are set to distinguish between safe and unsafe operating conditions
at a CCP and should not be confused with operational limits that are established for reasons
other than food safety. The commonly used control factors with critical limits for pro-
cessing water to meet are as follows:
1. Total bacterial count. Total bacterial count proved to be the most practical
and sensitive indicator of the removal and inactivation of microorganisms in
individual processes [31].
2. Total coliform bacteria. Coliform bacteria are used as indicators of microbial
contamination of drinking water because they are easily detected and found in
the digestive tract of warm-blooded animals. While not all of them are disease
producers, they are often found in association with other microbes that are capa-
ble of causing disease. Coliform bacteria are more tolerant to adverse environ-
ments than many disease-causing organisms; therefore, their absence from water
indicates bacteriological safety for human beings [31].
3. Fecal coliform (mostly E. coli). Fecal coliform constitutes a portion of the
coliform bacteria group. They are originated in the intestinal tract of warm-
blooded animals and passed into the environment in feces. Fecal coliform is
often used as an indicator of the fecal contamination of domestic water supply
[32].
4. Coagulase test. A positive response indicates that Staphylococcus aureus, Lis-
teria monocytogenes, Legionella spp., and some other related pathogens should
be taken into consideration.
5. Temperature. In many food processing operations the optimal temperature is
decided by more than one single factor. Besides the reduction of the risk of
microbial hazards, the maintenance of other quality attributes should also be
considered. Take the wash water temperature, for example. Rodriguez de Led-
esma et al. [33] used hot water (95°C) for the decontamination of poultry skin
and found a significant reduction in the microflora. However, cold water at 5°C,
instead of hot water, should be used to wash fresh-cut vegetables to optimize
the produce quality [27].
6. Antimicrobial chemicals. The effectiveness of antimicrobial agents depends
on their chemical and physical states, treatment conditions (water temperature,
acidity, and contact time), and the resistance of pathogens [34]. Chlorine, for
example, is commonly added to water to maintain a concentration of 50–200
ppm, at a pH of 6.0–7.5, with contact time of 1–2 min for post-harvest treat-
ments of fresh produce. Ozone has been used to sanitize wash and flume water
in packing house operations. Ultraviolet radiation may also be used to disinfect
processing water [26]. Chlorine dioxide, trisodium phosphate, and organic acids
(such as lactic and acetic acids) have been studied for use as antimicrobial agents
in produce wash water [35]. Operators should investigate available options of
water sanitation and choose the most appropriate one for their individual opera-
tions.
7. pH. Adjusting the pH of processing water down to a certain level may be an
effective safeguard against many pathogens. However, when hypochlorites are
used as the antimicrobial agent, the reduction in pH may be offset by the in-
creased self-decomposition of these chemicals [36].
8. Contact time or flow rate. The effectiveness of a cleaning or cooling operation
is affected by contact time [37]. The flow rate of processing water is usually a
convenient measure of the contact time.
9. Pressure. When a pressure wash is used, critical control limits on the pressure
should be set and monitored.
Critical control limits must be based on scientific knowledge. It is not unusual to
implement more than one criterion of food safety at a single CCP.
C. Corrective Actions
When water quality deviates out of control limits, suitable corrective actions must be
undertaken in order to re-establish control as quickly as possible. These actions must be
planned in advance and should be able to determine and correct the cause of noncompli-
ance. The product produced during the period of the deviation must be held and tested
for acceptability for human consumption before it is released to the market.
Corrective actions for water quality deviation include adjusting pH, temperature,
flow rate, recycled water mixture ratio, and chlorine addition and may involve turning on
the backup water treatment system to keep the normal process operation uninterrupted.
When the deviation persists, discontinuation of the production is required for identification
of the possible causes. It is essential to record the whole event, including the actions taken
to correct the deviation, the identification of deviant lots, and the actions taken to ensure
the safety of these lots. These records must remain on file for a reasonable period after
the expiration date or expected shelf-life of the product.
D. Verifications
According to the Codex Alimentarius [38], verification of CCP is the application of meth-
ods, procedures, tests, and other evaluations, in addition to monitoring, to determine com-
pliance with the HACCP plan. The first phase of the process is the scientific or technical
verification to prove that critical limits at CCPs are satisfactory. The critical limits of
water quality are usually set by laws or regulations [39]. There is no need for factory
operators to verify the scientific basis of these limits. The second phase of verification is
to assure the effectiveness of the HACCP plan. The actions include evaluating the execu-
tion of water management procedure, reviewing the CCP records, and determining whether
appropriate risk management decisions and product dispositions are made when deviations
occur. Supervisors should be appointed to carry out periodical cross-checks among the
records of CCPs, disinfectant consumption, maintenance expenses, and utility bills to vali-
date the accuracy. The most recent sample report for the water analysis should be retained
on file in the food processing plant. The third phase of verification consists of revalidations,
independent auditing, and/or other procedures to ensure the performance of the HACCP
plan. The water safety management plan should be discussed, and if necessary amended,
according to the frequency of water quality deviation, a shift in quantity and quality of
water supply and demand, and any changes of the HACCP plan that affect the water
supply mechanism of the food plant.
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Rome: Codex Alimentarius Commission, 1999.
2. FXR Van Leeuwen. Safe drinking water: the toxicologist’s approach. Food Chem Toxicol 38:
S51–S58, 2000.
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its use in food manufacturing operations. Trends Food Sci Technol 8:69–74, 1997.
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Information. Addendum to Vol. 2. Geneva, Switzerland: World Health Organization.
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9. S Fass, ML Dincher, DJ Reasoner, D Gatel, JC Block. Fate of Escherichia coli experimentally
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10:41–45, 1994.
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distribution systems. Appl Environ Microbiol 44(4):972–987, 1982.
14. DS Herson, B McGonogle, MA Payer, KH Baker. Attachment as a factor in the protection
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drinking water distribution system. Water Res 33(4):1014–1026, 1999.
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17. HF Ridgway, BH Olson. Scanning electron microscope evidence for bacterial colonization of
a drinking water distribution system. Appl Environ Microbiol 41(1):274–287, 1981.
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bution system. Appl Environ Microbiol 56(3):628–639, 1990.
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Desalination 119:213–216, 1998.
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21. CL Hamann, JB McEwen, AG Myers. Guide to selection of water treatment process. In: FW
Pontius, ed. Water Quality and Treatment, 4th Ed. New York: McGraw-Hill, 1990, pp 157–
187.
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system biofilms. Appl Environ Microbiol 53:2714–2714, 1987.
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24. CFASN. Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables.
Washington, DC: U.S. Department of Health and Human Services, 1998.
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Rome: Codex Alimentarius Commission, October 23–28, 2000.
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washing and sanitizing systems: a review. J Food Prot 55:133–140, 1992.
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Protection Agency, 2000.

12
Water Use in the Beverage Industry
DANIEL W. BENA
PepsiCo Beverages International, Purchase, New York, U.S.A.
I. INTRODUCTION
One part in 1,000,000,000,000,000 parts! Believe it or not, analytic measurements down
to this detection level (parts per quadrillion) are quickly becoming routine for certain
classes of organic compounds (e.g., the polychlorinated dibenzo-dioxins and -furans).
With the lightning-fast progress being made by chemists, physicists, and other scientists
we can only expect this trend to continue. Consequently, everyone involved with water
in the food and beverage industries—either as an ingredient, product, or process chemi-
cal—will be forced to learn more about this often complex matrix, from its origin through
the paths it travels and the contaminants it meets along the way to the point where it
enters the production facility.
Water brings with it an inconceivable number of potential components—some con-
sidered contaminants, others considered therapeutic, and still others considered essential
for life. The treatment technologist’s challenge then becomes determining which compo-
nents should be retained (and how), which should be reduced (and how)—and what the
consequences of this selection might be. These consequences could potentially range from
a minor, aesthetic defect in finished product to a beverage or food product which results
in widespread public illness. The seriousness of a thorough understanding of water treat-
ment is a unifying principle throughout this chapter.
Over the past five years, the beverage industry’s usable technology focus has moved
from coagulation, ion exchange, filtration, carbon adsorption, and ultraviolet disinfection
to the use of membranes in technologies ranging from reverse osmosis, nanofiltration,
ultrafiltration, and microfiltration; continuous electrodeionization; electrodialysis; selec-
tive exchangers; and sophisticated controls and automation. Our quality focus has ex-
panded to include organics, inorganics, and pathogens that are serious health concerns
and present new treatment obstacles and detection capability at a level to defy imagination,
which promises tighter and tighter regulatory guidelines. Our business focus is now largely
driven and supported by regulatory guidelines and compliance requirements that demand
in-house programs and reporting protocols. Over the next few years, millions of dollars
will be spent on replacing or upgrading existing water treatment equipment or technology
to keep pace with these new challenges. It will be a transition period of substantial turbu-
lence, and we intend to offer insights into the advantages and shortcomings of all technol-
ogy to aid the water technologist in making the best decisions for a given water supply.
II. WATER SOURCES

Perhaps the best place to begin a discussion of water sources is with an initial reference
to the hydrologic cycle. As its name implies, the hydrologic cycle describes the continuous
movement of water throughout its phases of state (solid, liquid, and vapor) within our
hydrosphere; it is pictorially summarized in Fig. 1. This ‘‘movement,’’ or transformation,
can be imagined in five major steps [1]:
1. Water moving from the earth to the sky. In this part of the cycle, the movement
of water from the earth to the sky involves a combination of three pathways:
(1) evaporation, where water absorbs solar radiation which allows its transfor-
mation from water liquid to water vapor; (2) transpiration, where water is re-
leased to the atmosphere by plants as part of their normal physiological pro-
cesses; and (3) sublimation, where water (in its solid state as ice and snow)
passes directly to the vapor state. The first two pathways are often combined
and referred to simply as evapotranspiration.
Figure 1 The hydrologic cycle. (Courtesy Hamele-Bena, 2001.)

2. Water vapor forming water liquid. The active pathway in this step of the hydro-
logic cycle is one of condensation, due to temperature gradients within the atmo-
sphere. Water vapor, which ‘‘moved from earth to sky,’’ and which is then
stored in cloud formations, begins to form small droplets of water and/or small
crystals of ice. As this condensing water continues to form to eventually ‘‘satu-
rate’’ the sky, the next step is imminent.
3. Water falling back to earth, in the form of snow, ice, rain, sleet, and hail. The
hydrologic cycle may be compared, on a much smaller and simplified scale, to
a laboratory distillation. The aqueous sample in the ‘‘pot’’ is forced to move
from liquid to vapor state, then the vapor is forced to condense back to liquid,
and this purified liquid falls back to a collecting vessel. Ironically, despite the
constant recycling of water through the hydrologic cycle, Table 1 illustrates that
it may not be as pure as you think! These data, though reprinted in 1990 [2],
were originally collected decades ago. A comparable analysis using today’s
environment and current analytic methodology would be interesting; unfortu-
nately, it is likely that the table would need to be expanded, especially to include
parameters such as the result of acid precipitation, industrial discharge to the
atmosphere, and emerging pathogens.
4. Water penetrating the ground. A single pathway describes this movement of
water downward through the soil, but it is generally divided into two compo-
nents. There is Infiltration, where water soaks into the soil and moves toward
the root zones of area plant life. As part of the cycle, this water is then incorpo-
rated by the plants and eventually reintroduced via transpirative processes. Per-
colation describes a similar movement of water through the soil, but generally
to greater depths—past the root zones and toward the aquifers, or water-bearing
geological strata, which will be discussed in more detail in the next sections.
It is this movement of water through the soil that represents a ‘‘double-edged
sword.’’ On one hand, infiltration provides a perfect opportunity for the water
to become contaminated on its journey—from underground storage tanks, septic
systems, naturally occurring contaminants, and other sources. On the other hand,
it also provides one of the most effective attenuative mechanisms for many
Table 1 Chemical Analyses of Rain, Snow, and Hail

Rain after Rain after
Parameter (ppm) 4 hr 22 hr Snow Hail
Total hardness, as CaCO3 43 8 18 28
Calcium hardness 42 8 14 25
Magnesium hardness 1 11 4 3
Alkalinity 19 5 — 4
Sodium 5 0.11 5 —
Ammonia 1.5 2 6 1
Chloride 7 4 12 7
Sulfate 26 3 21 17
Nitrate 1 — 1 —
Iron 0.9 0.1 1.2 2.4
Silica 0.15 0.15 3 1

contaminants. That is, through complex ion-exchange, adsorptive, and microbi-
ological processes in the soil, contaminants may be reduced in concentration
or completely transformed chemically into some other compound before reach-
ing many ground water supplies.
5. Water returning to the oceans. This explains the pathway of surface runoff. The
soil becomes ‘‘saturated’’ (this term is used loosely here, since saturated and
unsaturated zones have very specific meanings to hydrogeologists) and flows
downhill (piezometrically, and usually downhill topographically, but not al-
ways) over the surface and near the surface. The moving water can incorporate
anything in its path including physical debris, chemical contaminants, and mi-
croorganisms as it moves toward the rivers, streams, etc., and on back to the
oceans, where it again joins the evapotranspirative section of the hydrologic
cycle.
Since this effect is cyclical, it may be entered at any point along its route, and
followed through to some endpoint. Though the hydrologic cycle is often viewed as basic
and fundamental, it does underscore the conservative and recyclable nature of these pro-
cesses. As a result, the quality and safety of the water used in our products and processes
is, to some extent, directly linked to how that water supply traverses the hydrologic cycle,
and with which contaminants and impurities it comes in contact. Our knowledge of the
basic and allied sciences is ever increasing, and the importance of water quality and overall
water resources management increases in direct response. Now, the toxicological and other
health-related impacts of our ingredient water are under more study than ever before. As
the skills of the analytic chemist lead to ever-decreasing lower limits of detection, the
chemicophysical and microbiological integrity of our water supplies will be under more
scrutiny and of greater importance than at any other time in history. This chapter addresses
the selection, treatment, and safety of this dynamic ingredient as used in the beverage
industry.
As an introduction, Table 2 affords an overall view of the world’s water distribution
[3]. These numbers will vary depending on which source and what year of publication
are cited. The overall illustration, however, is the same. The key things to glean from the
Table 2 Estimated World Water Balance

Surface area Volume Volume Equivalent
Parameter (km2 ⫻ 10⫺6 ) (km3 ⫻ 10⫺6 ) (%) depth (m) Residence time
Oceans and seas 361 1370 94 2500 ⬃4000 years
Lakes and reservoirs 1.55 0.13 ⬍0.01 0.25 ⬃10 years
Swamps ⬍0.1 ⬍0.01 ⬍0.01 0.007 1 to 10 years
River channels ⬍0.1 ⬍0.01 ⬍0.01 0.003 ⬃2 weeks
Soil moisture 130 0.07 ⬍0.01 0.13 2 weeks to 1 year
Ground water 130 60 4 120 2 weeks to 10,000
years
Icecaps and glaciers 17.8 30 2 60 10 to 10,000
years
Atmospheric water 504 0.01 ⬍0.01 0.025 ⬃10 days
Biospheric water ⬍0.1 ⬍0.01 ⬍0.01 0.001 ⬃1 week

table are these: (1) the vast majority of the world’s water is trapped in the oceans, which
are not yet considered economically feasible as useable drinking water supplies on a large
scale; (2) if we remove the oceans from consideration and we remove the water trapped
in glaciers and the polar ice caps, only one to five percent of the world’s water (depending
on the source cited) is considered treatable for use; and (3) of this small percentage, the
vast majority of the supply (in some cases close to 100 %) is found in the form of ground
water.
Unfortunately, the citation of available water, alone, does not automatically mean
that these supplies are accessible or safe. According to D. A. Okun [4], in 1980 nearly
2 billion people did not have access to water supply and sanitation services. In 1990 it
was estimated that more than 2.7 billion people in developing countries lacked access to
these basic services (1.7 billion without access to sanitation, over 1 billion without access
to water). Ten years later at the first World Water Conference, held at the Hague, a full
20% of the global population was cited as being without access to safe drinking water
[5]. Many feel that even these numbers are grossly underestimated due to the classification
of exactly what water supply and sanitation ‘‘services’’ mean. As a country’s geographic
region, economic standing, and political infrastructure vary, so do the extent of what is
acceptable in the provision of water supplies. Since we now know that the overall supply
of water is a finite entity, let us examine the different water sources from which we may
select our supply.
A. Water Sources
Water sources may be classified into two major categories, ground water and surface
water. Ground water examples include consolidated and unconsolidated aquifers (dis-
cussed later), artesian supplies, springs, etc., in short, water supplies that invade the satu-
rated zone of the subsurface environment. Surface water examples include reservoirs,
oceans, lakes, rivers, etc. The two categories differ greatly in the characteristics of the
water they supply, as does water from groups even within the same category. Surface
waters are usually higher in suspended solids, color, and turbidity than ground waters and
lower in total dissolved solids. The temperature of ground waters (depending on depth)
is remarkably consistent—sometimes within a few degrees per year; in contrast, surface
supplies, subject to the sun’s radiation, are remarkably variable in temperature. As far as
flow characteristics, surface waters are usually turbulent, while ground waters are usually
laminar. Typical flows for some ground water supplies may be one meter per day, in
contrast to some surface waters that flow one meter per second. Due to this wide variabil-
ity, the often asked question ‘‘what does a typical surface water look like in terms of its
chemistry?’’ is impossible to answer with certainty. The best we can do is provide generali-
ties, with the condition that there are truly exceptions to every rule. Table 3 has been
compiled by the author to present a relative comparison of surface and ground water
supplies. Just when you think you have a thorough understanding of a particular supply,
tread carefully; you may not!
1. Surface Water Supplies

In general, surface supplies can be highly variable in every respect—chemically (total
dissolved solids, alkalinity, etc.), microbiologically (bacteria, viruses, etc.), and physically
(turbidity, color, etc.). Many surface waters are easily subject to contamination which may
present in many forms, including (1) bacteria and other organisms from animal wastes
Table 3 Relative Comparison of Ground and Surface Supplies
Parameter Ground water Surface water
Total dissolved solids Higher Lower
Suspended solids Lower Higher
Turbidity and color Lower Higher
Alkalinity Higher Lower
Total organic carbon Lower Higher
Microbiology
Protection from bacteria and Highly protected Highly susceptible
viruses
Protection from protozoa Almost completely protected Highly susceptible
Presence of iron and/or man- Common Rare
ganese bacteria
Hydrogen sulfide gas Common Uncommon
Aeration/dissolved oxygen Lower Higher
Temperature More consistent More variable
Flow rate Very slow (1 m/day) Very fast (1 m/sec)
Flow pattern Laminar Turbulent
Susceptibility to pollution Low High
through surface runoff
Time for a contaminant plume Very long—often decades, Usually short—days/months,
to resolve potentially centuries sometimes years
via direct introduction (animals) or indirect introduction (poorly or untreated wastewater);

(2) algae blooms, which are typically acute, seasonal events; (3) ‘‘natural’’ chemical con-
tamination as evidenced by high levels of natural organic matter (primarily the humic
substances from decaying vegetation and animal waste); and (4) ‘‘synthetic’’ chemical
contamination from surface runoff (outflow) of agricultural chemicals (pesticides, herbi-
cides, insecticides, etc.).
Again, it must be underscored that the preceding characteristics, and those that fol-
low, are intended to provide general trends in terms of water composition and characteris-
tics. During the author’s industrial tenure, exceptions to virtually every characteristic de-
scribed have been observed.
a. Streams. In general, streams are often of reasonable chemical/physical composition.
Due to their locations and physical dimensions, they offer easy access for a multitude of
animal life. With this comes the frequent introduction of microorganisms of fecal origin,
in addition to appreciable amounts of organic matter. This organic material is typically
considered the precursor material of trihalomethanes and a host of other chemical byprod-
ucts which can be formed once this water supply is disinfected. Smaller streams are often
influenced by rain events, whereby their flows are increased, with subsequent increase in
suspended solids and turbidity. Larger streams are generally at higher risk of having indus-
trial waste (often poorly or inadequately treated) discharged into them. They are often
more of a concern, due in part to their larger surface area, in terms of accepting surface
runoff and subsurface drainage.
b. Lakes. Natural lakes, due to their relatively stagnant flow patterns, coupled with
their long water residence time, are usually of consistent composition insofar as surface
supplies are concerned. One major climatic event which may have drastic changes in lake
water quality is the phenomenon of seasonal inversion. This refers to the phenomenon
whereby water at the surface of the lake reaches a temperature at which it is most dense
(3.98°C, or 39.2°F). The water below it has not yet reached this state; therefore, density
and temperature gradients are formed. This ‘‘heavy’’ water then begins to descend, and
displaces the water below it. This displaced water then inverts and moves from the bottom
of the lake toward the upper portion. This agitation brings with it much of the sediment
and associated unwanted components, which make municipal and industrial monitoring
even more critical during this time. As you might imagine, this phenomenon of inversion
and its related thermal stratification are actually much more complex, and their effects on
aquatic life and the eutrophication process (basically, the nutrient enrichment of a body
of water, usually lakes or ponds, which results in growth of certain forms of algae and
some higher plant life) have been studied under many other scientific disciplines. Unfortu-
nately, as is the case with many large streams, industrial waste effluent and sewage treat-
ment plant discharge are often reintroduced into the same lake that originally supplied
the influent water. These practices are coming under more scrutiny, and there is ever
increasing political pressure for regulatory reform.
c. Reservoirs. Impounding reservoirs, or manmade lakes, are similar in overall charac-
teristics to those described for natural lakes. They are often regarded as huge storage
reservoirs for municipal water supplies prior to treatment. As surface supplies go, reser-
voirs are of fairly consistent quality, of reasonable turbidity (due in large part to natural
oxidation and settling mechanisms), and often afford lower bacteria counts than other
surface supplies [6]. However, as a consequence of their relatively low flow patterns and
lack of agitation, algae blooms are often a problem.
d. Rivers. Rivers represent perhaps the most difficult of the surface supplies to address.
In general, they are of highly inconsistent quality, have very high turbidity and suspended
solids, are prone to considerable temperature fluctuations, and vary widely with respect
to their flow patterns (that is, areas of excessive turbulence and areas of minimal movement
may exist within close proximity). Rivers, as a result of their great length and flows, are
recipients of surface runoff from many types of areas. For example, a river might flow
across areas of agrarian activity, with the potential to incorporate pesticides, herbicides,
nitrate, and other contaminants along its route. This same river might later flow through
an industrial zone, pick up runoff from poorly contained chemical storage tanks, drains,
sewers, etc., and possibly even meet the discharge of one or more municipal waste treat-
ment plants. Imagine the contaminant ‘‘soup’’ that would result. For this reason, any
methods of treatment for river water must be preceded by thorough characterization of
the supply. The treatment itself must be capable of addressing a wide range of quickly
changing water quality.
2. Ground Water Supplies
In comparison to surface supplies, ground water supplies are generally more consistent
in every respect—thermally, microbially, chemically, and physically. They have histori-
cally been considered a much safer supply, or one which produces ‘‘purer’’ water. Two
hundred years ago this blanket statement might have been more universally true. Along
with the development of the chemical and related industries came the increased potential
for ground water contamination. Prior to this, the concerns over ground water were few—
maybe the well was dug a little too close to the septic tank or cess pool, and incidences
of diarrhea and other gastrointestinal ailments were increasing (so digging another one
farther away or a little deeper were the apparent solutions). Possibly the well was under
the influence of a salt water or brackish supply, and intrusion of high levels of salts were
becoming evident (usually noticed by taste). In many cases, the two former solutions
would have applied here as well.
Though this example is a gross oversimplification, the facts remain that with increas-
ing industry came increasing underground chemical storage, increasing contaminant spills,
increasing numbers of poorly located and/or poorly constructed septic systems, along with
a host of other problems for the ground water environment that needed to be addressed
(and, in fact, many still do).
As with surface water supplies, there are different classifications of ground water—
some more preferred than others. A brief discussion of each, in terms understood by the
novice hydrogeologist (which is a discipline becoming increasingly important for anyone
involved with water operations), follows.
a. Aquifers and the Underground Environment. An aquifer is defined as ‘‘a geologic
formation with sufficient interconnected porosity and permeability to store and transmit
significant quantities of water under natural hydraulic gradients’’ [7]. Critical terms in
this description are store, transmit, and significant quantities. All three should be satisfied
to consider a supply an aquifer. The first two are straightforward—huge amounts may be
stored, but unable to be transmitted, in which case this supply, however large, should not
be considered an aquifer. The third term is more nebulous and linked to the intended use
of the supply, e.g., a residential well, a large municipality, or multiple industrial users
tapped into a community well. Clearly, ‘‘significant quantities’’ would be defined differ-
ently for these three applications. Before discussing aquifers in more detail, Fig. 2 should
be reviewed. It describes the different layers or zones encountered as we move downward
from the surface of the ground to the water-bearing strata below it.
As we move from the surface, the first zone encountered is the unsaturated zone
(also referred to as the vadose zone). In this area, the geologic media (dirt, clay, sand,
etc.) contains a mixture of water and void spaces with air, hence the terms unsaturated
or variably saturated. Continuing downward, we reach the capillary fringe, which is gen-
Figure 2 The underground environment. (From Ref. 35.)

erally considered the beginning of the saturated zone, but is sometimes considered a dis-
tinct entity. This interface between unsaturated and saturated zones is not completely un-
derstood and is the subject of much study with regard to movement of certain contaminants
within it. The saturated zone is the area where air is at a minimum and water is at a
maximum. The geologic media here are saturated with water. Dissolved oxygen in the
saturated zone is extremely rare; many deep ground water formations exist under anaerobic
or hypoxic conditions. It is within the saturated zone where actual ground water supplies
are found and where most production wells are placed. Throughout the saturated zone,
many strata of varying permeability will be found. Most importantly, this is where we
find our aquifers.
b. Unconfined and Confined Aquifers. Aquifers may be grouped into two broad catego-
ries: unconfined aquifers and confined aquifers. Unconfined aquifers (sometimes referred
to as water table aquifers) are those water-bearing, geologic formations which are under
atmospheric pressure at their upper boundary. The water table (sometimes referred to as
the phreatic surface) is the upper boundary of the saturated zone. Water levels in wells
which tap unconfined aquifers should be the same as the level of the water table. The
plane that connects the upper levels of water in all wells which penetrate unconfined
aquifers is known as the potentiometric surface. Confined aquifers (sometimes called arte-
sian aquifers) are those water-bearing, geologic formations whose upper and lower bound-
aries are comprised of geologic material of low permeability and which are under pressure
greater than atmospheric. Older definitions may describe the boundary layers (or confining
layers) of a confined aquifer as being of no permeability (that is, impermeable). This is
inaccurate, as even the least permeable geologic materials still exhibit some degree of
permeability. Some hydrogeologists further classify these confining layers accordingly,
as aquitards, aquicludes, and aquifuges. While all three exhibit very low permeabilities,
aquitards are the most permeable of the three, followed by aquicludes, and finally aqui-
fuges, which are as close to impermeable as we know. Confined aquifers are sometimes
further described as semiconfined (also partially confined, or leaky confined) or highly
confined (also fully confined), depending on the leakage or seepage through the confining
layers.
Just as the water in unconfined aquifers will form a potentiometric surface, or water
table plane, the water levels in wells tapping confined aquifers will also form a plane. It
may still be referred to as a potentiometric surface, but, intuitively, not a water table plane.
In the case of confined aquifers, due to the internal pressures, the water levels in wells
which tap them may often exceed the level of the water table (which may result in a
flowing artesian well). In the beverage industry, conversational knowledge of confined
and unconfined aquifers will account for nearly all of the hydrogeologic discussions into
which a beverage technologist might become engaged. For purposes of completeness, two
more topics will be briefly addressed.
In addition to aquifers being classified as confined or unconfined, the geologic mate-
rial of the aquifer may be described as consolidated or unconsolidated. Unconsolidated
deposits are formed from loose geologic material, such as sand, clay, silt, gravel, and even
sea shell remains. Consolidated deposits are formed by mineral particles combining from
heat and pressure, or via chemical mechanisms. They include sedimentary (previously
unconsolidated) rocks, such as limestone, dolomite, shale, and sandstone; igneous (formed
from molten) rocks, such as granite and basalt; and metamorphic rocks, such as limestone
and gneiss [8]. Fractured rock formations almost always refer to fractures or fissures in
consolidated deposits. Ground water and contaminant flows through this type of formation
are highly unpredictable, since it is difficult to determine which route the water will take
through this hard rock maze. Carbonate aquifers (also karstic formations) are formations
of limestone and other water-soluble rocks whose fractures have been widened by erosion
to form sinkholes, caves, or tunnels [9]. As you might expect, with such little resistance
the flows through fractured and carbonate formations can be rapid enough to rival surface
water sources. Flows up to 1500 feet per day, though rare, have been reported.
B. Source Selection Considerations

The categories mentioned briefly discussed the major sources of supplies for potable water.
Obviously, there are others (oceans, lagoons, glaciers, etc.) and many possible combina-
tions of supplies. Remember, the keys to any consideration of a water source are as fol-
lows:
1. First and foremost, sanitary quality, wherever possible. In some areas of the
world, the potability of a supply—even a municipal supply—may not be guar-
anteed.
2. Chemical/physical quality. Is it safe? Is it too high a risk to even consider? Can
it be treated economically and within regulatory guidelines? These questions
must be answered on a case-by-case basis and will depend on the degree of due
diligence desired by a parent company, presiding regulations, corporate policies,
and the risk assessment of the impurities themselves.
3. Consistency of composition. Is it consistent? Will it vary beyond the capability
of the proposed treatment? Gathering any and all available data will aid in an-
swering this question. Make use of municipal monitoring data, rainfall data,
hydrogeologic or surface water surveys, etc.
4. Volume/supply. Can it currently meet your needs? Will it in the future? In
addition to the quality and safety components, supply is a key parameter to help
ensure that the volume of water will be available for the long-term needs of
the business. In many areas, the volume of withdrawal of water from an aquifer
falls under government control or guidance, and this must be considered.
5. Recharge. Is runoff a concern? This is related to the previous discussion of the
hydrologic cycle. The volume of recharge, or replenishment, of the aquifer is
important, as is the quality and origin of the water being used for that recharge.
6. Future plans for the source or surrounding areas is a municipality planning to
develop the source and treat it? Are there multiple taps? Is there planned con-
struction or industrial entry to the area? These questions highlight the value
of considering water a dynamic ingredient throughout its supply chain. Many
beverage plant issues have resulted from municipal water treatment plant opera-
tors effecting a change to the municipal treatment without alerting the beverage
plant personnel. For example, if polyphosphate use is instituted by a municipal-
ity for corrosion control within its distribution system, this could result in a
gross upset to the floc formation in conventional lime treatment systems.
Water, unlike virtually any other raw material, often does not provide an opportunity for
sourcing from an alternative supplier. Consequently, selection of a source after thorough
characterization is paramount, and subsequent treatment design is critical to helping assure
that only a safe, consistent, high quality treated water is used by food and beverage plants.
C. Specifications and Guidelines
Frankly, in the Unites States, Canada, the European Union, and most other first world
countries, the expectations for water treatment are clearly delineated by the regulatory
agency having jurisdiction. That is, drinking water must meet the National Primary Drink-
ing Water Standards [10,11] promulgated by the U.S. Environmental Protection Agency
(EPA), the Directive of the European Union (EU) on the Quality of Water Intended for
Human Consumption [12], or some analogous drinking water standard. Indeed, many of
these standards are founded, to varying degree, on the Guidelines for Drinking Water
Quality established by the World Health Organization (WHO) [13,14]. Packaged water,
or the water used to make carbonated beverages, usually have corresponding regulations.
In the United States, for example, the Food and Drug Administration (FDA) established
a bottled water standard of identity, which, with only a few exceptions, mirrors the EPA’s
Drinking Water Standards.
The challenges come when we establish our beverage businesses in second and third
world countries where the regulatory standards are perhaps not as refined as for those
countries mentioned previously. In these countries, the beverage producer is not afforded
the luxury of knowing that the water entering their plant will consistently meet U.S. EPA
drinking water standards or the EU standards for water intended for human consumption.
In these situations, it becomes even more critical that rigorous water source assessment,
careful treatment selection, and conscientious long-term monitoring are performed with
even greater diligence.
Table 4 was compiled by the author for informational purposes only to compare the
major standards for drinking water around the globe. The National Primary Drinking Wa-
ter Standards of the EPA are compared to the EU Standards for Water Intended for Human
Consumption, and finally with the Guidelines for Drinking Water Quality of the World
Health Organization.
For a beverage producer, as is likely the case with any of our food industry allies,
we cannot—and should not—rely on any external body to assure the quality and consis-
tency we require for the production of our trademark products. Certainly, a conscientious
municipal monitoring scheme established by the EPA or analogous regulatory organization
often increases our confidence that a particular water supply will reach our plant with
some level of safety and consistency, but this should not be expected; rather, it should
be viewed as an added benefit to complement our already-dependable in-plant treatment
system.
III. WATER TREATMENT

A. Goals of Treatment
In light of the mounting scientific evidence for the myriad chemical compounds related
to their adverse health effects—at a time when the terms carcinogen, mutagen, and terato-
gen are practically becoming part of the vernacular—the primary reason for water treat-
ment is to safeguard public health and safety. All other reasons for treatment are secondary,
and include the following:
1. To assure compliance with all levels of regulatory guidelines and mandates.
The product water for carbonated soft drinks has historically had to meet not
only the primary drinking water standards of the Environmental Protection
Table 4 Comparison of Major Drinking Water Standards and Guidelines
USEPA 1a USEPA 2b EU
WHO WHO MCL MCL indicator
Parameter health aesthetics health aesthetics EU parameters
Inorganic constituents (mg/L,
unless otherwise
noted)
Aluminum 0.2 0.05–0.2 0.2
Ammonia 1.5 0.5 (ammonium)
Alimony 0.005P 0.006 0.005
Arsenic 0.01P 0.05 (interim) 0.01
Asbestos U 7 MFL (⬎10 µ)
Barium 0.7 2
Beryllium NAD 0.004
Boron 0.5P 1
Cadmium 0.003 0.005 0.005
Calcium
Chloride 250 250 250
Chromium 0.05P 0.1 (total) 0.05
Copper 2P 1 1.3 (action level) 1 2
Cyanide 0.07 0.2 (as free) 0.05
Fluoride 1.5 4 2 1.5
Hydrogen sulfide 0.05
Iron 0.3 0.3 0.2
Lead 0.01 0.015 (action 0.01
level)
Magnesium
Manganese 0.5P 0.1 0.05 0.05
Mercury (total) 0.001 0.002 (inorganic) 0.001
Molybdenum 0.07
Nickel 0.02P 0.1 0.02
Nitrate (as NO 3 ) 50 10 (as N) 50

Nitrite (as NO 2 ) 3P (acute); 0.2P 1 (as N) 0.5
(chronic)
Nitrate/nitrite Sum of [conc: 10, total (as N)
GV] ⱕ1
Potassium
Selenium 0.01 0.05 0.01
Silver U 0.1
Sodium 200 200
Sulfate 250 500P 250 250
Thallium 0.002
Tin U
Zinc 3 5
Organic constituents (µg/L)
Chlorinated alkanes
Carbon tetrachloride 2 5
1,1-Dichloroethane NAD
1,2-Dichloroethane 30 5 3
1,2-Dichloromethane 20 5
1,2-Dichloropropane 5
1,1,1-Trichloroethane 2000P 200
1,1,2-Trichloroethane 5
Chlorinated ethenes (or
ethylenes)
1,1-Dichloroethene 30 7
1,2-Dichloroethene 50 70 (cis)
100 (trans)
Trichloroethene 70P 5 10 total
Tetrachloroethene 40 5
Vinyl chloride 5 2 0.5

Table 4 Continued
Aromatic hydrocarbons
Benzene 10 5 1
Benzo(a)pyrene 0.7 0.2 0.01
Ethylbenzene 300 2–200 700
Fluoranthene U
Phenols
Polycyclic aromatic hy- 0.1
drocarbons (PAHs), as
sum of Benzo(g hi)
perylene, benzo(b)
fluoranthene, benzo
(k)fluoranthene, in-
deno(1,2,3-cd)pyrene
Styrene 20 4–2600 100
Toluene 700 24–170 1000
Xylenes (o, m, and p) 500 20–1800 10,000 total
Chlorinated benzenes
Monochlorobenzene 300 10–120 100
1,2-Dichlorobenzene 1000 1–10 600
1,3-Dichlorobenzene NAD
1,4-Dichlorobenzene 300 0.3–30 75
1,2,4-Trichlorobenzene 70
Trichlorobenzenes (total) 20 5–50

Miscellaneous organics
Acrylamide 0.5 TT 0.1
Dialkyltins NAD
Di(2-ethylhexyl)adipate 80 400
Di(2-ethylhexyl)phthalate 8 6
Edetic acid (EDTA) 600
Epichlorohydrin 0.4P TT 0.1
Hexachlorobutadiene 0.6
Microcystin-LR cyano- 1P
bacterial toxin
Nitrilotriacetic acid 200
Polychlorinated bi- 0.5
phenyls (PCBs), as
decachlorobiphenyl
Tributyltin oxide 2
Pesticides (µg/L)
Total pesticides 0.5 (and 0.1
each)
Alachlor 20 2 0.1
Aldicarb 10 3 0.1
Aldicarb sulfone 2 0.1
Aldicarb sulfoxide 4 0.1
Aldrin/dieldrin 0.03 0.03
Atrazine 2 3 0.1
Bentazone 300 0.1
Carbofuran 7 40 0.1
Chlordane 0.2 2 0.1
4-Chloro-2-methylphenoxy 2 0.1
acetic acid (MCPA)
Chlorotoluron 30 0.1
Cyanazine 0.6 0.1
Dalapon 200 0.1

Table 4 Continued
1,2-Dibromo-3-chloro- 1 0.2 0.1
propane (DBCP)
1,2-Dibromoethane 0.4–15P 0.1
Dichlorodiphenyl trichloro- 2 0.1
ethane (DDT)
2,4-Dichlorophenoxyacetic 30 70 0.1
acid (2,4-D)
1,2-Dichloropropane 40P 5 0.1
1,3-Dichloropropane NAD 0.1
1,3-Dichloropropene 20 0.1
Dinoseb 7 0.1
Diquat 10P 20 0.1
Dioxin (2,3,7,8-TCDD) 0.00003 0.1
Endothall 100 0.1
Endrin 2 0.1
Ethylene NAD 0.05 0.1
Dibromide
Glyphosate U 700 0.1
Heptachlor 0.03 0.4 0.03
Heptachlor epoxide Total of 0.2 0.03
Both
Hexachlorobenzene 1 1 0.1
Hexachlorocyclopentadiene 50 0.1
Isoproturon 9 0.1
Lindane 2 0.2 0.1
Methoxychlor 20 40 0.1

4(2-Methyl-4-chloro- NAD 0.1
phenoxy) butyric acid
(MCPB)
Metolachlor 10 0.1
Molinate 6 0.1
Oxamyl (vydate) 200 0.1
Pendimethalin 20 0.1
Pentachlorophenol 9P 1 0.1
Permethrin 20 0.1
Picloram 500 0.1
Propanil 20 0.1
Pyridate 100 0.1
Simazine 2 4 0.1
Terbuthylazine 7 0.1
Toxaphene 3 0.1
Trifluralin 20 0.1
Chlorphenoxy herbicides
other than 2,4-D and
MCPA
4(2,4-Dichlorophenoxy) 90 0.1
butyric acid (2,4-DB)
Dichlorprop 100 0.1
Fenoprop 9 0.1
Mecoprop 10 0.1
Silvex (2,4,5-TP) 50 0.1
2,4,5-Trichloro- 9 0.1
phenoxyacetic acid
(2,4,5-T)
Disinfectants and disinfection
byproducts (D-DBPs)
(µg/L)
Bromate 25P 100 10
Monochloramine 3000

Table 4 Continued
Chloral hydrate (trichloro- 10P
acetal dehyde)
Chloramines (total) 4000 MRDL
Chlorate NAD
Chlorine 5000 600–1000 4000 MRDL
Chlorine dioxide 800 MRDL
Chlorite 200P 1000
Chloroacetone NAD
3-Chloro-4-dichloromethyl- NAD
5-hydroxy-2(5H)-
furanone (MX)
Chloropicrin NAD
Cyanogen chloride (as CN) 70
Dichloramine NAD
Formaldehyde 900
Trichloramine NAD
Other disinfectants
Chlorophenols
2-Chlorophenol NAD 0.1–10
2,4-Dichlorophenol NAD 0.3–40
2,4,6-Trichlorophenol 200 2–300
Halogenated acetic acids
Monochloroacetic acid NAD
Dichloroacetic acid 50P
Trichloroacetic acid 100P
Haloacetic acids (HAA- 60 total
5), includes mono-,di-,
and trichloroacetic
acid and mono- and di-
bromoacetic acid)

Halogenated acetonitriles
Bromochloroacetonitrile NAD
Dibromoacetonitrile 100P
Dichloroacetonitrile 90P
Trichloroacetonitrile 1P
Trihalomethanes (THMs)
Bromodichloromethane 60
Bromoform 100
Chloroform 200
Dibromochloromethane 100
Total THMs Sum of [conc: 80 100
GV] ⱕ1
Other chemical/physical pa-
rameters
Color 15 TCU 15 Co-Pt Acceptable to customers and
no abnormal change
Conductivity 2500 µS/cm @20°C
Corrosivity Noncor-
rosive
Foaming agents 0.5 mg/L
Odor Acceptable TON ⫽ 3 Acceptable to consumers and
no abnormal change
Oxidizability 5 mg/L O 2
pH ⬍8 for effective 6.5–8.5 ⱖ6.5 and ⱕ9.5
disinfection
w/chlorine
Taste acceptable Acceptable to consumers and
no abnormal change
Total dissolved solids 1000 mg/L 500 mg/L
(TDS)
Total organic carbon No abnormal change
(TOC)
Turbidity 5 NTU TT Acceptable to consumers and
no abnormal change

Table 4 Continued
Radiologic constituents
Alpha activity, gross 0.1 Bq/L 15 pCi/L (includes
Ra-226; ex-
cludes radon
and uranium)
Beta activity, gross 1 Bq/L 4 mRem/year
Combined radium-226 and 5 pCi/L
radium-228
Radium-226 200P pCi/L
Radium-228 20P pCi/L
Radon 300P pCi/L
Total indicative dose 0.1 mSv/year
Tritium 100 Bq/L
Uranium 0.002P mg/L 0.02P mg/L
Microbiologic constituents
All water intended for
drinking
Clostridium perfringens 0/100 mL
(including spores)
Colony count @22°C No abnormal change
Cryptosporidium TT (MCLG ⫽ 0)
E. coli or thermotolerant 0/100 mL ⬍5% samples pos- 0/100 mL
coliform bacteria itive
Enterococci 0/100 mL
Giardia lamblia TT (99.9% reduc-
tion)
Legionella TT
Heterotrophic plate count TT (500 cfu/mL)
Total coliform bacteria 0/100 mL
Total plate count @35°C
Viruses TT (99.99% reduc-
tion)
Water for sale in bottles or
containers
E. coli 0/250 mL
Enterococci 0/250 mL
Pseudomonas aeruginosa 0/250 mL
Colony count @22°C 100/mL
Colony count @37°C 20/mL
a
1° refers to the primary maximum contaminant levels (MCL) established by the EPA, which are enforceable limits.
b
2° refers to the secondary maximum contaminant levels (SMCL) established by the EPA, which are generally not enforceable on a federal level.
Notes: Blank cells indicate the absence of a standard for that parameter.
Chemicals that have been assigned a ‘‘provisional guideline’’ value by WHO, or a ‘‘proposed MCL’’ by USEPA, are followed by the letter P.
Chemicals listed by WHO as ‘‘not of health significance at concentrations normally found in drinking water’’ are designated with the letter U.
Chemicals evaluated by WHO and assigned the status of having ‘‘no adequate data to permit recommendation of a health-based guideline value are designated with the letters
NAD.
In most cases, standard IUPAC chemical nomenclature was applied, so the unsaturated alkene family of compounds will end in the suffix -ene. Be aware that some regulatory
agencies continue to use the older common names, which bear the suffix -ylene. So, for example, trichloroethene and trichloroethylene are identical.
MCLG: maximum contaminant level goal
GV: guideline value, a maximum level recommended by WHO for the provision of safe drinking water
MRDL: maximum residual disinfectant level, established by the EPA
TT: treatment technique, an approach developed by EPA to provide direction to municipalities as to which parameters require installation of an acceptable treatment technique
to demonstrate reduction of the respective contaminant(s)
MFL: million fibers per liter, an established measure of asbestos levels
TCU: total color units
Co-Pt: cobalt platinum color units
NTU: nephelometric turbidity units
TON: threshold odor number
µS/cm: microsiemens per centimeter, a standard expression of conductivity
mSv/year: milliSievert per year, a standard expression of committed effective dose of radiation
pCi/L: picoCurie per liter, the U.S. expression of the activity of ionizing radiation
Bq/L: Becquerel per liter, the Standard International (SI) system of expressing activity for ionizing radiation (1 Curie ⫽ 3.7 ⫻ 1010 Becquerel and 1 pCi ⫽ 10⫺12 Ci; therefore
pCi/L ⫻ 0.037 ⫽ Bq/L)
mrem/year: milliroentgen equivalent man per year, the U.S. expression of radiation dose; applies to total body and individual organ exposure, calculated on the basis of a 2 L/
day drinking water intake
Source: From Refs. 10–14.

Agency (in the United States), but all applicable local standards as well. This
same philosophy of multiple levels of compliance holds true as we look at the
international arena as well. Here, compliance will be driven not only by national
standards (often founded to a varying degree on the World Health Organization
Guidelines for Drinking Water), but also by local (state, regional, etc.) regula-
tions and codes germane to each product category (bottled water, natural mineral
waters, juice drinks, teas, etc.)
2. To achieve specific product characteristics and improve product shelf-life. Cer-
tain soft drink products require ingredient water of varying composition. By
utilizing a variety of water treatment unit operations, the requisite composition
can be achieved (e.g., ion exchange demineralization for those products sensi-
tive to the profile of dissolved ionic solids). In addition, the shelf-life of the
individual product is often prolonged by removal of troublesome components
that could potentially result in aesthetically displeasing precipitation (e.g., pre-
venting the precipitation of calcium oxalate salts in tea by limiting the incoming
calcium load).
As mentioned, the wide range of chemicophysical characteristics required of our

ingredient water mandates the utilization of a variety of water treatment technology. Selec-
tion of the appropriate treatment chain is based upon several factors, including but not
limited to (1) water source—aquifer and watershed characteristics, municipal supply/con-
sistency, location, etc.; (2) proposed technology capability relative to raw water analyses
and desired product characteristics—removal of organics, inorganics, disinfection/inacti-
vation, color and odor control, etc.; (3) recommended support technology—filtration, pre-
ozonation, iron/manganese removal, etc.; (4) costs versus finished water profile—initial
investment, operating costs, equipment serviceability/parts accessibility, etc.; and (5) con-
tribution to plant effluent—total dissolved solids, water volume to drain, etc.
Where ingredient water for production of soft drinks is concerned, the typical
‘‘fleet’’ of treatment technology available to the beverage industry includes
1. Conventional lime treatment systems (CLTS)—coagulation/flocculation, hy-

drated lime, superchlorination. This treatment chain represents the majority of
most beverage treatment armadas worldwide. Historically, and as little as
twenty-five years ago, this combination of treatment was regarded as the ideal
treatment for raw water of virtually any quality. Indeed, this system, coupled
with the required support technology—fine sand filtration, granular activated
carbon, polishing filtration, and ultraviolet irradiation—does address a broad
range of water contaminants.
2. Ion exchange. This technology is routinely utilized for partial or complete de-
mineralization, softening, dealkalization or can be customized for selective re-
moval of a specific contaminant (e.g., denitratization).
3. Membrane technology. Clearly, this has seen the most growth in recent years
with the advent of more resistant membrane materials of construction and more
flexible rejection characteristics. Included in this category is the prototype of
the cross-flow, polymeric membrane filtration systems—reverse osmosis, along
with nanofiltration and ultrafiltration (both polymeric and ceramic). Also among
this group is electrodialysis technology for removal of ionic species in water
and continuous electrodeionization.
B. Primary Treatment Technology
1. Conventional Lime Treatment Systems
Conventional lime treatment systems, sometimes also referred to as traditional coagulation
or the cold lime process, remains one of the most common treatment techniques employed
in the carbonated beverage industry. Five years ago, one estimate placed approximately
85% of beverage water systems using conventional lime treatment (personal communica-
tion, Harry Delonge, 1996), but this number has been steadily decreasing over the years,
with this treatment modality being replaced by membrane systems. Operationally, at its
most fundamental level CLTS involves mixing three chemicals—a chlorine source, a co-
agulant, and hydrated lime—together in a reaction tank and allowing a contact time of
at least two hours for the ensuing reactions to proceed. The hydrated lime (traditionally
called ‘‘lime’’ even though calcium oxide is rarely used) increases the pH of the water
in the reaction tank to above 9.6, thereby converting the naturally occurring bicarbonate
alkalinity components to carbonate alkalinity. This is a critical reaction since at this pH,
calcium carbonate is virtually insoluble in water and begins to precipitate from solution.
At the same time, the coagulant, aided by steady, nonturbulent mixing, is overcoming the
repulsive negative charges present on natural organic debris in the water supply. This
charge neutralization and subsequent destabilization allows the coagulant to form a floc
of ever-increasing size and density. As it forms, it incorporates the precipitating calcium
carbonate, along with a host of other particulates present in the incoming water. The
chlorine source in conventional systems serves a dual purpose: (1) oxidation—both of
the soluble ferrous sulfate coagulant to the insoluble ferric form and of metallic contami-
nants like iron, manganese, arsenic, and others and (2) disinfection of the water in the
reaction tank. The efficiency of disinfection in these systems will be discussed in more
detail at a later point in this chapter. However, at high pH values (typically the range used
in CLTS), the dissociated chlorine equilibrium favors the existence of the hypochlorite
anion, which is approximately 100 times less effective as a germicide than the dominant
species at lower pH (hypochlorous acid). From a microbial safety perspective, if the ade-
quate free chlorine dosage is maintained in the reaction tank over the entire course of
the two-hour contact time, this will afford excellent bacterial and viral destruction. The
protozoans, like Cryptosporidium and Giardia, being more resilient to chlorine, will be
less affected by the chlorine at the high pH employed in conventional lime treatment
systems. However, the chlorine, aided by the physical entrapment and removal of these
organisms during the coagulation process, will still typically result in a substantial reduc-
tion in their numbers. Indeed, conventional coagulation is one of the effective barriers in
a multiple barrier approach against protozoans.
This floc that forms over the course of the two-hour reaction time in conventional
systems continues to grow in size and bulk, enmeshing suspended solids, particulates,
oxidized metals, organic debris, and a host of other impurities, and eventually settles
toward the bottom of the reaction tank. The settled floc comprises the ‘‘sludge’’ associated
with these conventional lime treatment systems, which must be frequently discharged in
order to keep this system in equilibrium. As the impurity-laden floc is discharged from
the bottom of the reaction tank, the treated water—now free of debris, low in alkalinity,
sanitized, and of a generally high quality—is withdrawn from the top of the reaction tank
to undergo further treatment through support processes prior to being used for final prod-
uct. Table 5 summarizes the advantages and disadvantages of these treatment systems.
From a water safety perspective, conventional lime treatment continues to offer excellent
Table 5 Advantages and Disadvantages of Conventional Lime Treatment Systems
Advantages Disadvantages
Removes alkalinity and hardness Does not effectively reduce nitrate, sulfate, or
chloride concentration
Removes organic debris, particulates, and natu- Sludge formation and disposal requirements
ral organic matter (NOM)
Reduces metal concentrations (iron, manga- May promote the formation of disinfection by-
nese, arsenic, others) and some radionu- products (trihalomethanes) under certain con-
clides ditions
Reduces some color compounds (tannins), off- Often difficult to operate consistently in waters
tastes, and off-odors with very low dissolved solids
Reduces bacteria, virus, and protozoan popula- Relatively large space requirements on plant
tions floor (footprint)
removal of a variety of water impurities. It is often adequate as a primary treatment for

many beverage water purification applications, but may also be used as a superb pretreat-
ment for membrane processes, ion exchange, or electrodialysis.
2. Membrane Technology
Membrane technology, in the application of water treatment for the beverage industry,
encompasses a broad range of polymeric and ceramic impurity removal techniques. This
may range from the use of a simple 10-µm microfilter to help remove granular activated
carbon fines to employment of the prototype polymeric membrane technology, reverse
osmosis. Figure 3 depicts the filtration spectrum, which provides a visual representation
of the relative particle size removal which may be expected of the common membrane
processes, including—in order of decreasing pore size—microfiltration, ultrafiltration, na-
nofiltration, and reverse osmosis. As we can see from the spectrum, particulate filters may
be used for the removal of relatively large suspended matter and are often employed at
the end of a water treatment chain as a ‘‘polishing filter’’ to remove any small floc parti-
cles, oxidized iron, carbon, or precipitated calcium carbonate that might have carried over
from the primary treatment process. Microfilters are often used for their controlled pore
size distribution (when absolute rated), which makes mechanical removal of bacteria from
water streams commonplace. Often for this application a stepped removal approach is
Figure 3 The filtration spectrum.

employed which will include filters of decreasing pore size oriented in series, so as to
minimize the plugging potential of the smallest pores (e.g., a 5- or 10 µm particulate filter,
followed by a 0.45-µm microfilter, and finally as low as a 0.2-µm filter to help assure
adequate bacterial reduction). Ultrafiltration (either polymeric or ceramic) is an excellent
tool for the removal of particulates, large organic matter (e.g., the humic and fulvic acids
which comprise natural organic matter in water supplies), and many types of microorgan-
isms, including viruses, bacteria, and protozoa. However, for removal at the level of dis-
solved inorganic salts, nanofiltration and reverse osmosis are our only two feasible options.
Table 6 compares the typical removal percentages of reverse osmosis, nanofiltration, and
ultrafiltration for a variety of water impurities [15].
The driving force behind the membranes used in water treatment applications for the
beverage industry is pressure, which is applied across the membrane to force the filtered or
purified water through the membrane, leaving the unwanted impurities behind. This con-
cept becomes even more critical when describing the operation of a reverse osmosis mem-
brane system. To understand reverse osmosis, we must first understand osmosis. Ac-
cording to The Drinking Water Dictionary [16], osmosis is a ‘‘natural phenomenon
whereby water (or some other solvent) diffuses from the lower-concentration side to the
higher-concentration side of a permselective (semipermeable) membrane barrier in a pro-
cess of equalizing concentrations on both sides.’’ The corresponding osmotic pressure is
the pressure exerted on the solution at equilibrium as a result of osmosis. This is illustrated
in Fig. 4.
In reverse osmosis, we apply a pressure to the concentrated side that is greater than
the osmotic pressure, which thereby reverses the osmotic flow . The result is that the water
now flows across the reverse osmosis membrane in the opposite direction to what was just
described with osmosis. The water is forced from areas of high to low solute concentration,
thereby leaving a very concentrated salt stream behind on the waste side of the membrane
and a very dilute, purified water stream on the product or permeate side of the membrane.
Table 6 Comparison of Reverse Osmosis, Nanofiltration and Ultrafiltration Membrane

Processes
Component Reverse osmosis Nanofiltration Ultrafiltration

Alkalinity 95 to 98% 50 to 70% None
TDS 95 to 98% 50 to 70% None
Particulates Near 100% Near 100% Near 100%
Organic matter Most ⬎100 MW Most ⬎200 MW Some ⬎2000 MW
THM precursors 90⫹% 90⫹% 30 to 60%
Sodium 90 to 99% 35 to 75% None
Chloride 90 to 99% 35 to 60% None
Hardness 90 to 99% 50 to 95⫹% None
Sulfate 90 to 99% 70 to 95⫹% None
Nitrate 90 to 95% 20 to 35% None
Protozoa Near 100% Near 100% Near 100%
Bacteria Near 100% Near 100% Near 100%
Viruses Near 100% Near 100% Near 100%
Operating pressure 200 to 450 psi 100 to 200 psi 80 to 150 psi
Note: Approximate removal percentages; actual performance is system specific.


Figure 4 Osmosis. (From Ref. 36.)
This is depicted in Fig. 5. This is an important concept to visualize, since it is this osmotic
pressure control which allows reverse osmosis to remove impurities from water down to
the level of dissolved ionic species. In fact, reverse osmosis can afford removal of from
95 to greater than 99% of many dissolved salts, resulting in a treated water exiting the
system with a total dissolved solids (TDS) concentration often below 10 mg/L, within
the range of many distilled water products.
Though ultrafiltration, nanofiltration, and reverse osmosis all afford efficient re-
moval of many microbial impurities, a critical point which must be understood is that
none of these processes—not even reverse osmosis—produces a commercially sterile
water. This is still a common misconception among many in the beverage and allied
industries. Owing to the nature of cross-flow technology, the high pressures used, integrity
of the seals, and variability in the pore structure of the membrane materials, these mem-
brane treatment operations will remove a large percentage of the microorganisms to which
they are introduced, though not all. If these processes are used as a primary treatment,
this should not preclude the need for additional disinfection of the water supply.
Figure 5 Reverse osmosis. (From Ref. 36.)

Key considerations when selecting and designing nanofiltration and reverse osmosis
treatment systems are the choice of proper pre- and postmembrane treatment operations.
The primary goal of pretreatment processes is to protect the integrity of the membranes,
since they often represent a substantial portion of the capital cost. These polymeric mem-
branes, usually some form of polyamide, though traditionally also available as cellulose
acetate, are susceptible to a variety of processes and impurities which may foul or degrade
them, thereby rendering them inefficient, ineffective, or, in the worst case, totally de-
stroyed. In general, the pretreatment processes will involve reducing the silt density index
(plugging potential) of the feed water to the membrane. This is often accomplished by
filtration through sand or mixed media, or via in-line coagulation. Pretreatment also in-
cludes some form of chlorine control, either assuring that it is removed (in the case of
polyamide membranes) or assuring that it is present to prevent biological degradation of
cellulose acetate membrane materials. Finally, the pretreatment processes will normally
include the in-line dosing of acid, antiscalant, or both. These steps help prevent a loss of
membrane performance due to metal oxide fouling, scaling, or related processes which
might occlude the membrane pores. Table 7 summarizes the various processes which
may cause fouling (usually partially or completely reversible) or degradation (usually
irreversible) of nanofiltration and reverse osmosis membranes. Potential solutions are also
listed.
The post-treatment of water exiting nanofiltration and reverse osmosis membrane
systems is also important and should be carefully considered. Unlike the case prior to
treatment, once the water has passed the membrane modules, it will be considerably more
pure than when it entered. As a result, much of the microbial load is gone, as are many
of the chemicophysical impurities. However, as we stressed previously, these membrane
processes should not be relied upon to produce a consistently commercially sterile water.
Consequently, post-treatment operations may include chemical or ultraviolet disinfection,
granular activated carbon treatment, and polishing filtration. In-plant process monitoring
is as critical with membrane processes as it is for any other treatment modality and will
usually include microbial monitoring to help gauge biofouling of the membranes and total
dissolved solids or conductivity to assess the gross rejection of the membranes toward
inorganic salts, pH, silt density index, chlorine residuals, and any other parameters as-
signed by the parent beverage company or suggested by the equipment supplier.
The advantages and disadvantages of reverse osmosis, as the gold standard of mem-
brane removal processes, are summarized in Table 8.
3. Ion Exchange
The process of ion exchange, like conventional lime treatment systems, has been known
to the beverage industry for decades. However, its early applications did not typically
include the water to be used for product, but rather involved softening of the water (re-
moval of calcium and magnesium) used for auxiliary plant purposes in order to prevent
scaling or avoid loss of efficiency in heat exchangers, boilers, and bottle washers. Today,
with the advent of many categories of resin materials, ion exchange is another of the
valuable tools used by the beverage water technologist to help assure that the treated water
used meets all of the applicable standards and guidelines expected.
In its most fundamental form, ion exchange, as the name implies, involves replacing
an ion which is less desirable in a particular application with one that is more desirable.
In the case of the early softeners mentioned, natural ion exchange materials (called zeo-
lites) were employed to exchange the hardness components (calcium and magnesium) in
Table 7 Causes of Fouling and Degradation of Reverse Osmosis and Nanofiltration
Membranes, Along with Possible Solutions
Fouling Degradation
Problem Potential solutions Problem Potential solutions

Suspended solids (in Multimedia filtration Oxidation Proper membrane se-
feed water) (sand, greensand, lection
carbon) Disinfectant removal
Ultrafiltration if required by mem-
Microfiltration brane (carbon, bi-
Plate and frame filtra- sulfite)
tion with diatoma- Proper dosing and
ceous earth feedback controls
Cartridge filtration
In-line coagulation
Coagulation
Oxidation of metallic Oxidation (aeration, Hydrolysis (mem- Proper membrane se-
components (iron, ozonation, chlori- brane breakdown lection
manganese, etc.) nation, etc.); filtra- at low pH) pH control (both op-
tion erating range and
Greensand filtration cleaning range)
Coagulation/lime Controlled acid feed
treatment
Acid feed
Precipitation/scaling Limit recovery (in de- Bacterial attack (espe- Proper membrane se-
(sulfates, carbon- sign phase) cially for unpro- lection
ates, silicates, etc.) Antiscalant addition tected cellulose Periodic membrane
pH control acetate mem- cleaning and sani-
Lime softening branes) tizing
Ion exchange Proper pretreatment
Microbial growth (bio- Chemical disinfection Solubilization (not Removal of com-
film formation) Ultraviolet disinfec- very common in pounds prior to
tion the beverage indus- membrane con-
Periodic membrane try, but due to high tact; usually via
cleaning and sani- concentrations of aeration or granu-
tizing organic com- lar activated
pounds with sol- carbon
vent properties)
water with sodium. The rationale here was that calcium and magnesium salts may often
precipitate as scale inside equipment; the corresponding sodium salts, however, were much
more soluble and hence did not pose a scaling concern. In this example, the supply of
sodium on the zeolite to be exchanged for calcium and magnesium is not present in endless
supply. Therefore, once the resin material is exhausted, it must be replenished—or ‘‘regen-
erated’’—with a new supply of the appropriate ion; in this case, the sodium zeolite soften-
ers are typically regenerated with brine (sodium chloride solution). Here the excess of
sodium overcomes the calcium and magnesium attached to the resin, and they are washed
to the drain. The resin, now fully regenerated, is again ready to be put into service. Figures

Table 8 Advantages and Disadvantages of Reverse Osmosis Systems
Advantages Disadvantages
Removes nearly all suspended material and Pretreatment must be carefully considered and
greater than 99% of dissolved salts in full- typically involves operating costs for chemi-
flow operation cals (acid, antiscalant, chlorine removal).
Significantly reduces microbial load (viruses, Does not produce a commercially sterile wa-
bacteria, and protozoans) ter.
Removes nearly all natural organic matter Membranes still represent a substantial portion
of the capital cost and may typically last 3–
5 years.
May be designed as a fully automated system Low-solids water may be aggressive toward
with little maintenance piping and equipment, so this must be con-
sidered for downstream operations.
Relatively small space requirements on the High pressure inlet pump is required.
plant floor (footprint)
6 and 7 illustrate the exchange of sodium for calcium and magnesium, and the regeneration
of the resin, respectively.
Ion exchange applications have broadened far beyond zeolite softening and include
complete demineralization (reduction of the total dissolved solids to near zero, if desired),
dealkalization (removal of alkalinity and hardness at the same time), anion or cation ex-
change alone, denitratization (nitrate removal), and a variety of other specialty applica-
tions, which include removal of silica, natural organic matter, iron, and other targeted
impurities. The specific application depends largely on the structure of the resin material
used, the characteristics of the water being treated, and the desired treated water profile.
Ion exchange resins for most beverage water treatment operations may be divided
into two major categories: (1) cation resins, which remove positively charged ions (ca-
Figure 6 Ion-exchange reactions (softening). (From Ref. 38.)

Figure 7 Ion-exchange regeneration (softening). (From Ref. 38.)
tions) like calcium, magnesium, and sodium, and which require regeneration with brine
or a mineral acid; and (2) anion resins, which remove negatively charged ions (anions),
like nitrate, sulfate, and chloride and which require regeneration with brine or alkali. Each
of these categories may be further divided into weak and strong subdivisions, that is, weak
acid and strong acid cation exchange resins and weak base and strong base anion exchange
resins. Due to the nature of the chemistry at work, the cation and acid belong together,
as do the anion and base. The term weak refers to the functional moiety on the resin itself
and the fact that these resins will remove the weakly bonded ions in their respective class,
whereas the strong resins will remove both weakly and strongly bonded ions in their
groups.
An increasingly popular ion exchange application for the beverage industry involves
the use of a weak acid cation exchange resin. This resin is typically charged with acid,
and instead of sodium (as in the zeolite softener) these resins will exchange the acid proton
or hydrogen ion for weakly bonded cations in the water. The predominant cations removed
are those that comprise hardness, calcium and magnesium. In addition, some sodium may
be removed in the process, but only after the hardness is removed. As the hardness is
removed, and exchanged for hydrogen ions, these hydrogen ions combine with the natu-
rally occurring bicarbonate alkalinity in the water to form carbonic acid (H2 CO3 ). This
newly formed carbonic acid quickly dissociates into water and carbon dioxide, and the
carbon dioxide is usually removed with a downstream degasifier. By forming the carbonic
acid and removing the carbon dioxide, the alkalinity of the water is reduced proportion-
ately. Hence, the weak acid cation exchange resin, in the acid form (as opposed to the
sodium form, as the zeolites), removes both hardness and alkalinity in one treatment unit.
The caution with this application is that if used alone, other operations must accompany
the ion exchange (e.g., disinfection, filtration, activated carbon, etc.) since softening and
alkalinity removal are the major benefits of this treatment. If anion impurities are a problem
in the water supply (nitrate, chloride, sulfate), then these weak acid resins will have no
effect on these contaminants. Some companies whose water source is of a demonstrated,
consistent supply use weak acid cation exchange resins preceded by in-line coagulation.
This combination affords the removal of turbidity, suspended solids, and some protozoans
(from the coagulation), along with the removal of alkalinity and hardness by the resin
itself.
Ion exchange alone affords no disinfection or microbial protection, unlike conven-
tional lime treatment systems and membrane processes. Consequently, they must be aug-
mented by the appropriate additional treatment to result in the final water quality profile
desired. In some cases, the resin beds themselves may promote the growth of bacterial
populations and, once established, may be very difficult to fully overcome. Some suppliers
recommend the installation of an ultraviolet disinfection loop to help protect the resin unit
from microbiological proliferation during periods when not in use. In general, cation resins
are more resilient materials and may be disinfected with a variety of sanitizers, including
chlorine solutions, permanganate, peracetic acid, and formaldehyde. This is usually not
true for anion resins, which may be more prone to osmotic shock from changes in ionic
strength, water temperature, or pH extremes. In some cases, anion resins—usually strong
base anion material—have been implicated in causing off-odors (‘‘fishy’’) in the treated
water exiting their beds, which may be due to the methylamine breakdown products of
some anion resins. In all cases, the supplier of the resins should be consulted for the proper
operational, regeneration, and disinfection procedures to be used with their particular resin.
C. Support Technology
Support technology is a term used to describe the ancillary unit operations which are
typically not considered primary treatment. Rather, they are intended to augment the pri-
mary treatment to result in a robust, complete treatment chain designed to deliver the
quality of treated water we require for food and beverage plant applications. Given this
definition, a wide variety of unit operations may be grouped into this category, but this
section will only address two of the more common support technologies—media filtration
and activated carbon purification.
1. Media Filtration
Media filtration, in the simplest terms, involves the passage of water through any of a
variety of coarse filtration materials. Traditionally, the most common medium for beverage
water treatment was simple filtering sand, supported by a bed of gravel. The major purpose
of these sand filters was—and still is—to provide a coarse straining of the water stream.
Sand filters may be located at different points in the treatment chain, but for conventional
lime treatment systems, the industry practice is to locate the sand filter downstream of
the reaction tank. Logically, this was done to capture any loose floc carryover, precipitated
calcium carbonate, or other particulates that might not have settled adequately in the reac-
tion tank. In some applications, like in-line coagulation, the deep bed sand filter which
is used serves not only to filter the floc that is intentionally formed in line, but to provide
part of the contact time of the water with the chlorine disinfectant.
As the choice of primary treatment technologies available to the beverage technolo-
gist has increased over time, so has the choice of support operations. In addition to sand,
other media are commercially available to suit a variety of applications. For example, some
reverse osmosis and nanofiltration membrane systems might incorporate ‘‘greensand’’ as
one of the pretreatment operations. Greensand is a naturally occurring mineral that consists
largely of dark greenish grains of glauconite possessing ion exchange properties [17] and
is used for the removal of soluble iron and manganese from water streams to prevent
fouling of downstream membrane systems. Other media used include garnet, anthracite,
and diatomaceous earth, each having its own niche application. These media may also be
combined in dual media or mixed media filters. Regardless of the medium selected, the
fundamental objectives of media filtration include (1) removal of particulates from the
overflow of reaction tanks, (2) preventing the occlusion of carbon pores, (3) avoiding
the surface occlusion or fouling of ion exchange resins, and (4) providing the required
contact time for chlorine and coagulant. In general, the supplier of water treatment equip-
ment will routinely suggest media with which they have had positive operating and quality
histories.
Media filtration, like virtually all water treatment processes, requires diligent mainte-
nance in order to help assure its on going performance. Since media filters remove particu-
late matter from the water, these impurities must then somehow be removed from the
filter itself. This is accomplished by frequent backwashing of the filter medium, often with
treated water, to suspend and expand the filter bed into the freeboard of the filter vessel,
thereby allowing collected impurities to be washed to the drain. Some media filters, more
commonly in municipal applications, augment the water backwash by the injection of air.
This air scouring also helps suspend the bed and conserves the overall volume of water
necessary for the backwash cycle. The frequency and conditions of backwash depend on
the filter media, vessel design, supplier recommendations and corporate policies, although
the range of operating conditions usually include a frequency of anywhere from daily to
monthly and a backwash rate of from two to five times the normal flow. Intimately linked
with the maintenance described is the routine sanitation of the media filters. Several meth-
ods may be used, including heat and chemical sanitizers, but this critical operation must
not be overlooked. It is possible for bacterial populations to become established in media
filter beds and subsequent mucilagenous biofilms to form in and on the filter media which
may be extremely resistant to removal.
2. Carbon Purification
In the field of water treatment, carbon purification is arguably the single unit operation
that provides the broadest protection against the widest range of possible contaminants.
In fact, the U.S. Environmental Protection Agency has routinely identified activated carbon
as the ‘‘best available technology’’ for the removal of a wide variety of volatile and
semivolatile organic impurities [10], which are summarized in Table 9. In addition to
these, thousands of other organic compounds show some degree of removal by activated
carbon. This application of organic impurity removal is relatively new to the beverage
industry, despite the fact that activated carbon has been a part of beverage water treatment
systems for many decades. The primary use of activated carbon in this field has been to
effect the removal of the chlorine species used to disinfect the treated water. Here, a
critical distinction must be drawn between the adsorptive mechanisms of contaminant
removal by carbon and the catalytic mechanisms carbon employs to dechlorinate. Adsorp-
tion refers to the adhesion, bonding, and other chemical attractive forces which retain
impurities on the surface of the carbon and within its pores. This is usually a reversible
process, to varying degree. The catalytic mechanism refers to the formation of a surface
oxide on the activated carbon medium as a result of the reaction of the carbon with the
hypochlorous acid, according to the following reaction:
HOCl ⫹ C* → HCl ⫹ C*O
hypochlorous acid carbon hydrochloric acid carbon surface oxide
Unlike adsorption, the catalytic reaction is not reversible, and, in fact, carbon bulk is
destroyed in the process.
Table 9 Organic Contaminants for Which Activated Carbon Has
Been Identified as the Best Available Technology for Their Removal
Alachlor Ethylbenzene
Aldicarb Ethylene dibromide (EDB)
Aldicarb sulfone Heptachlor
Aldicarb sulfoxide Heptachlor epoxide
Atrazine Hexachlorobenzene
Benzene Hexachlorocyclopentadiene
Benzo[a]pyrene Lindane
Carbofuran Methoxychlor
Carbon tetrachloride Monochlorobenzene
Chlordane Oxamyl (vydate)
Dalapon Pentachlorophenol
2,4-D Picloram
Di(2-ethylhexyl) adipate Polychlorinated biphenyls (PCB)
Di(2-ethylhexyl) phthalate Simazine
Dibromochloropropane (DBCP) Styrene
o-Dichlorobenzene 2,3,7,8-TCDD (dioxin)
para-Dichlorobenzene Tetrachlorethylene
1,2-Dichloroethane Toluene
1,1-Dichloroethylene Toxaphene
cis-1,2-Dichloroethylene 2,4,5-TP (silvex)
trans-1,2-Dichloroethylene 1,2,4-Trichlorobenzene
1,2-Dichloropropane 1,1,1-Trichloroethane
Dinoseb 1,1,2-Trichloroethane
Diquat Trichloroethylene
Endothall Xylene
Endrin
Source: Refs. 10, 11.
Carbon may be obtained from a variety of different starting materials, for example,
coal, wood, peach pits, coconut shells. The carbon is activated either thermally (steam)
or chemically. Steam activation, the more common, involves two steps: carbonization and
activation. Carbonization involves the conversion of the raw material into a disordered
carbon structure with a very low volatile content. Carbonization is done at elevated temper-
atures in an oxygen-lean environment which keeps it from burning. In activation, some
carbon atoms are vaporized, leaving behind the highly porous structure. Steam activation
is carried out in temperatures of approximately 1800 °F (982 °C). At these conditions,
carbon reacts with steam to form carbon monoxide and hydrogen, which exit as gases.
The result is a highly porous carbon material. Chemical activation is used to produce very
high pore volume in wood-based carbons, particularly in the medium-size pore range. The
most common process consists of mixing wood dust or some other cellulose-based mate-
rial with a strong dehydrating agent and then heating to a designated temperature. The
activating agent not only extracts moisture, but helps prevent collapse of the pore structure
during activation [18].
Activated carbon is generally available in the powdered or granular form, but granu-
lar activated carbon (GAC) is used for the vast majority of water treatment applications
in the beverage industry. In addition to the volatile organic impurities mentioned and the
removal of chlorine and chloramine, GAC also affords treated water protection against
adversely sensory-active compounds, like the microbial metabolites geosmin and 2-methyl
isoborneol. These compounds may be odor active in nanogram per liter concentrations,
and they represent a substantial proportion of off-odor complaints to municipal water
treatment works [19].
Operationally, perhaps even moreso than for media filtration, the activated carbon
unit operation must be diligently maintained and sanitized. Many microbial complaints
and sensory excursions in the beverage industry have been linked, at least in part, to
inadequate carbon bed management practices. One of the reasons for this required dili-
gence is that the core of the GAC bed has the potential to provide optimal conditions
for the growth of troublesome microorganisms—specifically, the chlorine is absent, the
environment can vary in its level of air or dissolved oxygen, and, in most cases, the organic
microbial nutrients abound (since GAC is so proficient at removing organic compounds,
including natural organic matter, from water supplies). These conditions combine to make
carbon an excellent medium for the support of microbial growth. Once established, the
extremely large surface area within the carbon pores can make control of an unwanted
microbial population a daunting task. As is the case with media filters, routine and diligent
backwashing and sanitization of the carbon bed should be viewed as an absolute require-
ment for any beverage plant water treatment system. Hot water, steam, or a combination
are generally employed to sanitize the carbon filters, provided their material of construc-
tion can withstand the temperature needed. When performed regularly, this helps prevent
a biofilm from becoming firmly established in the bed, and helps avoid the problems
often associated with poor carbon maintenance, including high bacteria counts, off-odor
production within the bed, poor dechlorination or chlorine breakthrough, and loss of ad-
sorptive capacity.
D. Disinfection
At the beginning of this chapter, the food and beverage producer’s commitment to con-
sumer and employee safety was stressed as being a paramount goal of water treatment in
our industry. Microbiological contamination, in addition to resulting in spoilage of the
beverage, represents an acute potential threat to the quality of our products and the integrity
of our trademarks. Therefore, overall microbial management is critical to the success of
any beverage producer. This section focuses on the major techniques employed for disin-
fection as it specifically relates to the water used for beverage products. As an introduction,
a distinction between cleaning, sanitizing, and sterilizing must be drawn.
Cleaning may be described as the removal of soil particles from surfaces by rinsing
and washing through the use of physical and chemical action. Sanitizing, in our industry,
refers to treating a cleaned surface to destroy contaminant organisms and reduce the total
vegetative cell population to a safe level. Finally, sterilizing is the complete destruction
of all organisms, including spores, through the use of chemical agents, heat, radiation, or
other means. These are largely intuitive, yet critical concepts to recognize. Unlike many
pharmaceutical or ultra–clean room applications, which may require commercially sterile
water, the beverage industry does not. Our requirements, in nearly all cases, dictate a
‘‘sanitary’’ treated water supply, not a ‘‘sterile’’ one. That is, we diligently ‘‘control any
contaminant organisms . . . to a safe level.’’
1. Primary Organisms of Concern
The specific organisms of concern for the water treatment system of a beverage producer
must be identified by the corporate research and development functions, with probable
guidance by any applicable drinking water and food regulations. The World Health Orga-
nization asserts that ‘‘infectious diseases caused by pathogenic bacteria, viruses, and proto-
zoa or by parasites are the most common and widespread health risk associated with
drinking water’’ [13]. It would be impossible and irrational to attempt to test all potential
microbial threats to a water supply. Consequently, the focus of most major regulatory
bodies is on testing and monitoring recognized ‘‘indicators’’ of water quality. Perhaps
the most notable and widely accepted group of indicator organisms is the coliform group,
which refers to gram-negative, rod-shaped bacteria capable of growth in the presence of
bile salts or other surface-active agents with similar growth-inhibiting properties and able
to ferment lactose at 35–37°C with the production of acid, gas, and aldehyde within 24–
48 hr. They are also oxidase negative and nonsporeforming. By definition, coliform bacte-
ria display beta-galactosidase activity [13].
The real threat to public health and safety is from those waterborne organisms trans-
mitted as a result of direct contact with fecal contamination. Because not all coliform
organisms are of fecal origin, other indicator tests are used to help detect the possibility
of unsanitary conditions in a water supply. These include fecal or thermotolerant coliform,
with Escherichia coli being the most prominent member [20], fecal Streptococci, and
anaerobic, sporeforming bacteria, the target of which is primarily Clostridium perfringens.
The most common bacterial measurement in municipal water supplies and in beverage
plant water treatment monitoring remain total coliform and E. coli. In addition, a total
bacterial plate count is commonplace for routine monitoring, but more as an indicator of
acceptable good manufacturing practices (GMP) rather than as an indicator of the presence
of fecal organisms. One notable exception to this industry practice is in the production
and packaging of a natural mineral water. In most countries where regulations for natural
mineral waters exist, disinfection is realistically not allowed for these products. Instead,
the focus is on impeccable selection and monitoring of a source as close to pristine as
possible. Part of this rigorous monitoring may include all of the organisms mentioned, in
addition to others (like Pseudomonas aeruginosa, for example). The rationale is to help
assure optimal confidence that the natural mineral water being abstracted from the source
and subjected to minimal treatment, at best, is as microbially risk-free as feasible.
Another organism that has recently become a threat to both the municipal and indus-
trial water treatment arenas is the protozoan Cryptosporidium parvum. Cryptosporidium
is a protozoan parasite affecting the gastrointestinal tract of humans and animals. It is
shed in the feces in the form of an ‘‘oocyst,’’ which has a hard shell to protect it from
the environment. This also makes it highly resistant to disinfection by chlorine and ozone;
although, UV disinfection has proven to be extremely effective at its inactivation. Water-
borne Cryptosporidium outbreaks have occurred in both large and small communities,
with the largest outbreak occurring in Milwaukee, WI in 1993, affecting an estimated
403,000 people. Such outbreaks have caused major disruption to residents, businesses,
and government. Infection with the Cryptosporidium organism may also have contributed
to the premature deaths of immunosuppressed individuals in these outbreaks. Because of
this, the finding of Cryptosporidium oocysts in many drinking water sources (rivers, lakes,
and reservoirs), and occasionally even in municipal treated water, has been a source of
considerable concern to drinking water and public health officials, as well as to the public
and the news media [21].
In addition to waterborne organisms of health concern, water supplies may also be
subject to inhabitation by ‘‘nuisance organisms.’’ These organisms, as their name implies,
are typically not associated with any direct health effects, but rather are known to cause
aesthetic or operational concerns to the water treatment plant or distribution network. In
reality, most beverage producers will not test for these nuisance organisms unless a prob-
lem is known to exist (which is usually detected initially by an off-odor in the water plant,
or by metallic particles in the system). Bacteria in this broad category include the following
[22]:
1. Iron bacteria. These bacteria incorporate ferrous iron as part of their normal
physiological processes and oxidize it to the insoluble ferric form. Genera in-
clude Leptothrix, Clonothrix, and Gallionella.
2. Manganese bacteria. Instead of iron, these bacteria may incorporate manganese
and oxidize it. Genera include Hyphomicrobium and Caulobacter.
3. Sulfur bacteria. Many subgroups of sulfur bacteria exist, depending on the spe-
cific sulfur form utilized as a nutrient substrate. The more troublesome group
to the beverage water treatment plant is the sulfate-reducing bacteria (SRB),
since they produce the malodorous hydrogen sulfide. These include the genera
Desulfovibrio and Desulfotomaculum. Some species of Pseudomonas have also
been implicated in producing organo-sulfur compounds in water.
2. The CT Concept
A critical concept when forming the foundation for any discussion of disinfection is the
CT concept. In this mathematical product, the C refers to the final residual concentration
of a particular chemical disinfectant, in mg/L, and the T refers to the minimum contact
time, in minutes, that the material being disinfected has been in contact with the disinfec-
tant. Therefore, the units of CT are expressed in mg-min/L. To explore this in more detail,
we must first recognize that every water supply has a natural disinfectant ‘‘demand.’’ The
demand may be described as the utilization of a disinfectant by components in the water
which must first be satisfied before a residual disinfectant concentration may be estab-
lished. Impurities like soluble metals, particulates, natural organic matter, microorganisms,
etc., all contribute to the demand of a particular water supply. Before we can confidently
begin to disinfect this supply, we must first provide the water with enough disinfectant
to react with these components. Once this is accomplished, we may then establish a ‘‘resid-
ual’’ disinfectant concentration. After this residual is established and confirmed via testing,
we must then maintain this residual in contact with the water over the course of the re-
quired contact time. This concept explains why in a conventional lime treatment system,
a chlorine dose as high as 12–20 mg/L is often required to result in a free chlorine residual
of between 6 and 8 mg/L. The dose must be adequate to satisfy the demand and then
establish a residual. Simply put, the residual is equivalent to the arithmetic difference
between the dose and the demand.
Many regulatory and industry organizations have adopted the CT concept to express
relative values of a disinfectant’s effectiveness against a particular organism under a de-
fined set of conditions (temperature, pH, etc.). Often, published tables of CT data will
include a subscript, for example, CT 99.9 , which describes the log removal of a particular
organism when tested against a particular disinfectant. The 99.9 subscript in this example
indicates that for this particular CT data, a three-log, or 99.9% reduction in the target
organism has been demonstrated.
Table 10 provides further illustration of the CT concept using real data from the
U.S. Environmental Protection Agency. The table values include CT 99 , or the CT ranges
within which 99% of the target organisms were inactivated by the disinfectant. A bacte-
rium, virus, and protozoan are compared insofar as their susceptibility to free chlorine,
Table 10 Comparison of CT Values for Inactivation at 5°C (mg-min/L)
Preformed Ozone,
Free chlorine, chloramine, Chlorine dioxide, pH 6–
Organism pH 6–7 pH 8–9 pH 6–7 7
E. coli (bacteria) 0.034–0.05 95–180 0.4–0.75 0.02
Polio 1 (virus) 1.1–2.5 770–3740 0.2–6.7 0.1–0.2
G. lamblia (protozoan) 47–150⫹ — — 0.5–0.6
Source: From Ref. 26.
preformed chloramine, chlorine dioxide, and ozone. Many conclusions may be drawn from
this single tabulation, which will summarize the discussion of CT:
1. Compared to the other disinfectants, preformed chloramine is virtually ineffec-
tive at inactivating polio 1 virus (note the very high CT value of 770–3740 mg-
min/L).
2. In general, ozone is the most effective disinfectant against all categories of the
organisms studied (note the very low CT values in the ozone column).
3. Except for preformed chloramine, the other disinfectants are markedly effective
against E. coli and Polio 1 (in most cases, CT values are well below 1).
Critical concepts with regard to CT data include: (1) the disinfectant demand must
first be satisfied; (2) the disinfectant residual must then be established; (3) this residual
must be maintained for the minimal contact time specified in order to provide adequate
protection; and (4) ‘‘dose’’ and ‘‘residual’’ must not be confused or equated.
3. Major Disinfectants
A variety of disinfectants is currently available for use in beverage water treatment applica-
tions, but this section will focus on the three most common: chlorine species, ozone, and
ultraviolet irradiation. The perspective presented will be from that of direct disinfection
of the water to be used for beverage production. Note, however, that the disinfection of
surfaces and equipment in the water treatment room and throughout the beverage plant
is often treated as a separate topic, and additional sanitizing techniques may be used for
these applications, with one of the most effective being heat. However, surface and plant
disinfection are beyond the scope of this chapter.
a. Chlorine Species. Chlorine is commercially available to the beverage industry as
compressed chlorine gas, solid calcium hypochlorite pellets, and sodium hypochlorite so-
lution of various concentrations. The traditional and likely the most commonly used form
for disinfection of treated water is the last, sodium hypochlorite solutions, although the
others are also employed. Chlorine gas is usually reserved for large-volume beverage
plants, and considerable drawbacks to its use are the strict transport, handling, storage,
metering, permitting, and use requirements being enforced by many regulatory agencies.
Calcium hypochlorite is utilized, although, in many markets, is more costly than sodium
hypochlorite. Irrespective of which form is chosen, once in aqueous solution, the chlorine
chemistry becomes essentially the same.
The chlorine species, when dissolved in water, will eventually dissociate into primar-
ily two active forms: hypochlorous acid (HOCl) and the hypochlorite anion (OCl-). The
ratio of these two chlorine species varies as a function of pH, with hypochlorous acid
predominating at acidic pH, and the hypochlorite anion predominating at alkaline pH [23].
Figure 8 depicts the relative equilibria, as a function of pH, for chlorine, hypochlorous
acid, and the hypochlorite anion. One critical concept to link with these chlorine equilibria
is that hypochlorous acid (predominant at lower pH) has been described as 80 to 100
times more potent a germicide than the hypochlorite anion (predominant at higher pH).
As a result of this, the World Health Organization suggests a pH of less than 8.0 to help
assure effective disinfection of water with chlorine. In conventional lime water treatment
systems, where the operating pH in the reaction tank is often above 10.0, the chlorine
equilibrium favors the existence of hypochlorite anion, which is why, in addition to
allowing adequate floc settling time, a minimum of 2 hr of retention must be designed in
these systems.
In summary; chlorine is an effective disinfectant against bacteria and viruses, al-
though it is less effective against protozoan organisms like Giardia and Cryptosporidium.
The effectiveness of chlorine varies markedly with pH, owing to the distribution between
the more effective hypochlorous acid and the less effective hypochlorite anion. The pre-
ferred operating range for chlorine disinfection is roughly pH 6.0 to 7.5; below this, corro-
sion may occur, and above this, its effectiveness declines. Though the actual disinfection
criteria for your application must be decided within your own corporation, a long-standing
industry practice for water disinfection using chlorine in conventional treatment systems
is to maintain a free chlorine residual of 6 to 8 mg/L over the course of a 2-hr contact
time. For other treatments, where the pH is lower, this CT is often decreased.
b. Ozone. Ozone (O3 ) is an unstable, gaseous, allotrope of oxygen (O2 ). It has a distinc-
tive pungent odor, from which its name is derived (from Greek ozein, to smell). It is
formed locally in air by the ionizing effects of environmental lightning and in the earth’s
stratosphere by ultraviolet irradiation. It also safeguards us from the damaging effects of
the sun by inhibiting the penetration of much of the sun’s ultraviolet waves, preventing
them from reaching the planet’s surface. It is also formed during combustion in automobile
engines, and thereby contributes to the troublesome phenomenon of photochemical smog.
Following the lead from many municipal drinking water companies that have used
ozone for decades, the beverage industry more formally recognized its use in 1981 by the
publication of ‘‘Ozone Treatment of Beverage Water’’ in the Proceedings of the Interna-
tional Society of Beverage Technologists [24] and then again in its 1987 proceedings with
Figure 8 Chlorine species as a function of pH. (Adapted from Ref. 23.)

‘‘Applications of Ozone in Soft Drink Bottling Plants’’ [25]. The major applications then,
which continue to be currently valid, are the use of ozone as an oxidant and as a disinfec-
tant. The major use of ozone in the beverage industry currently is the treatment of bottled
water. Its use in the treatment of water for carbonated soft drinks is still uncommon.
Commercially, ozone is produced via the corona silent arc discharge process [26].
The major drawback with the use of ozone, due to its very short half-life, is that it cannot
be efficiently stored. It must be produced on-site at the point of use. With the corona
discharge, a feed gas (oxygen or air) passes through an electrode pair (high and low volt-
age), where free electrons are of sufficient energy to split the diatomic (i.e., two atoms)
oxygen molecules apart. The single atomic oxygen species then recombine with other
diatomic oxygen to form a molecule with three atoms of oxygen—ozone. When com-
pressed purified oxygen gas is used as the feed, in place of treated air, roughly twice the
amount of ozone is produced for the same energy input. For most bottled water applica-
tions (where ozone is frequently used), even despite the increased output, the cost of the
compressed oxygen usually makes its use uneconomical. There are many designs of ozone
generators—tubular, plate, water-cooled, refrigerated air–cooled, etc.—but the most im-
portant design characteristic is the treatment of the feed gas. The ozone generator must
include modules for air compression and pressure regulation; cooling; particulate filtration;
water vapor removal (dryers); gas impurity removal (methane, ammonia, etc.); and oil
(hydrocarbon) removal. Along with the ozone generator should come some form of ozone
destruct device (usually thermal or catalytic) to destroy the excess ozone off-gas.
As a water disinfectant, the effectiveness of ozone varies widely with the specific
organism of interest. For example, at 5°C, and a pH of 6–7, to obtain the same degree
of inactivation (99%), the following CT conditions must be used [27]:
1. E. coli bacteria: CT ⫽ 0.02 mg-min/L
2. Polio 1 virus: CT ⫽ 0.1–0.2 mg-min/L
3. Giardia lamblia cysts: CT ⫽ 0.5–0.6 mg-min/L
4. Giardia muris cysts: CT ⫽ 1.8–2.0 mg-min/L
5. Cryptosporidium parvum cysts: 5–6 mg-min/L, estimated
As with any chemical disinfectant, when ozone is used for disinfecting water supplies,
the ozone demand must first be met, and then a residual ozone concentration established
and maintained for the desired contact time. An industry practice, which dates back to
data nearly four decades old, is to utilize an ozone CT value of 1.6 mg-min/L. This is
generally done by maintaining a residual of 0.4 mg/L ozone for 4 min. You will notice
from the data given, that a CT of 1.6 mg-min/L is adequate to provide at least a two-log
reduction in bacteria, virus, and Giardia lamblia populations. However, as with chlorine,
Cryptosporidium parvum remains resilient to inactivation, so higher CT values are neces-
sary to address this organism.
Operationally, the two major drawbacks to the more widespread application of ozone
to our industry include the fact that it must be generated on-site and used immediately
and cannot be stored, and due to its short half-life, it does not provide adequate residual
disinfectant activity. As with other disinfectants, the dose and half-life of ozone will vary
as a function of pH, temperature, organic matter, and other variables, but somewhat unique
to ozone is its behavior at varying levels of total dissolved solids (TDS). Table 11 illus-
trates the time, in minutes, for the disappearance of initial ozone doses of 0.64, 0.32, and
0.16 ppm in waters of varying levels of total dissolved solids [28]. Note the magnitude
of the inverse relationship between ozone half-life and total dissolved solids. The lower
Table 11 Ozone Half-Life as a Function of Total Dissolved Solids at 70°F
Time (in minutes) for disappearance of an
initial ozone concentration of
Total dissolved Ozone half-life
solids (ppm) (min) 0.64 ppm O 3 0.32 ppm O 3 0.16 ppm O 3
500 5.7 28.5 22.8 17.1
400–450 29 222 174 132
1 119 594 474 360
the level of total dissolved solids, the longer the ozone residual will last. Finally, ozone
is a very powerful chemical oxidant, and can be extremely aggressive toward equipment,
both in air and in aqueous phase. Care must be taken to ensure that all materials used are
suitable for ozone contact and that all employee safety precautions are observed.
c. Ultraviolet Irradiation. The last of the major disinfectants used for water treatment
in the beverage industry is ultraviolet irradiation. Ultraviolet (UV) radiation energy waves
are the range of electromagnetic waves 100 to 400 nm long (between the x-ray and visible
light spectra). The division of UV radiation may be classified as vacuum UV (100–200
nm), UV-C (200–280 nm), UV-B (280–315 nm), and UV-A (315–400 nm). In terms of
germicidal effects, the optimal UV range is between 245 and 285 nm. Ultraviolet disinfec-
tion utilizes a mercury source in the form of either low-pressure lamps that emit maximal
energy output at a wavelength of 253.7 nm; 2) medium-pressure lamps that emit energy
at wavelengths from 180 to 1370 nm; or lamps that emit at other wavelengths in a high-
intensity ‘‘pulsed’’ manner. Pulsed UV is a relatively new technology to the beverage
industry, and is not widely employed at present. While both low- and medium-pressure
designs have their own advantages and disadvantages, they have both proven to be ade-
quate for water disinfection applications.
The degree to which the destruction or inactivation of microorganisms occurs by
UV radiation is directly related to the UV dose. The UV dosage, D, is calculated as the
arithmetic product of intensity, I, in milli- or microwatt-seconds per square centimeter,
and time, t, in seconds. Internationally, the dose is often expressed in millijoules per square
centimeter, which is exactly equivalent to milliwatt-seconds per square centimeter (1 mJ/
cm2 ⫽ 1 mW-s/cm2 ⫽ 1000 µW-s/cm2 ). Research indicates that when microorganisms
are exposed to UV radiation, a constant fraction of the living population is inactivated
during each progressive increment in time. This dose-response relationship for germicidal
effect indicates that high-intensity UV energy over a short period of time would provide
the same kill as a lower intensity UV energy at a proportionally longer period of time.
The UV dose required for effective inactivation is determined by site-specific data relating
to the water quality and log removal required [29].
The mechanism of inactivation of microorganisms by UV is complicated, but has
been reported many times in the literature. Fundamentally, the organism’s genetic material
(e.g., bacterial deoxyribonucleic acid, or DNA) absorbs the UV radiation, which results
in a chemical disruption of the DNA’s chemical bases. Though many various photoprod-
ucts form as a result of this, the major rearrangement is the dimerization of the thymine
base. This change renders the organism unable to replicate its DNA and, therefore, unable
to reproduce. As you might expect, ultraviolet disinfection does not provide any residual
disinfectant activity.
Just as with ozone and chlorine, ultraviolet energy also has an accepted industrial
rule of thumb which has been established for decades. A typical UV system used for the
disinfection of beverage plant water treatment is sized to deliver a dose of at least 30 mJ/
cm2 at the end of its service life (typically 8000 hr). To achieve this, since UV intensity
naturally decreases over time as the lamp ages, the initial dose design is usually on the
order of 60 mJ/cm2. This design has traditionally been credited with providing at least a
three-log (99.9%) inactivation of bacterium, yeast, and virus populations. Data published
in late 1999 [30], and confirmed since then in several industry journals, suggest that the
same 30 mJ/cm2 dose also provides at least a three-log inactivation of Cryptosporidium
parvum, a protozoan organism highly resistant to disinfection by chlorine and ozone. Table
12 summarizes the relative effectiveness of a variety of disinfectants against C. parvum.
This is promising news for the water treatment industry, since it now adds UV to our
armamentarium of weapons to help ensure the microbial safety of our water supplies.
4. The Multiple Barrier Approach
The multiple barrier approach, as the term implies, refers to the installation of any combi-
nation of multiple barriers in a water treatment chain to help decrease the risk of microbial
contamination. These barriers may be physical (reverse osmosis, microfiltration, coagula-
tion, etc.), chemical (ozone, chlorine, UV, etc.), or a combination of the two. Multiple
barrier design, though it applies correctly to the protection against any microbial threat,
was the subject of increased interest after the Milwaukee Cryptosporidium outbreak in
1993. That outbreak, and the research done in its wake, helped demonstrate the resilience
of that protozoan organism to traditional disinfection. An alternative approach was needed.
That approach became the multiple barrier concept. The Milwaukee outbreak also arguably
spurred a heightened focus on the area of emerging pathogens, with the hope of being
able to proactively identify troublesome microorganisms and apply appropriate treatment
technology to address them.
The multiple barrier concept is becoming more recognized by both regulatory agen-
cies and members of industry. This trend is likely to continue, since intuitively it should
be able to address, at least to some degree, most microbial threats in the future. Considering
the wide range of chemical and physical unit operations and combinations thereof available
to the beverage water treatment technologist, we should be well-armed to design a robust
treatment system to address many of the threats that might face us in the future. The key
Table 12 Relative Comparison of Various Methods for 99%

Cryptosporidium Inactivation
Disinfectant Effectiveness Estimated CT-99

Free chlorine Poor 7200 mg-min/L
Chloramine Poor 7200 mg-min/L
Mixed oxidants Fair 1000 mg-min/L
Ozone Good 5–15 mg-min/L
Chlorine dioxide Good 80 mg-min/L
UV irradiation Excellent 2–5 mJ/cm2
Source: From Ref. 39.

is to work with municipalities, researchers, the private sector, and other resources to build
and sustain a network of expertise. Then, when a ‘‘new’’ pathogen arises, the industry
should draw from this skills reservoir to take the necessary precautions to continue to
protect public and consumer health and the integrity of our brands.
In the beverage industry, many plants can confidently apply at least three microbial
barriers—coagulation (conventional lime treatment systems), chlorine (primary disinfec-
tion), and UV irradiation (secondary disinfection and extremely effective against Cryp-
tosporidium). In general, the more barriers in place, the greater our confidence that we
are providing treated water with adequate protection against microbial impurities. This is
a simple concept but far reaching in implication.
IV. TESTING AND MONITORING

To keep pace with the changes in today’s regulatory environment, the food and beverage
industries must recognize a two-pronged approach as it relates to the testing of water in
their facilities. The first incorporates testing required from a regulatory perspective. In
this case, regulatory includes not only formal bodies like the Environmental Protection
Agency or the Councils of the European Union, but also our own corporate regulatory
departments. This type of testing is typically quite rigorous and is concerned primarily with
the protection of the consumer and the environment. The second approach incorporates the
day-to-day testing required to keep our treatment processes functioning effectively and
to assure that our final treated water used in product consistently meets acceptable stan-
dards. This section is intended as a primer to stimulate more in-depth investigation by
the individual company, rather than a complete treatise of analytic methodology that might
be employed.
What should you test? An anecdote paraphrased from a supposedly ‘‘ancient un-
named philosopher’’ was once credited with the quotation, ‘‘To some extent, water can
dissolve every naturally occurring substance on earth. Proof of this is limited only by our
ability to detect species’’ [31]. As modern analytic chemistry continues to evolve, this
philosopher must be heralded as the visionary he must have been. For example, Envi-
ronmental Protection Agency Method 1613B allows the quantitation of polychlorinated
dibenzodioxins (PCDDs) and polychlorinated dibenzofurans (PCDFs) down to part-per-
quadrillion levels [32]. As the levels of detection improve, the question will no longer
be ‘‘is this compound in our water?’’ Rather, it will become ‘‘we know it’s there, but
what level is acceptable?’’ To try to simplify this complex and case-specific area, the food
or beverage plant should consider dividing water-related testing into five categories:
1. Testing for new plant site qualification
2. Testing for regulatory compliance
3. In-plant testing
4. Testing to incorporate individual company requirements
5. Troubleshooting
A. Testing for New Plant Site Qualification

This category of testing is usually considered the most rigorous and typically encompasses
testing for the broadest range of potential contaminants. It is often driven by the federal
and local regulations that apply to the transaction of commercial real estate during a due
diligence period. In the United States, this may include a simple ‘‘transaction screen,’’
which is categorized by obtaining data primarily through visual inspection, surveys and
interviews, and previous testing; or it may range through a Phase III Environmental Site
Assessment, which is a data-based quantitation of an identified site hazard. For more
information, the American Society for Testing and Materials has published ‘‘Standard
Practices for Environmental Site Assessments’’ [33], which should be reviewed by anyone
involved in this initial phase of testing.
B. Testing for Regulatory Compliance

This category of testing is also rigorous and has the primary function of protecting public
health and safeguarding the corporate trademark. It typically represents an appreciable
cost to the food or beverage manufacturer. The expense may be due to the capital invest-
ment needed for compliance (e.g., a gas chromatograph with mass spectrometric detector
to monitor trihalomethanes and other volatile organic compounds in potable water) as
well as to the ongoing operating costs of external third-party laboratories or contracted
companies to manage a plant’s overall compliance. The food and beverage manufacturer
must be aware that regulatory compliance rarely, if ever, involves a single regulatory
agency. Two is a common number in the United States for example, the Environmental
Protection Agency for jurisdiction over potable water as it enters the food or beverage
processing plant and the Food and Drug Administration for jurisdiction over a finished
packaged water. Outside the United States, the maze of presiding regulatory bodies may
be even more complicated. For example, some years ago, at a natural mineral water facility
in Poland, the plant was expected to comply with the Council Directive of the European
Union (since the country followed EU trends); the Federal Regulations for Poland; the
regional Codes of the Vovoidship of Radom; and the local laws as promulgated by the
Warsaw authorities. The chemical, physical, microbiological, and radiological testing had
to, therefore, follow suit.
Tracking regulatory trends is best left to the experts, and virtually all major food
and beverage companies have entire departments devoted to doing just that. Historically,
compliance monitoring has been criticized for the tedium and analyst sophistication neces-
sary in the official analytic methods. Also, though the water-related agencies of the federal
government have been doing a laudable job, they have been doing so with ever-dwindling
resources. This has lead to an official documentation system which is sometimes months
or years behind the most current developments. However, the future is bright for regulatory
compliance monitoring as many regulatory bodies join the internet age [34].
C. In-Plant Testing
This category should include the more routine, plant floor–friendly testing that is required
to operate a food or beverage plant on a day-to-day basis. It is generally intended for use
as a surrogate system for fast, easy monitoring; the parameters measured should serve as
a red flag assessment for when the next phase of more intensive testing is warranted.
For example, in beverage water treatment systems, especially for those utilizing
polymeric membrane technology (i.e., reverse osmosis or nanofiltration), the measurement
of total dissolved solids is an excellent aggregate parameter to use as a surrogate measure
of the overall rejection performance of the membrane. Simply put, TDS provides a fast,
easy, in-line, reproducible method by which to monitor how effectively your membrane
is rejecting dissolved salts. If the TDS changes suddenly, it raises a red flag that further
data collection is necessary (e.g., visual inspection of the membrane elements; speciation
of the components of TDS—sulfate, chloride, sodium, etc.; among others). From the
standpoint of normal daily operation, however, we may not need to measure all the anions
and cations that comprise TDS. The decision as to which parameters should be included
on an in-plant testing protocol will vary with the type of industry, the specific application
of the process, an assessment of the potential risks associated with a process or product,
hazard analysis and critical control point (HACCP) evaluation, the presiding regulations
and guidelines that apply, and the company’s own internal mandates.
D. Testing to Incorporate Individual Company Requirements

This category is often a hybrid of the other testing categories included in this section.
The testing may be driven by regulatory mandates or voluntary ascription to impending
regulatory trends; historical lessons learned; product- or process-specific testing (e.g., indi-
vidual stability or sensory standards, consumer-driven requirements, etc.); and, parameters
that may affect plant effluent treatment (e.g., pH, TDS, biochemical oxygen demand, etc.)
Most of the points mentioned are self-explanatory, but in the author’s experience
the historical lessons category is often the most worthwhile when it comes to monitoring
parameters of importance. Every food and beverage company must be replete with anec-
dotes, for example, perhaps from a Principal Scientist with 40 years of corporate tenure,
which describe problems that occurred decades ago. Though some might scoff at these
war stories, most will admit that there is empirical validity to the adage those who do not
learn from their mistakes are destined to repeat them.
E. Troubleshooting
This category may be the most encompassing of all and cannot be distilled to a few concise
guidelines. The testing performed as a result of a troubleshooting exercise is often not
planned; is often forcibly undertaken under the threat of an impending plant shut down;
may potentially mean the difference between a minor, easily remedied plant operations
issue and a serious breach which warrants a product recall; and must always be performed
in a scientific, methodical fashion to maintain the integrity of the data and the value of
the conclusions which will be drawn.
As we continue to develop the ability to detect compounds at lower levels than ever
thought possible, we must also face the reality that we will undoubtedly find them in
many of the places we look. As contaminants move more toward ubiquity, this makes the
thoughtful development of appropriate testing protocols, acquisition of accurate and pre-
cise data, formulation of valid conclusions, and data-based action plans key to the future
success of food, beverage, pharmaceutical, and municipal water treatment industries.
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36. Pepsi-Cola Corporate Training Manual. Water Quality Tool, Membrane Treatment Module,
2001, pp 36–37.
37. J Lister. Berkefeld Water Treatment Applications for the Beverage Industry (unpublished inter-
nal presentation). Toronto, Canada, 2001.
38. Pepsi-Cola Corporate Training Manual. Water Quality Tool, Ion-Exchange Module, 2001,
pp 53–54.
39. D McCarty. UV Applications in Beverage Water Treatment (internal presentation), Erlanger,
KY, 2001.

13
Sanitation of Food Processing
Equipment
PEGGY STANFIELD
I. GENERAL CONSIDERATIONS
The information in this chapter has been derived from the following sources:
1. Food and Drug Administration (FDA) documents: Code of Federal Regulations,
current good manufacturing practices (CGMPs), the Food Code, hazard analysis
and critical control point (HACCP) programs;
2. U.S. Department of Agriculture (USDA) documents: Code of Federal Regula-
tions, HACCP programs, inspection manuals, directives, etc.;
3. Recommendations developed and distributed by major trade associations repre-
senting food, warehousing, and transport and related industries.
Food processing equipment used in all food plants (meat and nonmeat) is ‘‘predeter-
mined’’ under usual circumstances:
1. Mandatory specifications. Most of those used in processing low-acid (acidified,
etc.) foods in hermetically sealed containers (thermal processing) and meat and
poultry products are directly regulated by regulations promulgated by the FDA
and USDA in relation to safety and sanitation.
2. New establishments. Newly constructed establishments should take into consid-
eration all aspects of good manufacturing practices before their construction or
equipment purchases.
3. Most specialty equipment (for bakery, dairy, pasta, oil, etc.) is under voluntary/
mandatory requirements established and distributed by trade associations such
as the American Institute of Baking, Dairy and Food Industries Supply Associa-
tion, American Oil Chemical Society, and the National Sanitation Foundation.
Again, such equipment is in compliance with FDA/USDA GMPs, provided that
all instructions relating to maintenance and repair are adhered to.
4. With built-in designs to comply with FDA/USDA GMPs, this equipment saves
food processors time and money in looking for the ‘‘right’’ equipment.
5. Custom-made equipment. Plant personnel may build their own equipment or
have an outside contractor fabricate equipment for them. Even though it is cus-
tom made and not intended for resale, such equipment should be built to comply
with good manufacturing practices. The same standards are applicable to
custom-made equipment as are applicable to commercially available equipment.
6. Many food processing plants require some equipment that is custom made for
particular operational requirements. It may not be possible to comply with cer-
tain good manufacturing practices in the same way as other conventional equip-
ment. If so, it is always advisable to inform the appropriate state and federal
regulators of the circumstances.
7. All other food processing equipment that is commercially available.
The bottom line is that all food processing equipment, no matter how they are predeter-
mined, must comply with FDA, USDA, and state GMP guidelines.
Some equipment manufacturers or brokers are sometimes not interested in comply-
ing with FDA/USDA GMP. In such events, equipment is considered the same as custom
made, and food establishment operators should be aware of this responsibility before they
purchase any equipment.
All food processors using a variety of equipment, especially custom-made equip-
ment, should focus on correcting problems during the initial development of equipment
instead of resolving problems which may result when improperly designed or constructed
equipment is put into widespread use. This preventive mode of action benefits equipment
manufacturers, food processors, state and federal regulators, and American consumers.
In general, the following basic and standard equipment is usually considered to
comply with good manufacturing practice or their compliance is of minor significance:
Simple hand tools
Equipment used to prepare packaging materials
Equipment used on fully packaged product
Equipment used on operations involving inedible products that will not be mixed
with edible ones
Central cleaning system
Utensil and equipment cleaning machinery
Pails, buckets, etc.
Pallets for packaged product
Picking fingers
Tanks for fully finished oils
Simple can openers
Chutes, flumes, hangback racks, supporting stands, and brackets
Vegetable cleaning equipment (not applicable to spin-type washers/dryers)
Insect control units
Shipping containers
Pressure storage vessels for refrigerants (not applicable to CO2 snow-making equip-
ment)
Water softeners, water heaters, water meters, and chemical dispensers
Can and jar washers/cleaners
Mixing equipment
Hot air shrink tunnels
Air and water filters
Devices for measuring physical characteristics (temperature, pressure, etc.)
Rubber floor mats
The product contact areas of this equipment must be made up of approved materials.
II. MATERIALS FOR CONSTRUCTION AND REPAIR

A. Characteristics
Materials that are used in the construction of utensils and food-contact surfaces of equip-
ment may not allow the migration of deleterious substances or impart colors, odors, or
tastes to food, and under normal use conditions these should be
Safe
Durable, corrosion resistant, and nonabsorbent
Sufficient in weight and thickness to withstand repeated warewashing
Finished to have a smooth, easily cleanable surface
Resistant to pitting, chipping, crazing, scratching, scoring, distortion, and decompo-
sition
Multi-use equipment is subject to deterioration because of its nature, i.e., intended
use over an extended period of time. Certain materials allow harmful chemicals to be
transferred to the food being prepared, which could lead to foodborne illness. In addition,
some materials can affect the taste of the food being prepared. Surfaces that are unable
to be routinely cleaned and sanitized because the materials used could harbor foodborne
pathogens. Deterioration of the surfaces of equipment, such as pitting, may inhibit ade-
quate cleaning of the surfaces of equipment, so that food prepared on or in the equipment
becomes contaminated. Inability to effectively wash, rinse, and sanitize the surfaces of
food equipment may lead to the build-up of pathogenic organisms transmissible through
food. Studies regarding the rigor required to remove biofilms from smooth surfaces high-
light the need for materials of optimal quality in multi-use equipment.
It must be emphasized that each food processing operation is unique, which applies
to the equipment used. The acceptability and nonacceptability of any food processing
equipment or its component materials occasionally depends on the operation itself. This
must be taken into consideration when evaluating an item of equipment in relation to the
GMP.
B. Cast Iron
Cast iron is an alloy of iron and heavy metals which may leach into food if left in contact
with acidic foods for extended periods of time. Heavy metal poisoning has resulted from
such situations. The temporary or incidental contact that results from using cast iron as
a cooking surface and for dispensing utensils used as part of an uninterrupted, short-term
process is acceptable because of the brief contact time involved. Use limitations are as
follows:
1. In general, cast iron may not be used for utensils or food-contact surfaces of
equipment.
2. It may be used as a surface for cooking.
3. It may be used in utensils for serving food if the utensils are used only as part
of an uninterrupted process from cooking through service.
C. Some Acceptable Materials

Equipment should be constructed of materials that will not deteriorate from normal use
under the anticipated environment. For example, equipment must be constructed of materi-
als that will withstand one category of environment, e.g., generally humid operating envi-
ronment and high pressure, hot water cleaning with strong chemical cleaning agents. Of
course, there are other categories of food processing environments. In addition, all equip-
ment surfaces should be smooth, corrosion and abrasion resistant, shatterproof, nontoxic,
nonabsorbent, and not capable of migrating into food product (staining). The following
lists some acceptable food processing equipment and/or their component materials.
1. The Series 300 (18-8) Stainless Steel

The Series 300 (18-8) stainless steel is acceptable for general use. Other series have been
used for construction of food equipment, but their use is limited because they tend to rust
or discolor in certain applications. The abbreviation S/S is used throughout this chapter
to denote stainless steel construction.
2. Aluminum
Aluminum may pit and corrode when exposed to certain chemicals. When friction occurs
between aluminum and fats, a black oxide is produced which discolors the product. Ano-
dizing the aluminum does not eliminate this problem. Therefore, the use of aluminum is
limited to applications where the metal does not contact the product or in which the product
is suspended in water.
3. Surface Coatings and Platings

Surface coatings and platings may be used if the base material is nontoxic and rendered
noncorrosive and the plating material is USDA/FDA acceptable. Chrome, nickel, tin, and
zinc (galvanization) platings will generally be acceptable for most appropriate applica-
tions. Clearance of other plating materials and processes can be obtained by receiving a
favorable opinion for the intended use from the FDA, Office of Premarket Approval.
Surface coatings and platings must remain intact. If a surface coating or plating begins
to peel or crack, the FDA/USDA inspection will request correction from the management
and may even disallow the use of the equipment.
4. Hardwood
Hardwood may be used for dry curing, In addition, solid (unlaminated) pieces of hardwood
are acceptable as removable cutting boards provided the wood is maintained in a smooth,
sound condition and is free from cracks. Hardwood cutting boards must be of the shortest
dimension which is practical, preferably not exceeding 3 or 4 ft (0.91 or 1.22 m).

D. Some Unacceptable Materials
Cadmium, antimony, and lead are toxic materials that cannot be used as materials of
construction, either as a plating or the plated base material. Lead, however, may be used
in acceptable alloys in an amount not exceeding 5%.
Enamelware and porcelain are not acceptable for handling and processing food prod-
uct unless a food plant management provides reasons why they are needed.
Copper, bronze, and brass are not acceptable for direct product contact. These mate-
rials may be used in air and water lines or for gears and bushings outside the product
zone. Brass is acceptable for potable water systems and direct contact with brine, but not
for brine, or any solution, that is recirculated.
Leather and fabric are not acceptable materials unless a food plant management
provides reasons why they are needed.
E. Non–Food-Contact Surfaces
Non–food-contact surfaces of equipment that are exposed to splash, spillage, or other food
soiling or that require frequent cleaning should be constructed of a corrosion-resistant,
nonabsorbent, and smooth material.
Non–food-contact surfaces of equipment routinely exposed to splash or food debris
are required to be constructed of nonabsorbent materials to facilitate cleaning. Equipment
that is easily cleaned minimizes the presence of pathogenic organisms, moisture, and de-
bris and deters the attraction of rodents and insects.
III. DESIGN AND CONSTRUCTION

A. Durability and Strength
1. Equipment and Utensils
Equipment and utensils should be designed and constructed to be durable and to retain
their characteristic qualities under normal use conditions.
Equipment should be designed so that all product contact surfaces can be readily and
thoroughly cleaned with high temperature/high pressure water and caustic soap solution.
Components such as electric motors, electric components, etc., which cannot be cleaned
in this manner should be completely enclosed and sealed. Other considerations are
All product contact surfaces should be visible (or easily made visible) for inspection.
All product contact surfaces should be smooth and maintained free of pits, crevices,
and scale.
The product zone should be free of recesses, open seams, gaps, protruding ledges,
inside threads, inside shoulders, bolts, rivets, and dead ends.
Bearings (including greaseless bearings) should not be located in or above the prod-
uct zone. In addition, bearings should be constructed so that lubricants will not
leak or drip or be forced into the product zone.
Internal corners or angles in the product zone should have a smooth and continuous
radius of 0.25 in. (6.35 mm) or greater. (Lesser radii may be used for proper
functioning of parts or to facilitate drainage, provided these areas can be readily
cleaned.)

Equipment should be self-draining or designed to be evacuated of water.
Framework of equipment (if not completely enclosed and sealed) should be designed
to use as few horizonal frame members as possible. Furthermore, these compo-
nents should be rounded or of tubular construction. Angle is not acceptable except
as motor supports.
Equipment should be designed, constructed, and installed in a manner to protect
personnel from safety hazards such as sharp edges, moving parts, electric shocks,
excessive noise, and any other hazards. Safety guards should be removable for
cleaning and inspection purposes.
All welds, in both product- and non–product-contact areas, should be smooth, con-
tinuous, even, and relatively flush with the adjacent surfaces.
Equipment should not be painted on areas which are in or above the product zone.
External surfaces should not have open seams, gaps, crevices, or inaccessible re-
cesses.
Where parts must be retained by nuts or bolts, fixed studs with wing nuts should
be used instead of screws to a tapped hole.
Gasketing, packing materials, O rings, etc., must be nontoxic, nonporous, nonabsor-
bent, and unaffected by food products and cleaning compounds.
Equipment and utensils must be designed and constructed to be durable and capable
of retaining their original characteristics so that such items can continue to fulfill their
intended purpose for the duration of their life expectancy and to maintain their easy clean-
ability. If they cannot maintain their original characteristics, they may become difficult
to clean, allowing for the harborage of pathogenic microorganisms, insects, and rodents.
Equipment and utensils must be designed and constructed so that parts do not break and
end up in food as foreign objects or present injury hazards to consumers. A common
example of presenting an injury hazard is the tendency for tines of poorly designed single
service forks to break during use.
2. Food Temperature Measuring Devices
Food temperature measuring devices may not have sensors or stems constructed of glass,
except that thermometers with glass sensors or stems that are encased in a shatterproof
coating such as candy thermometers may be used.
Food temperature measuring devices that have glass sensors or stems present a likeli-
hood that glass will end up in food as a foreign object and create an injury hazard to the
consumer. In addition, the contents of the temperature measuring device, e.g., mercury,
may contaminate food or utensils.
B. Cleanability
1. Food-Contact Surfaces
Multi-use food-contact surfaces should be
Smooth
Free or breaks, open seams, cracks, chips, pits, and similar imperfections
Free of sharp internal angles, corners, and crevices
Finished to have smooth welds and joints
Accessible for cleaning and inspection by one of the following methods:
Without being disassembled
By disassembling without the use of tools
By easy disassembling with the use of only simple tools such as mallets,
screwdrivers, or wrenches that are kept near the equipment and are accessi-
ble for use
The purpose of the requirements for multi-use food-contact surfaces is to assure that such
surfaces are capable of being easily cleaned and accessible for cleaning. Food-contact
surfaces that do not meet these requirements provide a potential harbor for foodborne
pathogenic organisms. Surfaces which have imperfections such as cracks, chips, or pits
allow microorganisms to attach and form biofilms. Once established, these biofilms can
release pathogens to food. Biofilms are highly resistant to cleaning and sanitizing efforts.
The requirement for easy disassembly recognizes the reluctance of food employees to
disassemble and clean equipment if the task is difficult or requires the use of special,
complicated tools.
2. Clean-In-Place Systems
Clean-in-place (CIP) is defined as follows:
CIP means cleaned in place by the circulation or flowing by mechanical means

through a piping system of a detergent solution, water rinse, and sanitizing solu-
tion onto or over equipment surfaces that require cleaning, such as the method
used, in part, to clean and sanitize a frozen dessert machine.
CIP does not include the cleaning of equipment such as band saws, slicers, or mixers
that are subjected to in-place manual cleaning without the use of a CIP system.
Sanitation procedures for CIP systems must be as effective as those for cleaning and
sanitizing disassembled equipment. Only equipment that meets the following criteria may
be cleaned in place. Any equipment or portions of equipment not meeting these require-
ments should be disassembled for daily cleaning and inspection.
CIP equipment should meet the characteristics as specified.

Cleaning solutions, sanitizing solutions, and rinse water should circulate throughout
a fixed system and contact all interior surfaces of the system.
All internal surfaces should be either designed for self-draining (of cleaning and
sanitizing solutions) or physically disassembled for draining after rinsing. CIP
equipment that is not designed to be disassembled for cleaning should be designed
with inspection access points to assure that all interior food-contact surfaces
throughout the fixed system are being effectively cleaned.
Pipe interiors should be highly polished (120–180 grit abrasive) stainless steel or
some other acceptable, smooth surfaced material which is easy to inspect.
Easily removable elbows with quick-disconnect mechanisms should be located at
each change of direction.
All sections of the system should be capable of being completely disassembled for
periodic inspection of all internal surfaces.
All sections should be available for inspection without posing any safety hazard to
the inspector.
Certain types of equipment are designed to be cleaned in place where it is difficult

or impractical to disassemble the equipment for cleaning. Because of the closed nature
of the system, CIP cleaning must be monitored via access points to assure that cleaning
has been effective thoughout the system.
The CIP design must assure that all food-contact surfaces of the equipment are
contacted by the circulating cleaning and sanitizing solutions. Dead spots in the system,
i.e., areas which are not contacted by the cleaning and sanitizing solutions, could result
in the build-up of food debris and growth of pathogenic microorganisms. There is equal
concern that cleaning and sanitizing solutions might be retained in the system, which may
result in the inadvertent adulteration of food. Therefore, the CIP system must be self-
draining.
3. V Threads
V-type threads may not be used on food-contact surfaces. This section does not apply to
hot oil cooking or filtering equipment. V-type threads present a surface which is difficult
to clean routinely; therefore, they are not allowed on food-contact surfaces. The exception
provided for hot oil cooking fryers and filtering systems is based on the high temperatures
that are used in this equipment. The high temperature in effect sterilizes the equipment,
including debris in the V threads.
4. Hot Oil Filtering Equipment
Hot oil filtering equipment should meet the characteristics of cleanability and should be
readily accessible for filter replacement and cleaning of the filter.
To facilitate and assure effective cleaning of this equipment, cleanability require-
ments must be followed. The filter is designed to keep the oil free of undesired materials
and therefore must be readily accessible for replacement. Filtering the oil reduces the
likelihood that off-odors, tastes, and possibly toxic compounds may be imparted to food
as a result of debris build-up. To assure that filtering occurs, it is necessary for the filter
to be accessible for replacement.
5. Can Openers
Cutting or piercing parts of can openers should be readily removable for cleaning and for
replacement. Once can openers become pitted or the surface in any way becomes un-
cleanable, they must be replaced because they can no longer be adequately cleaned and
sanitized. Can openers must be designed to facilitate replacement.
6. Non–Food-Contact Surfaces
Non–food-contact surfaces should be free of unnecessary ledges, projections, and crevices
and be designed and constructed to allow easy cleaning and to facilitate maintenance.
Hard-to-clean areas could result in the attraction and harborage of insects and ro-
dents and allow the growth of foodborne pathogenic microorganisms. Well-designed
equipment enhances the ability to keep non–food-contact surfaces clean.
7. Kick Plates
Kick plates should be designed so that the areas behind them are accessible for inspection
and cleaning by being (1) removable by one of the methods specified under cleanability
or capable of being rotated open and (2) removable or capable of being rotated without
unlocking equipment doors. The use of kick plates is required to allow access for proper
cleaning. If kick plate design and installation does not meet these requirements, debris
could accumulate and create a situation that may attract insects and rodents.
C. Accuracy
1. Food Temperature Measuring Devices
The Metric Conversion Act of 1975 (amended in 1988) requires that all federal govern-
ment regulations use the Celsius scale for temperature measurement. The Fahrenheit scale
is included here for all other sectors of the country using Fahrenheit equivalents. The
Fahrenheit equivalent will also help those jurisdictions that require Celsius readings to
make the transition from Fahrenheit. Since 1°C is equivalent to approximately 2°F (1.8°F),
an accuracy of ⫾1°C is required.
Food temperature measuring devices that are scaled only in Celsius or dually scaled
in Celsius and Fahrenheit should be accurate to ⫾1°C (1.8°F).
Food temperature measuring devices that are scaled only in Fahrenheit should be
accurate to ⫾2°F.
The small margin of error specified for thermometer accuracy is due to the lack of a large
safety margin in the temperature requirements themselves. The requirement for Fahrenheit
thermometers to be accurate to 2°F is due to the lack of 1 degree increment scaling in
Fahrenheit thermometers currently being used, such as the metal stem thermometer.
2. Ambient Temperature Measuring Devices
A temperature measuring device used to measure the air temperature in a refrigeration
unit is not required to be as accurate as a food thermometer because the unit’s temperature
fluctuates with repeated opening and closing of the door and because accuracy in measur-
ing internal food temperatures is of more significance.
Ambient temperature measuring devices that are scaled in Celsius or dually scaled
in Celsius and Fahrenheit should be designed to be easily readable and accurate
to ⫾1.5°C (2.7°F) at the use range.
Ambient temperature measuring devices that are scaled only in Fahrenheit should
be accurate to ⫾3°F at the use range.
The Celsius scale is the federally recognized scale based on The Metric Conversion Act
of 1975 (amended in 1988), which requires the use of metric values. The ⫾1.5°C require-
ment is more stringent than the 3°F previously required since ⫾1.5°C is equivalent to
⫾2.7°F. The more rigid accuracy results from the practical application of metric equiva-
lents to the temperature gradations of Celsius thermometers. If Fahrenheit thermometers
are used, the ⫾3°F requirement applies because of the calibrated intervals of Fahrenheit
thermometers.
IV. FUNCTIONALITY, DESIGN, AND CONSTRUCTION

A. Ventilation Hood Systems
Exhaust ventilation hood systems in food preparation and warewashing areas including
components such as hoods, fans, guards, and ducting should be designed to prevent grease
or condensation from draining or dripping onto food, equipment, utensils, linens, and
single-service and single-use articles.
The dripping of grease or condensation onto food constitutes adulteration and may
involve contamination of the food with pathogenic organisms. Equipment, utensils, linens,
and single-service and single-use articles that are subjected to such drippage are no longer
clean.
B. Equipment Openings
Equipment openings and covers must be designed to protect stored or prepared food from
contaminants and foreign matter that may fall into the food. The requirement for an open-
ing to be flanged upward and for the cover to overlap the opening and be sloped to drain
prevents contaminants, especially liquids, from entering the food-contact area.
1. A cover or lid for equipment should overlap the opening and be sloped to drain.
2. An opening located within the top of a unit of equipment that is designed for
use with a cover or lid should be flanged upward at least 5 mm (0.2 in.).
3. Fixed piping, temperature measuring devices, rotary shafts, and other parts ex-
tending into equipment should be provided with a watertight joint at the point
where the item enters the equipment. This assumes that a watertight joint is not
provided.
4. If a watertight joint is not provided:
a. The piping, temperature measuring devices, rotary shafts, and other parts
extending through the openings should be equipped with an apron designed
to deflect condensation, drips, and dust from food openings.
b. The opening should be flanged (see item 2).
Some equipment may have parts that extend into the food-contact areas. If these parts are
not provided with a watertight joint at the point of entry into the food-contact area, liquids
may contaminate the food by adhering to shafts or other parts and running or dripping
into the food.
An apron on parts extending into the food-contact area is an acceptable alternative
to the watertight seal. If the apron is not properly designed and installed, condensation,
drips, and dust may gain access to the food.
1. Bearings and Gear Boxes
Equipment containing bearings and gears that require lubricants should be designed and
constructed so that the lubricant cannot leak, drip, or be forced into food or onto food-
contact surfaces.
It is not unusual for food equipment to contain bearings and gears. Lubricants neces-
sary for the operation of these types of equipment could contaminate food or food-contact
surfaces if the equipment is not properly designed and constructed.
2. Condenser Unit
If a condenser unit is an integral component of equipment, the condenser unit should be
separated from the food and food storage space by a dust-proof barrier. A dust-proof
barrier between a condenser and food storage areas of equipment protects food and food-
contact areas from contamination by dust that is accumulated and blown about as a result
of the condenser’s operation.
3. Temperature Measuring Devices
Requirements are as follows:
1. In a temperature-regulated storage unit (cool for refrigerator or warm/hot stor-
age room/equipment), the sensor of a temperature measuring device should be
located to measure the air temperature in the warmest part of a mechanically
refrigerated unit and in the coolest part of the storage unit.
2. Cold or hot holding equipment used for edible products should be equipped
with at least one integral or permanently affixed temperature measuring device
that is located to allow easy viewing of the device’s temperature display. There
are exceptions.
3. Item 2 does not apply to equipment for which the placement of a temperature
measuring device is not a practical means for measuring the ambient air sur-
rounding the edible product because of the design, type, and use of the equip-
ment, such as calrod units, heat lamps, cold plates, bainmaries, steam tables,
insulated food transport containers, and salad bars.
4. Temperature measuring devices should be designed to be easily readable.
5. Food temperature measuring devices should have a numerical scale, printed
record, or digital readout in increments no greater than 1°C or 2°F.
The placement of the temperature measuring device is important. If the device is

placed in the coldest location in the storage unit, it may not be representative of the tem-
perture of the unit. Food could be stored in areas of the unit that exceed requirements.
Therefore, the temperature measuring device must be placed in a location that is represen-
tative of the actual storage temperature of the unit to assure that all potentially hazardous
foods are stored at least at the minimum temperature required for the specified food.
A permanent temperature measuring device is required in any unit storing potentially
hazardous food because of the potential growth of pathogenic microorganisms should the
temperature of the unit exceed requirements. In order to facilitate routine monitoring of
the unit, the device must be clearly visible.
The exception to requiring a temperature measuring device for the types of equip-
ment listed is primarily due to equipment design and function. It would be difficult and
impractical to permanently mount a temperature measuring device on the equipment listed.
The futility of attempting to measure the temperature of unconfined air such as with heat
lamps and, in some cases, the brief period of time the equipment is used for a given food
negate the usefulness of ambient temperature monitoring at that point. In such cases, it
would be more practical and accurate to measure the internal temperature of the food.
The importance of maintaining potentially hazardous foods at the specified tempera-
tures requires that temperature measuring devices be easily readable. The inability to accu-
rately read a thermometer could result in food being held at unsafe temperatures.
Temperature measuring devices must be appropriately scaled per stated require-
ments to assure accurate readings. The required incremental gradations are more precise
for food measuring devices than for those used to measure ambient temperature because
of the significance at a given point in time, i.e., the potential for pathogenic growth, versus
the unit’s temperature. The food temperature will not necessarily match the ambient tem-
perature of the storage unit; it will depend on many variables including the temperature
of the food when it is placed in the unit, the temperature at which the unit is maintained,
and the length of time the food is stored in the unit.
4. Case Lot Handling Equipment

Equipment such as dollies, pallets, racks, and skids used to store and transport large quanti-
ties of packaged foods received from a supplier in a cased or overwrapped lot should be
designed to be moved by hand or by conveniently available equipment such as hand trucks
and forklifts. Proper design of case lot handling equipment facilitates moving case lots
for cleaning and for surveillance of insect or rodent activity.
V. WATER USAGE
A. Water Wasting Equipment
Water wasting equipment should be installed so that wastewater is delivered into the drain-
age system through an interrupted connection without flowing over the floor or is dis-
charged into a properly drained curbed area. Waste water from cooking tanks, soaking
tanks, chilling tanks, and other large vessels may be discharged for short distances across
the floor to a drain after operations have ceased and all product has been removed from
the area.
B. Protection of Water Supply

An air gap should be provided between the highest possible level of liquids in equipment
and a directly connected water supply line(s). The air gap must be at least twice the
diameter of the supply side orifice. If submerged lines are unavoidable due to design
considerations, then the equipment must include a functional vacuum breaker which will,
without fail, break the connection in the event of water pressure loss.
C. Recirculation of Water
Equipment which recirculates water as part of its intended function should be equipped
with sanitary recirculating components if the water directly or indirectly contacts food
product or the product contact surfaces. For example, recirculating pumps should be ac-
cepted for direct product contact and piping must be easily demountable with quick discon-
nect mechanisms at each change of direction.
In addition, establishment operators using equipment or systems which reuse water
may be required to have written approval of a water reuse procedure. However, the require-
ment is mandatory for meat and poultry processors by the USDA. Although the FDA does
not require a written approval at this stage, its GMP regulations make it clear that there
must be built-in safeguards in the reuse of water in a food plant.
D. Valves
Valves on drainage outlets should be easily demountable to the extent necessary for thor-
ough cleaning. Overflow pipes should be constructed so that all internal and external
surfaces can be thoroughly cleaned.
VI. OTHER EQUIPMENT

A. Piping Systems
Piping systems used to convey edible product (including pickle solutions) should be
readily disassembled for cleaning and inspection. Pumps, valves, and other such compo-
nents should comply with the sanitary requirements of good manufacturing practices
promulgated by USDA/FDA. Piping systems must be designed so that product flow will
be smooth and continuous, i.e., no traps or dead ends. Pipes must be either 300 series
stainless steel or a USDA/FDA acceptable plastic.
Clear demountable rigid plastic piping may be used for two-way flow provided it
is chemically and functionally acceptable. Opaque plastic piping may be used for one-
way purposes only.
The cited requirements apply to systems for conveying raw fat and to recirculate
cooking and frying oils. Black iron pipes with threaded or welded joints are acceptable
for conveying completely finished, rendered fats. Continuous rendering is not considered
complete until after the final centrifuge.
Pipeline conveying systems for aseptic processing and packaging should comply
with the requirements promulgated by the FDA and USDA in the U.S. Code of Federal
Regulations.
B. Magnetic Traps and Metal Detectors

The extensive exposure of some products to metal equipment such as grinders, choppers,
mixers, shovels, etc., causes the possibility of metal contamination. Magnetic traps have
been found effective in removing iron particles from chopped or semiliquid products.
However, these magnetic traps are not useful for removing nonmagnetic metals such as
stainless steel or aluminum. Therefore, the use of electronic metal detectors is highly
recommended for sausage emulsions, can filling lines (especially baby foods), etc. Metal
detectors are usually installed so an alarm (either a bell or light or both) is activated when
a metal fragment is in the detection zone. The production line should stop automatically
when the detector is activated. Alternatively, some systems are arranged so that the portion
of the product containing the metal contaminant(s) is automatically removed from the
production line.
The FDA and USDA do not currently regulate the use of metal detectors for normal
production. The agencies do encourage food plant operators to voluntarily use metal detec-
tors whenever possible. The agencies review and evaluate metal detectors using the same
sanitary standards applied to other types of equipment.
The sensitivity and reliability of metal detectors varies depending on aperture size,
type of food product, frequency and method of calibration, and numerous other variables.
Since many of the involved factors are not related to the design of the unit itself, the
agencies do not currently classify metal detectors. However, the following classification
standard is offered on a voluntary basis.
Classificationa Spherical diameter Type of metal

A 1/32 in. (0.794 mm) 316 stainless
B 1/16 in. (1.588 mm) 316 stainless
C 1/8 in. (3.175 mm) 316 stainless
Db
a
To test a metal detector, a metal sphere of the size and type indi-
cated (generally imbedded in an acceptable, non-metallic materials)
is passed through the center of the aperture. The detector must detect
in at least nine of the ten passes through to qualify for the applicable
classification.
b
The D classification identifies those detectors which are either not
sensitive to the 1/8 in. (3.175 mm) level or are installed in a manner
that prevents testing in the described fashion.

C. Conveyor Belts
Conveyor belts used in direct contact with food product must be moisture resistant and
nonabsorbent. Conveyor belts should have the edges sealed with the same material as is
used for the food-contact surface. In addition, belting material must be chemically accept-
able and approved by the FDA/USDA. Conveyors with troughlike sides and bed should
have a quick belt tension release device to allow cleaning under the belt.
D. Jet-Vacuum Equipment
Equipment used for cleaning jars or cans should have safety devices to indicate malfunc-
tion of either jet or vacuum elements. If necessary, vents to the outside should be provided
to control exhaust currents and to prevent dust and/or paper particles from being blown
back into cleaned containers.
E. Hoses
Hoses used for product contact should comply with recommendations of trade associations
or be accepted by both the FDA/USDA. The hose material must be installed in a manner
that allows for inspection of the interior surface. Sanitary connectors can be installed at
appropriate intervals to allow breakdown for visual inspection or use of inspection devices
such as boroscopes.
Hoses without sanitary connectors are acceptable for steam and water lines where
breakdown for cleaning and inspection is not necessary. However, hoses used for recircu-
lating water into and out of product contact areas must satisfy the requirement for product
contact hoses.
F. Pickle Lines
Pickle lines should be either stainless steel or some other USDA acceptable material. If
recirculated, pickle brine should be filtered and recirculated through a system that can be
disassembled to the extent necessary for thorough cleaning and inspection.
G. Smokehouses and Ovens

Smokehouses and ovens must be designed for easy cleaning and inspection of all inner
and outer surfaces. Ducts should be designed to be easily disassembled to the extent neces-
sary for thorough cleaning and inspection. Spray heads for dispensing liquid smoke must
be mounted below the level of the rails and trolleys. If liquid smoke is to be recirculated,
the pump and pipelines must be of sanitary type construction. Liquid smoke cannot be
recirculated if product is on rack trucks.
H. Screens and Filters

Screens and straining devices should be readily removable for cleaning and inspection
and should be designed to prevent incorrect installation. Permanent screens should be
constructed of noncorrosive metals. Synthetic filter materials should have clearance from
trade associations. The same applies to filters intended for direct product contact. Filter
paper should be single service. Filter cloths should be washable. Asbestos is not acceptable
for use as filtering material or for any other purpose.
I. Vent Stacks from Hoods
Vent stacks from covered cooking vats or hoods over cook tanks and CO2 equipment
should be arranged or constructed so as to prevent drainage of condensate back into the
product zone.
J. Ultraviolet Lamps
Ultraviolet (UV) lamps which generate ozone are restricted for use as described under
‘‘Ozone Producing Equipment.’’ Those which do not produce ozone may be used in any
area, provided shields are used to prevent exposure of workers to direct or reflected UV
rays. Otherwise, rooms where unshielded UV lights are used should be equipped with
switches at all entry points so the units may be turned off before workers enter. These
switches should be identified with suitable placards such as ‘‘Ultraviolet Lights.’’ Employ-
ees should not enter areas where unshielded UV lights are burning because of possible
damage to skin and eyes.
K. Heat Exchangers
Heat exchangers may be used to heat or cool product. Head exchangers may also be used
to heat or cool gases or liquids which directly contact product. However, extreme caution
should be exercised to prevent contamination. Inspectors and plant personnel should be
alert to the following conditions and requirements:
1. Only heat exchangers media authorized by trade associations, FDA, USDA, and
other standardization bodies in the United States, can be used for applications
involving food product. Common materials such as brine or ammonia need not
be submitted for review. Under no circumstances can toxic materials be used.
2. Heat exchangers should be routinely pressure tested to ensure that pinholes,
hairline cracks, loose fittings, or other similar defects are not present. Presence
of off-color, off-odor, and/or off-flavor may indicate leakage. Frequent deple-
tion of heat exchange media may also indicate leakage.
3. Pressure on the product side should be higher than the media side.
L. In-Plant Trucks
Trucks used to transport product within the plant should be constructed of stainless steel.
However, galvanized metal is acceptable provided it is maintained in a good state of repair
and is regalvanized when necessary. Trucks should be free of cracks and rough seams.
Metal wheels should be avoided as they cause deterioration of the floor surfaces. All trucks
should have some means of affixing a tag. This can be accomplished by drilling two holes
approximately 1 in. (25.4 mm) apart in the lip of the truck to accommodate string or wire.
M. Air Compressors
Compressed air may be used to directly contact product and/or product contact surfaces
provided the air is filtered before entering a compressor and it is clean and free of moisture,
oil, or other foreign material when contacting product or product contact surfaces. Lubri-
cants and coolants directly contacting air should be authorized by trade associations, FDA,
USDA, and other standardization bodies in the United States.
Compressed air storage tanks should have a drain. Water and oil traps must be
located between storage tanks and the point of use. Spent air must be exhausted in a
manner to prevent product contamination.
Air directly contacting product or product contact surfaces should be filtered as near
the air outlet as feasible. Filters should be readily removable for cleaning or replacement
and should be capable of filtering out 50-µm particles (measured in the longest dimension).
Air intake on votators should also be filtered.
N. Product Reconditioning Equipment

Product which is accidentally soiled may be cleaned on a separate, conveniently located
wash table or sink. This wash station should be properly equipped with sprays and a
removable, perforated plate to hold product off the bottom. The station should be identified
as a ‘‘product wash station’’ and cannot be used for hand or implement washing.
O. Electric Cords
Accepting the use of electric cords should be based on both sanitary and safety consider-
ations. Drop cords suspended from the ceiling may be retractable and used to connect
portable equipment on an as needed basis if the cords are properly wired to the power
source. Electric cords should not be strung across the floor even on a temporary basis.
P. Electric Insect Traps

Electric insect traps may be used in edible product handling and storage areas provided
the following conditions are met:
1. The equipment should be made of acceptable noncorrosive materials.
2. The traps must not be placed above uncovered product or above uncovered
product trafficways.
3. The electrified components are either apparent or properly identified, insulated
from nonelectrified components, and covered with a protective grille to prevent
electric shock hazard.
4. The equipment should have a removable shelf or drawer which collects all
trapped insects.
5. The equipment is designed and constructed so that all dead insects are trapped
in the removable shelf or drawer. (Insects must not collect on the protective
grill.)
Removable drawers or shelves should be emptied as often as necessary. If the drawer
or shelf becomes full of dead insects, then the fourth requirement above cannot be met
so the equipment should be rejected for use. Dead insects must be removed from the unit
before they create an odor problem. They cannot be left in the unit as bait.
Q. Inedible Product Equipment

Containers for handling and transporting inedible products should be watertight, main-
tained in a good state of repair (no rust or corrosion), and clearly marked with an appro-
priate identification. All inedible product containers in the plant should be uniformly iden-
tified. Inedible product containers should be cleaned before being moved into an edible
products department.
Metal barrels, tanks, or trucks may be used for holding inedible poultry products
in specially designated inedible product rooms. Alternatively, the containers may be stored
outside the building provided the storage area is paved, drained, and conveniently located.
These storage areas should also be equipped with nearby hose connections for cleanup.
R. Blow-Off Equipment Using Compressed Air

Filters used on the compressed air line should be readily removable for cleaning or replace-
ment and should be capable of filtering out 50µm particles.
The air pressure must be measured and recorded with appropriate devices and must
be set to deliver 75 to 125 psi (5.27 to 8.79 kg/cm2).
The blow air must be confined so that it is captured by a water curtain or by an
exhaust system that has a suction of at least 1500 cfm (425 hectoliters/min) at the point
of exhaust.
S. Ozone-Producing Equipment
Equipment which produces ozone may be used only in coolers designated for certain types
of products, e.g., aging meat. The ozone concentration in the air must be measured and
recorded with appropriate devices and cannot exceed 0.1 ppm. Ozone-generating equip-
ment should be turned off and the ozone permitted to dissipate before any in-house or
external inspection is performed.
T. Ozone Water Treatment and Recycling Equipment

Equipment used to ozonize and recycle water should be constructed from noncorrosive
material with safe and easy access for cleanup and sanitary inspection of all component
parts. Pumps and piping should be of acceptable sanitary type, demountable, and have
quick-disconnect mechanisms at each change of direction. Tanks, funnels, ozone genera-
tors, filter housings, and filter media should have FDA/USDA acceptance and approval
and they should be easily demountable for cleanup and sanitary inspection. A written
approval of a water reuse procedure may be needed by state and federal regulators. There
should also be written procedures for measuring and recording the total bacteria count
and the total organic carbon level (TOC) in the ozone-treated water returning to the source
of use. (Established guidelines: a total aerobic plate count of less than 1000/mL, coliform
less than 10/mL, and E. coli less than 2/mL.) All systems should have monitoring devices
on line
1. To measure and record the ozone level and concentration in the immediate area
(ozone concentration cannot exceed 0.1 ppm)
2. To measure and record ozone level and range of turbidity in the water being
returned to the source of use (all ozone must be dissipated at this time and
turbidity must be within the range of 0.5–5.0 NTU (nephelometric turbidity
units)
3. To automatically interrupt the water flow if the quality of the ozone-treated
water does not comply with established NTU guidelines.
U. Sanitizing Solutions and Testing Devices

A test kit or other device that accurately measures the concentration in milligrams per liter
of sanitizing solutions should be provided. Testing devices to measure the concentration of
sanitizing solutions are required for two reasons:
1. The use of chemical sanitizers requires minimum concentrations of the sanitizer
during the final rinse step to assure sanitization.
2. Too much sanitizer in the final rinse water could be toxic.
VII. EQUIPMENT LOCATION AND INSTALLATION

A. Fixed Equipment Spacing or Sealing
A unit of equipment that is fixed because it is not easily movable should be installed so
that it is
1. Spaced to allow access for cleaning along the sides, behind, and above the unit
2. Spaced from adjoining equipment, walls, and ceilings a distance of not more
than 1 mm or 1/32 in.
3. Sealed to adjoining equipment or walls, if the unit is exposed to spillage or
seepage
Table-mounted equipment that is not easily movable should be installed to allow
cleaning of the equipment and areas underneath and around the equipment by being
(1) sealed to the table or (2) elevated on legs as specified.
When the weight of the equipment exceeds 14 kg (30 lb), it is no longer considered
by the definition to be easily movable. Consequently, the following guide is noted:
1. Allow accessibility for cleaning on all sides, above, and underneath the units
or minimize the need for cleaning due to closely abutted surfaces.
2. Assure that equipment that is subject to moisture is sealed.
3. Prevent the harborage of insects and rodents.
4. Provide accessibility for the monitoring of pests.
B. Fixed Equipment Elevation or Sealing

Floor-mounted equipment that is not easily movable should be sealed to the floor or ele-
vated on legs that provide at least 15-cm (6-in.) clearance between the floor and the equip-
ment. However, if no part of the floor under the floor-mounted equipment is more than
15 cm (6 in.) from the point of cleaning access, the clearance space may be only 10 cm
(4 in.).
These suggestions do not apply to display shelving units, display refrigeration units,
and display freezer units located in the consumer shopping areas of a retail food store, if
the floor under the units is maintained clean.
Table-mounted equipment that is not easily movable should be elevated on legs that
provide at least 10-cm (4-in.) clearance between the table and the equipment. However,
the clearance space between the table and table-mounted equipment may be (1) 7.5 cm
(3 in.) if the horizontal distance of the table top under the equipment is no more than 50
cm (20 in.) from the point of access for cleaning or (2) 2.5 cm (2 in.) if the horizontal
distance of the table top under the equipment is no more than 7.5 cm (3 in.) from the
point of access for cleaning.
C. Summary
Stationary equipment or equipment not easily movable (i.e., no casters) should be installed
far enough from walls and support columns to allow thorough cleaning and inspection.
In addition, there must be ample clearance between the floor and the ceiling. If these
clearances are not possible, then equipment should be sealed watertight to the surfaces.
All wall-mounted cabinets, electric connections, and electronic components should be at
least 1 in. from the wall or sealed watertight to the wall.
The inability to adequately or effectively clean areas under equipment could create
a situation that may attract insects and rodents and accumulate pathogenic microorganisms
that are transmissible through food.
The effectiveness of cleaning is directly affected by the ability to access all areas
to clean fixed equipment. It may be necessary to elevate the equipment. When elevating
equipment is not feasible or is prohibitively expensive, sealing to prevent contamination
is required.
The economic impact of the requirement to elevate display units in retail food stores,
coupled with the fact that the design, weight, and size of such units are not conducive to
casters or legs, led to the exception for certain units located in consumer shopping areas,
provided the floor under the units is kept clean. This exception for retail food store display
equipment, including shelving, refrigeraion, and freezer units in the consumer shopping
areas, requires a rigorous cleaning schedule.
VIII. MAINTENANCE AND OPERATION

A. Equipment
Equipment should be in good repair and proper adjustment such that
1. Equipment should be maintained in a state of repair and condition that meets
the requirements specified in this chapter.
2. Equipment components such as doors, seals, hinges, fasteners, and kick plates
should be kept intact, tight, and adjusted in accordance with manufacturers’
specifications.
3. Cutting or piercing parts of can openers should be kept sharp to minimize the
creation of metal fragments that can contaiminate food when the container is
opened.
Proper maintenance of equipment to manufacturer specifications helps assure that it will
continue to operate as designed. Failure to properly maintain equipment could lead to
violations of the associated requirements that place the health of the consumer at risk.
For example, refrigeration units in disrepair may no longer be capable of properly cooling
or holding potentially hazardous foods at safe temperatures.
The cutting or piercing parts of can openers may accumulate metal fragments that
could lead to food containing foreign objects and, possibly, result in consumer injury.
Adequate cleaning and sanitization of dishes and utensils using a warewashing ma-
chine is directly dependent on the exposure time during the wash, rinse, and sanitizing
cycles. Failure to meet manufacturer and stated requirements for cycle times could result
in failure to clean and sanitize. For example, high temperature machines depend on the
build-up of heat on the surface of dishes to accomplish sanitization. If the exposure time
during any of the cycles is not met, the surface of the items may not reach the time–
temperature parameter required for sanitization. Exposure time is also important in ware-
washing machines that use a chemical sanitizer since the sanitizer must contact the items
long enough for sanitization to occur. In addition, a chemical sanitizer will not sanitize
a dirty dish; therefore, the cycle times during the wash and rinse phases are critical to
sanitization.
B. Cutting Surfaces
Cutting surfaces such as cutting boards and blocks that become scratched and scored may
be difficult to clean and sanitize. As a result, pathogenic microorganisms transmissible
through food may accumulate. These microorganisms may be transferred to foods that
are prepared on such surfaces.
Surfaces such as cutting blocks and boards that are subject to scratching and scoring
should be resurfaced if they can no longer be effectively cleaned and sanitized, or dis-
carded if they are not capable of being resurfaced.
IX. CLEANING OF EQUIPMENT AND UTENSILS
A. Objectives
Equipment food-contact surfaces and utensils should be clean to sight and touch. The
food-contact surfaces of cooking equipment and pans should be kept free of encrusted
grease deposits and other soil accumulations. Non–food-contact surfaces of equipment
should be kept free of an accumulation of dust, dirt, food residue, and other debris. The
objective of cleaning focuses on the need to remove organic matter from food-contact
surfaces so that sanitization can occur and to remove soil from non–food-contact surfaces
so that pathogenic microorganisms will not be allowed to accumulate and insects and
rodents will not be attracted.
B. Frequency
Non–food-contact surfaces of equipment should be cleaned at a frequency necessary to
preclude accumulation of soil residues. The presence of food debris or dirt on non–food-
contact surfaces may provide a suitable environment for the growth of microorganisms
which employees may inadvertently transfer to food. If these areas are not kept clean,
they may also provide harborage for roaches, flies, mice, and other pests.
C. Methods
1. Dry Cleaning
If used, dry cleaning methods such as brushing, scraping, and vacuuming should contact
only surfaces that are soiled with dry food residues that are not potentially hazardous.
Cleaning equipment used in dry cleaning food-contact surfaces may not be used for any
other purpose. Dry cleaning methods are indicated in only a few operations, which are
limited to dry foods that are not potentially hazardous. Under some circumstances, at-
tempts at wet cleaning may create microbiological concerns.
a. Precleaning. Food debris on equipment and utensils should be scrapped over a waste
disposal unit, scupper, or gargbage receptacle or should be removed in a warewashing
machine with a prewash cycle. If necessary for effective cleaning, utensils and equipment
should be preflushed, scrubbed with abrasives, or presoaked.
Precleaning of utensils, dishes, and food equipment allows for the removal of grease
and food debris to facilitate the cleaning action of the detergent. Depending upon the
condition of the surface to be cleaned, detergent alone may not be sufficient to loosen
soil for cleaning. Heavily soiled surfaces may need to be presoaked or scrubbed with an
abrasive.
2. Wet Cleaning
Equipment, food-contact surfaces, and utensils should be effectively washed to remove
or completely loosen soils by using the manual or mechanical means necessary, such as
the application of detergents containing wetting agents and emulsifiers; acid, alkaline, or
abrasive cleaners; hot water; brushes; scouring pads; or high-pressure sprays. The washing
procedures selected should be based on the type and purpose of the equipment or utensil,
and on the type of soil to be removed.
Because of the variety of cleaning agents available and the many different types of
soil to be removed, it is not possible to recommend one cleaning agent to fit all situations.
Each of the different types of cleaners works best under different conditions (e.g., some
work best on grease; some work best in warm water; others work best in hot water). The
specific chemical selected should be compatible with any other chemicals to be used in
the operation such as a sanitizer or drying agent.
X. SANITIZATION OF EQUIPMENT AND UTENSILS

A. Objective
Equipment food-contact surfaces and utensils should be sanitized. Effective sanitization
procedures destroy organisms of public health importance that may be present on wiping
cloths, food equipment, or utensils after cleaning, or which have been introduced into the
rinse solution. It is important that surfaces be clean before being sanitized to allow the
sanitizer to achieve its maximum benefit.
B. Frequency
Utensils and food-contact surfaces of equipment should be sanitized before use and after
cleaning. Sanitization is accomplished after the warewashing steps of cleaning and rinsing
so that utensils and food-contact surfaces are sanitized before coming in contact with food
and before use.
C. Methods
After being cleaned, equipment, food-contact surfaces, and utensils should be sanitized
by hot water manual operations by immersion for at least 30 sec as specified in standard
manuals or hot water mechanical operations by being cycled through equipment that is
set up as specified elsewhere achieving a utensil surface temperature of 71°C (160°F) as
measured by an irreversible registering temperature indicator or through the use of chemi-
cal means.
Chemical manual or mechanical operations, including the application of sanitizing
chemicals by immersion, manual swabbing, brushing, or pressure-spraying methods, using
a solution as specified in a standard manual, FDA/USDA regulations, or trade recommen-
dations includes (1) an exposure time of at least 10 sec for chlorine solution, (2) an expo-
sure time of at least 30 sec for other chemical sanitizer solutions, or (3) an exposure time
used in relationship with a combination of temperature, concentration, and pH that, when
evaluated for efficacy, yields sanitization as defined elsewhere.
Efficacious santization is dependent upon warewashing being conducted within cer-
tain parameters. Time is a parameter applicable to both chemical and hot water sanitiza-
tion. The time that hot water or chemicals contact utensils or food-contact surfaces must
be sufficient to destroy pathogens that may remain on surfaces after cleaning. Other param-
eters, such as temperature or chemical concentration, are used in combination with time
to deliver effective sanitization.
XI. PROTECTION OF CLEAN ITEMS

A. Drying
For equipment and utensils, air drying requirements include
1. After cleaning and sanitizing, equipment and utensils may not be cloth dried.
2. Equipment and utensils may be air dried or used after adequate draining as
specified in FDA regulations (21 CFR 178.1010) before contact with food.
3. Utensils that have been air dried may be polished with cloths that are maintained
clean and dry.
4. Items must be allowed to drain and to air dry before being stacked or stored.
Stacking wet items such as pans prevents them from drying and may allow an
environment where microorganisms can begin to grow. Cloth drying of equip-
ment and utensils is prohibited to prevent the possible transfer of microorigan-
isms to equipment or utensils.
B. Lubricating and Reassembling

Lubricants should be applied to food-contact surfaces that require lubrication in a manner
so that food-contact surfaces are not contaminated.
Equipment should be reassembled so that food contact surfaces are not contami-
nated.
C. Storing
Cleaned equipment and utensils should be stored (1) in a clean, dry location, (2) where
they are not exposed to splash, dust, or other contamination, and (3) at least 15 cm
(6 in.) above the floor. Further, equipment and utensils should be stored (1) in a self-
draining position and (2) covered or inverted.
Clean equipment and multi-use utensils which have been cleaned and sanitized can
become contaminated before their intended use in a variety of ways, such as through water
leakage, pest infection, or other insanitary conditions.
Cleaned and sanitized equipment and utensils may not be stored
In locker rooms
In toilet rooms
In mechanical rooms
Under sewer lines that are not shielded to intercept potential drips
Under leaking water lines including leaking automatic fire sprinkler heads or under
lines on which water has condensed
Under open stairwells
Under ther sources of contamination
The improper storage of clean and sanitized equipment, and utensils may allow contamina-
tion before their intended use. Contamination can be caused by moisture from adsorption,
flooding, drippage, or splash. It can also be caused by food debris, toxic materials, litter,
dust, and other materials. The contamination is often related to unhygienic employee prac-
tices, unacceptable high-risk storage locations, or improper construction of storage facili-
ties.
XII. CONCLUSION
For any food processor, the sanitation of equipment is a permanent problem. Contamina-
tion of food or food ingredients by unclean equipment has been the cause of foodborne
diseases in human population throughout the history of modern civilization. It is important
that a food processor comply with good manufacturing practices to reduce the potential
of equipment being the source of human pathogens or poisonous chemicals.
ACKNOWLEDGMENT
Most data provided in this chapter have beem modified with permission from documents
prepared by Science Technology System, West Sacramento, CA.

14
Workers’ Personal Hygiene
TIN SHING CHAO

U.S. Department of Labor, Honolulu, Hawaii, U.S.A.
I. INTRODUCTION
Because the food processing industry is labor intensive, that is, reliant on large numbers
of employees, personnel is a key resource to a company. It is management’s responsibility
to hire hygiene-conscious employees. The economic effect of a foodborne disease outbreak
can be devastating to a food processing plant. The public has a right to expect safe, sani-
tary, and wholesome food from any food producing company.
II. FOOD POISONING

Reports of foodborne and waterborne diseases are periodically published in the United
States. The number of outbreaks reported are thought to be fewer than the actual number
of outbreaks. Since many of the symptoms resemble symptoms of the 24-hour flu, the
actual outbreaks occurring in the United States are probably far greater than the number
being reported. Several key events are necessary for a foodborne disease outbreak. You
may remember the story of Typhoid Mary, a real-life case that cost many people’s lives
as a result of poor personal hygiene practices. The practice of clean habits in a food
processing area is the only way to achieve a satisfactory standard of hygiene.
III. A BRIEF OVERVIEW OF BACTERIA

Bacteria are small, single-celled organisms which can only be seen under a microscope.
They are everywhere in our surroundings, and as most bacteria cannot live by themselves
they have to be transferred to something by coming into direct contact with it. Some
bacteria form spores. These spores can withstand high temperatures for long periods of
time, and on return to favorable conditions they become normal bacteria again, which
then multiply. Some bacteria secrete exogenous toxins outside their bodies. These toxins,
when mixed with food, render the food itself poisonous, and symptoms of food poisoning
follow within a few hours.
Other bacteria cause food poisoning by virtue of large numbers bacteria in food
entering the digestive system, multiplying further, and setting up an infection. Certain
bacteria produce heat-resistant toxins. Foods in which this toxin have been produced may
still cause illness even when the food is heated to boiling and boiled for half an hour.
Some bacteria will grow in the absence of air (anaerobes); others need it (aerobes).
Bacteria multiply by dividing in two, under favorable conditions, about once every
20 min. Therefore, one bacterium could multiply in 10–12 hr to between 500 million and
1000 million bacteria.
Not all bacteria are harmful. Some are useful (e.g., those used in cheese production
and wine making). Some cause food spoilage (e.g., souring of milk). Some bacteria that
are conveyed by food cause disease other than food poisoning. These include typhoid,
paratyphoid, dysentery, and scarlet fever. In these cases the bacteria do not multiply in
the food; they are only carried by it, and the disease is known as a foodborne disease.
With bacterial food poisoning the bacteria multiply in the food. Time between eating the
contaminated food (ingesting) to the beginning of the symptoms of the illness (onset)
depends on the types of bacteria causing the illness. Table 1 on pages 214–215 provides
selected information on foodborne illnesses. It is excerpted from the work of Mr. Lance
Wong, the education officer for the State of Hawaii Food Safety Consultation and Education
Program. He used the National Restaurant Association Educational Foundation’s HACCP
Reference Book (1993) and Control of Communicable Disease in Men (1990), edited by
Abram S. Beneson. The intent of this table is to aid food plant workers to learn about differ-
ent causative agents, their incubation periods, their symptoms, and the food they could be
harbored in to improve awareness of the most common foodborne diseases. Certain favor-
able conditions must be met in order for bacteria to multiply. These are food of the right
kind, at suitable temperature, with adequate moisture, and over sufficient elapsed time.
Food-poisoning bacteria live in the soil; in human intestines, nose, throat, skin, cuts,
sores, spots, etc.; and in animals, insects, and birds.
IV. SPREAD OF INFECTION

Foodborne pathogenic bacteria can be spread by (1) food handlers’ coughing and sneezing
and via their hands; (2) animal, insect, and bird droppings, hair, etc.; and (3) inanimate
objects such as towels, dish cloths, knives, boards, and any other tools used in food pro-
cessing.
V. PREVENTION OF FOOD POISONING FROM BACTERIA

There are several ways we can prevent food poisoning from bacteria. One way to prevent
bacteria from spreading from place to place is sound hygiene practice. If bacteria has
already spread to the food, it is still possible to prevent food poisoning by controlling
bacteria from multiplying to a level that could cause a human to get sick. Temperature
is a factor to control the growth rate of the bacteria. Safe temperature for cold food shall
be 45°F (7.2°C) or below, and safe temperature for hot food shall be 140°F (60°C) or
above. Unfortunately, food intoxication or food poisoning is not affected by temperature.
Once the toxicant produced by the bacteria had been ingested, people will get sick. The
only way to prevent it is to discard the food item and not consume or taste it.
VI. PERSON-TO-PERSON CONTAMINATION

Humans play a very important part in spreading the infecting bacteria. We can also be
the ones to break the chain of contamination. Once the chain is broken we can prevent
bacteria from spreading from place to place and from multiplying. Most of the time, be-
cause food is mishandled by people, the chain of contamination continues until someone
gets sick or dies before actions are taken to prevent further outbreaks.
Prior to the discussion of personal hygiene, it is important for one to understand
how people and the environment can easily contaminate food. This discussion is based
on the assumption of a real world situation and will be limited to demonstrate how easily
a food item could be contaminated before and after reaching a food processing plant. The
author believes if every person who handles food could achieve personal hygiene to its
highest standards, food contamination could be kept to a minimum. Every single person
throughout the chain can play a very important part in preventing food being contaminated.
Take, for example, a chicken farmer who supplies the birds to a food processing
plant. We assume the chicken farmer has not been to a food handler safety class and all
he cares about is his profits. The food processing plant purchased the birds from this
chicken farmer because he offered the best price among its competitors. This chicken
farm occupied several acres of land since its opening. Maintenance of the premises was
minimal and they have only cleaned their farm once in the past ten years. The environment
is a source of contamination. One of the workers who worked at the chicken farm had a
cold and had diarrhea, but he continued to work at the farm. This person is a source of
contamination. The refrigerated truck used to hold the chicken had held raw beef and raw
pork, but it was not cleaned before different products were stored. This is a possible source
of cross-contamination. The driver had delivered some raw chickens to a food processing
plant, and at their receiving areas the receiving clerk did not check the temperature of the
delivery and it was 25°F (14°C) above the safe temperature. This was a temperature abuse
that would possibly lead to a foodborne outbreak. The receiving temperature was 70°F
(21.1°C). Since that day was a national holiday, the processing plant was short-staffed,
and the receiving clerk was called by a supervisor from another department to help. The
birds he just received were left on the transporting cart at room temperature. We assumed
that the birds produced in that chicken farm are contaminated with salmonella. The day
was hot and the temperature inside the processing plant was about 80°F (26.7°C). Salmo-
nella on the chicken was multiplying in a log phase. This is temperature abuse again.
Bacteria multiply when a favorable condition exists. When the clerk came back in a few
hours he then realized that the chickens were still left out at the receiving area. He then
quickly pushes the cart into the holding refrigerator. The temperature of the holding refrig-
erator is in the danger zone since it was opened many times during the day. The next day
when people came back from the national holiday they were all tired and lazy. After they
used the toilet they did not wash their hands before returning to work. The food was likely
to be further contaminated by the workers. Chickens were processed but somehow the
cooking temperature did not reach an internal temperature of 160°F (71.1°C) or above.
No one checked the final cooking temperature. The chicken was separated and packed
into individual packages and shipped to the supermarket. Consumers who purchased these
chicken products are likely to have a food poisoning event.
Table 1 Foodborne Illness Information Table
Disease Causative agent Incubation period Symptoms Food implicated
Salmonellosis Salmonella 6–48 hr (usually 12–24 hr) Fever, headache, abdominal Poultry, poultry salads, pork,
pain, diarrhea, nausea, meat and meat products,
sometimes vomiting milk, shell eggs, egg cus-
tards and sauces, other pro-
tein foods
Shigellosis Shigella 1–7 days Diarrhea (often bloody with Potato, tuna, shrimp, turkey,
mucus), fever, chills, nau- macaroni and fruit salads,
sea, abdominal pain lettuce, moist and mixed
foods
Listeriosis Listeria monocytogenes 4–21 days Fever, headache, nausea, vom- Unpasteurized milk and
iting, chills, backache, men- cheese, seafood, vegetables,
ingitis, stillbirths poultry and meats, and pre-
pared chilled ready-to-eat
foods
Campylobateriosis Campylobacter jejuni 1–10 days (usually 3–5 Diarrhea (often bloody with Unpasteurized milk and dairy
days) mucus), fever, nausea, ab- products, poultry, pork,
dominal pain, vomiting beef, lamb
Vibrio parahaemolyticus Vibrio parahaemolyticus 4–96 hr (usually 12–24 hr) Watery diarrhea, abdominal Raw or inadequately cooked
gastroenteritis cramps, nausea, vomiting, seafood or any food cross-
fever, headache contaminated by handling
raw seafood
Norwalk virus gastroenter- Norwalk and Norwalk-like 24–48 hr Nausea, vomiting, diarrhea, ab- Raw shellfish, raw vegetables,
itis viral agent dominal pain, headache, salads, prepared salads, wa-
low grade fever ter contaminated from hu-
man feces

Infectious hepatitis Hepatitis A virus 15–20 days (average 28– Fever, malaise, anorexia, nau- Contaminated water, food con-
30 days) sea, abdominal discomfort, taminated by infected food
jaundice handlers, including sand-
wiches and salads, raw or
undercooked mollusks
Clostridium perfringens Clostridium perfringens 8–24 hr (usually 24 hr) Abdominal pain, diarrhea, Improperly cooled or inade-
enteritis toxin nausea quately reheated foods
(meats, stews, sauce, gra-
vies, soups)
Pathogenic E. coli diarrhea Pathogenic strains of E. 12–72 hr Diarrhea (often bloody), se- Raw and uncooked ground
or hemorrhagic colitis coli (e.g., 0157:H7) vere abdominal pain, vom- beef and other red meats,
iting, kidney complications raw milk
Bacillus cereus gastroenter- Bacillus cereus toxin 1–6 hr (vomiting) Nausea, vomiting, abdominal Cooked rice, potatoes, pasta,
itis 6–24 hr (diarrhea) cramps, diarrhea green beans, vegetable
sprouts, dry spices
Staphylococcal intoxication Staphylococcus aureus 1–6 hr (usually 2–4 hr) Vomiting, nausea, diarrhea, de- Ham and other meats, dairy
toxin hydration products, custards, salads
(potato), cream-filled des-
serts
Botulism Clostridium botulinum 12–36 hr Nausea, diarrhea, vomiting, Low-acid canned or vacuum-
toxin cramps, headache, vertigo, packed foods, smoked
paralysis, death meats, condiments
Ciguatera fish poisoning Ciguatoxin 2–24 hr (usually 3–5 hr) Weakness, muscle and joint Numerous varieties of
pain, diarrhea, chills, numb- tropical/reef fish (e.g., barra-
ness, nausea, temperature re- cuda, ulua, kahala, kole,
versal, vomiting po’ou)
Scombroid fish poisoning Histamine and related Few minutes to several Flushed face, headache, rapid Mainly mahi mahi, ahi, aku,
compounds hours heart rate, cramps, diarrhea, akule, opelu, au, ulua
itching, breathing trouble

It is important for everyone who participates in the process to be aware of the safe
handling of food and to practice good personal hygiene. Contaminated chicken went from
the chicken farmer to the processing plant, from the processing plant to the supermarket,
and from the market to the consumer. The contamination chain could be broken at any
point through the practice of sound hygiene measures to prevent foodborne outbreaks.
Remember, the consumer counts on food processors to produce safe and healthy food.
And as a food-processing worker you should be proud that you are being part of this
process in producing clean and wholesome food.
VII. PERSONAL CLEANLINESS

A person wants to live a happy life. In order to achieve this goal, it is necessary for a
person to set their state of mind to live a happy life. One has to perform certain activities
to make one’s life a happy one, and through the joy of achievement they would become
a happy person. Achieving personal cleanliness works on the same principle. An ordinary
person would want to stay clean and healthy. In a food processing plant, higher standards
should be set. Self-respect is also necessary in every food processing plant because pride
in one’s appearance promotes a high standard of cleanliness and physical fitness. Persons
with ill health or who are not clean about themselves should not handle food. There are
certain activities that will help a person to achieve this goal of personal hygiene.
A. Bathing
Regular bathing at least once a day is essential; otherwise germs can be transferred onto
the clothes and so onto food. There are germs living on our body. Some of these germs
are beneficial to us, but some of the pathogenic germs are bad. If foods are being contami-
nated, people who consume the food will become sick and might even die from consuming
such contaminated foods. Therefore, it is important for a person to bathe or shower daily
to stay clean.
B. Hands
Hands must be thoroughly washed frequently, particularly after using the bathroom, before
commencing work, and whenever food is to be handled. They should be washed in hot
water with the aid of brush and soap; rinsed; and dried on a clean towel, suitable paper
towel, or by a hand hot-air drier. Hands and fingernails if not kept clean can be a great
source of danger as they can so easily transfer harmful bacteria onto food. Many people
think when they are using antibacterial hand soap, the germs or bacteria will be automati-
cally washed off. This may be true, but in order for the antibacterial hand soap to work
properly, follow the directions on the bottle. It will tell you, for example, how long you
have to leave the soap on, and you have to continue rubbing both of your hands continu-
ously for a certain amount of time in order for certain hand soap to effectively remove
bacteria. The author has attended many food handler classes, and one instructor had said
the proper way of washing one’s hands is to continue to rub both of your hands with hand
soap, especially the finger tips, for at least 30 seconds. Try it yourself with a timer for
30 seconds and compare it to how much time you have used to wash your hands in the
past. You will discover how long to wash and scrub your hands.
Many food processing plants are now providing hand gloves to their employees.
For many of the workers, if not properly trained, this might give them a false sense of
security. They may have a misconception that if gloves were used, food would not be
contaminated. Sometimes, they can forget to change their gloves after touching their nose,
scratching their heads, or even picking up something dropped on the floor with the gloves
on. Therefore, workers who use hand gloves should be aware of this point.
Rings, watches, and jewelry should not be worn when food is handled. Particles of
food may be caught under a ring, and germs could multiply until they are transferred into
food. Watches (apart from the fact that steam ruins them) should not be worn when han-
dling food. For example, in a salad and cabbage processing plant, foodstuffs have to be
plunged into plenty of water; they may not be properly washed because a watch is worn.
Jewelry should not be worn in a food processing plant, since it may fall off into food,
unknown to the wearer.
C. Fingernails
Fingernails should always be kept clean and short as dirt can easily lodge under the nail
and be discharged when, for example, handling and processing food, thereby introducing
bacteria into food. Fingernails should be cleaned with a nailbrush, and nail varnish should
not be worn when one has to process food at a food processing plant.
D. Hair
Hair should be washed regularly and kept covered when food is being handled. Hair that
is not cared for is likely to come out or shed dandruff, which may fall into food, becoming
an unwanted food additive. Men’s hair should be kept short as it is easier to keep clean;
it also looks neater. Women’s hair should be covered as much as possible. The hair should
never be scratched, combed, or touched while handling or processing food because germs
and bacteria could be transferred via the hands to the food.
E. Nose
The nose should not be touched when food is being handled. If a handkerchief is used,
the hands should be washed afterward. Ideally, a paper handkerchief should be used and
then discarded, the hands being washed afterward. The nose is an area harboring vast
numbers of harmful bacteria; it is therefore very important that neither food, people, nor
working surfaces are sneezed over, thus, spreading germs and bacteria.
F. Mouth
There are germs and bacteria in the areas of the mouth; therefore, the mouth or lips should
not be touched by hands or utensils which may come into contact with food. No cooking
utensils should be used for tasting food, nor should fingers be used for this purpose as
germs and bacteria may be transferred to food. A clean teaspoon should be used for tasting
and washed well afterward. Coughing over food and working areas should be avoided as
germs and bacteria are spread long distances if not trapped in a handkerchief.
G. Ears
The ear holes should not be handled in food processing areas as, again, germs and bacteria
can be transferred into food by touching the ear and then food.
H. Teeth
Sound teeth are essential to good health. They should be kept clean and visits to the dentist
should be regular so that teeth can be kept in good repair. One should brush one’s teeth
daily at least two times and floss after every meal.
I. Feet
As food handlers stand for many hours, care of the feet is important. They should be
washed regularly, and the toenails kept short and clean. Tired feet can cause general tired-
ness, which leads to carelessness, and this often results in a lowering of the standards of
hygiene.
J. Cuts, Burns, Sores, Etc.

It is particularly important to keep all cuts, burns, scratches, and similar openings of the
skin covered with a waterproof dressing. Where the skin is septic, as with certain cuts,
spots, sores, and carbuncles, there are vast numbers of harmful bacteria which must not
be permitted to get on food. In most cases people suffering in this way should not handle
food in order to prevent harmful germs being accidentally transferred to food.
K. Cosmetics
Cosmetics, if used by food handlers, should be used in moderation. They should not be
applied in the food processing area and hands should be washed well afterward. Cosmetics
should be put on clean skin and not used to cover up dirt.
L. Smoking
Smoking must never take place where there is food being processed. When a cigarette is
taken from the mouth, germs and bacteria from the mouth can be transferred to the fingers
and so onto food. When a cigarette is put down, the end which has been in the mouth
can transfer germs to the working surface. Ash on food is most objectionable and it should
be remembered that smoking where there is food handling is against the law.
M. Spitting
Spitting should never occur, because germs and bacteria can be spread by this objection-
able habit. There are times when you need to spit out things. Do it in the bathroom and
spit directly into the toilet bowl and flush it after spitting. Don’t forget to wash your mouth
and your hands before returning to work.
N. Clothing and Cloths

Clean white protective clothing and clean underclothes should be worn at all times. Dirty
clothes enable germs and bacteria to multiply, and if dirty clothing comes into contact
with food the food may be contaminated. Cloths used for wiping clean utensils or used
for holding hot cooking utensils or used to wipe working surfaces in case of spills should
also be kept clean and stored in the sanitizing solutions when not in use. Be sure to change
the sanitizing solutions at regular intervals because the organic materials accumulating
will compromise the strength of the sanitizing solution. Outdoor clothing and other cloth-
ing taken off before wearing white working clothes should be kept in a locker away from
the food processing area.
VIII. GENERAL HEALTH AND FITNESS

The maintenance of good health is essential to prevent the introduction of germs and
bacteria into the food processing areas. To keep physically fit, adequate rest, exercise,
fresh air, and wholesome diet are essential.
Persons employed in a food processing kitchen require adequate sleep and relax-
ation, as they are on the move all the time, often in a hot atmosphere where the tempo
of work may be very fast. Frequently, the hours are long or extended over a long period
of time, as with split duty, or they may extend into the night. In off-duty periods it may
be wise to get some rest rather than spend all the time energetically. The amount of sleep
and rest required depends on each person’s needs, and the variation between one person
and the next is considerable.
People working in conditions of nervous tension, extreme heat, and odd hours need
a change of environment and, particularly, fresh air. Swimming, walking, or cycling in
the countryside may be suitable ways of obtaining both exercise and fresh air.
A well-balanced diet, correctly cooked, and pure water will assist in keeping a person
fit. The habit of ‘‘picking’’ (eating small pieces of food while working) is bad; it spoils
the appetite and does not allow the stomach to rest. This bad habit may transfer germs
and bacteria from your mouth to your hands into food, contaminating the food being
handled. Meals should be taken regularly; long periods of work without food are also bad
for the stomach. Hungry workers might lose their concentration; accidents may happen
if a person is tired and has not enough energy to carry on with work. Pure water is ideal
for replacing liquids lost by perspiring in a hot working area. A soft drink may be used
to replace some of the salt as well as fluid lost in sweating.
IX. EMPLOYEE TRAINING

The importance of training employees to meet company standards, industry standards,
regulatory standards, and consumer expectations cannot be overemphasized; this is one
of the key elements to help a company survive and be competitive.
The traditional ways of training employees such as in a classroom setting, using
textbooks, and showing videos may still be a viable way to train a company’s employees.
But in recent years a new concept has been developed. It is behavior-based training. The
author believes that if a company focuses on behavior, rather than the individual, one can
change the organization. A lot of the companies lack the education, training, and experi-
ence to change people’s behavior, believing that changing people should be left to psychia-
trists and clinical psychologists. This concept is wrong. Focusing on observable behavior
and learning from mistakes could help renew a company. Instead of trying to change
attitudes, perceptions, and cognition (because they are too difficult to define), we suggest
focusing on system factors that indirectly change attitudes, commitment, and motivation,
such as management systems, policies, and supervisory behavior. Direct with activators,
and motivate with consequences. Activators are signals that precede our behavior and tell
us what to do to receive a consequence; however, we behave only in ways that result in
a desired consequence, or the avoidance of an undesired consequence. Focus on positive
consequences to improve behavior. For example: a worker in a food processing plant uses
a machine to cut chickens in half, but if operated carelessly there is a risk of losing a
hand (negative consequence). The significance of this negative consequence is the risk of
losing a hand; the probability of negative events as a result of risky behavior is usually
very low because no one would want a hand to be cut off. If there were a one-to-one
correlation of losing your hand when a certain behavior took place, the behavior usually
wouldn’t occur. Finally, if good positive personal hygiene behaviors are repeatedly re-
warded, sooner or later they will become good habits, which can be part of the organiza-
tional behavior and can also influence other workers in the same plant.
X. CONTINUOUS EVALUATION
In order to ensure a personal hygiene training program works for your organization, it is
important for management to have a continued evaluation program to ensure effective
hygiene practices are incorporated in an organization. A periodic inspection is a useful
tool to determine its effectiveness. Supervisors should always lead by example. Supervi-
sors should also observe how employees perform their hygiene practices to identify if
there is a need to retrain employees. Statistics show that most people forget what they
learn after a period of time. It is suggested to have an annual or biannual retraining if the
company can afford the time to retrain their employees.
XI. CONCLUSION
Bacteria are present all around us. Some of them are beneficial, but some are not. It
is important for individuals who work in a food processing plant to break the chain of
contamination by following sound hygiene practices. Everyone is important in keeping
the food safe from farm to table. It is true that the government has set rules and regulations
for different food processing plants to follow, but these rules and regulations will not be
effective unless enforced and followed by the workers. Remember that consumers are
counting on food processors to safeguard this process. Let us work together with our
employers and our government to ensure that products are produced in our processing
plants under sound hygienic conditions.

15
Worker Safety and Regulatory
Requirements
TIN SHING CHAO

I. INTRODUCTION
More than 90 million Americans spend their days at a job. They are the most important
assets of this country. Yet before 1970 there were no uniform and comprehensive provi-
sions for their safety and protection against workplace hazards. On December 29, 1970,
the Senate and House of Representatives of the 91st Congress enacted Public Law 91-
596. It is also known as the Williams–Steiger Act, and is also cited as the Occupational
Safety and Health Act of 1970 (the Act). The Act was later amended by Public Law 101-
552, Section 3101, November 5, 1990.
II. CONGRESSIONAL FINDINGS AND PURPOSE

The U.S. Congress found that personal injuries and illnesses arising out of work situations
impose a substantial burden upon and are a hindrance to interstate commerce in terms of
lost production, wage loss, medical expenses, and disability compensation payments. The
congress declared that its purpose and policy is to assure, so far as possible, every working
man and woman in the nation safe and healthful working conditions, to preserve our
human resources, and to provide for the general welfare of all working people. This is
enacted through regulation of commerce among the several states and with foreign nations
in several areas [1]:
1. By encouraging employers and employees in their efforts to reduce the number

of occupational safety and health hazards at their places of employment and
to stimulate employers and employees to institute new, and to perfect existing,
programs for providing safe and healthful working conditions
2. By providing that employers and employees have separate and independent
responsibilities and rights with respect to achieving safe and healthful working
conditions
3. By authorizing the Secretary of Labor to set mandatory occupational safety
and health standards applicable to businesses affecting interstate commerce
and by creating an Occupational Safety and Health Review Commission for
carrying out adjudicatory function under the Act
4. By building upon advances already made through employer and employee
initiatives for providing safe and healthful working conditions
5. By providing for research in the field of occupational safety and health, includ-
ing the psychological factors involved and by developing innovative methods,
techniques, and approaches for dealing with occupational safety and health
problems
6. By exploring ways to discover latent diseases, establishing causal connections
between diseases and work in environmental conditions, and conducting other
research relating to health problems often different from those involved in
occupational safety
7. By providing medical criteria which will assure insofar as practicable that no
employee will suffer diminished health, functional capacity, or life expectancy
as a result of work experience
8. By providing for training programs to increase the number and competence
of personnel engaged in the field of occupational safety and health
9. By providing for the development and promulgation of occupational safety
and health standards
10. By providing an effective enforcement program which shall include a prohibi-
tion against giving advance notice of any inspection and sanctions for any
individual violating this prohibition
11. By encouraging the states to assume the fullest responsibility for the adminis-
tration and enforcement of their occupational safety and health laws by provid-
ing grants to the states to assist in identifying their needs and responsibilities
in the area of occupational safety and health, to develop plans in accordance
with the provision of this Act, to improve the administration and enforcement
of state occupational safety and health laws, and to conduct experimental and
demonstration projects in connection therewith
12. By encouraging joint labor management efforts to reduce injuries and disease
arising out of employment
III. THE ACT

The purpose of the Act is to assure safe and healthful working conditions for working
men and women. It is enacted by authorizing enforcement of the standards developed
under the Act, by assisting and encouraging the states in their efforts to assure safe and
healthful working conditions, and by providing for research, information, education, and
training in the field of occupational safety and health [1].

A. Coverage
The Act extends to all employers and employees in all fifty states, the District of Columbia,
Puerto Rico, and all other territories under the federal government jurisdiction. Coverage
is provided either by the Federal Occupational Safety and Health Administration (OSHA)
or approved state programs. The Occupational Safety and Health Act of 1970 encourages
states to develop and operate their own job safety and health plans. States with approved
plans under section 18(b) of the Occupational Safety and Health Act must adopt standards
and enforce requirements that are as effective as federal requirements. There are currently
25 state plan states; 23 of these states administer plans covering both private and public
(state and local government) employees, the other two states—Connecticut and New
York—cover public employees only. Plan states must adopt standards comparable to fed-
eral requirements within 6 months of a federal standard’s promulgation. Until such time
as a state standard is promulgated, Federal OSHA provides interim enforcement assistance,
as appropriate, in the states. Criteria for state plans are listed under 29 CFR 1902, State
Plans for the Development and Enforcement of State Standards [1]. An employer is any
person engaged in a business affecting commerce who has employees, but this does not
included the United States or any state or political subdivision of a state. The following
are not covered under the act: (1) self-employed persons; (2) farms at which only immedi-
ate members of the farm employer’s family are employed; and (3) working conditions
regulated by other federal agencies under other federal statutes.
IV. OCCUPATIONAL SAFETY AND HEALTH LAW

The Code of Federal Regulations is a codification of the general and permanent rules
published in the Federal Register by the executive departments and agencies of the federal
government. The Code is divided into 50 titles, which represent broad areas subject to
federal regulation. Each title is divided into subchapters covering specific regulatory areas.
Title 29 refers to labor laws. It is composed of nine volumes. The Occupational Safety
and Health Laws are recorded under 29 CFR Parts 1900–1910.999, Parts 1910.1000 to
end, Parts 1911–1925, Part 1926, and Parts 1927 to end [2].
V. OSHA INSPECTION
Under the Occupational Safety and Health Act of 1970 Act, the Occupational Safety and
Health Administration is authorized under the Act to conduct workplace inspections to
determine whether employers are complying with the OSHA standards issued by the
agency for safe and healthful workplaces. The Occupational Safety and Health Adminis-
tration also enforces Section 5(a)(1) of the Act, also known as the General Duty Clause,
which requires that every working man and woman be provided with a safe and health-
ful workplace. Workplace safety and health inspections are performed by OSHA compli-
ance safety and health officers who are knowledgeable and experienced in the occupa-
tional safety and health field and who are trained in OSHA standards and in the
recognition of safety and health hazards. Similarly, states with their own occupational
safety and health programs must conduct inspections using qualified state compliance
safety and health officers.

Inspections are usually conducted without advance notice. In fact, alerting an em-
ployer without proper authorization in advance of an OSHA inspection can bring a fine
up to $1,000 and/or a 6-month jail term. This is true for Federal OSHA compliance officers
as well as state inspectors. There are, however, special circumstances under which OSHA
may give advance notice to the employer, but such a notice will normally be less than
24 hours. If an employer refuses to admit an OSHA compliance officer or if an employer
attempts to interfere with the inspection, the Act permits appropriate legal action, such
as obtaining a warrant to inspect [3].
A. Inspection Priorities
Not all 6.2 million workplaces covered by the Act can be inspected immediately. The
worst situations need attention first. Therefore, OSHA has established a system of inspec-
tion priorities. Imminently dangerous situations are given top priority. An imminent danger
is any condition where there is reasonable certainty that a danger exists that can be ex-
pected to cause death or serious physical harm immediately or before the danger can be
eliminated through normal enforcement procedures.
Second priority is given to investigation of fatalities and accidents resulting in hospi-
talization of three or more employees. Such catastrophes must be reported to OSHA by
the employer within 8 hr. The OSHA inspectors will investigate and determine the cause
of such accidents and whether existing OSHA standards were violated.
Third priority is given to formal employee complaints of alleged violations or stan-
dards, or of unsafe or unhealthful working conditions, and to referrals from other govern-
ment authorities about specific workplace hazards. The Act gives each employee the right
to request an OSHA inspection when the employee believes he or she is in imminent
danger from a hazard or when he or she thinks that there is a violation of an OSHA
standard that posts physical harm. The Occupational Safety and Health Administration
will maintain confidentiality if requested, and will inform employees of any action it takes
regarding the complaint.
Next in priority are programmed inspections aimed at specified high-hazard indus-
tries, workplaces, occupations, or health substances, or other industries in OSHA’s current
inspection procedures. Industries are selected for inspection on the basis of factors such
as injury incident rates, previous citation history, employee exposure to toxic substances,
or random selection. Special emphasis programs also may be developed and may be re-
gional or national in scope, depending on the distribution of the workplaces involved.
Comprehensive safety inspections in manufacturing will be conducted normally in those
establishments with lost-workday injury rates at or above the Bureau of Labor Statistics
(BLS) national rate for manufacturing currently in use by OSHA. States with their own
occupational safety and health programs may use somewhat different systems to identify
industries for inspection.
An establishment can expect a follow-up inspection if an OSHA violation has been
issued to the establishment. A follow-up inspection determines if previously cited viola-
tions have been corrected. If an employer has failed to abate a violation, the compliance
officer informs the employer that he or she is subject to ‘‘Failure to Abate’’ alleged viola-
tions, and additional daily penalties may be incurred while such failure to abate the viola-
tion continues [3].

B. Opening Conference
When the OSHA compliance officer arrives at the establishment, he or she will display
official credentials and ask to meet with an appropriate employer representative. In the
opening conference, the compliance officer will explain how the establishment was se-
lected. The compliance officer also will ascertain whether an OSHA-funded consultation
visit is in progress or whether the facility is pursuing or has received an inspection exemp-
tion through the consultation program. If so, the inspection may be terminated. Before
the inspection, the compliance officer explains the purpose of the visit, the scope of the
inspection, and the standards that apply. The employer will be given information on how
to obtain a copy of applicable safety and health standards as well as a copy of any com-
plaint that may be involved (with the employee’s name deleted).
The employer will be asked to select an employer representative to accompany the
compliance officer during the inspection. An authorized employee representative also is
given an opportunity to attend the opening conference and to accompany the compliance
officer during the inspection. If a recognized bargaining agent represents the employees,
the agent ordinarily will designate the employee representative to accompany the compli-
ance officer.
The Act does not require an employee representative for each inspection. Where
there is no authorized employee representative, the compliance officer must consult with
a reasonable number of employees concerning safety and health matters in the workplace
[3].
C. The Inspection Process

The compliance officer determines the route and duration of the inspection. While talking
with employees, the compliance officer makes every effort to minimize any work interrup-
tions. The compliance officer observes safety and health conditions and practices; consults
with employees privately, if necessary; takes photos and instrument readings, examines
records, collects air samples, measures noise levels, and surveys existing engineering con-
trols; and monitors employee exposure to toxic fumes, gas, and dusts.
An inspection tour may cover part or all of an establishment, even if the inspection
resulted from a specific complaint, fatality, or catastrophe.
Trade secrets observed by the compliance officer will be kept confidential. An in-
spector who releases confidential information without authorization is subject to a $1,000
fine and/or 1 year in jail. The employer may require that the employee representative have
confidential clearance for any area in question.
Employees are consulted during the inspection tour. The compliance officer may
stop and question workers, in private, about safety and health conditions and practices in
their workplaces. Each employee is protected under the Act from discrimination by the
employer for exercising his or her rights.
During the course of inspection, the compliance officer will point out to the employer
any unsafe or unhealthful working conditions observed. At the same time, the compliance
officer will discuss possible corrective action if the employer so desires.
Some apparent violations detected by the compliance officer can be corrected imme-
diately. When they are corrected on the spot, the compliance officer records such correc-
tions to help judge good faith in compliance. Although corrected, the apparent violations

may still serve as the basis for citation and, if appropriate, a notice of proposed penalty
[3].
D. Closing Conference
At the conclusion of the inspection, the compliance officer conducts a closing conference
with the employer and the employee representative. It is a time for free discussion of
problems and needs, a time for frank questions and answers. The compliance officer also
will give the employer a copy of the employer rights and responsibilities following an
OSHA inspection and will discuss briefly the information in the booklet and will answer
any questions.
The compliance officer discusses with the employer all unsafe or unhealthful condi-
tions observed during the inspection and indicates all apparent violations for which a
citation and a proposed penalty may be issued or recommended. The employer is informed
of appeal rights. During the closing conference, the employer may wish to produce records
to show compliance efforts and to provide information that can help OSHA determine
how much time may be needed to abate all alleged violations.
When appropriate, more than one closing conference may be held. This is usually
necessary when health hazards are being evaluated or when laboratory reports are required.
If an employee representative does not participate in either the opening or the closing
conference held with the employer, a separate discussion is held with the employee repre-
sentative, if requested, to discuss matters of interest to employees [3].
VI. STANDARDS RELATED TO SAFETY AND HEALTH HAZARDS

IN THE WORKPLACE
For the purpose of this chapter, food processing plants are covered under 29 CFR Parts
1902–1908, Regulatory Standards, Occupational Safety and Health Standards under 29
CFR Parts 1910. This is also commonly known as the General Industry Standard. Most
common violations and standards will be discussed in this section [4].
A. Section 5(a)(1): General Duties Clause

Section 5(a)(1) is commonly known as the General Duties Clause. It is used when no
applicable standards can be found to cite a particular hazard. Section 5(a)(1) of the Act
states each employer shall furnish to each employee employment and a place of employ-
ment which is free from recognized hazards that cause or are likely to cause death or
serious physical harm to employees.
B. 29 CFR Part 1903: Inspection, Citations, and Proposed Penalties

The purpose of Part 1903 is to prescribe rules and to set forth general enforcement policies
rather than substantive or procedural rules. Such policies may be modified in specific
circumstances where the Secretary of Labor or a designee determines that an alternative
course of action would better serve the objective of the Act.
Section 1903.2. This standard requires each employer to post and keep posted a
notice informing employees of the protections and obligations provided under the Act,
and to provide assistance and information, including copies of the Act and of specific

safety and health standards. If there is any question, employees should contact the em-
ployer or the nearest office of the Department of Labor. Such notice shall be posted by
the employer in each establishment in a conspicuous place or places where notices to
employees are customarily posted. This poster is commonly known as the OSHA poster.
This standard also requires the employer who has obtained copies of the Act and applicable
rules and regulations to make such rules and regulations available upon request to any
employee or their authorized representative. Any employer failing to comply with the
provision of this section may be subject to citation and penalty.
Section 1903.8. This section requires the employer to allow a representative of
the employees an opportunity to accompany the compliance safety and health officer dur-
ing the physical inspection of any workplace for the purpose of aiding such inspection.
Section 1903.19. Inspections by OSHA are intended to result in the abatement of
violations of the Occupational Safety and Health Act of 1970. Within 10 calendar days
after the abatement date, the employer must certify to OSHA (state plans may vary) that
each cited violation has been abated. The employer’s certification that abatement is com-
pleted must include, for each cited violation, the following information: (1) the employer’s
name and address; (2) the inspection number to which the submission relates; (3) the
citation and item numbers to which the submission relates; (4) a statement that the informa-
tion submitted is accurate; and (5) the signature of the employer or authorized representa-
tive.
There are times when abatement plans may be required; this is indicated on the
citation and the employer must submit an abatement plan for each cited violation within
25 calendar days (state plans may vary) from the final order of the date. An employer
who is required to submit an abatement plan may also be required to submit periodic
progress reports for each cited violation, as indicated on the citation. The date on which
an initial progress report must be submitted may be no sooner than 30 calendar days after
submission of abatement plan (states plans may vary).
The employer is also required to inform affected employees and their representa-
tive(s) about abatement activities by posting a copy of each document submitted to the
agency or a summary of the document near the place where violation occurred.
C. 29 CFR Part 1904: Recording and Reporting Occupational

Injuries and Illness
OSHA’s rule addressing the recording and reporting of occupational injuries and illnesses
affects approximately 1.4 million establishments. A number of specific industries in the
retail, services, finance, insurance, and real estate sectors are now classified as low-hazard
industries and are exempt from most requirements of the rules, as are small businesses
with 10 or fewer employees.
On January 1, 2002, OSHA enacted a whole new set of rules replacing the old
recording and reporting system—except for key provisions covering hearing loss and
musculoskeletal disorders, which OSHA has delayed for one year while the agency recon-
siders these issues. The newly revised rules improve employment, call for greater em-
ployee privacy protection, create simpler forms (OSHA 300, 301, 300A), provide clearer
regulatory requirements, and allow employers more flexibility to use computers to meet
OSHA regulatory requirements. State programs will have six months to adopt the federal

rules or come up with their own systems as effective as the federal system. To know more
about these new rules, go to: www.OSHA.gov or www.DOL.gov.
D. 29 CFR Part 1910: Occupational Safety and Health Standards

Section 6(a) of the Williams–Steiger Occupational Safety and Health Act of 1970 allows
the Secretary of Labor to promulgate occupational safety and health standards. Title 29
CFR 1910 is commonly known as the General Industry Standards [2].
Section 1910.1020: Keeping Medical Records. This section discusses the re-
quirements regarding how the employer shall keep medical records.
Section 1910.1020(d)(1)(i). This standard requires the employer to preserve and
maintain medical records for each employee for at least the duration of employment plus
30 years. Exception to this paragraph include health insurance claims records maintained
separately from the employer’s medical program and its records as well as first aid records
if made on-site by a nonphysician and maintained separately from the employer’s medical
program and its records. The medical records of employees who have worked less than
1 year for the employer are provided to the employee upon termination of employment.
Section 1910.1020(d)(1)(ii). This standard requires the employer to preserve and
maintain each employee’s exposure record for at least 30 years. Exceptions to this para-
graph include
1. Background data to environmental (workplace) monitoring or measuring, such

as laboratory reports and work sheets
2. Material safety data sheets and records concerning the identity of a substance
or agent
3. Biological monitoring results designed as exposure records by specific occupa-
tional safety and health standards, which shall be preserved and maintained as
required by the specific standard
Section 1910.1020(g)(1)(i). This standard requires the employer to inform current

employees upon their first entering into employment and at least annually thereafter of
the existence, location, and availability of any records covered by 29 CFR 1910.1020.
E. Subpart D: Walking/Working Surfaces

Slips, trips, and falls are among the most reported causes of occupational injuries. Falls
are not always from elevation. Many falls are at the same level as slips and trips.
Section 1910.22(a)(1). This standard requires all places of employment, passage-
ways, storerooms, and services be kept clean and orderly and in a sanitary condition. Poor
housekeeping could be one of the biggest elements contributing to an unsafe working
place.
Section 1910.22(a)(2). This standard requires the floor of every workroom be
maintained in a clean and, so far as possible, a dry condition.
Section 1910.22(d)(1). This standard requires every building or structure used for
mercantile trade, business, industrial use, or storage to post the load limit signs approved
by the building official in a conspicuous place in each space to which they relate.
Section 1910.23(a)(1). This standard requires every stairway floor opening be
guarded by a standard railing.
Section 1910.23(c)(1). This standard requires every open-sided floor or platform
that is 4 ft or more above the adjacent floor or ground level be guarded by a standard
railing.
Section 1910.23(c)(3). This standard requires that open-sided floors, walkways,
platforms, or runways which are above or adjacent to dangerous equipment, pickling or
galvanizing tanks, degreasing units, and other similar hazards are guarded with a standard
railing and toe board. This is regardless of height.
Section 1910.23(d)(1). This standard requires that every flight of stairs having
four or more risers be equipped with standard stair railings or handrails, according to the
requirements as listed under Section 1910.23(d)(1)(i)–(v).
Section 1910.24(b). This standard requires fixed stairs be provided for access from
one structure to another where operations necessitate regular travel between levels, and
for access to operating platforms at any equipment which require attention routinely during
operations. Fixed stairs shall also be provided
1. Where access to elevation is daily, or at each shift, for such purposes as gauging,
inspection, regular maintenance, etc.
2. Where such work may expose employees to acids, caustics, gases, or other
harmful substances
3. Where the carrying of tools or equipment by hand is normally required
Section 1910.25. This section is intended to prescribe rules and establish minimum
requirements for the construction, care, and use of common types of portable wood lad-
ders. Subsection 1910.25(b)(2)(xv) requires that a ladder which is used to gain access to
a roof shall extend at least 3 ft above the point of support, at cave, gutter, or roofline.
Section 1910.26. This standard requires metal ladders be designed without struc-
tural defects or have accident hazards such as sharp edges, burns, etc. The metal selected
shall be of sufficient strength to meet the test requirements and shall be protected against
corrosion unless inherently corrosion-resistant.
F. Subpart E: Means of Egress

A means of egress is a continuous and unobstructed way of exit travel from any point in
a building or structure to a public way. This consists of three separate and distinct parts:
the way of exit access, the exit, and the way of exit discharge. A means of egress comprises
the vertical and horizontal ways of travel and shall include intervening room spaces, door-
ways, hallways, corridors, passageways, balconies, ramps, stairs, enclosures, lobbies, esca-
lators, horizontal exits, courts, and yards.
Section 1910.37(f)(1). This standard requires all exits shall be so located and exit
access be arranged so that exits are readily accessible at all times. The most common
problem found is blocked exits which are not readily accessible.
Section 1910.37(f)(6). This standard requires the minimum width of any way of
exit access shall in no case be less than 28 in.
Section 1910.37(q). This standard requires exits shall be marked by a readily visi-
ble sign. Any door, passage, or stairway that is neither an exit nor a way of exit access,
which is so located or arranged as to be likely to be mistaken for an exit, shall be identified
by a sign reading ‘‘not an exit’’ or similar designation. It can also be identified by a
sign indicating its actual character, such as ‘‘to basement,’’ ‘‘storeroom,’’ ‘‘linen
closet,’’ or the like.
Section 1910.38(a). This standard applies to all emergency action plans required
by a particular OSHA standard. The emergency action plan shall be in writing except for
those employers with 10 or fewer employees, who may communicate the plan orally to
employees. The following elements at a minimum shall be included in the plan:
1. Emergency escape procedures and emergency escape route assignments
2. Procedures to be followed by employees who remain to operate critical plant
operations before they evacuate
3. Procedures to account for all employees after emergency evacuation has been
completed
4. Rescue and medical duties for those employees who are to perform them
5. The preferred means of reporting fires and other emergencies
6. Names or regular job titles of persons or departments who can be contacted for
further information or explanation of duties under the plan
Section 1910.38(a)(5). This standard requires that the employer, before imple-
menting the emergency action plan, shall designate and train a sufficient number of persons
to assist in the safe and orderly emergency evacuation of employees.
Section 1910.38(b). This standard applies to all fire prevention plans required by
a particular OSHA standard. The fire prevention plan must be in writing, except for em-
ployers with 10 or fewer employees, who may communicate the plan orally to employees.
The following elements at a minimum shall be included in the plan:
1. A list of major workplace fire hazards and their proper handling and storage
potential ignition sources and their control procedures as well as the type of
fire protection equipment or systems which can control a fire involving them
2. Names or regular job titles of those personnel responsible for maintenance of
equipment and systems installed to prevent or control ignitions or fires
3. Names or regular job titles of these personnel responsible for control of fuel
source hazards
Section 1910.38(b)(4). This standard requires the employer to apprise employees
of the fire hazards of the materials and processes to which they are exposed. The employer
shall also review with each employee upon initial assignment those parts of the fire preven-
tion plan for which the employee must know to protect the employee in the event of
emergency.
G. Subpart G: Occupational Health and Environmental Control

Section 1910.95. Protection against noise exposure shall be provided when em-
ployees are exposed to a sound level exceeding an 8-hr time-weighted level of 85 decibels
(the action level) or an 8-hr time-weighted level of 90 decibels (the permissible exposure
level). Employers are required to monitor and determine if employees were being exposed
to noise over the action level. The employer shall notify each employee exposed at or
above the action level. The employers are required to establish and maintain an audiomet-
ric testing program and establish a valid baseline audiogram within 6 months of an employ-
ee’s first exposure at or above the action level. At least annually after obtaining the baseline
audiogram, the employer shall obtain a new audiogram for each affected employee. Hear-
ing protectors shall be available to all employees exposed to an 8-hr time-weighted level
of 85 decibels or greater at no cost to employees. Hearing protectors shall be replaced
as necessary. The employer shall institute an annually repeated training program for the
employees who are exposed to noise at or above the action level and to ensure employee
participation in such training program.
Section 1910.95(c). This standard requires the employer to administer a continu-
ing, effective hearing conservation program whenever employees’ noise exposure equal
to or exceeding an 8-hr time-weighted level of 85 decibels measured on the A scale, or
equivalently a dose of 50%. The requirements are listed in 29 CFR 1910.95(c)–(o).
H. Subpart H: Hazardous Materials

Section 1910.101(a). This standard requires the employer to determine whether
compressed gas cylinders under its control are in a safe condition to the extent that can
be determined by visual inspection. Visual and other inspections shall be conducted as
prescribed in the hazardous regulations of the Department of Transportation (49 CFR
171–179 and 14 CFR 103). Where those regulations are not applicable, visual and other
inspections shall be conducted in accordance with Compressed Gas Association Pamphlets
C-6-1968 and C-8-1962.
Section 1910.101(b). This standard requires the employer to follow the Com-
pressed Gas Association Pamphlet P-1-1965 for the in-plant handling, storage, and utiliza-
tion of all compressed gases in cylinders, portable tanks, rail tankcars, or motor vehicle
cargo tanks.
Section 1910.106. This section discusses the flammable and combustible liquids
separated into different classes and their handling and storage requirements.
Section 1910.119. This standard, commonly known as the Process Safety Manage-
ment (PSM) standard, contains the requirements for preventing or minimizing the conse-
quence of catastrophic releases of toxic reactive, flammable, or explosive chemicals. These
releases may result in toxic exposure, fire, or explosive hazards. There are 137 chemicals
listed and regulated by this standard. Their total quality if exceeding the allowed amount
is subject to all requirements of the standards. Many companies will try to substitute lesser
hazardous chemicals in order to avoid complying with this standard because compliance
requires a lot of work and is often quite expensive. When they have to have one of the
137 regulated chemicals on site they will try to keep the total quantity lower than the
regulated level so that the standard will not apply. Those who have operations covered
under this standard are subjected to all the requirements of this standard. The subjects of
various subsections include
1910.119(c) Employee participation
1910.119(d) Process safety information
1910.119(e) Process hazard analysis
1910.119(f) Operating procedures
1910.119(g) Training
1910.119(h) Contractors
1910.119(i) Pre–start-up safety review
1910.119(j) Mechanical integrity
1910.119(k) Hot work permit
1910.119(l) Management of change
1910.119(m) Incident investigation
1910.119(n) Emergency planning and response
1910.119(o) Compliance audits
1910.119(p) Trade secrets
Section 1910.120. This standard is commonly known as the Hazwooper Standard.
This section covers
1. Cleanup operations required by a governmental body—whether federal, state,

local, or other—involving hazardous substances. These include cleanups con-
ducted at uncontrolled hazard waste sites, any site on the state priority sites list,
sites recommended for the Environmental Protection Agency (EPA) National
Priorities List (NPL), and sites which are identified for initial government inves-
tigation before substance has been ascertained.
2. Corrective actions involving cleanup operations at sites covered by the Re-
sources Conservation and Recovery Act of 1976.
3. Voluntary cleanup operations at sites recognized by federal, state, local, or other
governmental bodies as uncontrolled hazardous waste sites.
4. Operations involving hazardous waste that are conducted at treatment, storage,
or disposal (TSD) facilities regulated by 40 CFR Parts 264 and 265 pursuant
to the Resource Conservation and Recovery Act (RCRA) or by agencies under
agreement with EPA to implement RCRA regulations.
5. Emergency response operations for release of, or substantial threats of release
of, hazardous substances without regard to the location of the hazard.
Most commonly used chemicals that are used as refrigerants, such as anhydrous ammonia,
and chemicals used for cleaning-in-process (CIP) for cleanup, such as chlorine or ozone,
could be subjected to Section 1910.119 and 1910.120 requirements.
I. Subpart I: Personal Protective Equipment

This standard requires the employer to provide protective equipment including personal
protective equipment (PPE) for eye, face, head, and extremities. Protective clothing, respi-
ratory devices, and protective shields and barriers shall be used and maintained in a sani-
tary and reliable condition wherever it is necessary. Such equipment protects individuals
from process or environmental hazards, chemical hazards, radiological hazards, or me-
chanical irritants encountered in a manner capable of causing injury or impairment in the
function of any part of the body through absorption, inhalation, or physical contact.
Section 1910.132(d)(1). This standard requires the employer to assess the work-
place to determine if hazards are present, or are likely to be present, which would necessi-
tate the use of personal protective equipment. If such hazards are present, or likely to be
present, the employer shall
1. Select and have each affected employee use the type(s) of PPE that will protect
the affected employee from the hazard identified in the hazard assessment
2. Communicate selection decisions to each affected employee
3. Select PPE that properly fits each affected employee
Section 1910.132(d)(2). This standard requires the employer to verify that the
required workplace hazard assessment has been performed through a written certification.
This certification should include the name of the person certifying that evaluation has
been performed, the date(s) of hazard assessment, and a title that identifies the document
as a certification of hazard assessment.
Section 1910.132(f). This standard requires the employer to provide training to
each employee who is required by 29 CFR 1910.132 to use PPE. These employees shall
be trained to know at least the following:
1. When PPE is necessary
2. What PPE is necessary
3. How to properly don, doff, adjust, and wear PPE
4. The limitation of PPE
5. The proper care, maintenance, useful life, and disposal of the PPE
Section 1910.133. This standard requires the employer to ensure that each affected
employee uses appropriate eye or face protection when exposed to eye or face hazards
from flying particles, molten metal, liquid chemicals, acids or caustic liquids, chemical
gases or vapors, or potentially injurious light radiation. Protective devices purchased after
July 5, 1994 shall comply with American National Standard Institute (ANSI) Z87.1-1989.
Section 1910.134. This section deals with the control of those occupational dis-
eases caused by breathing air contaminated with harmful dusts, fogs, fumes, mists, gases,
smokes, sprays, or vapors. The primary objective is to prevent atmospheric contamination.
This shall be accomplished as far as feasible by accepted engineering control measures.
When effective engineering controls are not feasible or while they are being instituted,
appropriate respirators shall be used pursuant to the requirements of this standard.
Section 1910.135. This standard requires the employer to ensure that each affected
employee wears a protective helmet when working in areas where there is a potential for
injuries to the head from falling objects. Protective helmets purchased after July 5, 1994
shall comply with ANSI Z89.1-1969.
Section 1910.136. This standard requires the employer to ensure each affected
employee uses protective footwear when working in areas where there is a danger of foot
injuries due to falling or rolling objects, or objects piercing the sole, and where such
employees’ feet are exposed to electrical hazards. Protective footwear purchased after July
5, 1994 shall comply with ANSI Z41.1-1967.
Section 1910.138. This standard requires the employer to select and require em-
ployees to use appropriate hand protection when employees’ hands are exposed to hazards
such as those from skin absorption of harmful substances, severe cuts or lacerations, severe
abrasions, punctures, chemical burns, thermal burns, and harmful temperature extremes.
J. Subpart J: General Environmental Controls

Section 1910.141. This standard requires permanent places of employment to meet
the minimum requirements of sanitation facilities.
Section 1910.146. This standard contains the requirements for practice and proce-
dures to protect employees in general industry from any operation of the workplace that
contains the hazards of entry into permit-required confined spaces. This section does not
apply to agriculture, to construction, or to shipyard employment.
A confined space means a space that (1) is large enough and so configured that an
employee can bodily enter and perform assigned work; (2) has limited or restricted means
for entry or exit; and (3) is not designed for continuous employee occupancy.
A permit-required confined space means a confined space that has one or more of
the following characteristics:
1. Contains or has a potential to contain a hazardous atmosphere
2. Contains a material that has the potential for engulfing an entrant
3. Has an internal configuration such that an entrant could be trapped or asphyxi-
ated by inwardly converging walls or by a floor which slopes downwards and
tapers to a smaller cross-section
4. Contains any other recognized serious safety or health hazards
If such a hazard exists in the workplace, the employer is required to comply with the
following provisions:
1910.146(d) Requires the employer to establish a permit space program
1910.146(e) Requires the employer to document the completion of measurements
required by 29 CFR 1910.146(d)(3) by preparing entry permits before entry
1910.146(f) Requires the employer to establish entry permit document compliance
of this section
1910.146(g) Requires the employer to provide training so that all employees
whose work is regulated by this standard acquires the understanding, knowledge,
and skills necessary for the safe performance of the duties assigned under this
standard
1910.146(h) Requires the employer to train authorized entrants to understand their
duties
1910.146(i) Requires the employer to train attendants to understand their duties
1910.146(j) Requires the employer to train entry supervisors to understand their
duties
1910.146(k) Requires the employers to train employees who are entering the per-
mit space to perform rescue services and make training available to have persons
other than their employees perform permit space rescue
Section 1910.147. This standard is commonly known as the Control of Hazardous
Energy Lock-Out/Tag-Out (LOTO) Standard. This standard covers the servicing and
maintenance of machines and equipment in which the unexpected energization or start-
up of the machines or equipment, or release of stored energy, could cause injury to employ-
ees. This standard establishes the minimum performance requirements for the control of
such hazardous energy. Appendix A to 1910.147 states a typical minimal lockout proce-
dure for reference.
Section 1910.147(c)(1). This requires the employer to establish a program con-
sisting of energy control procedures, employee training, and periodic inspections. Such a
program ensures that all energy sources are isolated before any employee performs servic-
ing or maintenance on equipment or a machine, where the unexpected energizing, start-
up, or release of stored energy could occur and cause injury to employee.
Section 1910.147(c)(7). This standard requires the employer to train and to ensure
that the purpose and function of the energy control program is understood by employees
and that the knowledge and skills required for the safe application, usage, and removal
of the equipment are acquired by employees.
K. Subpart K: Medical and First Aid

Section 1910.151. This standard sets requirements for medical and first aid.
Section 1910.151(c). This standard requires the employer to provide suitable facil-
ities for quick drenching or flushing of the eyes or body when the eyes or body may be
exposed to injuries from corrosive materials.

L. Subpart L: Fire Protection
Section 1910.155. This standard sets the requirements for fire brigades and all
portable and fixed fire suppression equipment, fire detection systems, and fire or employee
alarm systems installed to meet the fire protection requirements of 29 CFR 1910.
Section 1910.156. This standard contains the requirements for the organization,
training, and personal protective equipment of fire brigades whenever established by an
employer.
Section 1910.157. This standard applies to the placement, use, maintenance, and
testing of portable fire extinguishers provided for employee use. Where the employer has
an emergency action plan and a fire prevention plan which meets the requirements of 29
CFR 1910.38, then only the requirements of 1910.157(e) and (f) apply.
Section 1910.159. This section sets the requirements for all automatic sprinkler
systems installed to meet the particular OSHA standard.
Section 1910.164. This standard requires all automatic fire detection systems in-
stalled to meet the requirements of the OSHA standard.
Section 1910.165. This standard applies to all emergency employee alarms in-
stalled to meet a particular OSHA standard. The requirements are that maintenance, testing
and inspection shall be applied to all local fire alarm signaling systems used to alert em-
ployees, regardless of other functions of the system.
M. Subpart O: Machinery and Machine Guarding

Section 1910.212(a)(1). This standard requires the employer to provide one or
more methods of machine-guarding to protect the operator and other employees in the
machine area from hazards such as those created by point of operation, ingoing nip points,
rotating parts, flying chips, and sparks.
Section 1910.212(a)(2). This standard requires the guards for the machine be af-
fixed to the machine where possible or secured elsewhere if for any reason attachment to
the machine is not possible. The guard shall be such that it does not offer an accident
hazard in itself.
Section 1910.215. This standard sets the minimum requirements for safeguarding
of abrasive wheels. Specific requirements for maximum exposure angles, tongue guards,
tool rests, and other minimum safety requirements are listed in different tables and figures
in this standard.
Section 1910.219(d)(1). This standard sets the guarding requirements for pulleys
that are 7 ft or less from the floor or working platform. Where the point of contact between
belt and pulley is more than 6 in. from the floor or platform, it may be guarded with a
disk covering the spokes.
Section 1910.219(e)(1). This standard covers guards on horizontal belts and ropes.
On horizontal belts and ropes, where both runs of horizontal belts are 7 ft or less from
the floor level, the guard shall extend to at least 15 in. above the belt or to a standard
height as listed in Table 0-12 (Table of Standard Materials and Dimensions) [5]. However,
when both runs of a horizontal belt are 42 in. or less from the floor, it shall be fully
enclosed.
Section 1910.219(i)(1). This standard requires all revolving collars including split
collars, be cylindrical and that crews or bolts used in collars shall not project beyond the
largest periphery of the collar.

Section 1910.219(i)(2). This section requires the couplings shall be so constructed
as to present no hazard from bolts, nuts, set screws, or revolving surfaces. Bolts, nuts,
and set screws will, however, be allowed where they are covered with safety sleeves or
where they are used parallel with the shafting and are countersunk or else do not extend
beyond the flange of the coupling.
N. Subpart P: Hand and Portable Power Tools

Section 1910.242. This standard requires the employer to be responsible for the
safe condition of the tools and equipment used by employees, including tools and equip-
ment which may be furnished by employees.
Section 1910.243. This standard requires the guarding of all portable, power-
driven circular saws having a blade diameter greater than 2 in. It shall be equipped with
a guard above and below the base plate or shoe. The upper guard shall cover the saw to
the depth of the teeth, except for the minimum arc required to permit the base to be tilted
for bevel cuts. The lower guard shall cover the saw to the depth of the teeth, except for
the minimum arc required to allow proper retraction and contact with the work. When
the tool is withdrawn from the work area, the lower guard must automatically and instantly
return to covering position.
O. Subpart Q: Welding, Cutting, and Brazing

Section 1910.252. This standard provides the basic precautions and special pre-
cautions of the fire protection and prevention responsibilities of welders and cutters and
their supervisors, which includes outside contractors and those in management on whose
property cutting and welding are to be performed. The standards for fire prevention in
use of cutting and welding processes are listed under National Fire Protection Association
(NFPA) Standard 51B, 1962, which is incorporated as reference as specified in 29 CFR
1910.6.
Section 1910.253(b)(2)(ii). This standard requires that cylinders kept inside build-
ings be stored in a well-protected, well-ventilated, dry location at least 20 ft from high
combustibles such as oil or excelsior. Assigned storage spaces shall be located where
cylinders will not be knocked over or damaged by passing or falling objects or subject
to tampering by unauthorized persons.
Section 1910.253(b)(4)(i). This standard requires that oxygen cylinders not be
stored near highly combustible material, especially oil and grease; or near reserved stocks
of carbide and acetylene or other fuel-gas cylinders, or near any other substance likely to
cause or accelerate fire, or in an acetylene generator compartment.
Section 1910.253(b)(4)(iii). This standard requires the storage of oxygen cylinders
to be separated from fuel-gas cylinders or combustible materials by a minimum of 20 ft
or by a noncombustible barrier at least 5 ft high, having a fire resistant rating of at least
one-half hour.
Section 1910.253(b)(5). This standard requires cylinders, cylinder valves, coup-
lings, regulators, hoses, and similar apparatus be kept free from oily or greasy substances.
Organic materials such as oil and grease can cause oxygen to self-ignite and will be an
explosion hazard.

P. Subpart S: Electrical Safety
This subpart addresses electrical safety requirements that are necessary for the practical
safeguarding of employees in their workplaces and is divided into five major divisions as
follows:
1. Design safety standards for electrical systems contained in Sections 1910.302

through 1910.330
2. Safety-related work practices contained in Sections 1910.331 through 1910.360
3. Safety-related maintenance requirements contained in Sections 1910.361
through 1910.380
4. Safety requirements for special equipment contained in Sections 1910.381
through 1910.398
5. Definitions applicable to each division contained in Section 1910.399
Section 1910.303(b)(1). This standard requires the employer to perform inspec-

tions to identify hazards. It requires electrical equipment to be free from recognized haz-
ards that are likely to cause death or serious physical harm to employees.
Section 1910.303(b)(2). This standard requires listed or labeled equipment to be
used or installed in accordance with any instructions included in the listing or labeling.
Section 1910.303(e). This standard requires that electrical equipment may not be
used unless the manufacturer’s name, trademark, or other descriptive marking which may
identify the organization responsible for the product is placed on the equipment. Other
markings shall be provided giving voltage, current, wattage, or other rating as necessary.
Section 1910.303(f). This standard requires each disconnecting means be legibly
marked to indicate its purpose, unless located and arranged so the purpose is evident. Each
service, feeder, and branch circuit and its disconnecting means shall be legibly marked to
indicate its purpose.
Section 1910.303(g). This standard requires that for equipment rated 600 mV nor-
mal, sufficient access and workspace shall be provided and maintained to permit ready
and safe operation and maintenance of such equipment.
Section 1910.304(a)(2). This standard requires that no ground conductor may be
attached to any terminal or lead so as to reverse designated polarity.
Section 1910.304(f)(4). This standard requires the path to ground from circuits,
equipment, and enclosures be permanent and continuous.
Section 1910.305(a)(2)(iii)(F). This standard requires that lamps used for general
illumination be protected from accidental contact or breakage. Protection shall be provided
by elevation of at least 7 ft from normal working surface or by a suitable fixture or lamp
holder with a guard.
Section 1910.305(b)(1). This standard requires conductors entering any box, cabi-
nets, or fittings be protected from abrasion, and any openings through which conductors
enter shall be effectively closed. Accumulated dust will cause an arc between conductors
and may then cause an electrical fire.
Section 1910.305(b)(2). This standard requires all pull boxes, junction boxes, and
fittings are to be provided with covers approved for the purpose. If metal covers are used,
they must be grounded.
Section 1910.305(e)(1). This standard requires that cabinets, cutout boxes, fittings,
boxes, and panel board enclosures in damp or wet locations be installed so as to prevent

moisture or water from entering and accumulating within the enclosures. In wet locations
the enclosures shall be weatherproof.
Section 1910.305(g). This standard sets the requirement for the use of flexible
cords and cables. The most commonly found violation, in Section 1910.305(g)(1)(iii),
includes flexible cords and cables used as a substitute for the fixed wiring of a structure.
This subsection addresses
1. Flexible cords and cables running through holes in walls, ceilings, or floors
2. Flexible cords and cables running through doorways, windows, or similar open-
ings
3. Flexible cords and cables attached to building surfaces
4. Flexible cords and cables concealed behind buildings, walls, ceilings, or floors
Section 1910.332(a). This standard requires the employer to train employees who
face a risk of electrical shock that is not reduced to a safe level by the electrical installation
requirements of Sections 1910.303 through 1910.308.
Section 1910.322(b)(1). This standard requires the employer to train employees in
and become familiar with the safety-related work practices required by Sections 1910.331
through 1910.335.
Section 1910.322(b)(2). This standard sets additional requirements for the em-
ployer to train unqualified employees who are covered by Section 1910.322(a) but who
are not qualified persons. They shall be trained and be familiar with any electrically related
safety practices not specifically addressed by Sections 1910.331 through 1910.335 but
which are necessary for their safety.
Section 1910.334(a)(2)(ii). This standard requires the employer, during visual in-
spection, to remove any defective or damaged equipment that might expose an employee
to injury. No employees may use such until appropriate repairs and tests are done to render
the equipment safe.
Q. Subpart Z: Toxic and Hazardous Substances

Section 1910.1030. This standard is commonly known as the Bloodborne Patho-
gen Standard. It applies to all occupational exposure to blood or other potentially infectious
materials as defined in 1910.1030(b). This standard also covers but is not limited to first
responders and employees who are designated as first-aid providers in their job description.
Section 1910.1030(c). This standard requires employers to establish a written ex-
posure control plan designed to eliminate or minimize employee exposure.
Section 1910.1030(d). This standard discussed the different methods of compli-
ance such as universal compliance, engineering, and work practice controls.
Section 1910.1030(f). This standard requires the employer to make available the
hepatitis B vaccine and vaccination series to all employees who have occupational expo-
sure, and postexposure evaluation and follow-up to all employees who have had an expo-
sure incident.
Section 1910.1030(g)(1). This standard requires the employer to affix warning
labels and signs to containers of regulated waste; refrigerators and freezers containing
blood or other infectious materials; and other containers used to store, transport, or ship
blood or other potentially infectious materials.
Section 1910.1030(g)(2). This standard requires employers to ensure all employ-
ees with occupational exposure participate in a training program, which must be provided
at no cost to the employee and be held during working hours. Such training shall be
repeated annually. The elements of the minimum training program requirements are listed
under Sections 1910.1030(g)(2)(vii)A–N.
Section 1910.1030(h). This standard requires the employer to establish and main-
tain accurate records for each employee with occupational exposure, in accordance with
29 CFR 1910.20, for the duration of employment plus 30 years.
Section 1910.1200. This standard is commonly known as the Hazard Communica-
tion Standard or Employee Right-to-Know Standard. The purpose of this standard is to
ensure that the hazards of all chemicals produced or imported are evaluated, and that
information concerning their hazards is transmitted to employers and employees. This is
the most cited standard, topping any other OSHA citations.
Section 1910.1200(e)(1). This standard requires the employer to develop and
maintain at each workplace, a written hazard communication program which describes
the criteria set in 29 CFR Sections 1910.1200(f)–(h) for labels and other forms of warning,
material safety data sheets, and employee information and training.
Section 1910.1200(f)(5). This standard requires the employer to ensure that each
container of hazardous chemicals in the workplace is labeled, tagged, or marked with
the following information: (1) identity of the hazardous chemical(s) contained therein,
(2) appropriate hazard warnings or words, pictures, symbols, or combination thereof that
provide at least general information regarding the hazards of the chemicals and which, in
conjunction with other information immediately available to employees under the hazard
communication program, provide employees with specific information regarding the phys-
ical hazards of the hazardous chemical(s).
Section 1910.1200(g)(8). This standard requires the employer to maintain in the
workplace copies of the required material safety data sheets for each hazardous chemical
and ensure that they are readily accessible during each work shift to employees when they
are in their work area(s).
Section 1910.1200(h)(1). This standard requires the employer to provide employ-
ees with effective information and training on hazardous chemicals in their work areas at
the time of their initial assignment and whenever a new physical or health hazard the
employees have not previously been trained about is introduced into their work area. The
elements for minimum training requirements are listed under 29 CFR Sections
1910.1200(h)(3)(i)–(iv).
This discussion represents some of the most cited violations of an OSHA inspection
at the workplace. An effective safety and health program, discussed in the next section,
could also contribute to a safer workplace [12].
VII. SUGGESTED ELEMENTS OF AN EFFECTIVE SAFETY

AND HEALTH PROGRAM
A. Management Commitment and Worker Involvement
1. Visible top management leadership
2. Employee involvement in structure and operation of program and in decisions
that affect their safety and health
3. Clear worksite policy on safe and healthful work and working conditions
4. Goal(s) for safety and health program objectives for meeting goal(s)
5. Assignment and communication of responsibility for all aspects of program
6. Adequate authority and resources for parties to meet assigned responsibilities
7. Identification of managers, supervisors, and employees accountable for meeting
responsibilities
8. Annual program review to evaluate success in meeting goal(s) and objectives
B. Worksite Analysis
1. Regular site safety and health inspection
2. Reliable system for employees to report hazards and receive timely and appro-
priate response
C. Hazard Prevention and Control

1. Facility and equipment maintenance to prevent hazardous breakdowns
2. Medical programs to minimize injury and illness
3. Emergency plan and drills so that response of all parties will be second nature
D. Safety and Health Training

1. Training for managers on their safety and health responsibilities
2. Training for supervisors on their safety and health responsibilities and reasons
for them
3. Training for employees on general safety and health rules of worksite, specific
site hazards, safe work practice to control exposure, and role in emergency
situations
VIII. SAFETY RULES AND PRACTICES IN FOOD

PROCESSING OPERATIONS
A. Employee Responsibilities
Under 29 CFR 1960.10, Employee Responsibilities and Rights, the Occupational Safety
and Health Act requires each employee to comply with the standards, rules, regulations,
and orders issued by the agency in accordance with Section 19 of the Act. Executive order
12196 held employees responsible for their own actions and conduct. Employees shall
also use safety equipment, personal protective equipment, and other devices and pro-
cedures provided or directed by the agency and necessary for their protection. Employees
shall have the right to report unsafe and unhealthful working conditions to appropriate
officials. They are protected by law from being discriminated against by their employer
if they choose to exercise this right.
B. Protective Equipment and Clothing

Proper protective equipment and clothing can avoid many accidents. Many companies
have formulated a program of safety for their employees and mandate the use of safety
equipment in job performance. Safety equipment should meet the requirements of the
American National Standard Institute requirement for safety equipment. Efficiency of per-
formance can be increased and operating cost reduced by the application of proper training
of workers.

Safety equipment such as safety helmets (hats) must be worn for all jobs where
carcasses or products are conveyed on noncaptive overhead rails and where employees
drive ride-on industrial tractors. Helmets are recommended for all dressing floor and cooler
operations. Safety glasses or a face shield should be used for the protection of eyes or
face from damage or destruction by physical or chemical agents or by radiant energy.
This is an integral part of any good industrial safety program. Hand protection can be
achieved by using metal mesh gloves. These gloves are made from stainless steel that
conforms to the shape of the hand and the fingers to eliminate cutting injuries of workers’
hands. Various kinds of protective footwear are available on the market but steel-toed
safety shoes are the best for impact protection. For work done under wet conditions, rubber
boots or rubber shoes are available with steel box toes having similar impact specification
set by ANSI for foot protection.
C. Handling of Tools
There are many good reasons for the proper instruction and training of workers regarding
their handling of both hand and power tools. The knife is one of the most commonly used
tools in cutting. The careful use of the knife and observation of safe practices in cutting
will prevent accidents. Abuse of knives may lead to an injury. Automated and hand-
powered equipment play a very important role in the food industry. Many automated tools
are featured with safety switches, but that doesn’t mean one can ignore safely handling
of the tools. Power tools should be positioned on retractable power lines. This will keep
the equipment high above the head of the worker when not in use. Accidents are often
caused by slipping, which throws the worker into the power tool, such as a saw. Waste and
rubbish should be removed from the floor at regular intervals. Salt or other skid prevention
materials should also be used to prevent slipping. Operators should know the safety factors
as well as the care and maintenance of the power tools. Not paying attention to the moving
and working parts of power tools is often the cause of accidents. Safety factors concerning
the operation of the power tools should be observed. Factors needing attention include
adjustment of the power tool, adjustment of guides, and adjustment of the tool support.
Manufacturers produce a wide variety of grinders for the food services industry. The most
important safety measure for meat grinders is to never operate a grinder without a feed
pan or tray. When operating a large grinder, a fork or scoop should be used for feeding
or loading. A slicing machine should be used to cut chilled or frozen boneless meats/
poultry into thin slices. It is important to remember to use the product pusher plate to
slice end cuts. Fingers must be kept clear of the path of the blade. Also, do not disregard
safety for speed. Before cleaning the slicing machine be sure the power is shut off to
prevent accidental starting by touching the control switch.
IX. SOME PHYSICAL HAZARDS ENCOUNTERED

AT THE WORKPLACE
A. Electrical Hazards
All portable hand tools and production tools should be equipped with polarized grounded
receptacles. All extension cords should be the three-wire type designed to fit the polarized
receptacles. In most operations OSHA laws may require a lock-out/tag-out program to

be implemented to prevent unexpected energization or start-up of the machines or equip-
ment or release of stored energy.
B. Noise
Noise has been recognized as one of several causes of deafness. Employers should perform
noise monitoring as required by law to determine if employees are being exposed to an
8-hr time-weighted level of 85 decibels or more. If so, a hearing conservation program
should be implemented and personal protective equipment should be provided.
C. Pneumatic Stuffers
Pneumatic stuffers have enough wall thickness to withstand normal stuffing pressure.
Older stuffers are sometimes reamed or honed as interior walls become pitted or irregular.
State and federal laws require annual inspection of such devices to prevent explosion of
the stuffers.
D. Retorts
Hot water circulation lines should be periodically checked for hammering problems and
to determine the loss of wall thickness. All retort attachments should be periodically in-
spected for wear or cracking. Accumulation of water in insulated retorts will cause early
deterioration of the lower metal portions.
E. Boiler Feedwater
Boiler care and maintenance procedures will vary with size and type of installation. Be-
cause water treatment chemicals are an extremely important consideration in both safety
and life of boilers, qualified inspectors should be used to check the boiler regularly.
F. Conveyors
Conveyors present a special kind of hazard. Many conveyors are installed to transfer
products from one place to another or from a live to a dead roller section. Guarding of
the nip point of the rollers on the conveyors is necessary. It is also required by law to
safeguard conveyors. All conveyors should be equipped with covers or electronically inter-
locking devices to prevent injury to workers’ hands.
G. Lifts and Hoists

Movement of material by lifts, hoists, and cranes requires careful safety scrutiny. Hoisting
apparatus has been used sparingly in the meat industry. Most hoisting equipment found
in the market conform with ANSI standards. Some common causes of breakdown of hoists
are overloading, improvised or makeshift slinging, and using the wrong type cables for
the size lifted. It is important to select the correct chain for the job. Most new chains have
built-in safety and have a breaking point several times greater than the work load limits.
Frequent inspection and replacement of nonfunctioning parts could make a difference in
preventing accidents.

X. SOME CHEMICAL HAZARDS ENCOUNTERED
AT THE WORKPLACE
All chemical hazards are covered under 29 CFR 1910.1200, Hazard Communication Stan-
dard, and the employer is required by law to educate employees on the health and physical
hazards of the chemicals they use at their workplace.
A. Anhydrous Ammonia
Anhydrous ammonia is used as a refrigerant because of its efficiency in absorbing heat,
its economy, and its plentiful supply. Anhydrous ammonia has a powerful corrosive action
on tissue. One can smell odor starting at 20 parts per million (ppm). At 40 ppm a few
individuals could suffer slight eye irritation. At 100 ppm noticeable eye and upper respira-
tory tract irritation may occur. At 700 ppm severe eye irritation may occur. At 5000 ppm
serious edema, strangulation, and asphyxia may occur.
B. Hydrogen Sulfide
Hydrogen sulfide gas frequently accumulates in grease interceptor basins or in places
where there are large surface areas of low grade fats. Locations where this gas may accu-
mulate should have good ventilation.
C. Liquid Petroleum Gas

Liquid petroleum (LP) torches are frequently used in the meat industry. One great hazard
of LP gases is that they are heavier than air and tend to pocket or cloud. A source of
ignition will produce a serious explosion from a leaking container. All LP gases should
be stored in a well-ventilated place.
D. Methane
Sewer gas or methane gas frequently accumulates in manholes. Therefore, before entering
such confined spaces one should follow proper procedures to check for atmospheric haz-
ards. Title 29 CFR Section 1910.146 covers the requirements of entering a confined space.
E. Carbon Dioxide
Carbon dioxide (CO2) tends to accumulate at low levels and at the bottoms of enclosures
such as pits, silos, tanks, and the like. It is sometimes used in the packing industry for
immobilizing animals and for quick-freezing or cooling fresh meats. Adequately ventilated
areas will disperse the gas and prevent accumulation.
F. Carbon Monoxide
Carbon monoxide (CO) is a colorless, tasteless, and odorless gas, slightly lighter than air.
It is formed by incomplete combustion of organic materials. Exposure of approximately
200 ppm will result in headache and nausea. Overexposure could result in death.
G. Nitrogen
Nitrogen is a colorless, odorless, and tasteless gas. Nitrogen is frequently used for gas-
flushing certain packaged products to exclude oxygen. Adequate ventilation should be
provided when this gas is used.
H. Plastic Fumes
Fumes are generated when flexible plastic fumes used in packing are heat-sealed. The
fumes tend to accumulate in the immediate vicinity of heat elements. The fumes contain
methylethyl ketone (MEK), toluene, propylacetate, or other solvents. Both MEK and tolu-
ene are known cancer-causing agents. These fumes are irritating to eyes and mucous mem-
branes, and in high concentration can cause headache and drowsiness. Proper venting
should be employed at the sealing area.
XI. CONCLUSION
There are many hazards at the workplace. Some topics, such as ergonomics and workplace
violence, do not have a specific standard. Those hazards, however, are covered under
Section (5)(a)(1), the general duties clause. Currently, there are only limited numbers of
federal and state OSHA inspectors and certainly not enough to cover inspection of each
and every workplace. In real-life situations, many different factors contribute to an unsafe
work place or to a safer workplace. Safety is not the safety officer’s sole responsibility.
Everyone in the company, from the president to each employee, is responsible to partici-
pate and contribute to make the workplace safer for everyone. Keeping everyone safe at
work will preserve America’s most important asset—its people—and keep America’s
working force in a position of world leadership.
REFERENCES
1. Public law 91-596, Occupational Safety and Health Act of 1970.
2. Title 29, Code of Federal Regulations, Part 1910. Occupational Safety and Health Standard for
General Industry, Washington, DC: U.S. Government Printing Office.
3. OSHA. Publication OSHA 2098 (revised).
4. OSHA. Accessed at www.osha.gov.
5. U.S. Federal Register, Vol 37, no 202, October 18, 1972, p 22292.

16
Worker Training in Sanitation and
Personal Safety
TIN SHING CHAO

I. INTRODUCTION
Marjorie Davison, a Food and Drug Administration (FDA) Food Safety Initiative educa-
tion team leader, has said ‘‘The business of food safety education is to persuade or con-
vince someone to change unsafe food handling behavior.’’ She also said ‘‘Not only must
we provide people with information we must do it in a manner that results in changing
unsafe food handling behaviors to safe food handling behaviors. Constant reinforcement
of education messages is important to sustaining behavior change’’ [1]. A company-imple-
mented program’s, e.g., food sanitation or safety program, success depends upon the in-
formed participation of two elements of the employed personnel: (1) production workers
who have been properly oriented to their jobs and trained sufficiently until they have
established the correct work habits of proper sanitary procedures and (2) Supervisors, who
should also lead by example because they need to inspire their workers in following the
company’s established policy.
II. EMPLOYEE RIGHTS

Employees have rights which must be considered. In fact, some food processing plants
develop operating goals to ensure that management efforts reflect employee rights and
concerns as operating decisions are made. Federal and state laws are frequently updated
to specify more clearly the legal rights of employees. Labor laws cover minimum wage,
overtime hours, hiring practices, and many other issues in the area of employment manage-
ment. Managers must not violate such employee rights when they pursue productivity and
other operating goals. It may well be that federal, state, and local labor regulations will
continue to increase and managers will need to further improve their employee manage-
ment skills.
Employees want to ‘‘feel good’’ about themselves. Many feel that they have a right
to be trained for the job and, upon satisfactory completion, to be treated like professionals.
Employees do benefit from training. Effective training methods, coupled with reasonable
policies and procedures, written job requirements, and similar tools of employee manage-
ment go a long way in ensuring fair treatment and affording extra protection to both
employee and employer.
Today’s workforce may be better educated than ever before, but education has not
replaced the need for training in the food processing industry. In the future, workers may
be even better educated than they are today. Training will still be essential. The rapid
growth of technology seems to make it impossible to provide the level of education and
training the workforce of the future will need. Managers of today and tomorrow need to
strengthen their professionalism. This need may be more significant than ever for the
manager who is determined to survive and succeed [2].
III. TRAINING AND COACHING

Training can be defined as the process of acquiring and developing skills, knowledge, and
attitudes through instructional activities. It is usually distinguished from education in that
education is defined as learning that contributes to total life growth, while training is
limited to acquiring or developing competencies that meet specific needs. However, such
distinctions can be left to philosophical and academic discussions. Training will be viewed
in this chapter as any activity that results in learning. The effectiveness of training will
be measured by improved performance of the learner. This means that if knowledge, skills,
and attitudes have not been improved, then nothing was learned or what was learned was of
little value. If, on the other hand, the acquired knowledge does improve skills, strengthen
knowledge, and develop desirable attitudes, then the training will be considered effective.
Training, is performance based, utilizing the learning process to achieve improved
employee performance. Training might occur for reasons other than to improve job perfor-
mance. Training will be focused on achieving goals that are believed to be attainable
through improved performance.
Coaching can be defined as the constant reinforcement of learning that was acquired
through training. Coaching is what a manager or fellow employee says or does to encour-
age an employee to perform according to standards specified in the training. Through a
training system, an employee learns how and why to perform in a specified manner.
Through a coaching system, that same employee is challenged, encouraged, motivated,
and reinforced to carry out what was learned. Coaching is usually done at work stations
and often deals with a single skill. The objective of the manager or employee who is
coaching is to make suggestions or reinforce performance that will result in improvement
of a skill or work activity.
A manager who learns to coach is concerned about positive human relations. Coach-
ing is a supportive technique which is designed to encourage employees. Every employee
needs moral support to feel that the work being performed is really meaningful. Coaching
is a means of communicating that support. Employees never lose the need for feedback
about their performance. Even though they have performed the same task correctly for
many years, they will want to hear managers and coworkers express approval of their
work. On the other hand, bad habits could be developed in time as the employee knows
the job better. If a normal training session is conducted, the deficiency in performance
may be exposed to others and the experienced employees may lose face.
Training and coaching are basically line functions. That is, they are the responsibility
of the managers who actually supervise the employees in the operations phase of the
production process. Employees look to their supervisors on a daily basis for the standards
of how to perform their jobs. They need coaching and feedback to feel that their work is
important. While many companies have training personnel who are staff specialists, their
primary role should be to support line managers and to assist them in accomplishing the
line responsibilities of training and coaching [2].
IV. BENEFITS OF TRAINING

Training benefits the consumer, employees, and management. An organization that is train-
ing its personnel is constantly growing. There is excitement about the personal growth of
everyone involved, and that excitement may become the basis for high morale and motiva-
tion. There are many benefits of training.
A. Cost Savings
When training is well planned and carried out systematically, performance should improve
and cost savings can be realized. Training can contribute to reduced labor costs if it dis-
courages turnover and increases productivity. Employees tend to remain in jobs where
they are learning and growing.
B. Efficiency
When an employee knows the job and performs it efficiently, managers will find they
have more time for planning and other management responsibilities. If the staff is incompe-
tent, much of management’s time will be spent in close, direct supervision and in checking
the work performed by employees. When employees have been trained to function as a
skilled team, they will monitor their own performance and will accomplish their work,
freeing management for other activities.
C. Reduction of Stress, Turnover, and Absenteeism

Employees become frustrated when they have difficulty performing their jobs. Such frus-
trations lead to job stress, which may show up in several ways. Employees experiencing
job-induced stress may exhibit poor attitudes toward management and coworkers. They
may be careless, which causes sloppy work, increases chances of an accident, and increases
flagrant violations of work rules. As the situation continues, tardiness and absenteeism
often become a pattern. This creates scheduling difficulties and requires close supervision
by management. If the situation is not corrected quickly, employees may resign or might
need to be released. Turnover can be a major source of higher than necessary labor costs.
Good training should reduce turnover because it reduces job stress.
D. Job Advancement
Some employees may be motivated by an opportunity for job advancement. Within a
company there should be an opportunity for advancement and to show how training will
help prepare employees for promotions. When upward advancement is limited because
of the size of the operation, managers can show employees how they can advance laterally
by cross-training. Generally, the more each employee knows how to do, the more produc-
tive the entire staff will be.
E. Safety and Sanitation Awareness

Training can overcome many safety and sanitation problems that result from uninformed
or misinformed employees. Effective training experience leads to increased safety and
sanitation awareness and improved safety and sanitation procedures.
F. Improved Relationships
When managers spend the time and money to provide systematic training activities, they
are making an investment in their employees as well as in their own success. Also many
staff members will appreciate management for providing them the opportunity to grow.
Therefore, in developing and implementing a training session, management also learns
something in the process. This mutual growth is the basis for an improved management–
employee relationship. Both are striving toward common performance goals, and each
party benefits [2].
V. PROBLEMS IN TRAINING
A. Lack of Commitment
Perhaps the greatest obstacle to effective training in any company is the lack of manage-
ment commitment to training. Many organizations, large and small, do not budget any
money for training and only give lip service to its importance. Whenever profits decline,
the few dollars that may be allocated for employee training are among the first expenses
eliminated from the budget. Unfortunately many companies do not demonstrate a belief
that training is a cost-effective venture.
The lack of management commitment is understandable in many cases, because the
training that managers themselves received has never been planned and executed. The
emphasis has been on ‘‘time in training’’ rather than ‘‘mastery of competencies.’’ Just
sitting in a classroom for a certain length of time does not guarantee that training is taking
place. When training is designed to achieve performance-based results, it can be effective;
a proper return on the training investment will be realized.
B. Lack of Know-How
Another hindrance to training is lack of know-how within many organizations. Every year,
there are people without prior experience or training entering the food industry as invest-
ors, owners, and operators. These individuals have, in many cases, experienced great suc-
cess because of the overall growth of the industry; however, they often have great difficulty
in establishing realistic standards for their operations. Individuals with formal training and
experience in the food industry often join these organizations and help fill this void. Lack
of know-how can, of course, result in lack of standards and low productivity within an
organization.
C. Lack of Resources
Along with lack of know-how, training may be hindered by an apparent lack of resources.
Organizations that have clear standards generally develop good company manuals and
operating procedures. These become the basis for designing training programs. On the
other hand, organizations that lack know-how often have no manual or operating proce-
dures. If managers cannot agree on how the jobs should ideally be performed, management
will likely avoid writing procedures. In their absence, training, when attempted, often
becomes a futile effort.
There are many good training resources available to managers interested in devel-
oping and implementing training activities. These materials can be purchased and adopted
for use within the organization. As time passes, experience and trial and error will refine
the adaptations and provide the basis for tailor-made manuals and other company mate-
rials.
D. Employee Resistance
Employees may resist training and make it difficult to attain performance levels that meet
standards. This is likely to happen when training is poorly presented. Likewise, when
trainees are embarrassed, feel ridiculed, or fear the loss of jobs, a resistance to training
may be encountered. Employees are usually adults, and they expect to be treated as adults.
Adults require clear logic and some self-direction to be receptive to learning. It is important
to develop training techniques that take adult needs into consideration. Training that is
designed to consider the employees’ needs along with those of management is likely to
be readily accepted and welcomed.
E. Disorganization
Finally, training will not be fully effective if it is poorly organized. When inadequate
planning leads to operating problems and management institutes a ‘‘crash’’ training effort,
such attempts are frequently too little too late. Employees recognize the disorganization;
they may lose interest and are not likely to take the training seriously. Training, to be
fully effective, must be planned and executed on a systemic basis. This includes beginning
training for new employees, continuing training for existing employees, and regular coach-
ing for all employees [2].
VI. WHEN TRAINING WON’T WORK

Not all performance problems can be corrected through training and coaching. Sometimes
employees are fully aware of ways to perform their jobs but still fail to deliver that perfor-
mance. Retraining is not the answer to this situation. On a one-to-one basis, coaching
stands a somewhat better chance of getting results, but there may be other factors involved.
Sometimes there are barriers to performance that make all training and coaching ineffec-
tive. Therefore, managers must analyze the cause of poor performance to determine
whether training will be helpful.
Two common causes of poor performance by trained employees are inadequate
equipment to do the job the way they were taught and the lack of freedom to perform the
job without supervisory harassment. While it is essential to train employees, it is equally
important to provide them with all the equipment and materials they need to carry out their
work. They also need enough freedom to demonstrate that management has confidence in
their ability to perform.
There may be other causes of poor performance. When a performance problem is
identified, the real cause should be determined so that a solution can be implemented.
Training is only one alternative. Management must develop and accept standards which
management and employees can live with and employees can achieve.
Employee attitude can also cause training to fail. Some people have no regard for
standards set by others. When possible, these individuals should be identified during the
selection process and should be eliminated from further considerations; however, manag-
ers inherit such employees when they accept a position in an establishment where a previ-
ous manager has done an ineffective job of selection and training. In such cases, the
manager must attempt to change attitudes or remove these employees from the group in
order for group training and coaching to be effective [2].
VII. STAFF TRAINING

Basic staff training is very important to staff development and should be a well-defined
process. The training process can be divided into three phases. The first phase provides
an orientation to the program. This initial phase includes a review of program history,
structure, relationship to other programs, and statutory requirements. Specific emphasis
should be on the program’s goals and objectives. A structured approach is beneficial for
the workers to be familiarized with the company’s requirements and how everyone could
contribute to compliance of codes and requirements of federal and state laws. A basic
knowledge on terms and industry jargon could also help workers fit into the work environ-
ment smoothly and confidently. For example, in the sanitation program, it would be a
good idea to review the epidemiology of foodborne illness, including organisms, foods,
and contributing factors and case studies. Basic food microbiology, including the effects
of temperature, pH, water activity, and other hurdles and barriers to the survival and
growth of foodborne pathogens, are appropriate subjects. Scientific journal articles in the
field of food microbiology, food technology, and hazard analysis and critical control point
(HACCP) procedures should be made available to employees.
The next phase of training should be on-the-job-training or actual application. Em-
ployees can put the theories and education into work practices. Whatever was taught to
the employees they shall apply during real-world situations. The real test of knowledge
is knowing what to do when things actually happen. Supervisors should also observe and
evaluate employees on how well they follow the established procedures. Either a planned
or a surprise inspection would be a good tool to evaluate and to help identify the need
for retraining. Observation and measurements should be recorded in an unobtrusive man-
ner during the entire food cycle or operations and communicated to employees when the
evaluation is done.
The final phase of training is never finished. The standardization or retraining pro-
cess should be repeated on an annual basis. The company should establish continuing
education programs to keep staff current with the changing world and the latest informa-
tion and technology pertaining to its program. Management level employees are encour-
aged to join professional associations and organizations of their trade and to network with
other professionals.

VIII. SANITATION TRAINING IN THE WORKPLACE
A sanitation program should be planned and organized and treated as a part of the produc-
tion process. It is essential for a product produced in a processing plant to be free of
insect and rodent infestation as well as free of extraneous material and bacterial or other
contamination. Sanitation should be described as a way of life. It is a matter of living in
a clean manner. It affects all people everywhere. Sanitation as applied to food industries
is the way people work and live at the plant and involves such things as (1) personal
hygiene, (2) respect for the food and materials produced, (3) good appearance during
operations, (4) soundness of equipment and structure of the building, and (5) adequate
pest control.
There are two overall methods of maintaining sanitation: corrective and preventa-
tive.
Corrective maintenance of sanitation eliminates or diminishes undesirable situations
only when the condition has been discovered. For example, one method of controlling
rodents would be to wait until a mouse population is found to be flourishing in a storage
room and then carrying out the necessary steps to eliminate the rodents or lessen their
numbers.
The other and far superior method is to take preventative measures. This means a
program is set up to prevent undesirable situations from occurring and to maintain the
establishment in such a way that is not likely that such situations will occur. Preventative
sanitation is the way of life in food processing plants. It is understood that difficulties are
anticipated, but with everyone’s involvement all problems can be solved.
Preventative sanitation is based on the recognition that at least 80% of the job is
good housekeeping. The remaining 20% is an effective pest control program. The success
of an organized sanitation program depends on the participation of all plant personnel,
with a strong management leadership team spearheading the program. Training is also a
key element for such a program to be successful. All supervisory personnel should share
the responsibility of stimulating the interest of workers under them. Posters and bulletins
are often a helpful reminder to their employees to practice sanitation procedures. Individ-
ual desire to work in a clean environment is also important for a program to be successful.
Peer influence can be a very powerful tool for an employee to practice good sanitation.
Individual instruction as on-the-job training will always remain another method in correct-
ing unsatisfactory conditions.
Like a chain, effective sanitation is only as strong as its weakest link. There is no
magic formula or product. Sanitation is a way of life, not just to be practiced but to be
lived. Like weeds in a garden, it requires constant attention. Remember that microbes are
for the most part plant life and are subject to many of the same physical effects as higher
plants.
A good sanitation program can be either an offensive or defensive measure. Used
offensively, it can result in better quality products with corresponding economic benefits.
If used only defensively, it becomes simply another costly part of the company’s overhead.
IX. SAFETY TRAINING IN THE WORKPLACE

Safety in the workplace, specifically safety in food processing plants, was brought into
the public’s eye in September of 1991. Right after the Labor Day holiday a fire broke

out in the Imperial Food Products plant in Hamlet, North Carolina, killing 25 people
and hospitalizing 56 people. The plant was producing chicken nuggets and marinated
chicken breasts for fast-food and grocery sales. The fire began with a rupture in the hy-
draulic line powering a conveyor belt that carried chicken parts to the deep-fat fryer. The
fryer burst into flame when the hydraulic fluid and its vapor came into contact with the
hot oil.
What made this tragedy even more terrible was that plant workers were unable to
escape. At least two fire doors were padlocked and another was blocked by a delivery
truck [3,4]. In the aftermath of the fire, 83 additional violations were discovered. Among
these were a sprinkler system which apparently did not work, locked exits, inadequate
lighting, and unmarked exits. Imperial Food Products owners have been fined $808,150 for
these and other violations by the State of North Carolina Labor Commissioner. Criminal
indictments were handed down in March 1992 against two owners and the plant’s man-
ager. Imperial has also closed its other plants and disconnected telephones at its headquar-
ters [5].
This was obviously a tragedy of monumental proportions, especially in a small town.
Legally the fault lies with management. They were the ones responsible for operating a
safe plant as required by Occupational Safety and Health Administration (OSHA) laws.
They failed to do so, and they paid for the failure.
Investigation also revealed that some blame must also be placed on the workforce,
including several of those who paid with their lives as a result of the accident. Interviews
with survivors indicated the doors were routinely locked to prevent workers from stealing
chickens [6].
At this point we wish to focus on the concept that safety is everyone’s responsibility.
Management is ultimately responsible, but each worker must contribute to assuring that
the workplace is safe. How does a company go about assuring the safety of its employees?
There are certain points basic to workers safety. These happen to be very similar to those
that apply to food safety, plant sanitation, and other operations. They include (1) manage-
ment commitment to providing a safe workplace; (2) education of management and staff;
(3) safe plant design and maintenance; (4) proper equipment design and maintenance; (5)
knowledge of and adherence to federal, state, and local safety regulations; (6) evacuation
plans with posted warnings and directions; (7) monitoring to assure compliance; (8) main-
tenance of records of inspections and upkeep; and (9) a commitment by all personnel in
a workplace to maintain a safe work environment.
Another reason for maintaining a safe work environment, other than being a require-
ment of OSHA law, is liability. Each time there is an on-the-job injury, the company’s
insurance takes care of it. With each injury there is a potential for a rate increase. The
insurance industry calls it ‘‘experience modification rate.’’ The experience modification
rate is used to determine one’s insurance premiums. Take, for example, two companies
with the same number of employees; one has a bad record with many injuries and may
be put into a high risk pool by its insurance company and pay higher premiums. The other
company, with a low experience modification rate, might pay half or one-third of what
the high risk company is paying. It is a huge difference in terms of actual dollars. This
money saved could be used to implement a comprehensive safety and health program for
the establishment. Employees will be happier working in a safe environment; production
may increase and thus profits will rise. Employees might get a year end bonus from the
company. Mutual benefits exist for both the company and its employees.

A. Management Commitment
Everything starts from the top. If management is behind something and committed to it,
that program has a very good chance of succeeding.
B. Education
All supervisory staff and workers must be given a basic class in worker safety. This pro-
gram should include plant safety rules, specific requirements for specific work areas, and
safety regulations required by federal, state, and local ordinance. Also included should
be first-aid instructions, what to do in case of a fire or a disaster, and both manager and
worker responsibilities for their own safety and for others.
C. Safe Plant Design and Maintenance

The work environment contributes to a person’s attitude about safety. A plant that is
designed so that it is difficult to maintain or get around in will be more prone to problems.
This may not be so much of a problem for newly designed plants, but the old ones can
be nightmares.
There should be easy access through work areas, easily identifiable accessible exits
with lighted signs, good lighting, floors and walls that are easily cleanable, floors that are
nonskid, and safety walkways to avoid confrontation with moving carts or other equip-
ment.
D. Equipment Design and Maintenance

Equipment should be designed and maintained so that it is safe and operates properly.
Each unit should be checked regularly. A safety inspection is essential to identify problems
and deficiencies in the plant. Most items that fail usually show some indicative sign of
impending failure. Workers who work with the equipment daily should be trained to recog-
nize such signs, but the company should not depend on employees as primary persons to
identify such problem or deficiencies. The employer is responsible as required by OSHA
laws.
E. Knowledge of Adherence to Federal, State, and Local Safety

Regulations
Employees have the right to know about the laws governing their workplace and their
industry. It is the management’s responsibility to carry out the requirements of the law.
Most of the time these laws are the basis of establishing certain programs in a plant. After
establishing a written program, a company must implement such a program to assure
compliance with the regulations. A perfectly written program will bring a company no
good if it is not implemented to its fullest. Not knowing what is required is no excuse in
a court of law.
F. Evacuation Plan and Posting of Appropriate Warning and

Directions
Every establishment must have an evacuation plan and must communicate such plan to
each employee before they start to work. Regulations also require that a large number of

operations be marked. Areas where food and toxic materials are stored must be in separate
locations and marked with clear signs. Each separate container must also be marked. Dan-
ger signs should be posted on equipment. Color or date coding to identify certain processes
could also be used for a specific process. Exits should be marked with signs which can
lighted in case of power failure. Handling protocols for substances need to be developed
for each job. Job hazard analysis for each job needs to be prepared. Personal protective
equipment appropriate for such hazard needs are provided to employees who perform
such jobs.
G. Monitoring to Assure Compliance

A safety committee should be established with members from management and employee
representatives whose task it is to monitor safety concerns. A periodic inspection is re-
quired by OSHA laws to identify deficiencies. It is also recommended a company invite
an outside third party to inspect the facilities. Inspectors for OSHA provide consultation
services free to employers; all they need to do is to invite them for a consultation inspec-
tion. If the inspector find violations, you will be notified and be given a reasonable time
to correct such deficiency. The beauty of it is there will not be penalties assessed by the
consultation services as compared to the enforcement division penalties that will be as-
sessed on each inspection, even if it is corrected during an inspection.
H. Maintenance of Records of Inspections and Upkeep

Recordkeeping is essential in any operation, especially in a food plant. Without records,
problem solving is hamstrung, performance histories of equipment are unknown, and
maintenance and replacement of parts or equipment can be compromised. Records of
inspection could also be used to analyze the trends of injury and illness in a workplace
and to identify deficiencies or the need to retrain employees in certain processes. The
Occupational Safety and Health Administration has strict recordkeeping requirements;
certain medical records are required to be kept for the duration of employment plus thirty
years.
I. Commitment from All Personnel

Safety is everyone’s business. Each line worker is responsible for maintaining a safe work
area for oneself and for others. This also includes maintaining a work condition that is
not hazardous to oneself or others. Some companies have drug and alcohol testing prior
to appointment. If a worker were to come to work intoxicated, he or she would be a
menace to the workplace. Worker safety is crucial to operating a food processing plant.
A safe workplace could also cut down stress, turnover, and absenteeism. Management
can show their commitment to safety by going beyond the laws and trying to anticipate
anything that might go wrong. With commitment from both management and workers a
safety program can go a long way [7].
X. CONCLUSION
Safety and sanitation programs are essential elements for a company to survive. A com-
pany that cares for its employees and complies with federal, state, and local laws and
regulations will be more likely to be profitable than those who have high turnover rates
and high injury rates. Making safety and sanitation practices a way of life in a company
is not easy. After carefully selecting your employees, management should start by being
an example to employees and make good habits a norm for the company. With initial and
continued retraining, reenforced by rewards and peer coaching, a company surely aims
toward success. Employees who work at such an establishment can be proud of themselves
as part of this process that produces an exceptional product for consumers.
REFERENCES
1. Food and Drug Administration. Accessed at www.fda.gov.
2. LC Forrest Jr. Training for the Hospitality Industry. American Hotel and Motel Associations,
1983.
3. Chronicle Wire Services. Fire, locked doors trap plant’s workers—25 die. San Francisco Chron-
icle, Sept 4, 1991.
4. Associated Press. At least two exit doors were locked in plant fire. San Francisco Chronicle,
Sept 5, 1991.
5. Associated Press. Chicken plant fined in fire that killed 25. San Francisco Chronicle, Dec 31,
1991.
6. SB Garland. What a way to watch out for workers. Business Week, Sept 23, 1991.
7. RF Stier, MM Blumenthal. Safety in the processing plant. Baking and Snack, April, 1992.

17
Worker Safety and Types of Food
Establishments
PEGGY STANFIELD
I. STANDARD INDUSTRIAL CLASSIFICATION OF FOOD

ESTABLISHMENTS
Food and kindred products may be classified according to the Occupational Safety and
Health Administration’s (OSHA) ‘‘Standard Industrial Classification Manual’’ (SIC Man-
ual). This manual is revised periodically by supplements. Since the introduction of the
Internet, the use of this manual has increased tremendously. In this manual, food and
kindred products are placed under major group 20. This major group includes establish-
ments manufacturing or processing foods and beverages for human consumption and cer-
tain related products, such as manufactured ice, chewing gum, vegetable and animal fats
and oils, and prepared feeds for animals and fowls. Table 1 describes the industrial estab-
lishments according to categories of food and kindred products, and the group number
for each category is also given. Table 2 describes food establishment categories, opera-
tions, and product examples.
II. POTENTIAL OCCUPATIONAL HAZARDS IN A FOOD

PROCESSING PLANT
The potential hazards associated with the manufacturing processes in the nearly 50 subdi-
visions of food and kindred products are primarily safety hazards (see Table 3). The fol-
lowing safety hazards are generally common to all the processes:
1. Extensive manual handling of feed and in-process materials and of finished

products
Table 1 Classification of Industrial Establishments According to
Categories of Food and Kindred Products
Group
number Establishments of manufacturing or processing
201 Meat products
202 Dairy products
203 Canned and preserved fruits and vegetables
204 Grain mill products
205 Bakery products
206 Sugar and confectionery products
207 Fats and oils
208 Beverages
209 a Miscellaneous food preparations and kindred products
a
This group includes canned and cured fish and seafoods, fresh or frozen packaged
fish and seafood, roasted coffee, manufactured ice, macaroni, spaghetti, vermicelli
and noodles, and food preparations not elsewhere classified. This category includes
baking powder, yeast, and other leavening compounds; chocolate and cocoa prod-
ucts, except confectionery, made from purchased materials; peanut butter, pack-
aged tea (including instant); ground spices; potato, corn, and other chips; and vine-
gar and cider. There are others.
2. Extensive exposure to slippery floors and supports

3. Extensive use of sharp implements such as cutting hand tools, saws, and knives
4. Exposures to microorganisms, chemicals, allergens, viruses, molds, and dusts
on substances in the feed materials
5. Seasonal operating schedules, reflecting time of harvesting that influence safety
training effectiveness
Specifically, particularly high rates are associated with the meat processing, food preserva-
tion, sugar and confectionery, fat and oil recovery, and beverage processes. In general,
average rates are associated with the dairy, grain mill, and bakery processes.
The high injury and illness rates in the meat processing and fat and oil recovery
processes appear to result primarily from hazards associated with cutting and hand tools,
slippery floor conditions, and batch handling. There is little specific information that ex-
plains the elevated rates associated with the food preservation and sugar and confection
processes, but the seasonal schedules and temporary, untrained workforces employed to
meet harvest requirements are important factors. In the beet and cane sugar industry, contu-
sions and bruises to hands and feet, especially to maintenance workers, are a frequent
cause of injury; scalds from hot water are considered to be another important factor. The
foremost potential hazards associated with the beverage processes, particularly the bottled
and canned soft drink processes, are body strains and sprains arising from the manual
handling of the products.
Outbreaks of diseases of bacterial origin in meat processing facilities appear to be
foremost among the reported non–safety-related potential health problems associated with
that industry. Reports of brucellosis and skin sepsis in slaughtering and rendering plants,
psittacosis in a turkey processing plant, and antibodies to Escherichia coli enterotoxin in
beef and swine meat-packing workers were encountered. Respiratory illness resulting from
Table 2 Food Establishment Categories, Operations, and Product Examples
Food
establishments Operations product examples Product examples
Packing houses Slaughtering Dressed meat and fowl
(201) Dressing Meat products
Packing Processed meat
Processing
Dairies and cream- Churning Fluid milk
eries (202) Cheesemaking Butter
Condensing Cheeses
Freezing Evaporated milk
Ice cream
Canneries and pre- Canning Canned fruit and vegetables
serving (203) Drying Dried products
Pickling Pickled products
Freezing Frozen products
Grain mills (204) Flour milling Wheat, corn, and rye flour
Corn meal Corn products
Rice milling Rice
Wet corn milling
Prepared foods Prepared foods
Bakeries (205) Baking Bread
‘‘Dry’’ baking Cookies
Crackers
Sugar refineries and Extracting, concentrating, and crystalliz- Cane and beet sugars
confectioneries ing cane and beet sugar Molasses
(206) Processing confectioneries Syrup
Candies
Chewing gum
Fat and oil (207) Extracting vegetable oils and animal Vegetable oils
oils by pressing, heating and solution Animal and fish oils
Hydrogenating Shortening
Margarine
Edible oils
Beverages (208) Alcoholic: Beer, wine, and spirits
Brewing
Fermenting
Distilling
Nonalcoholic: Bottled and canned soft drinks
Extracting
Carbonating Carbonated drinks
Canning
Miscellaneous pre- Cooking Canned and frozen seafoods
pared foods Canning Roasted coffee
(209) Drying Noodles
Curing Macaroni
Roasting Ice
Ice making

Table 3 Food Processes, Safety Hazards and Controls
Controls process Occupational condition Potential hazard Control

Meat processing (201) Handling live, immobile, and slaugh- Strains, contusions Mechanization, training
tered animals
Cutting and use of sharp tools Lacerations, loss of body members Protective clothing, gloves, guards,
training
Wet flooring, platforms, decks Falls, sprains Drains, shields
Steam Burns, scalds Shields, reliefs
Animal-borne microorganisms Brucellosis, dermatitis Inspection
Dairy processes (202) Handling churns, homogenizers, plasti- Lacerations, contusions, etc., from Guards, shields, layout, clothing, insu-
cizers, evaporators, freezers moving machine parts lation
Handling in-process materials, prod- Strains and contusions Mechanization, training
ucts
Food preservation processes Cleaning, cutting, screening, peeling Lacerations, bruises, pinches in op- Guards, shields, clothing, layout, train-
(203) raw fruit and vegetables erating and maintaining the tools ing
and machines
Blanching, cooking, pasteurizing, cur- Burns, scalds, extreme temperatures Insulation, shields
ing, freezing products
Storing, packaging, shipping Cuts, bruises from packaging ma- Guards, gloves, shields, mechani-
chines, sprains zation
Grain mill processes (204) Operating and servicing breaking Bruises, contusions, pinches, lacera- Guards, varriers, training
rolls, sieves, conveying and elevat- tions, falls
ing equipment, manlifts
Handling feed, in-process material Body strains Mechanization, training
products
Dust, noise, vibration Respiratory and hearing effects Ventilation, insulation

Bakery processes (205) Mixing, kneading, and forming Injuries from moving parts Guards, shields, layout
machinery/conveyors
Baking ovens Burns, hot working environments Insulation, clothing, air conditioning
Handling in-process materials, prod- Strains Mechanization, training
ucts
Sugar and confectionery pro- Cleaning, grinding, shredding, and ex- Lacerations, contusions from moving Guards, protective clothing, layout,
cesses (206) traction machinery machine parts ventilation, drains, overflows
Purifiers and chemicals Lime, sulfur dioxide, chlorine dioxide, Controls, ventilation
formaldehyde
Concentrators, crystallizers Burns, spills, leaks Overflows, drains
Centrifuges, filters, dryers under op- Lacerations, contusions, burns Controls, maintenance, insulation-
erating and maintenance conditions sizing
Fat and oil recovery pro- Extracting oil and fat from animal and Burns and scalds from steam and li- Insulation, barriers, layout, controls
cesses (207) vegetable processes by steam dis- quor leaks, spills; breaks and leaks against overloads, spills, ventilation
tillation, mechanical expression, sol- from presses; vapors and gases and monitoring
vent extraction from extractors
Cleaning, grinding, shredding feeds Machine injuries Guards, training
Purification, hydrogenation processing Chemical effects Ventilation
Beverages (208) Handling in-process materials Body straining from lifting Increasing mechanization, training
Broken glass Lacerations Protective clothing, gloves

exposure to polyvinyl chloride pyrolysis fumes is a potential health hazard for meat wrap-
pers.
Brucellosis is an acute or subacute infectious disease with variable manifestations.
It is characterized by attacks of irregular fever, chills, sweating, and pain in muscles and
joints, which may last for months. The disease shows remissions and although relapses
are frequent, brucellosis does produce substantial immunity to reinfection. Because it can
be confused with almost any febrile episode, diagnosis is very difficult unless blood cul-
tures are positive. The Brucella species that are classically infective for man are found in
dairy cattle (Brucellosis abortus), hogs (B. suis), and sheep and goats (B. melitensis).
Each of these species may occasionally infect the other animals. Brucellae are distributed
throughout the infected animal and may remain viable for 21 days in a refrigerated carcass.
The tissues, blood, placenta and fetus, milk, and urine may be infectious. They may survive
the curing of ham, but are killed by smoking, cooking, and pasteurization. Brucellae may
invade through the eye, nasopharynx, genital tract, and gut, but unbroken skin is resistant.
Contact with swine is the probable source of infection.
An outbreak of psittacosis among workers in a turkey processing plant had been
reported. Cases occurred in employees working in the kill-and-pick, evisceration, and
packaging departments, and inhalation of infectious sprays of poultry blood and other
tissues was considered to be the primary route of infection. The results of the investigation
suggested, however, that workers having both frequent contact with turkey tissues and
skin injuries were more likely to be infected than other processing workers. Psittacosis
is a disease of bacterial origin (Chlamydia psittaci), which usually takes the form of a
pneumonia accompanied by fever, chills, headaches, body aches, cough, and often spleno-
megaly. Respiratory tract illness has been reported in meat wrappers exposed to polyvinyl
chloride (PVC) pyrolysis fumes while working with hot wire cutting machines. From the
data available, it appears that the major emissions from the meat wrapping film are di-2-
ethylhexyladipate and hydrogen chloride. Meat wrapping, however, is usually performed
in the meat departments of retail supermarkets. Respiratory distress has also been reported
in some meat cutters following exposure to heat-activated price labels; emissions from
heated price labels have recently been found to include phthalate anhydride, 2,5-di-tert-
amylquinone, and dicyclohexyl phthalate.
The rates for injury and illness in the industry’s processes are considerably above
the average for U.S. manufacturing and one of the highest in all manufacturing.
Design features that may reduce employee exposure to hazards basically involve
factors that ensure steady and uninterrupted equipment operation, such as sizing, strength,
capacity corrosion, and wear-resistance properties. Overloading, spills breakdowns, and
failures are major causes of potentially hazardous exposures. Engineering controls should
also provide adequate space for easy and safety access to the equipment by production
and maintenance workers and means for sensitive, reliable, and accurate monitoring of
process conditions.
In addition to those basic design controls, engineering controls apply to specific
working conditions. Adequate and reliable ventilating, scrubbing, and monitoring systems
should be provided to ensure good air in working areas. Vents for storage tanks and closed
areas may also be required, as well as comprehensive safety guarding systems for cutting
tools and moving machine parts, and proper electrical grounding. Insulating and isolating
barriers for excessive temperature, noise, or vibration may be appropriate in certain in-
stances. Maintenance tends to increase the potential for hazardous exposures because of
the unusual conditions that may develop and the special procedures that may be involved.
Table 3 describes food processes, safety hazards, and controls.
III. AN EXAMPLE OF WORKER SAFETY IN A BAKERY
ESTABLISHMENT
A. Identification
Industry: bakery products. Subgroup: bread, cake, and related products; cookies and crack-
ers. Standard Industrial Classification: 2051, 2052.
B. Process Description
Bakery goods include bread, cakes, pies, cookies, rolls, crackers, and pastries. Ingredients
consisting of flour, baking powder, sugar, salt, yeast, milk, eggs, cream, butter, lard short-
ening, extracts, jellies, syrups, nuts, artificial coloring, and dried or fresh fruits are blended
in a vertical or horizontal mixer after being brought from storage, measured, weighed,
sifted, and mixed. After mixing, the dough is raised, divided, formed, and proofed. Fruit
or flavored fillings are cooked and poured into dough shells. The final product is then
baked in electric or gas-fired ovens, processed, wrapped, and shipped. Loaves of bread
are also sliced and wrapped.
Figure 1 presents a simple outline of the process flow in this category of food estab-
lishments.
C. Injury Type and Sources

In bakery products, most of the injured employees are struck by or struck against some
object; fall or slip; or are caught in, under, or between objects. The injuries most commonly
encountered are dislocations, sprains, and strains and often involve machines and working
surfaces as sources of injury.
D. Inspection Analysis
When a company officer inspects the bakery establishment for safety concerns, he or she
should do the following analysis. The inspection should begin in the receiving and storage
Figure 1 Process flow for bread, cakes, and related products.

Table 4 OSHA Hazards Analysis
Activities or equipment Location
Major hazards
Amputation and mangled limbs from contact Mechanical power trans- Throughout plant
with gears, shafts, pulleys, belts, chains, and mission apparatus
sprockets
Slipping, tripping, and falling hazards Housekeeping Throughout plant
Amputation and mangled limbs from nip Point of operation Throughout plant
points and sharp blades
Electrocution from inadequate grounding Electrical connections Throughout plant
Burns from hot pipes and hot fat splashes. In- Ovens and open fat ket- Throughout plant
halation of carbon monoxide tles
Other hazards
Broken chain links and pulleys causing mixing Cranes and hoists Mixing areas
bowls to fall on employees
Back strains and pulled muscles Lifting Mixing and bak-
ing areas
Explosion or fire Combustible dusts Storage
areas where bins must be checked for safety ladders of nonsplintering material. Any OSHA
Class II hazardous locations must have approved electrical fixtures. Mixers should then
be checked for interlocks, along with agitator guards, size of openings, and cranes for
moving bowls over 80 lbs. Bread rollers must have in-running rollers guarded, and the
slicing machine must have a device to push the last loaf of bread through and be inter-
locked. Employees must be checked for personal protective equipment at hot fat kettles.
Machines must be grounded and have power transmission guarded throughout. Any hot
water or steam pipe must be guarded, especially in mixing and oven areas. Any conveyor
passing over an aisle must have a lower guard to protect employees passing underneath
baking machinery. Dividers, dough breaks, biscuit and cracker equipment, sugar and spice
pulverizers, cheese and fruit cutters, and dough sheeters shall have guards to protect nip
points and points of operation. Aisles must be clear of all tripping and slipping hazards,
particularly at open fat kettles. High noise areas must be surveyed or referred to an indus-
trial hygienist.
E. Occupational Safety and Health Administration Hazards Analysis

Table 4 presents the types of hazards, their causes, and their occurrence in the bakery
processing plant.
F. Other Pertinent Information

An Industrial hygienist referral must be made for flour dust, which can cause rhinitis,
buccopharyngeal disorders, bronchial asthma, and eye diseases. There is a high incidence
of pulmonary tuberculosis among bakers.
ACKNOWLEDGMENT
Most data in this chapter have been modified with permission from documents prepared
by Science Technology System, West Sacramento, California.
18
Rodent Pest Management
ROBERT M. CORRIGAN
RMC Pest Management Consulting, Richmond, Indiana, U.S.A.
I. INTRODUCTION
Commensal mice and rats are among the most significant of all pests of the food and
food-warehousing industry. Rodents attack foods or food ingredients directly, rendering
such foods contaminated and lost. The presence of feces, hairs, or any other parts of
rodents in, around, or on food, food preparation surfaces, or food containers is also consid-
ered adulteration.
From a legal aspect, the presence of rodents or rodent evidence is a violation of
Section 402(a) of the Food, Drug, and Cosmetic Act. Consequently, some inspection ser-
vices (e.g., American Institute of Baking, Manhattan, KS) have guidelines that may call
for an immediate unsatisfactory audit should even one decomposing rodent be found inside
a trap or bait station [1]. As a result of these strict guidelines, most of the service time
(and thus money) allocated in the food and warehouse industry toward the annual pest
management programs and budgets is spent on purchasing rodent control tools and on
contracted service time required for maintaining rodent control devices [2].
Rodent prevention programs and infestation reduction efforts for food plants should
be designed with a strong emphasis on the integrated pest management (IPM) approach.
Well-designed and implemented IPM programs are especially critical to ensure long-term,
cost-effective food safety.
II. RODENT BIOLOGY OVERVIEW

An in-depth discussion of the biology and behavior of the commensal rodents is not neces-
sary for the purposes of this book. The following discussion presents only an overview

of rodent biology as it applies to food plant rodent pest management. Readers interested
in additional information on rodent biology and behavior should consult the appropriate
references [2–4] at the end of the chapter.
The three principal rodent pests in the United States are (1) the house mouse, Mus
domesticus, or Mus musculus (both names are used for the same species); (2) the Norway
rat, Rattus norvegicus; and (3) the roof or black rat, Rattus rattus. A brief overview of
the pertinent aspects of the biology and behavior of each of these rodents as they relate
to routine food plant operations is given in Table 1.
The house mouse and Norway rat are found in all of the contiguous 50 states, al-
though the Norway rat is absent from some relatively large geographic areas of the West.
The roof rat occupies the coastal areas of Washington, Oregon, and California, as well
as large areas along the Gulf and Atlantic coast from Texas to Maryland. Roof rats are
not established in the midwestern states, although they are delivered there in supplies and
vehicles from time to time. In the states where roof rats do occur, rarely are they found
more than 100 miles inland.
By far, the house mouse is the primary food industry rodent pest because of its
wide distribution, its small size (enabling it to remain undetected inside many objects
and supplies), and its abundance in outdoor areas surrounding commercial and residential
buildings.
Most people are familiar with the ubiquitous house mouse (Fig. 1). It is a nonde-
script, brownish to grayish rodent with relatively large ears and small eyes. The adults
weigh from 0.5–1.0 oz (15–30 g). Newly weaned juveniles may weigh only about 10 g
(mousetraps suitable for their small size are required for effective control). Adult mice
measure between 5.5–7.5 in. (14–19 cm) long, including the 3- to 4-in. (8- to 10-cm)
tail. The house mouse is easily distinguished from the ‘‘field mouse’’ (Peromyscus spp.).
Peromyscus mice are characterized by a bright white pelage on the belly, feet, and the
underside of their furry tails.
The Norway rat is a large, robust rodent; however, its size is often exaggerated by
people who encounter this rat in a dark corner of a warehouse or alleyway (e.g., ‘‘it was
as big as an alley cat’’). Most adults measure about 16 in. (41 cm) in total length from
the nose to the end of the tail and weigh about 12 oz (340 g). Some rats achieve heavier
weights of 16 oz (453 g) or slightly more. The length of the tail is shorter than the body.
The typical pelage color is grayish brown, but it may vary from a pure gray to a blackish
or reddish brown. Because of individual variations in the fur color, rats should not be
identified by color alone.
The roof rat (or black rat) is considerably smaller than the Norway rat, weighing
about 8 oz (226 g) and measuring about 16 in. (41 cm) in total length from its nose to
the end of its tail. Although this is the same total length as the Norway rat, the roof rat’s
tail is longer than the body, a key identifying characteristic. In general appearance, the
roof rat is sleeker than the Norway rat. Roof rats are not always black in color. They may
be wholly black or brown-backed with the belly varying from gray to cream-colored or
white.
Weed seeds, nuts, grains, insects, and various small mammals, birds and aquatic
animals (for rodents living near water) comprise the ‘‘natural’’ foods of rodents living
outside in their natural habitats. Around human dwellings and commercial structures, ro-
dents become opportunistic foragers, adapting to many different types of foods depending
on availability. Rats and mice will consume cereal grains, garbage, insects, meat, fruits
and vegetables, and even manure from pets in suburban backyards.
Table 1 Overview of Biology and Behavior of Rodents as Applicable to Food Plant and Warehouse Infestations
Pups Daily Daily

per Annual Daily food fecal Typical harborage inside or around foraging
Rodent litter litters a consumption pellets food plants range b Important notes
House mouse 5–7 6–8 2–4 g 40–100 Within pallets, hollow walls, suspended 1–10 m Populations build up quickly out of sight and
ceilings, voids of large equipment, in hard to reach areas if food is easily
and among clutter available. Mice established within pallets
are not highly impacted by perimeter wall
traps.
Norway rat 8–12 4–7 15–35 g 25–40 Exterior and interior burrows, beneath 5–30 m Some rats inside food plants and warehouses
slabs, within hollow walls and ceil- exhibit extreme caution and do not interact
ings traps or bait stations.
Roof rat 8–12 4–7 10–25 g 25–40 Aerial rafters and roof areas; tree 5–100 m Some adults may be elusive, responding only
crowns adjacent to roof areas; silo to fruits, nuts, and vegetable types of
tops in structural voids foods. Inspections must be from aerial
sight areas.
a
Assuming a life span of one year.
b
Once established indoors or on the exterior periphery.

Figure 1 The house mouse (Mus domesticus) is the most important rodent pest of the food in-
dustry.
House mice are sporadic feeders, nibbling bits of food, and making as many as 20–
30 short visits to food per night, eating only tiny amounts during each visit. Most adult
mice consume about 3–4 g of food per night. Norway rats tend to get their daily food at
one or two locations, consuming up to 30 g per night. Roof rats are somewhat of a hybrid
in feeding behavior between the mouse and the rat, feeding in smaller amounts at several
locations and consuming up to 20 g of food per night.
Rats require 0.5–1.0 oz (15–30 mL) of water daily (unless feeding on moist or
succulent foods). House mice can survive for long periods without free water [5].
Rodents have impressive capacities for reproduction, especially if they become es-
tablished inside commercial facilities that provide constant warmth, easily obtainable food,
and protection from dangers and disturbance among clutter and junk piles. A food storage
warehouse, for example, that does not have a strict sanitation program, one where pallets
of food are pushed up against walls, allowing for hidden harborages—such a warehouse
is an ideal environment for a rodent population explosion.
For example, in a single year a female mouse produces about 6–8 litters, each litter
averaging 5–7 pups. The pups are born 19–21 days after mating, and they can reach
reproductive maturity in 6–10 weeks. In one study [6] of wild mice in outdoor pens simu-
lating a small number of mice exposed to readily available food and harborage, the new
mouse colony of 28 mice grew to 2000 mice in only 8 months. With these impressive
reproductive capabilities in mind, it should be obvious that no food manufacturer can
afford to be lax on any part of a rodent management program.
Providing they live for a full year and have ready access to food and water, female
Norway and roof rats typically produce about 4–7 litters, averaging 8–12 pups, following a
gestation period of about 3 weeks. Rats reach reproductive maturity between 8–12 weeks.
Both rats and mice have natural life spans ranging from 5 to 12 months. Commensal
rodents living in natural habitats (not in manmade structures) typically live only a few
months, although the dominant individuals may live for up to 1.5 years. Inside heated
structures, the longevity of the rodents depends on resource abundance and availability,
space, and rodent population densities. Thus, much of the success of rodent population
growth inside and around buildings depends on people.
III. RODENT IPM PROGRAMS

The components of a rodent integrated pest management program for food plants include
(1) exclusion, (2) sanitation, and (3) rodent elimination programs via the ‘‘three lines of
defense’’ system.
It cannot be overstated that exclusion and sanitation efforts must comprise the main
thrust of a food plant’s rodent control program. Being mammals, rodents require much
more food, shelter, and water than insects. Thus, rodents can be dramatically affected by
sanitation and pest exclusion efforts that reduce their basic survival elements, and thus
their potential to proliferate. In other words, sanitation is rodent control.
The principles of sanitary practice and hygienic design, including features that ad-
dress pest exclusion, are covered elsewhere in this book. Those chapters should be care-
fully reviewed to ensure a thorough understanding of the role these components play in
pest management operations. Still, a brief overview of exclusion and sanitation as they
specifically apply to rodent threats and pressures associated with food plant environments
is also presented here.
A. Rodent Exclusion
Rodents living outdoors embark on nightly explorations and occasional dispersal journeys.
Either by chance or by following air currents carrying food odors, some of these run into
the walls of residential and commercial buildings. During these forays, most rodents tend
to investigate any nooks and crannies they encounter. However, those openings from
which currents of warm air or food odors emanate are particularly prone to rodent invasion.
Upon discovering a useful opening, rodents usually mark it with urine or fecal pel-
lets. Because rodent excrement often contains pheromones [5,7], such marked areas may
attract other rodents to these actual or potential points of entry. It is obvious, then, that a
properly rodent-proofed building will admit fewer rodents than a building with unprotected
points of entry. Because mice require only a 0.25-in. (6-mm) gap to gain entry, even
openings appearing insignificant (to us) are important and should be sealed.
Exterior walls facing or close to open fields, wooded areas, and rail lines often are
the most prone to invasion. Several of the most rodent-vulnerable entry points are given
here: rail doors (where rail cars enter a building); rail pits; ramped bay doors; shipping
and receiving docks and dock levelers; doors with improper threshold closures; open man
doors; unsealed utility lines entering the plant; and the various unrepaired structural faults
and openings into the plant.
Rodents readily climb various brick and stone walls, conduit lines, building corners,
and drainage gutters to gain access to roof areas. They then enter the plant from any of
the various roof utility systems. All utility components located on roofs, such as ventilation
fans and air-handling systems, must be rodent-proofed. This is especially important in
those regions of the country where the roof rat is prevalent.
Even with thorough exclusion efforts, some rodents will inevitably gain entry to
most food plants over the course of a year. Nevertheless, the difference between 10 mice
or 75 mice entering a facility each year is dependent upon (1) the quality and thoroughness
of the facility’s rodent proofing, (2) the general sanitation program of the plant, and (3)
the attitude and cooperation of plant employees in keeping the doors closed as much as
operationally possible. Detailed information on pest proofing of buildings is readily avail-
able [2,8–10].
B. Sanitation
1. Exterior Areas
Although some rodents may get into a food plant or warehouse as stowaways on pallets
or in supplies, most interior rodent infestations originate from habitats immediately adja-
cent or close to the building exterior. It is for this reason that the plant exterior must be
held to the highest sanitation standards possible. Allowing weeds and landscaped areas
to grow unmanaged can result in substantial rodent populations flourishing at the threshold
of the premises. Similarly, allowing old equipment, conduit lines, food transfer shafts,
discarded screw conveyors, and similar items to accumulate on the ground adjacent to
exterior walls is tantamount to installing ‘‘rodent magnets’’ to the building periphery.
Rodents are behaviorally programmed to investigate the circular shadow openings of an
empty conduit pipe lying on the ground in the same manner that they are drawn to investi-
gate the opening of a hole in a tree trunk, a ground burrow, or the entryway of a curiosity
mouse trap.
Any fermenting food residues on a plant’s periphery or rooftop will attract rodents
that are opportunistically foraging about at night. All exterior food spills and residues
must be cleaned up as quickly as possible, and any large odiferous spills must be removed
without delay. Exterior out-of-sight and hard-to-reach areas such as dock leveler pits,
dumpster voids, and bone yards are especially important to keep clean.
Fines from roof vent blowout areas are also critical. Rodents will scale exterior
walls when following the odors of fermenting fines lying about on roofs.
2. Interior Areas
For interior areas, the maintenance of a clean and unobstructed continuous sanitation line
(also called an inspection aisle) along the entire interior side of the plant’s or warehouse’s
exterior walls is one of the most important aspects of sanitation relative to rodent pest
management [11,12]. Without this aisle, rodents can easily remain undetected and cause
significant contamination and destruction of product.
Extant regulations do not stipulate any specific minimum width for the inspection
aisle. However, as a practical matter when implementing good manufacturing practices
(GMPs), the aisle should be sufficiently wide to allow easy inspection and cleaning by
plant personnel and to facilitate trap placement by pest management professionals (PMPs)
(see below). Most plants allocate about 18–24 in. (46–61 cm) of space for the inspection
aisle.
The aisle is painted white to facilitate easy sighting of black dirt, rodent droppings,
and insects. Some food plants also install various types of heavy-duty flanges or poles to
discourage forklift operators from encroaching upon the line.
In warehouses, adequate space should also be maintained between rows of stacked
product to facilitate inspections and reduce incidents of breakage and spillage. This is
especially important in warehouses that store seed, dry bagged pet foods and other foods
in paper bags stacked on wooden pallets. In these situations, mice commonly take up
residence and carry out their feeding and propagation activities without any need to emerge
from the stacked product. These ‘‘pallet mice’’ are for the most part unaffected by the
standard perimeter baits and trapping programs [2]. By means of painted aisle lines on
the warehouse floor, order is maintained, spillage is reduced, and the overall environment
is made less attractive to rodents.
C. The Three Lines of Defense

1. Background
In addition to implementing sanitation and rodent proofing efforts, the use of rodent baits
and traps also plays a major preventive and remedial role in a food plant rodent IPM
program.
Baits and traps are typically utilized in a ‘‘perimeter defense’’ program consisting
of three (sometimes two) lines of defense. This program involves surrounding the plant’s
(1) property line (if one exists); (2) exterior walls, and (3) interior walls with bait and/
or trap stations (Fig. 2).
The goal of this program is to protect the plant by killing or capturing any rodents
foraging about outside on the property (that could potentially enter the plant) or to capture
any mice that might enter the premises through doors or openings or arrive within incom-
ing shipments. The most common strategy is to place mousetraps at intervals along the
inside of the exterior walls. Rat trap stations may also be placed in areas and at intervals
dictated by the need.
Interestingly, the perimeter defense program was not developed as a result of re-
search or any type of quantitative field trails. Rather this program appears to have evolved
from the recommendations of government and other publications on rodent control during
the 1940s and 1950s [13–15]. These publications provided general recommendations for
placement locations and spacing of rodent traps and bait containers for the control of
mouse and rat infestations, based on the reported foraging ranges (‘‘territories’’) of ro-
dents. These recommendations were broadly adopted for grain storage and warehousing
facilities [16,17]. Eventually, they were adapted for the food industry and the ‘‘standard
perimeter defense model,’’ based on the early recommendations, remains in place to this
day [1,18].
Recently, the general applicability of the three-line defense model to all situations
has been challenged. For example, the numbers of bait or trap stations as recommended
in the early publications may be appropriate for those facilities subject to intense and
continuous rodent activity. However, for facilities located in areas subject to only low
rodent pressure and which are designed and constructed in a manner that discourages
rodent intrusion, the ‘‘standard’’ perimeter defense program may be excessive and unnec-
essarily expensive. This is especially true for some of the modern ‘‘superfacilities’’ that
may be several million square feet in size.
Evidence that this challenge is justified may be found in the records of several food
plants and warehouses coast to coast that show the results of exterior and interior rodent
activity and capture monitoring over the past 10–15 years. Some of these facilities have
been able to consistently demonstrate that only a small percentage of their bait stations
and/or traps receive monthly activity. The managers of these plants may seek the advice
of pest management consultants on ways to tailor their rodent management programs to
Figure 2 A general schematic of a rodent protection program for a food plant warehouse using
the three lines of defense system: (1) along any property fence rows, bait or trap stations are installed
at 50- to 100-ft intervals; (2) along the building’s periphery exterior wall, bait or trap stations are
installed at 30- to 50-ft intervals; (3) inside, mousetraps (any of various models) are typically in-
stalled at 20- to 40-ft intervals along the entire wall perimeter. A shorter spacing on any of the
devices is determined by the amount of protection desired or by the specific situation and operations
of the facility. In areas where rodent pressure may be high, or for product areas needing additional
protection, more stations can be added accordingly. Illustration not drawn to scale.
match the demonstrated levels of rodent pressure without compromising product quality.
This careful approach to rodent management, based on documented experience, fits in
well with a basic premise of IPM: use pesticides only when need has been demonstrated
via monitoring and/or documented pest activity.
On the other hand, some facilities are subject to higher than average rodent activity,
at least in some areas around the plant. Accordingly, for these plants an increase in the
number of stations or interior traps (over and above the recommended standard) is called
for to better protect the plant and further decrease the number of rodents in the exterior
areas. Or such plants might do well to further customize their program by increasing the
number of units along those walls and in those areas subject to greater activity, while
maintaining the standard spacing and quantities for all other parts of the plant [2].
Perhaps the time has come to formally research the one-size-fits-all perimeter de-
fense model. Some plants may easily maintain outstanding food safety by setting out
relatively fewer bait stations (and thus decreasing pesticide use) and by implementing
strategic placement of rodent control devices based on reliable data.
For other plants, more rodent control devices may be required in excess of the stan-
dard recommendations. Obviously, these critical decisions cannot be reliably made without
accurate rodent capture and bait station activity records. Without any data to justify a
specific type of program, it makes sense to err on the side of safety and utilize the standard
perimeter defense program, as illustrated in Fig. 2.
2. New Technologies
Prior to a discussion of the practical implementation of rodent pest management programs,
an overview of the new technologies and techniques that have emerged over the past
decade will provide a sound basis for understanding the management programs described
in this chapter.
a. Rodenticide Baits. Rodenticide baits and their active ingredients have changed rela-
tively little over the past decade, with only one new active ingredient, difethialone (Gener-
ation ), coming on line. Although similar in mode of action to all of the current second-
generation anticoagulants, difethialone is formulated at 25 ppm, half the concentration of
other anticoagulant food baits.
The nonanticoagulant rodenticide bromethalin has been reformulated and remar-
keted (as Fastrac and Top Gun ) by two manufacturers since its introduction in the early
1980s. Because bromethalin produces death in rodents relatively quickly (1–3 days) com-
pared to anticoagulants (5–7 days), it is obviously an attractive agent for use in food plant
environments. Note, however, that each block of bromethalin bait is approximately twice
the cost of an anticoagulant bait.
b. Nontoxic Monitoring Food Baits. Nontoxic monitoring food baits have recently
made an appearance in the pest management industry. These blocks are simply the food
block bait carriers as used in the standard rodenticidal bait blocks, but they do not contain
any active ingredient. Monitoring food baits are used in exterior areas (as per discussion
below) to monitor for the presence of rodents prior to the installation of any rodenticide.
Should the monitoring blocks indicate feeding by rodents, a rodenticide block is
then installed into the active station. In this way, true IPM is being conducted, that is,
pesticides are not employed unless there is a pest present to justify their use. For food
plants and warehouses with only light rodent pressure, the use of bait monitors offers a
progressive path toward implementing the IPM concept. Currently, only one brand of
nontoxic monitoring block is available (Detex by Bell Laboratories). Zeneca (now
Syngenta) marketed Census in 1996, but discontinued the product due to a lack of interest
by the pest management and food industries.
c. Bait Stations. Bait stations (boxes, containers) have appeared in new designs and
construction materials over the past decade. Several different kinds of bait stations are
now available to the food industry for exterior baiting programs.
For the most part, the various designs impact the serviceability of the stations more
than adding to the actual efficacy of controlling rats and mice feeding from the stations.
In other words, most foraging wild rodents are apt to explore a hole in their pathway
regardless of the shape, color, or construction materials of the box containing the hole.
Still, stations that are easy to inspect, service, clean, and repair and that effectively present
baits while minimizing hazards to nontargets (organisms inadvertently impacted by pesti-
cides) and the environment are certainly important to the food industry overall.
Some new bait stations offer unique designs for easy opening and bait change-outs.
Others offer see-through covers. Some brands provide maximal tamper resistance via the
use of heavy-duty metal construction materials.
d. Trap Stations. Recently there has been an interest in the use of exterior bait stations
as ‘‘trap stations,’’ that is, installing either mouse- or rat traps into bait stations in lieu
of rodenticidal baits. The use of traps instead of baits offers a food plant two advantages:
it reduces the amount of pesticide used at the food plant and the offending rodent and its
threat to food safety are both immediately eliminated (contrast this with the anticoagulant-
poisoned mouse that continues to deposit feces and urine for up to a week while the
rodenticide takes effect). Several bait station manufactures have recently modified their
station designs to accommodate either the use of baits or the installation of mouse- or rat
traps.
e. Rodent Snap Traps. New designs in rodent snap traps have also occurred over the
past few years. The most common new mousetrap design is a ‘‘clam-style’’ trap, now
manufactured by a few of the leading trap manufacturers (e.g., Woodstream, Victor, and
Bell Laboratories). Clam-style traps offer ease of setting by simply pinching the back of
the trap with one hand. The captured mouse is emptied from the trap in the same fashion,
with no need to touch the mouse. Clam-style mousetraps can be installed inside various
bait stations and used in lieu of baits when carcass recovery is of paramount importance.
The Kness Manufacturing Company (makers of the well-known Ketch-All curios-
ity trap) produces the Snap-E trap that can be set with one hand. Here, too, the trap can
be emptied without touching the dead rodent. Snap-E traps are available for both rats and
mice.
f. Multiple-Catch Mousetraps. Several new variations on multiple-catch mousetraps
(MCTs) have taken place over the past few years. The most notable changes are that the
majority of the metal versions are also now being offered in heavy-duty plastic and in
slimmed-down sizes.
The substitution of plastic in place of the thin sheet metal for the trap body is wel-
comed by many professionals who have to service curiosity traps on a large scale. The
metal traps are prone to warping and rusting, which render the traps difficult, and thus
time consuming, to service. The plastic traps are not only easier to service, they are easier
to clean and can also withstand the occasional exposure to water (from floor cleaning
operations, discharge operations, etc.) without any adverse effects on the traps.
Another significant update in the use of multiple-catch traps inside food plants and
warehouses is the practice of inserting inexpensive cardboard glue traps into the holding
chambers of the traps. These ‘‘glue board inserts’’ provide several advantages to a food
plant. First, they furnish valuable insect monitoring feedback (as insects readily crawl into
these traps in their travels along the floor). Second, they eliminate the need for an inspector
to carefully inspect the trap with a flashlight before opening the trap to thoroughly service
it. Third, the glue board inserts eliminate the extra time needed to deal with live mice
caught in the trap at the time of inspection. And, fourth, because the rodents and insects
are captured and contained on the glue board, the hairs, feces, urine, insect fragments,
etc. are no longer a contamination threat to a food production facility. For the extra small
cost of adding the glue inserts to MCTs, a food plant can save significant amount of time
and provide a good deal of extra protection.
g. Battery-Powered Electrocution Traps. Rodent traps are now available that use ordi-
nary batteries for high voltage/low amperage electrocution traps. Some models are avail-
able with sensors that provide remote monitoring capability to count trap interactions and
electronically record them at a central site. Such a setup would be useful inside a ware-
house, for example.
However, each trap can only capture one rodent at a time and must then be reset.
Some rodents are capable of detecting or escaping the electric shock and avoid the trap
completely, especially if they have experienced a prior shock. Electrocution traps are
relatively expensive (at least 60 times more for rats and 150 times more for mice) com-
pared to a standard snap trap.
h. Electronic Monitoring Devices. As of 2001, several companies are experimenting

with electronic monitoring devices (EMDs) for detecting rodent activity in and around
rodent MCTs and/or exterior bait stations. Such devices can send a warning to a central
site within a food plant, prompting action to be focused on a specific trap. Providing the
EMDs prove to be reliable under all field conditions and record only rodent activity, then
they may be able to save many hours (and thus many dollars) associated with the manual
labor of weekly and monthly inspections of multiple-catch mousetraps and exterior bait
stations.
i. Bar Coding/Scanning Technology. Several food plants and pest professionals have
been using bar coding and field scanning equipment over the past 5 years to service bait
stations, indoor mousetraps, insect light traps, and stored-product pest pheromone traps.
Scanning technology can assist in efficiently capturing, compiling, and retrieving data
from each unit of all pest control equipment at a plant site.
j. Electronic Rodent Repellers. As of 2001, no breakthroughs have been made in the

technology of the electronic machines (e.g., ultrasonic, electromagnetic) that supposedly
deter rodents from entering buildings. See discussions below for additional details and
references that address these electronic devices.
3. Defense Lines 1 and 2

The first line of defense is comprised of rodenticide bait (or trap) stations along the outside
perimeter of the property line or fence line (if one exists). The second line of defense
employs bait or trap stations around the outside foundation wall of a building.
a. Rodenticide Baits. Rodenticides are pesticides designed to kill rodents. Four differ-
ent types of rodenticide formulations (food baits, liquid baits, tracking powders, and fumi-
gants) are available in the pest management industry. However, food baits are the primary
formulation used in the food industry.
Food bait rodenticides are available in several different formulations: (1) pellets,
(2) ground cereal meals, (3) extruded parafinized blocks (called bait blocks), and (4) seeds.
Each of these formulations is available either in bulk quantities or packaged into various
types of handy mini packs and place packs (as described below). Some examples of roden-
ticide active ingredients and trade names commonly used in the food industry are listed
in Table 2.
Table 2 Examples of Professional-Level Rodenticide Baits
Formulations
Examples of available for
Active ingredient and concentration trade names Manufacturer exterior uses

Brodifacoum (0.005%) Final Bell Laboratories Blocks, pellets,
Talon Syngenta packet style
Bromadiolone (0.005%) Contrac Bell Laboratories Blocks, pellets,
Maki Lipha Tech packet style
Difethialone (0.025%) Generation Lipha Tech Blocks, pellets,
packet style
Diphacinone (0.005%) AC 50 J. T. Eatons Blocks, pellets,
Ditrac Bell Laboratories packet style
Cholecalciferol (0.075%) Quintox Bell Laboratories Seeds, pellets,
packet style
Bromethalin (acute, nonanticoagulant) Fastrac Bell Laboratories Blocks, pellets,
(0.01%) Top Gun J. T. Eatons packet style
Notes: Products listed alphabetically. No endorsement of any product is implied or intended. Labels should be
checked to ensure product is registered for use in specific environments.
Rodenticidal baits used for exterior baiting programs around food plants are often
exposed to moisture from rain and snow or to wet or dirty rodents or other small mammals
and birds visiting the bait stations. Bait blocks are the most widely used formulation for
exterior rodent control programs because they provide excellent resistance to the elements
while remaining highly attractive to rodents. Bait blocks will melt down when tempera-
tures inside the bait containers exceed 100°F (37°C) for several hours (a common event
in many regions during hot weather). Some bait brands will also swell up and disintegrate
if exposed directly to water (sitting in puddles on the station floor, for example).
More importantly, block baits can be secured (via rods) inside bait stations, provid-
ing several advantages for exterior baiting programs [19]. The securement of the blocks
helps protect and preserve them from the elements such as the wet floor of a bait station
following rain or melting snow or from the wet bodies of animals visiting the stations.
Because the secured blocks are also elevated off the floor, they are less susceptible to
damage from slugs, grasshoppers, crickets, roaches, and other chewing insects that destroy
exterior rodent baits. Rodents cannot move or kick secured block baits into the entry ways
of the station where they are more accessible to reaching hands or paws of nontarget
mammals or beaks of birds. And secured blocks virtually eliminate the potential of rodents
carrying the bait out of the station (defeating the entire effort in using a tamper-resistant
bait station in the first place) (Fig. 3). Because of these advantages, the practice of securing
bait blocks is now standard in food plant rodent control programs, exceeding even the
tamper-resistant criteria of the Environmental Protection Agency (EPA).
Packet-style baits (often referred to as ‘‘toss packs,’’ ‘‘throw packs,’’ and ‘‘place
packs’’), sometimes also placed inside bait stations deployed outdoors, have some disad-
vantages. The rodents may not bother to gnaw through the packaging to get at the bait.
Nor do packet-style baits provide long-term protection from wetness once a rodent has
torn the packet open. Furthermore, unless secured, rodents can drag bait packets out of
the station and spill the bait on the ground. Such an event both makes the bait available
to nontarget animals (mammals and birds) and less available to other rodents.
Figure 3 Exterior bait stations typically comprise the first line of defense along property fence
rows of food plants and warehouses. Block baits are secured on rods to prevent baits from being
carried out of the stations by rodents and to prevent the bait being shaken out when the stations
are lifted. Secured blocks also help baits remain dry and fresh, thus maximizing bait longevity.
But in cases of extreme wetness or excessive heat that melts the paraffin blocks
(and where exterior traps are also not the appropriate choice), secured packet baits may
be the most appropriate bait formulation. Packet baits can be secured inside stations by
hanging the packet from the top end of one of the station’s interior dividing walls using
paper binder clamps (the pinch-style clips used to hold stacks of paper together). Some
plant PMPs use the packet style baits for only the months of intense heat or wetness and
then reinstall bait blocks for the rest of the year.
b. Bait Stations. Rodenticide baits around food plants must be placed inside protective
containers, called bait stations. For food plant exterior baiting programs (or any incidental
and temporary interior baiting program), all bait stations should be tamper-resistant mod-
els. Even if it is known that the public or wildlife or pets will not have access to the
stations, tamper-resistant bait stations provide better protection to the bait than non–tam-
per-resistant stations.
Most tamper-resistant bait stations are made of either metal or high-impact, heavy-
duty plastic (Table 3). Bait stations come in sizes for mice (small) and rats (large). For
all exterior baiting programs, only the rat-size bait stations are employed as they obviously
allow for both rat and mouse entry. The smaller mouse stations are occasionally used for
customized, indoor mouse control programs.
To be considered tamper resistant according to the EPA requirements, exterior bait
stations must be secured to the ground or to a heavy object, a wall or a fence. While there
are many ways to do this, a convenient, effective technique is to attach the station to
concrete ‘‘patio stepping stone’’ [19]. But take care to use an appropriately sized stone.
Table 3 Examples of Tamper-Resistant Exterior Bait/Trap Stations a
Bait ‘‘See-thru’’
Heavy securement inspection
molded system lid model
Brand name Manufacturer plastic Metal included option
Aegis Rodenticide Bait Station Aegis, Lipha Tech ⻫ Yes Yes
Checkpoint Ecolabs Corp. (pro- ⻫ Yes No
prietary station)
Duble-Truble Vertical Station ⻫ Yes No
J. T. Eatons Model 903 J. T. Eatons ⻫ Yes No
J. T. Eatons (metal) J. T. Eatons ⻫ Yes No
Protecta Bell Laboratories ⻫ Yes No
Protecta Low-Profile (LP) Bell Laboratories ⻫ Yes No
Rat Cafeteria b bait or MCT station Solvit Corp. ⻫ No No
a
Most bait stations can also be used as trap stations containing mousetraps or rat traps if pesticides are not desired or needed
for the exterior program.
b
The Rat Cafeteria station is large enough to accommodate some of the multiple-catch mousetraps.
Notes: Products listed alphabetically. No endorsement of any product is implied or intended. Labels should be checked to
ensure product is registered for use in specific environments.
For example, bevel-edged, low-profile stones serve well as anchor points and also lie low
to the ground. Patio stones that sit higher than 1.5 in. (3.8 cm) off the ground may reduce
the chances of mice readily entering the bait station. Cement blocks of approximately
12 ⫻ 12 ⫻ 1 in. (30 ⫻ 30 ⫻ 2.5 cm) provide a sufficient support base yet lie low to the
ground (Fig. 4).
c. Trap Stations. Currently there is a general trend and emphasis in urban and industrial
sectors of the United States to decrease the amount of pesticides that are used around
buildings, especially around food manufacturing facilities [2,3]. Some food plants, in ob-
servance of this trend, elect to substitute rodent traps for some or all of the outdoor bait
stations. Some plant managers also want to take every measure possible to preclude the
accidental transport (by rodents or by an employee or visitor) of rodenticide baits (or any
other pesticides) into the plant interior.
To reduce pesticide loads around food plants, mousetraps (or rat traps for plants
with rat pressure) can be installed inside rat-sized bait stations, thus converting them to
trap stations [2]. The trap stations (Fig. 5) are deployed at intervals along exterior fences
or walls as is done for conventional baiting programs. Depending on the particular station
model used, snap traps can be placed in the bait holding compartment or next to the entry
port of the station. To allow for multiple captures, each station should contain two traps.
Place one or two drops of peanut oil, vanilla extract, or some other food volatile on the
trap to serve as an attractant.
Plastic-base mousetraps offer excellent hassle-free setting and good longevity in wet
situations. The conventional wooden-base snap traps take too long to set and reset and
the bases may warp when exposed to water.
Trap stations may also be used to bait ants, cockroaches, crickets, and slugs where
these perimeter pests are a problem. Some large-size bait station models are now available
with clear lids facilitating easy inspection (Table 3). However, some stations may still
need to be opened to facilitate recording the results on an inspection ticket. Some PMPs
Figure 4 Bait or trap stations are typically installed along the perimeter foundation walls of food
plants of warehouses at varying spacing as a second line of defense against rodents migrating from
exterior areas to the building. Note the station is secured via the use of a heavy, low-profile patio
stepping stone.
Figure 5 Bait stations containing snap taps are recommended to capture any mice attempting to
gain easy and quick entry nearby facility doors that are open for prolonged periods.

and food plant personnel are changing over to bar code scanner inspection programs that
involve inserting laminated, bar-coded tickets into bait or trap stations.
Another technique tried by some PMPs is to put glue traps inside outdoor station
boxes as a means to capture mice. However, glue traps used outdoors, even when placed
inside bait stations, are likely to suffer the effects of being exposed to water, cold and
heat, and dust and dirt being blown into the box or tracked in by exploring animals. Glue
traps soon become ineffective under these conditions.
d. Exterior Multiple-Catch Traps. Any of the multiple-catch mousetraps (also called

curiosity traps) conventionally used for indoor perimeter walls (Table 4) can also be used
for exterior trapping programs. Some facilities use MCTs outdoors spaced at the same
intervals as bait stations. However, when employed in this manner, MCTs require more
labor (inspections, recordkeeping, and cleaning) than snap-trap stations. These traps are
perhaps best used in exterior areas as door flanking traps. Of course, MCTs cannot capture
rats.
When metal MCTs are used outdoors, they perform best if installed within some
type of protective cover. Otherwise, water, dirt, dust, and leaf litter get into the traps and
render them ineffective due to corrosion and jamming. These traps also become difficult
to service and clean in a short time.
Large (rat-sized) metal bait stations are available into which MCTs can be inserted
to create an MCT station (Table 3). Plastic slip-over covers are also available for some
models of MCTs.
Heavy-duty plastic MCT models are now available from nearly all the mousetrap
manufacturers (Table 4). Because plastic traps are less prone to corrosion or warping, and
thus can be quickly inspected, they are better suited for outdoor control programs. How-
ever, for maximal capture efficacy and trap longevity, outdoor plastic traps should be
placed inside trap stations or have some similar cover to protect them from the elements.
e. Placement/Spacing Guidelines for Bait and Trap Stations. Exterior rodent control
programs for food plants should be designed so that they are responsive to specific plant
operations and rodent pressures, as discussed previously. However, for routine rodent
prevention programs, the general guidelines for exterior baiting and trapping programs
are given here.
Table 4 Examples of Multiple-Catch Mousetraps

Profile
Brand name Manufacturer Wind-up Trapdoor size Metal Plastic
Ketch-All 
Kness Mfg. ⻫ High ⻫
Kwik-Katch Gremar Corp. ⻫ Medium ⻫
Mini-Mouser Kness Corp. ⻫ Medium ⻫
Mouse Master Micro-Gen ⻫ High ⻫
Protecta MC Bell Laboratories ⻫ Medium ⻫
PolyCat Woodsteam ⻫ Low ⻫
Repeater J. T. Eatons ⻫ Low ⻫
Tin Cat Woodstream ⻫ Low ⻫
Notes: Products listed alphabetically. No endorsement of any product is implied or intended. Labels should be
checked to ensure product is registered for use in specific environments.

• Property line fence: one bait/trap (B/T) station every 50–100 ft (15–30 m).
• Building perimeter: one B/T station every 30–50 ft (9–15 m). Additional stations
can be added at the discretion of the quality assurance (QA) manager or the
contracted PMP. Because mice and rats tend to gravitate toward escaping warm
air currents (or food odor currents), additional trap stations can be added to the
building perimeter in those places where substantial heat or food odors emerge
from under doors and from vents, openings around utility lines, and other similar
openings.
• A trap station (either snap traps within stations or multiple-catch traps within
protective covers) should be positioned to flank both sides of ramp bay doors
or other ground level openings through which mice (even bait-poisoned mice)
may gain easy entry. Mousetraps should also flank both sides of the interior
areas near these same locations.
• Along areas of minimal or light rodent pressure, as well along walls that have
no openings or structural faults, the maximal distances between B/T stations can
be used or some stations can be selectively culled.
• Bait/trap stations should be installed between any potential rodent harborage
(stored equipment, debris, etc.) and any potential entry point to the plant.
f. Inspecting, Servicing, and Recordkeeping of B/T Stations. For routine preventive

programs, exterior B/T stations can be inspected on a weekly, biweekly, or monthly sched-
ule, depending on the rodent pressure, time of year, company policy, and the types of
baits or traps used. Exterior trap stations are usually checked weekly or every two weeks.
Exterior bait stations containing standard food baits can be checked once to four times
each month, depending on location, rodent pressure, climatic conditions, and/or company
operating procedures.
For example, fence row stations containing one or two bait blocks on plant properties
that have low rodent pressure probably need not be serviced more often than once or twice
per month. Bait/trap stations located along exterior plant walls should be checked weekly.
Most rodenticide baits have an outdoor longevity of about 4–6 weeks. Baits that
are moldy or deteriorated should be changed out sooner than this. In stations where the
bait is consistently untouched, traps can be installed (replacing the bait stations) or the
station simply removed.
Proper recordkeeping of B/T stations is important not only to comply with various
company and contract guidelines, but also to help identify the rodent pressure affecting
the plant complex. Records should be reviewed on a regular basis (e.g., quarterly and
annually). These records can then be put to use in customizing a specific defense program
for a particular food plant. Good records also demonstrate to regulatory or private inspec-
tors that a well-organized rodent control program is currently in place.
All B/T stations are numbered and tagged with a service ticket that lists (1) the date
of last inspection, (2) initials of the inspector, (3) the rodenticide (if one is used) active
ingredient, and (4) the name and phone number of the responsible individual or company
servicing the stations. Records should reflect the level of rodent activity in the outdoor
stations. It is important for inspectors to be competent to identify specific evidence of
rodent activity. For example, some inspectors mistakenly identify cockroach and cricket
droppings as mouse droppings or toad droppings as rat feces [19].
Bar codes and scanning technology have become commonplace for industrial rodent
control programs. Such systems both save time and accurately record inspection results
scanned from laminated, bar-coded tickets installed inside the bait or trap stations. Many
PMPs utilize laminated punchcards to certify that a station has been serviced according
to schedule.
Two specific forms should be kept on file as evidence of an effective, long-term
rodent pest management program for a food plant: (1) A general inspection sheet in table
format that indicates for each bait or trap station the dates of inspections, rodenticide
active ingredient (if one is used), evidence of activity, and other appropriate information
and (2) a diagrammatic sketch illustrating the location of all exterior B/T stations. Copies
of the data and the diagram should be filed with the appropriate plant personnel, inspectors,
and the contracted pest control company, if one is used.
g. Inspections During Snow Cover. The kind and frequency of service to be provided
during periods of snow cover should be determined by the history of the rodent activity
at a particular location. If exterior stations are subject to ongoing rodent activity, several
(e.g., four to six) bait blocks can be installed within the stations beginning in early winter
(in other stations, one or two precautionary bait blocks per station should be sufficient).
When heavy snow cover prevents ready access to the stations, the extra baits will provide
the necessary protection until the snow melts and the normal service schedule can be
resumed. It is unusual for snowfall to keep bait stations inaccessible for more than 6–8
weeks. It is generally unnecessary to dig out and inspect each station solely for the pur-
poses of recordkeeping.
4. Defense Line 3
Despite well-maintained food plants and warehouses and state-of-the-art rodent pest man-
agement programs, a few mice (and the occasional rat) inevitably gain entry to food plants.
Therefore, the third line of defense against rodents involves the use of rodent traps posi-
tioned along interior perimeter walls at the ground floor level. Other floors and areas (e.g.,
grain elevator floors) may also require trap placements as determined by the nature of the
building structure and level of rodent pressure encountered.
It is important for food plant personnel to note that the action threshold for rodents
inside food plants is one rodent. One mouse can produce up to 50 (sometimes more)
droppings, as well as numerous deposits and thousands of microdroplets of urine in a 24-
hr period [5,20]. It is possible, then, for just one mouse to rapidly contaminate a wide
range and quantity of food product or food processing equipment. Thus, the presence of
even one mouse inside a food plant warrants immediate attention.
Real-world records and experiences over the past several decades from many differ-
ent food plants and PMPs across the United States have illustrated that in well-maintained
plants (regardless of size), with good pest-proofing, employee cooperation on keeping
doors closed, and effective exterior rodent prevention programs, the number of mice that
gain entry on an annual basis is usually low (e.g., rarely more than a half dozen or so).
Plants fitting this profile but also located in areas of low natural mouse populations may
not experience any mice (or only one or two) indoors over a period of several years.
On the other hand, plants that are situated near high natural populations of mice
may capture a dozen or so mice indoors each year in spite comprehensive rodent pest
management programs and strict adherence to GMPs.
The rodent management programs of those food-manufacturing facilities, including
even very large ones, in which more than a dozen or so mice are captured indoors annually,
signal a need for additional fine tuning. In these situations there may have been failures
in the basic elements of some, if not all, of the components of the rodent IPM program
as outlined and discussed in this chapter (rodent exclusion, sanitation, and the three lines
of defense).
Considering these factors, it should be apparent that interior rodent control programs
must be well designed and carefully implemented. In nearly every food plant, interior
mice are controlled by traps, usually MCTs. In exceptional situations, rodenticidal baits
are sometimes used for short periods to knock down infestations that, for whatever reason,
have become established (e.g., mice introduced to a plant or a warehouse via an infested
railcar or truck trailer) (see Section III.C.3.b for guidelines on the use of rodenticides
inside a food facility).
a. Interior Trapping Programs. Interior trapping programs involve the use of either
plastic or metal MCTs deployed along the interior side of all exterior (perimeter) walls.
Mice exploring strange new environments enter these traps, presumably to seek immediate
shelter. Captured mice usually succumb to hypothermia or to other physiological stresses
associated with capture and confinement. (See Table 4 for the most commonly used multi-
ple catch traps.)
Glue boards, now commonly added to MCTs (Fig. 6), facilitate expedient mouse
captures and removals and trap cleaning, as well as reduce biohazards and provide a sup-
plemental method for pest insect monitoring [2]. This combined approach, using glue
traps inside MCTs, is both cost and time efficient for mouse control and, as an added
benefit, for pest insect monitoring.
Some PMPs and food plant personnel are loyal to only one brand of MCT, believing
their favorite to be the superior mouse catcher. Others select among the different trap
Figure 6 A trapdoor, multiple-catch mousetrap for interior areas. Glue boards can be installed
into these traps rendering the trap both a mousetrap and a device for monitoring for the presence
of cockroaches, ants, and many other insect pests of importance to a food plant.

types and brands as local situations dictate. So far, field trials have not proven any differ-
ence between the various models in their ability to capture mice [21,22]. But there are
differences among traps relative to durability and ease of servicing, cleaning, repairing,
and handling [23].
trap placement, densities, and positioning. Multiple-catch traps must be
placed in locations that maximize the chances of any incoming mice encountering the
trap. Most mice entering a strange building for the first time (whether from the outside
or from a delivery vehicle) tend to scurry about from one protective nook and cranny to
another. Thus, for preventive and maintenance mouse control programs, MCTs are typi-
cally spaced along the entire interior perimeter (usually on the inspection line) of the
plant’s exterior walls in an effort to intercept such new arrivals.
Spacing guidelines for conventional rodent management programs call for one trap
to be installed along the sanitation lines every 20–40 ft (6.5–13 m). Facilities with nil to
minimal mouse activity can employ the maximum distance between the traps or, alterna-
tively, traps can be installed in those areas most vulnerable to mouse entry. Interior walls
that divide rooms or warehouse sections do not require a trap line unless circumstances
(e.g., interior ingredient sheds, etc.) dictate the need. MCTs should be placed at or near
potential mouse entry locations such as on both interior sides of exterior doorways, near
utility openings through walls, and at other openings to the outside.
In cases where an active mouse infestation develops or is discovered, MCTs can
be located in areas such as darkened corners, runways along walls and pallets, behind
appliances and other large objects, in suspended ceilings, and in all other areas where
inspection determines mouse activity.
The positioning of the trap entrances of the wind-up models in relation to a wall is
not of critical importance to the trap’s effectiveness, although in some cases one position
may prove to have an edge over another position. A barrier-type placement (i.e., the trap
placed perpendicular and flush against the wall so that the mouse must stop and enter or
run around the trap) may be more effective for capturing newly arriving mice such as
those darting into a warehouse via the bay doors (Fig. 7).
When placing the traps so that the entrance is facing the wall, a space of 1.5 in. (3.8
cm) between the wall and the trap should be used. This creates an ‘‘alleyway’’ between the
trap and the wall. Such spaces are attractive to rodents; they will investigate the hole they
find in the alleyway. When wind-up MCTs are used in situations of established mouse
populations, the mice will investigate the traps at their leisure, and either position can be
used. With the trap-door mousetrap, the trap should be positioned so the trap entrances
are closest to the wall or to suspected mouse runways.
servicing multiple-catch traps. Multiple-catch traps must be kept clean and
well maintained. Traps that are not cleaned regularly can serve as sources of filth contami-
nation. Although it is true that traps with ‘‘mousey odors’’ from previous captures tend
to capture more mice than traps without such odors, this does not warrant leaving unser-
viced a trap that contains hair, body parts, or foul odors in any food plant environment.
In less sensitive areas of the plant (e.g., nonfood areas), traps can be ‘‘cleaned’’ using a
wire brush, a rag, and a putty knife to remove dead bodies and associated dirt. This proce-
dure will not eliminate any residual odors. The use of glue boards inside the MCTs helps
to keep the traps clean and facilitates fast servicing of traps containing mice.
Rancid or dirty traps should be removed from the premises and replaced with new
or clean traps. Enclose and seal dirty traps inside plastic bags while they are transported
out of the food facility. Some plant procedures stipulate that any trap that has caught a
Figure 7 Wind-up multiple-catch mousetraps should be checked weekly for the presence of any
mice. Mice enter MCTs as an opportunistic response to investigate new holes in their territories or in
their attempts to quickly locate new protective harborages when they enter unfamiliar environments.
mouse or other animal must be replaced, sanitized, or steam cleaned after each capture.
In many cases, it is more cost effective to simply discard very dirty traps.
Most MCTs now come with transparent plastic inspection plates. Simply by looking
through the inspection port, the inspector can see immediately if there is a live mouse or
other animal in the trap before opening it. This saves considerable time when many traps
need to be inspected and serviced. The presence of ‘‘see-thru’’ plates has no effect on
whether or not mice enter the traps.
However, all traps should be opened and thoroughly inspected before being put back
into service. Shining a light through the viewing holes or inspection plate as the only
inspection step is not sufficient. Mice may be hiding in, or next to, the tunnels in the low-
profile model, and mice may be trapped in the back area of the wind-up traps. Moreover,
dead mice, crickets, beetles, and other objects may become lodged between the various
parts of the MCTs, rendering the trap ineffective or serving as a source of bacterial contam-
ination.
Periodic maintenance and repairs of traps are essential to ensure the traps remain
effective and easy to inspect. Inspecting traps that are difficult to open, close, wind up,
and redeploy can be time consuming and thus costly. Moreover, it is annoying to handle
traps in disrepair; sometimes pest management personnel just ignore the difficult traps.
When the panels of sheet metal traps warp, they must be repaired. Traps with gaps in
side and end panels serve no purpose at all; mice will likely escape from ‘‘gappy’’ traps
or from traps that are broken or malfunctioning.
Minor repairs on metal traps can often be done on site. The covers can be waxed
with candle wax and oiled to make the panels open or slide with ease. Wind up and treadle
door mechanisms of MCTs should be oiled periodically (use mineral oil). Tools such as
a putty knife, small pliers for repairing bent metal, a long thin screwdriver, and a small
vial of light pharmaceutical-grade mineral oil (no odor) can be carried in the inspector’s
belt pouch for on-the-job trap maintenance.
Alternatives to the sheet metal traps are the relatively new plastic MCTs. These
traps are easier to handle, inspect, and keep clean, and there are no bent metal panels to
repair. Plastic traps also have greater utility in wet areas (sheet metal traps exposed to
water corrode quickly). On the other hand, when a plastic trap gets bumped by a forklift
or when some other mechanical force creates a hole or crack, there is no saving the trap
(some sheet metal traps exposed to such abuse might be salvaged).
installing mousetraps in forklift traffic areas. In areas of food plants and
warehouses where traps are subject to forklift traffic, maintaining MCTs can be frustrating,
difficult, and costly. In these areas the traps are regularly bumped, nudged, or ruined by
the forklifts.
Even a minor bump by a forklift truck against a plastic trap usually results in gaps
or warped and split panels. Since mice can escape through gaps only 0.25 in. (6 mm)
wide, such minor gaps render the trap ineffective. Moreover, dinged traps are difficult
and annoying to service by the attending technician and are time consuming when they
need to be repaired.
Metal protective covers, available from manufacturers or local machine shops, serve
to significantly protect the mousetraps from the occasional minor accident. However, a
direct hit by a forklift on a trap usually demolishes both the trap and its cover.
For areas subject to constant forklift activity, glue board or snap-trap stations made
of polyvinyl chloride (PVC) may be more cost effective without compromising effective-
ness. To protect a glue board station, use heavy-duty PVC tubing, 1.5 in. (3.8 cm) in
diameter. To protect the small, clam-style mousetraps, use 2-in. (5.1-cm) diameter
tubing [2].
Cut the PVC pipe into lengths of approximately 9 in. (23 cm). Insert any of the
standard, inexpensive cardboard glue traps into the PVC pipe. To make a trap station, put
one of the plastic, clam-style mousetraps into each end of the pipe. Because of its shape,
the PVC trap station fits snugly against the wall–floor junction, out of the way of forklifts
and other traffic. The wall–floor junction is also where mice and insects typically travel.
These pipe stations are not as vulnerable to accidental contact as the boxy MCT
traps. Because of the strength of the circular plastic tube, the PVC trap station can with-
stand virtually any amount of weight and/or forklift contact. In warehouses that have
constant forklift–mousetrap interactions, the PVC trap station system can mean significant
savings over the course of a year, besides guaranteeing that working traps are always in
place.
The PVC glue trap works as both a forklift-proof mousetrap and as an insect moni-
toring trap. This trap can also be installed onto ledges, overhead beams, and other locations
where conventional traps and monitoring devices do not fit.
The PVC trap is affixed by the use of self-adhesive, heavy-duty Velcro  fabric. One
strip of Velcro (about 4 in., or 10 cm, long) attached to the PVC tube is pressed against
the complementary Velcro strip glued to the wall surface. A self-adhesive inspection label
(available with many of the standard MCTs and bait stations) can be affixed to the outside
of the trap station.
The PVC trap is also suitable for wet situations that would cause corrosion and
eventual malfunction of metal mousetraps. However, substantial wetness may, given suf-
ficient time, neutralize the sticky surface of glue traps, rendering them ineffective. In these
cases, either plastic MCTs or PVC snap-trap stations might be appropriate.
The PVC glue trap is not appropriate in cold storage areas or near doors and other
areas subject to freezing temperatures because these glues do not perform adequately in
cold temperatures. Nor is the PVC glue trap appropriate in areas where there may be
abundant dust or debris. In these areas, the PVC snap-trap stations would be used. Like
the standard MCT traps, PVC traps need to be checked weekly to replace any dusty glue
boards or to reset snap traps.
Some adult mice tend to avoid stepping onto sticky surfaces. Also, forklifts hitting
the PVC snap-trap stations often trip the enclosed mechanism. Still, for those factories or
warehouses where the occasional mouse is the typical scenario, a PVC glue trap in working
condition in high forklift activity areas holds greater potential for capturing mice than
beat-up, warped, or gappy MCTs.
As an aside, and as a bonus for PMPs faced with this difficult problem, pest sparrows
moving about inside a building have a propensity for entering PVC glue traps (especially
when birdseed is set out as a bait at the tube entrance and just inside the trap station).
b. The Use of Rodenticide Baits Inside Food Plants. Much concern (and confusion)
exists within the food and the pest management industries regarding the use of rodenticide
baits inside food plants. In general, most food plants restrict the use of baits to exterior
areas and employ only trapping programs for interior areas.
However, regulations do allow for baits to be used inside all areas of food plants
regulated by both the Food and Drug Administration and the U.S. Department of Agricul-
ture (USDA) if (1) conditions warrant such use; (2) they are used in such a manner so
as to not present an adulteration threat; and (3) in the case of USDA facilities, they are
used with the permission of the inspector in charge under the specific USDA guidelines
for such use.
Many food plants operate on a general philosophy that the risks of using baits inside
the plant outweigh their value. The risks associated with using baits inside food plants
include the following:
No control over the recovery of poisoned rodents.

Rodents may translocate the bait and contaminate product. (With the new bait se-
curement technology, this issue is of much less significance than in years past.)
Damage from forklifts or other plant operations may scatter bait, and thus present
a contamination potential. (Careful placement negates this concern.)
Baits may attract and serve as a breeding medium for stored-product or other insects
(not very likely unless baits are ignored for prolonged periods).
A disgruntled employee might sabotage product by inserting the bait into product
or product containers (true, but such an employee might use any one of many
different chemicals or objects to sabotage product).
Some argue that the risks associated with bait applications are insignificant or mini-
mal when baits are applied using proper precautions and suitable bait stations, adhering
to federal and in-house regulations and using only the meal or secured block formulations
to minimize bait translocation. But others contend that if any possibility, however small,
of bait contamination exists, this is reason enough not to allow their use inside a food
plant.
In general, if a plant is employing good exterior rodent control, effective rodent-
proofing, and good sanitation programs, rodent baits should have only a minor or ‘‘last
resort’’ role for use inside a plant. But a policy or attitude of never allowing baits inside the
food plants may not be justified based on risk alone and does not recognize the reliability of
a comprehensive rodent control program.
Here are some examples of situations when baiting inside food plant may be re-
quired:
Some mice and rats will not respond to snap traps and/or glue traps.
Where there is a major infestation or a persistent rodent problem, a management
plan that involves the integrated application of as many rodent control tools as
possible is the one most likely to achieve the fastest reduction of the rodent popu-
lation. By using this multifaceted, integrated approach in a timely manner, the
chance of adulteration of the product by rodents is markedly reduced.
Some important considerations regarding the use of rodenticides inside food plants
are as follows:
Inside USDA-regulated food plants, permission to use pesticides must be granted
by the inspector-in-charge, and all USDA regulations and guidelines must be
carefully followed.
Rodenticides should not be used indoors as an ongoing, preventive program.
Bait stations should be deployed only in areas of chronic activity as determined by
thorough inspections.
Only the minimal effective amounts of bait per placement and only those formula-
tions and bait stations that minimize the possibility of bait translocation (e.g.,
secured bait blocks) should be used.
Baits should never be installed where they may be impacted by foot or forklift traffic.
Daily monitoring and strict recordkeeping must be the rule for all bait placements.
All baits should be removed and careful follow-up monitoring resumed upon suc-
cessful eradication of the rodents, and preventive trapping programs should be
continued.
D. Monitoring Rodent Pressure

It is common practice in food plants to maintain individual inspection tickets or bar codes
on each B/T station and interior MCT, showing the date of inspection and the activity
status for each station or trap. However, valuable rodent control information can be devel-
oped if a log of all captures for each trap is maintained on a monthly, quarterly, and yearly
basis.
Bar-coded and scanned capture data are easily gathered and downloaded for analysis.
Simple plot diagrams, overlaid onto a plant or warehouse floor plan, can pinpoint those
areas of a plant or warehouse that are most vulnerable to mouse invasions from outdoors,
as well as clearly indicating those areas that may be adequately serviced by only the
minimum number of trap or bait stations.
What is the point of maintaining and inspecting traps that on an annual basis for
several years never record a rodent capture? Such stations can be either removed or moved
to an area where they will do more good (general inspections should, however, continue
in those areas left without traps). Similarly, suppose the capture plot data reveal that a
part of the plant is repeatedly receiving mouse or rat activity. Such areas must be evaluated
as to why there is recurring rodent activity and measures must be taken to remedy the
problem (e.g., implementing a rodent exclusion program; increasing the number of traps
or exterior bait stations).
Those perimeter walls of a facility that face areas of potential rodent harborage such
as fields, ditches, weedy patches, ornamental plantings, etc., are more likely (but not al-
ways) to have greater rodent pressure than those sides bordered by parking lots. The
number of rodent control devices set out in any particular area either inside or outside a
food factory should be calculated on both the rodent capture history and the potential for
rodent incursions from adjacent habitats with suitable rodent harborage.
E. Miscellaneous Approaches: Ultrasonic and Other Electronic

Devices
Some food plant and warehouse personnel occasionally inquire about or purchase various
models of ultrasonic machines or other ‘‘electronic repellers’’ designed to drive rodents
away from buildings. A few experts in food sanitation have allowed that ultrasonic ma-
chines can enhance protection to a level over and above what might be expected from
standard baiting and trapping programs [8].
Every few years or so, manufacturers of ultrasonic repeller machines claim to have
made new breakthroughs that make their products even more effective than before. It is
important to note, however, that no reports of formal scientific experiments proving the
efficacy of these units around commercial food plants, warehouses, or other commercial
buildings have been published in any peer-reviewed scientific journal during the 35 years
that these devices have been marketed.
Of course, it has been demonstrated, under laboratory or other very closely con-
trolled conditions, characterized by a minimal number of environmental variables, that
locomotory activities of rats and mice can be affected to some extent by ultrasonic beams
[24,25]. However, rarely is the foraging behavior of hungry rodents struggling for survival
in the wild as simple as the behavior that would be observed in observation arenas or
laboratory settings. There are many environmental and structural variables in and around
food factories and warehouses that affect the path and intensity of ultrasonic waves and
that attenuate their effects, if any, on incoming rodents (e.g., predicted path of the rodents;
alternative pathways; trucks, pallets, and products causing sound shadows; the physical
condition and biological drive of the specific rodent). Also, the number of doors needing
coverage in a typical food plant or warehouse would, in some cases, require a relatively
expensive investment in ultrasonic equipment. Considering the proven effectiveness of a
quality, comprehensive rodent IPM program, the questionable certainty of deriving a cost
benefit from adding these unproven devices is indeed problematical [1,21,27].
IV. SUMMARY
Most food plants are subject to significant rodent pressure, mostly from the common house
mouse, during the course of a year. Keeping incidents of rodent infestation few or nonexis-
tent requires a serious commitment by food plant management to implement exceptional
exterior and interior good manufacturing practices relative to pest-proofing and sanitation
efforts. Good manufacturing (or warehousing) practices must then be backed up with a
comprehensive rodent pest management program. Taken together, these programs become
a working definition of integrated pest management.
The choices of specific kinds of stations, bait formulations, and traps, as well as the
particulars of placement and servicing of all these devices, are important considerations
in the overall goal of achieving thorough and cost-effective protection of a food plant
from rodents. However, the food industry (and pest management professionals) should
avoid implementing yard-stick, one-size-fits-all rodent control programs that are the same
for every plant without regard for each plant’s specific history, type of operation, location,
and building construction.
Rodent activity and capture data should be maintained and analyzed on a quarterly
basis to design site-specific rodent management programs that are efficient and thus cost
effective. Food plant professionals should be wary of electronic repellers or any other
untested technology that claims to protect food plants with nothing more that the plugging
in of some gadget into an electric outlet. Rather, food plant managers should rely on
correctly established and well-maintained IPM programs.
Finally, and most importantly, exterior bait stations and interior preventive traps—
even when installed to maximal levels—cannot compensate for deficiencies in sanitation
and pest-proofing.
REFERENCES
1. AIB. Consolidated Standards of Food Safety. Manhattan, KS: American Institute of Baking,
2001.
2. RM Corrigan. Rodent pest management for the food and warehousing industry. In: Rodent
Pest Management: A Practical Guide for Pest Management Professionals. Cleveland, OH: GIE
Media, 2001.
3. SC Frantz, DE Davis. Bionomics and integrated pest management of commensal rodents. In:
4. AN Meyer. Rodent control in practice: food stores. In: A Buckle, R Smith, eds. Rodent Pests
and Their Control. Wallingford, UK: CAB International, 1994, pp 273–290.
5. FH Bronson. The adaptability of the house mouse. Scientific American 250(3):116–125, 1984.
6. WZ Lidicker. Social behaviour and density regulation in house mice living in large enclosures.
J Animal Ecology 45:677–699, 1976.
7. JL Hurst. The complex network of olfactory communication in populations of wild house
mice, Mus domesticus Rutty: urine marking and investigation within family groups. Animal
Behavior 35(5):705–725, 1989.
8. T Imholte, T Imholte-Tauscher. Engineering for Food Safety and Sanitation: A Guide to the
Sanitary Design of Food Plants and Food Plant Equipment, 2nd Ed. Woodinville, WA: Techni-
cal Institute of Food Safety, 1999.
9. AG Jenson. Proofing of Buildings Against Rats, Mice and Other Pests. Ministry of Agriculture,
Fisheries and Food Technical Bulletin 12. London: HMSO, 1979.
10. HG Scott. Design and construction: building out pests. In: JR Gorham, ed. Ecology and Man-
agement of Food-Industry Pests. Arlington, VA: Association of Official Analytical Chemists,
1991, pp 331–343.
11. RM Corrigan. The science behind the inspection aisle. The Sanitarian 3(1):6, 10–11.
12. V Walter. Justifying the warehouse perimeter strip. Pest Control 50(10):46, 1982.
13. USDI. Rat Control Methods. U.S. Department of the Interior Fish and Wildlife Service Circu-
lar 13, 1948.
14. USDI. Control of House Mice. U.S. Department of the Interior Fish and Wildlife Service
Wildlife Leaflet 349, 1953.
15. J Silver, FE Garlough. Rat Control. U.S. Department of the Interior Fish and Wildlife Service
Conservation Bulletin 19, 1941.

16. AOM. Section I: Federal Food Drug and Cosmetic Act of 1938 as It Now Applies to the
Grain Trade. Section II: AOM’s Sanitation Committee’s Suggested Procedure. Association of
Operative Millers Bulletin, May, pp 1958–1962, 1952.
17. RT Cotton. Pests of Stored Grain and Grain Products. Minneapolis, MN: Burgess Publishing
Company, 1956.
18. JA Troller. Sanitation in Food Processing. New York: Academic Press, 1983.
19. RM Corrigan. Exterior rodent baiting programs. Pest Control 60(7):33–37; 60(8):38–41, 1992.
20. FP Rowe. Wild house mouse biology and control. In: RJ Berry, ed. Biology of the House
Mouse. Symposia of the Royal Zoological Society of London No 47, pp 575–589, 1981.
21. M Temme. House mouse behavior in multiple-catch traps. Pest Control 48(3):16, 18–19, 1980.
22. RM Corrigan. Multiple catch traps: trapping strategies. Pest Control Technol 16(9):45–50,
1988.
23. RM Corrigan. Evaluating multiple catch mousetraps. Pest Control Technol 21(8):36–46, 1993.
24. SA Shumake, AL Kolz, KA Crane, RE Johnson. Variables affecting ultrasound repellency in
Philippine rats. J Wildlife Management 46(1):148–155, 1982.
25. JH Greaves, FP Rowe. Responses of confined rodent populations to an ultrasound generator.
J Wildlife Management 33(2):409–417, 1969.
26. M Lund. Ultrasound devices. In: A Prakash, ed. Rodent Pest Management. Boca Raton, FL:
CRC Press, 1988, pp 407–409.
27. WE Howard, RE Marsh. Ultrasonics and electromagnetic control of rodents. Acta Zoologica
Fennica 173:187–189, 1985.
28. RM Corrigan, J Klotz. Food Plant Pest Management (correspondence course). West Lafayette,
IN: Purdue University, 1995.
29. GW Bennett, JM Owens, RM Corrigan. Truman’s Scientific Guide to Pest Control Operations,
5th Ed. Duluth, MN: Advanstar Communications, 1997.
30. M Holcomb. Clean up your act, or the bugs may take over. Pest Control 65(11):78, 1997.

19
Insects and Mites
LINDA MASON
Purdue University, West Lafayette, Indiana, U.S.A.
I. INTRODUCTION AND IMPORTANCE

Arthropod pests cause considerable losses to the food industry. It is estimated that pests
may cause postharvest losses between 8 and 25% in developed countries and as high as
70–75% in developing countries [1]. These losses could be in the form of direct product
loss due to pests consuming food or to arthropod fragments and feces causing contamina-
tion. Direct consumption by arthropod pests most often happens in raw commodities but
can also occur in ingredients and finished products.
Insect and mite pests may also change the taste of food products by adding their
secretions, excrement, and dead bodies to the food. Sawtoothed grain beetles and merchant
grain beetles can impart a strong off-flavor if infested ingredients are processed into fin-
ished product. (Scientific names for all arthropods mentioned in this chapter are given in
Table 1). Red and confused flour beetles secrete a disagreeable odor from their scent
glands that makes heavily infested flour unusable.
Insect fragments may also pose a health hazard [2]. Larval dermestid beetles are
clothed with barbed hairs (hastisetae) that may be of some danger to infants if consumed
in large quantities. Another important emerging issue associated with arthropod contami-
nation of food is arthropod-borne allergens. Consumption of insect or mite fragments or
byproducts (cast skins, excreta, and pheromones) may provoke severe allergic reactions
in highly sensitive individuals [3].
Finally, because some insects (especially cockroaches, ants, and flies) have the po-
tential to carry disease-causing bacteria, these and other arthropod pests are a major con-
cern to the food industry and one that should be taken seriously [4,5].

Table 1 Scientific Names of Arthropod Taxa Noted in This Chapter
Common name Scientific name Family Other category

American cockroach Periplaneta americana Blattidae Dictyoptera
Angoumois grain moth Sitotroga cerealella Gelichiidae Lepidoptera
Ants — Formicidae Hymenoptera
Australian spider beetle Ptinus ocellus Ptinidae Coleoptera
Beetles — — Coleoptera
Black carpet beetle Attagenus unicolor Dermestidae Coleoptera
Booklice — — Psocoptera
Brownbanded cockroach Supella longipalpa Blattellidae Dictyoptera
Brown cockroach Periplaneta brunnea Blattidae Dictyoptera
Brown spider beetle Ptinus clavipes Ptinidae Coleoptera
Cabinet beetle Trogoderma glabrum Dermestidae Coleoptera
Cheese mite Tyrolichus casei Acaridae Acari
Cigarette beetle Lasioderma serricorne Anobiidae Coleoptera
Cluster fly Pollenia rudis Calliphoridae Diptera
Cockroaches — — Dictyoptera
Confused flour beetle Tribolium confusum Tenebrionidae Coleoptera
Dark mealworm Tenebrio obscurus Tenebrionidae Coleoptera
Dermestid beetles — Dermestidae Coleoptera
Drosophilid fruit fly — Drosophilidae Diptera
Drugstore beetle Stegobium paniceum Anobiidae Coleoptera
Face fly Musca autumnalis Muscidae Diptera
False powderpost beetles — Bostrichidae Coleoptera
Filth flies — [Several families] Diptera
Flat grain beetle Cryptolestes pusillus Cucujidae Coleoptera
Flies — — Diptera
Fruit flies — Drosophilidae Diptera
German cockroach Blattella germanica Blattellidae Dictyoptera
Grain mite Acarus siro Acaridae Acari
Granary weevil Sitophilus granarius Curculionidae Coleoptera
Ground beetles — Carabidae Coleoptera
Indianmeal moth Plodia interpunctella Pyralidae Lipidoptera
Khapra beetle Trogoderma granarium Dermestidae Coleoptera
Lesser grain borer Rhyzopertha dominica Bostrichidae Coleoptera
Maize weevil Sitophilus zeamais Curculionidae Coleoptera
Mealworms Tenebrio spp. Tenebrionidae Coleoptera
Mediterranean flour moth Anagasta kuehniella Pyralidae Lepidoptera
Merchant grain beetle Oryzaephilus mercator Cucujidae Coleoptera
Mites — — Acari
Moth flies — Psychodidae Diptera
Moths — — Lepidoptera
Oriental cockroach Blatta orientalis Blattidae Dictyoptera
Phorid fly Megaselia scalaris Phoridae Diptera
Psocids Psocoptera
Red flour beetle Tribolium castaneum Tenebrionidae Coleoptera

A. Basics: What Makes an Insect or a Mite?
1. Mites
In the food industry, we are primarily concerned with insects and mites (spiders, consid-
ered occasional invaders, pose very little risk to food products). Although mites and insects
are arthropods, there are differences between them that are important both in the control
and in the identification of these two groups. Mites belong to the class Arachnida (insects
are in the class Insecta). Arachnids have two body regions (cephalothorax and abdomen)
without wings or antennae. Adults and nymphs have four pairs of legs; larvae have only
three pairs of legs (they acquire the fourth pair after the first molt). Most mites undergo
a form of simple metamorphosis (egg, larva, nymph, and adult); the first instar is called
a larva and the remaining immature stages are nymphs.
2. Insects
Insects have one pair of antennae, three body segments (head, thorax, and abdomen), and
three pairs of legs. Some kinds of insects also have one or, more typically, two pairs of
wings (rarely absent except for immature stages). The thorax is composed of three seg-
ments: prothorax, mesothorax, and metathorax. Each thoracic segment usually bears a pair
of legs; the wings are attached to the meso- and metathorax. Characteristics of the protho-
rax are often used to identify insect species.
In some orders (e.g., Coleoptera—beetles and weevils), the front pair of wings is
hardened into a thick covering that protects the second pair of wings. Most of the food-
infesting pests are very small (microscopic to 0.04 cm for mites; up to 0.63 cm long for
some of the beetles). Other useful morphological characteristics used to identify insects
are the six parts of the jointed leg. The most distal region of the leg, the tarsus, is composed
of several segments that can vary in number on each pair of legs or the number may be
identical on each pair. Comparing the number and shape of these segments helps to identify
similar-looking insects (e.g., adult mealworms versus adult ground beetles).
B. Metamorphosis
Insects undergo a series of morphological changes as they progress from hatchlings to
adults. These changes in form are termed metamorphosis. The two most common types
of metamorphosis are (1) simple and (2) complete.
1. Simple Metamorphosis
Cockroaches and psocids are examples of insects that have simple metamorphosis. These
insects go through three distinct phases: egg, nymph, and adult. The immatures (nymphs)
are smaller but resemble adults in general appearance although they lack wings (some
may have wing buds if the adults of the species possess wings). Nymphs grow into adults
by molting several times, each time increasing their size and body proportions. Control
strategies for these species are usually less complex because the adults and immature have
similar food and shelter preferences and also look alike, which makes identification easier.
2. Complete Metamorphosis
Common food pest insects with complete metamorphosis are beetles, moths, ants, and
flies. The stages of complete metamorphosis are egg, larva, pupa, and adult. Each stage
is completely different in form and may also vary in food and habitat preferences. Wings
develop internally; there are no compound eyes during the immature stages; and there is
a period of apparent inactivity (pupal stage) prior to adult emergence. Although identifica-
tion is usually based on the adult stage, larvae of this group are often the most destructive
stage. The pupal stage is a nonfeeding, transitional stage. The egg and pupal stages are
the most difficult to control due to low respiration rates and lack of movement.
C. Growth and Development

The rate at which an insect grows and develops through metamorphosis is very dependent
on ambient conditions. Without a thorough understanding of this concept, control of food
pests is very difficult. If the temperature, humidity, and food requirements are not within
species-specific ranges, the insect may exhibit retarded development. Normally it takes
an insect 30–45 days to complete one life cycle (egg to adult) (studies of this kind are
usually done under conditions of 21°C and 70% relative humidity (rh), often referred to
as standard laboratory conditions. All developmental period durations are highly sensitive
to ambient temperatures, humidities, and nutritional factors). If the environmental tempera-
ture is lowered, the life cycle may increase in duration; if the environmental temperature
increases, the life cycle may shorten to somewhat less than average. If the environmental
temperature exceeds the endpoint extremes (either too high or too low) for development,
the insect may die or enter into a dormant phase.
Some aspects have the ability to diapause, or go into a dormant state, before condi-
tions become unfavorable. The chief factor that initiates diapause is day length. However,
certain food and temperature variables can induce it in some insects. Typically, tempera-
tures below 5°C cause death; between 13–20°C development stops; between 13–25°C
and 33–35°C development slows; the range of 25 to 33°C is ideal; above 35°C death can
occur.
Plant managers can use this information to determine the rate at which insect popula-
tions will grow within a food processing facility. Under warmer conditions, the pest popu-
lations will grow rapidly, quickly getting out of control if management procedures are
not undertaken.
Extreme temperatures can be used to manage food-facility pests. Many processing
facilities are using heat ‘‘sterilization’’ (heating a facility to temperatures exceeding
54.5°C for an extended period of time) to kill insects within a structure or commodity.
Several precautions are needed and expert advice should be sought prior to doing a heat
sterilization of a facility.
II. PEST SUMMARIES

Stored-product pests are usually categorized into two groups, based on characteristics of
their life cycle. Internal pests spend most of the feeding portion of their life cycle within
a whole seed or kernel of grain; only rarely do they feed in processed foods. Examples
of internal feeding pests include the weevils, the lesser grain borer, and the Angoumois
grain moth.
External or surface feeders usually feed on processed foods. They spend the majority
of their lives on milled grains and grain-based food products. Adults of some species can
utilize certain nonfood products, specifically pollens and molds. The destructive life stages,
however, are found in processed foods.
A. Internal Feeders
1. Weevils
Adults of the rice, maize, and granary weevils measure from 0.3 to 0.6 cm in length.
Adult weevils are commonly called snout beetles because the head is elongated into a
‘‘snout’’ that contains the mouthparts. The larvae are small, white, legless grubs that spend
the entire larval stage inside whole kernels of grain. After a mated female oviposits a
single egg into the center of each kernel, she covers the resulting hole with a gellike,
foamy material. Under standard laboratory conditions, the eggs hatch in a few days; then
the larvae feed within the kernel for about 1 month; then they pupate, emerging as adults
1–2 weeks later. Rice and maize weevils are capable of flight; granary weevils cannot
fly.
2. Lesser Grain Borer
The adult lesser grain borer is a cylinder-shaped, dark-brown beetle about 0.3 cm long.
Its head is tucked so far under the prothorax that it is not visible from above. This beetle
belongs to a family known as the false powderpost beetles. Although most species in this
family infest wood and bamboo, the lesser grain borer specializes in consuming grain and
grain products. It can infest corn, rice, and barley, but it is most commonly found in wheat
and wheat-based products. Eggs are laid on the outside of the kernel. The newly hatched,
first-instar larva bores into the kernel, often following cracks and imperfections in the
kernel surface. Under standard laboratory conditions, development from egg to adult can
occur in 3 weeks. Adults are long-lived (4–5 months) and are strong fliers.
3. Angoumois Grain Moth
The adult Angoumois grain moth is a small, buff-colored insect with a wingspan of about
0.125 cm. Its most distinctive identification features are the long hairs on the fore- and
hind wings that give the wings a fringed appearance. Eggs, laid on or near grain, hatch
about 1 week later. Larvae bore into the kernels where they feed and develop. Pupation
occurs within the kernels. Adults emerge in about 2 weeks. Larvae produce a characteristic
webbing on the food materials. Preferred foods include corn, barley, rye, oats, and rice.
Adults do not feed on grain or other food products, thus do not cause damage. Larvae
can occasionally be found developing in caked material. It is important, therefore, to thor-
oughly clean food processing areas and equipment. Pheromone traps are very effective
for monitoring adult male populations.
B. External Feeders
1. Indianmeal Moth
The adult Indianmeal moth has a wingspan of about 0.125 cm. The copper-colored band
of scales on the distal three-fifths of the forewings makes this species easy to identify.
The short-lived adults (5–7 days) are most active at dusk. Mating occurs shortly after
adult emergence. The eggs are laid on food or food packages. The larvae feed on most
grain-based products but also on chocolate, beans, spices, cocoa, nuts, and dried fruit.
Larvae leave webbing behind as they feed, often causing particles of dry food to
clump. The webbing, which often contains frass (feces), can contaminate food and bind
equipment such as motors and augers. The combination of webbing and food is very
attractive as an oviposition site [6]. Thus, webbing removal is an important measure to
take to reduce future infestations. Mature larvae wander away from the food source looking
for a place to pupate. Their natural instinct is to crawl up vertical surfaces, making observa-
tion of this insect pest easier than it is for many other pests. Trailing larvae can be used
to identify an emerging pest population or locate an existing population. Adult male popu-
lations can be effectively monitored using pheromone traps.
One characteristic of this insect, and also many other stored-product moths, is the
ability to diapause (a period of slowed or suspended growth or dormancy). Diapause can
be initiated in response to cold temperatures, high population levels, or short photoperiod
[7,8]. Usually, the last larval instar is the one that diapauses, resulting in a flush of adult
emergence shortly after diapause terminates. Thus, an unheated warehouse that cools dur-
ing the winter may give the appearance that control has been achieved, when in fact the
larval population has diapaused and will resume activity when environmental conditions
favor growth, typically in the spring.
2. Mediterranean Flour Moth
The wingspan of the adult Mediterranean flour moth approaches 2.5 cm. The forewings
are a pale gray with transverse black lines and flecks; the hind wings are gray to dirty
white. At rest, this moth pushes up with the front legs, giving the body a sloped appearance.
Lifespan and biology, including diapause, are similar to the Indianmeal moth. Pheromone
trapping is very effective in monitoring this insect.
3. Flour Beetles
Adult red flour beetles and confused flour beetles measure 0.3 to 0.5 cm in length. These
two kinds of reddish-brown beetles are probably the most common and widespread, as
well as the most important economically, of the food pests. They are also nearly identical,
hence the ‘‘confused’’ in the common name. Probably the best identifying characteristics
are seen in the antennae. Each antenna of the red flour beetle ends abruptly in a three-
segmented club, while the antennae of the confused flour beetle gradually enlarge. Another
morphological character that can be used to distinguish the two species is that the sides
of the red flour beetle’s thorax are curved; the sides of the confused flour beetle’s thorax
are nearly straight.
A behavioral characteristic that can be used to differentiate red from confused flour
beetles is flight ability. Red flour beetles fly (but are not strong flyers); confused flour
beetles do not fly. As with all food pests, this kind of information becomes very important
when attempting to locate sources of infestation and existing infestations. In the case of
those arthropod pests that do not fly, it can be postulated that human activities must play
some significant role in moving these rather sedentary pests from one location to another.
To determine where additional infestations may be found or where the source of an ex-
isting infestation is located, follow the product flow. If an insect has flight ability, it can
readily move, perhaps from an adjacent room or even from a point outside the food manu-
facturing plant, to wherever there is available food. It may be understood, then, that locat-
ing the source of these highly mobile pests may be very difficult and may require consider-
ably more time and labor than might be the case for nonflying pests.
Red and confused flour beetles are major pests of flour. Since they cannot feed on
whole grains, they rely on other insects or rodents to first damage the kernels. Flour beetles
may be found in grain fines, dried fruit, chocolate, spices, rodent baits, botanical drugs,
peas, beans, vegetables, dried milk, peanuts, cacao, and forest products. Eggs are laid
directly on the product or packaging. Larvae are fairly active, but negatively phototactic,
so observing them is difficult. Pupae are naked (without any protection such as a cocoon
or pupal case), and pupation usually occurs near the surface of the food or in a nearby
sheltered place. Adults are attracted to light but have limited mobility to reach light traps,
especially in the case of the confused flour beetle.
Both species are capable of breeding year round in heated buildings. In unheated
buildings, only the adults are likely to be observed during cold weather. The confused
flour beetle is more common in the cooler parts of the world, while the red flour beetle
is more prevalent in warmer climates. However, given the worldwide trade in food prod-
ucts and raw ingredients, both species have become widely distributed, and it has been
observed that both species can sustain populations in any geographic location.
Eggs are laid in groups of twos or threes in the food material. Oviposition periods
are longer for the confused flour beetle (8 months versus 5 to 6 months) than the red flour
beetle. The life cycle from egg to adult may take about 7 weeks in the typical storage
environment. Adults are very long lived, some over 3 years, and eggs may be laid for
more than 1 year. Thus, considering the longevity and fecundity of these two flour beetles,
it may be understood why persistence is so important in managing these insects.
When large beetle populations are present, both species can give flour and other
processed foods a grayish tint. Compounding the problem is the fact that this graying
promotes the growth of molds that further contaminate the product. Additionally, both
species produce secretions that impart foul odors to the food products.
4. Drugstore Beetle
The adult drugstore beetle is a small (0.16–0.35 cm), light brown to red-brown, hump-
backed beetle with the head not visible from above. The wing covers have pits arranged
in longitudinal rows or grooves. Antennae have a three-segmented club. This beetle and
the cigarette beetle, both members of the family Anobiidae, could both be confused with
many wood-boring beetles. If the suspect, anobiid-like insect is found around food, it is
most likely a drugstore beetle or a cigarette beetle. If wooden pallets are present and food
residues are absent, identification should focus on some sort of wood-boring beetle.
The drugstore beetle larva is capable of feeding on a whole kernel of grain, but it
prefers processed grain products. Drugstore beetle larvae can also feed on leather, wool,
and other textiles, botanical drugs, spices, and tobacco. The adults do not feed [9]. Females
lay eggs singly in cracks or folds of food or packaging. Newly hatched larvae are nega-
tively phototactic and will actively seek access to food through minute holes in packaging.
Larvae can perforate tin foil and sheet lead; thus many kinds of packaging are readily
penetrated. From egg to adult takes 40 days under ideal conditions (30°C, 60–90% rh)
[10]. Adults can live up to 3 months, but the usual adult lifespan is 2–3 weeks. Drugstore
beetle adults are excellent flyers and are attracted to light.
5. Cigarette Beetle
The adult cigarette beetle (0.16–0.35 cm in length), a light brown insect with a humped
shape, is similar in appearance to the drugstore beetle, but it has smooth wing covers and
the antennae are sawlike. Eggs are laid in or near food. A complete life cycle, egg to egg,
takes 30–90 days, depending on the temperature and other influences. Larvae avoid light,
preferring to stay sheltered within the food source. After completing metamorphosis, the
adults often remain inside the pupal chamber for about 1 week. They mate shortly after
emergence. Adults live approximately 3 weeks. Although a major pest of tobacco, they
also feed on grain products, dried fruits and vegetables, textiles, botanical drugs, spices,
dried flowers, and books. This insect is also an excellent package penetrator and a strong
flyer. Flight activity peaks in the late afternoon and early evening.
6. Grain Beetles
Adults (0.3 cm in length) of the sawtoothed grain beetle and the merchant grain beetle
are very similar in appearance to each other but can be easily distinguished from other food
pest insects by the six sawlike projections on each side of the prothorax. To distinguish the
sawtoothed grain beetle from the merchant grain beetle, examine the area around the eyes.
The sawtoothed grain beetle has smaller eyes and the area just behind the eyes is much
larger (see illustrations in the references cited in Section VII). Another important distinc-
tion is that the sawtoothed grain beetle does not fly; the merchant grain is a weak flyer.
The life history strategies of the two species are very similar. Egg-to-egg develop-
ment time requires 30–50 days. Females lay eggs singly or in very small batches in crev-
ices in or around a food source. Larvae are very active and readily move about the food
as they feed. Common food sources include flour, cereals, and most other grain products;
chocolate; pasta; dried fruits; nuts; dried meats; and sugar. Larvae supplement their diet
by feeding on the eggs and dead adults of stored-product moths. Pupation occurs within
the food in a very crude cell. Adults emerge within 7 days and oviposition usually begins
with the first day of adult life. Adults usually live 6–10 months; however, they have been
known to live 2–3 years. Since adult sawtoothed and merchant grain beetles are not at-
tracted to light, light traps are not effective monitoring tools.
Sanitation is critical in controlling these pest species. Plant managers should be
aggressive when implementing control strategies. The sawlike teeth of the pupal stage
contain a foul-tasting repellent, apparently a defense mechanism. If large populations are
allowed to build within a food ingredient, the resulting food product will have an off-
flavor unappealing to human tastes.
7. Other Grain Beetles

Adult flat grain beetles and rusty grain beetles, both 0.15 cm in length, are among the
smallest grain-infesting beetles. Both can be distinguished from other flat grain beetles
by the presence of a raised line parallel to the outer margin of the thorax. It is very difficult
to distinguish these two beetles from each other. Male flat grain beetles have very long
antennae (about as long as the beetle’s body). Female flat grain beetles and both sexes
of the rusty grain beetle have short antennae.
Both species are cosmopolitan, but the geographic range of the flat grain beetle is
restricted by low temperature and low humidity. The rusty grain beetle is the more abun-
dant of the two in the wet tropics [10]. Both species feed on a wide variety of grain and
food products. In general, mold growth flavors larval development. Although incapable
of feeding on perfectly intact kernels, those with even the smallest cracks or defects are
vulnerable to attack. The larvae are also known to feed on dead insects.
The life cycles of these two pests are very similar and they are often found together.
Females lay their eggs singly in grain kernel furrows, grain debris, or processed product.
Larvae appear in 8–10 days and spend their time actively moving about on the food.
Pupation occurs within a cocoon made of food particles. Adults remain within the cocoon
for a few days before chewing their way out. The life cycle can be completed within 1
month; however, under extreme conditions, this may take up to 3 months. Adults and
larvae are cannibalistic on eggs, larvae, and pupae of their own species. Both species are
capable of flight. Spilled grain outdoors is a suitable breeding medium. From such outside
habitats, the beetles readily fly into food processing plants.
8. Dermestid Beetles
There are several members of the genus Trogoderma in the family Dermestidae that are
serious pests of stored products. Two species commonly found are the warehouse beetle
and the cabinet beetle, adults of both measuring 0.3 to 0.6 cm in length (adult size is
dependent on the size of the larva at the beginning of pupation). It is very difficult to
identify these insects at the species level. This task usually requires the expertise of an
entomologist trained in the taxonomy of this family. However, some characteristics can be
used to identify members of the genus Trogoderma. These are small, oval-shaped beetles,
basically dark colored but with the wing covers having a variety of brown and yellowish
scale patterns. Trogoderma larvae can be distinguished from other dermestid larvae in
that they grow to about 0.6 cm (compared to 1.4 cm for black carpet beetles) and are a
yellowish-tan color that is lighter than black carpet beetle larvae. Several long thin setae
(hairs) extend out from the tip of the abdomen, and rings of hair encircle the entire body
in distinct segments.
In the United States, Trogoderma beetles are not so important as pests as they are
in those countries where the most important pest dermestid, the khapra beetle, occurs.
This beetle is the most destructive pest of stored food and is the only insect the food
industry confronts that is under quarantine status. When an infestation of khapra beetle
is discovered within the borders of the United States, the U.S. Department of Agriculture
takes immediate effective measures to prevent the spread of this pest to adjacent areas.
Trogoderma larvae, more specifically their setae, or hairs, are an important health
concern, and infestations will certainly get serious attention from health and food regula-
tory officials [2]. Trogoderma larvae have two types of setae. One type, the hastiseta, has
numerous barbs on the end of the shaft, while the other type, spiciseta, is slender with
numerous pointed hairs. Both types are present in the cast skins left behind after a larval
molt and can be found in food products infested with Trogoderma larvae. If consumed,
the barbs and sharp hairs can be irritating to the mouth, esophagus, and other parts of the
digestive tract. This can be especially dangerous to infants and young children. Therefore,
it is important to take immediate action when this pest is detected within a food processing
facility.
The cabinet beetle is capable of infesting a wide variety of materials of both plant
and animal origin; however, it does best on processed cereals and animal feeds. Warehouse
beetle populations increase the fastest on animal feeds, barley, wheat, pollen, and grocery
products such as oatmeal, wheat germ and whole wheat flour. However, it can sustain
populations on cocoa, fishmeal, nuts, dried peas, candy, pastas, spices, dead animals, and
dead insects.
9. Spider Beetles
The various kinds of adult spider beetles are so named due to their very small head and
prothorax and large abdomen, causing some species to resemble spiders. They range in
length from 0.078 to 0.469 cm and have long hairy legs that also make them look spi-
derlike. Spider beetles in the genus Ptinus are more prevalent in colder climates, preferring
temperatures of 25°C or less. Thus, Ptinus species can often be found in unheated ware-
houses and plants, typically older wooden facilities with damp basements. Eggs are laid
in or on the larval food. After three larval molts, the larvae bore into old wood, food
packaging, or cardboard, where pupation occurs. Development times vary with each spe-
cies: Australian spider beetle: 3 months; brown spider beetle: 6–9 months; whitemarked
spider beetle: 1 month [11].
Spider beetles are scavengers that can be found feeding on milled or processed
grains, dried fruits, dried meats, textiles, animal droppings, and dead insects and verte-
brates. Animal nests are a favorite habitat where they ingest moist animal excreta. They
thrive in dark, moist cracks where spilled food materials accumulate. Since they prefer
the dark, they are most active at night. Spider beetles can remain active during freezing
temperatures, thus pest problems are possible year round in unheated facilities.
Inspecting for spider beetles is not like inspecting for most other stored-product
pests. The search area should be expanded to include suspected rodent, bird, bee, and
wasp nests; textiles; animal carcasses; and any hidden areas where grain dust could accu-
mulate (floor cracks, wall voids, false ceilings). Caution should be taken when cleaning
up these infestations, since there is a risk of contamination by pathogens present in rodent
urine. Sealed (nonvented) eye goggles, protective gloves, and a respirator with a HEPA
filter (contact public health officials for specific requirements) should be worn. Spider
beetle infestations are very difficult to manage because the beetles are active mainly at
night and feed on a wide variety of materials. Sanitation and sealing are key management
strategies.
10. Mealworms
People that fish or have reptilian pets are familiar with the immature stage of these two
food pests, the yellow mealworm and the dark mealworm, since they are commonly used
as bait and pet food. However, most consumers are unaware that the adults of these two
species are among the largest beetles (length 1.25 cm) closely associated with the food
industry. They may be confused with ground beetles, insects that occasionally invade
buildings. Since they are in the same family as the flour beetles, they may be incorrectly
identified as ‘‘large’’ flour beetles. Adult mealworms are oval in shape, more flattened
than ground beetles, have eleven-segmented antennae (filiform or moniliform) and a 5–
5–4 tarsal formula (ground beetles have a 5–5–5 tarsal formula). Dark mealworms are
dull black; yellow mealworms are shiny dark brown to black.
Mealworms overwinter as larvae, emerging as adults the following spring to mate
and lay eggs. Adult females live 2–3 months and oviposit intermittently as long as they
live. They prefer old, moldy, out-of-condition grains or grain products, but will feed on
cereals, crackers, and meat. The larvae (length 3.125 cm) can survive long periods of time
(6–9 months) without food or moisture. Poor sanitary conditions with ample moisture are
conducive to population outbreaks. The presence of mealworms within a food facility is
cause for concern. Ingestion of mealworm eggs can cause severe gastrointestinal upsets.
Mealworms are produced for human consumption and are served in restaurants around
the world. The strong-flying adults are attracted to lights.
C. Structure-Infesting Pests
1. Cockroaches
Cockroaches used to be the primary pests of structures, including food processing plants.
However, with the development of effective baits for population suppression, cockroaches
have declined in relative importance to other pests. This is not to say that they are not
important pests. Cockroaches have a close association with humans and commonly feed
on human foods, but they also often feed in unsanitary areas such as sewerage systems.
This connection between cockroaches and unsanitary habitats has led to the speculation
that they have the potential to transmit disease organisms to humans. Pathogenic organ-
isms, including bacteria, fungi, protozoans, viruses, and molds have been found on cock-
roaches. However, while only circumstantial evidence is available that directly points to
cockroaches as vectors of human disease, this evidence is compelling [5,12–14].
a. German Cockroach. The German cockroach (length 1.6 cm) is a common pest in
food processing plants. It is easily identified by two dark longitudinal stripes on the prono-
tum. The body is brown, females being slightly darker than males. Indoors, this insect
can breed year round. German cockroaches produce more eggs per egg capsule and the
immature stages complete their growth faster than any other cockroach species. Egg-to-
adult development can be completed in just over a month, although 2–3 months is more
common. Females carry the egg capsule until the eggs are just ready to hatch. This behav-
ior increases the survival rate of young German cockroaches by preventing egg capsule
mortality factors. The number of eggs per capsule is usually 30–40. Adults live 3–6
months. Rarely found outdoors, German cockroaches inhabit structures where food, water,
and harborage are available. They will feed on all types of human foods and also on glue,
toothpaste, soap, and many other organic materials.
b. American Cockroach. American cockroaches are very large roaches (3.75–5.3 cm
in length), red-brown in color, with fully developed wings that completely cover the abdo-
men. The pronotum has a dirty-yellow band around the margin. Egg capsules are either
dropped at random or glued to surfaces in protected locations. The nymphal stage lasts
for more than 1 year, sometimes 2 years. Wing pads become evident in the third or fourth
instar. Adult females live about 1 year, while males live only 6–9 months. Females can
produce egg capsules at very short intervals (every 4 days during the summer) and are
able to produce viable egg capsules without mating [13]. American cockroaches prefer
warm, damp locations. Steam tunnels, sewer lines, and boiler rooms are common sites.
They are strong flyers and easily migrate into buildings.
c. Brown Cockroach. This red-brown cockroach (length 3.1–3.8 cm) looks very simi-
lar to the American cockroach except the American cockroach is typically much larger
and the cerci (antenna-like projections at the rear of the abdomen) are triangular in shape
and less than twice as long as they are wide. The pronotum has a faint dirty-yellow band
around the edge. It has fully developed wings and can easily migrate into structures. It
usually is found in warm, damp locations (steam rooms, boiler rooms, steam tunnels);
however, during the summer, brown roaches can be found in large numbers outdoors. It
is more common in the southern United States, and although its distribution is probably
widening, misidentifications may explain some reports of its presence in northern climates.
Like the American cockroach, the egg capsules are either dropped randomly or glued near
the ceilings or elevated sites. Egg capsules generally have 25 eggs. Nymphs emerge in
about 35 days. Egg-to-adult development takes on average 200 days. Adults are long lived
(8–9 months).
d. Brownbanded Cockroach. Brownbanded cockroaches (length 1.25 cm) are light-
brown to brown and have two light yellow-brown bands running across their wings (when
the wings are at rest across the back), and there is a light area on either side of the prono-
tum. Females are darker and their wings cover only three-fourths of the abdomen. Egg
capsules (containing about 15 eggs) are carried by the female for 1–2 days, then attached
to a secluded surface. Nymphs appear in about 2 months and do not become adults for 3–
10 months, depending on environmental conditions. Adults live approximately 6 months.
Brown-banded cockroaches prefer a drier environment than most cockroaches and prefer
to hide in elevated areas above the ground floor.
e. Oriental Cockroach. The Oriental cockroach, a medium-sized blattid (male length
2.5 cm; female 3 cm) is very dark brown to black. Males have fully developed wings,
but apparently do not fly. Females have rudimentary wings that appear as wing buds.
Thus, females are often confused with nymphs but can be distinguished from the nymphs
by the presence of wing venation. Females carry the egg capsule containing about 16 eggs
for 1–5 days before depositing it in a sheltered location near food. Nymphs emerge about
2 months later. Depending on environmental conditions, development to adult may take
9 months to more than 2 years. Adult females live 1–6 months, while males live 3–5
months.
Oriental cockroaches are often abundant in commercial facilities. They are often
found in damp locations (drains, crawlspaces, sewer lines) but can also be found outside
in leaf litter, mulch, and trash. They prefer starchy foods, but they will feed on almost
any kind of organic matter.
2. Psocids
Psocids, commonly called booklice (but are neither lice nor mites, though often mistakenly
identified as such), are small (length 0.078–0.625 cm), colorless to gray or light brown
insects with scalelike wings (usually nonfunctional). Psocids undergo gradual metamor-
phosis, typically reaching adulthood within 1–2 months. Adults survive 1–3 months.
Many species are able to reproduce without mating (parthenogenesis). Psocids prefer
damp, warm, undisturbed conditions. Dry conditions or low humidity either stops or slows
development or causes desiccation and death.
Psocids feed primarily on molds, so any product that can sustain mold growth can
harbor a psocid population. They can also feed on starches, starchy glues used in bookbind-
ings, and dead insects. Raw grain to finished food products and everything in between
are vulnerable if the materials become moldy or are stored under humid conditions. The
most common complaint in warehouse situations is the presence of psocid populations on
wooden pallets that have been stored outside in the rain or on cardboard boxes that have
been stored under high moisture conditions.
During hot humid weather, psocid populations often build up on composite fiber
‘‘slipsheets’’ used to separate palletized stacks of newly manufactured metal cans. Unless
the cans are thoroughly sanitized before foods are put into them, some insects will be
canned with the product. Switching to plastic slipsheets and plastic pallets effectively
eliminates psocid problems in this segment of the food manufacturing industry.
The easiest way to prevent or eliminate psocid infestations is to reduce the relative
humidity to less than 50% and increase air movement to aid in moisture evaporation. If
moldy conditions exist, equipment, walls, and floors should be cleaned with a disinfectant
to remove the mold and then dried thoroughly. Although psocids are troublesome in that
they contaminate food products by their presence, they usually cause little direct damage
to bulk grains.
3. Flies
There are numerous species of flies that are very well adapted to living in and around
humans. Unfortunately, flies, like cockroaches, are capable of carrying disease-causing
organisms [4,5]. Public health and federal inspection officials always take note of fly
infestations during inspections. Identification of the breeding source is critical to managing
fly infestations. Without the proper identification of the fly species, the breeding source
may not be correctly identified.
Adult flies can be easily separated from other insects in that they only have one
pair of wings; each rear wing is represented by a small appendage called a haltere. Imma-
ture flies (maggots) do not have legs. To facilitate this discussion, three arbitrary categories
of flies are considered here: small flies, filth flies, and nuisance flies.
a. Small Flies
drosophilid fruit flies. Several different species lumped together under the
common name of fruit flies or vinegar flies are among the most common kinds of flies
in wet processing facilities where breeding occurs in decaying, moist organic matter. In
the case of those species with red or purple eyes, this distinctive eye color rules out identi-
fication as a phorid fly. Adult fruit flies have a tan-colored body and are usually about
0.3 cm in total length. Larvae are creamy white with a breathing tube at the rear end. The
brown-colored pupae bear distinctive hornlike stalks at one end. Eggs are deposited on
or near the surface of decaying organic matter. Females lay up to 500 eggs that hatch
within 1–2 days. Larvae feed for only 5–6 days and then crawl to a drier area for pupation.
Under ideal conditions, the egg-to-adult cycle can occur in 8 days. Thus, populations can
quickly build to tremendous numbers.
Sanitation and moisture control are critical to limiting population growth. Minimal
food is needed to complete the cycle. These flies can complete their life cycle with the
organic matter and moisture found in a damp mop. Garbage cans without liners are also
suspect. Light trapping is effective with recently emerged adults but is not a substitute
for sanitation.
phorid flies. Adult phorid flies (length 0.3 cm) are similar in size and appearance
to the fruit fly. However, they have a humpback-shaped thorax and lack red eyes. Phorid
fly wings also have two heavily sceloritized (dark) veins near the forward edge of the
wings. When disturbed, the adults tend to run for a short distance before taking flight.
The females have a brown, saddle-shaped segment near the end of the abdomen. Pupae
lack the two horns found on fruit fly pupae. This clue would be helpful in making an
identification if no adult flies were available. Like the fruit flies, phorids feed on and breed
in moist organic matter. They are a major concern in hospitals or long-term health care
facilities where they sometimes infest open wounds of patients.
Eggs are laid one at a time in groups of 20 to 40 over a 0.5-day period. The larvae
emerge in 24 hr and feed for 1–2 weeks, depending on temperature. The larvae will crawl
to a drier location to pupate. Egg-to-adult development can take from 2–4 weeks.
moth flies. Often confused with moths because of their scaly wings, these flies
are major pests of processing facilities, where they breed in drains and thus come into
contact with bacteria. The adults are yellowish, brownish-gray, or black and are about 0.3
cm in length. When resting, they hold their mothlike, hairy wings rooflike over the back.
Eggs are typically laid in the gelatinous film inside a drain or in decaying organic matter.
The larvae hatch within 2 days and feed for 2 weeks on drain sludge, bacteria, fungi, and
algae. Larval breathing is accomplished by extending a segmented breathing tube to the
surface. The pupal stage is short, about 1.5 days. Adults live 2 weeks and can often be
found resting on the walls of bathrooms. They are weak flyers, thus are usually found
near the breeding site. Adults become active at night, hovering close to the breeding site.
Adults feed on pollen or polluted water.
Moth flies in a facility indicate that they are either breeding within the facility or
in nearby sewage or water-treatment facilities. Drains should be scrubbed clean all the
way to the trap. If the source cannot be found in the drains, look for cracks in the slab.
Often pipes beneath the slab will break, depositing moist organic matter and allowing
breeding to occur out of sight. To confirm a breeding site, wait until dusk and then cover
the crack with tape or a plastic bag with double-sided tape inside. Check the tape for flies
in the morning. Since adults are active at night, some will likely get caught on the tape.
b. Filth Flies
houseflies. The most common fly worldwide, the housefly, is a medium-sized
(0.3–0.6 cm long), gray fly with four dark stripes on the back of the thorax. It is often
confused with the face fly. To separate the two kinds of flies, examine the calypter: bare
with no tuft of hairs—housefly; tuft of hairs present at point of attachment to the thorax—
face fly. Eggs are laid in groups of 75 to 150 in moist organic matter, typically animal
feces. Eggs hatch in about 1 day, and the larvae will then burrow deep within the food
medium. They can pupate within 3 days, although a week or two is not unknown. The
adults feed on the same food as the larvae and can be found sampling most human foods.
Adults typically feed on liquids, but can also feed on solids by regurgitating digestive fluids
onto the food. This regurgitated product dissolves the food enough that the mouthparts can
sponge up the mixture.
Adults are strong fliers, able to fly up to 20 miles, although 1–2 miles is more
common. Adults, when not active during the day, prefer to rest low (less than 1.5 m) on
vertical surfaces. During the night, they may rest at greater heights. Because the adults
are attracted to lights, the use of properly installed light traps can decrease the risk of
pest invasion from outdoors. Trash should be stored away from any entrances to the facility
and removed on a regular basis (at least weekly).
blow flies and bottleflies. Several species of blow flies or bottleflies (length
0.6–1.25 cm) have been known to infest buildings where food in manufactured. These
flies are very important agents in the natural decomposition of dead animals, often being
the first insects to lay eggs on such substrates. Forensic entomologists are often able to
set the time of death by examining the size and type of maggots present on a human
corpse. If a carcass is not available, the flies seek out garbage or other decaying organic
matter, including feces, on which to oviposit. The larvae burrow within the carcass to
feed, but crawl away from it and then burrow into the soil to pupate. These flies overwinter
in either the larval or pupal stage.
The adult flies are easily identified by the metallic blue, green, blue-green, or yellow-
brown sheen of their bodies. The adults are very active during the day, often buzzing
around windows, doors, and oviposition sites. At night, inspection of suspected breeding
areas may reveal adults resting nearby. The presence of these flies may indicate that an
animal has died within the structure, possibly in the walls or attic, or in a multiple-catch
rodent trap that was not promptly serviced.
c. Nuisance Flies
cluster flies. Cluster flies (adult length 0.93 cm) are closely related to blow flies
(same family) but are closer in size to house flies. The nonmetallic gray body lacks thoracic
stripes. Golden hairs, easily seen with 30⫻ hand lens, are situated on the thorax right
behind the head and around the base of the wings. When viewed from above, the body
appears to be narrow, due to the wings completely overlapping the back. When crushed,
adults smell like buckwheat honey.
Unlike most flies that appear in food facilities, cluster flies do not feed on decaying
organic matter. Instead, larvae are parasites of earthworms. Eggs are laid singly in soil
cracks. Eggs hatch in 3 days and the newly emerged larvae seek out earthworms. The
larvae burrow into an earthworm and feed for about three weeks. Egg-to-adult develop-
ment typically takes 1–1.5 months. During most of the year, cluster flies are not a problem.
They become a nuisance with the onset of cooler weather when the adults enter structures
in large numbers seeking overwintering sites. The adults are attracted to light-colored
south and west walls that radiate heat on cool nights. Once they gain access to the structure,
they crawl into small cracks. Unseasonably warm weather causes overwintering adults to
become active. Since they are seeking warmth and attracted to light, they are usually found
on windowsills or in light traps.
Since cluster flies breed in earthworms, there are no practical methods to control
this pest at the breeding site. Emphasis must be placed on sealing structures so that the
flies cannot gain entrance in the fall. Insecticidal treatment of exterior surfaces, where
adults rest before entering structures, can reduce the numbers that eventually gain access
to the structure. Timing of these treatments is critical and dependent on local weather
conditions.
D. Noninsect Pests—Mites
Both the grain mite and the cheese mite (length of both 0.039 cm) are much smaller than
most adult ticks and, in fact, are barely visible to the naked eye. Mites have an unseg-
mented abdomen broadly attached to the thorax. Adults and nymphs have eight legs, larvae
have six. Mites are very difficult to identify to species except under high magnification.
Grain mites are largely transparent, with tan mouthparts and legs; cheese mites are pearly
white, with yellow to red-brown legs. Mites are very common in cereals, dried fruits,
cheese, and most stored foods. Heavily infested food, which deteriorates rapidly due to
the presence of dead and live mites as well as their fecal material, has a characteristic
sweet or minty odor that is easily detected by the human nose. Infested product may also
be coated with ‘‘mite dust’’ composed of molted skins. Contact with some mites can cause
a skin condition known as baker’s itch or grocer’s itch.
Like psocids, mites require a minimum relative humidity of about 62%; below this
the population will die out [15]. Infestations occur more often when products are produced
or stored under cool, humid conditions. Eggs, deposited directly in the food material, hatch
into six-legged larvae in 3–4 days, and those larvae feed for 3 days before going quiescent
for a few days. Nymphs then transform into adults about 3 weeks later. Adults live 40
days. Grain mites have a nymphal resting phase (hypopus) that does not feed but can attach
to other animals (birds, rodents, insects), resulting in an increased chance for dispersal to
new food sources. Effective management strategies include keeping the relative humidity
below 60%, reducing moisture, and increasing air flow.
III. NONCHEMICAL METHODS FOR MANAGING FOOD

INDUSTRY PESTS
A. Exclusion
The best way to prevent an infestation of insects and mites inside a building is to prevent
them from getting inside. The easiest way to do this is to keep all doors and windows
closed and well sealed. Brush seals and weather stripping should be in good shape. If
spring-loaded return mechanisms are installed, they should be in good working order and
properly set so that doors close completely. If doors need to be kept open, then tight-
fitting screens should be installed. Screens should receive regular maintenance to repair
holes. Mesh should be as small as possible to prevent insect entry but still allow for
adequate air flow. Exclusion of most flies can be accomplished with 14*18 or 16*16 mesh
screen.
Air doors (or curtains or screens) are devices that are mounted over a doorway that
force a powerful stream of air downward to keep insects from entering while the door is
open. The problems with these devices are twofold. First, if installed above an exterior
door, changing air pressures on the exterior of the building may either pull the air stream
outside or push the air stream inward, carrying insects into the facility. To correct this,
air doors should only be used on interior doors to keep insects from penetrating further
into a facility. The second problem is that the mechanism is usually improperly adjusted
so that the stream of air is not strong enough to prevent insect penetration. A ventilation
engineer should be consulted to confirm the proper installation and maintenance of these
barriers.
B. Lighting and Trapping

1. Lighting for People
Lighting is one of the most important factors to be considered when the objective is to
minimize problems with nocturnal flying insects and stored-product pests that are attracted
to light. Two factors must be considered when lighting the exterior of a facility: bulb type
and fixture placement. Bulbs vary in their ability to attract insects; using the proper bulb
in the correct situation will result in the desired insect response. Mercury vapor bulbs are
most attractive to insects, while sodium vapor bulbs are least attractive.
When installing lights on the outside of a facility, mercury vapor bulbs should be
used on the perimeter of the facility grounds and parking lots. By using mercury vapor
bulbs away from the facility, any insect that is attracted to light will be drawn away from
the facility. If lighting is needed near the facility, sodium vapor bulbs should be used.
Sodium vapor bulbs have a pink, yellow, or orange glow that is much less attractive to
insects than light in the bright white or bluish spectrum.
Indirect lighting should be used whenever possible on or near a facility, so that the
actual light source is shielded from direct view. If insects come to rest on the building
exterior, there is a greater chance that they will be drawn into the facility when the doors
are opened. Treatment of exterior walls of the facility with a residual insecticide will most
likely not control the problem. Insects that are attracted to light are generally capable of
flying long distances. Therefore, those insects killed by a residual chemical treatment will
most likely be quickly replaced by new arrivals. The best way to light a facility for pest
prevention is to mount light fixtures a considerable distance from the facility so that the
light shines on the building, but the bulb is not near the building. Thus, insects that are
attracted to the light do not come to rest on or near the building.
2. Light Traps and Modified Light Traps

a. Light Traps. Light traps can also be used within the facility to monitor pest popula-
tions and to prevent insects from gaining deeper access inside a facility. Light traps should
be used when the potential for insect infestation (especially flying insects) is greatest.
Since devices designed for home use do not have the safety features required in food
manufacturing plants, only commercial units should be used.
Light traps used within a facility are most effective for nocturnal flying insects.
Flies, however, can be very slow to respond to light traps. Thus, plant managers should
not rely on light traps to take the place of structural sealing and enforcement of a closed-
door policy. There are numerous different types and sizes of light traps available on the
commercial market. They vary in the way in which they catch insects and how they deal
with attracted insects.
The first traps on the market were electrocuting traps and these traps are still very
popular. They use black light to attract the insects to the trap, where they contact an
electric grid that delivers a usually fatal electric shock. Dead and stunned insects fall into
a collection receptacle. It is very important to empty and clean these collection trays on
a regular basis. Some food pests also readily feed on dead insects (for example, the ware-
house beetle and other dermestids). If dead insects are allowed to accumulate in a trap,
a secondary pest infestation will start within the light trap. When this food source is ex-
hausted, insects will move to other locations within the facility, possibly to some previ-
ously uninfested product or processing area.
b. Add Glue Boards. Some traps feature a glue board in the collection tray. Glue boards
prevent whole insects or fragments of insects from being blown or jostled out of the trap,
and they prevent recovered stunned insects from leaving the trap. Newer light trap models
use a low voltage electric pulse to stun the insects, which then fall down onto the glue
board. This reduces the production of insect fragments and does not create the bug zapping
sound generated by the electrocution-type traps.
The combination of a glue board and a black light (with no electric grid) is more
acceptable for placement in public access areas of a plant. Insects attracted to the light
become trapped on the glue board when attempting to rest near the light. Any light that
uses a glue board is suitable only for areas of a facility with low insect activity and low
dust production.
3. Trap Placement
Placement of traps is critical to a successful program. If the target pest is a fly, especially
houseflies and other filth flies, traps should be placed no more than 1.5 m above the floor.
If night flyers are the target, traps should be ceiling mounted but always in a location that
will permit inspection and cleaning. Lights should not be placed where they can be seen
from outside the building or where there is competition from other light sources. If light
traps are needed near bay doors, they should be placed above the top of the doorway and
perpendicular to the door so the light is not directed outside. Wall mounted traps should
also not be placed where visible from the exterior of the facility.
Do not install electric light traps outside, especially near the loading dock. They
will only attract more insects than they can catch. There is, however, one effective way
to use traps designed for outdoor installation, and that is for those food manufacturing
facilities situated near large bodies of water (lakes, rivers). Light traps can be placed away
(at least 9 m) from the building facing the facility (back of trap toward water). Insects
that are attracted to the lighted building will be pulled back toward the water and away
from the structure.
Never install light traps at ceiling level, directly over, or next to food production,
food handling, or food processing areas of a facility. This will attract more insects to the
site and there is a risk for insect fragment contamination. Do not install light traps within
4 m of an entry door. Insects will easily pass between the light trap and the entrance to
the facility and gain ready access without trap interception. Finally, do not place traps
where they can easily be damaged by forklifts or where there are strong air currents.
4. Trap Maintenance
Maintenance of light traps is crucial to program effectiveness. Annual replacement of
bulbs is mandatory, even if the bulb still appears to be bright. The older the bulb, the less
attractive it is to insects. The best time to replace the bulb is in the spring, so traps are
most effective during the time of the year when insect pressure is the greatest.
IV. MONITORING WITH PHEROMONE TRAPS

A. Pheromones
Insects, like all animals, live in a world abounding with odors. These odors fill the air,
coat the surfaces of plants, and emanate from food sources. Some chemicals released into
the atmosphere serve as chemical messengers to other individuals of the same species.
Such chemicals have been given a special name, pheromone (from the Greek pherein, to
carry, and horman, to excite). Pheromones, then, are chemicals secreted by an animal that
affect the behavior of other animals of the same species.
Typically, each specific pheromone conveys a specific message to the recipient ani-
mal in which it prompts a specific behavior or a specific physiological modification. For
example, the sting-release pheromone, emitted when a honeybee pulls away from the
animal it has stung, leaving its stinging apparatus stuck in the target host, ‘‘tells’’ nearby
bees something like ‘‘Danger! Come help me!’’ Each kind of stored-food moth and beetle
pest produces a rather large inventory of pheromones, each of which elicits a specific
behavioral response or, in some instances, a range of behavioral responses in other mem-
bers of the same species that happen to be situated within the range of influence of that
particular pheromone.
At low population densities, flour beetles, for example, aggregate in response to
the secretion of quinones; at intermediate densities they distribute randomly, and at high
population densities they distribute themselves uniformly. Thus, not only does the chemi-
cal send a message, but also the interpretation of the message received varies depending
on the condition of the receiver. Larvae of the Mediterranean flour moth secrete com-
pounds that also affect population dispersion. In crowded conditions, the responses include
both behavioral and physiological components: dispersion, lengthening of the generation
time, and lowering of the fecundity (egg-laying rate) of females.
B. Pheromone Traps
1. Aggregation Pheromones
The most common pheromones used in trapping programs are aggregation and sex phero-
mones. Long-lived adult insects usually produce aggregation pheromones, while short-
lived adults are more likely to produce sex pheromones. Aggregation pheromones, usually
secreted by the male, are especially useful to food pest managers because they can cause
a response in both males and females.
The beetles that produce aggregation pheromones are typically long lived (⬎1
month) and must feed in order to reproduce. Thus, the aggregation pheromone not only
signals the presence of food, but indicates that mates are available. Weevils (rice, maize,
and granary) produce aggregation pheromones that are attractive to both sexes. Maximal
production of this pheromone occurs when food is present. Since these beetles cannot
survive for more than 1 week without food, the advantage of signaling both food and
mate availability is obvious.
2. Sex Pheromones
The most commonly used pheromones in trapping programs are the sex pheromones. They
may be derived from either natural (collected from adults) or synthetic (produced in the
laboratory through a series of chemical reactions) sources.
Adults that produce sex pheromones are usually short lived (⬍1 month) and are
able to successfully mate without feeding (they rely on nutrient reserves acquired during
the larval stage). Though the pheromone is usually released by the female to attract males,
sex pheromones may be produced, and responded to, by either sex. The chemical is usually
released when the insect assumes a characteristic posture referred to as the ‘‘calling posi-
tion.’’ In this position, the abdominal apex is elevated and the pheromone-secreting glands
at the tip of the abdomen are extruded.
Species that produce sex pheromones usually have a highly synchronized communi-
cation system involving daily activity rhythms that determine the time and pattern of
pheromone release. For example, Indianmeal moths are generally active in the late eve-
ning, while Mediterranean flour moths are active in the early morning. The concentration
of the chemical released is very important in eliciting the correct response on the part of
the receiver. At low concentrations, the receiver might respond by flying toward the
source; higher concentrations may elicit courtship and mating behaviors.
Pest managers in many different types of food production and storage industries have
found that pheromone traps can be very useful in determining the location and intensity of
insect infestations. The use of pheromone traps for monitoring insect populations is now
commonplace. Since insects are very sensitive to low concentrations of these chemicals,
pheromone traps are excellent devices for discovering low population levels of adult in-
sects. The pheromones of many of the major insect pests of the food industry have been
identified and synthesized and can now be purchased from commercial suppliers. Also,
the traps and food attractants that can be used simultaneously with pheromones have been
improved and are readily available from commercial sources. To monitor with phero-
mones, small amounts of synthetic pheromone are placed within a lure (available in a
variety of designs) that allows for slow release of the pheromone. The lure is then placed
within one of several types of entrapment devices.
An example of a successful monitoring program may be seen in the tobacco industry.
This, of course, is not a food industry, but the principles illustrated may be applied to
food facilities. The cigarette beetle is a major pest of stored and processed tobacco. Phero-
mone traps deployed throughout a cigarette factory are very effective for pinpointing ciga-
rette beetle infestations. The advantages that pheromone traps provide to the industry over
conventional methods are (1) they can be placed in processing equipment and in other
areas likely to shelter insect populations, (2) they can compete with tobacco odors for the
insect’s attention, (3) they do not require additional expense to operate (e.g., electricity
for light traps), and (4) identification and counting of the trapped insects are easier since
only the target species is captured.
3. Trap Placement
There are no hard and fast rules about trap placement since each warehouse and food
processing facility is different and each presents its own challenges. Placement of traps
depends on the size of the building, availability of supporting posts, flow of product, type
of insect to be monitored, and the purpose of the monitoring effect. However, there are
some guidelines that should be followed in all kinds of food production facilities.
To minimize the attraction of insects from outside the facility, pheromone traps
should be placed away from doors and open windows when insects are active outdoors.
Of course, a management policy that allows the doors and windows of a food manufactur-
ing plant to remain open is uninformed at best. Even when the windows are properly
screened, sensitive insects will still respond to the pheromone scent and will therefore
gather on the exterior of the building and, from that vantage point, some of them may
gain access to the building interior in spite of all measures taken to exclude them.
It may be useful to place traps outside the facility to capture insects before they can
enter a building. Outdoor traps can also be used to monitor seasonal fluctuations in the
populations of the target insects. Timely discovery of pest problems outside a facility
could well serve as a warning of potential problems inside a facility. If pheromone traps
are to be placed on the outside of the facility, the weather conditions to which the trap
will be exposed should be considered when choosing a plastic trap or a waxed cardboard
trap.
Inside the facility, the issue of dust can be important, especially if sticky-type traps
are used. Glues used in aerial sticky traps are able to absorb some dust and still remain
effective. However, where dust is a serious problem, wing and funnel traps can be adjusted
to reduce the opening size. The addition of slotted side panels to rectangular beetle traps
can increase trap longevity. Regardless of the type of trap deployed, traps should be
checked more often in high dust situations to ensure that the glue remains effective.
Foot and vehicular traffic, as well as sanitation and maintenance activities, should
certainly be taken into consideration when placing a trap. A trap that has been run over
by a forklift is worthless for catching insects. Traps placed on the floor are prone to being
swept up, crushed, or displaced under pallets. Wall placement of traps is, therefore, more
likely to be the better option. Additionally, if traps are to be placed in areas that are prone
to dampness or moisture migration (brick and concrete floors and walls, areas where leaks
are common, or where hose washing is routine), select the plastic or wax-coated paper
designs because they are more resistant to moisture damage.
In situations where curious, unauthorized personnel are likely to tamper with the
traps, the traps should be enclosed in tamper-proof metal cages. Traps should be placed
in corners, near interior walls, and on supporting posts in grain bins. The specific location
of a trap will depend on the type of trap and the insect pest to be monitored. The best
locations are in areas where insects have been observed, in receiving areas, or in areas
with high potential for reinfestation. Traps designed to capture crawling insects should
be mounted on vertical surfaces 1 or 2 m above the floor; in other words, the trap should
be located in such a position so as to facilitate access by crawling insects. For flying
insects (especially moths), the trap should be placed at or near ceiling height or, in the
case of grain bulks, 2 or 3 m above the grain surface.
Traps should be placed close to areas that collect food debris such as under equip-
ment; near conveyors, ledges, closed storage areas, fire extinguisher cabinets, wall lockers,

electrical junction boxes, and motor guard units; and in areas where temperatures are
warmer and humidity higher and where sanitation is difficult. Specific label directions for
each pheromone trap should be closely followed.
V. MANAGEMENT INTERVENTIONS
There is considerable debate about when steps should be taken to correct an insect pest
problem. Unfortunately, there is no magic number, formula, or chart that will spell out
the level of action to be taken and when to take it (see also Chapter 20). In food storage
and processing environments, the threshold for intervention is often the presence of just
one insect. Management decisions based on detection alone assume that the probability
of detection is directly related to insect density. But this is true only if the trapping program
adequately covers the area that must be protected. It also assumes that pest biology, envi-
ronment, trap design, and all the other factors discussed here have been correctly taken
into account. Each of the several different kinds of stored-product insects responds in its
own way to pheromones. For example, moths are more readily attracted than beetles, and
short-lived beetles are more highly attracted than long-lived beetles. Thus, many factors
must be taken into account when evaluating the story that trap records are telling.
All records and associated notes should be carefully organized and filed for future
reference. Computer programs can be used to facilitate the summarizing of very large
amounts of information. Trapping records can be useful in establishing or refining quality
assurance programs. The capture of one or a few insects in a trap usually signals the
presence either of a small infestation or accidental entry of outdoor insects. Repeated
catches over a longer period of time would indicate the likelihood of an ongoing infestation
within the plant, while the consistent capture of large numbers of insects would very likely
mean that a major infestation is in progress.
If any pest insects happen to be present in a food manufacturing plant at the start
of monitoring, the first week of trapping will usually net a few of these insects. Data from
subsequent weeks of trapping will yield a more precise indication of the origin of the
problem. Further repeated intense trapping will usually pinpoint the problem area.
Since there are no magic numbers, action levels (the points that trigger interventions)
should be based on data collected and evaluated over the entire facility. Emphasis should
not be placed on the total insects caught in the facility, but rather on the change in the
number of insects trapped in each trap. Actions should be taken only if trap catches indicate
population growth in one or more areas of the facility, no matter if from zero to one or
10 to 100. Absolute numbers will vary from facility to facility. Let trapping history be
your guide.
VI. REFERENCE COLLECTIONS

In order to properly identify and manage populations of insects, a good reference library
and a representative collection of pest specimens should be available. Reference collec-
tions can be as simple as putting correctly identified insects in labeled photographic film
canisters. Preidentified insect specimen collections may also be purchased from several
pest management specialty supply companies.

VII. REFERENCE GUIDES TO PEST BIOLOGY, IDENTIFICATION,
AND CONTROL
The following is a list of the basic references that plant personnel should have available
to help identify and manage pest populations within food processing facilities.
American Institute of Baking. Basic Food Plant Sanitation Manual. Manhattan, KS:
American Institute of Baking, 1979.
American Institute of Baking. Quality Assurance Manual for Food Processors. Man-
hattan, KS: American Institute of Baking, 1991.
American Institute of Baking. Warehouse Sanitation Manual. Manhattan, KS: Amer-
ican Institute of Baking, 1984.
GW Bennett, JM Owens, RM Corrigan. Truman’s Scientific Guide to Pest Control
Operations, 5th Ed. Duluth, MN: Advanstar Communications, 1997.
FJ Baur, ed. Insect Management for Food Storage and Processing. St. Paul, MN:
American Association of Cereal Chemists, 1984.
JR Gorham, ed. Ecology and Management of Food-Industry Pests. Arlington, VA:
Association of Official Analytical Chemists, 1991.
JR Gorham, ed. Insect and Mite Pests in Food: An Illustrated Key. Agriculture
Handbook 655. Washington, DC: U.S. Department of Agriculture.
SA Hedges. Hide and Carpet Beetles/Wood-Boring Beetles, Vol 1 of Pest Control
Technology Field Guide for the Management of Structure-Infesting Beetles.
Cleveland, OH: GIE Media, 1996.
SA Hedges. Stored Product Beetles/Occasional and Overwintering Beetles, Volume
2 of Pest Control Technology Field Guide for the Management of Structure-
Infesting Beetles. Cleveland, OH: GIE Media, 1996.
SA Hedges. Pest Control Technology Field Guide for the Management of Structure-
Infesting Ants. Cleveland, OH: GIE Media, 1998.
R Krammer. Pest Control Technology Technician’s Handbook: A Guide to Pest
Identification and Management, 3rd Ed. Cleveland, OH: GIE Media, 1998.
A Mallis, ed. Handbook of Pest Control. 8th Ed. Cleveland, OH: Mallis Handbook
and Technical Training Company, 1997.
REFERENCES
1. JR Gorham, ed. Ecology and Management of Food-Industry Pests. Arlington, VA: Association
of Official Analytical Chemists, 1991.
extraneous materials. V. Strategy for evaluating hazardous and nonhazardous filth. Reg Tox-
icol Pharmacol 33:363–392, 2001.
3. AR Olsen. Regulatory action criteria for filth and other extraneous materials. II. Allergic mites:
an emerging food safety issue. Reg Toxicol Pharmacol 28:190–198, 1998.
4. AR Olsen. Regulatory action criteria for filth and other extraneous materials. III. Review of
flies and foodborne enteric disease. Reg Toxicol Pharmacol 28:199–211, 1998.
5. LD Foil, JR Gorham. Mechanical transmission of disease agents by arthropods. In: BF El-
dridge, JF Edman, eds. Medical Entomology. Dordrecht: Kluwer Academic Pubishers, 2000,
pp 461–514.
6. TW Phillips, MR Strand. Larval secretions and food odors affect orientation in female Plodia
interpunctella. Entomologia Experimentalis et Applicata 71:185–192, 1994.

7. CH Bell. Factors governing the induction of diapause in Ephestia elutella and Plodia interpunc-
tella. Physiol Entomol 1(2):83–91, 1976.
8. H Tsuji. Experimental studies on the larval diapause of the Indian meal moth Plodia interpunc-
tella. Thesis, Kyushu University, Fukuoka, Japan, 1963.
9. LP Lefkovitch. A laboratory study of Stegobium paniceum (L.) (Coleoptera: Anobiidae). J
Stored Products Res 3(3):199–212, 1967.
10. RT Arbogast. Beetles: Coleoptera. In: JR Gorham, ed. Ecology and Management of Food-
Industry Pests. Arlington, VA: Association of Official Analytical Chemists, 1991, pp 131–
174.
11. RW Howe. Spider Beetles: Ptinidae. In: JR Gorham, ed. Ecology and Management of Food-
Industry Pests. Arlington, VA: Association of Official Analytical Chemists, 1991, pp 177–
180.
12. IB Tarshis. The cockroach: a new suspect in the spread of infectious hepatitis. Am J Tropical
Med Hygiene 11(5):705–711, 1962.
13. LM Roth, ER Willis. The biotic associations of cockroaches. Smithsonian Miscellaneous Col-
lections 141:1–470, 1960.
14. PG Koehler, RS Patterson, RJ Brenner. Cockroaches. In: A. Mallis, ed. Handbook of Pest
Control. Cleveland, OH: Franzak and Foster, 1990, pp 101–174.
15. ME Solomon. Ecology of the flour mite, Acarus siro L. (⫽ Tyroglyphus farinae De G.). Ann
Appl Biol 50(1):178–184, 1962.

20
Pest Birds: Biology and Management
at Food Processing Facilities
JOHN B. GINGRICH
University of Delaware, Newark, Delaware, U.S.A.
THOMAS E. OSTERBERG
General Mills, Golden Valley, Minnesota, U.S.A.
I. INTRODUCTION
A. Importance of Birds and Their Management in Food Processing
Facilities
Birds are one of the few universally recognized components of our natural environment.
Birds serve alternately as predators, prey, food, and entertainment for hundreds of millions
of people on a global basis. For this reason, they are perhaps the most anthropomorphized
and widely appreciated group of animals other than domestic pets. Consequently, the
subject of birds as pests can be controversial, and the subject of bird management can
easily draw as much fire as politics or religion.
Because of their charisma, interesting behavior and aerial acrobatics, most people
value birds on an emotional level. Their intelligent and highly adaptive behavior also
makes them challenging pests of food processing plants and difficult to manage. Birds in
or around food processing facilities can cause direct physical damage to structures and
equipment, create an unwholesome appearance around docks and doorways, contaminate
food with feces and pathogens, and even carry ectoparasites (mites) that attack people.
B. Defining Pest Birds

Defining pests is a difficult and highly subjective task. Truly, one person’s pests are an-
other person’s pets. Defining the species of birds that are pests is also a sensitive issue.
Generally, any organism that is out of place and that interferes with human health or
commerce is considered a pest. No matter what species it is, any bird that enters a building
is a pest. Moreover, birds roost on loading docks, build nests in drains or downspouts,
defecate on doors and windows, and loaf around air intake ducts—these birds are also
pests.
Since federal, state, or local laws and regulations protect nearly all birds, places
where they can be controlled and the methods that can be used to control them are highly
restricted. Such laws and regulations as the Migratory Bird Act and the Endangered Spe-
cies Act prevents humans from killing and injuring most kinds of birds and, in some cases,
even disturbing birds. There are only a few exceptions. Most states formally recognize
two or three pest species and allow bird management programs against these species.
However, the types of bird management programs permitted and the sites that they are
allowed may be restricted [1].
The most commonly recognized pest species are the pigeon (Columba livia), the
house sparrow (Passer domesticus), and the European starling (Sturnus vulgaris). A few
states and locales also recognize herring gulls (Larus argentatus), crows (Corvus brachy-
rhynchos), ‘‘blackbirds’’ (a nonspecific common name that refers to several kinds of
black-feathered birds including grackles, Quiscalus quiscala, and starlings), woodpeckers
(referred to several species in the family Picidae), and cowbirds (Molothrus ater) as pest
species [1]. Canada geese (Branta canadensis are recognized as agricultural pests in some
areas [2]. However, these latter species nearly always require permits and special exemp-
tions from protective laws and regulations before any sort of control program can be
undertaken [1,2].
Pigeons, sparrows, and starlings, on the other hand, can often be managed without
permits and with only minimal restrictions. We will discuss legal issues and regulations
pertaining to birds in Section III.
C. Basic Bird Management Concepts

Bird management is based on the same sound integrated pest management (IPM) principles
that are used to manage other pests. The principles of IPM require that all available meth-
ods be used to eliminate, mitigate, or prevent pests from interfering with human health,
welfare, or commerce. Moreover, these principles dictate that before any pest management
program begins, careful evaluation of the problem and precise identification of the target
pests must be carried out.
In accordance with good IPM practices, it is customary to use the least invasive
and least toxic methods available that will effectively ameliorate the pest situation. In
other words, one should use good sanitation, sound storage practices, and exclusionary
tactics in structures to prevent birds from being pests prior to using other, more intrusive
methods.
If these methods fail or are impractical, then methods that include chemical or physi-
cal deterrents and chemical pesticides may be used. In any case, bird management pro-
grams should not be expected to decrease pest bird populations overnight. In fact, the
more permanent the solution is, the more likely that the decline in pest bird numbers will
take place gradually, perhaps over a period of weeks.
As with other animals, birds need food, water, and shelter in order to thrive and
reproduce. Creating an environment unfavorable for bird feeding or reproduction, and thus
slowly lowering the carrying capacity (ideally to zero), gradually causes more and more
birds to depart. Other techniques for bird management such as applying avicides or bird
repellents or resorting to shooting birds are undertaken only when quick suppression of
pest bird population is needed because of potentially serious impacts of birds on human
health or commerce. However, such methods often do not have a lasting impact unless
the underlying conditions that permit birds to thrive at the site are also eliminated.
II. DAMAGE, RISKS, AND DISEASES ASSOCIATED WITH BIRDS

A. Damage
Damage to property and equipment is a frequently overlooked impact of bird infestations.
Woodpeckers, although protected, often cause direct damage to siding, chimney, signs,
and telephone poles. Most often, damage from birds is caused by their acidic feces, which,
especially when moist, are very corrosive [3]. Bird feces accumulating on tar-based roof-
tops gradually cause the roofing to disintegrate, eventually causing leaks (Fig. 1). A light,
but continuous, infestation of birds on a flat roof can halve the life expectacy of a roof.
Likewise, bird feces damage air conditioning equipment, siding, insulation, and industrial
machinery [4].
Not only is equipment damaged, but also workers who are exposed to bird feces
experience increased health risks from disease when they work on contaminated machin-
ery or take breaks in feces-contaminated areas (Fig. 1). Additionally, bird feces pit the
paint of cars, airplanes, and boats. The longer the feces remain on the finish, the greater
the damage. Bird feces can also damage plastics as they are being molded and can drop
into other chemicals or liquids, producing a contaiminated product. Food contaminated
by bird feces must be destroyed. Large quantities of bird feces, especially pigeon feces,
on wet surfaces such as loading docks are a safety hazard because of the slippery condi-
tions they produce.
Figure 1 An employee break area contaminated with feces—an unsafe and unhealthful environ-
ment.

B. Risks
Risks of fires associated with bird nests are very real, especially when the nests are built
around electric motors or electrified signs. In fact, electric sign companies blame most of
their sign fires on bird nests.
Blockage of ventilation systems, especially chimneys, can lead to flue fires or even
carbon monoxide poisoning. A family of five died in a carbon monoxide poisoning inci-
dent just before Christmas, 1995, because bird-nesting materials blocked the exhaust sys-
tem of their fireplace.
Collapsed roofs can also occur when bird nests and droppings block gutters, drains,
or downspouts. The weight of dammed water quickly overloads roofs when gutters and
drains are blocked. In some cases, especially when pigeons nest in attics of homes or
commercial buildings, the ceilings and insulation accumulate great quantities of solid and
liquid bird waste. Over a period of years, the weight of the accumulated waste may cause
ceilings to collapse.
C. Diseases and Parasites

The risk of human disease outbreaks arising from bird-associated pathogens would proba-
bly rank as the greatest concern for most bird management professions. Moist bird feces
are a virtual culture medium for fungal spores and infectious bacteria, especially after the
feces have dried out or have been leached repeatedly by rains [3]. Birds themselves are
reservoirs of several viral diseases transmitted to humans by mosquitoes [1]. This section
surveys the most important pathogens and agents of disease according to the major group-
ings—fungi, bacteria, viruses, protozoans, and ectoparasites. A summary table (Table 1)
is provided as a convenient general reference, while details on diseases and their causative
agents follow.
1. Fungi
a. Aspergillosis. Aspergillosis is a disease of the lungs that can cause fever, cough,
hemoptysis (bloody cough), chest pain, and asthma. Occasionally, cutaneous infections
of open wounds or sores may occur. The most common pathogenic agents are Aspergillus
fumigatus, A. flavus, and occasionally A. niger [5]. Transmission occurs by airborne co-
nidia that colonize the respiratory tract after exposure to aerosolicized bird feces or infec-
tious soil at construction or renovation sites. Rarely, postsurgical infections occur in pa-
tients at central catheter sites or in burn wounds [6].
Transplant patients, hematologic malignancy patients, and AIDS patients occasion-
ally become infected in hospitals. If prolonged granulocytopenia occurs, fatality rates can
rise to nearly 100%. Incidence appears to have been increasing since 1983 (http://
www.cdc.gov), although good statistical information is lacking.
b. Cryptococcosis. Cryptococcosis occurs most frequently in people who have menin-
gitis or AIDS. Primary pulmonary infections seldom occur. The pathogen is an encapsu-
lated yeast, Cryptococcus neoformans, that occurs in soils worldwide, but is particularly
concentrated where soil and pigeon feces are commingled [7]. Transmission occurs by
inhalation of airborne yeast spores.
Cryptococcosis incidence averages only 0.2–0.9 per 100,000 in the general popula-
tion, but often reaches 2–4 per 1000 among AIDS patients. About 12% of the cases are

Table 1 Diseases Transmitted by Birds, Responsible Pathogen or Parasite, Mode of
Transmission, and Most Likely Bird Species Involved
Likely bird
species
Disease Pathogen/agent Transmission mode transmitting
Aspergillosis Aspergillus fumigatus, A. Aerosolized bird feces or soil PG, HS
flavus
Blastomycosis Blastomyces dermatitidis Soil contaminated with bird PG, ES, HS
feces
Cryptococcosis Cryptococcus neoformans Soil contaminated with bird PG
feces
Histoplasmosis Histoplasma capsulatum Spores taken in through PG, ES, HS?
HVAC ducts
Listeriosis Listeria monocytogenes Food or soil contaminated PG, ES, HS
with bird feces
Psittacosis Chlamydia psittaci Aerosolized bird feces HS, PG
Salmonellosis Salmonella typhimurium Food contaminated with PG, ES, HS
animal feces
Encephalitides St. Louis, Western, Eastern From birds through bite of HS, ES, PG
equine, and West Nile infective mosquitoes
viruses
Toxoplasmosis Toxoplasma gondii Food contaminated with PG, ES, HS
animal feces
Ectoparasites Mites, fleas, ticks, lice, bird Contact with birds or bird PG, ES, HP
bugs nesting material
Note: PG: pigeon; ES: European starling; HP: house sparrow.
fatal. In meningitis patients, blindness and permanent neurological damage can occur.
AIDS patients must take antifungal agents for life, as the disease is never cured.
c. Histoplasmosis. Histoplasmosis is probably the most common of the fungal diseases

that colonize the human respiratory tract. The areas of greatest endemicity in the United
States include the central and eastern states from the Mississippi and Ohio River valleys
northward to the St. Lawrence River. Although nearly 80% of populations in endemic
areas have antibodies to the etiologic agent, only a very small number actually get the
disease. The disease presents with an influenza-like illness with fever, cough, headaches,
and muscle pains.
This disease can cause acute or chronic pneumonias that are very difficult to cure. In
AIDS patients, the infection may present as septic shock. Chronic disease caused by this
pathogen can lead to permanent lung damage and blindness. Mortality in AIDS patients
who contract histoplasmosis is about 10%.
The pathogen Histoplasma capsulatum is transmitted on airborne particulates
emerging from disturbed soil contaminated by bird or bat droppings. Pigeon droppings
around HVAC systems, cooling towers, or air intake vents create a high degree of risk
for this disease (Fig. 2). High-risk groups include spelunkers, construction workers, ag-
ricultural workers, and immunocompromised persons, especially AIDS patients.

Figure 2 Pigeon feces accumulating around an HVAC system. This creates an ideal situation
for histoplasmosis and other fungal pathogens to be transmitted to workers inside the building.
d. Blastomycosis. Blastomycosis is another fungal disease that causes pneumonia. It

can disseminate to affect skin, bone, and other organ systems. This disease is caused by
inhalation of the conidial spores of Blastomyces dermatitidis that contaminate soil, primar-
ily in wooded areas or along waterways. High-risk groups include forestry workers, camp-
ers, hunters, and farmers (http://www.cdc.gov). Fatality rates up to 5% are reported, with
about 1–2 cases per 100,000 occurring in endemic areas.
2. Bacterial Diseases
a. Psittacosis. Psittacosis, also known as ornithosis or parrot fever, is a zoonotic dis-
ease that occurs in members of the parrot family and in turkeys and pigeons [5]. This
disease, transmitted to humans by inhalation of airborne particulates of dried bird feces
or by direct handling of infected birds, is the most common disease transmitted from birds
to people [8]. Dried bird feces may remain infected for weeks.
The disease, caused by Chlamydia psittaci, shows elevated risk in pet store workers,
farmers, and slaughterhouse workers who process turkeys. The disease starts, 1–4 weeks
after exposure, with signs that include headache, fever, chills, and sometimes pneumonia.
In birds, signs include poor appetite, a ruffled appearance, eye or nose discharges, and
diarrhea. Unfortunately, past infection with the disease does not confer immunity. Data
on incidence and prevalence are very sporadic.
b. Listeriosis. Listeriosis is a facultative zoonotic disease. Its reservoirs include water,

mud, and silage, as well as domestic and wild animals and man [5]. In humans, about
30% of cases occur in newborns less than 3 weeks old. In adults, most cases occur after
age 40, especially in immunocompromised persons. Incidence rates in the United States
for people requiring hospitalization are about 1 per 150,000 people. The disease manifests

itself as meningoencephalitis, with or without septicemia. Onset can be sudden, especially
in neonates. Neonates who acquire the disease within 4 days of birth have fatality rates
of up to 50%. In adults, fatality rates often approach 33%.
The ubiquitously present pathogenic agent for this disease is Listeria monocyto-
genes. The disease is transmitted by many vehicles, including unpasteurized milk, cheese,
and vegetables. Papular lesions on hands and arms may occur through direct contact with
infectious material or soil contaminated with infectious bird or animal feces. Mixtures of
soil and bird waste can remain infectious for months. Nosocomial outbreaks in nurseries
occur through contact with the hands of infected nursing or other medical staff. The incu-
bation period is highly variable, ranging from 3 to 70 days.
c. Salmonellosis. Salmonellosis, another common bacterial disease that is worldwide

in distribution, is also one of the more common zoonotic diseases. According to the Cen-
ters for Disease Control and Prevention (CDC), up to 1.4 million cases of this disease
may occur annually in the United States. Two of the causative agents, Salmonella typhimu-
rium and S. enteritidis, are generally considered foodborne pathogens [5]. However, con-
tamination of foodstuffs with these agent occurs through numerous vehicles, including
feces of infected birds. All three of our common pest bird species frequently harbor this
pathogen, additionally they habituate feedlots, poultry farms, and food processing plants
where the opportunity to contaminate foodstuffs is high [3].
The pathogens are most commonly passed through the fecal–oral route to animals
or food products contaminated with feces. Disease manifestations include severe headache,
abdominal pain, diarrhea, and dehydration. The disease is highly contagious, with an infec-
tive dose consisting of only 100 to 1000 organisms [5].
There are other bacterial pathogens that can be spread by birds, but because this
happens only infrequently, they are not considered in this chapter.
3. Viral Diseases
The human viral diseases associated with birds are not directly transmitted by birds to
people. However, birds are so important in the overall epidemiology of these diseases that
their role is considered essential to transmission. Encephalitides are the principal viral
diseases affecting humans for which birds are the principal reservoir hosts.
In the United States, the most important diseases in this group are eastern equine
encephalitis, St. Louis encephalitis, western encephalitis, Venezuelan encephalitis, and,
just recently, West Nile fever. Birds, including our U.S. pest species, have been implicated
as major reservoirs of this group of diseases.
Although few of the pest birds become ill themselves with this group of diseases,
they develop high viremias, permitting the mosquito vectors that feed on them to become
highly infective. In the United States, West Nile fever is an important exception to the
lack of morbidity observed in birds infected with encephalitis. Birds exposed to West Nile
fever virus frequently become ill or die from this pathogen. It is theorized that because
birds in the United States have not yet adapted to this recently introduced pathogen, they
are therefore highly susceptible to it.
Corvine birds (crows), sparrows, and starlings are generally susceptible to this virus,
although only crows have been observed dying in large numbers. Pigeons, while suscepti-
ble to some degree, do not appear to be adversely affected, according to recent information
from the CDC.

4. Protozoans
Toxoplasmosis is a systemic disease caused by Toxoplasma gondii [5]. The disease gener-
ally causes a mild, asymptomatic infection in humans, but also may present as a disease
resembling infectious mononucleosis. An acute case presents with swollen lymph glands
and high fever. This phase of the disease may give rise to cerebral involvement and pneu-
monia in immunocompromised persons. In pregnant women, the disease may lead to se-
vere fetal distress or even death in a newborn that acquires this disease from its mother.
The disease is transmitted through a number of routes, especially soil contaminated
with the feces of infected cats. Pigeon or cat feces contaminated with oocysts of this
pathogen may be inhaled or consumed with contaminated food.
5. Ectoparasites
Although birds host numerous mite species, two species are most commonly known to
transfer from birds to humans. These are Dermanyssus gallinae, the chicken mite, and
Ornithonyssus sylviarum, the northern fowl mite [9]. The bite of the chicken mite is often
painful and causes papular urticaria in humans. The bite of the northern fowl mite causes
immediate irritation and subsequent erythema, induration, and pruritis [9]. Chicken mites
may carry the viruses that cause encephalitides, although it is uncertain that they can
transmit them to humans. The northern fowl mite carries the pathogens of encephalitides
and ornithosis, although transmission to humans is, once again, uncertain. Additionally,
a number of other ectoparasites associated with birds may occasionally transfer to humans.
Pigeon nest bugs (Cimex columbarius) inhabit pigeon nesting sites and sometimes
transfer to humans after their usual hosts leave their nests [10].
Ceratophyllus columbae and C. gallinae, common bird fleas especially associated
with pigeons, may occasionally attack humans, but normally only in the prolonged absence
of their bird hosts.
Argas reflexus, the bird tick, is commonly associated with pigeons, but may also
occur on other birds [10]. It attacks humans when bird nests in and around human struc-
tures are abandoned.
Several species of biting lice, most notably Columbicola columbae and Campanu-
lotes bidentatus, infest pigeon feathers [10] and may occasionally bite humans when bird
feathers or nests are handed by humans.
The conenose bug (Triatoma rubrofasciata) is commonly associated with pigeons
and other bird species [10]. This bug can inflict a painful bite to humans when bird-nesting
material is handled.
III. PEST SPECIES AND THEIR BIOLOGY

A. Pigeons
The pigeon, also known as the European rock dove, is widely distributed througout the
world. Introduced into North America in the 17th century, it was then primarily used as
food. Birds often escaped, adapted rapidly to living in urban areas, and the rest is history.
A typical pigeon is 11–12 in. (28–31.5 cm) long and weights 13–14 oz (368.5–
397 g) [3]. It is generally light gray in color, but often with other colors mixed in, including
purple, white, green, brown, tan, and black (Fig. 3). Legs and feet exhibit a reddish color,
with three toes facing front and one to the rear.
Figure 3 The pigeon (Columba livia). This species is also called the European rock dove.
Pigeons feed on a variety of foods, including garbage, insects, seeds, and nuts [1].
They eat about 1 lb of food per week, but they do not have to eat every day. However,
pigeons must have water every day [3]. They are highly urban birds that frequently depend
on human structures for nesting, roosting, and loafing sites. Flocks consisting of 20 to
100 or more birds feed, roost, nest, and loaf together.
Nests, usually built by monogamous pairs, consist of crude, loosely formed aggrega-
tions of twigs, grasses, and sticks, the whole measuring about 12 in. (30.5 cm) across.
Nests are built on flat surfaces—ledges, rocky cliffs, alcoves, roofs, and under bridges.
Only one or two eggs are deposited in each nest, although more eggs are usually laid
before the first brood is weaned. After 17 to 19 days of incubation, the hatchlings (called
squabs) emerge and are fed a regurgitated substance called pigeon milk. Squabs eat this
substance exclusively for the first 5 days of life, after which they receive increasing
amounts of grains, food waste, insects, and water [1].
Young pigeons wean in about 10 days and fledge about 4–6 weeks after hatching.
Pigeons reproduce in all seasons, but peak reproduction occurs in the fall and spring in
temperate climates. Although pigeons can live up to 15 years in the wild, the average
urban pigeon lives only 3–4 years [3].
Pigeons have rather varied feeding, roosting, loafing, and nesting behavior. How-
ever, they tend to frequent the same sites year after year, resulting in huge accumulations
of feces, feathers, and nesting debris at their chosen sites. Pigeons prefer flat surfaces for
feeding or resting. Consequently, they are often seen feeding on rooftops or open grassy
areas. Grain spillage around food processing plants is major food source for pigeons [1].
Feeding and roosting sites are generally not in the same location; in fact, they may
be miles apart. Roosting and nesting sites are generally on ledges or rooftops of buildings.
These habitats put them in direct conflict with man, as they rapidly contaminate these
sites with excrement and feathers. When they nest or roost around cooling towers or
rooftop HVAC systems, the chance to transmit one or more of the many fungal and bacte-
rial diseases they carry is greatly enhanced.
Pigeons also are great ‘‘loafers,’’ meaning that they may simply rest, especially
during the daytime, in places where they do not feed or roost, although such sites may
be close by. This aspect of their behavior makes management of flocks at loafing sites
difficult, since simply limiting the amount of food or water at these sites does little good
[1].
B. House Sparrows
The house sparrow (also known as the English sparrow), introduced to the United States
in the 1850s [3], is actually a member of the Old World weaver finch family (Ploceidae),
rather than a true North American sparrow (Fringillidae). House sparrows easily out-com-
pete many native birds for food and habitat and often displace purple martins (Progne
subis), eastern bluebirds (Sialia sialis), redheaded woodpeckers (Melanerpes erythro-
cephalus), cliff swallows (Petrochelidon pyrrhonota albifrons) and barn swallows
(Hirundo rustica erythrogaster) [11].
House sparrows are so prolific that a dozen nesting pairs may increase to thousands
in only 3 to 4 years. This small, stocky bird is about 5–6.25 in. (15–18 cm) in length.
The dorsal parts are reddish brown streaked with black, while the ventral aspect is a light
gray, with a black throat in the male. Sparrows feed primarily on fruits, buds, emerging
plants, and insects.
Nests are built in trees or on human structures such as loading docks, eaves, gutters,
ledges, signs, electrical substations and bridges. Five or six greenish, speckled eggs are
produced four to seven times per year, depending on the availability of food and water.
They hatch in 11–12 days, and fledge at about 15 days. Soon after leaving the nest, they
gather in small flocks for feeding purposes.
As the summer progresses adults join the flocks, and by the end of the summer
flocks may include several hundred birds each [1]. Sparrows build relatively large nests,
a jumble of grass stems, leaves, twigs, and trash. Nesting areas quickly become defiled
by feces and, therefore, are highly likely to harbor pathogens in fecal or nesting material.
Sparrows are important reservoirs for St. Louis encephalitis, but are generally unharmed
by the virus [12].
Their propensity for feeding or nesting in flocks means that they can be very trouble-
some around food processing facilities and warehouses. This problem is exacerbated by
their small size and aggressive feeding style, which often lead them to invade buildings
and become trapped in highly visible production or distribution sites, from which they
are ejected only with great difficulty. Like pigeons, sparrows return to the same nesting,
feeding, and roosting sites year after year. These sites are generally all located within a
2-mile radius of one another.
C. European Starlings
The European starling (family Sturnidae) was introduced to New York in the 1890s. After
about 30 years of living in the northeast, starlings rapidly spread from coast to coast, and
now extend all the way to Alaska [13]. In 1988, their U.S. population was estimated to
be approximately 140 million [3]. This species is a robin-sized bird that appears mainly
dark, sometimes with glossy purple feathers that are flecked with brown spots upon closer
inspection. These spots increase in number and are more pronounced in winter plumage
(Fig. 4). Their bills are yellow in spring and summer.
Figure 4 The European starling (Sturnis vulgaris) shown in winter plumage. This photo shows
a bird invading and nesting above a dock door where bird netting was ripped by careless repairs
to the door mechanism.
In springtime, they build nests of fibrous materials lined with fine grasses in building
cavities, in crevices, between loading dock door tracks, behind signs and marquees, and
in numerous natural sites. They produce an average of two broods per season, with four
to seven young per brood. The eggs are bluish to white. Hatching occurs in about 12 days.
The birds fledge in 2 to 3 weeks.
During the breeding season, mated birds disperse to nest sites, while ‘‘bachelor’’
birds travel together in small flocks to feed and roost. As summer progresses, more bache-
lor birds and their parents join the flocks. By late summer, flocks may number in the
hundreds or thousands, and become increasingly difficult to manage. Trees are favored
roosing sites, and at such roosts thousands of birds in a few trees make a lot of noise and
deposit copious quantities of droppings and shed feathers. Feeding and roosing sites are
often widely separated, often by as much as 70 miles [1].
Starlings are primarily insectivorous, but also feed widely on fruits such as grapes,
figs, cherries, and apples. In winter they increase their feeding on grain and seeds; these
foods may constitute a large part of their diet in this season. However, when food is scarce
they will feed voraciously on nearly anything, including garbage. Their close association
with people in urban areas makes them threats to transmit fungal and bacterial diseases
directly and also to serve as reservoirs for viral encephalitides [15]. Their aggressive forag-
ing behavior also makes them second behind sparrows with regard to building invasions.
IV. LAWS AND REGULATIONS PERTAINING TO BIRDS AND BIRD

MANAGEMENT
Prior to reviewing bird management methods, it is important to recognize the limitations
imposed by federal, state, and local laws. The Migratory Bird Treaty Act of 1918 (16
USC 703–712) is the cornerstone for migratory bird protection and conservation in the
United States [14]. The first provision of the act prohibits shooting of native migratory
birds in the United States, except in accordance with regulations promulgated by the Secre-
tary of Agriculture (37 Stat. 847). This law was supplemented by treaties with Canada
(1916), Mexico (1936), Japan (1972), and the former Soviet Union (1978).
In addition to prohibiting killing, the act prohibited taking, capturing, possessing,
selling, purchasing, exporting, importing, or transporting any migratory bird, bird part,
nest, or eggs. The word take is defined to mean to ‘‘pursue, hunt, shoot, wound, kill, trap,
capture, or collect, or attempt to pursue, hunt, shoot, wound, kill, capture, or collect’’ (50
CFR 10.12).
The exceptions permitted by law are hunting specific game birds with possession
of a hunting license, legitimate research activities, display in zoological gardens, bird-
banding, and similar activities. Of 1043 native species in the United States, 83% (868
species) are protected by this law.
The species not protected include domesticated game fowl, introduced species, and
island species that belong to groups not covered by the act. Additionally, blackbirds—
red-wing (Agelaius phoeniceus), yellow-headed (Xanathocephalus xanthocephalus), tri-
colored red-winged, rusty (Euphagus carolinus), and Brewer’s blackbird (Euphagus
cyanocephalus)—cowbirds, grackles, crows, and magpies (Pica pica hudsonia) are not
covered by the act when concentrated in such large numbers and under such conditions
as to constitute a health hazard or other nuisance [15].
The Endangered Species Act of 1978 (87 Stat. 884, 16 USC 1531–1543) protects
endangered species and their habitats, as determined by the Secretary of the Interior. A
list of threatened and endangered species is published in the Code of Federal Regulations
(50 CFR 17). Executive Order 11643 (1972) limits the use of chemical toxicants against
predatory animals and birds. This order contains restrictions and exemptions pertaining
to use of toxicants on federal lands only.
In addition to these national-level laws and regulations, numerous states and local
jurisdictions restrict the use of avicides, repellents, and bird control techniques. Frequently,
these regulations are stricter than federal codes, hence superseding them. These regulations
often require permits and prohibit nest destruction or other bird harassment methods. It
should be noted that in bird sanctuaries, even pest birds cannot be controlled without
involved legal procedures [15].
V. PREVENTION OF BIRD INFESTATIONS THROUGH GOOD

SANITATION PRACTICES
Bird management efforts focus on habitat modification in combination with structural
exclusion techniques represent the best overall strategy. Such modification involves the
systematic removal of food, water, and shelter sources necessary to sustain a pest bird
population [16]. Most kinds of urban pest birds actively scavenge in trash and garbage.
Reducing the availability of these vital resources increases dramatically the level of stress
in the local pest bird population and can, over time, result in drastically reduced numbers
of birds.
The food plant sanitation management program should be written so that it includes
the periodic inspection of the exterior grounds and the roof areas of all buildings. During
the inspection, any area containing spills of food material should be identified, followed
by the prompt removal of the spilled material. The source of the spillage should be noted
as well for follow-up corrective action. Such inspections should be performed at regular
intervals (at least monthly). Reports generated from such inspections can be used to de-
velop a history of circumstances that lead to bird infestations. This history can subse-
quently be used in developing a successful control strategy.
Naturally occurring food sources may also be available. Such sources must be identi-
fied and eliminated whenever possible. With respect to the facility grounds and landscap-
ing, planting of various trees and shrubs for aesthetic purposes often also provides food
and shelter for birds. While pleasing to the eye, plants that produce berries and seeds are
a major attraction for birds. In addition, insect pests that harbor in such plantings are often
prey for birds. Therefore, it is best to minimize plantings around the facility and especially
to keep plantings as far as possible from the exterior walls.
When plantings are done, they should be done in consultation with a horticulturalist
or local wildlife extension specialist. Should the decision be made to install trees, shrubs,
and ground covers, choose plants with foliage that is least attractive to pest birds.
Most birds require water daily. As with food, water is vital for birds, and large
populations cannot be sustained without it. Therefore it is important for the sanitation
management system to account for all available water sources, making every effort to limit
the amount of water available to pest birds. A periodic inspection of the plant grounds, to
include building roofs, parking lots, rain gutters, downspouts and drainage ditches, must
be made so that all water sources are identified and eliminated if possible. Ideally, such
inspections sould be conducted at least monthly until all water sources are identified.
In some cases, it is possible to completely eliminate the source. Rain gutters and
downspouts can be periodically cleaned to remove blockages that restrict flow and result
in pooling. Plugged roof drains can be cleaned so that standing water on roofs is elimi-
nated. Pooled water in parking lots can be swept to the nearest storm water drain. The
labor costs sustained in the manual removal of pooled water in the parking lot can be
balanced against the cost associated with adequate repairs to prevent water pooling. In a
word, prevention of water pooling may be the least expensive, long-term option when
compared to the ongoing costs associated with the remedial removal of water after every
rain shower. If, indeed, pooled water in a parking lot is identified as a contributing factor
in sustaining large bird populations around the facility, it would follow that costs associ-
ated with overall bird-control efforts would be positively impacted by a preventive ap-
proach to the problem, rather than a reactive one.
In other situations, for example drainage ditches, restricting accessibility to water
is difficult. Depending upon the type of pest bird, the size of the local population, and
the relative importance of the water source to the population, drainage ditches can be
protected from pest birds with netting so that the water in the ditch is difficult to access.
By limiting usable water sources, pest bird populations can be greatly reduced.
Shelter from the elements, from predators, and for the rearing of young is another
important factor necessary for birds to thrive. With respect to reducing the amount of
available shelter, the following specific points should be considered:
1. Tree and shrub canopy reduction. Reduce or elminate dense tree canopies and
other foliage from around the structure to be protected [16]. Trim branches to
reduce roosting sites for European starling populations. Sparrows may nest, as
well as roost, in low shrubs. Plantings that are well trimmed and thinned will
help to keep sparrow populations low.
2. Vine removal. Remove vines and other foliage from building structures. Spar-
rows find such vines very attractive for nesting [16].
3. Keeping grass short. Sparrows are seedeaters; keeping grass mowed short re-
duces the quantity of natural seed available. Short grass also helps to reduce
the available harborage for insects that are also highly utilized as a source of
food by sparrows [17].
4. Minimizing Ground Cover. Trim or remove excessive ground cover that can
act as bird harborage and habitats for insects. Insects thriving in lush ground
cover serve as food for birds.
5. Nest Removal. Consistently remove nests as they are being constructed. Dur-
ing the nesting season, nests should be moved at 10–14 day intervals to discour-
age birds from nesting [18]. Effective methods include physical removal using
poles with attached hooks or destruction of the nest with high-pressure water
[16]. After removal, discard all nesting materials (sparrows will recycle debris
from destroyed nests if they have access to them). Employees should be properly
protected when handling nesting materials. At a minimum, workers should wear
chemical splash goggles, latex gloves, and a disposable respirator. Although
nest destruction campaigns are generally effective in reducing the numbers of
birds around a structure, such programs require persistent effort throughout the
nesting season.
6. Keeping waste disposal areas clean. Maintain clean compactor/dumpster
areas. These areas are visited frequently by birds and other pests for food and
water. Keeping such areas well maintained and free of spillage will help to
minimize birds and other pests. If water pools around the dumpsters, install a
drain. Pooled water is highly attractive to birds and other pests.
VI. PREVENTION OF BIRD INFESTATIONS THROUGH SOUND

STRUCTURAL MODIFICATIONS AND DESIGN PRACTICES
A. Structural Modifications
This important component of habitat modification can pay huge dividends in reducing the
attractiveness of food processing facilities to pest birds. Birds will utilize almost any gap,
crack, or protected site for nesting or resting sites [19]. As a part of the facility inspection,
make a list of all areas that contain possible nesting or resting sites, then determine the
best methods to get rid of the problem sites. Specific examples of modifications that reduce
the carrying capacity of the facility are as follows:
Block spaces under corrugated roofs to preclude nesting activity of sparrows [16].
Materials that can be used, depending on the specific circumstances, include hard-
ware cloth, expandable foam, sheet metal, and bird netting. When using foam, it
is important to use a precision foam gun (not an areosol can) so that no gaps are
left. The birds will take advantage of any gaps, enlarging them to gain access.
Remove signs from the side of buildings, or place them tightly against the side of
the building. Sparrows are notorious for building nests between signs and build-
ings [18]. Lighted signs, providing both shelter and warmth, are highly attractive
to pest birds. Where sign removal is impossible or placement is not flush, block
the gaps between the building and the sign with an appropriate netting or screening
material [3].
When designing new dock areas and protected overhangs, consider the use of tubular
supports (square or oval) rather than I beams. I beams provide abundant nesting
and roosing areas. Seal the ends of the tube members completely to prevent pest
entry into the interior area of the tube. Useful types of exclusion materials include
hardware cloth, sheet metal, and expandable foam.
Lights placed directly on building exterior walls often serve as nesting sites, espe-
cially for sparrows. Moreover, exterior lighting can be highly attractive to flying
insects that will, over time, enter the facility. Rather than placing lights directly
on the building, they should be erected on poles distanced from the building and
directed toward the area to be illuminated. Insects are attracted to the area of
greatest light intensity, meaning they will gravitate toward the light itself, now
located many feet from the building.
Lights on poles can also be attractive as nesting sites for birds. Several simple physi-
cal deterrents can be used to keep birds off such lights. Metal or plastic ‘‘bird spikes’’
can be trimmed to the most appropriate size and affixed to the light with a high-quality,
weather-resistant adhesive.
Other options, depending upon the size of the light and adjacent obstructions, include
the use of springing wires available from commercial suppliers of bird exclusion devices.
This device consists of long, protruding ‘‘legs’’ attached to a central spindle that slowly
rotates with air movement. The horizontal movement, coupled with the up-and-down
movement of the legs, is bothersome to birds.
Another consideration is that building lights should be sodium vapor lamps as op-
posed to mercury vapor lamps. The former lamps are generally unattractive to insects,
while the latter lamps are highly attractive.
Fire alarm bells are notorious nesting sites, especially for sparrows. As with lights,
there are probably alternative locations where fire alarms can be installed. However, con-
sultation with fire safety professionals is highly recommended before making such
changes.
B. Structural Design
The best opportunity to build birds out of a food processing facility is during the design
phase [3]. Incorporating sound structural features at this point can make a facility resistant
to bird encroachment and can greatly reduce the cost of later corrective action. Some of
the most important design features that should be considered are as follows:
In general, any flat, protected site can be used by pest birds for roosting and nesting.
Therefore, structural designs that limit such sites help prevent bird encroachment.
The use of I beams as structural support members should be avoided and tube
members used instead.
Overhangs in loading/receiving dock areas should be constructed using a cantilever
design that limits the number of open supports. If horizontal supports are required,
these should be tube members, not I beams. If ‘‘I’’ beams must be used, then the
open ends will require sealing or netting to restrict access to pest birds.
Window ledges and other similar structures should be limited to the greatest extend
possible. Pigeons nearly always find these ledges and, if they afford protection
from the elements and from natural predators, will soon roost and probably nest
as well.
Other ledges can be made undesirable as roosing or nesting sites by increasing the
Figure 5 Building out birds. The overhang of this building is constructed at a 45° angle to keep
birds from nesting at the site.
angle of the upper surface to at least 45° (Fig. 5). Birds will avoid using such
sites. This is a difficult and expensive retrofit for existing structures. As an alterna-
tive, there are various physical exclusion devices that can be placed on such ledges
to deny access to birds. These devices will be discussed in Section VII.
Avoid affixing anything to the side of the building that could be used as a nesting
site. Signs, lights, and fire alarms all provide suitable nest sites.
Openings into the building must be sealed. Areas under corrugated roofs can be
sealed or netted to exclude birds.
Dock doors must be kept closed when not in use. It is a common practice to erect
plastic strips along the threshold of the dock door in an attempt to limit birds
from entering the facility. Invariably, however, employees find these strips a nui-
sance and either cut them off short or tie them back against the doorframe, essen-
tially negating their effectiveness.
High-speed, automatic dock doors are available that, when properly synchronized
with an electric eye, remain closed when not in use. These doors must be properly timed
and periodically adjusted so that they close tightly, close at the appopriate time and speed,
and do not risk employee injury.
Manual, roll-up doors are sometimes used at dock entrances. Keeping roll-up doors
closed requires a conscientious effort by employees (workers are often inclined to leave
the doors open for ventilation and convenience). Roll-up doors also present high potential
for insect infestation inside the housing of the roll-up mechanism. The space inside the
housing is virtually impossible to access for cleaning.
VII. PEST MANAGEMENT METHODS FOR BIRDS IN FOOD

PROCESSING PLANT
Once birds become established in or around food processing plants, it then becomes a
challenge to devise corrective methods that can be implemented. There are many creative
and effective solutions that could be considered. However, we will focus on the most
frequently used and most cost-effective methods. Before starting any of these methods,
it is important to conduct a bird survey to establish the kinds and numbers of birds present,
their feeding, resting, and nesting sites, and their activity patterns [3]. Avoiding this step
can be a costly mistake because birds frequently present different behavior patterns at
different times of the day. For example, excluding birds only from the area where you
see birds resting at noon may overlook places where they might be roosting overnight,
and nesting sites might be overlooked altogether.
As a general rule, bird surveys should be conducted in the early morning, at noon,
and again about dusk. This will provide the broadest array of information on bird activity
for the least amount of time spent. These surveys should be done formally, using binocu-
lars and a survey form on which to record specific bird activities [3]. Based on this survey,
the bird management specialist should be able to determine the sites of activity, appropriate
management methods, cost, and likely outcomes.
If the bird management involves harming birds, or is likely to result in sighting of
disoriented or trapped birds by the public, then a public relations campaign may be needed
before starting the bird management progam. Failure to consider public relations may
doom the campaign and totally negate any benefits obtained [3].
A. Exclusion
Exclusion can be accomplished by a variety of measures, many of which have already
been discussed in broad terms. In general, exclusion is least objectionable to the public
and most apt to yield permanent results. Holes and gaps can be sealed with hardware
cloth, mortar patching, sheet metal, expandable foam, and netting.
Large nesting sites on docks built with I beams or exposed metal framing generally
are most effectively eliminated by installation of bird net [1]. Similarly, netting is probably
the most economically efficient method for protecting large cooling tower areas or rooftop
HVAC systems against bird damage (Fig. 6).
Netting is usually made of a synthetic plastic mesh that comes in different grid sizes,
depending on the type of bird to be excluded [1]. Mesh sizes are generally 0.75 in. (2
cm) for sparrows, 1.25 in. (3.2 cm) for starlings, and 2.0 in. (5 cm) for pigeons. It is
important to note that in order to satisfy the terms of the manufacturer guarantees, the
Figure 6 Building out birds at a loading dock. The overhang of this dock is cantilevered in such
a way that birds cannot use the supports for nesting.
netting must be installed on a wire cable frame solidly affixed to the building and stretched
taut using turnbuckles, ensuring that everything is square.
It is very important that netting installation be done by a professional installer, since
special equipment and skills are needed to do a proper job. Improperly installed netting
not only nearly always fails to exclude birds, but also voids manufacturer guarantees.
Eventually, it will have to be torn down and done right.
It is also important at the outset to install trap doors and access panels in the netting
for replacing lights, entering overhead panels, and repairing equipment so that the net is
not cut later by building engineers who do not appreciate the cost of repairing netting.
Netting comes in several colors, so it is easy to pick a type of net that is virtually invisible
to the casual observer.
B. Repellents and Deterrents

Repellents and deterrents can be categorized into three types; virual, auditory, and tactile.
1. Visual Repellents
Visual repellents in the form of fake owls and hawks, enlarged eyes, shiny flags, balloons,
and flashing lights have been used but with limited success. While such devices may work
for a short period of time, the birds generally become accommodated to them within a
matter of days and ignore them thereafter [3]. There are many reports about fake owls
installed on a rooftop, with dozens of pigeons roosting or loafing all around them.
2. Auditory Repellents
Auditory repellents do not fare much better. Examples of auditory repellents include
alarms, horns, gunfire recordings, explosion recordings, ‘‘canned corn’’ (noisemaking py-
rotechnics), and bird distress calls. Pigeons and sparrows seldom respond for more than
a brief period, as these species are well adapted to the noisy situations normally encoun-
tered in urban and industrial settings. Recorded bird distress calls will cause starlings to
leave a roost, but usually also cause them to roost in a nearby area, from which they then
likewise must be dislodged. Such tactics generally result in the alarm recording being
ferried from one area to another for nights on end, annoying the public, and requiring a
considerable investment in labor and equipment.
Ultrasonic devices do not work at all. Since birds have a hearing range similar to
humans [20], they are unable to detect ultrasonic waves.
3. Tactile Deterrents
Tactile deterrents include various formulations of polybutylene or polybutene, otherwise
known as ‘‘hotfoot.’’ While these repellents do work, they are sticky and messy, especially
on porous surfaces. On hot days, the repellent material may become runny and drip down
onto signs or the sides of buildings. Moreover, the material quickly becomes coated with
soot, nesting materials, feathers, and feces, resulting in a messy, black paste that is un-
sightly, difficult to remove, and ineffective.
Two other widely used products are considered tactile repellents, although they
could also be considered as exclusionary products. Porcupine wire is one of the more
common products used for birds. It comes in a variety of designs, most often with prickly,
3- to 4-in. (7.5- to 10-cm) spikes extending upward. These products come in 3- to 5-ft
(0.9 to 1.6-m) strips of wire or plastic spokes. Each strip covers 3–5 in. (7.5–12.5 cm)
of width on a ledge. They can easily be affixed to ledges, beams, or other bird resting
sites with a silicone glue (Fig. 7).
Normally ledges that are used for this type of installation will be less than 1 ft wide
(⬎31.5 cm), so that not more than three rows of porcupine wire need to be installed.
Porcupine wire is highly effective against pigeons and starlings, but less so against spar-
Figure 7 Bird netting is used to exclude pigeons from a large rooftop HVAC system.
rows, which may actually drop nesting materials among the spikes and even establish
nests in it under some conditions.
Pin and wire is another commonly used structural tactile deterrent. It is generally
used in the same situation where porcupine wire is used, i.e., on ledges not over 1 ft (31.5
cm) wide. The product is tricky to install correctly, but is less visually noticeable than
porcupine wire and less likely to be used by sparrows for nesting space. Pins must be
installed by fixing them into a masonry surface using a drill. Thin wires, stretched tightly
between the pins, usually in parallel rows, vibrate with the slightest touch. It is the vibra-
tion of the wire that appears to unnerve birds that attempt to settle on ledges protected
by pin and wire. Some versions of pin and wire may also be electrified, making them
even more disruptive for birds.
The ‘‘spider legs’’ set-up is another effective tool for protecting small flat surfaces
against birds. The legs radiate outward 3–4 ft (94.5–126 cm) from a central spindle that
moves with air currents, allowing the springy wires to scare birds off the surface (Fig. 8).
C. Trapping
Trapping of birds can be effective when done professionally and in the right situations.
The most difficult situation is trapping a sparrow or starling inside a building with a high
ceiling. The pest bird may remain near the ceiling of the building most of the time, making
only occasional forays to food or water sources at floor level. Traps designed for individual
sparrows or starlings can occasionally be successful. However, the trap must be prebaited
for 1–2 days to allow the bird to become accommodated to it and must have virtually the
only source of food or water available. It should always be used with the food that the
bird is most accustomed to eating. Where the public is present, placing the trap out of
sight is an essential, but sometimes difficult, task.
Removal of trapped birds must be done discreetly, and release well away (several
miles/kilometers) from the premises is required to prevent them from returning. Pigeon
traps can be used effectively on rooftops where pigeons frequently rest or loaf. These
traps typically have two one-way doors that allow entry but not exit. Prebaiting the traps
with whole, dried corn for 3–4 days is generally required prior to setting the trap doors.
After this, the traps may be set in the morning and pigeons removed in the late afternoon
or evening. One bird should always be left in the trap as a decoy at the end of the day.
To be effective for a typical flock of 50 to 100 birds, four or five traps must be set
in a range of sites on the rooftop. Each trap will hold 6–8 birds, so the program may
need to be continued for a week or more to trap out the flock. For humane reasons, water
must also be provided in the traps. After trapping, birds need to be removed and relocated
miles/kilometers away from the trap sites. The alternative is to take them to an isolated
site and dispatch them humanely by shooting them with a pellet gun. In any case, such
actions must be done in areas where it is legal to do so, and certainly out of view of the
public.
In some situations—for example, in a high-ceilinged building infested by spar-
rows—trapping with mist netting may be the only practical solution. Because mist netting
is normally used only by research scientists or by personnel of the U.S Fish and Wildlife
Service (USFWS), purchasing such netting is highly restricted and must be done with the
ultimate permission of the USFWS (because mist netting is virtually invisible to birds,
special precautions are taken to prevent it from being used illegally). The net, 23–49 ft
(7–15 m) high by 33–66 ft (10–20 m) wide, stretched between poles, is placed in what
have been observed to be bird flight routes in the facility. Be advised that the netting
becomes easily entangled and requires skill and patience to use. At this point, one can
wait for the birds to fly into the netting or one can attempt to drive the birds into it.
Birds trapped in such a manner must be carefully extricated and then released well
away from the building. This netting cannot be used outdoors without permission of the
USFWS.
Another method for trapping individual sparrows or starlings is to install rodent glue
boards in the facility. Prebait covered glue boards with a food favored by the bird species
of interest. For sparrows bread or popcorn can be used, while for starlings grapes or raisins
are attractive. After 24 hr of prebaiting, the paper covering the glue is removed. Stuck
birds should be removed with mineral oil or salid oil and released away from the building.
Trapping large numbers of birds on a rooftop or other flat surface can occasionally
be accomplished by use of netting shot from a small cannon designed for this purpose.
This method, for use only by professional bird management companies, may require ap-
proval from the USFWS. The netting, approximately 24.6 ⫻ 49 ft (7.5 ⫻ 15 m), is shot
from the cannon in a projectile that carries the netting over the birds and drops it. After
the birds are carefully removed from the netting, they are carried to a distant site and
released.
D. Avicides
Avicides are becoming more and more restricted in their use, and the number of registered
avicides approved by the Environmental Protection Agency (EPA) continues to decline
year after year. Virtually all uses of toxic bird perches, for example, formerly widely used
for starlings and sparrows, have had their registrations cancelled by the EPA.
The number of registered products containing the most widely used avicide, 4-
aminopyridine, is fewer than just a few years ago. Those products that are still registered
are labeled for use only in a diluted strength that makes most birds sick but does not kill
them. This product is typically used in conjuction with bait containing corn or other feed
attractants. Birds that consume this toxicant generally become distressed and disoriented
with 30–60 min, often dropping to the ground and making distressed sounds and move-
ments. The noises, as well as the appearance of affected birds, generally frighten away
other birds in the area, particularly pigeons.
Needless to say, pigeons that fly in a drunken fashion and drop out the sky in a
public place can cause a huge public relations problem. This type of product must be used
very discreetly, preferably before or after business hours or on weekends.
A product specifically for starlings, 3-chloro-p-toluidine hydrochloride, is a pellet-
type bait that kills slowly over 2–3 days and has no secondary poisoning effects. It kills
only a few selected species of birds, which, however, also includes chickens, turkeys, or
other poultry.
Strychnine-laced bird control products can still be used in very limited situations,
but most of these products will likely be phased out as their registrations expire. Those
strychnine products still in current use have limited applications, mainly in agricultural
settings. They are highly and rapidly toxic to birds of all species, as well as other animals.
Moreover, they are well known for causing secondary poisoning effects in nontarget ani-
mals. Consequently, the labels for these products specify that they are restricted use prod-
ucts (applied only by certified pesticide applicators) that may be used only during the
winter. Use of this bait should only be undertaken after consultation with the USFWS.
E. Shooting
When all else fails, shooting may be undertaken in very restricted circumstances. Such a
program is usually initiated when small numbers of birds are in indoor food areas and
must be eliminated quickly and when other methods are unlikely to succeed. Prior to
starting such a program, police and local authorities must be consulted to ensure that
shooting is not a violation of local ordinance. Shooting should be undertaken with a pellet
rifle using a heavy pellet so that a quick kill is obtained. A skilled shooter should be used,
one who can kill birds outright without wounding them.
Once a program is begun, it must persist until all birds are either shot or depart the
area. In some outdoor settings, a 0.22 gauge rifle or 0.410 shotgun can also be used.
However, these are more apt to cause concerns for authorities. When employing a shooting
program, bear in mind that the relief obtained is generally quite temporary, and birds will
soon reappear if the conditions that attracted birds to the area in the first place are not
eliminated.
F. Biological Control
Although this method is seldom used, except at airports or large military bases, it can be
quite effective. The method requires the employment of a falconer and trained peregrine
falcons. Once falcons are observed by other birds, the pest birds generally leave quickly,
with very few or no birds having to be killed. This method is quite expensive and may
require a falconer to be present for up to a week or more to prevent new flocks of pest
birds from coming in to take advantage of the territories vacated by the departed flocks.
VIII. SUMMARY
Pest management of birds around food processing plants can be one of the most daunting
challenges facing food production plant managers. A pest bird problem is often ignored
until it becomes a critical issue and health inspectors threaten to close the plant. Unfortu-
nately, rectifying such situations often requires much longer than the immediate solution
the plant manger hopes for. Problems of poor sanitation and structural defects that make
buildings attractive to birds are difficult to fix; but without fixing these deficiencies many
bird management methods work slowly or poorly.
A good bird management program involves learning about the pest bird, its biology,
and its behavior. Therefore, plant managers should engage the services of bird manage-
ment professionals early on, rather than attempting makeshift fixes to solve their problem.
The best solutions for bird infestations are those that are well grounded in detailed knowl-
edge of bird behavior, are painstakingly applied, and lead to permanent reductions in pest
populations. Additionally, plant managers are generally not knowledgeable about federal,
state, and local laws and regulations pertaining to birds and bird control.
What appears to be a simple solution can result in killing songbirds or other protected
species, which in turn can lead to a public relations disaster, a severe fine, or worse. The
successful program, which usually involves integrating several complementary ap-
proaches, is best achieved by using a professional bird management company. While these
companies are few in number and sometimes expensive, the results are nearly always
worth the costs, especially if you wish to avoid bad publicity from environmental groups
and news media.
REFERENCES
1. National Pest Control Association. Bird Management Manual. Dunn Loring, VA: National
Pest Control Association, 1982.
2. USDA-APHIS. ADC assistance with waterfowl. United States Department of Agriculture,
Animal and Plant Health Inspection Service ADC Factsheet, Annapolis, MD, 1995.
4th Ed. Duluth, MN: Advanstar Communications, 1988, pp 333–351.
4. RE Marsh, WE Howard, Pigeon control—a review of the options. Pest Control Technology,
March: 68–78, 1991.
5. J Chin, ed. Control of Communicable Diseases Manual, 17th Ed. Washington, DC: American
Public Health Association, 2000, pp 60–62, 296–299, 405–407, 440–444, 500–503.
6. G Mehta. Aspergillus endocarditis after open-heart surgery: an epidemiological investigation.
J Hospital Infections 15:245–253, 1990.
7. CW Emmons. Annotations, the birds. Lancet 928, 1963.
8. RJP Thearle. Urban bird problems. In: RK Murton, EN Wright, eds. The Problems of Urban
Birds. Symposia of the Institute of Biology, No. 17, 1967, pp 181–197.
9. HD Newson. Medically important anthropods. In: GW Hunter, JC Swartzwelder, DF Clyde,
eds. Tropical Medicine, 5th Ed. Philadelphia: WB Saunders, 1976, pp 701–782.
10. WB Herms, MT James. Medical Entomology, 5th Ed. New York: Macmillan, 1961, pp 87–
120.
11. WD Fitzwater. How to control house sparrows. Pest Control Technology, April: 60–70, 1990.
12. W. Ebeling. Urban Entomology. Los Angeles: The University of California Press, 1975.
13. RE Marsh, WE Howard. Vertebrate pests. In: A Mallis, ed. Handbook of Pest Control, 7th
Ed. Cleveland, OH: Franzak and Foster, 1990, pp. 771–831.
14. CA Faanes, C Vaughn, JM Andrew. Birders and U.S. federal laws. Birding 24(5):299–302,
1992.
15. National Pest Management Association. Addressing pest management concerns. Pest Manage-
ment 5(4):15–21, 1986.
16. FJ Baur, WB Jackson. Bird Control in Food Plants. St. Paul, MN: The American Association
of Cereal Chemists, 1982, pp 26, 27, 55.
5th Ed. Duluth, MN: Advanstar Communication, 1997, p. 366.
18. RE Marsh, RM Timm. Vertebrate pests. In: A. Mallis, ed. Handbook of Pest Control, 8th ed.
Cleveland, OH: Mallis Handbook and Technical Training Company, 1997, p 998.
19. Urban ecosystem management: birds. The IPM Practitioner 3(3):2–3, 1981.
20. DM Hammershock. Ultrasonics as a method of bird control. U.S. Flight Dynamics Lab. Rpt.
WL-TR-92-3033, Wright–Patterson Air Force Base, OH: Air Force Systems Command, 1992.

21
Stored-Product Insect Pest
Management and Control
FRANKLIN ARTHUR
U.S. Department of Agriculture, Manhattan, Kansas, U.S.A.
THOMAS W. PHILLIPS
Oklahoma State University, Stillwater, Oklahoma, U.S.A.
I. INTRODUCTION
Insect pest management and control is a serious concern for food processing and milling
facilities. Contamination of products can have direct economic consequences either
through damage and quality deterioration or intangible losses associated with customer
dissatisfaction. In the past, most insect control programs at food plants were heavily depen-
dent upon insecticides, but in recent years the number of insecticidal compounds that can
be used to control insects inside and around food plants has been severely curtailed. New
regulatory requirements for current insecticides, consumer preferences for reduced chemi-
cal use, and the high costs of developing and registering new replacement insecticides
have all contributed to this decline.
The concept of integrated pest management (IPM) was extensively developed and
discussed during the latter portion of the 20th century. Now it is being promoted as the
model for controlling insects in most production agricultural systems [1]. Integrated pest
management is also being advocated for stored bulk grains [2–5]. However, this approach
becomes more difficult as agricultural products move from production areas to storage
facilities and then to the processing and milling arenas. The risks of contamination, infesta-
tion, and consumer complaints, and the value and vulnerability of the products, often
combine to produce what amounts to a zero tolerance for insects and damage. Although
products can certainly become infested after leaving the food plant as they move through

distribution chains and marketing channels, the manufacturer often receives the blame for
contaminated products.
Many aspects of traditional IPM programs are applicable for food plants, but others
may not be economically feasible. When discussing IPM, it is important to relate the
concepts to the particular pest management system that is being addressed, for IPM in
one system may not be viewed in the same manner when it is applied to a different system.
In this chapter, we describe and discuss components of the IPM approach as directed
toward insect control in food plants and processing facilities.
II. INTEGRATED PEST MANAGEMENT

The origin, historical development, definitions, and practical applications of IPM have
been described in a recent review [1]. Common elements among most definitions of IPM
include decision support for implementing insect control strategies, cost/benefit analyses,
impacts of multiple pests, and recognition of single and multiple control tactics integrated
into a systems approach. The concept of IPM was primarily developed by field crop ento-
mologists [6], and many programs for field crop pests have emphasized an economic injury
level (EIL) and an economic threshold (ET), with extensive scouting and sampling to
determine when the ET has been exceeded [7,8].
The concept of monitoring to determine the extent of insect infestations and the use
of multiple controls is also emphasized when discussing IPM for stored grains. As field
crops such as wheat and corn are harvested and placed into storage, there are a number
of factors that must be considered when discussing IPM strategies [4]:
1. The large size of bulk storage facilities increases the difficulty and complexity
of sampling and monitoring.
2. Risks associated with insect infestation and damage are more serious in stored
grain compared to field crops because stored grain cannot compensate for insect
damage through increased growth or other physiological responses. Also, stored
grain is being moved directly to the processing and manufacturing industry,
where there is little tolerance for insects and insect damage.
3. There is a serious limitation on the availability of insecticides that can be used
to control insects in stored grain, as older chemical protectants are being re-
moved from the market, and replacement products may not be as economical
or as effective [9]. The use of traditional insecticidal protectants as grain is
loaded into storage is decreasing.
4. The economics of the system may not support the scouting and consulting ser-
vices that are common for most field and orchard IPM programs.
5. There is a noticeable lack of clear action levels in stored-product IPM as com-
pared to field crops.
The difficulties in application of the IPM concept to stored grain can be compounded
when this approach is being applied to food plants, processing facilities, and mills. In this
system, there is essentially a zero tolerance for insects and contamination, especially with
the risk of having infested products passing through the distribution system and reaching
consumers. Although it may be easier to monitor insects within plants and mills compared
to bulk grain, there are problems with interpreting the information from insect traps. There
is limited involvement regarding an outside scouting and consulting industry, and most
of the data pertaining to the extent of insect infestations are kept confidential and private
within a particular company.
The use of IPM in field crops is based primarily on monitoring to determine if there
is an insect problem and selecting appropriate control strategies to correct that problem.
The concept of IPM as currently practiced in bulk grain and other food processing facilities
appears to emphasize a multiple-component approach based on preventing insect problems
from occurring, in addition to implementing controls after a problem is detected.
The multiple-strategy approach for bulk grains often involves a prebinning insectici-
dal treatment to disinfest storage bins, aeration to modify the storage environment after
grain is stored, monitoring pest populations during storage, and fumigation with phosphine
when necessary. In food plants and storage facilities, IPM can include but is not limited
to sanitation, exclusion of insects, monitoring programs, fumigants and alternatives to
those fumigants, and residual insecticidal treatments with conventional chemicals and new
products. These components are broadly classified as either nonchemical management
strategies or chemical management strategies.
In this chapter we will review the various IPM strategies and components regarding
stored-product insect control in food processing systems. We should note that our discus-
sion primarily refers to food processing systems only, as opposed to raw bulk grains. Also,
we are specifically discussing management for stored-product insects only. Management
of cockroaches and structural insects (Chapter 19), birds (Chapter 20), and mammalian
pests (Chapter 18) are covered elsewhere in this book.
III. NONCHEMICAL MANAGEMENT STRATEGIES

A. Design Modifications
Food plant design and engineering modifications for pest exclusion are covered elsewhere
in this book and in an excellent treatise on the subject [10]. Good design includes good
site selection and location, minimizing voids, wall spaces, cracks and crevices, and other
hidden or restricted areas that can harbor insects and other pests, constructing floors that
are easy to clean, providing for removal of accumulated material, and using manufacturing
equipment that can be easily cleaned to prevent the build-up of food sources that can
promote infestations. Other design considerations include installation of outside lighting
away from buildings, good separation and structural isolation of raw materials, and sepa-
rate areas for processing, packaging, and finished product storage [10].
B. Insect-Resistant Packaging
Insect-resistant packaging (see Chapter 25) is an extremely important control strategy that
is often overlooked when considering nonchemical control or exclusion techniques.
Stored-product insects vary in their ability to infest packages. They can be broadly classi-
fied as penetrators, capable of boring through packaging materials, and invaders that can
enter through seams or openings [11,12]. However, under certain conditions, invaders
may be able to penetrate a package. Also, different life stages of particular species may
vary in their ability to enter packages [12,13].
Different packaging films may vary in their ability to prevent insect entry. For exam-
ple, polyvinyl chloride polymer films are less resistant than polypropylene films [14].
Methods have been developed to quickly evaluate the effectiveness of new packaging
materials [15]. Proper selection and utilization of materials will protect packages while
they are stored at the food plant before they are shipped and may also ensure protection
of packages as they move through the marketing channels. New research has shown the
potential for incorporation of natural chemical repellents into packaging material and new
glues and sealing methods to improve the structural integrity of insect-resistant pack-
aging [16].
C. Sanitation
Sanitation as defined for the food processing and milling industries is often described by
a combination of approaches, such as cleaning and elimination of conditions that can
cause contamination, pest control operations, and maintaining a safe and healthy working
environment for employees [17]. Training manuals and management guides for industry
usually include descriptions of insect pests and guidelines for the use of insecticides
[16,18,19]. In our discussion of sanitation, we focus on cleaning operations and how they
can affect occurrence of insect pests and the efficacy of insecticides used to control these
pests.
Although the importance of sanitation is continually addressed in the development
of management programs for bulk-stored grains and oilseeds, there are few published
reports that document direct quantitative effects of sanitation. The effects appear to be
more directly related to improvements in other aspects of the management program, such
as the efficacy of insecticides.
In one Australian study conducted in stored wheat, hygiene and cleaning practices
by themselves had little effect on insect populations, but they greatly improved the efficacy
of protectant insecticides [20]. Similar results were noted in studies with in-shell peanuts.
Residues of pirimiphos-methyl would become concentrated in foreign material such as
dirt, twigs, sticks, and grass, and overall degradation of the insecticide was accelerated
compared to cleaned peanuts [21]. Insect populations were also significantly greater in
peanuts containing foreign material versus those in cleaned peanuts [22,23].
There are also few published reports of studies related to the food plant and milling
industries that document direct effects of cleaning. However, the presence of food materi-
als and extraneous trash may have a significant impact on the efficacy of insecticides. In
studies where red flour beetles (Tribolium castaneum) were provided with flour after short-
term exposures on concrete treated with cyfluthrin wettable powder (WP), survival dramat-
ically increased compared to beetles that were not given food [24].
The presence of accumulated flour also appeared to accelerate inactivation of
cyfluthrin residues on concrete. When beetles were put on extraneous substances such as
sawdust and wheat kernels, survival was increased relative to beetles put on clean sub-
strates [25]. Survival of red flour beetles and confused flour beetles (Tribolium confusum)
was greatly enhanced when beetles were given flour either while they were directly ex-
posed to the inert dust diatomaceous earth or after they were exposed for short time inter-
vals to the dust and held for defined time periods after exposure [26].
Concentrations of extraneous materials within food plants, especially food sources,
could form barriers so that insects cannot come into contact with residues on treated sur-
faces, provide insects with a means of removing insecticide particles, or increase survival
through the nutrition provided by the food source. These sites may become refuge areas
that can allow insects to escape and evade exposure when insecticides are targeted to
specific areas [27,28]. Many of these refuge sites could be eliminated through a regular
program of inspection and cleaning. Industrial plants often contract with outside sources
to provide regular inspections and sanitation audits so that management can be alerted to
potential problem sites within the food plant.
One final aspect of sanitation involves accurately recording customer complaints
and tracking returns so that problems that occur after products have left the food plant
can be identified and corrected. In most cases, food manufacturers and processors are
held responsible for contaminations that occur during distribution and marketing channels.
Consumers tend to address their concerns to the original source of the product, usually
the manufacturer. A tracking program could enable manufacturers to identify the specific
locations where problems are occurring and implement corrective actions.
D. Monitoring
Pest monitoring is one of the cornerstones of an effective IPM program. Only through
monitoring can the food plant managers know the insect species, relative abundance, and
the distribution of insect populations within the facility. This information is essential for
making pest management decisions. Pest monitoring can be carried out as part of the
routine sanitation plan in a food plant and should integrate personnel from pest control,
receiving, production, packaging, and shipping. Monitoring can involve active inspection
or sampling for pests or utilize monitoring tools such as traps to detect and assess insect
pest populations.
1. Visual Inspections
Visual inspections of a food plant for insect pests, whether conducted on a formal or
informal basis, should be part of the sanitation or pest manager’s work routine. Facilities
that process cereal grains or other dry food products such as baked goods and confectionar-
ies will be vulnerable to infestation by stored-product insects.
Guidelines have been developed for conducting walk-through inspections of such
plants to detect insects in predictable situations [18]. Debris accumulated from floor
sweepings, vacuum cleaning, and sifting equipment should be inspected for insects. Eleva-
tor boots and voids under the boots should be thoroughly examined, as insects can accumu-
late and breed in food in the ‘‘dead space’’ that is not contacted by the buckets. Ledges,
shelf tops, machinery tops, tops of exposed structural members, and other high surfaces
that are not easily cleaned should be regularly inspected for insects. Insects often accumu-
late on windowsills and other surfaces near windows because of the natural tendency of
insects to fly toward light. A vigilant inspector will learn the areas of the plant that are
most likely to reveal insect activity and focus on those during an inspection.
2. Traps
Insect traps are monitoring tools that capture insects over time and thus provide the man-
ager with specific information about insect activity. Trap-catch data are more readily ac-
quired than data from visual inspections. Most living insects are not easily observed during
sanitation inspections because they are hidden and therefore are not easy to see. Regular
monitoring using several insect traps of different types at multiple locations throughout
a facility can yield information regarding the presence of specific insect species, relative
changes in numbers and species composition over time, and the location of insects and
their relative abundance at different locations. Various trapping devices are available for
use, with some being more appropriate in certain situations than others.
a. Glue Boards. Glue boards, sticky cards, or ‘‘blunder’’ traps are typically flat pieces
of stiff card stock or fiber board coated with a sticky material (Fig. 1A). Glue boards have
been used for years by the pest control industry to capture and monitor rodent pests [29],
but they also have good utility for monitoring insects. Small sticky cards have proven
effective for monitoring cockroaches for pest management purposes [30]. Glue boards
without attractants are not specific and will capture any insect that blunders into them.
Glue boards are typically placed on the floor at a wall junction so that insects walking
along the wall can be trapped as they cross the board.
Some insects, such as the red flour beetle, avoid stepping onto a sticky surface [31],
so it is important to note that insect species differ in their response to traps. Glue boards
represent the traps of least sensitivity among the available designs, but they are inexpen-
sive and easy to use, especially in concert with a rodent control program, so they should
be checked for stored-product insects.
b. Light Traps. Light traps, equipped with sticky or electrocuting surfaces, attract fly-
ing insects to an artificial light source. Many insects, including stored-product insects,
will fly toward light in the visible-to-ultraviolet range of the electromagnetic spectrum
[32], thus most light traps are equipped with a filtered ultraviolet (‘‘black’’) light (Fig.
1B). Although the light is an insect attractant, light traps are relatively nonspecific and
are useful for any flying insects that may be sensitive to the wavelengths emitted from a
particular trap design.
The original reason for using light traps in structural pest control was, and still is
in most cases, to trap and monitor houseflies (Musca domestica) and other flies that carry
filth to food. Thus, light traps are used in restaurants, food services, and other facilities
that prepare food for immediate consumption.
Figure 1 (A) Sticky glue card that acts as a blunder trap for pedestrian insects and rodents. (B)
Light trap. Insects are attracted to ultraviolet lights, are disabled by the electrocuting grid behind
the lights, and then fall into a receptacle in the bottom of the trap. (C) Sticky trap for flying insects;
such a strap is typically baited with the sex pheromone of a moth or beetle. (D) Pitfall trap for
walking insects. A pheromone lure attracts insects to the vicinity of the trap; responding insects
climb the inclined wall and fall into the pit where they are trapped in oil.

However, light traps are very useful for monitoring stored-product insects in food
processing plants. The higher cost of light traps relative to other traps, and their relatively
large size and need for a power supply, will relegate their deployment to just a few key
locations throughout a plant.
Electrocuting-type traps are not recommended for monitoring purposes. Because
responding insects typically explode into many pieces upon contact with the electrocuting
grids, they become impossible to identify and count. Nonexploding electrocuting light
traps, and those equipped with a sticky trapping surface, are preferred because whole
insects can be identified and counted.
c. Pheromone Traps. Pheromone traps are the most species-specific and sensitive traps
available for monitoring insect pests. A pheromone is a chemical signal recognized among
members of the same species. These traps utilize a synthetic chemical copy of the natural
attractant of a given species to capture insects [33]. Synthetic pheromones are formulated
into slow-release dispensers. The volatile attractants are slowly evaporated from a lure
and thus are effective for several weeks or months.
Because pheromones are species-specific signals, they attract only members of the
target species, or sometimes those of closely related species, that use the pheromone in
the natural context. They are useful for monitoring a specific pest for which the pheromone
is available. Because sex and aggregation pheromones are strong attractants for insects
seeking out mates or breeding sites, pheromones traps can attract and detect the presence
of insects whose population might be at a relatively low level and probably would not be
detected by other means.
Although pheromones have been chemically identified for approximately 40 species
of stored-product insects, pheromone traps and lures are commercially available for just
the key pests [5,34–36]. Traps and lures are available and widely used for the Indianmeal
moth (Plodia interpunctella), the cigarette beetle (Lasioderma serricorne), the warehouse
beetle (Trogoderma variabile), and the red and confused flour beetles. Pheromones for
some of these species are also attractive to closely related species. The Indianmeal moth
pheromone attracts some other storage moths such as the almond moth (Cadra cautella)
and the Mediterranean flour moth (Ephestia kuehniella). The warehouse beetle pheromone
attracts other beetles in the genus Trogoderma.
Pheromones are typically sex specific or sex biased in the insects they attract. For
example, the pheromones for moths, cigarette beetles, and warehouse beetles are synthetic
mimics of the female-produced sex attractant, thus they attract only males. The male-
produced, aggregation pheromone of Tribolium spp. attracts both sexes, but more females
than males.
Pheromone traps come in various designs [33], most of which are intended for a
particular species or type of pest. The two fundamental designs are either for flying insects
or for crawling insects. Sticky traps are commonly used for flying moths and beetles,
capturing responding insects on a protected sticky surface (Fig. 1C). Sticky traps are rela-
tively inexpensive and easy to use, but are easily fouled with dust and debris or become
filled with insects and need replacement within a few weeks or month.
Nonstick traps for flying insects are reusable but more expensive than sticky traps,
and they incorporate a funnel or landing surface for the insects and a collection reservoir
for trapped insects. Crawling insects can be trapped with various designs of pitfall traps
(Fig. 1D) that are placed on surfaces such as floors or shelves. Insects may fly or crawl
to the vicinity of the pitfall trap and then walk into the trap and fall into some sort of
trapping reservoir. The best traps for pest monitoring are those that are easy to use and
have a proven reputation for effectiveness.
One misconception about pheromone traps is that a pest population can be controlled
by deploying these traps—this is not true for most situations. Traps usually attract only
a small percentage of the population that is within the effective range of the trap. Also,
female-produced sex pheromones attract only males; the females that lay eggs and perpetu-
ate the infestation are not affected. Since males of many insect species will mate with
multiple females, any males that are not trapped can easily contribute to the production
of a subsequent generation of pests [34]. New methods are being researched for using
pheromones in pest suppression, but current uses of pheromone traps are best used only
for monitoring purposes [33].
d. Trapping Strategies. Pest managers must be able to use information from traps to
assist in pest management decisions. Simply capturing one pest insect at one time in a
single trap tells the manager nothing except that a particular species is present. Multiple
traps must be deployed in various locations and they need to be checked many times,
usually on a regular, ongoing basis according to a set schedule.
Pheromone traps or glue boards should be deployed in all the major areas of a plant
or warehouse, usually along walls or shelves, with two or more traps per area (Fig. 2).
Light traps may not be used as often as other traps (because of the expense), but
at least one light trap per large area would be helpful. Light traps should be located away
from outer doors so that insects are not attracted into the plant from the outside. Traps
should be checked weekly or biweekly and the species and number of insects recorded.
Figure 2 A contour map showing the distribution of male adult warehouse beetles (Trogoderma
variabile) based on captures in pheromone-baited traps over a 1-week period in a food warehouse.
Trap locations are designated by asterisk and the darker shades of contour indicate higher insect
numbers. Concentrations of insects are depicted in the lower right of the map near some machinery
and in an inner room at the upper left. (Map and data are courtesy of Dr. James Campbell, USDA-
ARS; we deeply appreciate his contribution.)

A pattern of insect activity may become evident initially, with some areas having
more insects than others, and such a pattern may be corroborated upon subsequent checks
of the traps. Consistent relatively high numbers in one area should alert the manager to
do a thorough inspection of that area, or place a higher density of traps in the area, in
order to localize the infestation. Once infested products, machines, or other locations are
identified, the infestation can be neutralized by sanitation, removing or destroying infested
material, or targeted applications of insecticide.
e. Data Analysis. A recent development in the use and interpretation of trapping infor-
mation in the food and pest control industries is the analysis of trap data on computer
spreadsheets and the visualization of trap data with geographic information system (GIS)
software [30,37]. Services are now available in which each trap in a facility is equipped
with a bar code so that its identity and location can be logged on a portable computer via
a bar code reader. When checking traps, a service technician can read the bar code into
a handheld computer, entering the trap catch data for the trap, and all data are recorded
by date and trap identity. Upon return to the office, trap data can be downloaded to a
desktop computer where they may become part of a larger database for analysis of insect
population trends.
Additionally, trap data can now be analyzed with GIS software to generate maps that
predict locations that may have high levels of insect activity and thus assist the manager in
finding infestations or the source of trapped insects (Fig. 2) [30]. Whatever the method
of analysis, it is clear that computer-aided summary and organization of trapping data will
facilitate more knowledge of potential pest problems by managers than was ever possible
prior to widespread adoption of traps in monitoring programs.
An additional method for documenting the location of insect infestations is to moni-
tor and record customer complaints or products returned because of insect infestation. For
some companies, customer complaints may be the only means of detecting insect problems
in products because the packaged goods rarely display problems in short-term storage
after manufacture and before shipping. These infestations often develop in the marketing
channels as the product is delivered to the consumer. Reports by customers that include
production code numbers of infested packages allow the manufacturer to determine the
origin and production date of the finished product, then track that material through their
distribution system. Food manufacturers encourage information about infested products
from customers by providing toll-free telephone numbers printed on packages and offering
replacement product or other in-kind compensation for customers’ call-in complaints.
E. Temperature Manipulations
Cold treatments and heat treatments have both been used to either prevent infestation of
stored products or to eliminate existing infestations [38]. At extreme low or high tempera-
tures, stored-product insects can be killed, and reproduction and development can be cur-
tailed at more moderate high and low temperatures. The optimal range of development
for most stored-product insects is about 22 to 35°C, depending on the individual species,
and reproduction and development usually ceases at temperatures below 15°C [39,40].
1. Cold Treatments
Cold temperature treatments to disinfest entire warehouses and processing plants may be
appropriate only in extreme northern climates where outside temperatures are cold enough
to kill insects if this ambient air can be brought into a facility. However, there is always
a danger that this cold air could have a negative impact on equipment inside the building.
Small-scale treatments using cold temperatures to kill insects have been used in the dried
fruit and tree nut industries and in specialty organic markets [38]. However, the more
common use of cold temperatures is to prevent infestations from occurring by maintaining
finished products in a low-temperature environment of 15°C or less.
2. Heat Treatments
The upper thermal heat limit that causes death of most stored-product insects is in the
range of 50 to 60°C (120 to 130°F) [40]. The idea of using heat to control insects inside
mills is not new [41,42], but today there is renewed and expanded interest in using this
technology to control insects [10]. Heat is seen as an alternative to methyl bromide to
disinfest mills and other structures [43]. However, because most of the actual applications
and research are being done by private companies, the results of trials are not normally
published in the public domain, except for general descriptions in trade journals.
3. Combined Treatments
One new aspect of research with heat is to use the technology in combination with other
control options to improve the effectiveness of heat treatments. As an example, field and
laboratory trials [44,45] have shown that a combination of heat with diatomaceous earth
(DE), a natural product, may be an effective control strategy. Because the DE imposes
an added stress on the insects, a somewhat lower temperature matches the kill rate of a
higher temperature without DE. There is potential to expand this concept with other insec-
ticides, particularly with pyrethroids that do not degrade at high temperatures.
IV. CHEMICAL MANAGEMENT STRATEGIES

The number of available insecticides in the United States that can be used to control insects
in bulk-stored grain has declined in recent years, with few new products replacing them,
and this trend will continue in the future [9]. The same trend is also occurring for insecti-
cides that can be used in and around food plants, processing mills, and food warehouses.
There are many reasons for this decline, but there are several which should be emphasized.
First, the cost of developing and registering new conventional insecticides can ap-
proach 60 million U.S. dollars [9], and this figure will undoubtedly increase with each
passing year. The stored-grain and food-manufacturing industries are relatively minor mar-
kets compared to field crops. There is simply little economic incentive to develop new
products.
Second, new regulations and laws such as the 1996 Food Quality Protection Act
(FQPA) and the interpretation of those laws by the Environmental Protection Agency
(EPA) could lead to the elimination of many organophosphate and carbamate insecticides.
New toxicological studies will be required to reregister these chemicals, but it is very
unlikely that the chemical companies will invest the huge amount of money required to
provide the necessary data when the markets for these are small and unprofitable.
Third, many insect species have developed resistance to the older organophosphates,
such as malathion, that were heavily used in the past by the food manufacturing industry.
Numerous studies have documented extensive resistance to malathion in populations of
stored-product insects throughout the world [46].
A. Fumigants
One of the biggest challenges to the processing, milling, and food plant industries is the
impending loss of the fumigant methyl bromide, scheduled for complete reduction and
phase-out in the United States and most other developed countries by 2005. Several ‘‘alter-
natives’’ to methyl bromide have been identified, including, but not limited to, sanitation,
improved monitoring and surveillance, surface insecticidal treatments, crack and crevice
treatments, inert dusts, modified atmospheres, heat treatments, and several potential fumi-
gants [43,47].
Currently, there are no fumigants registered that can replace methyl bromide for
rapid disinfestation of infested products. Sulfuryl fluoride is toxic to stored-product pests
[48,49], but it requires long exposures to kill insect eggs. Sulfuryl fluoride may have the
best potential for registration in the United States to control insects inside food milling,
processing, and storage facilities. However, as of this writing, it has not been registered.
Hydrogen phosphide gas, or phosphine, is the only fumigant registered for food
plants besides methyl bromide. Phosphine requires more time to kill than methyl bromide
and it can be damaging to metals and electronics [50].
Because of the limited inventory of insecticides and options available for direct
control of insect pests in food facilities, it is also important to emphasize the integrated
aspects of insect pest management. This includes a discussion of physical, biological, and
environmental factors that can affect the efficacy of insecticides when they are used in
management programs.
B. Insecticide Treatments
1. Surface Treatments Versus Crack and Crevice Treatments
a. Surface Treatments. Surface treatments are those insecticides that can be applied to
large areas within a facility. Label directions usually give a specific amount or volume
of insecticide mixed in a given volume of water to cover a defined area. For example,
label directions for cyfluthrin, a pyrethroid insecticide, specify 9 or 19 g of the wettable
powder (WP) formulation or 8 or 16 mL of the emulsifiable concentrate (EC) formulation
in 1 gallon of water to cover 1000 ft 2. Label directions for a registered EC formulation
of hydroprene (Gentrol  ), an insect growth regulator (IGR), are also given in volume
quantities.
There are several registered formulations of the inert dust diatomaceous earth. Each
label states a certain amount or range of product per unit area, usually given as either
square feet or meters. These are currently the most common insecticides that are used as
general surface treatments. Malathion is still labeled as a surface treatment, but use of
this product has diminished considerably in recent years.
b. Crack and Crevice Treatments. Label instructions for products labeled as crack and
crevice or spot treatments often direct the user to make up a solution with a certain percent-
age of active ingredient, and then to shoot the spray into the crack or void space. Some-
times the insecticide can be used as a spot treatment to a small area. As an example, the
label wording may define the spot as 2 ft 2 or less, and there may be a restriction on the
total number or area of ‘‘spots’’ within a facility. Some crack and crevice treatments can
be applied to outside surfaces of a facility; here larger unit areas can be treated than would
be the case indoors.
Several insecticides are currently labeled for use as crack and crevice or spot treat-
ments, but many are the older organophosphate and carbamate insecticides that could be
impacted by the FQPA. As always, before applying an insecticide, managers must comply
with label instructions, ensure that the target insect pests are listed on the label, and ensure
that products are applied as specified.
2. Space Treatments
There are several aerosol products labeled for use inside food plants and warehouses, and
each may have restrictions for use. Some labels may state application as a space treatment
only to empty facilities, require users to cover food prior to application, or specify an
aeration and venting period after the application is complete. They can be dispensed by
timed application equipment in the headspaces of storage facilities. Label directions for
these insecticides specify application of a given amount of insecticide within a specific
space usually given as square feet or meters. Again, label directions must be followed
when applying insecticides as a space treatment.
3. Fumigants and Controlled Atmospheres
We have already mentioned the scheduled phase-out of methyl bromide, the most common
fumigant treatment inside postharvest structures. The grain fumigant phosphine cannot
normally be used inside structures because of its corrosive effects on metals [51]. New
formulations and mixtures are being developed to combat this problem.
Hermetic storage, which is a type of modified and controlled atmosphere, was used
in ancient times to control insects in food. Today, the controlled-or modified-atmospheres
technique is one of the most extensively researched areas in postharvest insect control in
raw grains and in structures. There is a large volume of published literature regarding the
effects of modified atmospheres on stored-product insects [51,52]. Most of the new ad-
vances in application technology are not published in scientific journals but are found
instead in proceedings from various research conferences held on a regular basis, including
the International Working Conferences on Stored-Product Protection and the recent Con-
trolled Atmosphere and Fumigation conferences [52].
Most modern uses of modified atmospheres involve creating a low-oxygen atmo-
sphere, usually by adding CO 2 or N 2 . Although modified atmospheres are known to have
toxic effects on insect species, they are not extensively used on a widespread basis to kill
insects in food plants because of the time and expense required for application, the need
for extensive monitoring during a treatment, difficulties in application to the entire facility
or building compared to other treatments, and potential contamination effects of CO 2 [51].
In addition, modified atmospheres can be toxic to humans as well as insects [51].
However, there are areas where modified atmospheres, vacuum sealing, low-
pressure treatments [53], and other similar methods may have potential for small-scale
applications within a food plant, such as specialized chamber treatments before products
are shipped to distribution centers. Given the lack of alternatives to methyl bromide and
the continuing improvements in application technology for controlled atmospheres, there
appears to be considerable potential for the increased use of modified atmospheres.
4. Future of New Products
The emphasis on insecticides in the future will be on the development of reduced-risk,
low-toxicity products. Because of the registration costs of new chemicals, it is likely than
many of these newer products will be those that are exempt from tolerance requirements
because registration costs will be lower for these chemicals [9]. Conventional chemicals
will be developed first for the more profitable areas where insecticides are used on a
regular and frequent basis, such as field crop pest control and traditional urban programs
for cockroaches and other human filth pests.
Research will also be conducted on the various factors that affect the efficacy of
insecticides, with the goal of understanding how these factors affect control when insecti-
cides are used in a management program. As an example, we will discuss several of these
factors and how they have an impact on the response of insects to various insecticidal
treatments.
V. FACTORS AFFECTING PESTICIDE EFFICACY

A. Surface and Substrate
The surfaces and substrates to which liquid formulations of contact insecticides are applied
often affect insecticidal efficacy, especially when the applied treatment is supposed to
have residual action. In general, insecticidal activity is reduced on porous surfaces such
as concrete and wood compared to activity on nonporous surfaces [54–58]. Most interior
floors of food plants and warehouses are made of concrete that, being alkaline, promotes
hydrolysis of the active ingredient, thus further reducing residual activity [51]. Painting
over porous surfaces often prolongs the active life of chemicals by forming a barrier and
may also reduce hydrolysis on concrete [51,57].
B. Insecticide Formulation
Wettable powder formulations are more persistent than the emulsifiable concentrates of
most organophosphate and pyrethroid insecticides that are either currently used for insect
control or have been tested in laboratory studies for control of stored-product insects
[55,57]. In tests with the pyrethroid cyfluthrin, longer exposure intervals were required
to give equivalent mortality levels of red flour beetles and confused flour beetles exposed
on concrete treated with the EC versus the WP formulation [59]. However, the efficacy
of the EC formulation was improved by painting the concrete with a waterproof sealant
prior to insecticide application [59].
There are many different formulations of diatomaceous earth that are commercially
available for use inside food plants and warehouses, and there is considerable variation
among these products [60,61]. The source of the DE and the physical characteristics of
the formulation are among the factors that contribute to this variation. Methods have been
developed to rapidly screen and assess different DE products [62]. However, caution
should be exercised in interpreting the results of experimental studies; results obtained
with one DE product may not be applicable to other products.
C. Temperature and Relative Humidity

The temperature and relative humidity at which stored-product insects are exposed to
insecticides can have a significant impact on the response of those species. In general,
organophosphates increase and pyrethroids decrease in toxicity as temperature rises [63].
Studies with cyfluthrin and the red flour beetle document this negative correlation with
temperature [64]. Mixed results have been produced in studies where stored-product in-
sects have been exposed at different temperatures to diatomaceous earth. Some studies
document a negative effect at increased temperatures [61,65], while others show a positive
effect [66]. Fumigants and modified atmospheres usually exhibit a positive increase in
toxicity with increasing temperature [51,52].
Humidity effects are probably more important when using DE inert dusts, because
toxicity of most DE products usually decreases as relative humidity increases [60,61]. In
studies with both red and confused flour beetles, longer time intervals were required to
produce equivalent levels of mortality as beetles were exposed at increasing humidity
levels [66]. Diatomaceous earth acts in part by causing water loss through disruption of
the cuticular layer [67]. Therefore, increased exposure intervals are necessary to kill insects
at higher humidities because water is lost at a slower rate.
Although there are few published reports concerning the effects of relative humidity
on the activity of IGRs, there is some evidence supporting a positive effect with humidity.
When last-instar red and confused flour beetle larvae were exposed on concrete treated
with hydroprene, both morphological defects in adult and the percentage of arrested larvae
increased with increases in humidity [68].
D. Species Variability
The specific target pest or pests should be precisely identified as part of the management
program. With all of the various insecticides that can be used in food plants, there may
be considerable variation concerning the response of various stored-product insect species.
In studies with DE products, Tribolium species and the lesser grain borer (Rhyzopertha
dominica) appear to be more tolerant than rice weevils (Sitophilus oryzae) or sawtoothed
grain beetles (Oryzaephilus surinamensis) [61].
Even closely related species can show considerable variation, and the order of sus-
ceptibility can change depending on the insecticide. The red flour beetle is more tolerant
than the confused flour beetle to cyfluthrin [69,70], but the reverse is true for deltamethrin
dust and diatomaceous earth [58,66]. Life stages of individual species can also vary in
their response to an insecticide. Indianmeal moth larvae are particularly difficult to kill
with residual insecticides compared to adult moths or even stored-product beetles [71–
73]. The eggs and sometimes pupae are the life stages that are most tolerant to conventional
fumigants [74,75] and to various controlled atmospheres [52].
VI. CONCLUSION
In this chapter we developed the concept of integrated pest management as it relates to
insect control in food plants and processing facilities. The various sections in this chapter
emphasize different aspects of management and describe how a combination or multiple
approach strategy may be the best way of viewing insect management for the future. The
ecosystem approach is used to develop management programs for field crops, and there
are several studies that describe the bulk-grain storage system as an ecosystem [76–78],
with inputs, processes, and likely outcomes depending on the interaction of these inputs
and processes. Perhaps the same approach could be used to develop new management
paradigms for the food manufacturing industries.
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127–137, 1992.

22
An Informal Look at Food Plant
Sanitation Programs
JERRY W. HEAPS
General Mills, Minneapolis, Minnesota, U.S.A.
I. INTRODUCTION
‘‘What, you want line downtime to clean?’’ Sound familiar? The objective of any food
plant sanitation program is to have an ongoing, evolving plan to deliver a plant that is
both pleasing to look at and economical to operate. This is also a plant that consistently
is free of ‘‘pests’’ (e.g., insects, birds, rodents, undesirable microbes, allergens), produces
wholesome products free of extraneous materials, and operates according to the letter of
the law (the federal Food, Drug, and Cosmetic Act and a host of local and state regula-
tions).
Clean is clean. Sanitarians do not like to argue about degrees of sanitation or clean-
liness. To these professionals and, one can say, for everybody who works in a food
plant, sanitation should be a way of life. It is everyone’s responsibility to help keep a
food plant clean and contribute to a successful sanitation program. In the competitive
food plant arena, the days no longer exist that employees can rely on leaving their work
areas dirty because ‘‘sanitation will come by later to clean it up.’’ Although this overview
of food plant sanitation programs is cached in rather informal language, the subject itself
is one of greatest seriousness and deserves the reader’s concentrated attention and action.
II. BASIC ELEMENTS OF SANITATION

Sanitation is the way people operate while they are at the plant, both inside and out. Many
specific tasks are involved, including
Complying with the current good manufacturing practices (GMPs) as outlined in
the Code of Federal Regulations (21 CFR 110)
Personal appearance and hygiene
Aesthetic appearance of plant exterior and interior
Stringent integrated pest management (IPM)
Attention to the detail of sanitary design.
Personal respect for the products being produced
III. A CLOSER LOOK AT SANITATION

Let’s take a closer look at each of these points.
A. Complying with GMPs

No one who makes food can argue with this—it’s the law! The GMPs are loaded with
references to food plant sanitation, and compliance requires that ‘‘sanitation programs’’
be implemented. Examples follow.
1. Buildings and Grounds
Subpart B, Buildings and Facilities, Paragraph 110.20, Plants and Grounds: Grounds ‘‘The
grounds about a food plant under the control of the operator shall be kept in a condition
that will protect against the contamination of food.’’ This means, but is not limited to,
the following:
Storing equipment properly (i.e., 18 inches up off the ground directly and in an area
protected from the weather)
Having a regular program to pick up waste and litter and cutting the grass and weeds
(or use EPA-labeled herbicides where applicable) in the immediate plant vicinity
to discourage the harborage of pests.
Paving roads and parking lots to help eliminate dust/debris; preventing the pooling
of water by having adequate drainage (pooled water may attract pests)
Having adequate and properly operating systems for waste treatment and disposal
carried out in a manner that prevents the contamination of areas where food is
exposed. Many times food plants have an outside waste compactor area but no
way to properly clean it. Install proper drainage plus hot/cold water of adequate
pressure to facilitate year-round regular sanitation of this critical area. Cover or
enclose it so rodents, birds, and insects are not attracted [see Part V of this book].
Paving outside rail yards. However, this is not the cheap. But have you ever tried
to clean food debris from crushed rock? When it’s dry or wet? Anything can be
done if you have enough time and labor. Most food plants today do not have
these luxuries. In contrast to a crushed rock base, a smooth, flat, hard surface is
more easily and effectively cleaned. Additionally, such cleaning is much more
likely to be done at the needed frequency.
2. Sanitary Operations
a. General Maintenance. From Paragraph 110.35, Sanitary Operations, ‘‘Buildings,
fixtures and other physical facilities of the plant shall be maintained in a ‘sanitary’ condi-
tion and shall be kept in repair sufficient to prevent food from becoming adulterated within
the meaning of the act. Cleaning and sanitizing of utensils and equipment shall be con-
ducted in a manner that protects against the contamination of food, food-contact surfaces,
or food packing materials.’’ This means a food plant must have a sanitation program to
keep all areas of the plant clean and the cleaning is done in a manner that does not contami-
nate food.
B. Personal Appearance and Hygiene

Refer to section 110.10, Personnel, of the GMPs for detailed information about this. It
states the obvious, i.e., any persons who work in and around a food plant must conduct
and present themselves in such a manner that food is not contaminated. This includes
personal ‘‘sanitation’’ or cleanliness as well as the clothing or uniforms worn by workers
in the plant.
This section details hand washing/sanitizing, removal of insecure jewelry, main-
taining gloves, wearing hair/beard restraints, not storing personal items in manufacturing
areas, only eating, drinking, and smoking where designated, and if you’re sick, don’t work
around food!
C. Facility Aesthetics
We’re all only human. Think about how much nicer it is to show up for work in an area
that looks nice and is clean. Design the work site sanitation program to accomplish this
goal.
D. Integrated Pest Management

Yes, pests are attracted to soils. When this term is used in a sanitation context, it refers
to undesirable residues of organic matter that result from the manufacturing of food. Pests
do not come about through abiogenesis. With no accumulated soils in and around a food
plant, you’ve eliminated a basic component for pest breeding—food. Pests need food,
water, warmth, and a harborage to thrive. Eliminate one or, better yet, all of these, and
you’ll be on your way to a pest-free food plant. Design sanitation programs to achieve
this goal. Pests are no different than people when you consider only those simple require-
ments needed to survive and thrive.
E. Sanitary Design
More will be said about this later, but this much can be said now: if buildings and equip-
ment are designed to be easily accessible for cleaning, sanitation programs can be designed
to take advantage of this. People will more readily respond to the request to clean a piece
of equipment that is of proper sanitary design. Conversely, if the equipment is poorly
designed, food plant personnel are quick to respond with the phrase, ‘‘we cannot get to
it or do not have time to take it apart to clean it properly, so if you think you can do it
better, go ahead.’’
A good rule of thumb I like to use is when you install or make something, ask
yourself, ‘‘if I had to clean that, could I or would I?’’ The answer no is not the response
we want.
F. Pride in Product
This is an easy one. Just ask yourself ‘‘would I serve this food to my family knowing
how it is made?’’ You’ve got to answer yes 100% of the time, with no reservations!
IV. MEANINGFUL SANITATION
Food plant sanitation programs must also be proactive, not reactive. You can make (save)
money through sanitation by preventing costly product recalls due to adulteration. I’ve
been told that a food company can expect to spend, at a minimum, $1 million to initiate
a product recall. Just think of the countless millions that will also be lost due to lost sales,
lost consumer confidence, and brand name damage.
Think of how much ‘‘sanitation’’ investment can be made with even the $1 million if
you prevent product recalls! Lax sanitation makes it very difficult to cover your sanitation
shortcomings. The very intelligent consumer, lightning-fast media, and an unforgiving
marketplace will quickly find ‘‘mistakes’’ Unfortunately, many professional sanitarians
have reduced food plant sanitation to the most basic of levels—keep the company out of
the headlines and the boss out of jail.
Let’s take a closer look at the proactive versus reactive food plant sanitation pro-
gram.
A. Proactive Approach
Proactive ⫽ prevent, prevent, prevent. Sanitation professionals must know their food plant
better than anyone else. Do not rely on third-party inspections, audits, assessments, or the
federal government to find poor sanitation practices. Sanitation programs are designed to
predict and prevent undesirable situations from occurring in the first place. More impor-
tantly, the goal is to maintain the plant in such a manner that it is unlikely that poor
sanitation practices will become established. This is a 24-hour/7-day-a-week job! Food
plants will get dirty and must be cleaned.
One must design sanitation programs and cleaning frequencies based on the type(s)
of products produced. Risks must be identified and managed. Soil accumulations can break
off and adulterate food as well as attract/harbor pests (e.g., microbes, insects). Dry opera-
tions can normally have a longer ‘‘break’’ from a complete sanitation cycle because dry
conditions are not as conducive to microbial growth as are wet operations.
B. Reactive Response
Reactive means it’s already too late. You receive the 2 a.m. phone call that ‘‘bugs’’ have
been found and what are you going to do about it. All of a sudden, the plant sanitation
department has a staff of one!
1. Risk Management
Sure, you can manage the risk by waiting until a problem is discovered, but you won’t
win in the marketplace with this strategy. The damage is done, product may be adulterated,
recall(s) may be needed, production time lost, headlines gained, a company’s brand dam-
aged, and people can lose their jobs! ‘‘Protect the brand’’ should be the rallying call for
proactive sanitation.
With this philosophy, everyone becomes a sanitation expert when the problem is
discovered, lots of blame and ‘‘woulda/coulda/shoulda’’ to go around. It’s costly to re-
gress and now worry about implementing permanent food plant sanitation control.
C. Reactive Versus Proactive Management

Unfortunately, the reactive sanitation still occurs in the industry. Management must treat
sanitation professionals as professionals, and this positive attitude must carry right on
through the hiring and compensation process. Food plant sanitation workers cannot be
looked at, and workers must not be treated, as the most disrespected members of the plant
workforce. Disrespect is likely to promote substandard performance on the job. People
react to the way they’re treated, positively or otherwise. Plant management cannot ignore
the sanitarian’s knowledge or requests for assistance when needed.
For the success of a proactive program, food plant management and sanitation pro-
fessionals must have knowledge of basic food safety pests that poor sanitation can mag-
nify. These could be macrobiological (i.e., insects, birds, rodents) or microbiological. Over
the past few years, allergen contaminants have become focal points of many plant sanita-
tion programs. To control all these pests, management teams and all plant personnel must
plan, organize, cooperate, supervise, and be held accountable for all assigned tasks.
V. SANITATION: MACRO VERSUS MICRO

These terms are finding their way into the lexicon of plant sanitarian. What do they mean?
How important are they?
A. Macrosanitation
Macrosanitation can be defined as practicing sanitation by cleaning areas/equipment easily
seen with the naked eye and at a height that requires minimal bending/reaching by the
individual. It’s easy to see soils that can be removed by minimal effort on the cleaners’
part. Once initiated and firmly in place in a food plant, it is a plant sanitation program
that will lead a facility down the road to a food safety incident. We do a very good job
of cleaning soils from areas that fall wtihin the definition of macrosanitation. Unfortu-
nately, these are not the soils that will get a food plant into trouble. It is the soils that
are missed due to the lack of a firmly embedded and practiced sanitation program of
microsanitation!
B. Microsanitation
Microsanitation can be defined as practicing sanitation by cleaning areas/equipment not
easily seen with the naked eye and require additional lighting (i.e., flashlights) or other
aids, such as ladders to allow cleaners to get to higher soiled locations. Microsanitation
also requires cleaners to get down low, sometimes on hands, knees, or bellies to clean up
under and around equipment areas that are not seen from straight-ahead viewing. This is
the type of sanitation program that must be practiced with rigor and frequency to remove
‘‘invisible’’ (that is, not readily noticed) soils that if missed during sanitation cycles will
become harborages for microbes or insect pests.
1. Attention to Details
Microsanitation is not easy or glamorous work. But it must be done. Cleaning personnel
must also be properly trained on where and why to be alert for microsanitation harborages
and be provided with the proper cleaning tools/chemicals to do the proper job. They must
be instructed to look high, look low, and get down on their hands and knees to thoroughly
inspect all nooks and crannies, for soil deposits. Microsanitation involves physical
scraping or scrubbing to remove soils, not just using high-pressure water or air alone.
Being good at microsanitation must be the goal and inspiration of all plant sanitarians
and sanitation personnel.
2. Proactive Sanitation
Proactive sanitation in a food plant is predominantly controlled by good housekeeping,
nothing scientific here. Food plants must be efficient operations to be successful. This
means all personnel working in a plant must ‘‘clean as you go’’ and keep their respective
work areas in good shape during their shifts. Plant managers no longer have the luxury
of being able to hire extra staff to pick up after others. When that sanitation crew hits the
floor to clean, time is not unlimited. They must get right to their cleaning assignments
and cannot waste time, nor be expected to pick up trash, sweep work areas, remove produc-
tion items such as packaging or raw materials that may become cross-contaminated during
sanitation procedures. The previous shift must have their work areas ‘‘secured’’ for sanita-
tion by shift’s end. Time taken by the sanitation crew to do this housekeeping cleaning
severely restricts their time left to do the actual cleaning of areas/equipment that prevents
pests. This thought process must cross over all departments in a plant, especially mainte-
nance, production, quality, and janitorial personnel.
If pests usually associated with defective sanitation have no food, water, harborage,
or suitable temperature, they cannot become established. Good housekeeping and general
sanitation practices are the key problem preventers and contributors to a clean, efficient,
and profitable food plant.
VI. ELEMENTS OF SUCCESS

The success of an organized food plant sanitation program depends on many things.
A. Management Participation
If the plant manager is not fully committed to running a clean plant, the others working
in the plant figure this out quickly. ‘‘He or she is all talk’’ is what you’ll hear from the
workforce. The plant manager must back up words and actions and support to be success-
ful. Managers must be familiar with the basics of sanitation and get out into the plant
onto the floor and work with their people to communicate expectations, goals, visions, or
desires.
Don’t stay in the office! I’ve inspected plants where, from the observed results, the
plant manager has no real clue as to what’s actually going on on the floor. He or she has
relied on the information subordinates have passed on up the chain of command. Of course,
no one likes to pass on bad news, so they don’t! Adequate sanitation equipment, budgets,
personnel, tools, and materials need to be provided with the plant manager’s blessing and
encouragement. Take the lead in the sanitation practices of your plant, Mr. or Ms. Plant
Manager. Be a leader by example.
B. Plant Sanitarian
This individual is recommended no matter how large an operation is. A full-time, duly
compensated position, that reports to the plant manager is the best scenario, as this elimi-
nates any conflict of interest one may have when the sanitarian reports to the production
or quality departments. This position is different from a janitor or sanitation supervisor.
Technical training is vital to the success of a sanitarian.
A successful plant sanitarian should also not be expected to do many other jobs day

to day. This should be a supervisory position with adequate time allotted to properly
perform the duties of a sanitarian (i.e., inspecting, auditing, planning, and supervising).
Being able to communicate and work well with others is an asset to a successful sanitarian.
Professional sanitarians must be given the resources and time for continuing technical
training so the train-the-trainer philosophy can be used to transfer this knowledge to the
plant’s workforce.
Because there are so many rules and regulations that impact food manufacturing,
the plant sanitarian is expected to maintain pace in the acquisition of knowledge concern-
ing pests, microbes, laws/regulations food safety systems and the science of cleaning.
This does not necessarily mean a plant sanitarian must be college degreed. However, such
college-level training will certainty be an asset in this job. Conversely, I’ve had the positive
experience of knowing many excellent plant sanitarians that have learned through years
of continuing education and experience on the job—stuff not taught in school. It’s a great
catch when a plant sanitarian is hired with the technical skills to do the job plus the ability
to hit the ground running in a food plant by quickly assimilating the day-to-day operations
and understanding the role of plant sanitation. This sanitarian is a keeper.
C. Self-Inspection Program
The GMP/sanitation self-inspection program is the rock-hard foundation of a successful,
proactive food plant sanitation program. A formal food safety committee needs to be
formed. Its members are multidisciplinary (i.e., production, quality, management, and
maintenance), comprising salaried and nonsalaried workers alike. Members should be ro-
tated on and off the committee as this greatly benefits in the cross-training of all plant
personnel as to what is expected, accepted, right, and wrong with GMPs/sanitation.
1. Sanitary Design
Sanitary design, or lack thereof, of equipment and buildings must not be overlooked during
these inspections. If equipment is improperly designed and cannot be easily cleaned or
disassembled to clean, it will remain dirty because most people do not have the luxury
of extra time to do all that’s necessary to clean it properly. An excellent reference book
on sanitary design is Engineering for Food Safety and Sanitation [1]. Every food plant
sanitarian and plant engineer should wear this book out from a reference and guidance
standpoint.
2. Detailed Inspections
The goal of this committee is to do detailed inspections of the entire plant on at least a
monthly basis. Why monthly? Because under the best conditions, stored product insects
can go through a life cycle (egg, larva, pupa, and adult) in 4 of 5 weeks. The thinking is
that if you identify and eliminate potential poor GMP/sanitation conditions, you will stay
ahead of any infestation problems.
Deficiencies observed during these inspections must be documented for proper fol-
low-up and corrective actions. This is a key point! Deficiency completion must be noted
as many of us are very good at creating to-do lists but do a poor job of following through
to completion/closure of such tasks. Most food plants do not need more lists. Deficiencies
not completed at the time of the next self-inspection should be prioritized for completion
ASAP. If capital is needed, this should be noted and the appropriate requisitions initiated.

3. Subdivision of Tasks
If the food plant is large, I recommend dividing it into four areas and inspect one area
per week. Such inspections must be focused and detailed. It is better to do one good
inspection versus many cursory ones. Plant interior and exterior areas are both included.
Be sure to inspect areas no people dare to go during normal day-to-day operations or
walking routes. Look high, look low! Have you been on the roof or in your basement
storage areas lately? People that work in a food plant must know their plant, inside and
out, better than anyone else. If I’m coming in to do a first-time inspection of your plant,
I should not be able to find ‘‘new’’ areas that have been overlooked during the monthly
inspections. That’s what your own in-house self-inspections should be doing! Don’t allow
a stranger (e.g., regulatory inspector or other third party) to come into your plant and find
areas or niches that you did not even know existed. Know thy plant! Inspect every nook
and cranny at least once, assuring for yourself that this area should be no problem.
4. Independent Sanitation Audits

An excellent idea is to have, at least annually, an independent third party do a GMP
inspection of the plant. This can be used as a benchmark and learning experience for the
existing plant food safety committee. Many large food companies have corporate sanitari-
ans to do this; many commercial companies are available, too.
Not meant to be an inclusive list or an endorsement of one over the other, examples
of such commercial companies that I’ve had experience with are American Institute of
Baking (AIB) (800-633-5137); American Sanitation Institute (ASI) (800-477-0778); Sil-
liker Laboratories (708-957-7878); Cook & Thurber (608-831-6958); and Randolph and
Associates (205-979-6455).
One can debate on the need to score such an inspection. Human nature being what
it is, we like numbers, scores, and data. Scoring can be done as a reference point but we
must not get caught up in a numbers game. I know of no perfect scoring system. Focus
on the deficiencies noted, root-cause analysis, and future prevention of recurrences. Any
inspection, no matter who does it, is just a point-in-time reference. A food plant is a
dynamic environment that constantly moves and changes. Solid, rigorous food safety sys-
tems and sanitation programs are the only way to predict and prevent problems.
D. Master Schedules
Master sanitation or cleaning schedules (MSS/MCS) (Figures 1 and 2) are the backbone
of the planned supervision of a food plant sanitation program. The MSS are the preventive
building blocks to operating a clean and efficient plant. When properly designed and imple-
mented, one should be able to answer the question ‘‘when was the last time this piece of
equipment, structure, or area was cleaned?’’
1. Simple and Current

Master sanitation schedules need not be fancy or computerized. They must be kept simple
and current. Place the cleaning task and frequency down one side of the paper with the
dates across the top. The goal is to list other-than-daily cleaning tasks, cleaning frequency,
and date/employee initials showing when the task was successfully completed.
Cleaning frequencies are determined by how quickly ‘‘soiling’’ occurs. Sanitarians
must not be afraid to change these frequencies based on plant operations, equipment lay-
Figure 1 Sample master sanitation schedule for daily cleaning tasks.

Figure 2 Sample master sanitation schedule for scheduling cleaning tasks not to be done daily.
out, or needs. In fact, this is a must! Constantly evaluate the effectiveness of a MSS and
react accordingly.
2. Timing Inspections
If your plant is one that is prone to infestation by stored-product insects, remember to
time your cleaning frequencies to their life cycle (e.g., monthly). You’re focusing on other-
than-daily cleaning tasks. Frequencies could be weekly, biweekly, monthly, quarterly,
semiannually, and annually. Inspect each plant area individually and place those off-the-
beaten-path sites or items on the MSS. For example, give attention to exterior building
perimeter and fence lines, trash disposal docks, exterior screens, exterior fan louvers, rail
pit areas, storage closets, overheads, dust collectors, catch pans, dock levelers, pallet rack
and equipment leg bases, elevator pits, floor drains, light shield interiors, air curtains,
boiler rooms, and shop/maintenance areas. All should receive MSS considerations and
periodic cleaning. Cleaning frequencies are based on the nature and speed of the soil build-
up and the nature of the product (dry versus wet and concerns about insect or microbial
growth).
3. Cover All the Bases
Don’t forget the building exterior for MSS considerations! For example, docks, garbage/
waste/trash pick-up areas, roof, rain gutters, parking lots, and bulding/property perimeters
all should be placed on a MSS for periodic cleaning. Do not leave MSS slots vacant! No
documented data is interpreted as the task was not done. If the line was ‘‘down,’’ note
that on the MSS. Keeping a MSS current is your only ally when you must answer the
question ‘‘when was this last cleaned?’’
In summary, an MSS is not your normal daily, or production, cleaning but other-
than-daily cleaning tasks. To be effective and workable, the MSS must be realistic, taking
into consideration available personnel, production schedules, and special types of equip-
ment being used. The MSS should serve as a reminder of upcoming sanitation tasks to
be done as well as serving as a running checklist of tasks completed. The MSS should
be kept simple. Each plant is unique, with its own challenges. Clean is clean, though, and
this principle must remain constant for all plants.
As an adjunct to a MSS, each food plant should develop documented cleaning proce-
dures. These should be designed as a simple document that is given to employees to help
them better understand how to effectively clean an area or piece of equipment. Cleaning
procedures can include needed tools and equipment, personal safety equipment require-
ments, time allowed for cleaning, chemical needs and dilution rates, and equipment safety
concerns such as lock out/tag out.
The lock out/tag out program is a requirement of the Occupational Safety and Health
Administration. Basically, it says that every plant must have a documented program/em-
ployee training in this area as a means of preventing equipment from engaging while its
being worked on. It’s an accident prevention program and aimed at not allowing equipment
to be turned on while someone is working on it. Each applicable employee is given his
or her own personal, identifiable, lock out/tag out lock and tag and must place this at the
power disconnect point before starting work on the equipment. No one else is allowed to
remove this lock/tag, only the person that put it on in the first place.
E. Training
The best laid plans and organization of a food plant sanitation program are doomed to
failure unless the mantra ‘‘train, train, train’’ is recited and used. Sanitation comes from
the heart, and all plant personnel must truly want to work in a clean plant. The training
not only involves the what and how, but must also include the why. People want to do a
good job but do not like to be told to do something for the sake of doing it. Sanitation
professionals must communicate the why-this-is-important sanitation message to employ-
ees. Don’t tell an employee how to clean; show them, too. When we do, we remember!
Many plants have monthly employee meetings to review and train people in such
areas as GMPs, sanitation, and personal safety. Many times, a plant can utilize its outside
sanitation chemical vendors to assist in technical subject material training. In any event,
no matter how training is done it must be documented for reference and done in such a
manner that all employees understand. Your imagination is the limit on training tech-
niques.
F. Plant Environments
1. Cleaning Dry Areas
There are some subtle differences in the cleaning of a wet plant or dry plant. For example,
if the plant produces dry or dust-prone products, compressed air is the worst sanitation
enemy. Trying to ‘‘blow down’’ a dusty area only relocates most soils and insects if
present. Vacuuming is the preferred method of cleaning dry, dust-prone areas. Such clean-
ing equipment must also be properly used and serviced, otherwise the vacuums themselves
may become pest harborages. Place them on your MSS. Remember: treat the root cause,
not the symptom. If dust is a problem, equipment leaks are usually the culprit. Fix the
leaks. Over the long-term, it’s cheaper than spending time and resources to chase dust.
Keep water out of dry, cleaned areas; many dry products will mold if adequate
moisture is present. Flour may contain the microbial pathogens Salmonella and Listeria.
Moisture is what they need to flourish. Water and flour mixtures not thoroughly removed
can also dry to form a crust-hard layer that can easily hide insects underneath. I’ve seen
situations where this layer around equipment leg bases has actually been painted white
because it was assumed it belonged there! An inspector comes along to find this, loosens
the crust, and insects are found!
2. Cleaning Wet Areas
When designing a sanitation program to clean wet areas, be wary of automatic cleaning
equipment such as CIP (clean in place) or COP (clean out of place). The word automatic
can lull us into a false sense of security. Use your home washing machine as an example.
Clothes will not become clean on their own by just turning on the machine. You need to
be sure you have the proper wash time, water temperature, velocity or agitation, and proper
amount of soap. We can simplify these to time, temperature, velocity and chemical concen-
tration.
This is not so different in a food plant situation, but here we’re cleaning equipment
not clothes. These CIP and COP systems are designed to be effective and efficient only
if these four parameters are consistently met. We cannot forget soil type, either. Different
soils require different combinations of the four parameters for effective cleaning. For
example, carbohydrates, proteins, and fats cannot be cleaned the same way. Each is unique
in its requirements. Know your soil type. Sanitarians do not have to memorize all of this
information or be college degreed to succeed. Experience is a valuable teacher. Work with
your plant sanitation chemical vendor on these parameters. Lean on them. Let them be
your guide. Clean is clean. You’ll know in a hurry if it works or not.
Don’t just rely on turning on the CIP or COP equipment switch, then walk away
and assume all is well. What happens when you assume? Pumps break, gaskets leak,
piping changes! Programs should be implemented to document and verify time, tempera-
ture, velocity, and concentration, too. These can be simple chart recorders, thermometers,
pH paper strips, titrations, or pumping a known volume of fluid through a known pipe
length in a specific amount of time to determine velocity. For CIP systems, a velocity of
at least 5 ft/sec through pipes is the benchmark standard.
3. Sanitation 4 ⫻ 4
Going back to the washing machine example, heavily soiled clothes need to be prerinsed
before washing for effective cleaning. Food plant equipment or utensils are no different.
There are four recommended steps here, too. They are prerinse, wash, rinse, and sanitize.
Putting them together, you have the sanitation four (time, temperature, velocity, concentra-
tion) ⫻ four (prerinse, wash, rinse, and sanitize). This combination will give you consis-
tently clean CIP or COP equipment.
Many food plants consider this sanitation 4 ⫻ 4 to be an essential prerequisite to
the implementation of a hazard analysis and critical control points (HACCP) program.
This means that after each major sanitation cycle, these sanitation CCPs must be docu-
mented and acceptable before the line is turned over to production. This review is part
of the documented postsanitation, pre-operational (pre-op) inspection that should be done
on all lines.
To avoid any conflict of interest, the persons that do the actual cleaning should be
different from the people doing the pre-op inspections. You’re looking for ‘‘visible soil’’
and GMP violations during these inspections. Adenosine triphosphate (ATP) or biolumi-
nescent technology is available for use as a quick method to test for the presence of organic
residues on allegedly clean food-contact surfaces. Note that ATP cannot be used in dusty
environments; dust accumulations give false positive results.
VII. SUMMARY
In summary, food plant sanitation programs are not easy or cheap, nor do they happen
on their own. You harvest what you sow. If corners are cut, problems will follow. A
successful sanitation program needs commitment from the top down—plant manager to
personnel working on the floor. It’s a way of life in a food plant. Plant sanitation personnel
must be recognized as a vital link in the successful operation of a plant and treated as
such. Sanitation programs must be well thought out and documented. Ongoing training
must occur. Audits and inspections play a key role in assuring the successful operation
of a sanitation program.
‘‘So you want the line down to clean?’’ ‘‘How much time do you need and when
do you need it?’’ That’s the response we’re looking for!
REFERENCE
1. T Imholte-Tauscher. Engineering for Food Safety and Sanitation. A Guide to the Sanitary De-
sign of Food Plants and Food Plant Equipment, 2nd Ed. Woodinville, WA: Technical Institute
of Food Safety, 1999.

23
Sanitation and Warehousing
Y. H. HUI
WAI-KIT NIP
University of Hawaii at Manoa, Honolulu, Hawaii, U.S.A.
J. RICHARD GORHAM
Consultant, Xenia, Ohio, U.S.A.
I. INTRODUCTION
This document concentrates on the receipt, storage, and distribution of foods and food
products in relation to current good manufacturing practice regulations (CGMPRs). Note
that the narrative is presented in the teacher–student format and that the active voice is
used. The data have been compiled from three major sources:
1. Food and Drug Administration (FDA) documents: Code of Federal Regulations,
Current Good Manufacturing Practices (CGMPs), the Food Code, Hazard Anal-
ysis and Critical Control Point (HACCP) programs
2. U.S. Department of Agriculture (USDA) documents: Code of Federal Regula-
tions, HACCP programs, inspection manuals, directives, etc.
3. Recommendations developed and distributed by major trade associations repre-
senting food, warehousing, and transport and related industries

II. BASIC REQUIREMENTS FOR SANITATION IN A FOOD
PROCESSING PLANT
Various aspects of the following basic sanitation topics are covered in other chapters of
this book:
1. Grounds and buildings
2. Fixtures and equipment
3. Sanitary facilities
a. Water supply, sewage, and plumbing
b. Toilet and handwashing facilities
c. Dressing and locker areas
d. Eating areas
4. Sanitary operations
a. Keep buildings and equipment sanitary
b. Rubbish and pest management
III. PROCEDURES AND CONTROLS

As the responsible sanitation officer in your company, you will consider the following:
Implement overall sanitation under the supervision of an individual assigned respon-
sibility for this function.
Conduct operations in the receiving, inspecting, transporting, handling, segregating,
recouping, and storing of foods in accordance with appropriate sanitation princi-
ples.
Take reasonable precautions, including assuring that food warehouse procedures do
not contribute to contamination of foods by harmful chemicals, objectionable
odors, or other objectionable materials.
A. Incoming Product Shipments

The integrity of the food warehouse sanitation program requires that the materials re-
ceived, including foods and their packaging materials, must not be exposed to contamina-
tion by reason of infestation by insects, birds, rodents, or other vermin, or by introduction
of filth or other contaminants. It is often useful, when practical, to work with suppliers
and shippers in advance to establish guidelines for acceptance, rejection, and, where appro-
priate, reconditioning of particular products, taking into consideration factors such as the
nature, method of shipment, and ownership of the product, in order to facilitate the effec-
tive implementation of these programs. Within a reasonable time after arrival of a railcar
or truck, and before product is unloaded, the product should be inspected to the extent
permitted by the loading of the vehicle for evidence of damage or of insect or rodent
infestation, objectionable odor, or other form of contamination.
Where an adequate inspection has not been possible prior to unloading, further in-
spect such product during and immediately after unloading.
If damaged product has been accepted, keep it separate from other product, and
recondition or otherwise handle it as necessary in a manner which will not expose foods
or the food warehouse to contamination or infestation.
If the inspection reveals evidence of infestation or contamination, determine whether
the condition is only ‘‘suspect’’ or is superficial (such as surface infestation of flying
insects which may be on, but have not penetrated, soiled, or compromised the integrity
of the packaging) and might be fully correctable by fumigation or other means. In each
such case, remove the product from the food warehouse area, utilizing the vehicle in which
it arrived, if feasible, after closing and sealing it.
In case of contamination, if rejection is appropriate (based on the origin and owner-
ship of the product), promptly notify the carrier and shipper of the time, place, and circum-
stances of the rejection.
After removal from the food warehouse because of suspect and/or superficial condi-
tions, concentrated efforts can be made to further evaluate the actual condition of the
product and to recondition it when possible.
Give special attention to product which has been previously rejected, or has other-
wise been removed from the food warehouse because of suspect and/or superficial condi-
tions, when it is subsequently received again to assure that the product and packaging are
fully acceptable on reinspection.
In the event of serious question or of failure to agree with the shipper or carrier, as
appropriate, as to condition or reconditioning, consider requesting evaluation of the sus-
pect or rejected product by appropriate federal, state, or local authorities.
B. Product Storage and Stock Rotation

Place foods received into the food warehouse for handling or storage in a manner that
will facilitate cleaning and the implementation of insect, rodent, and other sanitary controls
and will maintain product wholesomeness. Adopt and implement effective procedures to
provide stock rotation appropriate to the particular food.
C. Contaminated or Damaged Foods

Unless promptly and adequately repaired or corrected at or near the point of detection,
promptly separate foods which are identified as being damaged or are otherwise suspect
from other foods for further inspection, sorting, and disposition.
Promptly destroy or remove from the food warehouse product determined to present
a hazard of contamination to foods in the food warehouse.
D. Hazardous Nonfood Products and Packaging Protection

Handle and store nonfood products that present hazards of contamination to foods stored
in the same food warehouse by reason of undesirable odors, toxicity of contents, or other-
wise in a manner which will keep them from contaminating the foods.
Take special measures to safeguard from damage and infestation those foods that
are particularly susceptible to such risks.
Exercise care in moving, handling, and storing product to avoid damage to packag-
ing that would affect the contents of food packaging, would cause spillage, or would
otherwise contribute to the creation of insanitary conditions.
E. Shipping Precautions and Temperature Controls

Prior to loading with foods, inspect railcar, truck, and trailer interiors for general cleanli-
ness and for freedom from moisture; from foreign materials which would cause product
contamination (such as broken glass, oil, toxic chemicals, etc.) or damage to packaging
and contents (such as nails, boards, harmful protrusions, etc.); and from wall, floor, or
ceiling defects that could contribute to insanitary conditions. Clean, repair, or reject them
as necessary to protect foods before loading.
Exercise care in loading foods to avoid spillage or damage to packaging and con-
tents.
Maintain docks, rail sidings, truck bays, and driveways free from accumulations of
debris and spillage.
Maintain warehouse temperatures (particularly for refrigerated and frozen food stor-
age areas) that are in compliance with applicable regulatory temperature requirements, if
any, for maintaining the wholesomeness of the particular foods received and held in such
areas.
F. Housekeeping, Sanitation, and Inspection

Establish a regularly scheduled program of general housekeeping, sanitation, and inspec-
tion to maintain floors, walls, fixtures, equipment, and other physical facilities in a state
of sanitation sufficient to protect foods from contamination or adulteration and to prevent
waste from becoming an attractant and harborage or breeding place for vermin.
In addition, develop and implement an effective program and procedure for timely
cleanup of any debris and spillage resulting from accidents or other unscheduled occur-
rences.
G. Pest Control Measures

Implement pest control measures designed to prevent the entrance of pests, to deny them
harborage, and to detect and eliminate them with such schedules, instructions, and proce-
dures and by such trained and qualified personnel or professional representatives as may
be necessary, based on the nature of the foods and other products handled, the structure
and condition of the building and equipment, and the surroundings of the warehouse.
Monitor traps and bait stations, whether inside or outside of buildings, on a regular
basis. Use covered interior bait stations designed, located, or protected to prevent spillage.
Where appropriate, use bait stations constructed of moisture-proof materials.
Use only pesticides with labels showing EPA registration numbers, and only for the
uses specified in the labeling. Have them applied only by responsible personnel in accor-
dance with the manufacturer’s labeling instructions and in a manner that prevents contami-
nation of foods. While not in use, clearly mark and store pesticides in a secure place apart
from foods.
H. Food Sanitation Audit Programs

Establish programs internally and/or through outside consultants for effective auditing of
the food warehouse sanitation program.
IV. PERSONNEL
A. Employee Practices
Prohibit employees affected by disease in a communicable form, while carriers of such
disease, or while afflicted with boils, sores, infected wounds, or other abnormal sources
of bacterial infection, from working in the food warehouse in capacities in which there
is a likelihood of food becoming contaminated or of disease being transmitted to other
persons.
Prohibit clothing or other personal belongings from being stored and food and bever-
ages from being consumed and tobacco from being used in areas where foods are handled
or stored.
Instruct employees who are working in direct contact with exposed or partially ex-
posed foods, such as produce items in mesh bags, etc., to maintain personal cleanliness
and to conform to hygienic practices to avoid contamination of such foods with microor-
ganisms or foreign substances such as human hair, perspiration, cosmetics, tobacco, chem-
icals, and medicaments and, if gloves are used in handling such foods, to use only gloves
which are of an impermeable material in handling such foods and to maintain them in a
clean and sanitary condition.
B. Management Responsibilities
Assign responsibility for the overall food warehouse sanitation program and authority
commensurate with this responsibility to persons who, by education, training, and/or expe-
rience, are able to identify sanitation risks and failures and food contamination hazards.
Instruct employees in the sanitation and hygienic practices appropriate to their duties
and the locations of their work assignments within the food warehouse. Instruct employees
to report observations of infestations (such as evidence of rodents, insects, or harborages)
or construction defects permitting entry or harborage of pests or other developments of
insanitary conditions.
Exercise programs of follow-up and control to ensure that your employees, consul-
tants, and outside services are doing their jobs effectively.
V. IMPLEMENTATION PLAN
This plan has been prepared to assist the food warehouse operator in implementation of
the recommendations just discussed. Information in this plan will require adaptation for
specific application to your operations.
Since no single document can provide all the necessary information for every situa-
tion or specify the only methods for compliance, develop your own plan or company
guidelines to reflect your individual applications in the general areas dealt with in the
recommendations and this plan.
A. General Considerations
To ensure product wholesomeness and proper sanitation, the food warehouse sanitation
program must have the commitment of top management, must be implemented by the
supervisor of operations, and must be supported by the entire food warehouse staff. Pre-
ventive sanitation—the performance of inspection, sanitation, building maintenance, and
pest control functions designed to prevent insanitation in preference to correcting it—
should be an important goal of food warehouse management and of food warehouse opera-
tions.
B. Organization and Programs

A program to ensure continued success in safeguarding the wholesomeness of food and
in providing good sanitation will ordinarily include
1. An organizational chart showing chain of authority and responsibility
2. A flow diagram of receiving, storage, and shipping operations
3. Regular maintenance schedules
4. Regular sanitation programs
5. Regular pest control programs
6. An effective program of follow-up and control, including reports to responsible
executive officer(s)
VI. CHECK POINTS AND ADDITIONAL GUIDES

In any sanitation program, checklists have the same usefulness as the preflight checklists
a pilot uses before flying. The data presented so far can be transformed into checklists
for implementation and evaluation by assigned individuals or groups in a food processing
facility. They are provided herein.
A. Grounds
Keep nearby grounds free of liquid or solid emissions that could be sources of con-
tamination.
Prevent grounds from providing conditions for insect or rodent harborage.
Check paving, drainage, weed and litter control regularly.
Stack materials that are stored in the open neatly and away from buildings and on
racks above ground level when feasible.
‘‘No vegetation strips’’ around exterior building walls and at property lines adjacent
to properties containing potential harborages are helpful for discovering and dis-
couraging travel by rodents.
B. Buildings
Provide separate and sufficient space for placement of equipment and storage of
materials necessary for proper operations.
Separate activities that might cause contamination of stored foods with chemicals,
filth, or other harmful material.
Check structural conditions, pest barriers, and repair of windows, screens, and doors
continuously.
Seal and clean floor–wall junctions and fill holes and cracks; a painted inspection
strip is also recommended.
Keep offices—including overhead offices—in the food warehouse clean and do not
permit them to become attractants or harborages for insects or vermin. Include
them in the pest control program.
Check false ceilings for harborage of insects and rodents.
Give basements, attics, elevators, and rail sidings, etc., special attention.
C. Sanitary Operations
Keep walls, ceilings, and rafters free of soil, insect webbing, mold, and similar
materials.
Do not leave unscreened doors and windows open unnecessarily.
Do not permit dust to accumulate.
Keep floors free of product spillage, oil drippage, and buildup in all areas.
Provide proper trash and refuse storage and removal.
Store tools and equipment properly.
Clean and flush floor drains regularly.
Maintain railroad and truck courts free of debris and properly patrol them for pest
control.
Keep eating and break areas, locker rooms, etc., clean and orderly. Vending ma-
chines are often overlooked; keep them and the areas adjacent to them clean and
sanitary. Maintain equipment in a properly functioning condition and do not per-
mit it to serve as a source of sanitation or harborage problems.
D. Receiving and Inspection

Inspect the materials which are being received for evidence of damage; insect, bird,
rodent, or other vermin infestation; and moisture, odor, or chemical contamina-
tion.
Exclude contaminated materials, including product, pallets, and slipsheets, from the
building.
If damaged merchandise is accepted, segregate it for special handling.
Make sure that incoming and outgoing vehicles are free of conditions that could
contaminate product—no birds, rodents, insects, spillage, or objectionable odor
should be evident.
Code or mark foods received at the receiving point to ensure proper stock rotation.
To facilitate handling of rejected and suspect product, it is often a good idea to
develop procedures with individual shippers, carriers, and/or manufacturers for
reinspections, returns, etc.
E. Storage
Store products in an orderly manner and stack in such a way that date codes are
visible for proper rotation.
Generally, it is desirable to stack foods on pallets or racks (or on slipsheets, where
a clamp truck operation is utilized) away from walls so as to allow for inspection
aisles between stacks and walls. Painting inspection aisles in a light color is often
helpful in maintaining their effectiveness. Where full inspection aisles are not
provided, take special care (such as more frequent inspection, rotation, and re-
moval of product for cleaning) to ensure sanitary, pest-free conditions.
Separate bagged and baled foods to provide visibility between stacks.
Dispose of contaminated or infested merchandise, or otherwise remove it from the
food warehouse promptly.
Promptly remove damaged merchandise and broken containers from general food
storage areas. Handle and process salvageable merchandise separately in an area
isolated from general food storage; this area probably will require extra sanitation
and pest control attention.
If salvage operations include the repackaging or other manipulation of exposed foods
(other than items such as fresh produce received unpackaged or in partially open
packages), conduct such operations in compliance with the food sanitation prac-
tices, guidelines, or regulations (such as 21 CFR 110, GMPs, and other FDA
documents) that are applicable to handling exposed foods.
Do not intermingle chemicals, including pesticides, with food or food products. Such
products must be kept in locked storage, separate from food-handling areas.
F. Pest Control
Maintain written schedules, log activity, and monitor traps and bait stations regu-
larly.
Use covered bait stations that are of such types and so located as to reduce the
danger of spillage, and where appropriate use moisture-proof bait stations.
Keep the pesticides that are used in the food warehouse secured and separate from
foods. Permit their use only by properly trained personnel. Use only types regis-
tered and approved by an appropriate government agency for the intended use.
Check especially for (1) rodent burrows in nearby grounds, (2) activity at floor–
wall junctions and doorways, and (3) insect crawl marks in duct accumulation,
especially on overhead pipes, beams, and windowsills, around flour, sugar, and
pet food storage.
Where feasible, seal load levelers at docks to prevent trash accumulations and rodent
harborage and entry; otherwise clean them frequently.
Look for insect activity in folds of bagged foods.
Use black light, supplemented with means for distinguishing other chemicals that
fluoresce, to check for rodent urine stains; and use flashlights to check for other
evidence of contamination.
G. Shipping
Make sure that transportation equipment into which food warehouse food is loaded
is maintained in a sanitary condition comparable to that of the food warehouse.
Make sure that rail cars, trailers and trucks are (1) free of birds, rodents, and insects
or contamination from them and (2) free of accumulations of dirt or dunnage and
in good repair with no holes, cracks, or crevices that could provide entrances or
harborages for pests.
H. Follow-Up
Implement programs of follow-up and control to ensure that your employees, consultants,
and outside services are doing their jobs effectively.
VII. CASE STUDY: INSPECTING INCOMING FOOD MATERIALS

AND RAW INGREDIENTS
In its effort to help quality control programs in food plants, the FDA has issued a special
bulletin titled ‘‘Inspecting Incoming Food Materials’’ [USDHHS, PHS, FDA, HHS Publi-
cation No. (FDA) 76-2017]. Because of its important educational value, every food plant
should make an effort to assure that its quality control personnel become familiar with
its content. A slightly modified version of this bulletin is presented here. The format is
that of teacher (FDA) and student (employee).
A. Introduction
If you are given the job of inspecting and unloading cartons of incoming food materials,
be familiar with this section. It will help you make a good start. A sample inspection form
(Fig. 1) is provided to guide you during your inspection. Discuss these materials with
your supervisor and ask him/her for any additional guidelines or instructions.
Remember, a good thorough inspection of incoming food materials is the first line
of defense against producing infested or otherwise contaminated finished products. By
following the guidelines of this inspection report and recording your findings, you will
make a good beginning and will greatly help your supervisor to make the correct decision
regarding rejection or acceptance of incoming shipments. Many firms provide additional
consumer protection by notifying the local FDA office regarding shipments they have
rejected. Commercial firms are free to reproduce this form to use as a supplement to their
own inspection form or excerpt portions from it and devise a new form.
B. Why Should You Inspect Incoming Food Materials?

To make your money, your firm must handle only good products. Rotten, spoiled,
or contaminated food materials will never change into good products!
Very often, firms that accept contaminated and spoiled food materials are forced to
go out of business. When this happens, employees lose their jobs!
Contaminated and spoiled food can make people sick, including you, your family,
and anyone else who may eat this food.
Since most of us cannot be there to inspect the food materials as they are delivered
to your firm, we depend on you to make a good inspection and to make sure
contaminated food materials do not enter your plant.
C. Will You Inspect?

To do this right, you have to know how to inspect and what is needed to make a good
inspection.
D. Before the Shipment Arrives

Before the shipment arrives, make sure of the following:
The storage space for the shipment is clean and dry.
The equipment you will use to handle incoming food materials is clean and in good
repair.
You have the following tools so you can make a good inspection:
magnifying glass
flashlight
black light (ultraviolet light) source (for identifying rodent urine)
sample containers (plastic bags with self-seals or glass jars with covers)
sample thief, trier, and spatula
other equipment to aid inspection of specific products
inspection report form
marking pencil
You do not contaminate the product during sampling.
You follow specific instructions given by your supervisor.
If you follow these and your supervisor’s instructions and use the equipment properly,
you will make a good inspection and help assure that only clean, wholesome ingredients
and food materials are used in the products you help manufacture.
Figure 1 Sample inspection report for incoming food materials.
Figure 1 Continued.
E. Note Outside Condition of Carrier

The outside condition of the carrier may indicate contents were exposed to contamination
while in transit. The reasons are simple; mud, dirt, water, oil stains, or heavy insect debris
on the outside of a carrier may have found its way to the products. For example, if the
outside is wet, seepage may have occurred and contaminated the contents.
The shipment is more likely to be contaminated if the carrier is (1) an open-bed
truck that is not properly covered or (2) a truck or boxcar that is visibly damaged.
Notify your supervisor if you suspect shipment was exposed to contamination while
in transit. Also note in your inspection report the type of carrier bringing the shipment.
F. Is the Seal Broken?

The manufacturer affixed the seal to assure that you receive the high quality products
manufactured and shipped; if the seal is broken, the acceptability of the products in the
shipment should be suspected. The reasons are as follows:
A broken seal may indicate that some of the merchandise was stolen or that poor
quality products may have been substituted after your shipment was loaded and
before arrival at your plant.
Toxic nonfood items may have been added to the load, possibly contaminating your
products, and removed before delivery of your shipment.
Compartment doors may have been opened to air out foul odors shortly before arrival
at your receiving dock. Odors may have accumulated from trash, filth, or spillage
from previous shipment or your present shipment.
Do not accept shipment if seal is broken; notify your supervisor before proceeding
further with the inspection and receiving.
G. Open the Doors

Check for off-odors and high temperatures. If you find off-odors in any shipment or the
temperature is high in refrigerated loads, it may mean the delivered products are unsafe.
The reasons are as follows:
1. Foul odors may have been caused by the failure to remove food particles, filth,
and infestation resulting from previous shipments or failure to clean the carrier
properly before loading your shipment.
2. The products may have been decomposed before being loaded, causing the off-
odor.
3. The products may have absorbed harmful off-odors before shipment.
4. Toxic solvents, petroleum products, or chemicals may have been carried with
your shipment and unloaded before arrival at your receiving dock.
5. Frozen products, in the refrigerated load, may have been allowed to thaw during
shipment, permitting bacteria to grow and produce off-odors.
6. High temperatures in refrigerated compartments will allow the few bacteria nor-
mally present in the products to increase to dangerous numbers and to produce
harmful decomposition products and odors.
Do not accept shipment if off-odor or high temperature is observed. Instead, close the
compartment doors immediately and tell your supervisor. Such products can be a danger
to health and therefore may be seized.
H. Note Condition of Cargo

Packages, cartons, and similar types of containers protect the products they contain. If
they are broken, crushed, or otherwise damaged, their contents will be exposed to possible
contamination. The reasons are as follows:
It is difficult to prevent contamination of food products in damaged packages, car-
tons, or other containers.
Broken packages or containers may mean the product was contaminated and vio-
lative before it was loaded and shipped. The damage may have occurred while
the product was in storage and contents exposed to insects, rodents, or other con-
tamination while awaiting shipment.
Harmful chemicals or pesticides may have entered the broken containers.
The shipment may have been improperly stacked or mishandled while loading or
not protected while en route to your plant.
Do not invite trouble; set aside all damaged cartons, containers, and packages. Do
not tape over or repair holes or other damages you may find in packages or cartons; report
to your supervisor if you discover many broken or damaged cartons.
I. Look for Insect, Rodent, or Bird Activity

Finding insects, rodent excreta, bird feathers or droppings, or rodent urine (detected with
ultraviolet light) is evidence that the products were exposed to contamination, making
them unfit for food. Do not accept shipments containing insect, rodent, or other filth. The
reasons are as follows:
Insects, rodents and birds are often carriers of disease-producing bacteria and para-
sites. Rodent excreta or droppings and urine can transfer these organisms to food
products.
Products may have been contaminated with this filth before being shipped to your
plant.
The FDA will seize products stored in your warehouse if they are exposed to or
contain insect or rodent or other filth. The filth does not have to be found in
exposed products to make the product subject to legal actions.
Notify your supervisor as soon as possible when you find evidence of insect, rodent,
bird, or other contamination in the shipment.
J. Collect Random Samples

Random samples should be collected from the shipment and examined for contamination
either on the spot or in the laboratory. The reasons are as follows:
It is not possible nor practical to examine the contents of every packaged product
in the shipment because the package is not saleable after opening and may become
contaminated before being used.
Random samples that are representative of those in the entire shipment can be relied
upon to show if products are acceptable or contaminated.
We can get a true picture of the entire lot only if the samples are collected randomly
(i.e., every tenth, twelfth, thirtieth, etc., package, depending on the number in the
shipment).
If you are given the job to unload and inspect the shipment and no one is available
for on-the-spot examination of the contents of packages, ask your supervisor for instruc-
tions as to the number of cartons of packages he/she wants you to take randomly from
the load to set aside for later examination, either on the spot or in the laboratory. Follow
the instructions carefully because it is important that samples be collected randomly.
If you are assigned to make on-the-spot examinations of collected samples, be sure
you follow proper instructions and know how to use all of the inspection tools listed in
the ‘‘Inspecting Incoming Food Materials’’ booklet. Ask your supervisor for more specific
instructions for on-the-spot or laboratory examinations. Proper sample collection and ex-
amination will help prevent accepting contaminated shipments that should be rejected.
Do your part to help your supervisor make the proper decision.
K. Are Nonfood Items in the Shipment?
Write in your report any nonfood products (liquid or dry) that you find in the shipment
with the food items. Such products may be poisonous and can be a source of food product
contamination. For example, there is no way you can be sure containers of nonfood prod-
ucts will not leak or break during shipment or storage and contaminate the food items,
making them poisonous or otherwise unfit to eat, which can happen without your knowing
since no change in the appearance of the food products may take place.
You don’t have to find the poisonous stuff in the material to reject the shipment.
The Food, Drug, and Cosmetic Act, which protects consumers, says in simple words that
a food product is illegal if it is prepared, packed, or held (or shipped) under conditions
which may have caused it to become contaminated with filth or which may have caused
it to become dangerous to the health of consumers (such as by exposing it to poisonous
substances).
Be very careful about accepting foods shipped or stored with nonfood products that
may be poisonous.
L. Observe Inside Condition of Carrier after Unloading

Floors and walls in disrepair and residue wastes from nonfood shipments can cause con-
tamination. The reasons are as follows:
1. Cracks and broken boards are good hiding places for insects that could invade
the shipment while in transit.
2. Residues from nonfood items previously shipped in the carrier can contaminate
food products.
3. Presence of cracks, splinters, or broken boards may have prevented satisfactory
cleaning and sanitizing of the carrier’s interior prior to loading your shipment,
increasing the chance for contamination.
If the inside condition of the carrier you are inspecting is bad, mention it in your
inspection report. To discourage infestation, make sure all of the paper liners and wastes
from your shipment are removed and the truck or railcar is swept clean before releasing
it.
VIII. FDA WARNING LETTERS FOR DEFICIENCIES IN FOOD

STORAGE WAREHOUSES IN 2000
The FDA sends warning letters to a food company if an inspection shows sanitation defi-
ciency in the company’s processing operation. Four examples of such deficiencies from
warning letters issued in 2000 are provided here.
A. Mobile, Alabama
During the inspection, our investigator documented numerous insanitary conditions, which
caused the food products stored at your facility to become adulterated. The adulterated
food products are in violation of Sections 402(a)(3) and 402(a)(4) of the Federal Food,
Drug, and Cosmetic Act, in that they consist in whole or in part of filthy substances,
including rodent fecal pellets, and had been held under insanitary conditions whereby they
may have become contaminated with filth. Evidence of rodent activity was observed in,
on, and near foods stored in your warehouse and associated coolers. This evidence in-
cluded rodent excreta pellets, rodent urine stains, and gnawed food products. Evidence
of rodent gnawing was observed on several different food products, including honeydew
melons and carrots. Our FDA laboratory confirmed the findings of rodent excreta sampled
from your facility during the inspection. Our investigation of the general storage conditions
in the warehouse revealed: an approximate 0.5 ⫻ 7 in. opening to the outdoors at the
bottom of the east wall and an approximate 0.75 ⫻ 4 in. opening to the outdoors at the
bottom of the north wall in cooler number nine; an approximate 0.75 in. ⫻ 2 ft opening
at the bottom of the west wall in warehouse number two; and an approximate 2.5 ⫻ 1 in.
opening to the outdoors at the bottom of the east wall in warehouse number two, cooler
number one. Other conditions documented during the inspection include observations of
live birds and cats on and near foods stored in your warehouse.
B. Washington, D.C.
The violative conditions observed include
1. A dead rodent on the floor in the coffee/juice room
2. Examination of a commingled lot containing bagged wheat, cornmeal, and
potato starch revealed
a. Rodent excreta pellets inside a bag of semolina wheat
b. Over 100 rodent excreta pellets on bags of rice, in spilled product, and
on the pallet surface holding the bags
c. Bird droppings on a box of cornmeal and a bag of potato starch
3. Rodent nesting material and rodent excreta pellets on a pallet holding canned
eggplant
4. Rodent excreta pellets in the spice room
5. Rodent excreta pellets along the floor/wall areas of the jalapeno room
6. Rodent excreta pellets on the floor in the flour room
7. Rodent excreta pellets, damaged and spilled product, and bits of insulation
adjacent to a hole in the outside wall of the cooler
8. A live bird in the flour room
9. Bird excrement on spilled product, on pallet surfaces and storage racks, and
on boxes containing ‘‘Brand X’’ flour
10. Ten dead adult and five moth larvae on spilled product from an unlabeled,
damaged box in the spice room
11. Product spillage throughout the facility (jalapeno, spice, flour, and coffee/juice
rooms)
12. Storage of products against walls, no aisleways between products, clutter, de-
bris, machinery, and metal parts stored along various walls
13. Gaps measuring 1 to 2 in. in length along the base of the outer bay doors
14. Thermometers in the walk-in freezers not calibrated or tested for accuracy
C. Baltimore, Maryland
Here is a list of insanitary conditions observed by investigators during an inspection of
a warehouse and nut-manufacturing facility.
1. One live and 12 dead rodents in various locations throughout the facility.
2. Examination of a lot consisting of 17 50-lb bags of rolled oats revealed that
four bags contained fluorescent stains. Three of the four fluorescent stained
bags contained apparent rodent-gnawed holes.
3. Two of the three bags with the apparent rodent-gnawed holes also contained
at least 30 rodent excreta pellets inside the bags with the product. Approxi-
mately 100 rodent excreta pellets were on the floor adjacent to the lot.
4. Examination of a lot consisting of 30 boxes of lollipops (49 3-oz lollipops
each) revealed that two boxes contained apparent rodent gnawed areas. Three
lollipops in one of the boxes contained apparent rodent gnawing.
5. Examination of a lot consisting of six boxes (24 10.6-oz packages each) of
Popcorn Supply Kits revealed two boxes with apparent rodent evidence. One
of the two boxes contained an apparent rodent-gnawed hole, fluorescent stains,
rodent excreta pellets on the box, and apparent rodent-nesting material inside
the box. The other box contained an apparent rodent-gnawed hole and rodent
excreta pellet at the opening of the gnawed hole.
6. A lot consisting of eight cartons (6 6-lb 10-oz. cans each) and three individual
cans of cheddar cheese sauce contained fluorescent stains on the tops of two
of the cans. There was apparent rodent-nesting material and rodent excreta
pellets inside one carton.
7. A lot consisting of 59 50-lb bags of popcorn kernels contained nine bags with
fluorescent stains, one bag with an apparent rodent-gnawed area, and four ro-
dent excreta pellets on or adjacent to the bags.
8. A lot consisting of eight cartons (6 5-lb bags each) of caramel candies con-
tained one carton with apparent rodent gnawing. One of the bags in the carton
had an apparent rodent-gnawed hole and one rodent excreta pellet on its exte-
rior. Another bag had five rodent excreta pellets on its exterior.
9. A lot consisting of approximately 600 50-lb bags of shell peanuts contained
14 bags with fluorescent stains. Eight of the 14 bags contained apparent rodent-
gnawed holes. In some instances, the product itself bore fluorescent stains or
apparent rodent gnawing.
10. At least 771 rodent excreta pellets were observed on the floors in various loca-
tions throughout the facility (main and rear warehouses, restroom, retail dis-
play area, and the basement).
11. Structural defects were observed in at least six locations in the facility (gaps
under doors, holes in the walls) affording points of rodent entry and/or harbor-
age. There was a leaking drainpipe in the basement.
12. Manufacturing equipment, such as the nut roasters and popcorn machines, con-
tained accumulations of dust, dirt, debris, and/or rust.
13. Only one of the two restrooms was operable, and neither had soap or other
hand-washing solutions available.
D. Chicago, Illinois
The following sanitation deficiencies were observed during a food establishment inspec-
tion:
1. Rodent activity, in the form of rat excreta pellets, was observed on the roof of
the first-floor interior office, in the third floor near packaging materials, and
near a pallet of peppers in brine on the third floor.
2. A rodent-gnawed bag of pancake mix and rodent-gnawed margarine packages,
all on the second floor, demonstrated penetration to, and potentially direct con-
tamination of, product inside.
3. A structural hole in the surface of the third floor (opening into the ceiling of
the second floor) and another hole in a basement wall (near a pallet of cheese)
have provided potential avenues of entrance/egress of rodents.
4. A cat was noted running among stored food items on the second floor.
5. Cat feces were observed in the basement next to a pallet of cheese and on a
staircase between the second and third floors.
6. In your firm’s rear courtyard, rat burrow holes (including one at the base of
your building), a dead rodent, several flies, containers with rotten eggs, over-
filled trash dumpsters, unused manufacturing equipment, unidentified debris,
and plant overgrowth were observed.
7. Cheese and other perishable items refrigerated at an ‘‘unacceptable’’ tempera-
ture.
8. Various products stored directly against walls in the basement and on the first,
second, and third floors.
ACKNOWLEDGMENT
This chapter has been modified with permission from documents published by Science
Technology System, West Sacramento, California.

24
Metal Detection
ANDREW LOCK
Safeline, Inc., Tampa, Florida, U.S.A.
I. INTRODUCTION
At the end of World War II the fields of Europe were full of shrapnel and pieces of metal
ranging in size from minuscule to immense. In order to remove these metal contaminants
from harvested crops, such as potatoes, carrots, and beets, huge magnets were erected
above conveyor belts. As time went by, an obvious need for other food products to be
‘‘metal detected’’ was identified and more sophisticated technology was developed, even-
tually evolving into the very specialized metal detection systems available today.
While metal detection has always been important, and remains so today, there are
of course other kinds of foreign materials that must be detected and removed before or
during the manufacturing of food. The systems required to accomplish this are beyond
the scope of this chapter, but some leads to the wider literature on the subject are given
here.
Campbell [1] and Graves [2] discuss the broader aspects of the problem of foreign
objects in food (see also Chapters 5 and 6). Brennan et al. [3] consider only contaminants
in raw ingredients.
X-ray technology as applied to the detection of foreign bodies in food is now widely
utilized in food processing facilities. Riva [4] has provided a detailed account of the princi-
ples of x-ray inspection. Graves [2] has applied these principles to food inspection. Bone
fragments usually show up well on x-ray examination. However, in modern poultry pro-
duction requiring shorter grow-out periods, chicken bones are less calcified and are there-
fore more difficult to detect by x-rays; the standard system is plagued by both false nega-
tive and false positives. To remedy this problem, a system developed at the University
of Arkansas uses a combination of x-ray and laser imaging to reliably detect bone frag-
ments in boneless chicken filets of varying thickness [5].
For descriptions of X-ray inspection techniques and all the other systems of foreign
body detection in food, including the subject of this chapter, see Wallin and Haycock [6],
Graves et al. [7], and Campbell [1].
Development of machines for the specific purpose of detecting unwanted metal in
foods began in 1948 [6]. By 1980, the systems required to reliably detect metal fragments
were largely in place [8]. The Guide to Reducing Metal Contamination in the Food Pro-
cessing Industry, which now, with minor updates, becomes the present chapter, was first
published in 1990 and most recently revised in 1996 [9].
The focus of this chapter is quite narrow for two reasons: (1) because reliable sys-
tems of metal detection are so important in modern food processing, a detailed description
of one such system seems amply justified and (2) although other systems of metal detection
are available and reliable, the author’s technical expertise and experience are largely re-
stricted to the system described in the remainder of this chapter.
II. DEFINING THE CURRENT PROBLEM

Metal detectors are now accepted as essential equipment by most food and pharmaceutical
processors. Many companies set strict standards for detector sensitivity. However, install-
ing metal detectors will not necessarily guarantee a metal-free product; the detectors must
be an integral part of a carefully planned and implemented metal detection program.
The regulatory bodies in both the United States and United Kingdom have voiced
strong recommendations for the universal inspection of all food products by metal detec-
tion equipment. ‘‘The extensive exposure of some products to metal equipment such as
grinders, choppers, mixers, shovels, etc., causes the possibility of metal contamination . . .
therefore the use of electronic metal detectors is highly recommended . . .’’ [U.S. Depart-
ment of Agriculture (USDA) Technical Services].
Guidelines, issued by the Food and Drug Administration (FDA), update good manu-
facturing practices (GMPs) and offer more detailed guidance to the food industry to help
ensure a safe and sanitary food supply. ‘‘Effectiveness measures shall be taken to protect
against the inclusion of metal or other extraneous material in food. Compliance with this
requirement may be accomplished by using sieves, traps, electronic metal detectors, or
other suitable effective means’’ (Federal Register, Vol. 51, No. 118).
A. Sources of Contamination
The sources of contamination are so numerous that even the most stringent controls cannot
prevent the occasional incident. Working practices described later in this chapter will
minimize the likelihood of metal particles entering the production flow and maximize the
probability of reliably detecting and rejecting any that do. Contamination typically origi-
nates from these sources:
1. Raw Materials. Typical examples: metal tags and lead shot in meat, wire and
rust in wheat, screen wire in powdered material, tractor parts in vegetables,
hooks in fish, staples and wire strapping from containers.
2. Personal Effects. Typical examples: buttons, pens, jewelry, coins, keys, hair
clips, thumbtacks, paper clips.
3. Maintenance. Typical examples: screwdriver and similar tools, welding slag
and swarf (metal fragments from lathe work) following repairs, copper wire
cut off during electrical repairs, miscellaneous items resulting from inefficient
cleanup or carelessness.
4. In-Plant Processing. Typical examples: broken screens, metal slivers from
milling machines, foil from reclaimed products.
Every time the product is handled or passes through a process, there is some risk
of contamination. Crushers, mixers, blenders, slicers, and transport systems all contribute.
Identifying the likely source of each contamination incident is an important part of
developing an overall foreign material reduction plan. Inspecting raw materials will elimi-
nate many large, easily detected pieces of metal that further processing may break into
numerous difficult-to-detect pieces.
B. Why Are Metal Detectors Installed?

To prevent damage to processing equipment
To comply with stringent quality standards by major food producers/processors such
as high volume retailers, fast food chains, and food service and vendor certifica-
tion programs
To avoid the cost and implications of consumer complaints, adverse publicity, prod-
uct recall, and litigation
To win new markets and customers with high quality products
To comply with FDA/USDA directives and legislation such as ‘‘due diligence’’
III. BASIC PRINCIPLES

The most common types of metallic contamination in a broad range of industries include
ferrous (iron), nonferrous (copper, aluminum, lead), and various types of stainless steel. Of
these, ferrous metal is the easiest to detect—relatively simple detectors, or even magnetic
separators, can perform this task well.
Stainless steel alloys, used extensively in the food industry, are the most difficult
to detect, especially the common nonmagnetic grades. The nonferrous metals such as
copper and lead fall between these two extremes.
Only metal detectors using a balanced, three-coil system have the capability to detect
small particles of nonferrous and stainless steel. The three coils are wound on a nonmetallic
frame, each exactly parallel with the other (Fig. 1). The center coil is connected to a high
frequency transmitter. The two coils on each side of the center coil act as receivers. Be-
cause these two identical coils are positioned equidistant from the transmitter, the identical
signals they pick up induce an identical voltage in each (Fig. 2).
When a metal particle (embedded in product) passes into the inspection port (aperture)
of the detector, it disturbs the high frequency field under one coil, changing (by a few
microvolts) the voltage generated and disrupting the state of perfect balance. The resulting
signal, processed and amplified, warns of the presence of unwanted metal.
To prevent ambient electrical signals (e.g., from nearby metal items and machinery)
from disturbing the detector, the three-coil setup must be mounted inside a metal case
(usually aluminum) with an opening through the center to allow passage of the product.
For some applications where frequent wash-down is required, the case may be constructed
of stainless steel. The metal case, besides serving as a protective shield, gives strength
and rigidity to the assembly, both crucial for satisfactory operation of the detector.
Figure 1 Three-coil metal detector.
A. Mechanical Techniques
Other special mechanical and electrical techniques are essential to overcome many practi-
cal difficulties. The metal case itself will have an effect on the state of balance. Micro-
scopic movements (as small as 1 µm) of the coils relative to each other can cause an out-
of-balance voltage and a false ‘‘detect’’ signal.
A major challenge for metal detector manufacturers is to design a totally rigid, stable
system that will be unaffected by vibrations from motors, pulleys, auto-reject devices,
temperature changes, and nearby machinery and vehicles; frame material, coil specifica-
tions, and case design are all crucial here. To further increase mechanical rigidity, some
Figure 2 Receiver/transmitter/receiver sequence.

manufacturers fill the detector case with a material that prevents movement of the metal
case relative to the coils, thus producing a unit that is able to operate at maximum sensitiv-
ity under typical factory conditions.
B. Electronic Techniques
While the mechanical techniques just noted work toward minimizing false signals from
coil and case movements, the influence of other factors contributing to out-of-balance—
temperature changes, build-up of product in the aperture, aging electrical components,
minute alterations in the physical setup—can be countered by various electronic tech-
niques, thus making fine tuning by the operator unnecessary and ensuring long-term, opti-
mal operation of the detector.
Automatic balance control and quartz crystal control will not, by themselves, enable
the detector to recognize smaller pieces of metal. They will, however, enable the detector
to permanently maintain satisfactory sensitivity with no operator attention and without
false reject signals. For high performance over an extended period, automatic balance
control, quartz crystal control, and potted heads are all essential (all Safeline, Inc., heads
are solid potted, meaning that the heads are filled with a dense material, the potting; foam
potting is not used).
C. Ferrous-in-Foil Detection
When the product to be inspected is packaged inside an aluminum foil pack or dish, a
balanced-coil metal detector cannot be used. Required here is a detector that ignores alumi-
num foil but is sensitive to small pieces of ferrous contamination (Fig. 3). As a metal
particle enters the detector’s powerful magnetic field, it becomes magnetized. Then, as it
passes through the center coil, it generates a ‘‘detect’’ signal.
D. Metal-Free Zone
In order for a detector to operate properly, the space on each side of the aperture must
be free from metal parts, rollers, and supports. As a general rule, this space should be
approximately 1.5 ⫻ aperture height for fixed metal structures and 2 ⫻ aperture height
for moving metal such as reject devices or rollers.
IV. SENSITIVITY
Many factors influence the operating sensitivity of a metal detector: type of metal, shape
of metal, orientation of metal, aperture dimension, position of metal in the aperture, envi-
ronmental conditions, product, operating frequency, and throughput speed. When trying
to determine an operating sensitivity or compare capabilities of different detectors, the
following three factors are vital:
1. The sensitivity must be maintained permanently without operator attention (an

unstable unit requiring constant attention is useless).
2. The detector must not reject good product.
3. The detector must not generate false reject signals from vibrations and other
external influences.
(A)
(B)
Figure 3 Ferrous-in-foil detector showing (A) arrangement of magnets and (B) passage of food
through a magnetic field.
A. Types of Metal
All metals fall into three main categories: ferrous, nonferrous, and stainless steel. Probabil-
ity of detection depends on how easily they are magnetized and how readily they conduct
electrical current (Table 1).
Ferrous contamination, being both magnetic and a good electrical conductor, is eas-
Table 1 Characteristics of Metals

Magnetic Electrical
Metal type permeability conductivity Ease of detection
Ferrous (iron) Magnetic Good electrical con- Easily detected
ductor
Nonferrous (copper, Nonmagnetic Generally good or ex- Relatively easily de-
lead) cellent tected
Stainless steel (vari- Usually nonmagnetic Usually poor conduc- Relatively difficult to
ous grades) tors detect

ily detected. Most metal detectors are able to detect small ferrous particles. Nonferrous
metals such as copper, lead, and aluminum are nonmagnetic but, being good electrical
conductors, are generally quite easy to detect. Stainless steel comes in many different
grades, some magnetic and some nonmagnetic; conductivities vary. In the food-processing
and pharmaceutical industries, 304L (EN58E) and 316 (EN58) are the two most common
grades. Poor sensitivity to these grades is a major limitation of many modern metal detec-
tors. The problem of detecting stainless steel becomes even more acute when inspecting
wet or salty products.
A good indication of a detector’s overall capability is the sensitivity ratio between
ferrous and the most difficult to detect grade (304L) of stainless steel. This ratio can be
as good as 1:1.5 and as poor as 1: 2.5. A detector’s sensitivity predicts its ability to detect
real-world contaminants, such as metal slivers and bits of screen wire, that exhibit an
orientation effect.
B. Shape of Metal
Metal spheres are used as a standard to determine detector capabilities. There are two
reasons for this; (1) spheres are available in a range of metals and diameters; and (2) a
sphere has a constant shape no matter how it is presented to the detector (it has no orienta-
tion effect). The sensitivity of a detector is usually expressed as the diameter of a metal
sphere of a specific metal type that is just barely detectable in the center of the detector
aperture.
C. Orientation Effect
If a nonspherical particle of metal such as swarf or wire passes through a metal detector,
it will be easier to detect when passing in one orientation compared to another. This is
known as orientation effect. Figure 4 shows that a piece of ferrous wire is least detectable
when it presents at 90° to the direction of flow and most detectable when parallel to the
flow. Nonferrous and stainless steel wires are just the opposite. If this type of contamina-
tion is likely, care should be taken to ensure that the detector is, in fact, capable of detecting
it.
The orientation effect is only evident when the diameter of the wire is less than the
spherical sensitivity of the metal detector. With the detector sensitivity set at 1.5 mm
diameter, for example, only wires thinner than 1.5 mm diameter will show the orientation
effect. If the detector sensitivity is increased to 1.0 mm, only wires less than 1.0 mm
diameter will cause a problem. If the diameter of the wire is only about one-third the
diameter of the detectable sphere, it may not be detectable whatever its length. Clearly,
to minimize the orientation effect, it is better to operate the detector at the highest possible
sensitivity.
This, however, may cause other problems. As sensitivity levels increase, the problem
of drift becomes more acute; with some detectors, nuisance false rejects will increase to
an unacceptable level. The benefit of a stable detector becomes even more important.
Figure 5 compares a detector’s ability to detect three different wire samples at vari-
ous detector sensitivities. The left-hand column shows four alternative sensitivities. As
an example, when operating at 1.5-mm sensitivity, the piece of copper wire would need
to be 9 mm long to guarantee detection. At a 2.0-mm sensitivity, this would increase to
26 mm. Small change in detector sensitivity will make a great difference in its sensitivity
Figure 4 Effects of orientation: Detection is affected by the composition, shape, and orientation
of the contaminating material—wire contaminant.
Figure 5 Comparison of detector sensitivity to spherical standards versus elongated, thin contam-
inants.

to wire pieces. The goal is to operate the detector at the highest possible sensitivity. Auto
balance, quartz control, and a potted head all contribute to achieving this goal.
D. Aperture Dimensions
A large aperture is less sensitive than a small aperture. Both aperture width and aperture
height influence the detector’s sensitivity. The geometric center is the least sensitive part
of the aperture; the corners are the most sensitive; and all other points will lie somewhere
in between. The sensitivity gradient (the difference between these two extremes) depends
on the design of the coil and frame assembly. A large gradient may make the detector
unduly sensitive to contamination in the conveyor belt or packing material. A perfect
detector would have no gradient and would be equally sensitive at all points (Fig. 6).
E. Environmental Conditions
Metal detectors are influenced to varying degrees by environmental conditions such as
ambient electrical interference, building vibrations, and temperature fluctuations. These
effects become even more acute when operating at high sensitivities. Ovens, freezing
tunnels, and hot water wash-downs all create thermal shock that can result in false reject
signals. Automatic balance control solves the problem, but lacking that, one solution may
be to reduce the sensitivity of the machine.
F. Product
Because dry products such as confectionery and cereals are relatively easy to inspect,
sensitivity curves can be used to calculate the expected operating sensitivities. When in-
specting wet, conductive product, such as fresh meat, the situation is more complex. The
wet product creates an interference signal in the detector that must be canceled out before
inspection can begin. This tends to reduce the sensitivity of the detector in a way that
cannot be calculated empirically. To minimize the effect, a lower operating frequency is
often selected in the range 10–50 kHz. This reduces the interference signal from the prod-
uct but also reduces the sensitivity of the detector, especially to stainless steel. Generally,
actual product testing results show a slight improvement in ferrous sensitivity but a reduc-
tion in nonferrous and stainless steel sensitivity.
Figure 6 Effect of metal contaminant position as it passes through detector: (1) sensitivity is
least in the center of the detector aperture; (2) position of intermediate sensitivity; (3) position (in
corners) of maximum sensitivity; bar graph shows comparative sensitivities in relation to position
in detector aperture.

G. Inspection Speeds
Minimal and maximal inspection speeds are seldom a limiting factor for metal detectors,
especially with conveyor-type applications. The limit will vary from manufacturer to man-
ufacturer but will be a function of the detector aperture height. Typically this would be
around 8 m/sec (1500 ft/min) for a 125-mm (5-in.) high aperture. More important than
the absolute maximum and minimum is attaining uniform sensitivity over the full range
of speeds. The limit of performance can be reached on pneumatic pipelines at speeds in
excess of 35 m/sec (6000 ft/min) (this limit is not universal to all detectors).
V. INSPECTING WET OR CONDUCTIVE PRODUCTS

Products such as cheese, fresh meat, warm bread, jam, and pickles can create a signal in
a metal detector even when completely free of metal. This ‘‘product effect’’ is caused by
the salt or acid content making the product electrically conductive. To make inspection
possible, it is necessary to eliminate or reduce the product-effect signal in one of three
ways:
1. Sensitivity Reduction. By progressively reducing the sensitivity of the metal
detector, the signal from the product is made smaller and smaller until it is no
longer detectable. Despite the detector also becoming less sensitive to all metals,
it is usually the preferred option when product signals are small.
2. Frequency Reduction. The operating frequency of a metal detector is generally
in the range 10 kHz to 1 MHz. By selecting a frequency toward the low end of
this range, the product-effect signal decreases. Unfortunately, the signals from
nonferrous and stainless steel also decrease, causing the detector to be less sensi-
tive to these metals.
3. Product Compensation. Special electronic circuits can amplify and filter the
signals from the detector by differing amounts according to their characteristics.
The operator can adjust the filters to test a broad range of product signals. This
technique, product compensation, has the general effects of minimizing the
product signal, improving the detector’s sensitivity to ferrous metal, reducing
sensitivity to nonferrous and stainless steel, and making the detector more prone
to vibration from motors, reject devices, and other nearby machinery.
Inspecting conductive product is always a compromise and, in practice, a metal detector
manufacturer will use a combination of all three techniques to give the best operating
performance.
The effects of vibration and drift from temperature variations are more pronounced
on product-effect lines. Automatic balance control, quartz crystal frequency control, and
potting the detector head will help create total stability. This overcomes a common prob-
lem, often experienced by users, of a gradual increase in the amount of rejected product
which, when reinspected, is found to contain no contamination.
Finding individual pieces of metal contamination in the rejected product is important
for the following reasons: (1) if the source can be identified, then steps can be taken to
prevent reoccurrence; (2) it can give early indication of the break-up of a piece of machin-
ery; and (3) if line operators can see the results, it will help build confidence in the machine.
Rejected product should be reinspected during a break in production using either
the original detector or a separate off-line unit. You must take care not to risk mixing the
rejects with good product. If the product was originally frozen (such as hamburger) or
has changed temperature (such as bread), it may not be possible to duplicate the original
test conditions. Your company will need to decide how to proceed. Usually, a smaller
off-line detector will be needed to test the broken-up product.
To find the individual piece of metal contamination proceed as follows:
1. For discrete items, the rejected product should be repassed through the detector
three times in different orientations.
2. If no detection occurs, you may assume the product is not contaminated.
3. Remove any packing material and repass the product and packing material sepa-
rately.
4. Split the product in half and pass each half through the detector. Repeat the
process until the metal can be found.
5. After removing the metal piece, repass the remaining product to see if a second
piece is present.
6. Keep the piece on file, with line and time information.
A. Product Compensation—A Detailed Look

The signals created by various metals as they pass through the coils of a metal detector
can be split into two components, resistive and reactive, according to the conductivity
and magnetic permeability of the metal. The signal from ferrous metal (iron) is primarily
reactive; stainless steel is primarily resistive.
The signals vary in amplitude (length) according to the size of the fragment of
contaminating metal and in phase (direction) according to the resistive and reactive compo-
nents that, in turn, depend on metal type. Signals from ferrous metals are larger than
signals from the same size piece of nonferrous or stainless metal. Signals from vibration
and outside interference always occur along the horizontal reactive axis.
To improve sensitivity of the metal detector to the stainless signal and reduce the
sensitivity to vibration, special circuits—phase sensitive detection (PSD) (Fig. 7)—are
used to amplify the signals by differing amounts relative to phase. The PSD is shown as
a long, thin oval called the detection envelope. For a signal to be detected, it must pass
outside the detection envelope. Large signals from vibration are required before passing
outside the envelope and thus being detected, while only small signals from stainless steel
are necessary. This is the most satisfactory operating condition. A problem, however,
occurs when inspecting a conductive product such as cheese. The large product signal
(Fig. 8) passes outside the envelope and will be detected each time, even when the cheese
is metal-free.
By reducing the sensitivity of the detector, all the signals will become smaller until
the product signal no longer emerges from the detection envelope. Inspection will then
be possible. For small product effect this will usually be the preferable solution. An alterna-
tive solution is to electronically rotate the detection envelope until it is aligned with the
product signal (Fig. 9).
This adjustment, known as product compensation, can be carried out by the operator.
Since the product signal no longer passes outside the envelope, normal inspection is again
possible. Product compensation, however, has its drawbacks. Large signals from stainless
steel are needed to pass outside the envelope, so the detector becomes less sensitive to
these metals. At the same time, small signals from vibration will now pass outside the
envelope and be detected.
Figure 7 Vector diagram of varying signals of several different kinds of metals, passing through
a metal detector.
Undue sensitivity to vibration is often the limiting factor when inspecting with prod-
uct compensation. The exact phase of any product cannot be calcuated from data on salt
content or on pH; neither can detection sensitivities be calculated. Product testing, usually
available from metal detector manufacturers, is essential to determine the detector’s sensi-
tivity to a range of metals.
B. Automatic Product Compensation

Accurately adjusting the product compensation control requires operator competence if
optimal performance is the goal. If a number of different products or pack sizes are to be
checked on the same production line, adjusting the detector for each new product can
be time consuming. The recent introduction of microprocessor-based metal detectors has
Figure 8 Phase sensitive detection: signals from vibration are minimized, while signals from
stainless steel are maximized; only signals passing outside the detection envelope (long, slender
oval) can be detected.

(A)
(B)
Figure 9 (A) Conductive products may produce false positive signals, indicating metal contami-
nation where none exists. (B) Product compensation can be achieved by electronically rotating the
detection envelope so that signals generated by the product itself are contained within the detection
envelope.
resulted in major improvements when inspecting conductive products. By switching to

‘‘learn’’ or ‘‘automatic compensation’’ mode product compensation can be set automati-
cally, with no operator involvement. These settings can then be entered into a memory
to allow immediate recall when changing product, or even to allow remote setup of the
detector from a central computer.
VI. CONVEYOR AND REJECT SYSTEMS

A metal detector conveyor is much more than a modified transport conveyor. The conveyor
system that transports the product through the detector must meet certain strict criteria,
if it is to avoid influencing the detector. The design of both conveyor and auto-reject
device will have a major impact on the effectiveness of the overall metal detection pro-
gram. Unless special precautions and design techniques are incorporated, eddy current
loops and static build-up can influence the detector, downgrading sensitivity and causing
interference.
Metal detectors emit high frequency signals that generate tiny eddy currents that
flow all around the metal structure of the conveyor. These eddy currents have no effect on
the detector if they remain constant. However, if the conveyor structure has an intermittent
(bolted) joint of variable resistance, even remote from the detector, the eddy currents
briefly change and send large interference signals to the detector.
Typical sources of eddy current loops are any metal-to-metal contact such as a bolted
conveyor assembly or supports, pulley shafts and bearings, chain drives and guards, reject-
device supports, and metal conduit clamps. Frequently, oxidation of joints or changes in
bearing lubrication cause problems to increase with time.
A. Belting Types
Several factors need to be considered in choosing a suitable belting material. Static charges
can build with some types of materials, as when running over plastic skid plates, and
plastic-coated rollers and pulleys. Special antistatic belting, often made with conductive
carbon fillers or additives, can adversely affect the detector’s performance, especially
when the belt joint passes through the aperture.
With any type of belt the joint must be metal-free and made in such a way as to
prevent product build-up or an accumulation of grease. Metal fasteners or sewn and laced
joints are unsuitable.
The belt material itself must also be totally metal-free. Because tiny metal specks
in the material are extremely difficult to find, belt manufacturers producing consistently
high quality, metal-free belting would almost certainly need to use metal detection equip-
ment to inspect their raw materials.
Flat, dished, ribbed, cleated, and molded flexible wall belts are all acceptable. Solid
plastic chain belts of the ‘‘Intralox’’ style and round urethane belting running in grooved
rollers are ideal where spillage requiring frequent wash-down is likely. Endless ‘‘double
pass’’ belts (Fig. 10) offer a number of advantages in many applications, including rapid
replacement. However, because the face of the belt passes over rollers, they are not suitable
for transporting wet or sticky product such as meat trimmings.
B. Product Transfer
The process of transferring product onto the conveyor system needs special consideration
when the end rollers are large or the product is small. If the distance (D) between rollers
is more than half the product length, reliable transfer will not be possible. Installation of
Figure 10 Metal detector configured with a double-pass (endless) conveyor belt.

small, nonpowered, intermediate rollers or a dead plate positioned between the two rollers
is usually effective (Fig. 11A).
Single or double knife edges (Fig. 11B) permit transfer of very small items where
product registration (repeatability of the physical position of the product as it passes
through the metal detector) has to be retained, such as rows of confectionery at the outlet
of an enrober.
Sticky product such as raw dough and meat and bulk loose product such as loose
peanuts can be transferred by cascade (Fig. 11C).
For jar inspection, the detector system may be positioned alongside the existing
transport conveyor; product guides divert the jars from the line onto the detection system.
Acceptable products are then diverted back. When a contaminated item is detected, the
product guide moves pneumatically to reject the item from the line (Fig. 11D).
C. Transfer Speed
To allow easier identification of the contaminated items, it is often useful to accelerate
the product through the detector to create an increase in product spacing. When packs are
very close, the detector may be unable to determine which one is contaminated. Two or
three packs may need to be rejected to be sure of catching the right one. By increasing
the detector conveyor speed, product spacing is increased, permitting the individual items
to be identified.
When inspecting bulk and loose product, the burden height can be reduced by accel-
erating the product on transfer. This has the advantage of minimizing the volume of re-
jected product and permits a lower detector aperture, resulting in higher sensitivities (Fig.
12).
D. Automatic Rejection Systems

Ineffective reject systems are probably the weakest link in most detection programs, re-
sulting in contamination not being effectively and reliably rejected from the line. A cor-
rectly specified system should be foolproof and capable of rejecting all contaminated prod-
uct under all circumstances, independent of the frequency of occurrence or the location
of the metal inside the product.
Occasionally, automatic rejection is not used. The operator is expected to remove
contaminated product when the conveyor stops on detection, or at the sound of a bell, or
when a bright plastic disc drops on the line from an electronic ‘‘disc dropper’’ designed
to operate each time metal is detected. All these solutions are high risk since they depend
entirely on the efficiency of the line operator.
The choice of the most appropriate reject system depends on a number of factors;
advice of the detector manufacturer should always be sought. Options available include
1. Air blast—ideal for light, single-line product (Fig. 13A)

2. Pusher/punch—single-line discrete, spaced, and oriented product (Fig. 13B)
3. Sweep/diverter arm—random, nonoriented product (Fig. 13C)
4. End flap—bulk or discrete multiple items on wide belt (Fig. 13D)
5. Retracting belt—end pulley retracts to create a gap in the line; very reliable on
most applications (Fig. 13E)
6. Reversible belt—ideal for bulk, random, or sticky products (Figs. 13F,G)
Figure 11 Product transfer systems: (A) 1—successful transfer achieved only if product length
is at least D (distance) ⫻ 2; 2—transfer assisted by an intermediate idle roller. (B) Single and double
knife edge configurations are useful for very small product items. (C) Product transfer systems: the
cascade configuration is useful for sticky product or bulky, loose items. (D) Product transfer systems:
metal detector signals diversion of rejected item (marked with X) away from acceptable product
(product flow is from left to right).

Figure 12 Running the detector conveyor at a faster speed (V2 ) than the transfer conveyor (V1 )
allows for a thinner layer of product to pass through the detector and thereby increases detector
efficiency.
E. Inspection of Liquids
Inspection of pumped liquids and slurries can be achieved by replacing a short section of
the stainless steel transport pipe with a food-quality plastic pipe and passing it through a
metal detector (Fig. 14A). On detection of metal, a sanitary three-way valve diverts the
contamination; alternatively, the pump can be stopped and the contamination flushed out
manually. Typical products suitable for pipeline inspection include liquid chocolate, ice
cream, soup, and meat slurry.
For product likely to solidify if pumping stops, such as liquid chocolate, the
throughput pipe can be equipped with a hot water jacket (electric wire wrap heating cannot
be used). Hot water jackets also prevent an accumulation of fat inside the pipe when
pumping certain types of sausage meat emulsions.
Pumped product is seldom totally homogeneous. Voids and bubbles frequently oc-
cur, causing problems when adjusting the detector for optimal performance, especially
for highly conductive products.
Under normal conditions, because product is passing under all coils of the detector,
product effect tends to ‘‘cancel out;’’ the detector can then be adjusted to give high sensi-
tivity. If, however, a void or bubble passes under the first coil, the detector will sense a
large product difference, prompting a false reject (Figs. 14B,C). It is possible to adjust
the detector to eliminate the product signal, but unless the bubbles occur frequently or at
a predictable time (such as with a pump startup) it may take a long time. In these instances,
automatic product compensation will be of no help.
F. Inspection of Powders and Granules

Any free-flowing powder or granule-type product, such as peanuts, rice, plastic pellets,
milk powder, and cocoa beans, can be inspected under free-fall conditions using a gravity-
feed, free-fall detector and a high-speed diverter valve. Under normal conditions, there
are no moving parts such as motors, gears, rollers, or belts, and, with the relatively high
volumes that can pass through a small detector opening, very high sensitivity can be
achieved.
Figure 13 Automatic rejection systems (• indicates metal contaminant in product). (A) air blast;
(B) pusher/punch; (C) sweep arm; (D) end flap; (E) retracting belt; (F) reversible belt; (G) reversible
belt.
The detector and auto-reject device should be mounted on a rigid framework with
sufficient space between them to ensure that metal contamination is always rejected (Fig.
15A). Product flow may be continuous free-fall or batch free-fall. The application is not
suitable when product backs up in the throughout pipe and moves slowly.
The overall system height is often a limiting factor in the use of gravity feed systems,
Figure 13 Continued
Figure 14 Inspection of liquid foods. (A) Product passes through the detector by means of a
plastic pipe; contaminants are ejected upon signal to a rejection device. (B) Conduit pipe should
be completely filled to avoid false reject signals from the product itself. (C) Bubbles or other voids
in the product cause false rejects.
especially where little headroom exists. The following limiting variables have a direct
relationship on the overall system height.
1. Initial Fall Height of the Product. This will determine its velocity at the point
of inspection and also the time taken to arrive at the reject point. The fall height
should ideally be reduced to a minimum by locating the equipment as close as
possible to the point of initial fall.
2. Detector Aperture. This will determine the metal-free zone of the detector
and, in turn, the height of the input flange above the detector and the closest
Figure 15 Inspection of dry products. (A) Gravity-feed, free-fall detector with high-speed di-
verter valve (• indicates metal contaminant in product). (B) Auger-fed system utilizing a proprietary
zero meal-free zone (ZMFZ) detector.
point at which the reject device can be located. The aperture height will also
determine the distance the reject chute must travel to reject product.
3. System Response Time. This covers the speed of response of the relay or
solid-state output, air solenoid or air cylinder and the time taken to move the
reject flap to the reject position.
4. Reject Angle. The reject angle must not be so large as to create blockage or
bridging. As the length of the reject flap is reduced, the reject angle increases.
An angle of between 25 and 30° is considered a maximum for most products.
5. Reject Design. Product build-up on the reject device, a drop in air pressure,
and aging of bearings all slow down the speed of response. A sufficient safety
margin is needed in the design to ensure that metal is rejected with total reli-
ability.
G. Special Applications
Installing a custom-designed metal detector as an integral part of a packaging or processing
machine can have a number of distinct advantages for both the user and the supplier of
the original machinery.
1. Pouch Filling
Detectors can be installed to inspect powdered material prior to filling in preformed alumi-
num pouches. Apertures of 50 mm (2 in.) or 75 mm (3 in.) are usually sufficient, but
space limitations restrict the exterior case dimensions. Severe metal-free zone restrictions
occur because of the metal parts of the auger fillers. Up to three fillers—hence three
detectors—may be needed on a single pouch maker.
2. Vertical Form Fill Seal

A special detector can be fitted between a computerized weight scale and a vertical form
fill seal (VFFS) bagger (Fig. 15B). Often a large detector, 150 mm (6 in.) or 200 mm (8
in.), is required, which would require a large metal-free zone. This detector technology
allows high sensitivity levels to be maintained in minimal space without false rejects,
making installation easier and avoiding the danger of product breakage. The entire line
may be stopped when metal is detected.
VII. ESTABLISHING AN EFFECTIVE METAL DETECTION PROGRAM

Metal detectors may be used at various stages of a production process.
1. Bulk Inspection. Eliminates metal before it can be broken into smaller pieces;
protects processing machinery from damage; avoids the product and packaging
waste that happens when a finished, high-value product is rejected. Typical ex-
amples include bulk inspection of meat blocks prior to grinding, ingredients for
pizza toppings, and grain.
2. Finished-Product Inspection. No danger of subsequent contamination; ensures
compliance with quality standards.
A combination of bulk and finished product inspection gives optimal protection.

Selecting a reliable metal detection system is just the first step in achieving the final
objective; minimizing, or eliminating the incidence of, metal contamination.
Those responsible for establishing and monitoring the program should make sure
that the proper procedures are clearly specified and implemented and that the line operators
and general work force are aware of them.
A. Sensitivity Standard
Establishing a sensitivity standard, while relatively easy for producers of small dry items
such as confectionery, can be more difficult when a wide range of ‘‘product-effect’’ lines
are in operation. Agreeing to a company standard minimum for finished-product inspection
will help overcome the possibility of a detector being installed at the wrong place in the
production line. An example is where inspection of finished cases is being considered
instead of inspecting each individual item. The larger detector would achieve lower sensi-
tivity, and frequently occurring metallic specks in the carton material would limit the
detector’s capabilities.
Equipment should be operated at its maximum reliable level; this may be better
than the agreed-upon standards for some applications. It is, however, more important for
equipment to work reliably, long term, and without false rejects, than to try to achieve a
Table 2 Standards for Dry, Nonconductive Products
Detector height Fe/Non-Fe Nonmagnetic stainless steel

Up to 50 mm (2 in.) 0.8 mm 1.2 mm
Up to 125 mm (5 in.) 1.2 mm 1.6 mm
Up to 200 mm (8 in.) 1.6 mm 2.2 mm
better sensitivity and create false alarms. For dry, nonconductive products, see Table 2
for the standards used by many food processors.
Standards for very wide detectors, such as those used at the outlet of ovens or enrob-
ers, may need to be slightly lower than those given in Table 2. For conductive products,
product testing is needed to determine detection capabilities. Test results, however, should
be considered only as estimates.
Both the acceptable standard minimum and the individual line specification should
be determined for both ferrous and nonmagnetic stainless steel. The line specification
should be marked clearly on the side of the detector and metal samples of the correct
diameters should be available for testing. Only authorized personnel should have access
to the detector controls.
B. Testing the Detector

Testing the metal detector with standard test samples should be carried out regularly to
confirm both detection and reliable rejection. The interval between tests will depend on
the implications of a failed test (see next section). A typical routine would be to test every
2–4 hr and at the beginning of each shift. If maintenance or repairs have been carried out
on the line during downtime, the metal detector must also be checked prior to line start
up. It is important to follow correct procedures.
1. Use correct test samples of ferrous and stainless steel mounted in a plastic card
or plastic block.
2. For discrete items, place the metal sample at the front of a well-identified prod-
uct and run it through the detector; make sure it breaks the photogate or other
reject device.
3. For bulk product, place the sample in the product flow.
4. Confirm the product with sample is detected and rejected.
5. For discrete items, repeat the test with the sample at the back of the product.
A more demanding test is to use two samples, properly spaced, to ensure multiple rejec-
tions.
Precautions must be taken to ensure that any test samples not rejected do not become
‘‘lost’’ in production. If the detector is positioned just prior to another processing machine,
such as a grinder or mixer, it is wise to attach the test sample to a piece of string.
C. Action Required If Test Fails

If the test sample is not detected or rejected, all output since the last successful test should
be considered suspect and possibly contaminated. The cause of failure should be deter-
mined. If the failure is the result of tampering or a change in production conditions, proce-
dures should be established to prevent reoccurrence. If the detector can be adjusted to
bring it back to correct operation, this should be done and noted on the test log.
If a test shows that a system is faulty, the user must decide what course of action
to take. Several options are available:
1. Continue production and repair the system as soon as possible.
2. Continue production and reinspect product through an off-line system.
3. Stop production.
4. Stop production and reinspect everything produced since the last successful test.
If this is not possible, quarantine warehoused product.
Only by stopping production, and preferably reinspecting product, can a company
be confident that an effective metal detection program is in place. A corporate policy
should be agreed upon and publicized ahead of time. The value of taking this position is
evident in the event of a complaint or litigation. The temptation to keep production lines
running uninspected can be reduced if the metal detector is equipped with an electronic
module that, without special skills or specialized equipment, can be easily replaced by an
operator.
D. Treatment of Rejected Product

All rejected product should be reinspected in the same detector during a break in produc-
tion, or in a separate off-line detector, to locate the offending metal piece. For discrete
items, the following procedure is suggested:
1. The contaminated items should be passed three times through the detectors in
various orientations. If there is no detection, the item can be considered accept-
able.
2. If the item is detected, remove any packing material and repass.
3. Divide product into smaller and smaller pieces until metal can be located.
4. Do not try to locate metal visibly by spreading product on a table, you will not
be successful.
Metal particles found should be shown to line personnel so they build up confidence
in the equipment and then kept for future reference and details recorded in a ‘‘Metal
Contamination Daily Log’’ (Fig. 16).
If the source is known, it should also be recorded. If not, investigations are extremely
useful in preventing a reoccurrence and can result in a change in maintenance procedures
or even a change in raw material suppliers. Locating and retaining the particles has the
added advantage that if a screen or blade, for example, is known to have broken into the
product, the individual pieces detected can be collected and the component ‘‘reassembled’’
to ensure nothing has been missed.
E. Performance Validation
A metal detector with a performance validation routine (PVR) can help ensure testing is
carried out properly at agreed time intervals with proper test samples and, if required,
provide hard copy documentation confirming the test. Approved personnel enter a personal
access number into the detector and then carry out the test with the correct sample size.
Hard copy documentation (Fig. 17) showing that testing has been carried out can

Figure 16 Sample metal contamination daily log.
be provided through a local printer or downloaded to a central computer with detector

network capability. ‘‘Proof of Inspection’’ (Fig. 17) is useful evidence in the event of
a customer complaint and to confirm compliance to an inspection standard in a vendor
certification program.
F. Detector Networking
Microprocessor-based metal detectors may be networked together and linked back to a
central computer. This provides the user with two important benefits.
1. Real-Time Status. By glancing at the computer monitor, a supervisor may be
immediately reassured that all detectors are operating properly and have been
recently tested. Warning ‘‘flags’’ can be displayed and corrective action imme-
diately taken if a sudden increase in rejections occurs, if a detector fails, or if
metal is detected but the reject device fails to remove it.
2. Accurate Documentation. All events such as rejections, faults, setup changes,
and quality assurance (QA) tests are stored in a database with the time and date
they occurred. The information may be viewed or printed out in various report
formats. In the event of a complaint, a printout can prove the product was in-
spected by a detector that was properly adjusted as well as confirm when and
who tested the unit with test samples.

Figure 17 Sample daily metal detection test sheet.
VIII. REASONS WHY YOUR PROGRAM MAY FAIL

Relatively few incidents of metal being undetected are a result of detector failure. They
are usually associated with poor working methods by company employees and faulty
system design. Often the complaints do not result from tiny metal pieces but from larger
items such as washers, bolts, and pieces of blades and screens that should be detectable
by even the most basic type of detector. There will always be a limit to the smallest metal
piece detectable; processors should ensure that this limit is understood and acceptable in
their operation.
A. Conveyor Design
The design and method of manufacture of the conveyor will have a great influence on
the detector. It is an integral part of the complete inspection system and, in almost all
cases, the detector’s maximum sensitivity cannot be achieved when fitted to an existing
general-purpose transport conveyor. Fully welded structures, incorporating correct, metal-
free zones and properly isolated rollers, pulleys, cross-structures and detector-head mount-
ing, are essential to obtain the highest reliable performance.
Conveyor belting must be metal-free to a very high standard and suitably jointed.
Antistatic belting should be avoided. If these problems are not solved at the onset, the
common outcome is a gradual increase in false rejects.
B. Nonpositive Reject System

This is probably the weakest link in the whole inspection system. Common problems are
(1) reject device not suitable for the application; (2) system design not capable of removing
consecutive contaminated packs; (3) failure of the reject device due to low air pressure,
solenoid failure, or blockage; (4) downstream product backup through the detector; and
(5) product spacing and reject-device design not compatible.
A major benefit (illustrated by the following case study) of single-source responsibil-
ity for conveyor, reject device, and metal detector is that all of these issues can be ad-
dressed at the design stage. A frozen pizza manufacturer was using eight identical detector
systems with air blast rejection but no photogating. The equipment was tested each hour
by placing the test sample, in the center of the pizza; each time the test was successful.
A consultant suggested that the test be repeated with the test sample on the front edge of
the pizza. The QA manager was amazed as he watched the pizza in front of the test sample
get rejected and the contaminated sample continue down the production line. The reason
for the ongoing customer complaints became clear. Simple, readily available control de-
vices could have been installed to make sure the reject device was operating properly and
that contaminated packs were always rejected.
C. Production Continuing When the System Is Faulty

A firm policy should be established dictating the action required in the event of a detector
fault. Halting production is the safe option. Alternatively, product can be stored for subse-
quent inspection in an off-line unit prior to release. If your detectors have user-replaceable,
quick-change modules, a repair can be effected in minutes and the temptation to keep
running, without functional detectors, avoided.
The drive motor of the conveyor can be wired to stop or the reject device set to
operate continuously in the event of detector failure. Automatic self-checking is an essen-
tial feature of any metal detector. Its purpose is to continually monitor the detector and
give an alarm if it fails or if the sensitivity falls. This automatic checking can be extended
to cover all associated items such as reject mechanisms.
D. Rejected Product Returned to Production

If product is rejected onto the floor or into an open container, it can be easily returned to
production in error or, when production schedules are tight, intentionally. Rejection into
lockable reject bins helps overcome the problem. A warning device should be incorporated
to indicate when the bin is full. Frequent false rejects and erratic operation can undermine
the operator’s confidence in equipment. In contrast, showing line operators the various
metal pieces found will build confidence in the equipment.
Most microprocessor equipment will display the number of rejected items on the
control panel; this should be compared to the actual number found. Good recordkeeping
will highlight those lines or shifts that seem to have suspiciously few rejects.
E. Line Operators’ Working Practices

To prevent the detector being switched off or reduced in sensitivity, access to the controls
should be restricted to QA personnel or to a responsible supervisor trained in the adjust-
ment of the machine. Other problems sometimes encountered include air supply to reject
device disconnected, reject bin overfull, and reject arms tied open with string. Simple
checking devices are available to monitor all system components.
F. Conveyor System Used as a Pack-Off System

On production lines where all the products are taken off the conveyor by hand, the reject
device should be positioned as close as possible to the detector and the space in between
covered with a clear guard. This prevents contaminated items from being removed (by
mistake) before they have arrived at the reject point.
G. Subsequent Contamination After Inspection

For QA applications, the ideal point of inspection is immediately after packing or as close
to final packing as possible. When the packaging material includes aluminum foil, inspec-
tion can be done before packing with a ferrous-type detector or after packing with a fer-
rous-in-foil detector. The latter is recommended only when no alternatives are available
because ferrous-in-foil units cannot detect stainless steel and nonferrous metals.
Intentional metal contamination is very difficult to prevent. Inspection as late as
possible in the process and minimizing the access to finished product will help. Employees
under notice of termination should not be allowed in sensitive production areas. If sabotage
is of particular concern, discussions with the metal detector manufacturer are likely to
prove worthwhile.
H. Users Unaware of Detector Limitations

Many operators are unaware of the practical limitations of the detectors they use. A detec-
tor working at a 2-mm sensitivity, for example, will not necessarily detect all metal pieces
larger than 2 mm. A thin piece of screen wire could be 25 mm (1 in.) long or more and
still pass undetected.
An understanding of the orientation effect will prevent onset of a false sense of
security. This understanding can influence the location of the detector in the production
process and prevent it from being installed to perform a task for which it is unsuitable.
Even slight reductions in operating sensitivity can have a significant effect on the perfor-
mance of the detector, a point seldom appreciated by the user.
I. Detector Drift
Detector drift, resulting in changing sensitivities, false alarms, or nuisance signals, occurs
over a period of time due to temperature and humidity variations, aging of electronic
components, and build-up of product in the aperture. Typically, sensitivity to ferrous metal
improves, and sensitivity to nonferrous and stainless steel diminishes. For this reason, it
is always important to routinely test the detector with all three types of metal. Quartz
frequency control and automatic balance control will go a long way toward eliminating
drift and ensuring constant sensitivities.
IX. DEVELOPING A METAL CONTAMINATION CONTROL SYSTEM

Money spent reducing complaints inevitably yields a better return than money spent an-
swering them. The real value of a quality program is determined by its ability to contribute
to profits and to customer satisfaction. An argument for quality improvements is often
weak when it has to deal in generalities and opinions. It becomes more convincing and
realistic if it can quantify the costs and savings. These costs can generally be split into
three broad areas:
1. Prevention Costs. These highly cost-effective measures cover items such as
supplier capability surveys, employee education and training, and establishing
GMPs—all activities specifically designed to prevent contamination or defects.
2. Appraisal Costs. These costs, associated with testing, inspection, and ongoing
evaluation of the production process, are necessary to ensure conformance with
quality standards.
3. Failure Costs. These costs, potentially the highest by far, cover failures oc-
curring both before and after shipment of product. A metal-contaminated prod-
uct found before shipment is a failure resulting in product and packing wastage,
possible machinery damage and loss of output; if found only after shipment,
the results may be loss of customer satisfaction, product recall, adverse public-
ity, and potential lawsuits.
Prevention and appraisal costs (generally low) are incurred because poor quality
controls may exist. Failure costs (generally high) are incurred because poor quality con-
trols do exist. An integrated approach—carefully set up, rigorously followed, proactive
rather than reactive, and used to prevent contamination rather than just detect it—must
be developed and melded into the total QA program.
Responsibility for quality should include suppliers in order to ensure their standards
are equally demanding. Often contamination in the supplier’s product is more easily de-
tected before it is further processed and broken into smaller pieces.
The objective should be to have control over the whole production process—the
incoming raw materials, the environment, the processing, and the packaging. As a first
step, a Foreign Material Task Force should be formed to develop, implement, and coordi-
nate the foreign material control system. Ideally, it should include senior personnel from
production, QA, engineering, and maintenance.
The Task Force has three main responsibilities: (1) establishing and monitoring
CCPs; (2) developing GMPs; and (3) providing documentation and trend analysis.
A. Critical Control Points

Conducting a hazard analysis and establishing critical control points (HACCP) are impor-
tant first steps in taking a proactive step toward reducing contamination. A flow diagram
should be developed showing the traffic pattern of all products in each production stage,
from the incoming raw materials to the final warehousing of finished product. Depending
on the complexity and number of different processes, as many as ten separate flow dia-
grams may be required. Every point in the product flow should be considered and each
one that might create a potential hazard is identified as a CCP. After each CCP is coded,
the method and frequency of checking are determined. Control points are established not
only where metal contamination hazards are possible, but also for any other quality-related
matter.
B. Good Manufacturing Process

In addition to identifying CCPs, other potential sources of contamination, not related di-
rectly to the production process, need to be identified and procedures introduced to elimi-
nate danger. Examples follow:
1, Specifications for incoming raw materials should state that they are required to
be free from foreign body contamination and should indicate specific precau-
tions required of the supplier. Procedures would depend upon product type, such
as powdered material to be screened and passed through a detector, carcass
meat should not be labeled with metal tags, and containers should not be stapled.
2. Paper clips should not be used on documents in production areas.
3. No thumbtacks should be used on any notice board.
4. No hair clips, watches, jewelry should be allowed in production areas.
5. Protective clothing should have no outside pockets; laundered items are to be
checked for loose buttons prior to reissue.
6. Only magnetic ‘‘Band-Aid’’ wound dressings to be used by personnel (to aid
detection of lost dressings.
7. Conveyor lines carrying open containers should be covered until the containers
are closed or capped.
8. Holding containers should be covered.
9. Step bridges over production lines should have enclosed sides and should be
checked regularly.
Many other specific effective measures can be carried out relevant to particular
industries and manufacturing processes. Effective training is fundamental for all involved,
from those who design plant layout to the production-line operator—all must have a com-
mitment to the avoidance of foreign bodies. Programs should include an explanation of
the company’s QA philosophy and details of the CCPs. Documentation and reporting
procedures should be detailed and individual responsibilities for reporting potential haz-
ards such as defective machinery made clear.
Poor maintenance practices are often related to metallic contamination. Lists of rou-
tine and preventive maintenance tasks that can be performed outside normal production
hours should be drawn up and regularly updated. Other effective procedures include (1)
equipment maintenance, especially welding and drilling, should not be done when produc-
tion lines are operating; screens should be provided to prevent spread of welding slag and
swarf; (2) for major work on new installations, complete floor to roof screens should be
used; (3) magnetic mats, brushes, and vacuum cleaners should be used for cleanup and
on repaired equipment prior to returning the equipment to the production area; (4) startup

team responsibilities, with particular emphasis on CCPs, should be detailed; and (5) on
completion of any repairs or installations, a member of the QA team should inspect the
plant and surrounding area.
Implementing proper procedures and working practices can help make the ‘‘quality
philosophy’’ permeate the whole company. Appropriate channels for rapid feedback and
revision, in light of new experience, will keep the systems ‘‘live.’’ Every piece of metal
that is prevented from entering the production process represents success.
C. Documentation and Trend Analysis

The effectiveness of monitoring CCPs can be reliably determined by efficient collection
of data and by trend analysis. The importance of recording each incident of metal contami-
nation has been noted. Trend analysis of contamination type and frequency, line by line
or machine by machine, can identify specific sources of trouble such as a raw material
supplier, production staff or shift, and inadequate maintenance. Using this information
over a period of time will help determine the effectiveness of the QA program and, equally
Figure 18 Sample metal detection policy.

important, will be the first step in quantifying, in monetary terms, the savings or increased
profits generated.
Monitoring the CCPs should result in a significant reduction of contamination de-
fects in a short period of time. Two different trend charts are used: one to record the
number of pieces of metal contamination detected on a weekly basis, the other to track
the number of consumer complaints. Each incident should be investigated to determine
if the failure is a result of ineffective monitoring of the CCPs, if a new, previously unidenti-
fied CCP is responsible, or if the metal particle is smaller than the operating capability
of the metal detector.
X. WHAT TO DO IF THE TEST FAILS

A company’s metal detection policy (see Fig. 18, for example) should be defined and
publicized. In addition, whenever possible, you should require your raw material suppliers
to adopt a similar policy so they do not ship you contaminated product. Many major
corporations now make metal detection a part of their Vendor Certification Programs. If
a metal detector failure occurs, causing production to be stopped until a factory-trained
technician can schedule a service visit, the loss of output will be substantial. Alternatively,
if production continues, your metal detection program will be compromised and you can-
not be certain of producing a metal-free product.
One of the great benefits of using metal detectors that incorporate a universal, quick-
change electronic module, designed for fast and easy replacement, is that it minimizes
service costs (which may be relatively minor when compared to the cost of lost produc-
tion). But, more importantly, it avoids the temptation to run a production line unprotected,
without the benefit of a functional detector.
Outside audits of equipment, performed by certified quality auditors, are an addi-
tional service that is available to assure users that equipment is in compliance. Experienced
metal detection experts can often spot potential problem areas and suggest solutions before
they become apparent to the user.
REFERENCES
1. A Campbell. Guidelines for the prevention and control of foreign bodies in food. Guideline
No. 5. Chipping Campden, England: Campden & Chorleywood Food Research Association,
1995.
2. M Graves. X-ray machine vision for on-line quality control in food processing. Ph.D. disserta-
tion, University of Cardiff, Cardiff, Wales, 1999.
3. JG Brennan, JR Butters, ND Cowell, AEV Lilley. Food Engineering Operations, 3rd Ed. Lon-
don: Elsevier Applied Science, 1990.
4. G Riva. Principles of x-ray inspection. REC 4142, Part No. 067336. Markham, ON: Thermo
Electron Corporation, 2000 [available only from the author at Gigi.Riva@ThermoRamsey.com].
5. Y Tao, JG Ibarra. Thickness-compensated x-ray imaging detection of bone fragments in de-
boned poultry—model analysis. Trans Am Soc Agric Eng 43(2):453–459, 2000.
6. P Wallin, P Haycock. Foreign Body Prevention, Detection and Control: A Practical Approach.
London: Blackie Academic & Professional, 1998.
7. M Graves, A Smith, B Batchelor. Approaches to foreign body detection in foods. Trends Food
Sci Technol 9(1[91]): 21–27, 1998.
8. AP Lock. Metal detection. Food Proc Ind 49(1):31, 35–36, 1980.
9. A Lock. The Guide to Reducing Metal Contamination in the Food Processing Industry. Tampa,
FL: Safeline, 1996.

25
Packaging
MICHAEL A. MULLEN
U.S. Department of Agriculture, Manhattan, Kansas, U.S.A.
SHARON V. MOWERY
Kansas State University, Manhattan, Kansas, U.S.A.
I. INTRODUCTION
Today, consumers are faced with a number of challenges from the moment they enter the
grocery store. The myriad of packages are designed not only to attract and sell the products
we consume, but also to maintain the highest possible quality. Food and beverage packag-
ing is a $70 billion market in the United States and more than $200 billion worldwide
[1]. When developing a package for a food product, several factors must be considered.
The type of package, rigid or flexible, the ability of the package to maintain food quality,
cost and availability of materials, and consumer acceptance are all essential factors. Be-
cause of the abundant supply of similar products, attractive packaging that catches the
consumers’ eye and ensures them of a high quality product is essential.
Excessive packaging can result in needless expense, while cheap packaging can lead
to contamination by insects and microorganisms and consequent reduction in the quality
of the product. Other concerns must also include tamper resistance and environmental
impacts including both the manufacture and the eventual disposal of the packaging materi-
als. Convenience for the consumer is important. It does little good to use a can that is
very difficult to open when a simple plastic pouch with a zipper seal will do [2,3,4].
Many consumers have had the unfortunate experience of opening a box of crackers
or a bag of flour and discovering a thriving colony of Indianmeal moths, flour beetles, or
other insects. Even worse is the feeling one gets while eating a bowl of breakfast cereal
and finding small wriggling insects floating in the milk. This is the packaging equivalent
of finding half a worm in an apple.
Although the food processor may take all possible precautions to package an insect-
free commodity, the manufacturer may have no control over what is done with the product
during shipping and at storage facilities once the product leaves the factory. Food proces-
sors and consumers are especially sensitive to these problems and manufacturers are ex-
tremely concerned with providing the consumer with high quality products that meet their
needs. They know that if the consumer finds an insect in a cereal package, that unhappy
event can make a lasting and often irreversible negative impression, ultimately resulting
in the loss of a customer. A pet food manufacturer recently reported $1 million in losses
in one year in one product line due to insect infestation.
Many companies have implemented package-testing programs to improve insect
resistance of packages to insect attack [5]. Insect-resistant packaging is the only way to
prevent insect infestation without using insecticides or repellents [6]. Improved packages
both reduce direct losses and preserve company image, because consumers usually hold
the manufacturer responsible for the insect infestation, regardless of where or how the
package became infested [7].
Insect infestation is mainly the result of transportation-related problems or prolonged
storage under less-than-optimal conditions in a warehouse or on a grocer’s shelf. Not only
are the packaged commodities value-added because they have gone through the expense of
growing, harvesting, processing, packaging, storing, and transporting, they also represent
goodwill and, ultimately, profits [8]. Since 1990, pet food manufacturers have shown that
insect-related losses in their products have declined with the use of insect-resistant pack-
aging.
Packages are designed to protect food products from the point of manufacture to
the point at which they are finally consumed. This process often means packages will have
to provide protection for up to several years. Unfortunately, there is no perfect package that
will provide the protection needed for all products under all conditions. Packages are
usually tailored to fit the product being protected. The value of the product, length of time
it must be protected, the economics of delivering a high quality product to the consumer,
and other factors must be considered when designing and developing insect-resistant pack-
aging.
II. HISTORY OF FOOD PACKAGING

The earliest accounts of humans utilizing materials to contain food date back to about
10,000 BCE. These containers were usually made from natural materials such as gourds,
leaves, shells, and human skulls [9]. Ancient man also used the bladders and skins of
animals to contain food. Humans began to use pottery around 6000 BCE. This method
of food containment allowed for the shipment of food throughout the then civilized world.
By 3000 BCE, glass containers had come into use and the mass production of these was
introduced in Rome around 14 CE.
The first documented use of paper was in the 1500s; paperboard boxes, paper bags,
and tinplate cans were developed in the early 1800s. Later forms of packaging included
glass, leather bags, wooden barrels, and metals. The onset of the industrial revolution in
1750 led to the development of simple machines that produced mass quantities of food
products, resulting in a greater need for packaging.
Population movement from rural areas to cities meant that fewer people lived on
farms. As individual storage space for food products decreased, foods were stored in

smaller quantities and it became necessary to purchase foods more frequently. To reduce
spoilage it became increasingly important that food products be maintained in a safe,
healthy, and sanitary fashion.
Tin cans allowed for the preservation of perishable foods; their introduction was an
important step in maintaining a reliable food supply. In 1921, aluminum foil showed great
potential in the form of the first foil-laminated paperboard folding carton. The National
Biscuit Company was the first to use paperboard for packaging [9]. In France in 1936,
rubber hydrochloride (Pliofilm) was used to pack perishable foods [9].
By the end of the 1930s, the Simplex bag machine, manufactured by the FMC Cor-
poration, was producing cellophane bags used for the packaging of many foods. Following
this lead, plastic packaging materials took hold and were developed throughout the 1970s
and 1980s in the form of polyethylene terephthalate (polyester) (PET) bottles, barrier
plastic bottles/sheets, and aseptic packages, to name just a few [9]. Plastics and other
innovative packaging materials led the way into the 1990s and are still being developed
to prevent food spoilage, enhance food storability, and prevent insect infestation.
III. BIOLOGY AND HABITS OF STORED PRODUCT INSECTS

Most stored product insect pests are cosmopolitan. They have become established across
the world over the years by way of international trade [10]. In their attempts to survive
many of the species of stored product insects will infest packaged foods where they have
an ample supply of nourishment for their offspring and where they are protected from
chemicals that may be used to kill them. Because of distribution practices contaminated
products can often be moved from one geographical location to another. In local ware-
houses and retail stores, infestations can be spread from package to package. While food
products can become infested at any point in the marketing channel, they are most likely
to become infested during extended storage periods. Some products are more susceptible
to insect infestation than others. These products can serve as insect reservoirs, leading to
the infestation of other products [7]. Dry pet foods are often the source of infestation.
Most pet foods are packed in multiwall paper bags that are generally not very insect
resistant because they lack adequate seals and closures. Food may also become infested
during shipment in trucks, railcars, and ships, as well as during storage at the retail level.
Infestation also occurs in the home pantry, but with the increased use of resealable pack-
ages these losses have been reduced.
A. How Insects Enter Packages

To begin a discussion of insect-resistant packaging, it is important to understand the insect
pests that most commonly attack packaged foods. Highland [7,11] separated package pests
into two categories, penetrators and invaders (Table 1).
Invaders are insects that typically have weakly developed mouthparts at both the
larval and adult stages [12]. The invaders account for more than 75% of the infestations
encountered [13]. Invaders commonly enter packages through openings resulting from
mechanical damage, defective seals, or holes made by other insects penetrating the pack-
age [6]. The newly hatched larvae of invaders typically cause the most damage because
they are able to fit through holes as small as 0.1 mm wide [12].

Table 1 Classification of Pests that Commonly Infest Packaged Food
Penetrators Invaders
Red flour beetle, Tribolium castaneum Red flour beetle, T. castaneum
Confused flour beetle, Tribolium confusum Confused flour beetle, T. confusum
Warehouse beetle, Trogoderma variabile Merchant grain beetle, Oryzaephilus mercator
Rice weevil, Sitophilus oryzae Sawtoothed grain beetle, O. surinamensis
Almond moth larvae, Cadra cautella Almond moth larvae, C. cautella
Indianmeal moth larvae, Plodia interpunctella Indianmeal moth larvae, P. interpunctella
Lesser grain borer, Rhyzopertha dominica Squarenecked grain beetle, Cathartus quadri-
Cadelle, Tenebroides mauritanicus collis
Drugstore beetle, Stegobium paniceum Flat grain beetle, Cryptolestes pusillus
Rice moth larvae, Corcyra cephalonica
Typical insect penetration into food packaging materials [6,14] is illustrated in Fig.
1. Most infestations are the result of invasion through seams and closures—rarely through
penetrations [8]. For example, adult sawtoothed grain beetles have been shown to enter
packaging through openings less than 1 mm in diameter; adult red flour beetles can enter
holes in packaging that are less than 1.35 mm in diameter [7]. Many insects prefer to lay
eggs in tight spaces such as those formed when multiwall paper bags or paperboard cartons
are folded to create closures. These refugia provide a safe place to lay eggs and also give
the newly hatched larvae an ideal location to invade the packages.
1. Penetrators
Insects classified as penetrators are those that can chew holes directly into packaging
materials. Penetrators are more effective in the larval stage; however, some adult beetles
can effect penetration [11].
Insects such as the lesser grain borer, Rhyzopertha dominica (Fab.), the cigarette
beetle, Lasioderma serricorne (Fab.), the warehouse beetle, Trogoderma variabile Ballion,
the rice weevil, Sitophilus oryzae (L.), the cadelle, Tenebroides mauritanicus (L.), and
the larvae of the rice moth, Corcyra cephalonica (Stainton), are known to be good package
penetrators and are capable of boring through one or more layers of flexible packaging
materials.
Larvae of the Indianmeal moth, Plodia interpunctella (Hübner), under some condi-
tions are also good penetrators and may be the most serious pests of packaged foods [6,11].
The warehouse beetle is more specialized in the food products it infests and is often
found in packages of dry pet food and dry pastas. It may create an additional problem to
the consumer because the cast skins of the larvae can cause allergic reactions [15].
The drugstore beetle, Stegobium paniceum (L.), is an able penetrator, infesting a
wide variety of foods [16].
2. Invaders
Other species, classified as invaders, enter packages through existing openings. Some com-
mon invaders include the sawtoothed grain beetle, Oryzaephilus surinamensis (L.), the
red flour beetle, Tribolium castaneum (Herbst), the confused flour beetle, T. confusum

Figure 1 Diagrammatic representation of insect penetration into food packaging. F shows scratch
marks (made by mandibular action) surrounding a tiny hole through which penetration into the
package was achieved. (From Ref. 15.)
Jacquelin du Val, and the flat grain beetle, Cryptolestes pusillus (Schoenherr) [6]. The
most important invaders are larvae of the genus Tribolium (flour beetles), the genus Ory-
zaephilus (grain beetles), and freshly hatched moth larvae [11], especially Indianmeal
moth larvae.
The classifications of invaders and penetrators are regularly used to describe packag-
ing pests, but these classifications are in fact artificial; some invaders can become penetra-
tors under certain circumstances and vice versa. Although classified as invaders, larvae of
the Indianmeal moth and the almond moth, Cadra cautella (Walker) (also called Ephestia
cautella), can penetrate packages given the right conditions [5].
Both penetrators and invaders will exploit package flaws or other existing openings
in order to reach a food product, and some invaders can chew directly into weak packaging
materials such as paper and cellophane.
Considering that insect infestation of stored food products is of such importance to
the industry, disproportionately little has been done to describe the behaviors and mecha-
nisms by which insects invade packaged goods. Although it is generally thought invaders
enter packages through existing openings, little information is available to support this
belief.

B. Mechanisms of Entry
Aside from adult stored-product moths, which do not feed, most stored-product insect
adults and larvae feed in order to sustain themselves. When faced with consumer food
packages, both invaders and penetrators will take advantage of any sort of opening in a
packaging material in order to gain entry [17]. These openings may form as a result of
the chewing of penetrators, mechanical damage (rips, tears, punctures) resulting from nor-
mal wear and tear throughout the handling process, or defective seals in the packaging.
C. Odor Escape Through Openings

Olfaction is the means by which stored-product insects identify packaged consumer food
products as a location in which to carry out important life functions such as fulfillment
of nutritional demands, mate-finding, and places for oviposition. When an insect ‘‘smells’’
food, it will try to reach it. Barrer and Jay [18] determined that the odor of kibbled wheat,
when diffused into a 10-m 3 cage through ten 1-mm diameter holes, strongly attracted
gravid, free-flying Cadra cautella (Walker) females that were seeking oviposition sites.
When C. cautella females cannot gain direct access to the grain, it is believed they will
oviposit in the immediate vicinity of the opening through which the food odor is escaping,
possibly to allow some larvae access to the grain upon hatching [18].
Mated female sawtoothed grain beetles have been shown to have a more rapid re-
sponse to the odor of carob distillate than virgin females. It has been speculated that the
more rapid response of these female beetles to food odor is somehow related to the process
of egg production [19].
The age of an insect has an effect on response to food odor. White [19] determined
that 2-day-old adult sawtoothed grain beetles showed a significant preference for the odor
of carob distillate; the response increased with age up to 16–20 days. However, Honda
et al. [20] showed that newly emerged adult Sitophilus zeamais less than 10 days old are
more sensitive to attractants from rice than are older weevils.
IV. PACKAGE TYPES

A. Package Design
Most nonperishable food items are shipped in consumer-sized packages and most of these,
with the exception of canned food, are susceptible to insect attack [21]. Seals and closures
can often be improved by changing glue patterns or the type of glue used. Generally, a
glue pattern that forms a complete seal with no channels for the insect to crawl through
is the most insect resistant. Sharp folds and buckles should be avoided because they
weaken the material and provide easier access by pest insects [12].
Insect resistance can also be improved by overwrapping the packages with materials
such as oriented polypropylene films [5]. For maximal effectiveness, overwraps should
fit tightly around the package. If overwraps are not completely sealed, insects often can
gain entry at the corners of folded flaps. However, if the overwrap is sealed tightly, the
movement of insects will be restricted, thus reducing the chances of infestation. Since it
is impossible to prevent all vulnerable spots, it is important to be alert to the problems
incomplete seals can cause.
Another means of discouraging insect infestation is through the use of odor barriers
[21]. Food odors may be prevented from escaping the package through the use of barrier
materials, resulting in a package that is ‘‘invisible’’ to invading insects. Flexible packag-
ing, incorporating acrylic, polyvinylidene chloride (PVdC), or ethylene vinyl alcohol
(EVOH), can improve odor retention [9]. These materials have been used with some suc-
cess. However, any flaw in the package will negate the odor-proof qualities of the package
[6]. Mullen [8] showed that when odor barriers were used to protect a commodity, only
those packages with flaws became infested.
B. Packaging Materials
Food products are packaged in a wide variety of paper and plastic materials. New materi-
als, constantly being added to the list, are far too numerous to discuss in detail in this
forum. Paper is still one of the most widely used products and is certainly one of the most
easily penetrated materials. Paper is often used with foil and polyethylene to form
multiwall packages. This type of packaging, often found in pet food bags, provides excel-
lent strength, serves as a moisture barrier, and can be grease proof. It provides little protec-
tion from insect penetration because of the difficulty in making an adequate seal.
Bags with a heat sealable inner layer can be sealed, but the outer plies must be
folded and glued. The sealed end flaps of these packages provide insects with dark, pro-
tected areas in which eggs can be deposited. Newly hatched larvae seldom have trouble
entering the package through existing openings in commercially sealed packages—80%
of such packages have leaks. Odors escaping through these minute openings attract pests
to the vicinity of the perforations. These holes are often sufficiently large in diameter to
permit entry of the first instar larvae of most stored-product insects.
A well-sealed, airtight package can create additional problems. Changes in air pres-
sure or temperature can cause swelling or shrinking of the package [12]. One technique
to prevent this is to build in small ventilation holes that allow the pressure to equalize.
Invading insects can access the package through these minute holes. This problem can
be avoided by creating a torturous path for the insects to follow. One of the simplest ways
to accomplish this is to build in a double heat seal with vents at opposite ends of each
seal. This method has been shown to allow for pressure equalization while limiting insect
invasion.
Cellophane is one of the oldest plastic films to be commercialized. The desirable
physical characteristics of cellophane include transparency, clarity, and heat sealability.
Many of these attributes were lacking until nitrocellulose was developed in 1927 [9].
Studies on cellophane-wrapped packages conducted at the U.S. Grain Marketing and Prod-
uct Research Center (GMPRC) have shown that both dry cat food and raisins packaged
in cellophane were very susceptible to penetration by a variety of stored-product insects
including the Indianmeal moth, the warehouse beetle, and the cigarette beetle.
Paper and cellophane are probably the least resistant to insect penetration of all the
flexible packaging materials in use today. Depending on environmental conditions, some
insect species can penetrate kraft paper in less than 1 day [11]. Adding multiply construc-
tion adds little to the resistance.
Polyester (PET), first developed in 1941, has good resistance to insect penetration,
but its use in packaging has been limited because of high cost, less coverage per pound
of material, and limited shrink properties [22,23]. In recent years there has been a dramatic
increase in the use of PET and metalized PET in flexible packaging. Polyvinylidene chlo-
ride is a good odor barrier, but used alone can be breached by invading insects. However,
laminates containing PET and PVdC provide very good protection against insect penetra-
tion when the PET side is exposed to insects [24]. These materials are commonly used
to protect refrigerated or frozen food.
The tough, 10-mil polyethylene wrapper around meals ready to eat (MREs), a pack-
aged food dispensed to military personnel, is generally resistant to penetration. However,
under extremely crowded conditions, T. castaneum adults have been known to penetrate
these packages. Even laminates can be susceptible to insect attack.
Plastic has several advantages over paper for packaging. For example, it can ensure
to a much greater extent than paper that the contained materials will remain in their original
condition. Plastic packages can be colorful, attractive, and made into different sizes and
shapes. Work done at the GMPRC has shown that many plastic materials resist infestation
by most stored-product pests.
The materials available include low density polyethylene (LDPE), ethylene vinyl
acetate (EVA), high density polyethylene (HDPE), linear low density polyethylene
(LLDP), ultra low density polyethylene (ULDPE), ethylene acrylic acid copolymers
(EAAC), polyolefin plastomers (PP), and enhanced polyethylene resins (EPER) [2–4].
Each has unique characteristics and uses.
Because of its high clarity and ability to be extruded, LDPE is used as a coating
for paper/paperboard and bread bags and in applications where strength is not essential.
Similar to LDPE, EVA is used in applications such as ice bags and wrappings for
fresh produce, cereal, cheese, and crackers.
Being both an excellent barrier to moisture and stiffer than other PEs, HDPE works
well as bags for cereals, crackers, cake mixes, and dry foods. It can also be used for
thermoformed trays and blow-molded applications such as milk jugs.
Linear low density polyethylene is often used as a frozen food film and in bag-in-
box applications; ULDPE has excellent tear and puncture resistance and is often used in
poultry packaging, bag-in-box applications and fresh cut produce.
Ethylene acrylic acid copolymers adhere well to other substrates like foil, nylon,
and polyethylene. It is often used as packaging for snack foods and processed luncheon
meats. With its excellent sealing properties and toughness, PP is used for fresh cut produce,
cheese, meats, and cereals.
Enhanced polyethylene resins [3,4] is similar to polyethylene, but has high stiffness
and good impact strength. It is used as a freezer film, bag-in-box, cook-in meat packaging,
and for cereals and crackers.
Recently, stand-up plastic pouches have become popular and have been shown to
be very resistant to insect penetration. Studies by Cline and Highland [25] showed that
insect survival in airtight plastic pouches was reduced and that no insects survived in
unpenetrated packages after 12 weeks.
V. PROTOCOL FOR DETERMINING

INSECT-RESISTANT PACKAGING
Studies of noninsecticidal methods of insect-proofing packages, conducted at the GMPRC,
were designed to maximize infestation pressure. These simple procedures have been highly
effective in developing and improving packaging methods for better insect resistance. In
a typical test, different types of commercially prepared packages are exposed to five spe-
cies of insects consisting of the red flour beetle, the sawtoothed grain beetle, the Indian-
meal moth, the cigarette beetle, and the warehouse beetle. These species represent a good
cross-section of both penetrators and invaders and are representative of the most common
insect pests associated with packaged foods.
The packages are placed in an environmentally controlled (27 ⫾ 2°C, 50 ⫾ 5%
RH) chamber measuring 3 ⫻ 9 ⫻ 2.5 m (40 m 3 ) in size. Approximately 1000 specimens
of each of four kinds of beetles (red flour beetle, cigarette beetle, sawtoothed grain beetle,
and warehouse beetle) and 300 adult Indianmeal moths are added to each test chamber.
Eight to ten individual packages of each type are used for each sample period (break-
down). Breakdowns are made biweekly or monthly depending on the commodity and its
potential for infestation. Tests are run for approximately 3 months. This is generally the
maximal amount of time most packages will resist the infestation pressure by these large
numbers of insects.
At the end of each exposure period, the packages are carefully checked for obvious
signs of infestation, which are recorded if present. Signs include penetration holes (entry or
exit) and obvious flaws in the seams and closures. After the packages have been externally
examined, they are opened and the commodity inside the package is examined for insect
infestation. Insects of each species are identified, counted, and the numbers recorded.
After each test, a report is prepared and suggestions are made to improve the packages.
Manufacturers use this information to improve the performance of future package designs.
Packaging studies have been conducted on a variety of commodities in cooperation
with a number of food manufacturers. Dry pet foods, breakfast cereals, baby foods, rice
products, military rations, and raisins are some of the products that have been included
in these package-improvement studies. The results are generally positive; one company
reported a 40% reduction in complaints due to insect-related problems.
VI. REPELLENT TREATMENTS

Repellents, as the word implies, have the characteristic of repelling insect entry or move-
ment across a treated surface. The technique of using of repellent coatings on packages
to prevent insect infestation is in need of much more research. In 1978, Highland [23] listed
the development of repellent treatments as a priority topic needing additional research.
Through the years, many repellent formulations have been tried but with little if
any success. Studies conducted by the senior author included natural and synthetic com-
pounds such as Neem oil, methyl salicylate, DEET derivatives, and insect growth regula-
tors. Many of these compounds were effective in laboratory choice tests. However, food
odors from the packages either greatly reduced or completely eliminated the effectiveness
of the repellent treatment.
Another problem is the migration of the repellent compound through the packaging
material. Recently, methyl salicylate received approval by both the Environmental Protec-
tion Agency and Food and Drug Administration as a package treatment. This is especially
significant because it represents the first such approval and should make it easier for other
materials to be approved.
VII. SUMMARY
The pursuit of new developments in insect-resistant packaging is becoming increasingly
important to both consumers and manufacturers for two reasons: (1) demanding production
schedules sometimes outpace the sanitation chores needed to protect the processing plant
from insect infestation and (2) more stringent restrictions on pesticide use in food pro-
cessing facilities makes successful pest management more problematic.
When food products are packaged using insect-resistant techniques, the consumer
is assured of insect-free food and the manufacturer is protected against both lawsuits aris-
ing from insect infestations in consumer-sized packaging and loss of consumer good will.
Future research in this area will lead to the development of more effective packaging
methods to ensure that packaged foods remain insect free until consumed.
REFERENCES
1. SL Wilkinson. In defense of food. Chem Eng News 76(24):26–32, 1998.
2. LK Kindle. Packaging . . . bending to meet a changing society. Food Processing 61(1):63–
65, 2001.
3. JH Briston, LL Katan. Plastics Films. London: J. H. Briston and the Plastics and Rubber
Institute, 1983.
4. RC Griffin, S Sacharow. Principles of Package Development. Westport, CT: AVI Publishing,
1972.
5. MA Mullen, SV Mowery. Insect-resistant packaging. Int Food Hygiene 11(6):13–14,
2000.
6. MA Mullen, HA Highland. Package defects and their effect on insect infestation of instant
dry non-fat milk. J Packaging Technol 2:266–267, 1988.
7. HA Highland. Insect infestation of packages. In: FJ Baur, ed. Insect Management for Food
Storage and Processing. St. Paul, MN: American Association of Cereal Chemists, 1984, pp
309–320.
8. MA Mullen. Keeping bugs at bay. Feed Management 48(3):29–33, 1997.
9. S Sacharow, AL Brody. Packaging: An Introduction. Duluth, MN: Harcourt Brace Jovanovich,
1987.
10. HA Highland. Chemical treatments and construction features used for insect resistance. Pack-
age Devel Syst 7(3):36–38, 1977.
11. R Wohlgemuth. Protection of stored foodstuffs against insect infestation by packaging. Chem
Ind 10:330–334, 1979.
12. LD Collins. How food packaging affects insect invasion. Pest Control 31(10):26–29, 1963.
13. PM Brickey Jr, JS Gecan, A Rothschild. Method for determining direction of insect boring
through food packaging materials. J Assoc Off Anal Chem 56(3):640–642, 1973.
14. HA Highland. Protecting packages against insects. In: JR Gorham, ed. Ecology and Manage-
ment of Food-Industry Pests. Arlington, VA: Association of Official Analytical Chemists,
1991, pp 345–350.
extraneous materials. V. Strategy for evaluating hazardous and nonhazardous filth. Reg Tox-
icol Pharmacol 33:363–392, 2001.
16. DK Mueller. Stored Product Protection—A Period of Transition. Indianapolis: Insects Lim-
ited, 1998, pp 207–212.
17. LD Cline, HA Highland. Minimum size of holes allowing passage of adults of stored-product
Coleoptera. J Georgia Entomol Soc 16(4):525–531, 1981.
18. PM Barrer, EG Jay. Laboratory observations on the ability of Ephestia cautella (Walker)
(Lepidoptera: Physitidae) to locate and to oviposit in response to a source of grain odour. J
Stored Products Res 16:1–7, 1980.
19. PR White. Factors affecting the antennal and behavioural responses of the sawtoothed grain
beetle, Oryzaephilus surinamensis, to food odour and aggregation pheromone. Physiol Ento-
mol 14:349–359, 1989.
20. HL Honda, I Yamamoto, R Yamamoto. Attractant for rice weevil, Sitophilus zeamais (Coleop-

tera: Rhynchophoridae), from rice grains. I. Bioassay method for the attractancy of rice grains
to rice weevils. Appl Entomol Zool 4:23–31, 1969.
21. MA Mullen. Rapid determination of the effectiveness of insect resistant packaging. J Stored
Products Res 30:95–97, 1994.
22. S Sacharow, RC Griffin Jr. Basic Guide to Plastics in Packaging. Boston: Cahner Books, 1973.
23. HA Highland. Insect resistance of food packaging—a review. J Food Processing Preservation
2:123–130, 1978.
24. KM Rao, SA Jacob, MS Mohan. Resistance of flexible packaging materials to some important
pests of stored products. Indian J Entomol 34(2):94–101, 1972.
25. LD Cline, HA Highland. Survival of four species of stored-product insects in airtight laminated
food pouches. J Econom Entomol 71(1):66–68.

26
Beverage Plant Sanitation and
HACCP
HENRY C. CARSBERG
Henry C. Carsberg & Associates, Anacortes, Washington, U.S.A.
I. INTRODUCTION
Sanitation is a vital ingredient in the area of food safety [1]. Some have viewed a sanitation
program as a ‘‘necessary evil’’ when in reality a successful sanitation program is the
number one reason for product success. Whenever a processor takes a chance (and at the
same time likely violates the Federal Food, Drug, and Cosmetic Act) and allows a product
to be packed or processed under unsanitary conditions, product degradation may be ex-
pected.
Good sanitation starts at the top, with upper management’s attitude about sanita-
tion—its value and importance to the product they intend to produce. It is never easy to
explain the cost of a large recall or the enormous legal costs and bad publicity that comes
with a recall. If a processor is lacking the expertise to develop a professional sanitation
program, management should consider having a knowledgeable consultant come in to
devise a program that meets the processor’s specific needs.
There are so many things to consider—from the clean-in-place (CIP) system to
restrooms, floors, drains, outside areas, and pest elimination—that nothing short of a de-
tailed and fully implemented sanitation program will meet the need. Proper training of
personnel is of critical importance, untrained personnel can cause even the best program
to fail. Personnel need to be trained in all aspects of food safety and sanitation, utilizing
both workshops and ongoing on-the-job training. All employees must develop proper work
and personal habits while working in a beverage environment. Good housekeeping is of
major importance to reduce pests and to help prevent any possibility of foreign material
entering the product.

Nothing can be left to chance. Every new hire must be made aware of the Food
and Drug Administration (FDA) good manufacturing practices (GMPs). The GMPs are
the basic rules of the processing environment, rules that personnel must follow and rules
that management must follow up on. Management should institute an ongoing program
to review the GMPs.
II. BASIC CLEANING SEQUENCE

This basic cleaning sequence is used for everything other than the CIP system.
A. Prerinse
Prerinse all equipment and areas. Work from the top of equipment down to the floor. This
will remove the larger, less firmly attached particles and some of the bacteria.
B. Apply Cleaning Product

The next step is to apply cleaning product. The cleaning agent used should be based upon
The type of soil (residues from food manufacturing processes)
The surface to be cleaned
The degree of agitation required
The environment—where the waste products are going
The temperature at which the product was processed
The time allowed for sanitation
The use cost of the product
The concentration of the cleaning chemical
The method used for applying and removing the cleaning product
C. Hand Detail and Inspect

There are no short cuts in a sanitation system. Some hand detailing will be required. There
are no magic formulas that can eliminate organic challenge without some handwork. Also,
while hand detailing, personnel are better able to inspect the surfaces to be sure they are
clean.
D. Postrinse
Postrinse comes next. This step is of utmost importance because the cleaning chemicals,
the organic challenge (the ingredient residues, called soils, that stick to food-contact sur-
faces must be cleaned off ), and some bacteria are all being removed.
Since sanitizers range in pH from 3.2 to 7, any high-pH cleaning product (with a
pH of 12 to 13, for example) unless totally rinsed away will diminish the efficacy of the
sanitizer. In short, a high pH cleaner brings up the low pH of the sanitizer, causing it to
lose its effectiveness. If the cleaning agent is not thoroughly washed away, the result may
be a poor kill rate of bacteria and mold.
E. Apply Sanitizer
The next steep is the application of the sanitizer. Sanitizers can be quaternary compounds
with or without acid, acid-anionic sanitizers, iodophors, chlorine, chlorine dioxide, para-
cetic acid, and others. When using one of the quaternary sanitizers, it is recommended
that you alternate it with an oxidizer type of sanitizer such as an iodophor or an acid-
anionic sanitizer to prevent the bacteria from becoming resistant to the quaternary product.
One important fact to remember is that all sanitizers are classified as pesticides and must
be approved by the Environmental Protection Agency (EPA). Therefore, all sanitizers
must be used in conformance to the label directions.
III. SOFT DRINKS AND BEER

Soft drinks and beer are on the acidic side of the pH scale. While pathogenic microorgan-
isms do not pose a major food safety problem in this industry, they can cause quality
problems by producing off-color and off-tastes. Soft drinks, with their phosphoric acid
content, and beer, with its low pH, are among the safest beverages to consume.
From the standpoint of taste and eye appeal, there are microorganisms that can cause
an off-taste or turbidity. The undesirable taste can range from sour to oversweet to a sulfur
type flavor. The primary sanitation concerns for beer and soft drinks focus on the following
factors.
A. Water Supply
Water supply is critical due to the possibility of contamination by foreign materials such
as silt, sand, or clay if the source is from a well. There are many types of filtration systems
that may be employed to prevent soil residues from entering the system in the event that
a well is used as the water source. Sometimes even municipal water treatment plants
inadvertently propel sand particles into the distribution system, thus water being supplied
by a modern treatment plant does not necessarily guarantee freedom from unwanted for-
eign matter.
Other water supply considerations include the mineral content of the water, the im-
pact of chlorinated water on taste or color, and the potential for contamination by patho-
genic bacterial and parasites. Nothing regarding water supply should be taken for granted.
Water is, after all, the main ingredient of soft drinks and beer.
B. Containers
Cans, bottles, jugs, and other containers can also be a source of contamination by the
presence of foreign objects such as wood, metal shavings, and other materials. Product
containers (i.e., empty containers being fed into the filler line) must be checked according
to a standard sampling plan. Single-use containers are rinsed with water immediately be-
fore being refilled with product, this additional preventive measure provides the consumer
with an extra measure of protection.
In the case of returnable containers such as bottles and kegs, the cleaning agents
used to prepare these containers for reuse must be thoroughly rinsed away and the efficacy
of the cleaning and rinsing procedures should be checked by standard analytical methods.
C. Bottle Filler
Bottling equipment can cause glass bottles to break, thus creating a potentially serious
hazard. Broken glass sometimes falls into product containers when the bottles get stuck
on approach to the filler but the conveyor keeps on moving, smashing the bottles against
each other.
D. Ingredients and Raw Materials

Raw ingredients must be inspected for foreign matter and analyzed according to standard
sampling and analytical procedures. In the case of facilities that process grain, a rodent
and insect prevention and elimination program should be in force.
Since ingredients can come from so many different sources, letters of compliance
from suppliers stating that they process under a hazard analysis critical control point
(HACCP) system, as well as audits of suppliers’ facilities, may well be reasonably required
by processors. The fact that there have been many instances of foreign objects and micro-
bial contamination having been found in both raw ingredients and in finished product is
testimony to the need for constant vigilance by quality control and sanitation personnel,
indeed by all employees.
IV. JUICE
Juices are in a category by themselves. In those instances (becoming less common as
time passes) where juice is marketed without pasteurization, the danger from foodborne
pathogen is much greater than in the case of pasteurized juices. In the case of unpasteurized
juice, the fruit must be washed with a cleaning agent of neutral or near neutral pH and
then rinsed thoroughly to eliminate any dirt and bacteria from the skin prior to crushing.
The kinds of sanitation procedures used in wine making are also applicable to the pressing
of fruit juice (see Section VI).
For sanitizing the skin of the fruit, chlorine dioxide can be used. Chlorine dioxide,
used in a low (parts per million) concentration, will eliminate 99% of the surface bacteria.
It is also effective if dirt or organic challenge is involved. Hazards can become especially
serious when fruit is picked up from the ground and then squeezed or crushed into juice.
Escherichia coli, Salmonella spp, Listeria monocytogenes, and other pathogens that occur
in the earth underneath fruit trees often contaminate the skin of apples or other fruits. If
the fruits are not washed, rinsed, and sanitized, these pathogens become incorporated into
the product. Even when the juice is subsequently pasteurized, some bacteria such as certain
spore-forming bacilli are able to survive and may eventually cause problems for the con-
sumer.
V. BREWERY SANITATION
The low pH of beer restricts pathogen activity and imposes limitations on an array of
spoilage microbes. Bacteria of greatest significance in this environment are non–spore
formers [2]. Spore-forming bacteria such as Clostridium spp. may be involved in the spoil-
age of brewery by-products such as spent grain.
The non–spore-forming bacteria found in breweries may contribute to a wide variety
of problems in the wort (unfermented infusion of malt), including pH elevation, acidifica-
tion, acetification, subsequent incomplete fermentation, and ropiness [3]. Microbial con-
tamination of this sort may also be directly or indirectly responsible for various off-odors
and biological hazes in finished beer [2].
In order to control these kinds of bacterial contamination, a complete sanitation
program is required, one that also includes such environmental factors as the HVAC sys-
tem and the immediate environs of the processing plant. Preventing contamination is at
least as important as cleaning up contaminated surfaces and raw materials.
Heat pasteurization, a very common method of preventing microbial contamination,
is used not just in the beverage industry, but also with milk and other dairy products.
When using a heat pasteurization method, time and temperature charts must be kept and
retained on file, and the pasteurizer must be checked and tested on a regular timetable.
The pasteurizer and the associated piping are cleaned using a CIP system.
A. Cold Pasteurization
The application of sanitizing chemicals could be termed ‘‘cold pasteurization.’’ The inven-
tory of sanitizing agents often changes as new products and new formulations are devel-
oped by the manufacturers. The safety and efficacy of each new product or new formula-
tion is subject to review by EPA.
The bacterial count of pitching yeast (yeast added to wort) may be reduced by treat-
ment with diluted acids such as phosphoric, sulfuric, and tartaric. However, these acid
treatments, while effectively reducing unwanted bacterial flora, may adversely affect the
yeast cultures to such an extent that retarded fermentations occur in the first few cycles
after treatment.
B. Beer Pasteurization
The majority of brewers utilize pasteurization to achieve a stable product, especially with
respect to flavor and smoothness. Overheating during pasteurization, however, can have
an adverse effect on flavor and can cause haze. It is essential to strictly adhere to the
precise time and temperature parameters for effective microbial destruction [3].
Some breweries have adopted sterile filtration as a substitute for pasteurization. To
reduce the risk of the bacteria breaching the filter barriers, the filters should be replaced
every 2 weeks.
Ceiling mounted cooling units are commonly used to cool the product. Suspended
under each cooling unit is a pan that catches condensate and conveys it to a floor drain.
These pans must be cleaned on a scheduled basis in order to prevent the proliferation of
Legionella and other dangerous or deleterious microbes in the condensate. These microbes
are subject to being transported on air currents to all areas of the plant.
A regular cleaning and sanitizing cycle must be put into force. One preventive mea-
sure that can be taken is to place iodine tablets (West Argo, Kansas City, MO) in the drip
pan to suppress bacteria growth.
VI. WINE PRODUCTION

To produce a quality product, it is essential to remove all the soils that affect the taste,
appearance, and shelf-life of wine. The reddish tartrate deposits that accumulate on tank
interiors as a result of fermentation are among the more common kinds of soils. These
and other tenacious soils must be cleaned from the surfaces of the processing equipment
throughout the winery in order to suppress unwanted microbial growth [2].
One important and sometimes overlooked item to keep in mind is that farm imple-
ments and other tools used in the maintenance of the winery must be kept separate and
far removed from the crusher and other wine-making equipment.
The water used in a winery must have specific chemical and microbial properties
[3]. A low pH is inimical to steel and other surfaces, and a high pH favors calcium precipi-
tation. The biological oxygen demand (BOD) should be less than 3 mg/L. Since water
can be a potential carrier of molds, yeasts, and acetic or lactic acid bacteria, only water
that is free of these and other contaminants should be used [2].
All areas of the winery must be cleaned, this includes but is not limited to the
bottling area; barrels; tanks; cooperage; all equipment including destemers, crushers, and
conveyors; and floors, walls, and ceilings. Wine is very susceptible to contamination by
and deterioration due to spoilage bacteria [4]. Even though wine is on the lower end
of the pH scale, some kinds of bacteria are still capable of deleteriously affecting the
beverage.
A. Pomace Disposal
It is essential to dispose of the pomace as rapidly as possible after pressing. It must not
be allowed to stand in or near the fermentation room since it rapidly acetifies. Fruit flies
(Drosophilidae) breeding in the pomace may then carry acetic acid bacteria to clean fer-
menting vats. Pomace should either be further processed (to render it innocuous) or scat-
tered as a thin layer on fields where it dries quickly and does not become a suitable
breeding medium for fruit flies [2].
VII. PEST MANAGEMENT

Rodents and flies and other insects must be controlled in order to prevent microbial con-
tamination, spoilage, and foodborne diseases. The most effective strategy for pest control
is to retain a qualified pest management professional (PMP). In order to effectively back
up and support the PMP’s advice, the sanitation staff must become very familiar with the
various methods available for pest control. A licensed professional, along with a trained
staff, can be very effective against pests in the processing environment.
VIII. SANITATION EQUIPMENT

The selection of appropriate sanitation equipment and its proper use are prerequisites to
a thorough and economical method of cleaning and sanitizing. With good equipment and
trained personnel on hand, accurate dilution rates of chemical products can be achieved
and labor costs can be reduced. Given here are some examples of sanitation equipment.
A. Foam Tanks
A foam tank is like a giant aerosol can. The system is powered by compressed air. The tank,
fashioned of stainless steel, is filled with water, the appropriate chemical added, the lid
secured, and the air hose connected. When the application wand is set to the ‘‘on’’ position,
the cleaning agent is released as a foam. Sanitizers in foam formulation tend to cling longer
to the target surfaces, thus prolonging the cleaning action, than do simple water-based
formulations that quickly run off the target surfaces. (Lafferty Equip., Little Rock, AR.)
B. Central Foam System

In this centralized arrangement, the foam and sanitizer units are attached to a wall or to
a building support column. The chemicals and pumps are located in a separate room,
locked for security. From this central location, the cleaning and sanitizing products are
pumped to the various stations throughout the plant. Under this system, the operator can
precisely control the dilution rates of the cleaners and sanitizers.
In these cases where a centralized system cannot be used, independent foam-sanitizer
stations can be set up and provided with the necessary air and water connections. When
it is time for the cleaning cycle to begin, operators fill the individual stations with the
diluted chemicals brought out from a central mixing area. (Lafferty Equip., Little Rock, AR.)
C. Hose End Foamers

Hose end foamers, driven by water pressure from a hose, can be employed effectively.
The correct dilution of the concentrated cleaner/sanitizer is effected as the water passes
through the hose end attachment.
D. High-Pressure Systems
The high-pressure system generates 800 to 2300 psi to propel cleaners/sanitizers against
the surface to be cleaned. Care is advised when using high pressure because the force
of the impacting liquid can dislodge microbes and soils and propel them to distant areas
of the processing plant, sometimes contaminating surfaces that must be kept clean in or-
der to produce a quality product.
E. Water
The temperature of the water-cleaning chemical mix should not exceed the range of 123
to 130°F. Water at temperatures higher than recommended will cook product residues
(soils), causing them to stick to equipment surfaces and promote the formation of biofilms.
The heat causes microscopic pores in the metal to expand, allowing proteins and other
food components to enter into the pores and then become trapped when the pores later
contract upon cooling.
By carefully selecting cleaning equipment and cleaning chemicals from the wide
selection of equipment and materials available from industrial suppliers, plant manage-
ment, in consultation with sanitarian advisors, can implement a cleaning/sanitizing pro-
gram that is both economical and effective.
IX. THE HACCP SYSTEM

The HACCP system, developed by NASA and the U.S. Army Natick Soldier Center in the
1960s, was used by the Pillsbury Company to minimize hazards from potential microbial
contaminants in the production of food to be consumed by astronauts in the space program.
The HACCP system is useless unless all members of management, quality control, produc-
tion, sanitation, and other personnel in the plant buy into the design and implementation
of the program. The HACCP team usually consists of one member each from management,
sales, production, sanitation, and quality control.
The HACCP program consists of the following steps:
1. Formulate an organizational chart and a narrative of the company.
2. Write a description of the products.
3. Outline the methods of distribution and storage.
4. Identify the intended use and the consumer.
5. Develop a flow diagram.
6. Set up the hazard analysis worksheets.
7. Identify all potential hazards.
8. Identify the potential process hazards. Hazards are grouped as chemical, such
as cleaning compounds; biological, such as microorganisms; or mechanical,
such as wood, glass, and metal.
Once the HACCP flow diagrams and worksheets are complete, critical limits are
then determined, and a method for monitoring each critical control point is put in place.
Temperature monitoring forms, incoming ingredient forms, and all other required forms
are designed and put in place.
The HACCP plan can be very detailed or it can be very simple, perhaps having
only one critical control point (CCP). The key is not to see how many CCPs can be found,
but rather which CCPs really affect food safety. In some instances, due to in-house time
constraints and lack of expertise, a consultant can be brought on board to design the
HACCP program and the standard sanitary operating procedures (SSOPs), and then draw
up an integrated plan that ties together all the disparate aspects of the plant sanitation
program.
X. SUMMARY
Most soils found in beverage plants are high in sugar content, are water soluble, and are
relatively easy to remove. Unwanted microorganisms may be difficult to remove from the
processing environment, but failure to do so may well come to be expressed in diminished
product acceptability. Rigid control over the quality of raw materials is an esential first
step toward ensuring that these ingredients going into the processing stream are free of
contamination.
It is important, too, that all employees receive instruction about proper storage prac-
tices so that pest harborages are not created and proper cleaning proceeds unimpeded.
Designing and carefully implementing a proper sanitation program will save money
and will increase product quality. By carefully determining the soil load, the surfaces to
be cleaned, the temperatures of the various manufacturing and cleaning processes at each
stage in the production stream; by minimizing the environmental impacts of food pro-
cessing and cleaning/sanitizing wastes; by careful selection of cleaning products with due
regard for effectiveness, costs, and environmental impacts; by giving as much attention
as needed to hand detailing; by proper execution of both prerinse and postrinse; and by
acquiring and maintaining the suitable manufacturing and cleaning equipment, the produc-
tion of a quality product will be largely ensured.
Above all, adequate training of plant personnel will greatly enhance product quality,
will promote safety for both employees and consumers, and will go a long way toward
ensuring that the company remains on a sound economic basis.
REFERENCES
1. JG Brennan, JR Butters, ND Cowell, AEV Lilley. Food Engineering Operations, 3rd Ed. Lon-
don: Elsevier Applied Science, 1990, pp 497–522.
2. JS Hough, DE Briggs, R Stevens, TW Young. Malting and Brewery Science. Hopped Wort
and Beer. London. Chapman and Hall, 1971.
3. NG Marriott. Principles of Food Sanitation, 4th Ed. London: Chapman and Hall, 1999.
4. JM Jay. Modern Food Microbiology, 6th Ed. New York: Aspen Publishers, 2000.

27
Cereal Food Plant Sanitation
GREGORY A. UMLAND, A. JAY JOHNSON, and CHERYL SANTUCCI

Ringger Foods, Inc., Gridley, Illinois, U.S.A.
I. CLEANING CEREAL FOOD PLANTS

As is true with any cleaning project, the old adage holds: an ounce of prevention is worth
a pound of cure. Before setting up any cleaning schedule or program it would be wise to
invest in an edition of Engineering for Food Safety and Sanitation: A Guide to the Sanitary
Design of Food Plants and Food Plant Equipment [1] to see what can be done to avoid
unnecessary labor costs. Unfortunately, where cereal plants are found, grain dust will also
be found. The accumulation of grain dust is not only unsighly, but also provides food for
unwanted pests. By not avoiding or continually removing this food source, the plant is
putting the company’s business in jeopardy.
This chapter breaks down the subject of cleaning into five separate categories and
discusses each one individually. These areas are (1) receiving area, (2) mixing area, (3)
processing area, (4) packaging area, and (5) finished goods warehouse. Please keep in
mind that each plant and process is peculiar in its own right. Suggestions may not fit every
process or plant but are intended to cover basic situations.
A. Incoming Warehouse and Receiving

The first step again is prevention. No product should enter that is not first carefully in-
spected. Any outdated, opened, or damaged ingredients should be refused. Careful care
should also be given to the condition of the trailer. Holes or damage incurred that could
allow the entrance of pests should be noted and that trailer should be refused. The usual
18- to 24-in. borders around the perimeter walls should be painted white, maintained free
of product, and kept clean. The clean white color helps the warehouseman to remember
not to push product up against the walls and allows for easy inspection and observation
of any dead insects or pest activity. The floor should be swept on a daily or as needed
Figure 1 Forklifts can damage bags. All dust should be swept off the floor.
basis. If any bags are broken, they should be removed and destroyed immediately (Fig.
1); all dust and residual material should be swept up off the floor and adjacent material.
Blowing the bags clean with compressed air will only move the dust to another location;
use a vacuum instead. A lift should be used to remove any cobwebs on the ceiling area
according to the cleaning schedule (the author recommends at least monthly). All bagged
flour should be rotated or purchased so it is held no longer than a month if at all possible.
If flour or even other ingredients are over a month old they should be inspected at least
weekly. Bulk flours should be inspected for insects and foreign matter on a load by load
basis. If possible, an Entoleter should be used to destroy any larvae in the flour before
it enters the plant.
B. Mixing Area
Anywhere flour is moved or mixed there will be dust. The importance of good dust collec-
tion cannot be overemphasized in this area (Fig. 2). Any equipment located in the mixing
area should be of sanitary design with easy access for cleaning. Augers should have bot-
toms that do drop out; mixer lids should be removable; microsystems and other bins should
have clean-out doors; etc. The preferred method for cleaning is to stay dry. When water
is introduced to a dry system, bacteria can start growing where water does not dry or all
material is not removed from cracks and crevices. Microbial life is not unlike any other
life form; without water it will not flourish. Most employees prefer holding a hose to
operating a vacuum, using a brush, or sweeping, so it is important to keep air and water
hoses out of those areas or they will be used more than they should. Clean, food-grade,
color-coded brushes used only for cleaning purposes should be used. It is recommended
to keep them where they will be used, up and off the floor. These should be sanitized and
inspected on a frequent basis. The mix-room can be where they are kept. Vacuums are
preferred. It is best to have permanent vacuum hoses from a central vacuum system located
where they are easily accessible. Portable vacuums are also allowed, but care must be
taken to keep the filters and bags or bins clean. Attachments should also be color coded.
One color should be used for the floor and another should be used for food contact areas.
Periodically water can be used in cleaning a dry system, but it is essential that it is done
Figure 2 Dust collection systems are essential anywhere dust may be created by flour.
meticulously and that ample time is given for drying before the system is put back in use.
Remember that the dust that lies around in the mix room or any area of a cereal plant is
food for insects. Depending on the design of the system, on the ingredients, on manage-
ment’s philosophy, etc., cleaning may be performed hourly, per shift, per day, or per week.
C. Processing Area
There are many different processes for producing cereal, which are described in Breakfast
Cereals and How They Are Made [2]. Since the author is familiar with that of extrusion
we will cover that area in more detail.
Typically a flour mixture is conveyed to the extruder bin via air conveyance or other
means. As mentioned, when flour is moved dust is created. Once again, it is important
to have good dust collection in this area. Additionally, cooked or processed cereal can
also create dust and fines. This is especially true with the large amounts of air that are
passed through or over the cereal to dry it. Doors on ovens and coolers, etc., must be well
sealed (Fig. 3), and care should be taken to prevent or collect dust in these areas also.
Due to the nature of the process and the excess amount of waste that is created by
starting and stopping this type of equipment, most plants run continuously for 5 to 7 days
per week. This makes it impossible to clean inside the extruder frequently, so it must be
done during product changeovers. Typically water can be used in this area since water is
already present in the product at this point in the process. Proper chemical usage should
be observed with sufficient levels of cleaner and sanitizer. In order to be efficient, hoses
Figure 3 Oven doors should seal tightly and be well gasketed.
capable of moving large volumes of water should be used. Small garden hoses will take
forever and will not efficiently clean specific areas and equipment. Care must be taken
with pressure sprayers, since high-pressure spray can move dirt to other areas. While
running the line, the dryer the area is kept, the better off the plant will be. Cereal waste
mixed with water will foster bacteria growth. Keep areas as clean and dry as possible.
When dismantling the equipment, it is important not to place parts on the floor
before cleaning. If available or possible, move parts to a wash room or sink that is designed
for cleaning equipment. If parts cannot be moved, place them on a clean plastic or stainless
steel pallet/rack before and while cleaning (Fig. 4). Do not use wooden pallets for cleaning,
storing, or transporting food equipment. Generally speaking, where equipment is dry, clean
it dry; where equipment is wet, clean it wet.
D. Packaging Area
Cleaning in this area should normally be done on a dry basis. Dust collection is key to
keeping the packaging area clean. Packaging materials should be moved though in a first
in/first out fashion. Large amounts of packaging materials should not be staged for long
periods of time in this area. Walls should be kept clear with the usual border.
E. Finished Goods Area

The same care to keep broken or damaged product out of the raw materials warehouse
should be used in the finished goods warehouse. Cobwebs should be promptly removed.
Figure 4 Equipment that has been broken down should be placed on a plastic pallet for cleaning.
Figure 5 The door sweep has been damaged due to daily use and should be repaired to prevent
pest entry.

Walls should be kept free and clear with 18- to 24-in white borders. Room should be
kept available between aisles of product for inspection purposes. Floors should be swept
frequently (at a minimum weekly, if not daily) and any broken pallets promptly removed.
All materials should be stretch wrapped in this area. If pallets are stacked, a slipsheet
should protect the top tier of product from the bottom of the second and subsequent pallets.
F. Building(s) and Grounds

The interior and exterior of the building(s) should be maintained in such a manner as to
eliminate or reduce pest entry. On the interior of the building, be certain that there is no
damage to the structure that allows pests or rodents to enter the building. There should
be properly placed mousetraps in the facility. Check all door and window jambs, door
sweeps, screening, and other potential entry points (Fig. 5). During regularly scheduled
inspections, be careful to observe any areas such as cracks and crevices where dust may
gather and insects can live. Furthermore, it is important to evaluate the location and design
of the openings through walls for items such as electrical lines, ventilation ducts (proper
screening on fans), and plumbing. Interior walls, floors, and ceilings should be of a smooth
and impervious material (Figs. 6 and 7). When cracks develop in these areas, it is impera-
tive that they be repaired immediately.
On the exterior of the building, the property should be maintained so that no harbor-
ages exist up alongside of the building. This can allow pests to get into the interior. Grasses
should be maintained and trimmed on a regular basis. Bushes and trees should not be up
against the building, as they may become ‘‘homes’’ for unwanted guests into the facility.
Rodent stations should be placed outside of the building to reduce the number of pests
that may want to gain entry into the facility (Fig. 8). During the exterior inspections, the
inspector should also look for stored equipment, pallet storage, or other outdoor storage.
Figure 6 This area was designed with an angled slope from the wall to the floor to reduce water
build-up at the floor–wall junction.

Figure 7 This is an example of a ceiling that is easily cleanable.
Figure 8 This exterior rat trap is used to prevent rodent entry into the facility.
All of these items can provide harborages for pests. Also include the roof as part of the
regular inspection. There may be standing water or organic matter accumulating. This
will also provide for an inspection of the equipment on the roof to be certain of cleanliness
and condition.
It is important to maintain a well-lit facility. Exterior lighting should be anchored
away from the building if possible so insects are not attracted to entry points. Many insects,
rodents, and pests like to live in cool dark places.
II. INSPECTION
Learning how to do proper inspections is something all employees should be familiar
with. This includes learning about ingredients, packaging materials, pests, and equipment.
The cooperation of all employees is essential in keeping the management informed of any
unsanitary conditions or other possible issues.
As mentioned earlier, it is imperative to do inspections of the interior and exterior
building and grounds. More information on this can be located in the Code of Federal
Regulations (21CFR 110).
Equipment inspection begins at the point just before it is brought into the facility
and continues until it is no longer in use or is discarded. Beginning at equipment entry,
it should be inspected for unwanted pests and safety hazards. Once installed, it should be
on a continual documented inspection program along with all other equipment in the facil-
ity. During these inspections, the equipment should be evaluated for dead spaces where
grain material may accumulate. Areas that are not easily or readily seen should also be
on the inspection list.
Inspection of the storage areas is extremely important as they directly relate to the
quality of the finished products produced. This inspection includes all raw materials, fin-
ished products, packaging materials, and equipment. In these areas, there needs to be
adequate ventilation for products stored and space to conduct the inspection. It is important
during these inspections to be certain that product is on a first in first out (FIFO) rotation
cycle. This does not allow raw materials or finished product to age unnecessarily. It is
equally important to keep adequate space in the aisles between and around the product
for both cleaning and inspection.
III. PEST CONTROL

Working in the breakfast cereal industry requires a vast knowledge in the area of pest
control. This includes insect, rodent, and bird control. In all cases, it is important to learn
the life cycles and feeding habits of the pests that may enter the facility.
A. Insects
Insect pests encountered in the cereal foods industry fall into four basic categories ac-
cording to their feeding habits: internal feeders, external feeders, scavengers, and second-
ary pests. The basic categories relating to plant sanitation, or more precisely, lack of
adequate cereal plant sanitation are the scavengers, since they typically feed on damaged
grains or grain dust.
The most important pests of stored foods in the scavenger category include the
confused flour beetle, the red flour beetle, the flat grain beetle, the sawtoothed grain beetle,
and the Mediterranean flour moth. They typically do not feed on whole, intact kernels of
grain, but upon damaged or processed grain products, including grain dust.
The confused flour beetle and red flour bettle are very small, about 3 mm in length
and are a reddish brown color. They are very similar in size, appearance, and habits.
Because of the small size and chewing mouthparts, they are capable of working into many
sealed containers, including multiwall paper bags and cardboard boxes. They can be distin-
guished from one another by the morphology of the antennae. The confused flour beetle
antenna is gradually enlarged to form a four-segmented club, whereas the red flour beetle
antenna enlarges abruptly to form a three-segmented club. The adult confused flour
beetle does not fly, but the adult red flour beetle is a strong flier, which may account for
the much more frequent appearance of this insect in farm stored grain. Both are primarily
a pest of milled grain products—grain dusts and surfaces of broken grains.
The flat grain beetle is one of the smallest of the common grain-infesting insects.
Adults are flattened, oblong, reddish brown and about 1 to 2 mm long. The distinguishing
characteristic is the antennae are slender and are about two-thirds as long as the insect
body—much longer in relation to the body than the antennae of the other grain investing
species. These insects mainly feed on damaged, decaying matter and the fungi associated
with it.
The sawtoothed grain beetle is similar in size and color to the flour beetles. It is
distinguished by six sawlike projections on each side of the thorax. It, like the confused
flour beetle, does not fly. Again, it is associated with milled grain products.
The Mediterranean flour moth is a common pest, infesting such items as flour, nuts,
chocolate, beans, spices, and dried fruits. Adults have a wingspan of about 1-in. The front
pair of wings is pale gray with wavy dark lines running across them. The hind wings are
dirty white. Females lay their eggs in accumulations of flour or other milled products. As
the larvae feed on the grain product, they spin silken threads. The threads fasten particles
together in a dense mat that is very characteristic of this insect.
Other grain infesting insects of importance to cereal mills are the cigarette beetle
and the closely related drugstore beetle. The cigarette beetle is about 0.1 in. long, stout,
and oval with the head bent down nearly at a right angle to the body. It breeds in a variety
of seeds and may occasionally be found attacking grains left in storage in the original
sacks for long periods.
The drugstore beetle is very similar in appearance, but is slightly more elongated
and has distinctly striated wing covers. It is a very general feeder, attacking a wide variety
of stored foods, seeds, and other grain-based foods.
B. Rodents
The three most commonly encountered rodents in the United States are the house mouse,
the Norway rat, and the roof rat. Because grain and finished grain products can provide
a nearly complete nutritionally balanced food source for rodents, it is imperative to main-
tain an active rodent control program. Both droppings and urine can transmit human and
animal diseases. This is why it is necessary to carefully monitor both the raw materials
and finished products.
Though all of these rodents have many similarities, they each have their own habits
too. It is necessary to know exactly which is causing the problem in order to control them
properly.
The house mouse tends to be one of the more difficult rodents to control due to its
size and body flexibility. The adult mouse is typically only 6–7 in. long (including tail)
and will only weigh between 0.5 to 0.75 oz. The tail of a mouse is slightly longer than
the combination of both the head and body. The female may begin reproducing around
1.5 months of age. They can wean an average of 30 to 35 young per year. The mouse
does not require a water source for survival as their bodies can get enough water from
the foods they eat. Although the mouse can live indoors or outdoors, they prefer living
indoors in dark secluded areas such as stored food products or equipment not in use.
The Norway rat is the larger of the rodents. They weight between 10 and 17 oz. as
an adult and measure up to 18 in. long from nose to end of tail. In the case of the Norway
rat, unlike the mouse, the tail is equal to or shorter than the combination of the head and
body. Norway rats differ from mice in that they require water as well as food to meet
their nutritional requirements. They also have been found to live in burrows, basements,
tunnels, and sewers. It is well known that they can swim and can be found in sewer
systems and can gain access to a food plant by poorly maintained drain covers.
The roof rat is, as its name suggests, usually found on the roof or trusses of buildings.
The roof rat is named as such because of its phenomenal ability to climb. They have been
spotted walking on electrical or phone wires, climbing trees, and building materials. The
roof rat is smaller than the Norway rat and larger than the house mouse. It can be easily
identified by the fact that the tail is longer than the combination of the head and body.
When full grown, the roof rat will usually weigh between 8 and 12 oz. It has fairly large
eyes (larger than the Norway rat or house mouse). They are usually found along the pacific
coast or warmer southern climates. Water, along with food, is also a nutritional require-
ment for these rodents.
C. Birds
Controlling the bird population can be difficult because they can live both inside and
outside a building. A first concern with birds is their ability to contaminate food products
as well as their nests being used by other insects as a harborage. However, before devel-
oping a plan to rid your facility of birds, check with a regulatory agency in your area.
There are only three birds considered to be pests or nuisances. These are the English
sparrow, the feral pigeon, and the European starling. The remaining birds are federally
protected to some extent.
Some birds are known to feed together such as the feral pigeon and the mourning
dove. This can cause difficulty in the control of pigeons, especially if a baiting program
is being implemented to kill pest pigeons, which may cause the mourning doves to die
as well. If the public becomes aware of this situation, they may become upset as most
people see feeding birds as assisting nature find food. They do not see birds as pests.
Some birds may have come to a plant to build their nests, lay eggs, and raise their
young. There are certain factors that may exist in the building that would cause them to
find this a desirable location to live. These would include overhead light fixtures attached
to the building, gutters, signs mounted to the building with a little space behind them, or
outdoor bushes or shrubs. Before starting a bird control program, be certain to know what
type(s) of bird needs to be controlled. Determine their behavior. Evaluate where the birds
come from and where they go when they leave the facility. Are they just there to loaf or
are they there to roost? If personnel in the food plant are not well versed in bird control,
a professional should be called in to conduct an evaluation of the situation. These profes-

sionals are experienced and knowledgeable of the regulatory ramifications for your loca-
tion.
In all cases, it is necessary to eliminate food sources available to them. Be certain
as grain is unloaded that spills are cleaned up and any residual grain is treated to make
it unappetizing to birds as well as other animals. Keep the buildings in repair so that the
birds may not enter. This includes screening all vents (Fig. 9), windows, and doors that
may be left open for air circulation. Using repellents may be necessary. Different types
exist, including sonic, visual, chemical, and mechanical devices. Trapping birds in cages
can be difficult. It is easier with some types of birds than others based on their feeding
habits. Finally, the use of avicides is advised only in the case of all other methods failing.
Only use avicides if they meet all federal, state, and local regulations. Be certain to check
out all regulations before using avicides and follow all label instructions.
IV. HACCP PLAN

Food safety plans are a large part of maintaining a sanitary environment for food produc-
tion. Hazard analysis and critical control point (HACCP) plans are preventative and are
designed to reduce the risk in food manufacturing. There are many prerequisite programs
that HACCP is based on. All of these prerequisite programs (the foundation of HACCP)
are what is used to control the plant environment that contributes to the overall safety of
the product. Without these essential programs, the development of a HACCP program
should not be undertaken. The HACCP system requires strict adherence to these prerequi-
site programs. The following list names just some of the prerequisite programs that may
be necessary to develop a useful HACCP plan. (Since each plant differs slightly, this list
is intended to be a typical list that may apply to many manufacturing facilities.)
Figure 9 An example of screening used to keep birds and pests out of the building.

Good manufacturing practices
Building and grounds
Utility systems
Water quality
Sanitary facilities
Sanitation
Pest control
Housekeeping
Product or ingredient storage
Carrier inspections (incoming and outgoing)
Receiving and storage
Hold release policy
Equipment calibration
Equipment design
Preventive maintenance
Employee training
General quality systems
Recall procedures
Laboratory testing approval
Health and safety recalls
Distribution
Code dating
Letters of guarantee
Residual chemical testing
Self-life
Rework
Environmental testing program
Raw material testing
Once all of the prerequisite programs are in place, a HACCP plan can be developed.
To begin the development of a HACCP plan, most facilities will draw a flowchart of their
process from raw receiving to finished product shipping. After the flowchart is drawn, it
is recomended that a hazard analysis and risk assessment be performed. A cross-functional
team should do this assessment, if possible. This may include personnel from quality
assurance, production, microbiology, operations, and others as appropriate. When conduct-
ing this assessment, look at potential hazards as they exist (biological, chemical, and physi-
cal) for each potential hazard associated with the product or process. Items that are already
controlled through prerequisite programs should not be considered CCPs. Begin to develop
the written form of the HACCP plan. A typical final CCP documentation chart should
include the following seven columns. CCP number; significant hazard; critical limit; moni-
oring (what, how, frequency, who); corrective actions; records, and verification (Table 1).
Once completed, train all employees how HACCP fits into their daily jobs and how this
preventative program provides a safer finished product. The final step in a HACCP plan
is verification. This assures that the plan is working.
These types of food safety programs and all of the prerequisites determine the safety
of the foods produced, assist in maintaining a clean and sanitary facility and reduce the
possibility of problems throughout. Having the knowledge within a facility as related to
sanitation, pest control, manufacturing, processing, and packaging provides the opportu-
Table 1 Critical Control Point Documentation Chart
Critical Critical
control limits
Monitoring
point Significant for each Corrective
number hazard measure What How Frequency Who action Records Verification
nity for a sanitary cereal food plant. Both the American Association of Cereal Chemists
and the American Institute of Baking offer workshops on HACCP.
REFERENCES
1. TJ Imholte. Engineering for Food Safety and Sanitation: A Guide to the Sanitary Design of
Food Plants and Food Plant Equipment, 2nd Ed. Woodinville, WA. Technical Institute of Food
Safety, 1999.
2. RB Fast, EF Caldwell, eds. Breakfast Cereals and How They Are Made, 2nd Ed. St. Paul, MN:
American Association of Cereal Chemists, 2000.
3. Lauhoff Grain Company. A guide to good manufacturing practices for the food industry. Dan-
ville, IL: Lauhoff Grain Company, [continuous publication], 1967, 1978, 1978, 1991.
4. R Mills, J Pedersen. A Flour Mill Sanitation Manual. St. Paul, MN: Eagan Press, 1990.

28
Plant Sanitation and HACCP
for Fruit Processing
ANDI SHAU-MEI OU and WEN-ZHE HWANG

National Chung Hsing University, Taichung, Taiwan
SHENG-DUN LIN
Hungkuang Institute of Technology, Taichung, Taiwan
I. INTRODUCTION
Fruit is an important food in our life. It provides us with rich vitamins, minerals, fiber,
pectin, organic acids, sugars, and other compounds contributing to all the sensory qualities
such as color, flavor, texture, and taste for eating enjoyment. It can also associate with
other foods to balance our diet and maintain our health and activity. As civilization devel-
oped, scientific techniques and promotion of trade economics have made fruit production
no longer the work of a few farmers; it has become an enterprise business as well. It not
only supplies the needs of local markets, but also is an important item in international
trade. Due to superior location, climate, production techniques, and hard-working farmers,
Taiwan produces various tropical, subtropical, and temperate fruits such as banana, pineap-
ple, citrus, watermelon, grapes, wax apple, litchi, guava, papaya, passion fruit, apple, pear,
peach, plum, etc. They are quite common not only for local consumption but also for
export.
In Taiwan, many fruit products are available to consumers in the market. Besides
the fresh fruits, many processed fruit products, such as juices, minimally processed fruits,
vinegar, wines, canned fruits, frozen fruits, dried fruits, candied fruits, jams, jelly, and
preserves, are also available. However, during processing and distribution, contamination
from biological, chemical, or physical sources may cause these products to become danger-
ous. The hazards mostly come from raw materials, unclean equipment, water sources,
insects, or infected workers. To solve this problem, many manufacturers spend enormous
effort to try to manage all the steps during processing or spend lots of money to inspect
the safety of products, but the effectiveness is very low. Since traditional quality manage-
ment cannot assure that food is safe, hazard control in each important step during pro-
cessing becomes an accurate way to efficiently improve food safety.
The hazard analysis and critical control point (HACCP) system, a systematic ap-
proach used in food production as a means to assure food safety as defined by the U.S.
National Advisory Committee on Microbiological Criteria for Foods (NACMCF), has
been developed. Although the NACMCF document only covers microbiological hazard
analysis, Corlett and Stier [1] extended the system to chemical and physical hazards in
food. It becomes applicable to all classes of food hazards. Therefore, it has been the
most effective, well-known management system for assuring food safety in food industries
throughout the world regardless of their location. Many countries have implemented
HACCP into their regulations to assure food safety [2,3]. The HACCP system is based
on the good manufacture practice (GMP) and sanitation standard operating procedures
(SSOP). Good manufacturing practice includes all management systems established and
audited for the plant environment, areas and facilities, machinery and equipment, organiza-
tion and personnel, sanitation, process control, quality control, control of warehouse and
distribution, labeling, consumer service, product recall, and records. Sanitation standard
operating procedures includes all sanitation management on plant environment, facility,
equipment, personnel, and manufacture practice [4–8]. Otherwise, fruit plants would have
too many critical control points to handle.
Before doing the hazard analysis, the manufacturer has to finish the following work:
1. Establish the HACCP executive team, organized with the company owner, man-
agers of production, quality assurance, marketing, purchasing personnel, and
microbiological inspectors, to establish, audit, and execute the HACCP plan
and the education program for personnel.
2. Thoroughly describe the product characteristics and the way they are distributed.
(This relates closely to the hazard analysis. The more detail the better. It includes
the source of raw materials, the storage and distribution of the products, and
the instruction of the product use.)
3. Thoroughly describe the intended consumers, such as ordinary people, elderly,
children, patients, etc., for the product.
4. Establish the flowchart for each product and number it for the hazard analysis
and recognition of important control points, control limits, controlling methods,
and correction of abnormal situations.
5. Thoroughly make sure the production procedure in the plant on site is the same
as the flowchart [4,6,9].
Then, according to the seven principles prescribed by NACMCF [10], the HACCP team
develops the HACCP working chart for the product. The seven principles are
1. The execution of the hazard analysis
2. The identification of CCPs in the process
3. The setup of critical limits for each CCP
4. The setup of monitoring requirements for each CCP
5. The setup of a correction strategy
6. The establishment of simple, easily understood and effective recordkeeping pro-
cedures
7. The verification of the HACCP process [4–6,10–17].
This chapter mainly describes the HACCP programs in fruit processing plants, such
as for canned fruits, frozen fruits, dried fruits, fruit juices, candied fruits, and fresh-cut
fruits. The HACCP program includes the processing flow diagrams and HACCP control
charts for processing steps, hazard analysis, methods of measurements, critical limits,
CCPs’, monitoring procedures/frequency, corrective actions, and records. It should be a
useful reference for fruit processing manufacturers in establishing their HACCP programs.
II. CANNED FRUIT

For this section, canning of pineapple rings is used as an example. Pineapple, a tropical
fruit, is commonly produced in Taiwan both for the fresh market and canning for ex-
porting.
A. The Processing Flowchart

The processing flowchart for canning pineapples is shown in Fig. 1. Pineapple fruit is
unloaded from bulk bins at the cannery and mechanically graded for size. Fruits of each
size are conveyed to working tables to cut off the bottom and top of the fruit and then
go through the semiautomatic shelling and coring machine to remove the shell and core. In
the United States, cannery for pineapple usually uses the Ginaca machine to automatically
remove the entire inedible portion of the fruit from the edible parts. The pineapple cylin-
ders are conveyed to trimming tables, and after trimming they pass through a spray washer
on their way to the slicing machine. The machine slices the cylinders transversely for
packing in cans. Filled cans enter a chamber under vacuum for 5–10 sec to remove air
from the fruit tissue. The cans are then syruped, sealed, and sterilized in a cooker at about
100°C until the center temperature of the can reaches 91°C. Cans are then cooled, trayed,
and stored until labeling and distribution.
B. Hazard Analysis and Risk Assessment

Table 1 shows the hazard analysis and risk assessment work. Sources of hazards may
come from raw materials or processed products; there may be microorganisms, insect
bodies, and pesticide residues in the raw materials; cans may be under vacuumed or under-
sterilized or may have sealing or other defects [18–21]. The hazards include biological,
chemical, and physical sources.
Biological Hazards. The incoming materials (pineapples, sugars, etc.) could be

contaminated with microorganisms. Pineapples could be contaminated with bacte-
ria, yeasts, or molds. Sucrose could be contaminated with bacterial spores and
yeasts, and water could be contaminated with pathogenic microorganisms. During
the processing steps, intermediate or final products could be contaminated by
microorganisms due to improper handling, and the inadequate inspection of the
final package could miss leaking cans which could become contaminated with
microorganisms.
Chemical Hazards. The incoming materials may contain some hazardous chemi-
cals. Pineapples could contain pesticide residues; water could be contaminated
with heavy metals and chemical residues; packaging material could be contami-
nated with harmful chemical residues which could leach into the product. In the
Figure 1 Process flowchart for canning pineapple.
processing steps, the intermediate product or product could become contaminated

from cleaning chemical residues because of improper rinsing.
Physical Hazard. Incoming materials could be contaminated with hazardous extra-
neous material (e.g., metal, plastic, and glass fragments and wood slivers).
C. Critical Control Points

The critical control points for the processing procedure are determined by a CCP decision
tree and there are six CCPs obtained as shown in Table 1. Four CCPs are chosen in the
step of raw material receiving and inspection, including pineapples, water, sucrose, and
empty can and cap. The other two CCPs are located in the steaming and sterilization steps.
D. Critical Limits
Establishing the critical limits of each CCP for canned pineapple is based on the national
sanitation regulations, experts’ suggestions, and the company’s own experience, as shown
in Table 1.
Table 1 HACCP Worksheet for Critical Control Points: Canning Pineapples
Monitoring
Critical control Corrective
point Hazards Critical limits What How Frequency Who actions Records
01 Pineapple Microorganisms No spoiled fruits; Spoiled fruit, pes- Visual inspection, Every delivery QC inspector Spoiled fruits are Materials test-
receiving (MO), pesti- no pesticide ticide residues chemical ana- rejected. ing records
cide residues residues ex- lysis (MTR)
ceeding food
sanitation stan-
dards
02 Sucrose Extraneous No extraneous Extraneous Visual inspection Every delivery QC inspector Reject when extra- MTR
receiving materials materials materials neous materials
are found.
03 Water receiving MO TPC ⱕ 100 CFU/ TPC, E. coli MO analysis Weekly QC inspector Water not used if Water records
mL; no E. coli TPC ⬎ 100
present CFU/mL or E.
coli present.
04 Empty can and Extraneous No extraneous Extraneous Visual inspection Every delivery QC inspector Reject when extra- MTR
cap receiving materials materials materials neous materials
are found.
19 Seaming Leaking According to CNS Appearance in- According to stan- Every 30 min Operator Seaming record
827 standards spection and dards of dou- for appear-
seaming in- ble seamer ance; every
spection after practice 3 hr for
opening can seaming
inspection
20 Sterilization MO Initial temperature Initial temperature Thermometer Every delivery Operator Product reworked Sterilization
⬎ 50°C; steril- if applicable us- record
izer is good ing the alterna-
tive process
schedule.
Sterilization tem- Temperature and Visual inspection Every batch Operator Thermometer
perature 98°C; time and timer
sterilization time record
23 min

E. Monitoring
Different monitoring methods for CCPs including physical, chemical, and sensory tests are
used, as shown in Table 1. Visual inspection and chemical analysis are used for pineapple
receiving; microbiological testing is used for water detection; visual inspection is used
for sucrose and empty can and cap receiving, and the seaming step; thermometers and
timers are used for the sterilization step.
F. Corrective Action
When the results of monitoring do not meet the critical limits, corrective action should
immediately be taken. For example, once the raw materials do not meet the specification,
they will be rejected, as indicated in Table 1.
G. Recordkeeping
A recordkeeping system to keep correct and comprehensive records is essential for the
success of the HACCP system. Records are the documentation needed to verify effective-
ness of the HACCP plan.
H. Verification
To verify the HACCP system of canned pineapples, an auditing team is organized from
the company’s executive level members. They review all the safety and quality assurance
records, such as the records for critical control points, the records for process deviation
and corrective actions, the records for sanitation quality inspections, the records for the
standard procedures of the sanitation management, and the records for the improvements
and corrections of governmental inspections, etc. In addition, they should examine the
accurate knowledge of supervisors for the critical control points, the critical limits, and
corrective actions as well as the overall effectiveness of the HACCP system to assure the
system is well undertaken.
III. FROZEN FRUIT

In this section, the frozen litchi is used as an example. Litchi (Litchi Chinensis Sonn.)
produced in Taiwan is mainly for the fresh market and frozen products for exporting to
Japan as well.
A. The Process Flowchart

The process flowchart for manufacturing frozen litchi is shown in Fig. 2. the litchi is
harvested during mid-May to mid-June in Taiwan. After arriving in the plant, the leaves
and stems of litchi are removed as soon as possible by a roller and trimmed with trimming
scissors. Litchi is then washed and individually quick-frozen by an individually quick-
freezing (IQF) freezer. The frozen litchi is stored at ⫺20°C before distribution.

First of all, the members of the HACCP team in the company need to collect all the
information about litchi from literature and plant experience. Then they discuss the poten-
tial hazards during litchi processing from the raw materials to finished products and selling.
Figure 2 Process flowchart for manufacturing frozen litchi.
Table 2 shows the identified hazards, and the levels of risk associated with each identified
hazard are assessed.
The hazards include microbiological, chemical, and physical hazards. For microbio-
logical hazards, many disease organisms are associated with postharvest decay of litchi;
the most important are Aspergillus, Pestalotiopsis, Peronophythora, and various yeasts
[22–26]. Disease control should begin with measures against fruit-piercing insects, partic-
ularly the fruit fly, since cracks in the pericarp allow entry of microorganisms. However,
microscopic cracks are present at harvest and increase after harvest [27]. Other microbio-
logical hazard sources for frozen litchi include water, which could be contaminated with
microorganisms, and packaging materials contaminated by the injured hands of operator,
for example.
The major chemical hazard for frozen litchi is pesticide residues. Others are the
solvent odors and solvent residues of polyethylene (PE) bags [19–21].
The major physical hazard for frozen litchi is metal contamination. Its source usually
comes from the metal surfaces of machines [19–21].

Based on factory experimental data and experience and the relevant literatures, four CCPs
are identified for frozen litchi using the CCP decision tree; these are shown in Table 2.
Table 2 HACCP Worksheet for Critical Control Points: Frozen Litchi
Monitoring
point Hazard Critical limits What How Frequency Who actions Records
01 Litchi Microorganisms No spoiled fruit; all Spoiled fruit; pes- Visual inspec- Every delivery QC inspector Fruits are rejected. Materials testing
receiving (MO), in- pesticide resi- ticide residues tion, chemical and yearly and oper- record (MTR)
sects, pesti- dues must be analysis ator
cide residues within standards
of food sanita-
tion.
02 Water MO TPC must be ⱕ TPC; E. coli Microbiologi- Weekly QC inspector Water not used Water record
receiving 100 CFU/mL; E. cal analysis when TPC ⬎
coli absent 100 CFU/mL or
E. coli present.
03 HDPE bags Solvent PE package must Solvent odor, sol- Smell and sol- Every delivery QC inspector Packages are MTR
receiving residues have no solvent vent residues vent analysis rejected.
odor; solvent resi-
dues must be
within standards
of food sanita-
tion.
09 Metal Metal Operable metal de- Ferrous and non- Automatic Continuously; Labeling If sensitivity check Metal detector re-
detection tector. ferrous metal screening line opera- operator of detector is not sult; QC prepares
tor evalu- on or fails, all deviation report,
ates rejects product since last determines
hourly. acceptable check source of metal,
held and re- and corrects it.
checked for
metal. Excessive
reject rate forces
line shutdown.
Contact mainte-
nance if neces-
sary, e.g., to fix
detector.

They include the steps of receiving litchi, water, PE packaging bags, and metal detection
after packing.
D. Critical Limits
The critical limit is a safe limit for each identified CCP. In order to eliminate hazards for
frozen litchi and assure consumer safety, the company’s HACCP team establishes the
critical limits for each CCP from SSOP, the company’s experimental data, and experts’
suggestions. The critical limits for each CCP are described in Table 2.
E. Monitoring
Monitoring methods for frozen litchi are shown in Table 2, including microbiological,
chemical, and sensory tests. The items, frequency, and responsible personnel for monitor-
ing are shown in Table 2. All monitoring data must be recorded clearly in order to assure
product safety and quality.
F. Corrective Actions
Corrective action must be taken whenever monitoring indicates that limits are not met.
Such action must be immediate to assure that the situation is rectified. The corrective
actions of each CCP for frozen litchi are shown in Table 2. For example, if the pesticide
residues of litchi exceed standards of food sanitation, they will be rejected.
G. Recordkeeping
Records are needed to verify effectiveness. The records for frozen litchi include material
testing, water, operator sanitizing, product recovery, and consumer complaints records,
among others.
H. Verification
In order to verify the HACCP system for frozen litchi the manufacturer operates in accor-
dance with the HACCP plan. Regular and annual audits are performed by the company’s
audit team or an external party. They review all records for frozen litchi. The result of
the audits are to be discussed at management meetings.
IV. DRIED FRUIT

Drying has been a common processing method for fruit since ancient times. This not only
demonstrates the preserving ability of fruit, but also indicates the unique flavors and
aromas for dried fruit compared to fresh. To dry fruit, it is necessary only to dry to the
stage where microorganisms will not grow, thereby retaining the flavor, color, and nutri-
ents consumers want. In this section, dried apple slices are used as an example to illustrate
the HACCP process.

The process flowchart of drying apple slices is shown in Fig. 3. Freshly harvested apples
are unloaded in the factory and immediately stored in the cold room below 8°C if neces-
sary. When a convenient processing time occurs, apples are washed, peeled, cored, and
Figure 3 Process flowchart for manufacturing dehydrated apple slices.
sliced. Because decoloration easily occurs after peeling, coring, and slicing, the step of
soaking in the ascorbic acid solution becomes essential if the use of sodium sulfite solution
is not preferred. After soaking, apple slices are heated by hot air at 60–70°C for 15–20
hr in a tunnel dehydrator and dried to the water content below 25%. Aluminum-laminated
plastic bags are used for packaging to protect the dried apples against moisture, light, air,
dust, microorganisms, foreign odors, insects, and rodents. Before distribution and sales,
the end products are carefully stored under proper condition.

The potential hazards for dehydrated apple slices listed by a company’s HACCP team are
shown in Table 3. Apples may be infected by microorganisms and contaminated by ex-
ceeding permitted dosages of pesticide residues. Water used in the processing may be
contaminated by microorganisms, especially E. coli, which must be absent in the water.
The solvent odor or residues in aluminum-laminated packaging bags may be harmful and
Table 3 HACCP Worksheet for Critical Control Points: Dehydrated Apple Slices
Monitoring
Corrective
Critical control point Hazard Critical limits What How Frequency Who actions Records
01 Apples receiving Microorganisms No spoiled fruit; no Spoiled fruit, Visual inspection, Every delivery QC inspector Spoiled fruits are re- Materials testing
(MO), pesti- pesticide residues pesticide chemical anal- and yearly jected. record (MTR)
cide residues exceeding stan- residues ysis
dards of food sani-
tation.
02 Water receiving MO TPC must be ⱕ 100 TPC, E. coli Microbiological Weekly QC inspector Water not used Water record
CFU/mL; E. coli analysis when TPC ⬎ 100
absent. CFU/mL or E.
coli present.
03 Ascorbic acid Specification Specification must Specification Inspection of Every delivery QC inspector Reject. MTR
receiving be according to certification
food additive stan-
dards.
04 Aluminum- Solvent No solvent odor Solvent odor, Solvent analysis Every delivery QC inspector Reject packaging MTR
laminated residues present in packag- solvent by smell materials.
packaging ing; no solvent residues
bags receiving residues ex-
ceeding the stan-
dards of food sani-
tation.
13 Hot air drying MO Hot air temperature Temperature Hot air tempera- Continuously Automatic Stop processing and Heating record
and drying time and time ture, drying recording, make adjustment
must be kept be- time operator
tween 60–70°C
and 15–20 hr, re-
spectively.
Product must be con-
tinuously dried to
its moisture con-
tent below 25%.

dangerous to workers and consumers. Therefore, it must be carefully examined to ensure
compliance with the standards of food sanitation. In the packaging step of the finished
dried apple slices, the product may be contaminated by the hands of the operators if they
are injured or dirty. The culls for dehydrated apple slices could be bought by consumers
and result in consumer complaints [19–21,28].

The company’s HACCP team collects the factory experimental data and experience, rele-
vant literature, and experts’ suggestions as references. Using the CCP decision tree to
identify the CCPs during the processing of dehydrated apple slices, five CCPs are shown
in Table 3. They include receiving apples, water, ascorbic acid, and aluminum-laminated
packaging bags and hot-air drying.
D. Critical Limits
Critical limits on hazards representing the boundaries of safety for each CCP are listed
in Table 3. The critical limits for each CCP are based on the relevant literature, experts’
suggestions, factory experience, and sanitation standards from the Department of Health,
Taiwan, ROC.
E. Monitoring
In order to assure product safety, the HACCP team identifies the monitoring methods and
procedures for each CCP (Table 3).
F. Corrective Actions
The company’s HACCP team established the preapproved action plan from factory experi-
ences, experts’ suggestions, and sanitation standards for food. Disposition of the dehy-
drated apple slices involved in the deviation should be determined according to the preap-
proved action plan. For example, when the pesticide residues in apple exceed the standards
of food sanitation, they will be rejected (Table 3).
G. Recordkeeping
Each CCP for dehydrated apple slices is documented. This documentation includes the
identification of the CCP, its limits, frequency of monitoring, person accountable for moni-
toring, and a shift check-off sheet signed by the accountable party denoting each time the
CCP monitoring procedure is performed.
H. Verification
In order to verify the HACCP system for dehydrated apple slices is working properly,
the company’s auditors review the HACCP plan, all deviations and disposition, the proper
functioning and accuracy of CCP monitoring equipment, CCP records, and random collec-
tion of ingredients or product samples.

V. FRUIT JUICES
Fruit juices provide vitamins and minerals as well as fibers. In Taiwan, most juices are
reconstituted from imported concentrated juices. For this section, the plastic-bottled single-
strength orange juice is used as an example.

The process flow diagram for orange juice is shown in Fig. 4. Citrus is the most common
fruit produced in Taiwan. However, the varieties grown in Taiwan mostly are for the
fresh market. The fruit juices available in the market are mostly from imported frozen
concentrates. Orange juice is not an exception. After being received, the frozen concen-
trated orange juice is stored at ⫺20°C until a convenient processing time occurs. To recon-
stitute it, the water has to be cleaned by membrane filtration before use. Ascorbic acid is
added to the treated water to enhance the nutrient value and prevent the oxidation reaction
as well. The reconstituted orange juice is then pasteurized at 93°C for 2 min before bot-
tling. The plastic bottles, usually polyethylene or polypropylene, are washed and heated
in boiling water for 10–20 min before hot-filling. After capping, the bottles immediately
are cooled to below room temperature and dried using high-velocity air. The bottles are
cased in cartons and stored in a cold storage room until distribution and selling.
Figure 4 Process flowchart for manufacturing orange juice from concentrated juice.

Biological Hazards. The primary hazard in orange juice is pathogenic microorgan-
isms, which have the ability to survive and/or grow under the acidic condition
of the juice. The most important pathogen in this regard is Salmonella because
of the ability of some strains to grow under refrigeration conditions and survive
at low pH [16]. The outbreak of E. coli O157:H7 associated with orange juice
in 1996 [29–30] also raised concern about this pathogen.
Chemical Hazards. The risk of chemical hazards may include cleaners, sanitizers,
and pesticides [19–21].
Physical Hazards. Incoming materials could be contaminated with hazardous ex-
traneous material (e.g., metal, plastic, and glass fragments and wood slivers) [19–
21].

Six CCPs for orange juice processing are decided by the CCP decision tree, as shown in
Table 4. They are raw material receiving and inspection, including concentrated orange
juice, water, ascorbic acid, and plastic bottles and caps. The other two CCPs are located
in the hot-filling and capping steps.
D. Critical Limits
The established critical limits for the CCPs described are based on national sanitation regu-
lation, experts’ suggestions, and the company’s experience and are shown in Table 4.
E. Monitoring
The monitoring methods include physical, chemical, and sensory tests, as shown in Table
4. The items and frequency as well as the supervisor are also shown in Table 4.
When the monitoring of CCPs indicates a deviation of a critical limit, corrective actions
must be taken. Corrective actions may involve the following steps: notifying a supervisor,
shutting down the process line, reprocessing, adjusting temperatures and times of process,
rejecting raw materials or ingredients, and holding or recalling product in distribution, as
shown in Table 4.
G. Recordkeeping
Establishing a correct and comprehensive recordkeeping system is essential to a HACCP
plan because records are the documentation needed to verify effectiveness.
H. Verification
To verify the HACCP system of orange juice processing, it is necessary to organize an
auditing team from the company’s executive level members. They will review all the
safety and quality assurance records, such as the records for critical control points, the
records for process deviation and corrective actions, the records for sanitation quality
inspections, the records for the standard procedures of the sanitation management, the
Table 4 HACCP Worksheet for Critical Control Points: Single-Strength Reconstituted Orange Juice
Monitoring
point Hazard Critical limits What How Frequency Who actions Records
01 Concentrated Microorganisms MO and pesticide res- MO, pesticide MO analysis, Every delivery QC inspector Fruits not accepted. Materials test-
orange juice (MO), pesti- idues within stan- residues chemical ing record
receiving cide residues dards of food sani- analysis (MTR)
tation
02 Water receiving MO TPC ⱕ 100 CFU/ TPC, E. coli Microbiologi- Weekly QC inspector Water not used if Water record
mL; E. coli absent cal analysis TPC ⬎ 100 CFU/
mL or E. coli
present.
03 Ascorbic acid Specification Specification must be Specification Inspection of Every delivery QC inspector Not accepted. MTR
receiving according to food certification
additive standards
04 Plastic bottles Extraneous Extraneous materials Extraneous Visual Every delivery QC inspector Product not accepted. MTR
and caps re- materials absent materials inspection
ceiving
13 Hot-filling MO MO in sterilization MO MO analysis Every hour QC inspector Stop process. Sterilization
room absent room record
14 Capping Leaks According to CNS Cap sealing According to Every 30 min Operator Stop processing and Seaming record
827 standards test cap sealing Every 3 hr Operator make adjustment.
operation
standards

records for the improvements and corrections of governmental inspections, etc. In addition,
they should examine the accurate knowledge of supervisors for the critical control points
and the critical limits, corrective actions, and the importance of the HACCP system as
well to assure the system is well undertaken.
VI. CANDIED FRUIT

Candied fruits in Taiwan are one of our traditional foods with characteristic flavors and
texture. Although it is not a major item in our diet, it is an important and almost essential
food in our amusement and relaxing hours. Candying fruits has been one of the most
important methods for preserving sour fruits after harvesting since ancient times. It plays
an important role on the supply–demand balance of agriculture products. In this section,
crisp mei (Japanese apricot) is the example for illustrating the HACCP system for candied
fruits.
A. Process Flowcharts
The process flowchart for manufacturing the crisp mei is shown in Fig. 5. The fresh mei
are harvested from mid-March to mid-April once a year in Taiwan. But the fresh mei
used for making crisp mei are only those harvested before Spring Festival (Chinese New
Year, usually in February) in order to keep the fruit’s crisp characteristics. The fresh mei
are unloaded from bulk bins at the factory and mechanically graded for size, with the
Figure 5 Process flowchart for manufacturing crisp mei (plum).

stems and leaves removed at the same time. After grading, the mei are vigorously mixed
with 5–10% salt in a roller to remove the green and astringent substances. The mei are
then soaked in the solution containing 1.25% CaCl 2 and 0.7% NaHSO 3 in the ratio of
1.5 :1 for mei for about 10 days. Before glazing, the mei are washed and glazed gradually
stepwise in intervals of 10%, from 35% to 65%. Each step must reach an equilibrium
sugar concentration between mei and syrup before going to the higher concentration step.
The end products of crisp mei usually have a sugar concentration of around 55–60%
in order to have water activity below the level of microbial growth. Otherwise, some
manufacturers may add potassium benzoate as a preservative. The concentration of potas-
sium benzoate must be lower than 1 g/kg product weight according to our food sanitation
regulation in Taiwan [19–21,30–31].

The company’s HACCP Team initially lists all perceived microbiological, chemical, and
physical hazards for crisp mei and indicates their location on the HACCP worksheet
(Table 5).
Microbiological Hazards. The potential hazards include the presence of bacteria,

mold, and insects in raw materials, in end product, and on the hands of operators.
Chemical Hazards. The potential hazards include the pesticide residues and speci-
fication in raw materials and the sulfite and preservatives residues in end product.
Physical Hazards. The potential hazards include extraneous materials in raw mate-
rials.

The six CCPs are identified by the CCP decision tree. The experimental data, factory
experience, and the literature are available to aid the company’s HACCP team in distin-
guishing true critical control points. Table 5 shows the location of each CCP in the process
for crisp mei.
D. Critical Limits
In order to assure product safety, every CCP has one or more preventive measure that
must be properly controlled. Each preventive measure has one or more corresponding
critical limit representing the boundary of safety. The critical limits have been established
for crisp mei by the regulation and practices of sanitation standards from the Department
of Health, Taiwan, ROC.
E. Monitoring
The monitoring item, method, frequency, and personnel responsible are identified on the
HACCP worksheet (Table 5). For example, the quality control (QC) inspector is responsi-
ble for monitoring the sodium bisulfite and calcium chloride receiving steps on every
delivery to ensure that their specifications are in accordance with food additive standards.
All records and documents for CCP monitoring must be signed by the individuals actually
doing the monitoring.
Table 5 HACCP Worksheet for Critical Control Points: Crisp Mei
Monitoring
Corrective
01 Mei receiving Microorganisms No spoiled fruit; Spoiled fruit, pesti- Visual inspection, Every delivery QC inspector Spoiled fruits are Materials test-
(MO), pesti- no pesticide res- cide residues chemical anal- and yearly rejected. ing record
cide residues idues outside ysis (MTR)
standards of
food sanitation
03 Sodium chloride Extraneous No extraneous ma- Extraneous mate- Visual inspection Every delivery QC inspector Reject when extra- MTR
receiving materials terials present rials neous materials
are found.
04 Sodium bisulfite Specification Specification ac- Specifications Inspection of Every delivery QC inspector Reject when ei- MTR
and calcium cording to food certification ther one does
chloride additive stan- not meet the
dards supply speci-
fication.
05 Sucrose Extraneous No extraneous ma- Extraneous Visual inspection Every delivery QC inspector Product not ac- MTR
receiving materials terials present materials cepted.
06 Water receiving MO TPC ⱕ 100 CFU/ TPC, E. coli Microbiological Weekly QC inspector Water not used Water record
mL; no E. coli analysis when TPC ⬎
present 100 CFU/mL
or E. coli is
present.
12 Crisp mei Sulfites, MO, Sulfite, MO, and Sulfites, preserva- Chemical and Every batch QC inspector Discard when pre- Product record
preservative preservatives tives, MO MO analyses servatives or
residues within MO residues
standards of present.
food sanitation

Table 5 lists the corrective actions to be taken for any failure at each CCP. For example,
when the pesticide residues in mei exceed the standards of food sanitation, the QC inspec-
tor must report the deviation to the plant manager and quality control, and the mei must
be rejected.
G. Recordkeeping
The monitoring of the CCPs for crisp mei are properly documented and recorded in a
suitable format, validated, and signed by the responsible person. All records are kept for
at least 1 year.
H. Verification
In order to assure all CCPs are under control and that any corrective action is implemented,
the company’s auditors review all records for crisp mei. The results of the audit are then
discussed with relevant personnel, including the factory management team or QC manage-
ment.
VII. FRESH-CUT FRUIT

Recently, ready-to-eat foods, e.g., fresh-cut fruit slices, have become popular. However,
freshness and safety should carefully be examined. Fresh-cut fruit slices may consist of
a single type of fruit or a combination of many types of fruits. The contamination of
microorganisms from different sources may cause serious safety problems. In this section,
fresh-cut watermelon slices is the example for illustrating the HACCP system of fresh-
cut fruits.
A. The Process Flow Diagram

The process flow diagram for manufacturing the fresh-cut watermelon is shown in Fig.
6. Watermelon received in the plant is put into a cold room for storage. Before processing,
watermelon is washed in a washing tank and then transferred to a working table to peel
and slice. The slices are dipped in a mixture of sugar and ascorbic acid solution for a
certain time when necessary. The slices are then weighed and placed in a polystylene
foam tray and wrapped with the polyethylene film. The products are stacked in a paper-
board carton in place and stored at 4–7°C in a cold storage room before distribution. The
numbers in the figure represent all the important critical points which should be carefully
controlled for microbiological, chemical, and physical hazards, as shown in Table 6.

Biological Hazards. The raw material watermelon could be contaminated with
spoilage and/or pathogenic microorganisms. Water received also could be con-
taminated with pathogenic microorganisms [19–21,28,30a,32–36].
Chemical Hazards. The incoming materials may contain hazardous chemicals.
Watermelon could contain pesticide residues; water could be contaminated with
heavy metals and chemical residues; packaging material (polystylene foam tray
and wrapping film) could be contaminated with harmful chemical residues which
Figure 6 Process flowchart for manufacturing fresh-cut watermelon slices.
could leach into the product. In the processing steps, the intermediate product or
end product could become contaminated from cleaning chemical residues because
of improper rinsing.
Physical Hazards. Incoming materials could be contaminated with hazardous ex-
traneous material (e.g., metal, plastic, and glass fragments and wood slivers).

Four CCPs for the processing of packaged fresh-cut watermelon slices are chosen by CCP
decision tree, as shown in Table 6. All of them are located in the steps of raw material
inspection and receiving, including watermelon, water, polystylene foam tray, and wrap-
ping film receiving.
D. Critical Limits
The established critical limits of each CCP for the packaged fresh-cut watermelon slices
are based on the national sanitation regulations, experts’ suggestions, and the company’s
own experience, as shown in Table 6.
E. Monitoring
As shown in Table 6, the monitoring methods for CCPs include physical, chemical, and
sensory tests. The items and frequency as well as the supervisor are also shown in Table
6.
Table 6 HACCP Worksheet for Critical Control Points: Fresh-Cut Watermelon Slices
Monitoring
Corrective
01 Watermelon Microorganisms No spoiled fruit; no Spoiled fruit, Visual inspec- Every delivery QC inspector Fruits are re- Materials test-
receiving (MO) and chemi- pesticide residues pesticide tion, chemical and yearly jected. ing record
cal contamina- beyond standards residues analysis (MTR)
tion, e.g., MO or of food sanitation.
pesticide residues
on watermelon
surface
02 Water receiving MO contamination TPC must be ⬍ 100 TPC, E. coli Microbiologi- Weekly QC inspector Water not used Water record
CFU/mL; no E. cal analysis when TPC ⬎
coli present. 100 CFU/mL
or E. coli
present.
03 Polystylene foam Chemical contamina- Polystyrene foam Solvent odor, Solvent analysis Every delivery QC inspector Foam trays are MTR
tray receiving tion, e.g., solvent tray must have no solvent by smell rejected.
residues solvent odor or residues
solvent residues
beyond standards
of food sanitation.
04 Wrapping film Chemical contamina- Wrapping film must Solvent odor, Solvent analysis Every delivery QC inspector Wrapping films MTR
receiving tion, e.g., solvent have no solvent solvent by smell are rejected.
residues odor or solvent residues
residues beyond
standards of food
sanitation.

When the hygienic condition of packaged fresh-cut watermelon slices does not meet the
national sanitation standards, corrective action should immediately be taken. For example,
once the raw materials do not meet the specification, they will be rejected, as indicated
in Table 6.
G. Recordkeeping
Keeping correct and comprehensive records is essential for assuring that the HACCP is
implemented correctly and the packaged fresh-cut watermelon slices meet all the sanitation
standards and quality.
H. Verification
To verify the HACCP system of packaged fresh-cut watermelon slices, an auditing team
is organized from the company’s executive level members. They review all the safety and
quality assurance records, such as the records for critical control points, the records for
process deviation and corrective actions, the records for sanitation quality inspections, the
records for the standard procedures of the sanitation management, the records for the
improvements and corrections of governmental inspections, etc. In addition, they should
examine the accurate knowledge of supervisors for the critical control points and the criti-
cal limits, corrective actions, and the importance of HACCP system as well to assure the
system is well undertaken.
VIII. CONCLUSION
The HACCP system in seafood, meat, and poultry products has been established for some
time. But for fruit and vegetable products, the HACCP system has just recently been
started, even in the United States and other countries. There are many different kinds of
fruits and processing methods. This chapter describes six different types of processed
fruit; one kind of each is used as an example. The HACCP system described here for
each type of processed fruit is based on the GMP and SSOP already established in the
company.
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29
Sanitation in Grain Storage and
Handling
MICHAEL D. TOEWS and BHADRIRAJU SUBRAMANYAM

Kansas State University, Manhattan, Kansas, U.S.A.
I. INTRODUCTION
Sanitation or cleanliness is an overlooked component of safe and cost-effective grain stor-
age. Good sanitary practices benefit the grain manager in several key areas. Aside from
the obvious safety hazards including explosions and personnel exposure when working
with grain containing excess particulate matter, it is beneficial to store clean grain because
of the decreased costs associated with aeration and insect management. Aeration is much
more efficient in clean grain because of reduced air flow resistance when compared with
aeration in unclean grain. Unclean grain promotes rapid insect, mite, and mold activity
and grain deterioration. Fumigant penetration can be affected because of smaller air spaces
in unclean grain resulting in poor insect management. The effectiveness of pesticides
applied to stored grain to protect against insect attack is also greatly reduced in unclean
grain.
The problems associated with unclean grain have been addressed by entomologists
with reference to insects; mycologists with reference to storage molds; engineers with
reference to aeration and drying or changes in physical properties of grain; and by safety
experts with reference to explosion hazards and allergenic reactions in workers. The litera-
ture is scattered in various reputed national and international journals. Our purpose in
writing this chapter is not to review all the available literature, but to provide a broad
understanding about the problems associated with storing and handling unclean grain and
to suggest practical techniques for mitigating these problems. Therefore, only a few rele-
vant papers from different disciplines were selected to support our arguments. To our
knowledge, this is the first time that information from various disciplines has been summa-
rized to focus specifically on issues pertinent to sanitation in grain storage and handling.
II. DEFINITIONS
Material contaminants can be separated from unclean grain, and standard procedures have
been established to separate these contaminants. The level of contaminants separated from
the grain is quantified for assigning a numerical grade to that particular lot of grain. This
procedure is formally termed grain grading and occurs anytime grain is sold. To better
understand some terms, let us examine how U.S. wheat is manually graded and how
contaminants are offically defined during the grading process. A representative sample
(⬃1000 g) of wheat is removed from a lot and its moisture content (wet basis) determined
using an approved moisture meter (moisture is not a grade factor, but the buyer can spec-
ify the level of moisture needed). Next, material other than wheat will be systematically
removed using sieves or an approved dockage tester. Dockage is officially defined as ‘‘all
matter other than wheat that can be removed from the original sample by use of an ap-
proved device,’’ according to procedures prescribed in the U.S. Federal Grain Inspection
Service instructions [1]. Official grading sieves are a 4.8-mm (0.1875-in.) round-hole
sieve on the top and a 1.98-mm (0.0781-in.) round-hole sieve on the bottom. All material
that is retained on the top sieve or that falls through the bottom sieve is considered dock-
age. Common constituents found in dockage include weed seeds, weed stems, chaff,
straw, grains other than wheat, sand, dirt, and dust. For Manitou wheat grown in Canada,
Sinha [2] reported 12 components in dockage. The 12 components were lambs quarter
seeds, wild mustard seeds, wild buckwheat seeds, wild oats, Canada thistle seeds, red
root pigweed seeds, giant ragweed seeds, perennial sow thistle seeds, fine black soil,
cracked and broken wheat kernels, small wheat kernels, and chaff. Wild buckwhet seeds,
cracked and broken wheat, and small wheat kernels made up 62% of the total dockage.
Lambs quarter seeds, wild mustard seeds, red root pigweed seeds, and fine black soil
made up 26% of the total dockage. Other components made up the remaining 12% of the
dockage.
After separating dockage from the sample, test weight (bulk density) is determined
using an approved test weight (Winchester bushel) apparatus [3]. Test weight is a grade
factor for all grains and is related to the processing yield and quality of the final product.
The shrunken and broken kernels, officially defined as those that pass through a 1.6-mm
(0.064-in.) ⫻ 9.5-mm (0.375-in.) slotted sieve, are separated and weighed. The material
still remaining in the grain sample, other than wheat, is considered foreign material. The
foreign material may include insect parts, small seeds, stones, and pieces of stems. Foreign
material is actually handpicked from a subsample (30 g) of the original wheat sample and
then weighed. The final step includes hand selecting damaged kernels from the remaining
grain sample. Damaged kernels are those remaining broken pieces or whole kernels that
are weather damaged, diseased, frost damaged, germ damaged, heat damaged, insect
bored, mold damaged, or otherwise materially damaged.
Grain grade and dockage are important determinants of grain value. To determine
official grade the maximal allowable limits of any single grading factor cannot be ex-
ceeded. Table 1 shows the allowable limits of each contaminant in wheat. A numerical
grade is assigned based on one, or more than one, of these grade factors. Discounts may
be applied to wheat not meeting the grade factors. A grading factor not discussed in the
preceding paragraphs is total defects, and it is defined as the total sum of shrunken and
broken kernels, foreign material, and damaged kernels. It is important to note that each
numerical grade also has a maximal allowable amount for total defects. Grade is expressed
at the bottom of the scale ticket as the official grade, the wheat class, and the percent
Table 1 Maximum Limits of Contaminants Found in Wheat
Shrunken
and broken Foreign Damaged Total
Grade Dockage (%) kernels (%) material (%) kernels (%) defects (%)
US No 1 Not counted 3.0 0.4 2.0 3.0
US No 4 Not counted 12.0 3.0 10.0 12.0
US No 5 Not counted 20.0 5.0 15.0 20.0
Note: Wheat not meeting standards for US grades 1–5 is considered sample grade.
Source: Ref. 1.
dockage (e.g., U.S. No. 1 hard red winter, 1.2% dockage). Dockage is a non–grade-
determining factor in the U.S. wheat grading system. However, dockage level is a negoti-
able contract term impacting the monetary value of the commodity.
The Federal Grain Inspection Service approves the use of mechanical dockage test-
ers in place of hand sieves to determine dockage content. Mechanical dockage testers
provide more consistent results than hand sieving procedures. In addition, mechanical
testers save grading personnel time, because various constituents in the grain are also
separated during dockage removal. These machines house an aspirator, a riddle for re-
moval of large materials, and three sieve carriages that hold interchangeable grains. Prior
to sieving a sample, the air control (blows chaff from the kernels) and speed of the machine
can be adjusted to further facilitate a variety of grains and conditions. Official procedures
exist for conditions such as wheat with more than 0.5% cheat by weight. In this case, a
sieve that removes only the cheat is added in one of the sieve carriages. The federal grain
standards and practical procedures for inspecting grain are published by the United States
Department of Agriculture’s Grain Inspection, Packers, and Stockyards Administration.
Interested readers can obtain a copy online at http://www.usda.gov/gipsa/reference-library/
library.htm.
In this chapter, sanitation is discussed with reference to constituents other than grain
that occur in grain at the time of harvest, handling, and storage. The terms dockage, broken
corn and foreign material (BCFM), broken kernels, dust, and fine material are used inter-
changeably. Throughout this chapter, the term dockage is frequently used to include all
of these materials that occur in bulk-stored grain or in any lot of grain. This was done
deliberately, because these various constituents occur together in grain, unless the grain
is cleaned prior to storage. Furthermore, the problems associated with these various con-
stituents in grain, in terms of grain deterioration, are somewhat similar.
III. SOURCES OF DOCKAGE

Dockage in harvested grain can be affected by a number of factors. Age, condition, and
adjustments of harvesting machinery lead to substantial changes in dockage content. Older
combines were not as sophisticated and do not have the ability to separate the wheat chaff
and weed seeds from the grain as effectively compared to more modern combines. Like-
wise, incorrect setting, even of modern machinery, could result in excess straw or chaff
in the grain. The presence of certain types of weeds in the production field at harvest time
will also contribute to increased dockage. Cheat grass (or cheat), wild rye, and pigweed
are similar in size to wheat kernels, and therefore cannot be completely removed by the
combine. Cheat can be such a severe problem in parts of the Great Plains that grading
personnel must adjust the grading apparatus to remove cheat (technically considered dock-
age) before continuing with the grading process or they will overestimate the value of the
load. Planting certified seed, application of chemicals, and increasing cultivation are all
effective means of reducing weeds in the field and consequently weed seeds in the har-
vested grain. Lyon and Baltensperger [4] showed that dockage and foreign material in
harvested wheat were lower when producers followed a 3-year, as opposed to a 2-year,
cropping system. Particularly during dry years, the wheat kernels may not accumulate
maximal dry matter resulting in more shrunken kernels. This condition is usually brought
about by climatic conditions or biological organisms (insects and molds).
Machine threshing versus hand threshing results in kernels possessing various de-
grees of damage [5]. Even slight damage to, or fissures in, seed coats makes the kernels
susceptible to insect infestation. Kernel breakage during combining occurs due to impact
on sound kernels and impact on kernels that have varying degrees of fissures. Sharma et
al. [6] found that rough rice at 17–19% moisture was more susceptible to breakage than
rice at 10.7–11.5% moisture. An increase in cylinder peripheral speed and the number of
passes through the thresher increased dehusking. The susceptibility to breakage in corn
[7] and wheat [8] was inversely related to moisture content. Kernel breakage can occur
if grain is dropped from a height into a storage facility [9] and due to pneumatic conveying
[10]. The breakage in both cases was greater at lower moisture contents.
There are several species of stored-grain beetles that are capable of damaging sound
kernels. These species include the rice weevils, granary weevils, maize weevils, lesser
grain borers, and larger grain borers. Both adults and larvae of these species cause grain
damage. Feeding by adults of these species results in production of grain dust. Damage
caused to grain by adult feeding provides a site of entry for storage molds, and the grain
dust creates conditions more conducive for other stored-product insects such as red and
confused flour beetles and sawtoothed grain beetles. These species are incapable of damag-
ing or effectively developing on sound kernels, but survive and multiply on broken kernels
and grain dust [11]. The dust produced by insect feeding could affect grain bulk density.
For example, the reduction in bulk density containing 0.4% of dust produced by lesser
grain borers ranged from 0.5–1% [12].
Handling grain, especially corn, increases the amount of dust found in the commod-
ity. Any time grain is handled (harvested, augered, pneumatically conveyed, dropped,
aspirated, or otherwise moved), there is some abrasion (often termed scouring) of the
outer seed coat or pericarp resulting in the formation of grain dust. Foster and Holman
[13] found that the quantity of fine material in wheat did not appreciably increase with
four handlings, but corn kernels cracked and broke releasing additional fine material with
each successive handling. A similar study also found that dockage increased in corn with
each successive transfer from one bin to another [14]. Moisture content of corn also plays
a factor, as drier seeds break more readily thereby producing more dockage and dust.
Grain-handling systems increase dust concentration, and typical concentrations range from
0.11–0.55% by weight [15]. The amount of broken kernels and dust produced increases
with the number of times it is transferred at the elevator [16] or in overseas shipments

[17]. In one of the corn lots, 2, 5, and 15 transfers resulted in 0.9, 4, and 9% breakage,
respectively [16].
IV. DOCKAGE IN BULK-STORED GRAIN

When grain is dropped into a storage facility, the fine material, which is lighter than the
grain, accumulates just below the point of fall, forming a ‘‘spout line.’’ Additionally,
whole and broken kernels tend to segregate in transit due to continuous vibration. Corn
containing 2–3% of fine material had more than 50% accumulated in the spout line area
[18]. Hall [19] showed that corn containing 4.4% fine material had up to 27% in parts of
the spout line. He showed that the width of the spout line in stored corn was related to
the particle size of the fine material. His data showed that accumulation of fines in stored
wheat was not as great as in corn, because in the former case fines were carried with the
wheat.
Data from 31 bins at 18 elevators in Kansas storing wheat sampled over a 7.6 month
period showed that the bins contained an average of 1.4% fine material (range 0.5–4.2%)
[20]. Wheat stored on farms in Kansas sampled in September, November, and January
had 1.1% fine material (range 0.4–2.5%). Reed and Pedersen [21] reported that the amount
of fine material in farm-stored wheat (after passing through a 0.16-cm ⫻ 0.95-cm oblong-
hole sieve) was greater in the bin center (3.1%) than in other bin positions (range 2.5–
2.7%). They reported that the center spout line was present in many bins, but the degree
of accumulation was not as heavy as those reported by Hall [19]. These spout line areas
are conducive for insect and mold activities. The type of insect species, for example, those
that attack sound kernels (internal feeders) or those that prefer broken kernels and dockage
(external feeders), associated with bulk-stored grain may be related to the distribution and
amount of dockage present. Dry grain heating due to insects or wet grain heating due to
molds [11] in bulk-stored grain generally starts in spout line areas. Grain heating because
of fungal activity and subsequent grain deterioration is common in spout line areas [22].
Heavy infestations of 17 insect species and 14 mite species developed in 18 hot spots in
stored wheat, oats, and barley in 13 farm granaries in Manitoba and Saskatchewan, Canada
[23].
A portion of the dockage in grain accumulates under the false bin floor or on the
bin floor after all of the grain is withdrawn from a bin. Unless bins are cleaned before
storing new grain, the residual dockage in the bins serves as an excellent site for supporting
insect infestations. In uncleaned bins, application of a residual insecticide does not provide
effective insect control, because the dockage particles absorb the applied insecticide and
very little is available for insect contact (see Section V.C). In addition, the presence of
food helps the insects survive insecticide exposure. The efficacy of residual pesticides is
improved on clean dust-free surfaces. Therefore, sanitation of empty bins followed by a
residual pesticide application is essential for controlling insects [24]. Grain producers are
very conscientious about bin sanitation. Producer surveys done in 1984 and 1986 in Kansas
[21] showed that 96.5% of the producers swept empty bins, and 79% treated bins with
an insecticide. Grain cleaning removes dockage, but only 2.4% of the producers cleaned
wheat before storage [21]. A 1991 survey in Kansas indicated a similar trend [25]. A
recent survey of 293 producers in Idaho, Illinois, Indiana, Kansas, Michigan, Minnesota,
Nebraska, North Dakota, Ohio, and Washington revealed that about 98% cleaned empty
bins before filling them with grain [26]. A survey of 286 commercial elevator operators

in those same states [26] showed that only 23% of operators cleaned wheat before storing
it. However, barely half of these same producers resealed leaky bin bases, and less than
half cleaned their handling equipment. Another national survey of producers [27] showed
that 14.5% of farmers vacuumed bin floors, and only 5.8% of farmers hosed down empty
bin walls.
In many farm bins and country elevators, dust collection systems for segregating
dust from grain are impractical or cost prohibitive. As farm-stored grain is moved into
country elevators, safety and health-related issues and deterioration by insects and molds
due to the presence of dust continue to occur. In the elevator system, grain movement
results in grain dust accumulation at various locations of the facility. This accumulated
dust serves as a feeding or oviposition site for stored-grain insects. For example, grain
dust sampled from several locations within four elevators in Kansas revealed that they
contained dermestid larvae [28]. Insects colonizing grain dust residues can later infest
grain stored in bins or grain that has been recently fumigated. Therefore, sanitation of not
only the grain, but also the facilities holding and handling the grain should be practiced
on a regular basis to minimize insect and mold problems.
V. PROBLEMS ASSOCIATED WITH DOCKAGE

A. Moisture Distribution
Moisture transfer in grain occurs predominantly by convection when there are differences
between the outdoor and grain temperatures [29]. When outdoor temperatures are warmer
relative to grain temperatures, the outer grain layers get warmer at a faster rate than the
grain center. Air movement in the bin periphery is upward, and air movement near the
bin center is downward. The convection currents result in moisture condensation at
the bin bottom. When outdoor temperatures are cooler than grain temperature, grain near
the bin periphery cools faster than at the bin center, resulting in moisture condensation
near the grain surface [30]. Mathematical models predicted that convection currents in-
creased grain moisture content by 2 percentage points [29], although increases of 3–5
percentage points have been observed by some researchers. Moisture migration and prob-
lems associated with moisture accumulation, such as insect and mold deterioration, are
more common in unaerated bins than in aerated bins. Reed and Worman [25] reported a
3% moisture increase of the surface grain layers from August to February in unaerated
farm bins in Kansas.
Moisture migration occurs because of nonisothermal conditions within the grain
mass. The presence of dockage may affect the movement of air through the grain mass
and indirectly affect moisture transfer within the grain bulk. The presence of fine materials
in the spout line area may result in greater accumulation of moisture in this fraction relative
to the grain, because the smaller dust particles with greater surface area–to–volume ratios
tend to be more absorptive. However, a recent study showed that ground and whole corn
kernels equilibrated to the same moisture content at a given temperature. Throne [31]
showed that at 30°C and 43 and 75% RH, finely cracked, medium cracked, coarsely
cracked, whole slit, and whole undamaged corn kernels equilibrated to the same moisture
content (at each of the humidities). At 43% RH all fractions of corn and whole corn
equilibrated to about 10.3% moisture, while at 75% RH the whole and processed corn
components equilibrated to 14.7% moisture. Nevertheless, the presence of fine material
with high moisture content favors rapid development of insects, mites, and molds.
Temperature fluctuations are greater near the grain surface than in other parts of the
grain mass [29]. Therefore, the grain temperature near the surface increases rapidly during
the day and stays warmer for extended periods than temperature in the rest of the grain
bulk. High moisture, temperature, and fines are prime conditions for insect and mold
population explosions. The presence of molds may favor establishment of a variety of
insect species that feed on molds, such as hairy fungus beetles, square-nosed fungus bee-
tles, and foreign grain beetles.
B. Insect Infestations
Flinn et al. [32] reviewed the effects of fine material in grain on insect infestations, and
their major conclusions are discussed here. The amount of fine material had a minor effect
on population growth rates of insects in wheat, but had a major effect on insects in corn.
The population growth rates of internal feeders, such as lesser grain borers and weevils,
were not influenced by the amount of fine material, because they are capable of damaging
sound kernels. The sawtoothed grain beetle, an external feeder, required fine material for
optimal growth. The survival, development, and progeny production of insects are affected
by the condition of grain. For example, maize weevils prefer whole kernels and develop
less effectively on cracked kernels or flour, whereas red flour beetles do well on floury
materials as opposed to whole kernels. Table 2 shows progeny production of maize weevils
and red flour beetles in whole, cracked, and flour components of pearl millet [33]. In
whole sorghum, maize weevils produced about 18 times more progeny than on finely
ground flour [34].
The proportion of dockage influenced infestation of wheat by red and confused flour
beetles [35,36]. White [37] reported that the exposure of germ in damaged kernels was
necessary for survival of young red flour beetle larvae, and the rate of development was
related to the degree of germ exposure. Cline [38] showed that the flat grain beetle’s
longevity and progeny production on whole-corn kernels, cracked corn, corn meal, or corn
halves were greatly reduced at 43% RH, but not at 75 or 84% RH. Coarsely cracked corn
was a better diet for this species than whole corn, meal, or halves. Sinha [2] showed that
the proportion of eggs of several stored-grain insects that developed into adults varied
with the amount of dockage in wheat and grain temperature. For example, wheat with
Table 2 Progeny Production in Whole or Processed Pearl Millet (300 g)

Originally Infested with Maize Weevils or Red Flour Beetles
Species Grain condition No. insects

Maize weevil Whole kernels 1342
90% whole, 10% cracked 1149
100% cracked 75
Flour 50
Red flour beetle Whole kernels 269
90% whole, 10% cracked 245
100% cracked 612
Flour 1417
Note: Maize weevils and red flour beetles were examined 76–78 days after infestation at
26.7°C, 65–70% RH.
Source: Ref. 33.

7% dockage significantly increased the number of sawtoothed grain beetle adults devel-
oping from eggs. However, higher dockage levels adversely affected survival of foreign
grain beetles at 30 and 33°C, but not at 27°C. Adult emergence of American black flour
beetles was highest at the 5% dockage level, whereas for red flour beetles, the 10% dock-
age level was most favorable at 27°C. However, at 33°C red flour beetles multiplied well
on dockage-free wheat. Rusty grain beetle adult production from eggs was similar in wheat
containing 2, 5, and 7% dockage at 27°C. However, at 33°C red flour beetles multiplied
well on dockage-free wheat. Rusty grain beetle adult production from eggs was similar
in wheat containing 2, 5, and 7% dockage at 27°C. At 33°C rusty grain beetles did not
multiply rapidly in wheat containing 5 and 10% dockage compared to clean wheat. These
findings suggest that removal of dockage/fines from grain before storing may reduce infes-
tations of external feeders. Dockage removal will not have any effect on internal feeders
such as weevils and borers.
C. Reduced Efficacy of Pesticides

Broken kernels and fine material in grain tend to absorb the applied insecticide, making
less available for deposition on kernels [39]. The amount of pesticide residue in dockage
may increase with increasing dockage levels. Anderegg and Madisen [39] applied 10 ppm
(w/w) malathion to 12.5% clean wheat and wheat containing 3 levels of dockage at 26°C
and 60% RH, under dark conditions. They found about 88.2% of the original residue on
clean grain after 2 months of storage. During the same time period, wheat containing 2.5,
5, and 10% dockage contained about 73, 67, and 53%, respectively, of the original residue.
Malathion residues in dockage increased with increasing dockage levels in grain. Strong
and Sbur [40] reported that malathion toxicity to granary weevils, rice weevils, and con-
fused flour beetles lasted longer on clean wheat than on wheat containing damaged kernels
and fine material. Malation was less effective against confused flour beetles when applied
to a 50% mixture of whole and cracked wheat, but was more effective when applied to
100% whole grain. [41].
Degradation of malathion applied at the rate of 11.6 ppm to cleaned sorghum, and
sorghum containing 3.8% foreign material was studied over a 12-month period [42]. For-
eign material did not influence the rate of disappearance of malathion. However, the au-
thors did not show the actual amount of residue that was present at the beginning of the
study.
Dockage includes varying amounts of plant parts and weed seeds, and therefore it
may be at higher moisture content than the grain. At the time of bin filling, organophos-
phate grain protectants (malathion, chlorpyrifos-methyl, or pirimiphos-methyl) are applied
to grain to manage infestations in storage. The degradation of organophosphate grain pro-
tectants increases with increasing moisture contents [43,44]. Therefore, removal of such
high moisture dockage improves the deposition of protectants on kernels. Furthermore,
residues tend to persist longer on cleaned than uncleaned grain.
Because dockage has greater absorptive ability, the effectiveness of fumigants, espe-
cially liquid grain fumigants that were used for stored grain insect control several decades
ago, was greatly reduced [45,46]. These liquid grain fumigants have been banned in the
United States and are no longer legal to use. Currently, phosphine is the most commonly
used grain fumigant [26]. The presence of dockage may obstruct the distribution of this
fumigant within the grain mass resulting in some areas receiving less than the lethal con-
centration required to kill the insects.
The presence of dockage or dust on bin floors or elevator floors will result in poor
performance of the residual pesticides such as cyfluthrin or diatomaceous earth, because
the dust prevents insects from coming in contact with the pesticide or the insects may
transfer some of the pesticide picked-up onto the dust [47,48]. In addition, the presence
of food may result in insects recovering from pesticide poisoning.
D. Improper Aeration
Aeration involves forcing ambient air at low velocity through a static grain mass to cool
the grain and eliminate temperature gradients [49]. Aeration is affected by the distribution
and amount of dockage in grain. Aeration is used to uniformly cool grain temperatures
to a point where insect and mite survival, growth, and reproduction are greatly minimized.
Depending on the species, this temperature is generally around 20°C or below. Reed and
Worman [25] reported that 76.5% of Kansas farm–stored wheat was equipped for aeration.
However, only 64% of producers and 66% of elevator managers actually aerated their
wheat. Aeration is more effective in clean grain than in grain containing dockage. Fines
accumulated within the interstitial spaces of kernels offer resistance to airflow during
aeration or grain drying, resulting in inadequate aeration or drying.
E. Problems During Unloading

The separation of fine material from grains entail a cost and causes problems to grain
handlers. The nonuniform distribution of fines in bins also results in grain containing
varying percentages of fines, as the grain in bins is loaded into trucks or rail cars. There-
fore, the first load that is removed may have a higher percentage of fines, resulting in that
lot not meeting the specific grain standards. The grain bulk as a whole may meet the grain
standard, but the first truck or railcar load may not. This may result in the rejection of
the shipment or application of penalties for not meeting the grade/contract requirements.
F. Safety and Health Hazards

Grain dust can cause human health problems and create a safety hazard. Potential health
hazards include occupational respiratory diseases and irritation to the eyes, ears, nose,
throat, or skin. The Occupational Safety and Health Administration standard [50] for
worker exposure to dust is 15 mg/m3 for total and 5 mg/m3 for respirable fractions. Grain
dust can impair visibility in the general working area (dump pit or elevator head house),
cause unpleasant odors, and decrease employee morale and productivity. These situations
potentially lead to negative community relations depending on the proximity to other
commercial or residential structures.
Most dust control systems at grain elevators do not separate and capture all dust
particles. Instead they mimize dust levels in worker areas. The operation of dust control
systems has little effect on dust concentrations inside elevator legs [51]. The level of dust
in these legs can provide the fuel needed for dust explosions, provided other conditions
such as oxygen, ignition source, and containment criteria are met. Generally, for a grain
dust explosion to occur, the dust suspended in air should be less than 100 µm in aerody-
namic diameter, and the suspended material must be at or above the minimum explosive
concentration. Typically the accepted minimum explosive concentration of grain dust is
50 g/m3 [52]. This minimum concentration, however, varies with the dust moisture content,
particle size distribution, and ratio of inert and organic dust [53]. Lesikar et al. [54] deter-
mined the minimum explosive concentration to be around 100 g/m3. There has been limited
evidence [55] to suggest that liquid fumigants and other gases such as methane could
work synergistically with dusts and cause explosions below the mimumum explosive con-
centrations. Therefore, potential fumigants should be evaluated with dusts to determine
if they alter the minimum concentration for explosions.
Small and dry dust particles heat up and explode quicker than large and moist parti-
cles. Explosions most frequently originate from vertical elevator legs. However, other
conveying or processing equipment, storage bins, and dust collectors can produce sus-
pended particulate material when they are in operation. The ignition source is commonly
an overheated bearing or misaligned belt. Other sources of ignition may include welding,
electric motors that are not ‘‘explosion proof,’’ and electrostatic discharge [56].
Anatomy of an explosion in a grain-handling facility consists of a smaller primary
explosion, which triggers one or more much larger secondary explosions [57]. The primary
explosion produces a relatively slow-moving fire wave and a fast-moving pressure wave.
The primary explosion generally ruptures the leg housing or containment, while the con-
cussion and resulting pressure wave will cause dust resting on beams, equipment, overhead
pipes, walls, and the floor to become airborne. All of this newly suspended dust then gets
ignited when the fire wave reaches that area, often resulting in severe damage and death.
Secondary explosions can produce pressures exceeding 551.6 kPa (80 psi). To put this
into perspective, only 13.8 kPa (2 psi) is needed to knock down a brick wall [56].
G. Penalties at Time of Sale

Dockage and foreign material in grain could result in price or weight discounts applied
at the time of sale. In Kansas, 41.2% of producers indicated that their wheat delivered to
elevators received a price discount, whereas 59% of producers indicated that they received
a weight discount. The percentage of lots receiving discounts increased with an increase
in dockage level [25].
VI. MINIMIZING PROBLEMS CAUSED BY DOCKAGE

A. Grain Cleaning
Grain cleaning is generally not practiced because many producers either apply a grain
protectant during bin filling or fumigate the grain some time after bin filling. Economists
continue to debate the financial feasibility of removing dockage and foreign material from
U.S. wheat prior to export. The equation is not always clear, because some export markets
will pay a premium for grain containing low levels of dockage, while other markets do
not. Webb et al. [58] expressed economic reasons for all U.S. export wheat to be cleaned
to a dockage level between 0.35 and 0.40%. Likewise, Hennessy and Wahl [59] discerned
that cleaning would be marginally profitable when dockage levels exceeded certain limits.
While additional cost is incurred when cleaning, the cleanings themselves can be sold in
specialty markets for animal feed, thereby recovering some of the costs. However, Johnson
and Wilson [60] proposed a series of equations that indicated why cleaning would result
in increased cost for all wheat exports, even though only certain markets require lower
dockage levels. If this were true, the U.S. grain would be less cost competitive in the
global market.
Grain elevator operators in the midwestern United States (where most of the grain
is produced) have little economic incentive to provide dockage-free grain. The Kansas
Grain and Feed Association member grain elevators were surveyed for their procedures
regarding dockage [61]. This survey concluded that the majority of elevator operators
measured and assessed for dockage at the point of sale, but only 4% of respondents actually
paid premiums for cleaner wheat. A follow-up study showed that large commercial eleva-
tors (handling 2 million bushels per year) were more likely to make a profit by cleaning
grain [62]. Value of the cleanings themselves had a great deal of influence on the decision
to clean. These data indicated that marketability of cleanings varied greatly from location
to location.
Hyberg et al. [63] concluded that the direct costs of cleaning wheat exceeded the
domestic benefits. Their reasoning was based on extensive economic data and the observa-
tion that domestic mills do not offer a premium for cleaner wheat, because the cleaning
costs at flour mills are static regardless of the grain condition. This study included proposed
benefits such as sale of cleanings and savings in transportation costs; lower costs for
drying, aeration, storage, and insect control; smaller discounts for test weight, foreign
material, and shrunken and broken kernels; insurance savings; and greater kernel unifor-
mity. However, the study by Hyberg et al. [63] did not consider potential benefits of
cleaning, such as less dust production from repeated handling which greatly improves
safety and reduces health-related hazards. Furthermore, cleaner wheat can be effectively
managed by aeration [49], thereby reducing reliance on grain protectants and fumigants.
The use of grain protectants and fumigants only when needed would reduce the rapid
development of resistance in insects and prolong the usable life of the pesticides. Resis-
tance in stored-grain insects to different classes of pesticides is widespread in the United
States and around the world [64]. These potential benefits are difficult to assess from an
economic viewpoint, but the outcome of the economic analysis may change if such benefits
are considered.
B. Use of Grain Spreaders

One method to overcome the nonuniform distribution of fines is to use grain spreaders.
Many grain spreaders are electric. Mechanical grain spreaders are used to prevent accumu-
lation of fines, and are more popularly believed to level the grain without manual labor.
The manual or gravity models also do an excellet job of distributing the fines. Only 15%
of wheat producers (n ⫽ 48) and 17% of corn producers (n ⫽ 41) in Minnesota used
spreaders [65]. A recent national survey [27] showed that 4.4% of concrete elevators and
10.7% of commercial steel storage facilities were equipped with spreaders.
Some mechanical spreaders include the Spreads-All A-3 High Capacity Spreader,
Spreads-All E-2 Spreader, and NECO Grain Leveler. These spreaders were described in
detail by Stephens and Foster [66]. The first two spreaders rotate about a vertical axis,
and the latter one is no longer in production but has a revolving horizontal auger with a
perforated outer tube that is suspended at the center of the bin and rides on a track installed
at the bin eave [66]. In dry corn containing less than 6% fines (foreign matter), filling the
bin with a vertical spout in the bin center resulted in 12–25% of fines accumulating just
below the spout and about 2% accumulating near the walls. However, when a spreader
was used, the fines ranged from 4–10% near the bin center and 1–3% near the bin walls.
All three spreaders performed similarly. The spreaders helped in uniformly distributed
the fines within the bulk-stored corn. The use of grain spreaders increased the grain bulk
density by 13–20%. This increase in bulk density is a result of fines filling in the void
spaces among kernels. Furthermore, a reduction in void spaces reduces the radius of the
intergranular spaces and increases its length, thereby increasing resistance to airflow.
Therefore, when mechanical spreaders are used, airflow rates for aeration or drying should
be increased to compensate for the increased resistance. Consequently, the power costs
will also increase with increased airflow rates [66].
C. Coring
Another effective method for removing fines and trash from the grain is to unload the
core (grain in the bin center) from each 60- to 120-cm (2- to 4-ft) layer as the bin is being
filled. After filling the structure, a few loads should be removed (through the bottom of
the structure) until an inverted cone of half the bin diameter is formed [30]. Less than
30% of producers and commercial grain operators followed this practice [26].
D. Use of Oils
The fine material in stored-grain facilities may contribute to dust explosions [67], as well
as adversely affect the health of grain handlers exposed to it [68]. Explosion prevention
through engineering has been investigated with ventilation (dust collection) and oil appli-
cations to reduce dust suspension in air at grain transfer points. Ventilation systems offer
the advantage of working with a diversity of grains, and protection is not time dependent.
Parnell [69] described a cyclone for air pollution abatement. Basic operating principles
of centrifugal collectors are discussed by Mody and Jakhete [70]. However, ventilation
systems are expensive, and dust disposal can be difficult.
The U.S. Food and Drug Administration in 1982 approved the use of food-grade
mineral oil on grain to suppress dust. The approval included treatment of grains intended
for human food at 0.02% by weight and grains intended for animal feed at 0.06% by
weight [71]. Oil (mineral or vegetable) applications are relatively inexpensive and work
well for short time periods. White et al. [72] determined that canola oil and white mineral
oil did not appreciably change the storability of wheat in the laboratory for up to 1 year.
Mounts et al. [73] showed that single 800-ppm applications of soybean oil and lecithin
mixtures had no significant odor or grade effect on soybeans, hard red winter wheat, soft
red winter heat, or corn when stored for up to one year. However, Peplinski et al. [74]
found that oil treatment reduced the test weight of corn.
Several researchers have tested various oils for their ability to suppress dusts. Cocke
et al. [75] using textile oil at 0.04% by weight on stored wheat reported that the dust
levels were suppressed by 59%. Increasing the oil level to 0.07% by weight reduced dust
levels by 92%. However, oil levels above 0.07% did not further reduce dust levels. They
observed similar results in tests with corn and soybeans. Deodorized soybean oil and
mineral oil suppressed dust levels in corn, wheat, and soybeans in commercial facilities.
Oils at 0.03–0.1% were effective in reducing dust concentrations up to 90% over a 3-
month period [76]. Jones and Parnell [77] observed similar results with mineral oil on
corn, wheat, and soybeans. Lai et al. [76] reported that water at 0.1–0.3% was an effective
dust suppressant for a short time period. However, it is illegal to add water to stored grain.
Rapeseed oil, used by Hsieh et al. [78] on wheat, effectively suppressed the dust, and the
application of oil did not affect any functional qualities. In general, oils are effective dust
suppressants and do not appreciably affect end use qualities of the grain.
Do oils affect the physical properties of grain? In order to verify this, Jayas et al.
[79] tested canola oil and mineral oil at 0.05–0.2% on clean wheat and wheat mixed with
5 or 10% dust to determine effects on bulk density, particle density, filling and emptying
angles of repose, and friction coefficients against plywood, concrete, and galvanized steel.
The oils had very little effect on bulk density changes. Grain dust increased particle density
because oils increased dust adherence to kernels. Grain dust increased the filling and emp-
tying angles of repose by 37 and 23%, respectively, at the 5% dust level, and by 43 and
26%, respectively, at the 10% dust level. The addition of oil increased these angles, espe-
cially at 0.05–0.1% levels by 10–30%. Grain dust increased the friction coefficient against
all surfaces, except galvanized steel. Coefficients were the same for wheat containing 5
or 10% dust. Oils also increased these friction coefficients, except on galvanized steel.
However, corrugated steel had the highest friction coefficient. The authors concluded that
on smooth galvanized steel, addition of oil to dusty grain increased lateral wall loads or
pressures and decreased vertical wall loads. They recommend that when calculating loads
on storage structures, the effects of oils and dust levels should be considered.
VII. BENEFITS OF MINIMIZING DOCKAGE LEVELS IN STORED

GRAIN
In this chapter, we have broadly addressed the sources of dockage, problems associated
with dockage in grain storage and handling, methods for cleaning grain, and methods for
suppressing dockage (dust) levels in bulk-stored grain. From the overview presented, it
is abundantly clear that there are many tangible benefits for removing or minimizing dock-
age levels in grain. These include (1) increased storage capacity, (2) reduced incidence and
population growth of external feeding insects, (3) reduced mold incidence, (4) improved
aeration, grain drying, and fumigation, (5) improved coverage of grain protectants and
consequently improved efficacy against insects, (6) a more uniform distribution of fines
within the grain mass resulting in load uniformity, (7) a significant reduction in explosion
hazards, (8) improved air quality in and around grain-handling facilities, (9) decreased
occupational exposure of workers to respirable grain dust fractions, and (10) potential
economic benefits for marketing cleaner grain. Grain that is dockage-free or grain that
has very little dockage will produce less dust when processed in flour and feed mills.
Reduced dust levels in mills may decrease insect incidence and abundance and increase
effectiveness of residual pesticides, thereby ensuring production of food or feed that is
wholesome. More importantly, air quality of the mill environment and safety to workers
would be greatly improved.
ACKNOWLEDGMENTS
This paper is Contribution No. 02-125-13 of the Kansas State University Agricultural
Experiment Station.
Mention of product or trade name does not constitute an endorsement for its use
by Kansas State University.
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30
Sanitation and Safety for a Fats
and Oils Processing Plant
RICHARD D. O’BRIEN
Fats and Oils Consultant, Plano, Texas, U.S.A.
I. INTRODUCTION
Fats and oils have been recovered for thousands of years from oil-bearing seeds, nuts,
beans, fruits, and animal tissues. These raw materials have been and continue to be impor-
tant ingredients for foods, cosmetics, lubricants, and chemicals. The extracted fats and
oils vary from pleasant smelling products that contain few impurities to very offensive
smelling, highly impure materials. Fortunately, researchers have developed technologies
for processing fats and oils products to make them more suitable for foods and other
applications. Developments in lipid processing technology have produced ingredients that
have been instrumental in the development of many of the current food products available
that provide the functional and nutritional requirements of discerning and better-informed
consumers. Processes have been developed to make them flavorless, odorless, and lighter
in color; modify their melting behavior; rearrange the molecular structure; remove poten-
tial disease-causing impurities; capture possible harmful materials, and effect other
changes to make them more desirable for their intended applications.
Process control is practiced during fats and oils processing to assure that safe, nutri-
tious, pleasant, cost-effective products are produced that perform as intended. These prod-
ucts must meet all of the applicable legal requirements for a food product and customers’
standards of quality, performance, economics, and aesthetics. Each fat and oil’s process
has individual critical control requirements that contribute to the quality assurance of the
finished product. In practice, fats and oils critical control points fall into the areas of
safety, quality, compliance, and economics. The hazard analysis and critical control points
(HACCP) system, a part of the process control system, is a method that assesses and
monitors food safety.
The basic concept of HACCP can be stated by the maxim ‘‘an ounce of prevention
is worth a pound of cure.’’ The HACCP system is based on the principle that food safety
issues can be eliminated or minimized by prevention during production rather than by
detection in the finished product. Development of a HACCP plan focuses on the identifica-
tion of critical points, along with procedures or activities that will adequately control them
to ensure safe production of a food product. Food safety hazards include all microbiologi-
cal, chemical, and foreign materials that, if consumed, could cause injury or harm [1].
II. EDIBLE FATS AND OILS COMPONENTS

The primary constituents of extracted fats and oils by triglycerides, but they also contain
varying amounts of nonglyceride materials. Some of the nonglyceride components are
undesirable and can be considered a food safety hazard, while others are very beneficial.
Therefore, the objective in all of fats and oils processing is to remove the objectionable
materials with the least possible damage to the desirable constituents. In most cases, free
fatty acids, phospholipids, moisture, color pigments, oxidation products, waxes, trace met-
als, proteins, pesticides, meal, dirt, and other gross impurities are the materials that need
to be removed. Most vegetable oils contain tocopherols, which are natural antioxidants
that protect the oils from oxidation and should be retained. For some products, neither
the color pigments nor waxes are detrimental and need not be removed. The major product
quality concerns are with free fatty acids, phospholipids, oxidation products, proteins, and
trace metals; all materials that affect the odor, flavor, and flavor stability of edible fats
and oils products. In the United States, fats and oils color is usually a major concern in
a cosmetic sense so pigment adsorption is a major impurities concern, especially for prod-
ucts marketed directly to consumers. The major food safety concerns are with residual
pesticides, mold, bacteria, and impurities developed during processing or with mishand-
ling.
A. Pesticides
Pesticides have been used for increased agriculture production throughout the world. Stud-
ies have shown that the majority of the pesticides applied eventually reach the soil surface
where they gradually spread, translocate to other environments, or degrade. Translocation
to oil-bearing plant seeds has also been demonstrated by studies. Processing studies have
shown that neither solvent extraction nor bleaching affected the pesticide levels in vegeta-
ble oils. However, it was found that pesticides were removed by volatization during hydro-
genation and/or deodorization [2–4]. United States government agencies have recognized
that the insecticides are distilled from edible oils during the deodorization process and
have forbidden the use of deodorizer distillates in animal feeds.
B. Mold and Bacteria

Moisture content is one of the most important factors in determining the storability of oil
seeds, fruits, nuts, and animal fats. Both molds and bacteria have critical moisture levels
for proliferation and enzymes function in an aqueous substrate. Microtoxins, or mold-
derived toxins, can infest oil seeds, nuts, and fruits that are routinely used as an oil source.
Only a small portion of the toxin is retained in the separated oil received during normal
processing. Filtration of the extracted oil lowers the aflatoxin level, and conventional re-
fining and bleaching effectively removes any residual aflatoxin [5].
C. In-Process Tank Impurities
Storage tanks throughout the process are normally dedicated to a particular source oil or
modified product. Even so these tanks are emptied and cleaned on a regular basis to remove
the sludge which collects on the tank bottoms. This sludge is composed of polymerized
oils, burnt particles, acid salts, high melting oil fractions and other impurities which de-
velop and settle out of the oils during storage. Cleaning equipment using high-pressure jets
rotating horizontally and vertically are effective in the large tanks ranging from 40,000- to
million-pound capacities. High temperatures, in the range of 185°F (85°C), and an appro-
priate detergent suitable for use in food plants are used for washing before rinsing with
clear water, and, finally, the tanks are sweetened with freshly processed oil.
D. Separation of Impurities
From the time that crude vegetable oils are expressed from the bean, nut, fruit, or seed,
and meat fat rendered from the fatty tissues, until the finished oil product is packaged,
edible fats and oils pass through clarification or filtration steps in almost evey stage of
the processing sequence. Even finished oils are subjected to a final filtration before packag-
ing or loading into tank cars and trucks. The three generally used methods of separating
impurities from oils are distillation, centrifugation, and filtration. Pesticides and other im-
purities are removed from fats and oils with deodorization, which is a steam distillation
process. Centrifuges are utilized to separate fines from solvent-extracted and screw-
pressed vegetable oils and to separate the saponified materials after caustic refining and
the gums participated with degumming processes. Filtration is employed as well as these
processes and in all of the other major fats and oils processes to remove impurities.
Filtration is the process of passing a fluid through a permeable filter media in order
to separate particles form the fluid. The particles may be either in suspension or in solution.
A filter medium is a porous material which allows a fluid to pass through yet retain the
particles to be removed. Examples of filter media are filter paper, filter cloth, and filter
screens. Filters of various types are used throughout fats and oils processing beginning
with clarification of the oils after extraction or rendering. Oils are filtered after bleaching
to remove the bleaching earth which has absorbed the color pigments and secondary oxida-
tion products; after hydrogenation to remove the nickel catalyst which promoted the reac-
tion; and after deodorization to remove minute quantities of burnt and polymerization
particles which can develop during the high temperature process. Polish filters are utilized
in the fats and oils process after movement of the product from one location to another
to insure that any impurities developed during that particular process are removed immedi-
ately.
III. PROCESSING FLOW SEQUENCE

A HACCP process hazard analysis begins with a detailed examination and evaluation of
the processing and handling facilities for the purpose of identifying the location and sever-
ity of food safety hazards. Hazard analysis begins with a current flowchart of the produc-
tion process, which provides a means to evaluate potential hazards. A complete HACCP
analysis encompasses all processes from the field to the final consumer. This evaluation
reviews each process or operation for situations that could result in adulteration with injuri-
ous materials, which fall into one or more of three categories, microbiological, foreign
material, and chemical. After determining the location of potential hazards, the next step
is to determine where critical control points exist. Critical control points are the positions
in the process flow where inadequate control would result in a contamination for which
there are no downstream provisions to correct them. After the critical points are identified,
it is essential to establish safe operating standards and monitoring procedures, frequencies,
and responsibilities.
Edible fats and oils processing involves a series of processes in which both physical
and chemical changes are made to the raw material. Figure 1 illustrates most of the poten-
tial processing flow sequencing to produe the various fats and oils products. The sanitaiton
concerns for fats and oils processing plants are similar to those of any other food processor;
for example; rodent, insect, and bird control; broken windows, leaking walls or roofs,
unsecured doors, and screened doors; dirty floor drains; cracks in floors; etc. But, the risks
are somewhat less since all of the processing is performed within closed systems. Many
of these systems are protected from the atmosphere with vacuum, pressure, or nitrogen.
Practically the only time that fats and oils products are exposed to the atmosphere is
during filling into a package or a tanker for shipment. Therefore, the major product hazard
concerns with fats and oils processing are the removal or impurities which have gained
access to the product prior to processing, added as a processing aid, or developed during
processing.
Processing of fats and oils is initiated by an extraction or rendering process to re-
move the fat or oil from the seed, bean, nut, fruit, or fatty tissues. Vegetable oils processing
after extraction almost always includes neutralization or refining, bleaching, and deodor-
ization, with the major differences being the choice of equipment and techniques utilized.
Rendered animal fats are normally clarified to remove impurities, bleached, and deodor-
Figure 1 Fats and oils processing flow sequence.

ized, again with equipment and techniques selection providing the major differences. Clar-
ification, neutralization, bleaching, and deodorization are all purification processes which
affect the flavor, flavor stability, and appearance of the fat or oil product while removing
harmful impurities.
Vegetable oils and animal fats are natural products with variable characteristics con-
tributed by nature. The fats and oils products selected for a particular application are made
on the basis of functionality. Each source oil or fat has characteristic functionality traits
which can be modified with the hydrogenation, interesterification, or fractionation pro-
cesses. The natural or modified fats and oils products can also be blended to change the
melting profiles, solidifation points, crystal tendencies, and other physical characteristics
of the fats and oils ingredients. A review of the major fats and oils processes follows with
an emphasis on the critical control points for food safety.
A. Extraction
Cleaning is the first step in the processing of vegetable oils. Typically, oilseeds contain
stems, pods, leaves, broken grain, dirt, sand, small stones, and other extraneous seeds.
These foreign materials reduce the oil content, adversely affect oil quality, and increase
the wear and damage potential to the extraction equipment. Shaker screens are used to
separate the particles on the basis of size, whereas aspiration separates on the basis of
density and buoyancy in a stream of air. Tramp iron, extraneous metal acquired during
harvesting, storage, or transportation is removed to prevent damage to the equipment by
the placement of magnets in chutes just ahead of vulnerable processing equipment.
Extraction of oil from materials of plant origin is usually done by pressing, with
the use of a continuous screw press or by extraction with volatile solvents. Prior to 1940,
mechanical pressing was the primary method used. Mechanical pressing had limits because
the oil recovery is poorer than with solvent extraction, and the high temperatures generated
damaged both the oil and the meal. Solvent allows a more complete oil extraction at lower
temperatures. Solvent extraction plants can be either batch or continuous. The continuous
extraction plants can be percolation, immersion, or direct extraction plants. Generally, the
oilseeds may be divided by oil content: above and below 20% oil content. In most cases,
oilseeds with a low oil content are subjected to both continuous and batch solvent extrac-
tion. High oil content seeds are normally extracted in two stages—first pressing and then
solvent extraction—however, many single-step continuous direct solvent extraction sys-
tems are currently in use.
To be used legally in the United States, oilseed extraction solvents and food pro-
cessing substances must have been subjected to an approval by the U.S. Food and Drug
Administration (FDA) or the U.S. Department of Agriculture (USDA), be generally recog-
nized as safe (GRAS) for this use, or be used in accordance with food additives regulation
promulgated by the U.S. FDA. Commercial hexane has been in major use since the 1940s,
as an oilseed extraction solvent on the determination that it is GRAS, and it may also be
subject to a prior sanction. Like many other food-processing substances, there is no U.S.
FDA regulation specifically listing n-hexane as GRAS or having prior sanction. However,
it has been cleared in as a solvent in a number of other food products, one of them a
cocoa butter substitute with a 5 ppm maximum limit. Because edible fats and oils are
subjected to deodorization and other purification processes as a part of the manufacturing
process before being used as a food product, they should not contain any of the extraction
solvent, if proper practices are followed [6].
B. Rendering
The fatty tissue from meat animals which is not a part of the carcass or that trimmed from
the carcass in preparation for sale is the raw material from which lard and tallow is ob-
tained. Separation of fat from the fatty tissues of animals is called rendering. The rendering
process consists of two basic steps. First, the meat byproduct is heated to evaporate the
moisture, to melt the fat present, and to condition the animal fibrous tissue. Two alternative
cooking temperatures are used: fat temperatures below 120°F and fat temperatures above
180°F. A more complete separation of the fat and protein is accomplished with the higher
temperature processing, but a better quality protein is obtained with the lower temperature
processing. Normally, the value of the protein dictates that the lower temperature, poorer
separation technique be used, which probably leaves trace quantities of protein in the
rendered lard or tallow. After cooking, the fat is separated from the solid proteinaceous
material. In batch rendering the cooked material is allowed to separate and the fat to drain,
followed by filtration, to complete the separation. Continuous rendering, introduced to
replace the batch systems, normally consists of a continuous cooker which requires less
cooking time and is more energy efficient with better quality control [7].
C. Refining Systems
Processors have the option of approaching edible oil purification in two ways; either chem-
ical or physical refining. The two systems utilize very similar processes, with the major
difference being the method used for free fatty acid removal. Chemical refining, the con-
ventional method used for removal of the nonglyceride impurities from edible fats and
oils, consists of optional degumming, caustic neutralization, bleaching, and deodorization.
The alkali refining process produces good quality oil and is flexible with the ability to
treat different oils and different qualities of individual oils. However, caustic refining has
three major drawbacks: (1) the soap produced promotes a tendency for emulsion formation
which will occlude neutral oil to increase oil losses, (2) oil losses are particularly high
when processing oils with free fatty acids over 3.0%, and (3) disposal of the soapstock
produced has become more difficult.
The second process, which has become known as physical refining, consists of re-
moving the fatty acids from the oil by steam distillation under vacuum after the phospha-
tides have been removed by a degumming process followed by a pretreatment process
before bleaching. The major advantages for physical refining are the elimination of soap-
stock, lower capital costs, and fewer processes to operate and maintain. The objective of
the initial processing step in either refining method is the removal of phosphatides, color
bodies, and trace metals. Removal of these nontriglyceride impurities is crucial to ensure
good product quality. Herein lies the major drawback for the physical refining system;
i.e., complete phosphatide removal with degumming and bleaching is very difficult. Some
of the other problems with physical refining systems can be (1) additional bleaching earth
usually required, (2) pesticides are codistilled with the fatty acids during steam refining,
(3) phosphoric acid treatment may darken the gums produced and incomplete removal
can produce off flavors in the oil after deodorization, (4) steam distillation or deodorizer
units must be designed to handle higher concentrations of free fatty acids, (5) cottonseed
oil cannot be physically refined because the gossypol pigment must be removed with
alkali refining, and (6) it may be necessary to steam refine before hydrogenation or other
processing to adjust melting characteristics and deodorize again following these processes.
Physical refining is favored for processing high free acidity oils with low phosphatide
contents; it has been demonstrated to produce good quality product from coconut, palm
kernel, palm, lard, tallow, and some of the seed oils [8].
D. Degumming
Degumming is the treatment of crude vegetable oils with water, salt solutions, or dilute
acids such as phosphoric, citric, or maleic to remove phosphatides, waxes, and other impu-
rities. Degumming converts the phosphatides to hydrated gums, which are insoluble in
oil for separation as a slude by settling, filtering, or centrifugal action. Phosphatide removal
is the first process for the physical refining system and can also be for chemical refining.
However, with chemical refining the processor has the option of removing the phospha-
tides for their byproduct value as lecithin or treating them as impurities to be removed
along with free fatty acids during caustic neutralization.
E. Caustic Neutralization
The conventional caustic neutralization process is the most widely used and most well
known purification system. The addition of an alkali solution to a crude oil brings about
a number of chemical and physical reactions: (1) the alkali combines with the free fatty
acid present to form soaps, (2) the phosphatides absorb alkali and are coagulated through
hydration, (3) pigments are degraded, absorbed by the gums, or made water soluble by
the alkali, and (4) the insoluble matter is entrained with the other coagulable material.
Efficient separation of the soapstock from the neutralized oil is a significant factor in
caustic neutralization, which is usually accomplished with centrifugal separators. The con-
ventional caustic soda neutralization systems have the flexibility to efficiently refine all
of the crude oils presently utilized for food products [9].
Caustic neutralization is ordinarily accomplished by treating the fat or oil with di-
luted sodium hydroxide. This treatment forms soapstock with the free fatty acids, phospha-
tides, trace metals, pigments, and other nonglyceride impurities that can be separated by
settling or centrifugal force from the neutralized oil. The neutral oil is usually water
washed and again separated by settling or centrifuged to remove trace impurities and
residual soaps from the neutralization and separation processes. After water washing, the
oil is either dried with a vacuum dryer or immediately bleached to remove the trace quanti-
ties of water remaining.
F. Bleaching
Edible fats and oils bleaching is popularly and correctly regarded as the partial or complete
removal of color; however, bleaching is also an integral process in both the chemical and
physical refining systems. Bleaching is relied upon to clean up the traces of soap and
phosphatides remaining after caustic neutralization and water washing for the chemical
refining system. For physical refining, the technical feasibility depends upon bleaching as
a pretreatment to remove phosphatides, trace metals, waxes, and the color pigments. An-
other, very important function of bleaching, in both refining systems, is the removal of
peroxides and secondary oxidation products.
The usual method of bleaching is by adsorption of the pigments and other nonglycer-
ide impurities on bleaching earth. In a typical process, the bleaching materials are added
to the oil in an agitated vessel either at atmospheric pressure or under a vacuum. The oil
is heated to bleaching temperature and held to allow contact time with the bleaching earth.
After the adsorbent has captured the color pigments, soap, phosphatides, trace metals, and
polar materials, it becomes an impurity which must be removed from the oil with a filtra-
tion system. Control point impurities analyses are used to monitor the removal of the
potential food safety hazard.
G. Animal Fat Purification Systems

Traditionally, the method used to purify meat fats has been a form of physical refining.
The two main impurities in meat fats are proteins carried over from the rendering process
and free fatty acids. The pretreatment phase for meat fats is the removal of the protein-
aceous materials. Typically this is easily accomplished by adding small amounts of diato-
maceous earth and/or bleaching earth followed by filtration. An alternative clarification
or pretreatment method is to water wash the fat to remove the proteins. This method also
requires bleaching or at least drying to remove the moisture remaining in the oil after
water washing. A third method for meat fat clarification is caustic refining. Chemical
refining is usually reserved for poor quality animal fats or for specialty products used
undeodorized to preserve the characteristic meat fat flavor. The caustic refining system
consists of caustic neutralization, water washing, and vacuum drying.
H. Hydrogenation
The hydrogenation process is an important tool for the edible fats and oils processor. With
hydrogenation, liquid oils can be converted into plastic or hard fats more suitable for a
particular food product. There are two reasons to hydrogenate a fat or oil: (1) to change
the physical form for product functionality improvement and (2) to improve oxidative
stability. Hydrogenation involves the chemical addition of hydrogen to the double bonds
in the unsaturated fatty acids. The reaction is carried out by mixing heated oil and hydrogen
gas in the presence of a catalyst. After the hyhdrogenation end point has been achieved,
the hardened oil is cooled and filtered to remove the nickel catalyst.
Most hydrogenations are preformed in batch reactors due to the variation in raw
materials and the desired end products. Normally, batch hydrogenation is performed in
an agitated tank reactor with heating and cooling capabilities designed to withstand pres-
sures of 7 to 10 bar. First, the catalyst is suspended in the oil. Then, hydrogen gas, dis-
persed as bubbles, must be dissolved in the oil to reach the surface of the catalyst. The
three reaction variables, pressure, temperature, and rate of agitation, are controlled to re-
duce batch-to-batch variation for preparation of the desired hydrogenated product or base-
stock. The typical analytical evaluations for endpoint control which measure consistency
are refractive index, iodine value, and various melting points. A food safety control point
would be the incomplete removal of the nickel catalyst after the reaction is completed;
however, this is not a critical control point because the postbleaching process immediately
following hydrogenation is designed to remove any remaining trace catalyst impurities.
I. Postbleaching
A separate bleaching operation, immediately following the hydrogenation process, has
three purposes: (1) insurance that all traces of the prooxidant hydrogenation catalyst that
has escaped the filtration system after hydrogenation have been removed, (2) to remove
undesirable colors generally of a greenish hue accentuated during hydrogenation by heat

bleaching of the red and yellow pigments, and (3) removal of peroxide and secondary
oxidation products. Postbleach systems are usually batch systems for the same reason as
for hydrogenation systems, production of a wide variety of hydrogenated basestocks.
J. Fractionation
Edible fats and oils are fractionated to provide new materials more useful than the natural
product. Fractionation may be practiced to remove an undesirable component, which is
the case with dewaxing and winterization, or to provide two or more functional products
from the same original fat or oil as is the case with cocoa butter equivalents or substitutes
and high stability oils.
The three fractionation process types practiced commercially to produce the value
added products are (1) dry fractionation, (2) solvent fractionation, and (3) aqueous deter-
gent fractionation. Dry fractionation, which includes winterization, dewaxing, hydraulic
pressing, and crystal fractionation processes, is probably the most widely practiced. Sol-
vent or aqueous detergent fractionation processes provide better separation of specific
fractions for the most sophisticated fats and oils products. All of these fractionation pro-
cesses practice the three successive stages of fractionation: (1) cooling the oil to supersatu-
ration to form the nuclei for crystallization, (2) progressive growth of the crystalline and
liquid phases, and (3) separation of the crystalline and liquid fractions. A food safety
control point identified for the solvent fractionation system would naturally be removal
of the solvent used. Complete solvent removal is assured with steam distillation in the
deodorization process which is downstream.
K. Interesterification
The interesterification process can alter the original order of distribution of the fatty acids
in the triglyeride-producing products with melting and crystallization characteristics differ-
ent from the original oil or fat. Unlike hydrogenation, interesterification neither affects
the degree of saturation nor causes isomerization of the fatty acid double bond. It does
not change the fatty acid composition of the starting material but rearranges the fatty avids
on the glycerol molecule. The process of interesterification can be considered as the re-
moval of fatty acids from the glyceride molecules, then shuffling and replacing them on
the glyceride molecules at random. This change in the distribution of the fatty acids affects
the structural properties and melting behavior of the fats and oils. Commercially, the inter-
esterification process has been utilized for the production of confectionery fats, margarine
oils, cooking oils, frying fats, shortenings, and other special application fats and oils
products.
Two types of chemical interesterification process are practiced: random and directed.
Random rearrangement of fats and oils can be accomplished using either a batch or contin-
uous process. Both random interesterification processes perform the three important re-
arrangement steps: (1) pretreatment of the oil, (2) reaction with the catalyst, and (3) deacti-
vation of the catalyst. In the directed rearrangement process, one or more of the triglyceride
products of the interesterification reaction is selectively removed from the ongoing reac-
tion. Continuous processes are normally used for directed rearrangements for better con-
trol. Trisaturated glyerides are crystallized and separated from the reaction, which upsets
the reaction equilibrium so that more trisaturated glycerides are produced.

L. Blending
Different stocks are blended to produce the specified composition, consistency, and stabil-
ity requirements for the various fats and oils products, such as shortenings, frying fats,
margarine oils, specialty products, and even some salad or cooking oils. The basestocks
may be composed of hydrogenated fats and oils, interesterified products, refined and
bleached vegetable oils, purified animal fats, and/or fractions from winterization, dewax-
ing, or another form of fractionation. The products are blended to meet both the composi-
tion and analytical consistency controls identified by the product developers and quality
assurance. The consistency controls frequently include analytical testing for solids fat
index, iodine value, various melting points, fatty acid composition, and other evaluations
designed to ensure compliance with customer requirements. The blending process requires
scale tanks and meters to proportion the basestocks accurately for each different product.
The blend tanks should be equipped with agitators and heating to assure a uniform blend
for consistency control [9].
M. Deodorization
With conventional edible oil processing, deodorization is the last in a series of process
steps used to improve the taste, odor, stability, and the food safety of the fats and oils by
the removal of undesirable substances. In this process, the fats and oils products are steam
distilled under vacuum. The object is to remove the volatile impurities from the oil. The
foremost concern from a quality aspect is the volatile impurities removal, which are the
objectionable flavors and odors; however, deodorization is also very important from a
food safety aspect. Steam distillation removes any trace pesticide and heavy metals content
obtained during the growing process. Deodorization is primarily a high-temperature, high-
vacuum, steam distillation process to remove volatile, odoriferous materials present in
edible fats and oils. It is the last major processing step through which the flavor and odor
and many of the stability qualities of a fat or oil product can be changed. From this point
forward, efforts must be directed toward retaining the quality that has been built into the
fat and oil product with all of the preceding processes [9].
The odoriferous substances in fats and oils are generally considered to be free fatty
acids, peroxides, aldehydes, ketones, alcohols, and other organic compounds. Experience
has shown that the removal of flavor, odor, and other undesirables correlates well with
the reduction of free fatty acids. Therefore, all commercial deodorization consists of steam
stripping the oil for free fatty removal. Currently, batch, semicontinuous, and continuous
systems of various designs are utilized by edible fats and oils processors to produce deo-
dorized oil. All of the systems utilize steam stripping with four interrelated operating
variables: vacuum, temperature, stripping steam rate, and holding time.
N. Liquid Oil Filling and Packaging

Most salad and cooking oils are packaged shortly after deodorization in containers for
home, restaurant, or large food processor use. The processing necessary for most oils is
oxidative stability preservation measures such as nitrogen protection, temperature control,
light avoidance, and the addition of any additives required by the individual products.
The oil is filtered for a final time in-line to the bottle filler. The effectiveness of this final
filtration is monitored with laboratory filterable impurities testing of packaged product
samples obtained utilizing a statistical sampling plan. Food safety concerns for retail liquid
oil were lessened with the packaging change from glass to plastic containers. Glass break-
age and contamination of other containers were major concerns when glass bottles were
used. Exposure of the oil to the atmopshere is limited to a microsecond for most filling
lines with a temper-evident seal applied to the container before the cap is applied.
O. Shortening Plasticization and Packaging

Plasticized shortening products can be defined as fats with a consistency that can be readily
spread, mixed, or worked. Considerably more is involved in the plasticization of shorten-
ing and margarine than merely lowering the temperature to cause solidification. Slow
cooling of these products produces a grainy, pasty, nonuniform mushy product that lacks
the appearance, texture, and functional characteristics associated with plasticized products.
Development of these characteristics is a function of controlled crystallization or plastici-
zation. The final consistency of a shortening is the culmination of all the factors influencing
crystallization and plasticization: chilling, working, tempering, pressure, and gas incorpo-
ration.
The plasticization process involves the rapid chilling and homogenization of shorten-
ing mixture. Most shortenings are quick chilled in closed thin-film scraped-wall heat ex-
changers with extrusion valves to deliver a smooth homogeneous product to the package
at 17 to 27 atm pressure. Nitrogen is injected at 13 ⫾ 1% into most shortenings to increase
the product’s workability and provide a white, creamy appearance. After packaging, many
processors temper shortenings at temperatures slightly above the packaging temperature
to allow the crystal structure of the hard fraction to reach equilibrium and form a stable
matrix. After tempering, shortenings are usually stored and shipped at controlled tempera-
tures of 70 to 80°F (21.1 to 26.7°C) to avoid crystal change and loss of the plastic proper-
ties [10].
Shortenings are only exposed to the atmosphere during the actual filling of the prod-
uct into the container, which is less than 15 sec for the slowest filling lines. Protection
from contamination from the atmosphere is provided at the filling lines with covers and
other protective devices. As in most of the other fats and oils processes the oil is filtered
for a final time while being pumped to the plasticization equipment. Laboratory filterable
impurities testing of the packaged product will determine if this filtration effectively re-
moved any particles of polymerized or charred oil that may have developed during storage
or movement to the shortening filling department. A positive finding at this point is only
resolved by reworking the packaged product involved. This necessitates a remelting of
the product reprocessing that may include bleaching and deodorization. Shortenings free
of impurities and that meet all of the other quality requirements are released for shipment
after the product has crystallized to the predetermined consistency.
Plasticization provides a safety risk that requires careful control: metal contamina-
tion from the plasticization equipment. The scraped wall heat exchangers have very tight
tolerances between the floating metal scraper blades and the chilling surface. A malfunc-
tion of this equipment can distribute shreds of metal into the product. Protective devices
such as magnetic traps downstream of the plasticization equipment, screens to filter the
product, and metal detection after packaging is used on almost all shortening and marga-
rine packaging lines. The magnetic traps and the screens need to be inspected on a routine
basis, probably daily, to insure that no problems have developed since the last inspection.
Metal particle findings necessitate a hold on the release of the product filled on that particu-
lar line during the period covered by the last inspection. Packaged product metal detectors
usually isolate the package with a positive detection. Inspection of these packages must
include the package itself because the detection levels must be set to very sensitive levels.
At these levels the equipment will alarm with the tramp metal contained in many packages.
The package metal detectors should be tested hourly with a test wand or package with
metal contents at the lowest detection level.
P. Margarine Mixing, Chilling, and Packaging

Margarine was developed and continues to be a butter substitute. It is a flavored food
product containing 80% fat, made by blending selected fats and oils with other ingredients,
such as milk, salt, and colors, and fortified with vitamin A to produce a table, cooking,
or baking fat product that serves the purpose of dairy butter but is different in composition
and can be varied for different applications. Now spreads have been developed as marga-
rine substitutes. The major difference between spreads and margarine is that spreads are
not required to contain a minimum of 80% fat.
Processing for margarines and spreads begins with the preparation of an emulsion
of the ingredients. Emulsions are prepared by adding the oil soluble ingredients to heated
margarine oil formulations in an agitated emulsion tank. Concurrently, a pasteurized aque-
ous phase is prepared by mixing all of the water-soluble ingredients together in another
vat. The water phase is then added to the oil phase to make the emulsion. The emulsion
is rapidly chilled with scraped wall heat exchangers similar to those used for shortening
products. The plasticized products are then formed into prints, or filled into the various
containers for consumer, restaurant, or food processor use. Most margarine and spread
products are stored at refrigerator temperatures immediately after packaging, except for
some specialized baking products [9].
The high moisture content with or without milk makes margarine and spreads a
good growth media for microorganisms. Bacteria need food, moisture, and heat to grow.
They are not mobile and have to be transported from place to place, most often by
hands, shoes, and clothes. Therefore, the first preventive measures to practice are the good
manufacturing practices (GMPs). The generic first area for any HACCP program for all
areas of the plant, but with special attention in the margarine areas, is employee hygiene
to prevent the spreading of human bacteria like E. coli. The equipment must be kept clean
and sanitized to prevent the growth of microorganisms. Normally, margarine processing
equipment are cleaned and sanitized with clean-in-place (CIP) systems. In many plants,
a highly acidic solution may be held in the equipment and lines during down periods to
discourage bacterial growth. Additionally, any suspect ingredient should be pasteurized
before use. Many margarine producers will pasteurize the water phase of the margarine
or spread emulsions using continuous in-line high-temperature/short-time (HTST) pas-
teurization techniques. Formulation-wise, it is desirable to add preservatives to the product,
where permitted. After packaging, margarine and spread products are stored, shipped, and
displayed in the grocery stores under refrigeration.
The product safety preventive measures are followed up with testing for harmful
microorganism contamination. The types of bacteria that most margarine manufactures
check for are [9]
Coliform. Some members of the coliform group are found in the intestines of all
warm blooded animals. They are not generally considered pathogenic or disease
producing but rather as ‘‘fellow travelers’’ with intestinal pathogens. Coliforms
do not survive pasteurization. When found in pasteurized product, their presence
is suggestive or unsanitary conditions or practices during production, packaging,
or storage. Coliform testing measures the quality of the sanitation procedures.
Standard Plate Count. Total plate count is valuable as a sanitation indicator and
for quality information. The bacteria that grow at the total plate count incubation
temperature are known as mesophiles and include a wide variety of microorgan-
isms. The media used is nutrient rich and nonselective. Both pathogenic and non-
pathogenic organisms may be present.
Yeast and Mold. Yeast and mold have very similar growth parameters. Both are
able to survive extremes in conditions, such as pH, water activity, and high con-
centrations of sugar, that most bacteria cannot tolerate. Since yeast and mold can
survive such conditions, they are important spoilage organisms in margarine and
spread products. The presence of yeast and mold in these products indicates poor
sanitation practices.
Thermophile. The term thermophile is used to describe a group of microorganisms
that grow in the 131 to 194°F (55° to 90°C) range. These organisms are very
heat sensitive and can cause spoilage of product. They will grow into spores if
held at elevated temperatures or if the product is improperly cooled.
Pathogenic Microorganisms. A pathogen is an organism that causes disease. The
two types that are of interest for margarine and spread products are infections
and intoxications. Salmonella, E. coliform, and Listeria are infectious organisms
that can grow in margarine-type products. These live organisms are poisonous to
humans and cause food poisoning when they are ingested. The other organism
that pose a problem is Staphylococcus. Some strains of Staphylococcus produce
a toxin that is poisonous to humans when ingested. Pasteurization will kill the
organism, but once the toxin has been formed it remains active. This is the reason
hand contamination of product after pasteurization can have very critical effects.
Q. Flaking and Spray Chilling

Fat flakes describe the higher melting fat and oil products solidified in a thin flake form
for ease of handling, quick remelting, or for a specific function in a good product. Chill
rolls and processed oil formulations have been adapted to produce several different flaked
products that can provide distinctive performance characteristics in specialty formulated
foods. The flaked products, produced almost exclusively for the restaurant and food pro-
cessor consumers, are hardfats or stearines, shortening chips, icing stabilizers, confectioner
fats, hard emulsifiers, and other customer-specific products.
The flake products are solidified on a chill roll, which has been described as an
endless moving chilling surface, held at a temperature below the crystallization point of
the applied fat or oil product to form a congealed film on the outer surface. Specifically,
chill rolls are usually 4-ft diameter hollow metal cylinders, in various lengths, with a
machined and ground smooth surface, internally refrigerated, that revolve slowly on longi-
tudinal and horizontal axes, with several options for feeding the melted oil onto the surface.
After application, a thin film of liquid fat is carried over the roll, and as the revolution
of the roll continues the fat is partially solidified. The solidified fat is scraped from the
roll by a doctor blade positioned ahead of the feeding mechanism with all of the chill roll
designs. Flakes are packaged in kraft bags, corrugated cartons with vinyl liners, or other
suitable containers for storage and shipment [10].
Spray-chilled or powdered fats are specialized products developed for ease of incor-
poration, handling, melting efficiency, uniform delivery with addition systems, encapsula-
tion, and other special purpose uses. The spray-chilling process consists of atomizing a
molten fat in a crystallization zone or tower, maintained under temperature conditions
where a very fine mist of the melted fat is contacted with cooled air or gas to cause
crystallization without marked supercooling [9].
Flaked products present the most opportunity for product contamination during pro-
cessing of all the fats and oils products. During chilling the product is exposed to the
atmosphere longer than any of the other packaging operations. Most chill rolls are pro-
tected from airborne contamination with shields, but the chill time and slow packaging
rate require constant attention by the packaging employees. Metal contamination is also
a product risk with some of the chill roll arrangements using application rolls or metal
doctor blades. Metal detection after packaging and constant visual attention by the packag-
ing employee have effectively identified any problems. Nevertheless, the preventive mea-
sures are proper equipment maintenance, proper equipment set-up, and diligent inspection
of the equipment.
R. Bulk Fats and Oils Shipments

Food processors that use fats and oils in large quantities many times have the facilities
to handle this ingredient liquid in bulk. All of the products packaged for shipment and
use can be provided to the customers in tank cars or tank trucks, except margarine and
spread mixes which contain milk and salt. The customers for these bulk products must
have fats and oils bulk handling systems to receive, store, and handle the liquid products.
Impurities and contamination are the two major food safety concerns which are controlled
with a thorough inspection of the cleanliness of the tankers and inline filtration of the oil
during loading. Oil purity is monitored with laboratory filterable impurities evaluations
of representative sample obtained from the tanker after loading. An impurity deviation at
this point necessitates unloading of the tanker and reprocessing to remove the impurity
identified. In addition, it is standard practice for the bulk oil customer to again filter the
oil as it is being unloaded into his facility.
REFERENCES
1. R Vail. Fundamentals of HACCP. Cereal Foods World 39(5):393–395, 1994.
2. KJ Smith, PB Polen, DM DeVries, FB Coon. Removal of chlorinated pesticides from crude
vegetable oils by simulated commercial processing procedures. J Am Oil Chem Soc 45(9):
866–869, 1968.
3. TL Mounts, CD Evans, HJ Dutton, JC Cowan. Some radiochemical experiments on minor
constituents in soybean oil. J Am Oil Chem Soc 46(9):472–484, 1969.
4. MM Chaudry, AI Nelson, EG Perkins. Distribution of aldrin and dieldrin in soybeans, oil,
and by-products during processing. J Am Oil Chem Soc 53(11):695–697, 1976.
5. WA Parker, D Melnick. Absence of aflatoxin from refined vegetable oils, J Am Oil Chem
Soc 43(11):635–638, 1966.
6. PJ Wakelyn. Regulatory considerations for oilseed processors and oil refiners. In: P Wan et
al., eds. Introduction to Fats and Oils Technology, 2nd Ed. Champaign, IL: AOCS Press, 2000,
pp 319–321.
7. WH Prokop. Rendering systems for processing animal by-product materials. J Am Oil Chem
Soc 62(4):805–811, 1985.
8. FVK Young. Physical refining. In DR Erickson, ed. Edible Fats and Oils Processing: Basic

Principles and Modern Practices: World Conference Proceedings, Champaign, IL: American
Oil Chemists Society, 1990, pp 124–135.
9. RD O’Brien. Fats and Oils Formulating and Processing for Applications. Lancaster, PA: Tech-
nomic Publishing Co., 1998, pp 1–4, 47–54, 129–131, 168–175, 182–183, 251–253, 258–
260, 264–266, 483, 525, 652–653.
10. RD O’Brien. Soybean oil crystallization and fractionation. In: DR Erickson, ed. Practical
Handbook of Soybean Processing and Utilization. Champaign, IL: AOCS Press and United
Soybean Board, 1995, pp 260–264.

31
Poultry Processing, Product
Sanitation, and HACCP
T. C. CHEN
Mississippi State University, Mississippi State, Mississippi, U.S.A.
PING-LIEH THOMAS WANG

Fieldale Farms Corporation, Baldwin, Georgia, U.S.A.
I. TRENDS IN POULTRY MEAT CONSUMPTION

Poultry is one of the world’s fastest growing meat sources. Poultry includes mainly broil-
ers, other chickens, turkeys, ducks, and geese; however, broilers account for nearly 70%
of the total. This growth in the world poultry market has resulted from increased income
and demand. Between 1970 and 1990, developing countries boosted poultry output nearly
four times, which resulted in an increase of the world poultry meat share from 25 to 36%.
During the past 25 years, there has been a 200% rise in total world poultry meat
consumption. The number is especially significant in comparison with a rise of only 73%
for red meat consumption. The major reason for this increase is the lower price of poultry
in comparison with that of red meat. Other factors include changes in food habits and
dietary considerations that highlight the low fat content of poultry. In 1992, nutrition was
chosen as the number one factor in the purchase of chicken by consumers, and price came
in second.
The largest poultry meat producing country in the world is the United States. Effi-
ciencies attainable from technology have changed the U.S. poultry industry. Through inte-
gration, consolidation (larger and fewer firms), shortening the production cycle, and con-
centrating production in fewer states, the U.S. poultry industry has experienced a larger
and growing domestic market. Per capita poultry consumption moved past the pork sector

Table 1 Per Capita Consumption of Muscle Foods in the United States, in Pounds
Year Beef Pork Chicken a Turkey a Seafood
1960 59.1 48.6 19.2 4.9 10.3
1965 70.4 43.6 22.9 6.0 10.9
1970 79.6 48.1 27.4 6.4 11.7
1975 83.0 38.3 26.4 6.5 12.1
1980 72.1 52.1 32.7 8.1 12.4
1985 74.6 47.7 36.4 9.1 15.0
1990 63.9 46.4 42.4 13.8 15.0
1995 63.6 48.4 48.2 13.9 14.8
2000 64.5 47.7 52.9 13.7 15.2
Source: ERS, U.S. Department of Agriculture.

a
Boneless edible weight.
in 1985 and passed the beef sector in 1989. Today, poultry meat is the number one meat
in the United States, with a per capita yearly consumption of 94.7 lb (Table 1).
Marketing of poultry products has truly been one of the keys to success of the poultry
industry in the United States. The combination of more healthful image, competitive price,
and most recently the development of further-processed products has been largely respon-
sible for the rapid growth in poultry consumption. Fast-food cutlets now offer poultry
items such as chicken nuggets, fillets, tenders, etc. Families can now buy cut-up parts for
convenience; thereby avoiding wasted leftovers. Many of the U.S. broiler companies have
aimed their marketing strategies at providing the products needed by the fast-food chains
and have been successful with that approach. The increasing popularity of deboned breast
meat led poultry companies to further segment the market through bird weights. Compa-
nies started growing heavier birds for deboning since the amount of labor to process a
small breast was nearly the same as for a large breast, and therefore the labor cost per
pound was less for the larger breast.
II. POULTRY PROCESSING TECHNOLOGY

The technology of the poultry meat industry differs from red meat industries. Poultry
processing refers to slaughtering, feather removal, and evisceration. Historically, the most
important development in the processing industry was the invention of the rubber picking
finger. By the mid-1940s, rubber fingered picking machines were perfected and much of
the hand labor formerly used for pinning carcasses was eliminated. Mandatory poultry
inspection also helped the progress of the poultry processing industry. To meet inspection
requirements, many plants had to modernize their facilities and adopt strict quality control
programs.
As broiler meat dominates poultry meat, broiler processing steps will be considered
as the normal procedure. The following are the abridged processing procedures [1–3]:
1. Live bird pick-up and hauling. Whenever possible, live birds or broilers are
caught at night for loading. At that time they are easier to catch, struggle less, and settle
down in the coops faster, and especially in the summer, the weather is cooler at night.
The normal procedure in the broiler house is to raise the feeders and waterers above the

reach of the birds at least 1–4 hr prior to the arrival of the live haul crew. The optimal
withdrawal time for feed and water is about 10–12 hr. Live bird shrinkage can range from
0.3 to 0.5% per hour over a 24-hr period. Minimizing bruises on the carcass and allowing
sufficient time to clear the digestive tract are the major concerns during live bird pick-up
and hauling.
2. Receiving and holding. Truckloads of live birds are held in a holding shed at
the processing plant while awaiting unloading. Adequate ventilation is necessary to pre-
vent live birds from dying of heat prostration.
3. Hanging on the kill line. In removing birds from crates, bruises and broken
bones must be avoided. The hanging of all poultry on shackles should be done in a manner
to minimize struggling of the birds. Birds that struggle excessively, as evidenced by wild
wing flapping, can bruise their wings as well as birds adjacent to them.
4. Humane slaughter. In the United States, the law requires that all animals be
stunned prior to slaughter. The method of choice in the poultry industry is electrical stun-
ning. The killing operation can be performed either manually or mechanically. ‘‘Modified
kosher’’ killed birds are those with the jugular veins severed just below the jowls so that
the windpipe and esophagus remain uncut. The longer the bleeding time, the more blood
removed and the fewer downgraded birds. Most processors allow from 90 to 180 sec for
bleeding prior to scalding.
Electrical stunning is the most widely accepted method for immobilizing poultry
prior to slaughter. Development and implementation of low voltage stunning systems (10
to 14 V, pulsed direct current, 500 Hz, 10–12 mA per bird) for broilers has been well
received by the industry. When too high an amperage is used, the wing tips are often pink
in color. Breast rub pads are used to calm the birds from live-hanging through the stunning.
The metal grate at the bottom of the stunner cabinet is immersed roughly 1 cm in 1%
NaCl solution. Ground bars are attached to assure the flow of current.
5. Scalding. Bird feather release is attained by immersing the birds in hot water.
A surge agitation–type tank is generally used, with the carcasses conveyed through hot
water. The scalding procedure requires close attention to both time and temperature. Ade-
quate heat must be applied to effect the relaxation of muscles in feather follicles. De-
pending on the water temperature, there are several scalding conditions: soft-(122°F, or
50°C), semi-(125–130°F, or 51.7–54.4°C), sub-(138–140°F, or 58.9–60°C), and hard-
scalding (⬎145°F, or 62.8°C). For a semi-scald operation, a temperature of 125 to 130°F
(51.7 to 54.4°C) is used and the scald time varies from 1.5 to 2.5 min, depending on the
scalding temperature. Scalding carcasses in the range between 130–138°F (54.4–58.9°C)
should be avoided because the temperature is too hot to keep all the skin intact and too
low to remove all the epidermal layer of skin. Many processing plants scald broilers at
138–139°F (58.9–59.4°C) for 140–150 sec. The force required to remove feathers from
the carcass decreases as the scalding temperature increases. Scalding procedures have a
direct effect on appearance of the defeathered carcass and tenderness of surface muscles.
From the sanitation standpoint, counterflow multistage scalding is the solution to
improve the hygiene of the scalding operation. Recently, a new scalding system has been
developed. In a completely enclosed environment, the carcasses are showered with hot
water and then conveyed through humidity cabinets where they are sprayed with steam
at 140°F (60°C). The noise and odor levels are greatly reduced for this operation.
6. Defeathering. After the carcasses leave the scalder, they enter a series of de-
feathering machines such as ‘‘roughers’’ or ‘‘pickers,’’ each with a specialized purpose.

The total time of the entire defeathering operation is about 30 sec. Feather removal is
achieved by rotating rubber fingers beating on the body surface to rub the feather free of
the follicles.
For some processors, after defeathering the carcasses pass through a pinning, singe-
ing, and bird washing area. Adequate feather removal is essential for the acceptable carcass
appearance.
7. Head removal. The head-removal operation may take place in the defeathering
area. The bird’s neck passes through a V-shaped device to separate the head as the body
is pulled forward by the overhead conveyer.
8. Hock cutting and bird transfer. After passing the bird washer, the carcasses
are moved through a hock cutter that separates the shanks at the hock joint and the car-
casses drop onto a conveyor for transfer to the evisceration area. Scalding and defeathering
are confined to a room separate from the others because of high noise levels, humidity,
and sanitation consideration.
9. Evisceration and inspection. The carcasses are eviscerated by removing the
shanks, head, preen gland, viscera, crop, and lungs from the defeathered carcasses. The
evisceration operation also includes the harvesting of giblets.
Defeathered carcasses are hung on the evisceration line. The usual positioning of
poultry on this line is by hanging the feet in shackles. In plants equipped with mechanical
eviscerating equipment, only the two-point suspension is used. An incision is made
through the abdominal wall under the tail. The cut is continued around the vent so that
intestines are free of any connection to the skin or abdominal wall muscle. All organs of
the body cavity are removed through this opening. After the abdomen is open and partially
cleared of intestinal organs, an employee from the U.S. Department of Agriculture
(USDA) inspects each carcass for wholesomeness. The inspector examines both the out-
side and inside of the carcass and the viscera. A trimmer removes parts with broken bones,
bruised tissue, breast blisters, improperly trimmed shanks, or others that have been deter-
mined to be unwholesome by the inspector. When the carcass is passed by the inspector,
the giblets are harvested and cleaned and the carcass is given a thorough washing, inside
and outside, to remove blood clots or other foreign material.
In the United States, typically each dressing line supplies carcasses for two eviscera-
tion lines. Depending upon the inspection system used, evisceration line speeds are limited
to either 70 or 91 birds per minute for the Streamlined Inspection System (SIS) or New
Enhanced Line Speeds (NELS) system, respectively.
10. Washing and chilling. Chilling poultry carcasses is essential for control of
microbial growth. Poultry carcasses can be chilled in cold running tap water, crushed ice,
slush ice, slush ice agitated with compressed air, or a circulating pump. According to
USDA regulations, carcasses must be chilled to at least 40°F (4.4°C) internal temperature.
In addition, the chiller overflow rate must be maintained at one-half gallon of water per
bird chilled in order to minimize the microbial build-up in the chilling water. The carcasses
are dropped from the evisceration line into a prechiller, which also serves as an effective
washer. A second chiller is in line and has a water temperature of less than 35.6°F (2°C).
As cooling the product takes time, the onset and resolution of rigor mortis may occur
during the chilling process. The chilled carcasses are ready for packaging or cutting into
parts prior to the packaging.
The amount of moisture pick-up allowed during chilling varies with the class of
poultry and with the product disposition. Maximum pick-up allowed for broilers going
directly to consumers is 8%; whereas broilers to be shipped and rehandled in a distant
market are allowed 12%. After chilling, the carcasses are hung on a drip line and conveyed
to the packaging area. The carcasses are allowed 2.5 to 4 min to drain the excess moisture.
11. Grading. In some plants, carcass grading is done next to the exit point of
the chiller. In others, it may be performed at various points before the birds reach the
giblet stuffing station of sizing bins. Grading identification is based on either plant or
USDA grade. Training and supervision of graders are under the direction of a federal
grader. Grade factors for ready-to-cook broiler carcasses include conformation, fleshing,
fat covering, defeathering (pin and hair feather), exposed flesh, discoloration, disjointed
and broken bones, missing parts, and freezing defects.
12. Packaging. The majority of chilled poultry is packaged as whole carcasses,
parts, or deboned or ground products at the processing plant. The individual package is
weighed, priced and printed with the store’s label and bar code for automated check out.
The packaged poultry is placed in cardboard boxes and delivered to the warehouse for
redistribution.
On January 26, 2000, all the poultry processing plants, regardless of size, in the
United States were required to implement a pathogen reduction/hazard analysis and criti-
cal control point (HACCP) plan. All HACCP plans must address zero tolerance for fecal
material, or ‘‘zero fecal.’’ This means that there must be no fecal material present on the
carcass before the carcass enters a chiller. The two most common ways for plants to
increase compliance with the regulations are through increased bird washing and the use
of antimicrobials such as chlorine and trisodium phosphate (TSP). Different combinations
of inside/outside washer, brush washer, and cabinet washer have been implemented to
increase HACCP compliance.
III. NEW FOOD SAFETY RULES

On July 6, 1996, President Clinton announced sweeping reform of federal food safety
rules for meat and poultry. The new rules modernize a 90-year-old inspection program.
This was the fundamental change in meat and poultry inspection called for by the National
Academy of Sciences and many other experts throughout government, industry, and the
consumer community. This new HACCP-based food safety system builds on the public
health principle of prevention for every meat and poultry production process [4–6]. The
major points outlined are:
1. Every plant must have a written HACCP plan for each product they produce.
2. Plants will be required to do microbiological testing for generic E. coli to verify
the process is in control.
3. Plants will be required to meet specific performance standards for the presence
of Salmonella.
4. Plants will be required to have a written standard operating procedure for preop-
erational and operational sanitation, including cleaning of plant and equipment
and recordkeeping.
5. The USDA will audit records and verify inspections to assure that the programs
are working.
6. The USDA will conduct Salmonella tests to ensure that each plant is meeting
the established performance standard.
Overall, a written HACCP plan is the heart of the new inspection program. These
new rules apply to over 6200 slaughtering and processing plants that operate under federal
inspection. The same or equivalent requirements will apply to state-inspected meat and
poultry plants and to foreign plants that export to the United States.
The implementation dates for HACCP are based on plant size. The largest plants
were required to have their HACCP systems in place by January 26, 1998. Smaller plants
(less than 500 employees) had until January 25, 1999. Very small plants (less than 10
employees or an annual sales of less than $2.5 million) had until January 25, 2000.
To be effective, HACCP-based processing control must be combined with objective
means of verifying that meat and poultry plants are achieving acceptable levels of food
safety performance. The Food Safety and Inspection Service (FSIS) of the USDA required
all slaughtering plants to conduct microbial testing for generic E. coli on January 27, 1997.
In addition, FSIS is establishing pathogen reduction performance standards for Salmonella,
and the implementation dates for the standards are based on plant size and coincide with
those for the HACCP plan.
All plants must prepare and implement plant-specific standard operating procedures
(SOPs) for sanitation. This implementation date was January 27, 1997.
IV. PREREQUISITE PROGRAMS FOR HACCP

The production of safe poultry products requires that a HACCP system be built upon
a solid foundation of prerequisite programs. Without adequate programs such as good
manufacturing practices (GMPs), sanitation standard operating procedures (SSOPs) and
operational SOPs, HACCP is like building a skyscraper in a marsh [7]. Many of the
conditions and practices are specified in federal, state, and local regulations and guidelines.
In addition, industry often adopts policies and procedures that are specific to its operations.
This has been accomplished through the application of GMPs.
According to a publication from the National Advisory Committee on Microbiologi-
cal Criterial for Food, which was published in 1997 [8], common prerequisite programs
may include, but are not limited to
1. Facilities. The facilities should be located, constructed, and maintained ac-

cording to sanitary design principles.
2. Supplier control. Continuing supplier guarantee and supplier HACCP system
verification.
3. Specifications. Written specifications for all ingredients, products, and pack-
aging materials.
4. Production equipment. Constructed and installed according to sanitary de-
sign principles. Preventive maintenance and calibration schedules should be
established and documented.
5. Cleaning and sanitation. All procedures should be written and followed.
6. Personal hygiene. All persons enter the manufacturing plans should follow
the requirements for personal hygiene.
7. Training. All employees should receive training in personal hygiene, GMPs,
cleaning and sanitation procedures, personal safety, and their role in the
HACCP program.
8. Chemical control. Documented procedures must be in place to assure the
segregation and proper use of non-food chemicals in the plant. These chemicals
include cleaning chemicals, fumigants, pesticides, and rodenticides.
9. Receiving, storage, and shipping. All raw materials and products should be
stored under sanitary conditions.
10. Traceability and recall. All raw materials and products should be lot-coded
and a recall system in place so that rapid and complete traces and recalls can
be done when necesssary.
11. Pest control. An effective pest control system should be in place.
Other prerequisite programs might include quality assurance procedures; standard op-
erating procedures for sanitation and processes; product formulations and recipes; glass
control; procedures for receiving, storage, and shipping; labeling; and employee food and
ingredient handling practices.
Good manufacturing practices and sanitation standard operating procedures are two
fundamental programs which have been developed and implemented in all USDA-in-
spected meat and poultry processing plants. These programs are closely interrelated and
an import part of processing control. Plants that have GMPs and SSOPs will have a much
easier time developing HACCP plans than companies which do not have them. The rela-
tionship among these programs can be demonstrated in the following pyramid:
V. GOOD MANUFACTURING PRACTICES

Good manufacturing practices are the minimum sanitary and processing requirements nec-
essary to ensure the production of wholesome food; GMPs are broad and general in nature.
They can be used to explain tasks which are part of many jobs. In many cases, GMPs
are often referred to as CGMPs, which means current good manufacturing practices.
Good manufacturing practices are usually written for each of the following areas:
1. Personnel. Includes disease control, cleanliness, education and training, and

supervision.
2. Buildings and facilities. Includes the building surrounding grounds, plant con-
struction and design, sanitary operations, etc.
3. Equipment and utensils. All plant equipment and utensils should be so de-
signed and of such material and workmanship to be adequately cleanable and
should be properly maintained.
4. Production and process control. Includes sanitation practices for all functions;
inspection, storage, and cleaning of raw materials and ingredients; and proce-
dures for processing operations.
5. Records and reports. Record filing and maintaining for supplier, processing
and production and distribution. It also includes a record retention schedule.
6. Defect action levels. The defect limit at which FDA will take action. The
levels are set on the basis of no hazards to health and does not excuse failure
to observe the sanitary requirements.
7. Miscellaneous. Such as visitor rules.
The Food and Drug Administrations (FDA) requirements for GMPs are listed in
Title 21, Code of Federal Regulations, Part 110.
VI. SANITATION STANDARD OPERATING PROCEDURES

The new regulations require that all meat and poultry plants develop, implement and main-
tain written sanitation standard operating procedures [9]. Each SSOP must itemize the
daily sanitation procedures plant personnel will conduct before and during operations to
prevent direct contamination or adulteration. Additionally, plans must identify the plant
official(s) responsible for implementing and monitoring daily sanitation activities.
The inspection agency has intentionally left the SSOP requirements vague to grant
establishments maximal flexibility. The principal evidence that a plan has been followed
will be the written documentation/checklists confirming that various tasks have been per-
formed. Records relating to SSOPs, including records regarding any deviations and correc-
tive actions, are to be held for at least 6 months and be available to inspection for verifica-
tion and monitoring. All records relevant to the SSOPs must be stored in the establishment
for at least 48 hr after the day they were created. After that, the records may be stored
off-site, provided they can be made available to agency officials within 24 hr.
Inspectors will not initially approve establishment SSOPs. However, the rules do
specify that FSIS inspectors ‘‘verify the adequacy and effectiveness’’ of the SSOPs.
A. Developing the SSOP Blueprint

An SSOP must
1. Describe all procedures (identifying preoperational and production procedures
separately) that an establishment will conduct to maintain proper sanitation.
2. Specify the frequency of the procedures.
3. Identify the individual(s) responsible for implementing and monitoring the
SSOP (not necessarily the employee actually performing the specific sanitation
task).
4. Be signed and dated by the indivual with on-site implementation authority (or
a higher level official) when adopted and modified.
B. Two Major Parts of Poultry Processing SSOPs

1. Preoperational Sanitation
All equipment should be cleaned and sanitized prior to starting production. The SOP
should include procedures for cleaning and sanitizing equipment, implementing method,
monitoring, recordkeeping, as well as corrective actions.
The following is an example for the procedures for cleaning and sanitizing equip-
ment:
1. The equipment is exposed for cleaning by removing covers and shields.
2. Product debris is removed.
3. Equipment parts are rinsed with water.
4. An approved cleaner or detergent is applied to the parts and cleaned according
to manufacturer directions.
5. Equipment parts are rinsed with potable water.
6. Equipment is sanitized with an approved sanitizer or disinfecting agent and
rinsed with potable water if required. Usually, the sanitizers are left on the
equipment for 10 min prior to the rinsing.
7. The equipment covers and shields are replaced.
8. The equipment is resanitized with an approved sanitizer and rinsed with potable
water if required.
In the United States the disinfectants cleared for use in poultry processing plants
are chlorinated compounds and quaternary ammonium compounds. Quaternary ammoni-
ums must be rinsed off before production begins.
Other recommended poultry processing equipment cleaning procedures are
1. Lock out/disconnect electrical power and cover electrical equipment.

2. Equipment breakdown by trained personnel.
3. Dry pick-up/large debris removal.
4. Prerinse (115–125°F, or 46.1–51.7°C), physical removal of material.
5. Cleaning compound application (125–130°F, or 51.7–54.4°C).
6. Additional cleaning/scrubbing, green padding, and agitation.
7. Inspection and touch up.
8. Sanitizing.
9. Monitoring.
10. Reassembly by trained personnel.
2. Operational Sanitation
The objective of this operational sanitation is to prevent the contamination of the products
during processing, cutting, and packaging. For example, the following statements should
be included in the standard operation procedures for evisceration:
1. Employees will clean hands, arms, and any personal protective equipment (such
as gloves, aprons, etc.) as often as necessary during the processing procedure.
2. The evisceration equipment is fitted with spray nozzles to help remove build-
up and to clean equipment during operation. The water used will be potable
water.
3. Processing employees will maintain clean hands, arms, clothes, and personal
protective equipment throughout the process. If contamination occurs, the em-
ployee is required to clean and sanitize the contaminated equipment.
4. Floors and ceilings are cleaned as needed to prevent product contamination.
Again, the SOP for a specified operation should include procedures for monitoring,
recordkeeping, and corrective action. In general, the plant manager is responsible for en-
suring that employee hygiene practices, sanitary conditions, and cleaning procedures are
maintained during the production. The quality control (QC) manager assigns staff that
monitors the operational sanitation procedures twice during a production shift.
Overall, in SSOP developing, the following items should be included:
1. Established detailed procedures to prevent contamination before and during op-
eration.
2. Identified person(s) responsible for evaluating the cleaning process effective-
ness and making corrections. Procedures for prevention of contamination should
be included.
3. Daily monitoring procedures and microbial tests.
4. Daily record and prescribed review procedures for verification with corrective
activities.
5. Procedures for the following areas: equipment, facilities, welfare, personnel,
and environment.
The bottom line for effective sanitation is improved company profits through reduced
product losses, increased shelf-life, and customer satisfaction.
VII. HACCP PLAN FOR POULTRY PROCESSING

Keeping low production cost is an important main goal for food manufacturers and proces-
sors. More automatic and high speed processing equipment have been used to minimize
processing times. New formulations have also been designed to reduce preparation time
by the consumer. These changes have increased the degree of risk regarding food safety.
According to most regulators and industry officials, the most effective and economical
way to combat food safety problems is through the use of a preventive HACCP system.
A. Definition
Hazard analysis is the identification of sensitive ingredients, critical processing points,
and relevant human factors as they affect product safety. Critical control points are those
areas of processing where loss of control would result in an unacceptable food safety risk.
B. History
The HACCP system was formalized by the Pillsbury Company as part of the work in a
program to develop foods for the space program. It was first presented at the 1971 National
Conference on Food Protection. The HACCP system began to gain considerable interest
when it was first applied to low-acid and acidified foods. In addition, the FDA started
using the HACCP approach in its investigation activities.
In 1980, the FDA, National Marine Fisheries Service (NMFS), USDA, and the US
Army Natick R&D Center asked NAS/NRC to convince a subcommittee to formulate
general principles for the application of microbiological criteria to food. In its report
(NAS/NRC, 1985), the subcommittee recommended the use of HACCP in food protection
programs and that food industry and regulatory personnel be trained in the elements of
HACCP.
To be effective, the HACCP program should deal only with issues related to food
safety and should not be incorporated into the company’s normal quality control system.
The same preventive approach can be used for quality and other nonsafety issues, but
these programs should not be called HACCP. Do things right the first time is the essence
of total quality control and preventing problems before they occur are the essence of the
HACCP system. They are very closely related. For HACCP to be effective, it must be
applied in all segments of the industry, from production to consumption, including grow-
ing, harvesting, ingredient production, processing, distribution, retailing, food service, and
the home.
C. Three Types of Hazards

1. Biological Hazards
Biological hazards are living organisms, including microorganisms, that can put human
health at risk. Biological hazards include bacteria, parasites, protozoa, viruses, etc. The
primary biological hazards of concern in meat and poultry processing are Salmonella,
Staphylococcus aureus, Campylobacter jejuni, Clostridium perfringens, Clostridium
botulinum, Listeria monocytogenes, and Escherichia coli O157:H7.
2. Chemical Hazards
There are two categories of chemical hazards:
1. Naturally occurring toxins, chemicals, or deleterious substances that are natural

constituents of foods and are not the result of environmental, agricultural, indus-
trial, or other contamination. Examples of these hazards include aflatoxins, my-
cotoxins, and shellfish toxins.
2. Added chemicals or deleterious substances that are intentionally or unintention-
ally added to foods at some point in growing, harvesting, storage, processing,
packaging, or distribution. This group of hazards includes pesticides, fungicides,
insecticides, fertilizers, drug residues, antibiotics, certain food additives, lubri-
cants, cleaners, paints, coatings, etc.
3. Physical Hazards
A physical hazard is any material not normally found in a food which causes illness or
injury to the consumer. Physical hazards include a variety of foreign objects such as glass,
metal, and plastic. Foreign objects which cannot cause illness or injury are not hazards.
D. General Steps for the Development of a HACCP Plan

The following steps may be taken to develop a HACCP plan [10,11]:
1. Assemble a HACCP team. This is a team of individuals representing certain
disciplines (e.g., engineering, quality assurance, production, microbiology, sanitation).
The team should include local personnel from the processing operation because they will
be the most knowledgeable of the actual conditions which occur during processing, includ-
ing the variability and limitation of the operation.
2. Describe the food and its distribution. This includes the characteristics of the
food ingredients, the ingredients’ intended shelf-life, processing methods, type of packag-
ing used, storage, and distribution system.
3. Identify intended use and consumers of the food, including the preparation and
cooking procedures, and the consumers.
4. Develop and verify flow diagram. The diagram should indicate where ingredi-
ents enter the flow, the various manufacturing and fabrication steps, packaging, storage,
distribution, point-of-sale, and consumer handling. A block type flow diagram and CCP
of a poultry processing plant is presented in Fig. 1.
5. Conduct analysis of hazards. Based on information developed in the previous
steps, a risk analysis should be conducted for microbial, chemical, and physical hazards
associated with the specific food on the processing line.
6. Identify critical control points. A critical control point is defined as a point,
step, or procedure in a processing at which control can be applied and, as a result, a food
safety hazard can be prevented, eliminated, or reduced to an acceptable level. Critical
control points can be identified from the manufacturing and distribution flow diagrams.
7. Establish critical limits. These are the pass/fail components of a HACCP sys-
tem: the maximum or minimum value to which a physical, biological or chemical hazard
must be controlled to prevent, eliminate, or reduce to an acceptable level the occurrence
of the identified food safety hazard.
8. Establish an effective monitoring system. Each critical control point should have
its own sampling plan, test methods, and decision criteria. Monitoring should be continu-
ous or should be done as frequently as necessary to give a reliable indication of hazard
control. For time concerns, the monitoring procedure must be a rapid method that can be
applied on the processing line.
9. Determine appropriate corrective actions. Corrective action plans must identify
what steps will be taken and who is responsible for taking action.
10. Verify that the system works. Periodic review should be conducted to ensure
that the HACCP program is working correctly. The first verification process is the initial
validation of the HACCP plan, which requires plant management to demonstrate the ade-
quacies of the CCPs, the critical limits, the monitoring and recordkeeping procedures, and
the corrective action plans. In addition, validation must include review of records as they
are generated.
Ongoing verification activities are the cornerstones of the second validation process.
These activities ensure the systems are being implemented as designed and include calibra-
tion of process-monitoring equipment, direct observation of monitoring activities, correc-
tive actions, and a review of the records.
The third verification process is the documented reassessment of the HACCP plan.
This step mandates that a HACCP-trained individual review the HACCP plan to determine
its continued adequacy whenever there is any relevant change such as a new product or
process.
In addition to the three verification activities plant officials must manage, FSIS per-
sonnel will conduct their own verification activities. These include reviewing the HACCP
plan, CCP records, and critical limits; determining the adequacy of corrective actions
taken; making direct observations or measurements at a CCP; and taking samples. The
frequency of these activities will depend on a plant’s prior history and the risk posed by
the operation.
11. Maintain accurate records. Effective recordkeeping is necessary to ensure a
HACCP program is completely documented. Slaughter records and processing records for
refrigerated products must be held for 1 year. Processing records for frozen, preserved,
or shelf-stable products must be held for 2 years.
E. Some Basic Components of a HACCP System

1. A hazard analysis is performed and potential hazards are identified and priori-
tized according to severity and risk.
Figure 1 Flow diagram and CCPs of a poultry processing plant.

2. Critical points in the operation which permit control of the hazards are identi-
fied.
3. Criteria (e.g., time, temperature, pH) are specified that indicate whether an oper-
ation is under control at a particular CCP.
4. Rapid tests are used to monitor whether the CCPs are under control. The sam-
pling frequency is determined by the severity and risk of the hazard.
5. Corrective action is taken when monitoring results indicate that the operation
is not under control.
6. Verification tests are used to check that the overall HACCP system is working
and that all hazards have been identified.
7. Records are maintained and reviewed. Records include action taken when crite-
ria have not been met.
F. Eight Control Points Identified for Poultry Processing

A HACCP team from poultry operation would conduct a hazard analysis for the production
of ready-to-cook chickens, which includes: (1) scalding, (2) venting, opening, and eviscer-
ating, (3) off-line reconditioning, (4) final washing, (5) carcass chilling, (6) product pack-
aging, (7) product chilling, and (8) storage and shipping (Fig. 1).
A CCP1 will assure the hazard control, while a CCP2 will minimize but cannot
assure the control of a hazard. Both types of CCPs are important and both must be con-
trolled. The chilling operation belongs to CCP1; scalding, washing, eviscerating, and final
washing belong to CCP2. Overall, the following recommendations are made to reduce
the safety risk in poultry operations:
1. Use chlorine in chiller.
2. Separate raw and cooked products.
3. For fresh product, keep processing area 50°F (10°C) or lower.
4. Improve fresh meat handling practices.
5. Commit to quality at the management level.
A HACCP master sheet of a poultry processing operation is given to further demonstrate
the stages of HACCP development in Table 2. The slaughter records and processing rec-
ords for refrigerated products must be held for 1 year. Processing records for frozen,
preserved, or shelf-stable products must be held for 2 years.
To facilitate the preparation of mandated HACCP plans, the FSIS of the USDA has
published many generic HACCP models. Much of the information can be found on the
internet at the following address: http://www.usda.gov/agency/fsis. Samples of various
poultry processing HACCP worksheets are given in Figs. 2–9.
G. Pathogen Reduction and Microbial Testing

The new HACCP rule mandates two microbial tests: company tests for generic E. coli
and FSIS testing for Salmonella. A wide range of pathogen-reduction technologies are
available for company officials to evaluate. The FSIS urges companies to consider imple-
menting the approved technologies. Antimicrobial treatments include washers or sprayers
that use either hot water or a solution of water and a substance approved by FSIS for the
use. Substances such as lactic, acetic, and citric acids; trisodium phosphate; and chlorine
are approved. In addition, the agency has approved spray-vacuum devices that use pressur-
ized steam or hot water.
Table 2 HACCP Master Sheet of Poultry Processing Plant
Monitoring procedures
Critical Control Critical Corrective
Point Hazard limits What How Frequency Who actions Record Verification
Scalding
CCP-1 Bio Biological Continuous Fresh water Water flow At start-up and Picking room Immediate ad- HACCP form: Verified daily
overflow input gauge on after each personnel justments Fresh water by HACCP
pipe break Added to coordinator
Scalder
Vent opening/
eviscerating
CCP-2 Bio Biological Zero tolerance Broken or miss- Visual in- Every hour Eviscerating Inform supervi- HACCP form: Verified daily
of malfunc- ing organs spection line person- sor and re- Vent by HACCP
tioning nel or de- test every 15 Opening/ coordinator
signee min Eviscerating
HACCP
form
Salvage/
reprocessing
CCP-3 Bio Biological ⱕ40°F in less Internal tem- Calibrated Every 2 hr QC technician Re-ice and re- HACCP form: Verified daily
than 2 hr perature probe ther- test every 30 Salvage/Re- by HACCP
mometer min processing coordinator
Area form
CCP-3 Chem Chemical ⱖ 20 ppm of Effective chlor- HACH chlorine Every hour QC technician Inform supervi- HACCP form: Verified daily
chlorine in ination test kits sor and re- Salvage/Re- by HACCP
rinse water test in 15 processing coordinator
min Area form
CCP-3 Phys Physical Approved lim- Foreign mate- Visual in- Every hour QC technician Rework lot HACCP form: Verified daily
its for off- rial spection Salvage/Re- by HACCP
line reprocessing coordinator
processing Area form
procedures
for extrane-
ous material

Table 2 Continued
Monitoring procedures
Critical Control Critical Corrective
Point Hazard limits What How Frequency Who actions Record Verification
Final wash station
CCP-4 Phys Physical Approved lim- Foreign mate- Visual in- Every hour QC technician Inform supervi- HACCP form: Verified daily
its for on- rial spection sor and re- Final Wash by HACCP
line pro- test in 15 HACCP coordinator
cessing pro- min form
cedures for
extraneous
material
chlorine in ination test kits sor and re- Final Wash by HACCP
rinse water test in 15 HACCP coordinator
min form
Carcass chilling
CCP-5 Bio Biological ⱕ40°F at Internal tem- Calibrated Every hour QC technician Shut down HACCP form: Verified daily
chiller exit perature probe ther- chiller or re- Carcass by HACCP
mometer tain lot and Chill Inspec- coordinator
re-ice and re- tion HACCP
test continu- form
ously
CCP-5 Bio Biological ⱖ0.5 gallon of Fresh water Water flow At start-up and Chiller super- Immediate ad- HACCP form: Verified daily
fresh water input gauge on after each visor or de- justments Carcass by HACCP
added per pipe break signee Chill Inspec- coordinator
bird tion HACCP
form
chlorine in ination test kits sor and re- Carcass by HACCP
chiller water test in 15 Chill Inspec- coordinator
min tion HACCP
form

CCP-5 Phys Physical Approved limits Foreign mate- Visual in- Every hour QC technician Retain lot and HACCP form: Verified daily
for postchill rial spection retest when Carcass Chill by HACCP
processing product is Inspection coordinator
procedures ready HACCP form
for extrane-
ous material
Giblet chilling
CCP-6 Bio Biological ⱕ40°F at Internal tem- Calibrated Every hour QC technician Re-ice and re- HACCP form: Verified daily
chiller exit perature probe ther- test every 30 Giblet Chill by HACCP
mometer min HACCP form coordinator
chlorine in ination test kits sor and retest Giblet Chill by HACCP
chiller water in 15 min HACCP form coordinator
CCP-6 Phys Physical Approved limits Foreign mate- Visual in- Every hour QC technician Retain lot and HACCP form: Verified daily
for giblet pro- rial spection retest when Giblet Chill by HACCP
cessing pro- product is re- HACCP form coordinator
cedures for worked
extraneous
material
Packing/Labeling
CCP-7 Bio Biological ⱕ55°F in Internal tem- Calibrated At start-up and QC technician Retail lot and HACCP form: Verified daily
packed pro- perature probe ther- after each retest when Product Han- by HACCP
duct mometer break product is dling coordinator
hold in the HACCP form
cooler
CCP-7 Phys Physical Visually intact Labeling mate- Visual in- At start-up and Production Control product HACCP form: Verified daily
rial integrity spection after each supervisor for corrective Product Han- by HACCP
break or designee action. dling coordinator
Immediate ad- HACCP form
justment to
procedures
Storage
CCP-8 Bio Biological USDA regula- Product tem- Calibrated At start-up and Cooler super- Control product HACCP form: Verified daily
tions for perature probe ther- after each visor or de- for corrective Storage Area by HACCP
product mometer break signee action. HACCP form coordinator
storage Immediate ad-
justment to
procedures

HACCP RECORD
Processing Plant
CCP—Picking Room Fresh Water Added to Scalder
Critical Limits
Fresh Water Input, ⬎ or ⫽ 1/2 Gallon per Bird (2 Checks Every Break Time)
Records Verified within 30 Minutes of Monitoring
Date: Shift:
Corrective Actions
1. Inform Picking Room supervision to determine cause, to effect immediate adjustment or apply other measure to prevent occurrence.
2. Effect appropriate scalder adjustment.
Figure 2 Sample picking room CCP form.

HACCP RECORD
Processing Plant
CCP—Vent Opening/Eviscerating HACCP Form
Critical Limits
0 Missing of Intestinal Organs (10 Birds Checked per 1 Hour of Production)
0 Extraneous Material i.e. Fecal Contamination (10 Birds Checked per 1 Hour of Production)
Date: Shift:
Corrective Actions
1. Inform Eviscerating Room Supervision to determine cause, to effect immediate adjustment or apply other measure to prevent occurrence.
2. Effect appropriate eviscerating adjustment.
Figure 3 Sample vent/opening/eviscerating CCP form.

HACCP RECORD
Processing Plant
CCP—Salvage/Reprocessing Area Form
Critical Limits
Temperature, ⬍ or ⫽ 40°F (3 Pieces of Parts Checked per 2 House of Production)
Chlorine, ⬎ or ⫽ 30 PPM of Chlorine (Every 1 Hour)
0 Extraneous Material i.e. Fecal Contamination (10 Birds Checked per Hour of Production)
Date: Shift:
Corrective Actions
Rework or recondition Product to remove contamination
Figure 4 Sample salvage/reprocessing area CCP form.

HACCP RECORD
Processing Plant
CCP—Final Wash HACCP Form
Critical Limits
Date: Shift:
Corrective Actions
1. Inform Maintenance and Supervision for immediate Correction or adjustment.
2. Retest after adjustment is effected.
Figure 5 Sample final wash CCP form.

HACCP RECORD
Processing Plant
CCP—Carcass Chill Inspection HACCP Form
Critical Limits
Temperature, ⬍ or ⫽ 40°F (3 Birds per 1 Hour of Production)
Fresh Water Input, ⬎ or ⫽ 1/2 gal. per Bird (Start-up and Each Break Time)
Date: Shift:
Thermometer Calibration Date: QC Tech. Signature:

Corrective Actions
1. QC/Chiller Supervisor to determine cause, to effect immediate adjustment or apply other measure to prevent occurrence.
2. All birds exiting the chiller until ⬍ 40°F is achieved.
Figure 6 Sample carcass chill CCP form.

HACCP RECORD
Processing Plant
CCP—Giblet Chill HACCP Form
Critical Limits
Temperature, ⬍ or ⫽ 40°F (3 Pieces Checked per 1 Hour of Production)
Date: Shift:
Thermometer Calibration Date: QC Tech. Signature:

Corrective Actions
1. Hold all out of specific products in holding cooler until ⬍ or ⫽ 40°F is achieved (Condemn if ⬎ 40°F in 2 hours)
2. Retest continuously until temperature is ⬍ or ⫽ 40°F.
Figure 7 Sample giblet chill CCP form.

HACCP RECORD
Processing Plant
CCP—Product Handling HACCP Form
Critical Limits
Temperature, ⬍ or ⫽ 55°F (2 Parts Checked Every Break Time)
Visually Intact of Packing Material Integrity on Product (2 Packs Checked Every Break Time)
Date: Shift:
Thermometer Calibration Date: Time: QC Technicians:

Corrective Actions
1. Inform Refrigeration and Supervision for immediate correction or adjustment.
2. Condemn all affected products (Temperature ⬎ 55°F).
Figure 8 Sample product handling CCP form.

HACCP RECORD
Processing Plant
CCP—Storage Area HACCP Form
Critical Limits
Temperature, ⬍ or ⫽ 28°F (2 Checks Every Break Time)
Date: Shift:
Thermometer Calibration Date: Time:

Corrective Actions
1. Inform Refrigeration and Supervision for immediate correction or adjustment.
2. Condemn all affected products (Temperature ⬎ 55°F).
Figure 9 Sample storage area CCP form.

All poultry slaughter plants test carcasses for E. coli. The testing frequency is based
upon the production volume; for chickens, 1 sample per 22,000 carcasses; for turkeys, 1
sample per 3000 carcasses.
For a very low volume establishment (less than 440,000 chickens per year, or not
more than 60,000 turkeys per year), alternative testing is required.
Before sampling starts, a company must prepare written procedures specifying when
samples will be taken, who is responsible for sampling, how samples will be handled,
and what test methods will be used. Poultry samples are to be collected after the drip line
and before packaging or cut-up, using a whole-bird rinse.
The performance criteria vary by species and are based upon FSIS baseline surveys.
An establishment will be deemed out of compliance if the level of E. coli found on the
most recent sample is above the upper permitted level or three samples are above the
lower permitted level. For broilers, the product is unacceptable if the level of E. coli on
any sample is above the upper permitted level of 1000 cfu/mL or three samples test posi-
tive above the lower permitted level of 100 cfu/mL.
Once a plant is subjected to mandatory HACCP requirements, FSIS will sample
carcasses and raw ground products for Salmonella. The standards for poultry products,
derived from FSIS national baseline surveys, are as follows:
Performance standard Number of Maximum

Class of product (% positive) sample tested number positive
Broiler 20.0 51 12
Ground chicken 44.6 53 26
Ground turkey 49.9 53 29
Failure to comply with a performance standard will be met with a measured response,
including possible suspension of inspection.
H. Benefits of HACCP Plan

The HACCP-based inspection program is better than the traditional inspection. The inspec-
tor is not confined to one location on a line. It allows the inspector to move up and down
the line to look for problem areas and to take action on those carcasses, if necessary.
Data published by the USDA’s FSIS indicated that 20% of broiler carcasses in-
spected in 1997 were contaminated with salmonella. Since the implementation of HACCP-
based inspection, this number was reduced to 10.3% for broiler carcasses inspected in
January 2000. In addition, on those 10.3% birds that tested positive for salmonella, the
actual numbers of organisms recovered were very, very low. In most cases, fir or six cells
were recovered from these birds [12]. It is a common understanding that 5 years ago this
salmonella on carcasses was 50% and was much more than that if we go back a few more
years. This reduction in the incidence of salmonella on broiler carcasses has demonstrated
the success of the HACCP-based inspection program in poultry food safety improvement.
REFERENCES
1. AW Brant, JW Goble, JA Hamann, CJ Wabeck, RE Walter. Guidelines for establishing and
operating broiler processing plants. Washington, DC: U.S. Department of Agriculture, 1982.

2. GJ Mountney, CR Parkhurst. Poultry Product Technology. New York: Haworth Press, 1995.
3. WJ Stadelman, VM Olson, GA Shemwell, S Pasch. Egg and Poultry-Meat Processing. Chi-
chester, England: Ellis Horwood, 1988.
4. K Nunes. The Mega-Reg, FSIS mandates HACCP, pathogen testing and SOPs and prepares
for the future. Meat & Poultry September:15–34, 1996.
5. USDA. The final rule on pathogen reduction and hazard analysis and critical control point
(HACCP) systems. Washington, DC: U.S. Department of Agriculture, 1996.
6. USDA. Sanitation standard operating procedures (SSOP) reference guide. Washington, DC:
U.S. Department of Agriculture, 1996.
7. D Buege, S Ingham. Cleaning and sanitizing, the cornerstone of quality. Meat & Poultry May:
25–39, 1996.
8. USDA. Hazard analysis and critical control point, principles and application guidelines. Wash-
ington, DC: U.S. Department of Agriculture, 1997.
9. R Savage. The sanitation S.O.P. deadline is finally here. Meat & Poultry January:59, 1997.
10. USDA. Generic HACCP model for poultry slaughter. Washington, DC: U.S. Department of
Agriculture, 1994.
11. U.S. Poultry & Egg Association. Introduction to HACCP, a pre-HACCP training guide. At-
lanta, GA: U.S. Poultry & Egg Association, 1997.
12. C Cannon. Where have all the pathogens gone? Poultry 8(5):14–17, 2000.

32
Seafood Processing: Basic Sanitation
Practices
PEGGY STANFIELD
I. BACKGROUND INFORMATION
The U.S. national regulatory authority for public protection and seafood regulation is
vested in the Food and Drug Administration (FDA). The FDA operates an oversight com-
pliance program for fishery products, which sets responsibility for product safety, whole-
someness, identity, and economic integrity with the processor or importer, who must com-
ply with regulations promulgated by the FDA. In addition, FDA operates the low-acid
canned food (LACF) program which is based on the hazard analysis and critical control
point (HACCP) concept and is focused on thermally processed, commercially sterile
foods, including seafood such as canned tuna and salmon.
The seafood processing regulations, which became effective on December 18, 1997,
require that a seafood processing plant (domestic and exporting foreign countries) imple-
ment a preventive system of food safety controls known as a hazard analysis and critical
control point plan. The plan essentially involves (1) identifying food safety hazards that,
in the absence of controls, are reasonably likely to occur in the products and (2) having
controls at ‘‘critical control points’’ in the processing operations to eliminate or minimize
the likelihood that the identified hazard will occur. These are the kinds of measures that
prudent processors already take. The HACCP plan provides a systematic way of taking
those measures that demonstrates to the FDA, customers, and consumers that the firm is
routinely practicing food safety by design. Seafood processors that have fully operating
HACCP systems advise us that they benefit in several ways, including having a more
safety-oriented workforce, less product waste, and generally fewer problems.
Most FCA in-plant inspections consider product safety, plant/food hygiene, and
economic fraud issues, while other inspections address subsets of these compliance con-
cerns. Samples may be taken during FDA inspections in accordance with the agency’s
compliance programs and operational plans or because of concerns raised during individ-
ual inspections. The FDA has laboratories around the country to analyze samples taken
by its investigators. These analyses are for a vast array of defects including chemical
contaminants, decomposition, net weight, radionuclides, various microbial pathogens,
food and color additives, drugs, pesticides, filth, and marine toxins such as paralytic shell-
fish poison (PSP) and domoic acid.
In addition, FDA has the authority to detain or temporarily hold food being imported
into the United States while it determines if the product is misbranded or adulterated. The
FDA receives notice of every seafood entry and, at its option, conducts wharf examina-
tions, collects and analyzes samples, and, where appropriate, detains individual shipments
or invokes ‘‘automatic detention,’’ requiring private or source country analysis of every
shipment of product when recurring problems are found before the product is allowed
entry.
Further, FDA has the authority to set tolerances in food for natural and manmade
contaminants, except for pesticides, which are set by EPA. The FDA regulates the use of
food and color additives in seafood and feed additives and drugs in aquaculture. The
FDA also has the authority to promulgate regulations for food plant sanitation [i.e., good
manufacturing practices (GMP) regulations], standards of identity, and common or usual
names for food products.
The FDA has the authority to take legal action against adulterated and misbranded
seafood and to recommend criminal prosecution or injunction of responsible firms and
individuals.
The FDA conducts both mandatory surveillance and enforcement inspections of
domestic seafood harvesters, growers, wholesalers, warehouses, carriers, and processors.
The frequency of inspection is at the agency’s discretion, and firms are required to submit
to these inspections, which are backed by federal statutes containing both criminal and
civil penalties.
The FDA provides financial support by contract to state regulatory agencies for the
inspection of food plants, including seafood.
The FDA also operates two other specific regulatory programs directed at seafood—
the Salmon Control Plan and the National Shellfish Sanitation Program (NSSP), recently
augmented by the Interstate Shellfish Sanitation Conference (ISSC). These are voluntary
programs involving individual states and the industry.
The Salmon Control Plan is a voluntary, cooperative program among the industry,
FDA, and the National Food Processors Association (NFPA). The plan is designed to
provide control over processing and plant sanitation and to address concerns about decom-
position in the salmon canning industry.
Consumer concerns about molluscan shellfish are addressed through the National
Shellfish Sanitation Program. It is administered by FDA and provides for the sanitary
harvest and production of fresh and frozen molluscan shellfish (oysters, clams, and mus-
sels). Participants include the 23 coastal shellfish-producing states and nine foreign coun-
tries.
The NSSP was created upon public health principles and controls formulated at the
original conference on shellfish sanitation called by the Surgeon General of the U.S. Public
Health Service in 1925. These fundamental components have evolved into the National
Shellfish Sanitation Program Manual of Operations. A prime control is proper evaluation
and control of harvest waters and a system of product identification which enables trace
back to harvest waters.
The FDA conducts reviews of foreign and domestic molluscan shellfish safety pro-
grams. Foreign reviews are conducted under a memorandum of understanding (MOU)
which FDA negotiates with each foreign government to assure that molluscan shellfish
products exported to the United States are acceptable.
The FDA’s regulation on HACCP for seafood processing have been in full force
since 1997. The HACCP system, in addition to other scientific and technical consider-
ations, is an extension of the basics of food processing sanitation, which uses FDA’s
current good manufacturing practice regulations (CGMPR) and the Food Code as frames
of reference. The FDA considers such sanitation compliance a prerequisite to HACCP
planning and implementation.
This chapter discusses those prerequisites of basic sanitation for seafood processing.
If you are a seafood processor and you are planning to start the HACCP program, you
must first examine the current practices of your operation to ascertain that it complies
with such prerequisites.
The information presented in this chapter has been modified from the CGMPR of
the FDA and the U.S. Department of Agriculture (USDA), the Food Code, and other
documents issued by the FDA on inspection of seafood processing plants.
The format and style used in this chapter reflects the instructional process between
a teacher (e.g., a training supervisor) and student (e.g., company personnel).
II. FRESH AND FROZEN FISH

A. Sanitation Critical Factors
The critical factors to remember when a company officer performs a sanitation inspection
of a processing plant for fresh and frozen fish are as follows:
1. Look for evidence of rodents, insects, birds, or pets within the plant.
2. Observe employee practices including hygenic practices, cleanliness of cloth-
ing, and the use of proper strength hand-dip solutions.
3. Check to see if fish are inspected upon receipt and during processing for decom-
position, off-odors, parasites, etc. Check for decomposition and parasites during
establishment inspection.
4. Ascertain if equipment is washed and sanitized during the day and at the begin-
ning and end of the daily production cycle.
5. Check if the fish are washed with a vigorous spray after eviseration and periodi-
cally throughout the process prior to packaging.
6. Determine the method and speed of freezing for frozen fish and fish products.
7. Check use of rodenticides and insecticides to assure that no contamination oc-
curs.
8. Observe handling from boats to finished package and observe any significant
objectionable conditions.
Specific details on the sanitation are as follows.
B. Raw Materials
1. Determine what tests are conducted on incoming fish for decomposition, para-
sites, chemical contamination, etc.
2. Determine disposition of incoming fish which have been found to be decom-
posed, contain excessive parasites, or contaminated with mercury, pesticides,
etc.
3. Conduct organoleptic examination of incoming fish products, especially those
which have thawed for processing or held for prolonged periods of time at room
temperature during processing. Give attention to fish arriving at the plant as to
effectiveness of elimination of decomposed fish, and check fish actually being
packed. Determine percentage of decomposed units encountered, classifying
each as passable (class 1), decomposed (class 2), or advanced decomposed
(class 3).
4. Examine susceptible fish for parasitic infestations (e.g., white fish, rose fish,
tullibees, ciscos, inconnus, bluefish, herring, etc.).
5. Check other raw materials and storage areas for rodents, insects, filth, or other
contaminating factors.
6. See required specification on other raw materials for bacterial load, etc. (e.g.,
received under a Salmonella-free certificate issued by a recognized government
or private agency).
7. Check for misuse of dangerous chemicals including insecticides and rodenti-
cides.
8. If fish are received directly from boats, see if hook is used for loading and
unloading or, for that matter, if a hook is used for any handling of the fish.
C. Manufacturing
1. Study manufacturing procedure. Include flow plan.
2. Study type of equipment used as to construction, materials, ease of cleaning,
etc.
3. Observe equipment cleaning and sanitizing procedures, and evaluate their ade-
quacy.
4. Observe evisceration procedure, filleting procedure, or other butchering proce-
dures used.
5. Determine source of water used in operation. Check that only potable water
from an approved source is used.
6. If, during processing of fish, there are long delays at room temperature, check
for decomposition.
7. Examine all handling steps and intermediate steps in processing that could
lead to the contamination of the fish with filth and/or bacteria.
8. Study holding times and temperatures during the processing operation.
9. If battering and/or breading fish is involved, check process carefully. In addi-
tion, check times and temperature and for other possible routes of filth and/
or microbial contamination.
10. Evaluate compliance with good manufacturing practices.
D. Controls
1. Check coding system. If no code marks are used, mark suspect lot packages
with fluorescent crayon for later sampling.
2. Review records regarding finished product assay for decomposition, parasites,
microbial load, pesticides, mercury, and for other quality factors.
3. Study labeling used on products.
4. Check use of preservatives on fish or ice.
E. Summary and Checklist

Check the following:
1. Compliance with CGMP.

2. Use of adequate and proper strength hand and equipment sanitizing solutions.
3. Proper cleanup.
4. Evidence of rodents, insects, birds, domestic animals, or any other source of
contamination.
Use the following list of indicators of sanitation to make a valid assessment of the
operations at different stages of the process flow.
Stage Assessment
Receive (unload fish) 1. Determination of condition of fish (acceptable
or decomposed)
2. Separate work area
Store 1. Suitable storage area (sanitation)
2. Time/temperature (icing, quality)
Wash 1. Removal of surface slime and dirt (sanitation)
2. Use of potable water
Fillet 1. Personnel sanitation
2. Equipment sanitation
Skin (either hand or 1. Personnel sanitation
machine) 2. Equipment sanitation
3. Separate work area, same area as fillet operation
Rinse 1. Potable water
2. Equipment sanitation
3. Time/temperature (quality)
Pack (either retail or Equipment sanitation
block) Personnel sanitation
Suitable packaging materials
Time/temperature (quality)
Separate work area
Freeze Time/temperature (quality)
III. CANNED TUNA

During a sanitation inspection, use the following critical factors:
1. Check adequacy of firm’s controls and review records covering the receipt of
tuna fish. Ascertain if only tuna below the mercury guidelines and not decom-
posed is processed. Determine disposition of decomposed or over-tolerance
tuna.
2. Conduct organoleptic analysis of incoming tuna and of tuna being processed.
3. Check food additives to determine that only those permitted by the standards
are used.
4. Check usage of insecticides and rodenticides to determine that they are used
properly and do not become incidental food additives.
5. Study controls over the canning operation to assure that only good quality tuna
is canned and that it is canned in accordance with FDA requirements.
B. Raw Materials
1. Determination adequacy of firm’s controls for assuring that they are not canning
decomposed tuna or tuna with excessive mercury.
2. Determine disposition of lots of tuna which are rejected because of excessive
mercury.
3. Review firm’s assay records and controls regarding mercury analysis of raw,
in-process, and finished canned tuna.
4. Ascertain adequacy of controls firm utilizes to assure that the species of tuna
canned are those allowed by standards.
5. Conduct organoleptic analysis of incoming raw tuna, frozen tuna which has
been thawed for canning, and any tuna being held for excessively long periods
at room temperature.
6. Determine disposition of any tuna which is found to be decomposed (destruc-
tion, diversion, etc.).
7. Check raw material storage area for presence of insects, rodents, or other possi-
ble contaminants.
8. Check food additives in storage to ascertain if they are allowed in canned tuna
as per 21 CFR 161.190(a) (Canned Tuna Standards).
9. Check firm’s storage of rodenticides and insecticides to determine that they
are used in accordance with instructions and are not becoming secondary food
additives.
C. Processing
1. Check firm’s can seamers to determine if they are functioning properly.
2. Determine adequacy of firm’s check on can seaming.
3. Determine if firm’s retorts or continuous cookers are functioning properly.
4. Review recording charts from retorts and continuous cookers to ascertain if tuna
was processed at proper time/temperature relationship.
5. Determine firm’s postprocessing can handling, how cans are cooled and whether
water is clean and chlorinated.
6. Examine fish at critical points in the processing procedure for organoleptic qual-
ity such as
a. In butchering state, prior to precook
b. After precook before being canned (no long holding time after precook)
c. After any period the tuna has been held excessively long at room tempera-
ture
7. Evaluate firm’s canning operation for compliance with the GMPRs for low-acid
foods (21 CFR 113).
8. Check plant for proper screening and rodent proofing to eliminate insects and/
or rodents.
D. Sanitation
Check the following:
1. Firm’s operation for compliance with GMPRs for human foods. (21 CFR 110—
Sanitation).
2. Firm’s equipment cleaning and sanitizing operation and its effectiveness.
3. Adequate hand washing and sanitizing facilities have been provided and signs
are posted directing employees to use them.
4. Employees use of hand sanitizing solutions and whether solutions are main-
tained at proper strength.
5. Firm’s usage of insecticides and rodenticides so they do not become incidental
food additives.
6. Freezers for proper storage temperatures and for sanitary storage.
7. Firm’s records regarding assay of finished product for mercury, decomposition,
and other quality factors.
8. Firm’s assay records to determine if the canned tuna complies with the standard
(21 CFR 161.190).
9. Food additives used are permitted by the standards and other legal requirements.
IV. OYSTERS
Most oyster shucking operations are handled by state inspection agencies. For procedures
see FDA standard guidelines on interstate shellfish sanitation. Microbiological consider-
ations are of prime importance in any shellfish gathering and processing plant. Time/
temperature abuses enter into most problems with the products. However, the high value
of these products has made economic violations even more profitable to the unethical
operator. During an evaluation of sanitation, use the critical factors as follows:
1. Check for evidence of contamination from the presence of cats, dogs, birds, or
vermin in the plant.
2. Check results of any testing conducted on incoming oysters including filth, de-
composition, pesticides, and bacteria.
3. Check for possible incorporation of excessive fresh water through (1) prolonged
contact with water or (2) insufficient drainage.
4. Determine if employee sanitation practices preclude adding contamination
(clean dress and proper use of 100 ppm chlorine equivalent hand sanitizers).
5. Determine if equipment is washed and sanitized about every 2 hr.
6. Check for time/temperature abuses that may cause rapid bacterial growth.
V. BLUE CRAB (FRESH AND PASTEURIZED)

During a sanitation evaluation, use critical factors as follows:
1. Check for evidence of contamination from rodents, insects, flies, birds, and
domestic pets.
2. Determine if employee sanitation practices preclude adding contamination
(clean dress and proper use of 100 ppm chlorine equivalent hand sanitizers),
particularly during pick-out of shells from crabmeat.
3. Determine if equipment is washed and sanitized about every 2 hr.
4. Check for time/temperature abuses which may cause rapid bacterial growth.
5. Check testing of incoming crabs for decomposition, bacterial load, pesticides,
and dead crab removal prior to processing.
6. Check firm’s usage of rodenticides and insecticides to determine that they do
not contaminate the in-process crabs.
Let us look at the sanitation aspects of the different stages of operation.
B. Raw Materials
1. Check receiving and handling process prior to cooking.
2. See if firm discards all dead crabs prior to cooking. If not, estimate percentage
of dead crabs utilized.
3. Note any rodent or insect activity in the receiving area.
4. If the firm refrigerates the live crabs prior to cooking, see if they are kept in a
separate cooler from the processed crabs.
5. Check results of any testing of incoming crabs including bacteriological results
and pesticides.
C. Manufacturing Process
To evaluate the sanitation of the manufacturing process, check on the following areas.
1. Cooking
Check product flow and determine time and temperature of cooking and type of cooker:
1. Retort.
2. Live Steam. Check boiler compound used.
3. Review recording charts for retorts.
4. Determine venting procedures.
2. Cooling
Check time and temperature relationship and
1. How long cooked crabs are held at room temperature
2. Any processing delays between cooking, cooling, and picking
3. Whether cooled crabs are refrigerated until picked
4. Whether cooked crabs are stored in same baskets as cooked in or are transferred
to another container
5. If refrigerator is used for storing cooled crabs, it is used only for this purpose
3. Picking
Check on the following sanitation aspects:
1. Is picking table cleaned and sanitized prior to use, at appropriate times during
the day, and at the end of the day.
2. If the picking table is not cleaned and sanitized between each new supply of
crabs, are all crabs on the table picked prior to the addition of new crabs. Check
handling of crab claws prior to picking.
3. Pickers hands for cuts, sores, etc.
4. That picking utensils are of proper construction.
a. See if all metal knives without wooden handles are used.
b. Check to see that the workers do not wrap the handles of the knives with
paper towels, cloth, or string.
c. See if all stainless steel or other metal shovels with steel handles and shafts
are used for placing the crabs onto the picking table. Check shovel storage
and see whether it is used for anything besides crabs.
5. If claws are picked mechanically, obtain procedure and check operation.
6. Check on how often pickers deliver the picked meat to the packing room.
4. Packing
1. See if picked crab meat is placed directly into the can or into holding pans. If
the crab is ‘‘deboned’’ prior to packing, check on how long it is held.
2. See if weighed crabmeat weighed into final cans is closed and iced at frequent
intervals. Determine if pickers do their own weighing and final packing.
3. Check on how finished packaged crab meat is stored or if it is shipped the same
day it is packaged.
4. See if ice used is from an approved source. Check storage of ice.
5. Pasteurization
1. Check the can closing system and can handling prior to pasteurization.
2. Check time/temperature of pasteurization process.
3. Check on how pasteurized cans are cooled and stored.
4. See if the finished canned crabmeat is stored in a refrigerator prior to shipping
and how long it is held prior to shipment.
5. Determine shipping operation: refrigerated trucks, iced baskets, etc.
6. Lighting, Ventilation, Refrigeration, Equipment
1. Determining if building is adequately lighted and ventilated.
2. Check if the cooling and refrigerating facilities are adequate to do the job.
3. See if equipment is of proper construction.
D. Overall Sanitation
1. See if the building provides for a separation of the various processes.
2. See if building is so constructed to be free from rodent or insect entry points
or harborages and whether there are rodents or insects in plant.
3. Check if product contact surfaces (tables, carts, pans, knives, etc.) are of proper
construction. See if seams are sealed to avoid product build-up.
4. Obtain in detail the firm’s plant and equipment cleaning and sanitizing proce-
dures and check if all equipment is cleaned and sanitized as necessary.
5. Determine if employee toilets and hand washing facilities are provided, main-
tained, and supplied and if handwashing facilities are located in various areas.
6. Determine if hand sanitizing solutions are provided at appropriate locations,
maintained at proper levels at all times, and used when necessary. Check hand
sanitizing solution strength at various intervals during the inspection. Check to
see if employees use hand dips when necessary.
7. Evaluate the firm’s operations and employee practices for compliance with the
human food (sanitation) GMPRs (21 CFR 110 and the Food Code).
8. Document any insanitary conditions noted that could lead to the contamination
of the firm’s crabs or crabmeat with filth and/or bacteria.
9. Check storage and disposal of solid waste, e.g., shells.
E. Check List For Crustacea Processor

Use the following table to obtain the information necessary to make a valid assessment
of the sanitation of a processor’s operation.
Stage Assessment
Receiving (unload) 1. Determination of condition (acceptable or decom-
posed)
2. Separation work area
Sorting 1. Removal of miscellaneous species of incidental
fish
2. Further determination of condition (quality)
Age 1. Sanitation
2. Time/temperature
Peeling (mechanical), 1. Sanitation
types (Model A) 2. Potable water
(PCA-1.5″ cook) 3. Separate work area (for peeling, washers, separa-
(choice for freezing) tors, and if applicable shaker-blower)
Washers 1. Sanitation
2. Portable water
3. Shell and debris removal (quality)
Shaker-blower (options) 1. Sanitation
2. Shell removal (quality)
In-house inspection 1. Sanitation
2. Shell removal
3. Separate work area for freezing
Size graded (machine Sanitation
or manual)
Package (cans or plas- Sanitation
tic) Personnel sanitation
Suitable packaging materials
Time/temperature
Separate work area
Freeze Time/temperature (quality)
VI. SCALLOPS
A. Background Information
The scallop industry encompasses three primary species: (1) sea scallops, (2) bay scallops,
and (3) calico scallops.
The processing of sea scallops is accomplished on board the vessel actually harvest-
ing the product. Boats which process sea scallops remain at sea from 3–12 days depending
on area and catch. In most cases, the calico scallops are harvested daily and processed at
shore processing plants rather than on board the vessel. The trend, however, is toward
on-board processing for this species also. Bay scallops pose a unique problem in that they
may be processed in a commercial plant or at home.
B. Sanitation Critical Factors

During the evaluation of food plant sanitation, use the following critical factors:
1. Check for evidence of contamination from rodents, insects, birds, or from do-
mestic animals.
2. Determine if equipment is washed and sanitized about every 2 hrs.
3. Check for time/temperature abuses which could cause rapid bacterial growth
and/or decomposition.
4. Determine if employee practices preclude the addition of contaminants. Check
for clean dress and proper use of 100 ppm chlorine equivalent hand sanitizers.
5. Determine method of icing or freezing of the scallops.
6. Ascertain if incoming scallops are tested for bacterial load, decomposition, pes-
ticides, etc. Review results of these tests.
7. Check usage of pesticides and rodenticides by firm to ascertain that they do not
become incidental food additives.
C. Raw Materials
Determine the following:
1. Geographical area where the scallops are harvested

2. Type of scallops harvested and processed by common or species name
3. How scallops are handled between harvesting and processing
D. Processing
1. Observe in detail the scallop processing operation. Make a flow plan.
2. Check shucking and evisceration process, to see if this process is physically
separated from the packaging and other operations.
3. Determine source of water used in the scallop washing and rinsing operations.
If treated by the processor, determine nature and extent of treatment.
4. See if equipment used in processing operation is of proper construction and
design.
5. Check firm’s cleaning and sanitizing operation.
6. Determine time and temperature of processing operation by checking
a. How long between harvest and chucking and the temperature of the scal-
lops
b. How long scallops are held at ambient air temperature and determine the
ambient temperature
c. How long between shucking and rinsing and the temperature of the scal-
lops
d. After being iced, how long before scallops reach an internal temperature
below 40°F
7. Check finished product packaging.
8. Determine source of ice used in icing operation and, if bagged ice is used,
source and type of bag, condition of bags, conditions of storage.
9. Check finished product storage facilities and condition.
10. Check on the use of any food additives to determine if used at allowable levels.
E. Overall Sanitation
1. See if building or vessel is free from rodent or insect activity.
2. Check that toilets and hand washing facilities provided are properly located and
maintained.
3. Determine strength and type of hand sanitizing solutions used and the sanitizer’s
location.
4. Note any employee practices that could lead to the contamination of the scallops
with filth and/or bacteria.
5. See if water and ice used in the process is from an approved source and list
source.
6. Determine method of shell and waste material disposal.
7. Evaluate the firm’s operation for compliance with the human foods (sanitation)
CGMPRs (21 CFR 110 and the Food Code).
8. Document any insanitary conditions noted which could lead to the contamina-
tion of this firm’s products with filth and/or bacteria.
VII. SHRIMP
Breading of shrimp has long posed a problem from an economic standpoint. In addition,
the time/temperature abuses present a great potential for food poisoning organisms. The
growing scarcity and consequential high value of the raw material make the breading
standards even more important. Review breaded shrimp standards (21 CFR 161) prior to
evaluating plant sanitation.
During a sanitation assessment, use critical factors as follows:
1. Check for the presence of cats, dogs, birds, or vermin in the plant.
2. Review testing of incoming shrimp. Check results of tests for decomposition,
bacterial load, pesticides, and other possible adulterants.
3. Evaluate operation for compliance with 21 CFR 12.1 (Raw Breaded Shrimp).
4. Watch for any time/temperature abuses in the handling of seafood.
5. Determine that employee hygienic practices are satisfactory, e.g., clean dress,
washing of hands, and use of 100 ppm chlorine equivalent hand sanitizers.
6. Note any equipment defects which cause seafood to lodge, decompose, then
dislodge into the pack.
7. Observe breading operations for suspected excesses (12 CFR 161.175/6) or lack
of coolant to keep batter mix below 50°F in an open system and below 40°F
in closed system.
Note the misuse of pesticides, abuse of color or food additives, deviations from
standards, etc.
B. Raw Materials: Receipt and Storage

Determine if
1. Shrimp and other raw materials are inspected upon receipt for decomposition,
microbial load, pesticides, and filth.
2. Raw materials susceptible to microbial contamination are received under a sup-
plier’s guarantee. Raw material specifications exist and only wholesome raw
materials are accepted into active inventory. Determine disposition of rejected
raw materials.
3. Shrimp receiving and storage facilities are physically adequate.
4. Frozen shrimp are stored at 0°F (⫺18°C) or below.
5. Fresh or partially processed shrimp are iced or otherwise refrigerated to main-
tain a temperature of 40°F (4°C) or below until they are ready to be processed.
6. Decomposed shrimp are being processed as follows:
a. Examine shrimp as received, and again after sorting, for decomposition.
Classify as passable (class 1), decomposed (class 2), or advanced decompo-
sition (class 3). Less experienced inspectional personnel should submit
some of class 2 and class 3 shrimp for confirmation by the laboratory.
b. Prompt handling and adequate sorting is necessary to prevent decomposi-
tion. Check times and temperatures.
c. Where decomposed shrimp are going into canned or cooked/peeled shrimp,
collect investigational samples of the finished pack. Give attention to dispo-
sition of loads showing a high percentage of decomposition which cannot
be adequately sorted and to disposition of reject shrimp. Make certain that
‘‘bait shrimp’’ is denatured.
7. Fresh raw shrimp are washed and chilled to 40°F (4°C) or below within two
hours of receipt. Frozen shrimp should be held at 0°F (⫺18°C) or below. Deter-
mine if they are examined organoleptically when received.
8. Peeled and deveined shrimp are promptly chilled to 40°F (4°C) or below.
C. Plant Sanitation
Determine if
1. The water (ice) is
a. From an approved source
b. Disinfected and contains residual chlorine
c. Sampled and analyzed for contamination
d. Handled in a sanitary manner
2. Drainage facilities are adequate to accommodate all seepage and wash water.
3. The plant has readily cleanable floors which are sloped and equipped with trap
drains.
4. The plant is free of the presence of vermin, dogs, cats, or birds.
5. The screening and fly control is adequate.
6. Offal, debris, and refuse is placed in covered containers and removed at least
daily or continuously.
7. Adequate hand-washing and sanitizing facilities are located in processing area
and are easily accessible to the preparation, peeling, and subsequent processing
operations.
8. Signs are posted directing employees handling shrimp and other raw materials
to wash and sanitize their hands after each absence from the work station.
9. Employees actually wash and sanitize their hands as necessary (before starting
work, after absences from the work station, when hands become soiled, etc.).
10. Hand sanitizing solutions are maintained at 100 ppm available chlorine or the
equivalent and are used.
11. Persons handling food or food contact surfaces wear clean outer garments,
maintain a high degree of personal cleanliness, and conform to good hygienic
practices.
12. Management prevents any person known to be affected with boils, sores, in-
fected wounds, or other sources of microbiological contamination from work-
ing in any capacity in which there is a reasonable possibility of contaminating
the food.
13. The product is processed to prevent contamination by exposure to areas in-
volved in earlier processing steps, refuse, or other objectionable conditions or
areas.
14. Food contact surfaces are constructed of metal or other readily cleanable mate-
rials.
15. Seams are smoothly bonded to prevent accumulation of shrimp, shrimp mate-
rial, or other debris.
16. Each freezer and cold storage compartment used for raw materials and in-
process or finished product is fitted with required temperature-indicating de-
vices.
17. Unenclosed batter application equipment is flushed and sanitized at least every
4 hr during plant operations and all batter application equipment is cleaned
and sanitized at the end of and the beginning of the day’s operation.
18. Breading application equipment and utensils are thoroughly cleaned and sani-
tized at the end of the day’s operation.
19. Utensils used in processing and product contact surfaces of equipment are
thoroughly cleaned and sanitized at least every 4 hr during operation.
20. All utensils and product contact surfaces excluding breading application equip-
ment and utensils are rinsed and sanitized before beginning the day’s operation.
21. Containers used to convey or store food are handled in a manner to preclude
direct or indirect contamination of the contents.
22. The nesting of containers is prohibited.
D. Processing
Determine if
1. Raw frozen shrimp are defrosted at recommended temperatures [air defrosting
at 45°F (7°C) or below, or in running water at 70°F (21°C) or below in less
than 2 hr].
2. Fresh raw shrimp are washed in clean potable water and chilled to 40°F (4°C)
or below.
3. Fresh shrimp are adequately washed, culled, and inspected.
4. Every lot of shrimp that has been partially processed in another plant, including
frozen shrimp, is inspected for wholesomeness and cleanliness.
5. Shrimp entering thaw tank are free from exterior packaging material and sub-
stantially free of linear material.
6. On removal from thaw tank shrimp are washed with a vigorous potable water
spray.
7. Shrimp are removed from thaw tank within 30 min after they are thawed.
8. During the grading, sizing, or peeling operation the (1) equipment is cleaned
and sanitized before use; (2) water is maintained at proper chemical strength
and temperature; and (3) raw materials are protected from contamination.
9. Sanitary drainage is provided to remove liquid waste from peeling tables.
10. Firm prohibits the practice of salvaging shrimp (i.e., repicking the accumulated
hulls and shells for missed shrimp or shrimp pieces).
11. Peeled and deveined shrimp are promptly chilled to 40°F (4°C) or below.
12. Peeled shrimp are transported from peeling machines or tables immediately
or, if containerized, within 20 min.
13. Peeled shrimp containers, if applicable, are cleaned and sanitized as often as
necessary, but in no case less frequently than every 3 h.
14. When a peeler is absent from the duty post, the container is cleaned and sani-
tized prior to resuming peeling.
15. Peeled shrimp that are transported from one building to another are properly
iced or refrigerated, covered and protected.
16. Shrimp are handled minimally and protected from contamination.
17. Shrimp which drop off processing line are discarded or reclaimed.
18. Shrimp are washed with a low-velocity spray or in unrecirculated flowing wa-
ter at 50°F (10°C) or below just prior to the initial batter or breading applica-
tion, whichever comes first, except in cases where a predust application is
included in the process.
19. Removal of batter or breading mixes or other dry ingredients from multiwalled
bags is accomplished in an acceptable manner.
20. Batter in enclosed equipment is assured a temperature of not more than 40°F
(4°C) and disposed of at the end of each work day, but in no circumstances
less often than every 12 hr.
21. Batter in an unenclosed system is maintained at or below 50°F (10°C) and
disposed of at least every 4 hr and at the end of the day’s operation.
22. Breading reused during a day’s operation is sifted through a 0.5 in. or smaller
mesh screen.
23. Breading remaining in the breading application equipment at the end of a day’s
operation is reused within 20 hr and is sifted as mentioned and stored in a
freezer in a covered sanitary manner.
24. Hand batter pans are cleaned, sanitized, and rinsed between each filling with
batter or breading.
E. Finished Product Process and Quality Assurance

Determine if
1. Processing and handling of finished product is (1) performed in a sanitary
manner, (2) protected from contamination, and (3) arranged to facilitate rapid
freezing.
2. Manual manipulation of breaded shrimp is kept to a minimum.
3. Aggregate processing time, excluding the time required for thawing frozen
material, is less than 2 hr, exclusive of iced or refrigerated storage time.
4. Breaded shrimp are placed into freezer within 30 min of packaging.
5. Breaded shrimp are frozen in a plate or blast freezer at ⫺20°F (⫺29°C) or
below.
6. Storage freezer is maintained at or below 0°F (⫺18°C).
7. In-line, environmental, and finished product samples are analyzed and evalu-
ated at least weekly for microbial conditions. Review these analytical records,
if available.
8. Firm has established microbiological specifications for the final product. If so,
review and report these specifications.
9. Firm withholds from distribution lots which do not meet their established mi-
crobiological standards.
10. Finished product is handled and stored in a manner which precludes contami-
nation.
11. Labels bear a cautionary statement to keep product frozen.
VIII. SMOKED FISH

During an evaluation of the sanitation of a smoking fish operation, use critical factors as
follows:
1. Check sanitary conditions under which firm is operating, including any evidence
of insanitation and contamination associated with insects, rodents, microorgan-
isms, chemicals, or other possible sources. Check raw material and packaging
material storage areas as well as other susceptible locations in the plant.
2. Review raw material receiving records for DDT and other pesticides, decompo-
sition, and bacteriological quality.
3. Check food and color additives to ascertain that they are allowed for use and
are being used properly.
4. Observe employee practices to make sure that they are not acting as routes of
contamination.
5. Ascertain if the various operations including raw material receipt and storage,
defrosting, brining, etc., are acceptable.
6. Review recording charts to ascertain what times/temperatures of smoking have
been, which may vary depending on the desired salt content the firm is trying
to achieve.
7. Check finished stored product (i.e., any smoked chubs in which nitrite is used)
to ascertain the internal temperature based on the time since smoking. (Tempera-
ture within 3 hr of cooking and again within 12 hr of cooking.)
B. Plant Sanitation and Facilities

1. Check method(s) for cleaning and sanitizing utensils, conveyors, smoking racks,
and other food-contact surfaces used in daily operations.
2. Check the strength and adequacy of hand sanitizing and equipment sanitizing
solutions. The minimum effective chlorine concentration for hand sanitizing
solutions is 100 ppm and for equipment sanitizing solutions is 200 ppm. Io-
dine solutions should be 15 ppm for hand sanitizing solutions and 25 ppm for
equipment sanitizing solutions. Determine if maintained at proper levels.
3. Determine method used to separate finished product cooling, packaging, and
storage areas from the uncooked product and processing areas.
4. Determine the adequacy of plant waste disposal operations.
5. Check if hand washing, toilet, and sanitizing facilities have been provided and
that signs have been posted directing the employees to wash and sanitize hands
following use.
C. Raw Materials
1. Source (area and distributor) and species of fish processed by the firm including
the type selected for full coverage during this inspection.
2. Process condition in which bulk fish is supplied (e.g., fresh, frozen, mild cured,
brined, etc.).
3. Quality of fish received. Organoleptic examination should be performed and
results reported.
4. Raw fish handling procedures (e.g., defrosting, draining procedures encoun-
tered).
5. Available chlorine or iodine concentrations in hand dip or equipment sanitizing
solutions, if used.
6. Time/temperature intervals for each step in the raw fish handling operations.
7. If incoming fish are sampled and analyzed for the presence of DDT and other
pesticides.
D. Processing
1. Salting and Brining
1. Size of fish or pieces of fish brined noting variations of fish size and sizing
procedures.
2. Form and grade of salt (NaCl) used in the brining.
3. Ratio of brine to fish. Determine actual or near estimates of weight of salt,
volume of water, and weight of fish being brined.
4. Concentrations of brine (NaCl) solutions in degrees Salinometer at the initiation
of brining, during brining, and at the conclusion of the brining operation. A
reduction in salt concentration in the brining solution after brining may indicate
salt uptake by the fish during brining. (Caution: if Salinometers are made of
glass, the degree of salinity should be read in a plastic graduate. Do not put the
salinometer directly into the tank with fish. It could break and contaminate the
fish with glass.)
5. Times/temperatures of brining solutions at different intervals during the brining
process. Include total brining time.
6. Method of agitation of brine solution during brining, if employed, noting num-
ber of times agitated and length of each agitation.
2. Heating, Cooking, and Smoking Operation
1. Check equipment used during heating, cooking, and smoking operation. Include
oven type, source of heat, type of smoke generators, product temperature moni-
toring equipment, humidity regulators, etc. (Temperature recording devices
should have an accuracy of ⫾2°F.)
2. Determine the methods and procedures used in drying, cooking, and smoking.
Include time/temperature data, results of temperature monitoring by the firm,
location of the temperature probes, and product rotation practices.
3. Cooling
1. Monitor time/temperature relationship during cooling to determine how long it
takes to reach an internal temperature of 38°F.
2. Determine method of cooling.
3. Check observable procedures and conditions which can contribute to the micro-
biological contamination of the processed fish. Include observations such as
extended cooling time and optimal incubation temperature, exposed to airborne
contamination, improper handling, or poor in-process storage conditions.
4. Determine if firm separates cooling facilities from raw processing and cooking
operations.
4. Packaging
Determine method and types of packing including:
1. Time/temperature relationship during packaging.
2. Any use of additives or prepackaging additive treatment. Include name and
quantity added, method of application, etc.
3. Observable practices and conditions which can contribute to the microbiological
contamination of the processed fish. Include lack of required facilities, excessive
product handling, improper storage, etc.
E. Storage and Distribution

1. Check type of equipment used for determining, recording, and maintaining stor-
age temperatures.
2. Determine actual storage compartment temperatures. Refrigerated storage tem-
peratures should be 38°F or below.
3. Determine method of distribution (e.g., refrigerated, iced, frozen, etc.).
F. Laboratory Controls
Check or determine the following:
1. Method and frequency of sampling. Identify salinity testing operations and eval-
uate testing procedures and frequency. Describe microbiological testing of pro-
cessed fish, how often, methods used, adequacy of testing, etc.
2. Checks made on in-process controls and laboratory equipment.
3. Use of outside laboratories, consultants, etc. Include name, location, and tests
each firm performs and how often tests are conducted.
4. Results of analysis from previous lots.
G. Overall Sanitation
1. Evaluate the firms operation for compliance with 21 CFR 110 (GMPRs for
human foods sanitation).
2. Evaluate the firm’s cleaning and sanitizing procedures.
3. Check if adequate hand washing and sanitizing facilities are provided and if
signs directing their use are provided. Evaluate employee use of hand dips and
if they are used when necessary.
4. See if hand dips and equipment sanitizing solutions are maintained at the proper
level and changed when necessary.
ACKNOWLEDGMENT
Most data provided in this chapter have been modified with permission from documents
prepared by Science Technology System, West Sacramento, CA.

33
Retail Foods Sanitation:
Prerequisites to HACCP
PEGGY STANFIELD
I. BACKGROUND
When we talk about retail food protection, we include many categories of business that
deal with food, e.g., restaurants, cafeterias (schools, prisons, hospitals), public eating
places (fairgrounds, events), and so on. As far as health agencies are concerned, delis,
grocery stores, etc., are also considered as retail food businesses. There is no doubt that
eventually all large restaurants and cafeterias will be required to implement a hazard analy-
sis and critical control point (HACCP) system. Before it can be implemented, most state
regulatory agencies want to make sure that all such food service establishments have in
place safety programs that serve as the foundation or prerequisites to a workable HACCP
program. This chapter discusses such fundamental safety practices and how they can even-
tually be incorporated into a sound HACCP program. The data have been modified from:
A HACCP Principles Guide for Operators of Food Establishments at the Retail Level
[DRAFT]. Food and Drug Administration: April 15, 1998.
The discussion for this chapter will be much facilitated by referring to the glossary
of terms frequently mentioned provided in the next section and taken from the Food Code.
II. GLOSSARY
Approved source Acceptable to the regulatory authority based on a determination
of conformity with principles, practices, and generally recognized standards that
protect public health.
Bacteria Living single-cell organisms, bacteria can be carried by water, wind, in-
sects, plants, animals, and people and survive well on skin and clothers and in
human hair. They also thrive in scabs, scars, the mouth, nose, throat, intestines,
and room-temperature foods.
CCP Critical control point
Contamination The unintended presence in food of potentially harmful substances,
including microorganisms, chemicals and physical objects.
Cross-contamination The transfer of harmful substances or disease-causing micro-
organisms to food by hands, food-contact surfaces, sponges, cloth towels, and
utensils that touch raw food, are not cleaned, and then touch ready-to-eat foods.
Cross-contamination can also occur when raw food touches or drips onto cooked
or ready-to-eat foods.
Corrective action An activity that is taken by a person whenever a critical limit
is not met.
Critical control point (CCP) An operational step or procedure in a process, produc-
tion method, or recipe, at which control can be applied to prevent, reduce, or
eliminate a food safety hazard.
Critical limit A measurable limit at a CCP that can be monitored to control the
identified hazard to a safe level in the food.
Fish
1. Fresh or saltwater finfish, crustaceans, and other forms of aquatic life
(including alligator, frog, aquatic turtle, jellyfish, sea cucumber, sea ur-
chin, and the roe of such animals), other than birds or mammals, and all
mollusks, if such life is intended for human consumption.
2. Includes an edible human food product derived in whole or in part from
fish, including fish that have been processed in any manner.
Food Raw, cooked, or processed edible substance, ice, beverage, chewing gum,
or ingredient used or intended for use or for sale in whole or in part for human
consumption.
Food establishment An operation at the retail level, i.e., that serves or offers food
directly to the consumer and that, in some cases, includes a production, storage,
or distributing operation that supplies the direct-to-consumer operation.
Foodborne illness Sickness resulting from acquiring a disease that is carried or
transmitted to humans by food containing harmful substances.
Foodborne outbreak The occurrence of two or more people experiencing the same
illness after eating the same food.
HACCP Hazard analysis and critical control points.
HACCP plan A written document based on the principles of HACCP and describes
the procedures to be followed to ensure the control of a specific process or procedure.
HACCP system The result of implementing the HACCP principles in an operation
that has a foundational, comprehensive, prerequisite program in place. A HACCP
system includes the HACCP plan and all standard operating procedures (SOPs).
Hazard A biological, physical, or chemical property that may cause a food to be
unsafe for human consumption.
Internal temperature The temperature of the internal portion of a food product.
Meat The flesh of animals used as food including the dressed flesh of cattle, swine,
sheep, or goats and other edible animals, except fish, poultry, and wild game
animals.
Microorganism A form of life that can be seen only with a microscope; includes
bacteria, viruses, yeast, and single-celled animals.
Molluscan shellfish Any edible species of raw, fresh, or frozen oysters, clams,
mussels, and scallops, or edible portions thereof, except when the scallop product
consists only of the shucked adductor muscle.
Monitoring The act of observing and making measurements to help determine if
critical limits are being used and maintained.
National Shellfish Sanitation Program (NSSP) The voluntary system by which
regulatory authorities for shellfish harvesting waters and shellfish processing and
transportation and the shellfish industry implement specified controls to ensure
that raw and frozen shellfish are safe for human consumption.
NSSP National Shellfish Sanitation Program.
Operational step An activity in a food establishment, such as receiving, storage,
preparation, cooking, etc.
Parasite An organism that grows, feeds, and is sheltered on or in a different organ-
ism and contributes to its host.
Pathogen A microorganism (bacterium, parasite, virus, or fungus) that is infectious
and causes disease.
Personal hygiene Individual cleanliness and habits.
Potentially hazardous food A food that is natural or synthetic and that requires
temperature control because it is capable of supporting one of the following:
1. The rapid and progressive growth of infectious or toxigenic microorgan-
isms
2. The growth and toxin production of Clostridium botulinum
3. In raw shell eggs, the growth of Salmonella enteritidis
Potentially hazardous food includes foods of animal origin that are raw or heat
treated; foods of plant origin that are heat treated or consist of raw seed sprouts;
cut melons; and garlic and oil mixtures that are not acidified or otherwise modified
at a processing plant in a way that results in mixtures that do not support growth
of pathogenic microorganisms as described.
Procedural step An individual activity in applying the HACCP plan to a food
establishment’s operations.
Process approach A method of categorizing food operations into one of three
modes:
1. Process 1: food preparation with no cook step wherein ready-to-eat food
is stored, prepared, and served
2. Process 2: food preparation for same day service wherein food is stored,
prepared, cooked, and served
3. Process 3: complex food preparation wherein food is stored, prepared,
cooked, cooled, reheated, hot held, and served.
Ready-to-eat food
1. A food that is in a form that is edible without washing, cooking, or addi-
tional preparation by the food establishment or consumer and that is rea-
sonably expected to be consumed in that form.
2. Ready-to-eat food includes potentially hazardous food that has been
cooked; raw, washed, and cut fruits and vegetables; whole, raw fruits and
vegetables that are presented for consumption without the need for further
washing, such as at a buffet; and other food presented for consumption
for which further washing or cooking is not required and from which
rinds, peels, husks, or shells have been removed.
Record A documentation of monitoring observation and verification activities.
Regulatory authority A federal, state, local, or tribal enforcement body or autho-
rized representative having jurisdiction over the food establishment.
Risk An estimate of the likely occurrence of a hazard.
SOP Standard operating procedure.
Shellfish Bivalve molluscan shellfish.
Standard operating procedure (SOP) A written method of controlling a practice
in accordance with predetermined spefications to obtain a desired outcome.
Temperature measuring device A thermometer, thermocouple, thermistor, or other
device for measuring the temperature of food, air, or water.
Toxin A poisonous substance that may be found in food.
Verification The use of methods, procedures, or tests by supervisors, designated
personnel, or regulators to determine if the food safety system based on the
HACCP principles is working to control identified hazards or if modifications
need to be made.
Virus A protein-wrapped genetic material which is the smallest and simplest life
form known (e.g., hepatitis A).
III. PREREQUISITE PROGRAMS

A. Food Code
The provisions of the Food Code provide a foundation on which to develop a food safety
system based upon the principles of HACCP. Major interventions in the Food Code are
demonstration of knowledge by the person in charge, employee health, no bare-hand con-
tact with ready-to-eat food, time and temperature control, and the use of a consumer advi-
sory regarding the consumption of raw or undercooked animal foods. There interventions
need to be addressed within the overall food safety program, which may entail inclusion
in standard operation procedures (SOPs) that can be considered as one major frame of
reference of sanitation and HACCP.
B. Standard Operation Procedures

1. Introduction
Many provisions of the Food Code address the design of food establishments and equip-
ment as well as acceptable operational practices. Adherence to design criteria and develop-
ment of SOPs affects the food preparation environment. Both are considered prerequisites
to the development of food safety systems based upon the HACCP principles. The SOPs
specify practices to address general hygiene and measures to prevent food from becoming
contaminated due to various aspects of the food environment. When SOPs are in place,
HACCP can be more effective because it can concentrate on the hazards associated with
the food and its preparation and not on the food preparation facility.
The SOPs specific to your operation describe the activities necessary to complete
tasks that accomplish compliance with the Food Code, are documented as a written refer-
ence, and are used to train the staff who are responsible for the tasks.
Three purposes for establishing SOPs for your operation are to protect your products
from contamination from microbial, chemical, and physical hazards; to control microbial
growth that can result from temperature abuse; and to ensure procedures are in place for
maintaining equipment. Standard operating procedures ensure that
1. Product is purchased from approved suppliers/sources.
2. The water in contact with food and food-contact surfaces and used in the manu-
facture of ice is potable.
3. Food-contact surfaces, including utensils, are cleaned, sanitized, and main-
tained in good condition.
4. Uncleaned and nonsanitized surfaces of equipment and utensils do not contact
raw or cooked ready-to-eat food.
5. Raw animal foods do not contaminate raw or cooked ready-to-eat food.
6. Toilet facilities are accessible and maintained.
7. Hand washing facilities are located in food preparation, food dispensing, and
warewashing areas and immediately adjacent to toilet rooms, and are equipped
with hand cleaning preparations and single-service towels or acceptable hand
drying devices.
8. An effective pest control system is in place.
9. Toxic compounds are properly labeled, stored, and safely used.
10. Contaminants such as condensate, lubricants, pesticides, cleaning compounds,
sanitizing agents, and additional toxic materials do not contact food, food pack-
aging material, or food-contact surfaces.
11. Food, food packaging materials, and food-contact surfaces do not come in
contact with and are not contaminated by physical hazards such as broken
glass from light fixtures, jewelry, etc.
2. Standard Operating Procedures to Control Contamination of Food
Procedures must be in place to ensure that proper personnel health and hygienic practices
are implemented, including
1. Restricting or excluding workers with certain symptoms such as vomiting or
diarrhea
2. Practicing effective hand washing
3. Restricting eating, smoking, and drinking in food preparation areas
4. Using hair restraints
5. Wearing clean clothing
6. Restricting the wearing of jewelry
3. Microbial Growth Control
These procedures ensure that all potentially hazardous food is received and stored at a
refrigerated temperature of 41°F (5°C) or below. Note that the Food Code makes some
allowances for specific foods that may be received at higher temperatures.
4. Equipment Maintenance
These procedures ensure that
1. Temperature measuring devices (e.g., thermometer or temperature recording
device) are calibrated regularly.
2. Cooking and hot holding equipment (grills, ovens, steam tables, conveyor cook-
ers, etc.) are routinely checked, calibrated if necessary, and operating to ensure
correct product temperature.
3. Cooling equipment (refrigerators, rapid chill units, freezers, salad bars, etc.) are
routinely checked, calibrated if necessary, and operating to ensure correct prod-
uct temperature.
4. Warewashing equipment is operating according to manufacturer’s specifica-
tions.
C. The Flow of Food

The flow of food, which is the path that food follows from receiving through serving, is
important for determining where potentially significant food safety hazards may occur.
At each operational step in the flow, active management of food preparation and processes
is an essential part of business operations. With a HACCP system, you set up control
measures to protect food at each stage in the process.
The examples of food processes listed are not intended to be all inclusive. For in-
stance, quick-service, full-service, and institutional providers are major types of food ser-
vice operations. Each of these has its own individual food safety processes. These pro-
cesses are likely to be different for a deli in a retail food store. Some operations may have
all three types of processes or variations of the three. Identifying the food process flows
specific to your operations is an important part of providing a framework for developing
a food safety management system.
1. Food Process with No Cook Step: Receive–Store–Prepare–
Hold–Serve
As mentioned, the important feature of this type of process is the absence of a cooking
step. Heating foods destroys bacteria, parasites, and viruses and is often a CCP. But since
this particular food flow does not include cooking, there is no step that will eliminate or
kill bacteria, parasites, or viruses. An example is tuna salad that is prepared and served
cold. Control in this process will focus on preventing
1. Bacterial growth (e.g., storage under refrigeration)
2. Contamination from employees (e.g., restriction of employees ill with diarrhea,
proper hand washing, preventing bare-hand contact with ready-to-eat foods,
etc.)
3. Cross-contamination from other foods (e.g., raw to ready-to-eat)
4. Cross-contamination from soiled equipment (e.g., cleaning and sanitizing)
5. Obtaining foods from approved sources (e.g., a supplier of raw fish or sushi
who adequately freezes fish to control parasites)
You should also think about some other factors, including
1. Are there any ingredients or menu items of special concern? (See Food Code.)
2. Is this a potentially hazardous food requiring specific temperature controls?
3. How willit be served? Immediately? On a buffet?
4. Does this food have a history of being associated with illnesses?
5. Will this require a great deal of preparation, making preparation time, employee
health, and bare-hand contact with ready-to-eat food a special concern?
6. How will an employee ill with diarrhea be restricted from working with food?
7. Are you serving food to a population that is known to be highly susceptible to
foodborne illness (e.g., residents of health care facilities, persons in child or
adult day care facilities, etc.)?
2. Food Preparation for Same-Day Service: Receive–Store–Prepare–
Cook–Hold–Serve
In this process, a food is prepared and served the same day. The food, such as chili, will
be cooked and held hot until service. Generally, the food will pass through the temperature
danger zone only once before it is served to the customer, thus minimizing the opportunity
for bacterial growth.
The preparation step may involve several processes, including thawing a frozen
food, mixing in other ingredients, or cutting or chopping. It is important to remember that
added ingredients may introduce additional contaminants to the food. Cutting or chopping
must be done carefully so that cross-contamination from cutting boards, utensils, aprons,
or hands does not occur. Control points at this operational step include good sanitation
and hand washing.
During cooking, food will be subjected to hot temperatures that will kill harmful
bacteria, parasites, and viruses that might be introduced before cooking, making cooking
a CCP. It is the operational step where raw animal foods are made safe to eat, and, there-
fore, time and temperature measurement is very important. Temperature of foods during
hot holding must be maintained until service so that harmful bacteria do not survive and
grow.
3. Complex Processes: Receive–Store–Prepare–Cook–Cool–Reheat–
Hot Hold–Serve
Failure to adequately control food product temperature is the one factor most commonly
associated with foodborne illness. Foods prepared in large volumes or in advance for next-
day service usually follow an extended process flow. These foods are likely to pass through
the temperature danger zone several times. The key in managing the operational steps
within the process is to minimize the time foods are at unsafe temperatures.
In some cases, a variety of foods and ingredients that require extensive employee
product preparation may be part of the process. A sound food safety management system
will incorporate SOPs for personal hygiene and cross-contamination prevention through-
out the flow of the food.
Before you set up a management system for your operational steps, there are several
factors you should consider. Multiple-step processes require proper equipment and facili-
ties. Your equipment needs to be designed to handle the volume of food you plan to
prepare. For example, if you use a process that requires the cooling of hot food, you
must provide equipment that will adequately and efficiently lower the food temperature
as quickly as possible. If you find that a recipe is too hard to safely prepare, you may
want to consider purchasing pre-prepared items from a reputable source.
IV. PROCEDURAL STEPS FOR DESIGNING THE HACCP SYSTEM

The most effective way to get started is to use a team approach to design and implement
a plan based on the HACCP principles. A team could be comprised of the owner and the
chef or cook. Although managers are responsible for designing the system, implementation
involves the efforts and commitment of every employee. Education and training of both
management and employees is important in their respective roles of producing safe foods.
You may consider working with outside consultants, university extension services, and
regulatory authorities to ensure your HACCP system is based on the best available science
and will control identified hazards.
A. Step 1: Group Menu Items

To get started, review how your menu items flow through your operation—note whether
they undergo a cook step for same day serving, receive additional cooling and reheating
following a cook step, or have no cook step involved. Refer to the Food Code for organiz-
ing your menu items by Processes 1, 2, and 3.
Looking at your menu, place each menu item or similar menu items (e.g., hot soups
or cold salads) into the appropriate group. You may discover that more than one food
process is conducted within your operation. These menu items may pose special hazards
that are not always readily apparent. To accomplish the first procedural step in developing
your food safety management system, identify the food processes specific to your menu
items and categorize your menu items according to one of the three process-specific lists:
Process number 1: Food preparation with no cook step—ready-to-eat food that is

stored, prepared, and served.
Process number 2: Food preparation for same-day service—food that is stored,
prepared, cooked, and served.
Process number 3: Complex food preparation—food that is stored, prepared,
cooked, cooled, reheated, hot held, and served.
See the following table for an example.
Process 1 Process 2 Process 3

Salad greens Hamburgers Soups
Fish for sushi Soup du jour Gravies
Fresh vegetables Hot vegetables Sauces
Oysters or clams served raw Entrees for ‘‘special of the day’’ Large roasts
Tuna salad with Caesar salad Cooked eggs Chili
dressing Taco filling
Coleslaw Egg rolls
Sliced sandwich meats
Sliced cheese
B. Step 2: Conduct Hazard Analysis

In developing a food safety system, you need to identify the hazards that exist in the flow
of foods in your operation, from receiving to serving Hazards include
1. Pathogens or toxins present in food when you receive them

2. Pathogens that may be introduced during preparation (e.g., using a raw animal
food as one ingredient)
3. Pathogen growth or toxin production during storage, preparation, or holding
4. Pathogens or toxins that survive heating
5. Contaminants (i.e., pathogens, chemicals, physical objects) that are introduced
to food by food workers or equipment
Since you have grouped your menu items, including ingredients, into the three pro-
cesses, you can identify hazards that are associated with each process. You will see that
the more complex the process is, the greater are the opportunities for hazards to occur.
In consultation with your regulatory authority, you need to identify the hazards asso-
ciated with various foods and ingredients, such as
1. Salmonella and Campylobacter jejuni in raw poultry.

2. E. coli O157:H7 in raw ground beef.
3. Staphylococcus aureus toxin formation in cooked ham
4. Bacillus cereus spore survival and toxin formation in cooked rice
5. Clostridium perfringens spore survival and subsequent growth in cooked foods
6. Hazards specific to seafood (see Food Code)
This list is only a brief sample of hazards associated with specific foods. By identifying
the hazards, you will be able to determine CCPs and critical limits on the worksheet.
Another way of fulfilling the hazard analysis step is to understand the hazards associated
with your specific menu items and to adhere to the critical limits established in the Food
Code. Those critical limits are based on the anticipated hazards.
1. Food Safety Management Worksheets and Summaries

Worksheets and summaries for your operational steps enable you to
1. Identify those operational steps in the food flow that are specific to your opera-
tion.
2. Write in your SOPs which are the general procedures that cross all flows and
products.
3. Reference the CCPs and critical limits pertaining to those process steps.
4. Develop monitoring procedures and corrective actions which are customized to
fit your operation.
5. Consider the type of recordkeeping you need to document that you are control-
ling significant food safety hazards.
A HACCP plan allows the flexibility for you to customize a food safety management
system specific to your operations. The worksheets are provided to assist you in developing
procedures to
1. Monitor CCPs.
2. Take corrective actions when critical limits are not met.
3. Establish a verification procedure.
Review the following worksheets and the summary page for each operational step. Deter-
mine the ones that are applicable to your operation and make copies of them so you can
fill in your groupings of menu items (which you did preliminarily in procedural step 1).
Then continue to use the forms and complete the information as you work through proce-
dural steps 3 through 9.
a. Receiving. At receiving, your main concern is contamination from pathogens and
the formation of harmful toxins. Obtaining food from approved sources and at proper
temperatures are important purchase specifications for preventing growth and contamina-
tion during receiving. Approved sources are suppliers who are regulated and inspected
by appropriate regulatory authorities. (See Table 1.)
Ready-to-eat, potentially hazardous food is a special concern at receiving. Because
this food will not be cooked before service, microbial growth could be considered a sig-
nificant hazard for receiving refrigerated, ready-to-eat foods. Having SOPs in place to
control product temperature is generally adequate to control the hazards present at receiv-
ing of these products. Besides checking the product temperature, you will want to check
the appearance, odor, color, and condition of the packaging.
Federal regulations require that processors of seafood and seafood products for inter-
state distribution have a HACCP plan. These establishments are approved sources for
seafood, and you may ask your interstate seafood supplier for documentation that the firm
has a HACCP plan in place. Processors of seafood and seafood products that are sold or
distributed only within a state may or may not be required to have a HACCP plan, de-
pending on the state, local, or tribal regulations.
Special consideration should be given to certain species of finfish and raw molluscan
shellfish. Molluscan shellfish (oysters, clams, mussels, and scallops) that are received raw
in the shell or shucked must be purchased from suppliers who are listed on the FDA
Interstate Certified Shellfish Shippers’ List or on a list maintained by your state shellfish
control authority. Shellfish received in the shell must bear a tag (or a label for shucked
shellfish) which states the date and location of harvest, in addition to other specific infor-
mation.
Finfish harvested from certain areas may naturally contain a certain toxin that is not
readily apparent. This toxin is called ciguatera. Other finfish may develop toxins after
harvest if strict temperature control is not maintained. This toxin is called scombrotoxin.
Temperature control is important at receiving because this toxin cannot be eliminated by
cooking. For more information on toxins in reef finfish, histamine formation in certain
species, and parasites in raw finfish requiring control, refer to the Food Code.
b. Storage. When food is in refrigerated storage, your management system should fo-
cus on preventing the growth of bacteria that may be present in the product. This is primar-
ily achieved through temperature control. Special attention needs to be given to controlling
and monitoring the temperatures of potentially hazardous ready-to-eat foods. (See Table
2.)
When determining the monitoring frequency of product storage temperature, it is
important to make sure that the interval between temperature checks is established to
ensure that the hazard is being controlled and time is allowed for an appropriate corrective
action. For example, if you are storing potentially hazardous ready-to-eat foods under
refrigeration, you may decide to set a critical limit for the refrigeration units to operate
at 41°F (5°C) or below. You may also want to set a target, or operating limit, of 40°F
(4.4°C), for example, in order to provide a safety cushion that allows you the opportunity
to see a trend toward exceeding 41°F (5°C) and to intervene with appropriate corrective
actions.
Monitoring procedures for ready-to-eat foods ideally include internal product tem-
perature checks. You need to assess whether it is realistic and practical for you to do this,
depending on the volume of food you are storing. You may choose to base your monitoring
Table 1 Receiving Worksheet
Corrective
Process Menu item Hazard CCP Critical limits Monitoring actions Verification Records
Process 1 Examples: salads, sushi Microbial contamination; Yes or no Receive at 41°F or
bacterial growth; para- below
sites; scombrotoxin, Approves source
ciguatera, or other Seafood HACCP plan
toxin contamination; Proper chemical storage/
chemical contami- use
nation
Process 2 Examples: hamburgers, Microbial contamination; Yes or no Receive at 41°F or
mahi-mahi bacterial growth; or below
scombrotoxin, cigua- Approved source
tera, or other toxin Seafood HACCP plan
contamination; chemi- Proper chemical storage/
cal contamination use
Process 3 Example: soups Microbial contamination; Yes or no Receive at 41°F or
bacterial growth; or below
scombrotoxin, cigua- Approved source
tera, or other toxin Seafood HACCP plan
contamination; chemi- Proper chemical storage/
cal contamination use

Table 2 Storage Worksheet
Corrective
Process 1 Examples: salads, sushi Bacterial growth, cross- Yes or no Store at 41°F or below
contamination, para- Separate raw from
sites, chemical contam- ready-to-eat food
ination Freeze fish to be con-
sumed raw at ⫺4°F
for 7 days or ⫺31°F
for 15 hr
Proper chemical stor-
age/use
Process 2 Examples: hamburgers, Bacterial growth, scom- Yes or no Store at 41°F or below
mahi-mahi brotoxin, cross-contam- Separate raw from
ination, chemical con- ready-to-eat food
tamination Proper chemical stor-
age/use
Process 3 Example: soups Bacterial growth, scom- Yes or no Storage at 41°F or
brotoxin, cross-contam- below
ination, chemical con- Separate raw from
tamination ready-to-eat food
Proper chemical stor-
age/use

system on the air temperature of the refrigerated equipment as an SOP. How often you
need to monitor the air temperature depends on
1. Whether the air temperature of the refrigerator accurately reflects the internal
product temperature (remember, your food safety refrigeration temperature must
be based on the internal product temperature of the food stored within a refriger-
ation unit, not the air temperature)
2. The capacity and use of your refrigeration equipment
3. The volume and type of food products stored in your cold storage units
4. The SOPs that support monitoring this process
5. Shift changes and other operational considerations
Standard operating procedures can be developed to control some hazards and assist
in implementing a food safety system that minimizes the potential for bacterial growth
and contamination. The control of cross-contamination can be done by separating raw
foods from ready-to-eat products within your operation’s refrigeration and storage facili-
ties.
Special consideration should be given to the storage of scombroid fish due to the
potential formation of histamine, a chemical hazard. To control histamine formation in
scombroid toxin–forming fish, it is recommended that storage be a CCP with the critical
limit not to exceed 41°F (5°C), as stated in the Food Code, unless you can show through
scientific data that the food safety hazard will not result.
c. Preparation. Of all the operational steps in food processes, preparation has the great-
est variety of activities that must be controlled, monitored, and in some cases documented.
It is impossible to include in this model a summary guide that covers the diversity in
menus, employee skills, and facility design that impact the preparation of food. The prepa-
ration step may involve several processes, including thawing a frozen food, mixing to-
gether several ingredients, cutting, chopping, slicing, or breading. (See Table 3.)
At the preparation step, SOPs can be developed to control some hazards and assist
in implementation of a food safety system that minimizes the potential for bacterial growth
and contamination from employees and equipment.
Front-line employees will most likely have the greatest need to work with the food.
A well-designed personal hygiene program that has been communicated to all employees
will minimize the potential for bacterial, parasitic, and viral contamination. Your program
must include instructions to your employees as to when and how to wash their hands.
Procedures need to be in place that either eliminate employees’ hand contact with ready-
to-eat foods or implement an alternative personal hygiene program that provides an equiva-
lent level of control of bacterial, parasitic, and viral hazards. It is also very important to
identify and restrict ill employees from working with food, especially if they have diarrhea.
Procedures must be in place to prevent cross-contamination from utensils and equip-
ment. Designated areas or procedures that separate the preparation of raw foods from
ready-to-eat foods minimize the potential for bacterial contamination. Proper cleaning and
sanitizing of equipment and work surfaces are an integral SOP to this operational step.
Batch preparation is an important tool for controlling bacterial growth because lim-
iting the amount of food prepared minimizes the time the food is kept at a temperature
that allows growth. Planning your preparation ahead assists in minimizing the time food
must be out of temperature at this operational step. Batch preparation also breaks the
growth cycle of bacteria before they can reach dangerous levels.
Table 3 Preparation Worksheet
Corrective
Process 1 Example: salads Bacterial growth, cross- Yes or no Store at 41°F or below
contamination, con- or use time to control
tamination from em- growth
ployees, chemical Separate raw from
contamination ready-to-eat food
Restrict ill employees;
control bare-hand con-
tact
Proper chemical storage/
use
Process 2 Examples: hamburgers, Bacterial growth, cross- Yes or no Store at 41°F or below
mahi-mahi contamination, con- or use time to control
tact
use
Process 3 Example: soups Bacterial growth, cross- Yes or no Store at 41°F or below
contamination, con- or use time to control
tact
use

When thawing frozen foods, maintaining proper product temperature and managing
time are the primary controls for minimizing bacterial growth. Procedures need to be in
place to minimize the potential for microbial, chemical, and physical contamination during
thawing.
Use of prechilled ingredients to prepare a cold product, such as tuna salad, will
assist you in maintaining temperature control for this process.
Special consideration should be given to disallowing bare hand contact in the prepa-
ration of ready-to-eat foods. You need to control the introduction of hazards during prepa-
ration. How will you accomplish controlling the hazard presented by hand contact with
ready-to-eat food? You should review your operation to determine whether this operational
step will be controlled as a CCP or an SOP.
d. Cooking. This operational step only applies to those foods that you have listed in
Processes 2 and 3. Cooking foods of animal origin is the most effective operational step
in food processes for reducing and eliminating biological contamination. Hot temperatures
will kill most harmful bacteria, and with relatively few exceptions, such as cooking plant
foods, this is a CCP. It is at this step that food will be made safe to eat. Therefore, product
temperature and time measurements are very important. If the appropriate product temper-
ature for the required amount of time is not achieved, bacteria, parasites, or viruses may
survive in the food. (See Table 4.)
Critical time and temperature limits vary according to the type of food. Employees
should view ensuring proper cooking temperatures as an essential element in producing
an acceptable product. A final cooking time and temperature chart for specific foods is
included for your review. Simply reference the foods specific to your food establishment
and incorporate the appropriate critical time and temperature limits into your management
system. (See Table 5.)
You will need to determine the best system for you to use that will ensure that the
proper cooking temperature and time are reached. Checking the internal product tempera-
ture is the most desirable monitoring method. However, when large volumes of food are
cooked, a temperature check of each individual item may not be practical. For instance,
a quick service food service operation may cook several hundred hamburgers during lunch.
If checking the temperature of each hamburger is not reasonable for you to do, then you
need to routinely verify that the specific process and cooking equipment are capable of
attaining a final internal product temperature at all locations in or on the cooking equip-
ment.
Once a specific process has been shown to work for you, the frequency of record-
keeping may be reduced. In these instances, a recordkeeping system should be established
to provide scheduled product temperature checks to ensure that the process is working.
Special consideration should be given to time and temperature in the cooking of
fish and other raw animal foods. To control the pathogens, it is recommended that cooking
be a CCP, based upon the critical limits established by the Food Code, unless you can
show through scientific data that the food safety hazard will not result.
e. Cooling. This operational step is only used for those foods that you have listed in
Process 3. One of the most labor intensive operational steps is rapidly cooling hot foods
to control microbial growth. Excessive time for the cooling of potentially hazardous foods
has been consistently identified as one of the factors contributing to foodborne illness.
Foods that have been cooked and held at improper temperatures provide an excellent
environment for the growth of disease causing microorganisms that may have survived
Table 4 Cooking Worksheet
Corrective
Process 1 Example: salads, sushi Does not apply Does not Does not apply Does not Does not Does not Does not
apply apply apply apply apply
Process 2 Examples: hamburgers, Bacterial, parasitic, or Yes or no Cook to product internal
mahi-mahi viral survival or temperature/time (see
growth Table 5)
Process 3 Example: soups Bacterial, parasitic, or Yes or no Cook to product internal
viral survival or temperature/time (see
growth Table 5)

Table 5 Food Code Cooking Temperatures and Times
Product Final internal temperature Time

1a 165°F 15 sec.
Poultry
Wild game animals
Stuffed fish
Stuffed meat
Stuffed pasta
Stuffed poultry
Stuffed ratites
Stuffing containing fish, meat, poultry,
or ratites
1b Animal foods cooked in a micro- 165°F; food rotated, stirred, Cover and allow to
wave oven covered stand for 2 min.
2a Pork, ratites, or injected meats 155°F 15 sec.
2b Ground meat, fish, or game animals 155°F 15 sec.
commercially raised for food
2c Game animals under a voluntary in- 155°F 15 sec.
spection program
2d Raw shell eggs that are not prepared 155°F 15 sec.
for immediate service
3a Raw shell eggs broken and prepared 145°F 15 sec.
in response to consumer order
and for immediate service
3b Fish and meat including game ani- 145°F 15 sec.
mals except as specifically refer-
enced in this table
4a Fruit and vegetables cooked for hot 140°F or above Instantaneous
holding
4b Ready-to-eat food from a commer- 140°F or above Instantaneous
cially sealed container for hot
holding
4c Ready-to-eat food from an intact 140°F or above Instantaneous
package (from a food processing
plant inspected by the regulatory
authority with jurisdiction over
the plant) for hot holding
5a Beef roast/corned beef roasts (Preheated oven tempera-
tures)
Less than 10 lb
Still dry: 350°F or more
Convection: 325°F or more
High humidity: 250°F or
less
More than 10 lb
Still dry: 250°F or more
Convection: 250°F or more
High humidity: 250°F or
less

Table 5 Continued
Product Final internal temperature Time
5b Beef roast/corned beef roasts (Internal food temperature for
specified amount of time)
Achieve one of the following:
130°F for 121 min
132°F for 77 min
134°F for 47 min
136°F for 32 min
138°F for 19 min
140°F for 12 min
142°F for 8 min
144°F for 5 min
145°F for 3 min
the cooking process (spore formers). Recontamination of a cooked food item by poor
employee practices of cross-contamination from other food products, utensils, and equip-
ment is a concern at this operational step. (See Table 6).
Special consideration should be given to large food items, such as roasts, turkeys,
thick soups, stews, chili, and large containers of rice or refried beans. These foods take
a long time to cool because of their mass and volume. If the hot food container is tightly
covered, the cooling rate will be further slowed down. By reducing the volume of the
food in an individual container and leaving an opening for heat to escape by keeping the
cover loose, the rate of cooling is dramatically increased.
Commercial refrigeration equipment is designed to hold cold food temperatures, not
cool large masses of food. Some alternatives for cooling foods include
1. Using rapid chill refrigeration equipment designed to cool the food to acceptable
temperatures quickly by using increased compressor capacity and high rates of
air circulation
2. Avoiding the need to cool large masses by preparing smaller batches closer to
periods of service
3. Stirring hot food while the food container is within an ice water bath
4. Redesigning your recipe so that you prepare and cook a smaller or concentrated
base and then add enough cold water or ice to make up the volume that you
need (for water-based soups, for example)
Whatever cooling method you choose, you need to verify that the process works. Once
again if a specific process has been shown to work for you, the frequency of recordkeeping
may be reduced. A recordkeeping system should be established to provide scheduled prod-
uct temperature checks to ensure the process is working.
f. Reheating This operational step applies only to those foods that you listed in Pro-
cess 3. If food is held at improper temperatures for enough time, pathogens have the
opportunity to multiply to dangerous numbers. Proper reheating provides an important
control for eliminating these organisms. It is especially effective in reducing contamination
from bacterial spore formers which survived the cooking process and may have multiplied
because foods were held at improper temperatures. (See Table 7.)
Table 6 Cooling Worksheet
Corrective
Process a Menu item Hazard CCP Critical limits Monitoring actions Verification Records
Process 1 Examples: salads, sushi Does not apply Does not Does not apply Does not Does not Does not Does not
Process 2 Examples: hamburgers, Does not apply Does not Does not apply Does not Does not Does not Does not
mahi-mahi apply apply apply apply apply
Process 3 Example: soups Bacterial growth, cross- Yes or no Cool food from 140°F
contamination, con- to 70°F within 2 hr
tamination from em- and from 70°F to
ployees or equipment 41°F within 4 hr
Separate raw from
ready-to-eat food
Control bare-hand con-
tact
a
Process 1: food preparation with no cook step—ready-to-eat food that is stored, prepared and served.
Process 2: food preparation for same-day service—food that is stored, prepared, cooked, and served.
Process 3: complex food preparation—food that is stored, prepared, cooked, cooled, reheated, hot held, and served.

Table 7 Reheating Worksheet
Corrective
Process 1 Examples: salads, sushi Does not apply Does not Does not apply Does not Does not Does not Does not
Process 2 Examples: hamburgers, Does not apply Does not Does not apply Does not Does not Does not Does not
mahi-mahi apply apply apply apply apply
Process 3 Example: soups Bacterial, parasitic, or Yes or no Reheat to 165°F within
viral survival or 2 hr.
growth
a
Process 1: food preparation with no cook step—ready-to-eat food that is stored, prepared, and served.

Although proper reheating will kill most organisms of concern, it will not eliminate
toxins, such as that produced by Staphylococcus aureus. If microbial controls and SOPs
at previous operational steps have not been followed correctly and staph toxin has been
formed in the food, reheating will not make the food safe.
Incorporating a comprehensive personal hygiene program throughout the process
will minimize the risk from staph toxin. Along with personal hygiene, preventing cross-
contamination through the use of cleaned and sanitized equipment and utensils is an impor-
tant control measure.
Special consideration should be given to the time and temperature in the reheating
of cooked foods. To control the pathogens, it is recommended that reheating be a CCP,
based upon the critical limits established by the Food Code, unless you can show through
scientific data that the food safety hazard will not result.
g. Holding. All three processes may involve holding. Proper temperature of the food
while being held is essential in controlling the growth of harmful bacteria. Cold tempera-
ture holding may occur in Processes 1, 2, or 3. Hot temperature holding occurs primarily
only in Processes 2 and 3. Where there is a cooking step as a CCP to elminate pathogens,
all but the spore-forming organisms should be killed or inactivated. If cooked food is not
held at the proper temperature, the rapid growth of these spore-forming bacteria is a major
food safety concern. (See Table 8.)
When food is held, cooled, and reheated in a food establishment there is an increased
risk from contamination caused by personnel, equipment, procedures, or other factors.
Harmful bacteria that are introduced into a product that is not held at proper temperature
have the opportunity to multiply to large numbers in a short period of time. Once again
management of personal hygiene and the prevention of cross-contamination impact the
safety of the food at this operational step.
Keeping food products at 140°F (60°C) or above during hot holding and keeping
food products at or below 41°F (5°C) is effective in preventing microbial growth. As an
alternative to temperature control, the Food Code details actions when time alone is used
as a control, including a comprehensive monitoring and food marking system to ensure
food safety.
How often you monitor the temperature of foods during hot holding determines
what type of corrective action you are able to take when 140°F (60°C) is not met. If the
critical limit is not met, your options for corrective action may include evaluating the time
the food is out of temperature to determine the severity of the hazard and based on that
information, reheating the food, if appropriate, or discarding it. Monitoring frequency may
mean the difference between reheating the food to 165°F (74°C) or discarding it.
When determining the monitoring frequency of cold product temperatures, it is im-
portant to make sure that the interval between temperature checks is established to ensure
that the hazard is being controlled and time is allowed for an appropriate corrective action.
For example, if you are holding potentially hazardous ready-to-eat foods under refrigera-
tion, such as potato salad at a salad bar, you may decide to set a critical limit at 41°F
(5°C) or below. You may also want to set a target, or operating limit, of 40°F (4.4°C),
for example, in order to provide a safety cushion that allows you the opportunity to see
a trend toward exceeding 41°F (5°C) and to intervene with appropriate corrective ac-
tions.
Special consideration should be given to the time and temperature in the hot or cold
holding of potentially hazardous foods to control pathogens. It is recommended that hot
Table 8 Holding Worksheet
Corrective
Process 1 Examples: salads, sushi Bacterial, parasitic, or Yes or no 41°F
viral introduction,
survival, or
growth
Process 2 Examples: hamburgers, Bacterial, parasitic, or Yes or no 140°F or 41°F
mahi-mahi viral introduction,
survival, or
growth
Process 3 Example: soups Bacterial, parasitic, or Yes or no 140°F or 41°F
viral introduction,
survival, or
growth
a
Process 1: food preparation with no cook step—ready-to-eat food that is stored, prepared, and served.

or cold holding be a CCP, based upon the critical limits established by the Food Code,
unless you can show through scientific data that the food safety hazard will not result.
h. Set-Up and Packing. Set-up and packing is an operational step used by some retail
food establishments including caterers (e.g., restaurant/caterer or interstate conveyance
caterer), commissaries, grocery stores (for display cases), schools, nursing homes, hospi-
tals, or services such as delivery of meals to home-bound persons. Set-up and packing
can be controlled through an SOP and may involve wrapping food items, assembling these
items onto trays, and packing them into a transportation carrier or placing them in a display
case. An example would be an airline flight kitchen where food entrees are wrapped,
assembled, and placed into portable food carts which are taken to a final holding cooler.
Hospital kitchens would be another example, where patient trays are assembled and placed
into carriers for transportation to nursing stations. Food may be placed into bulk containers
for transportation to another site where it is served. (See Table 9.)
This operational step might not be considered a CCP, but it is a special consideration
when setting up your program. This process can be controlled by strict adherence to SOPs
to minimize the potential for bacterial contamination and growth, to eliminate bare-hand
contact with ready-to-eat foods, to ensure proper hand washing, and to ensure food comes
into contact only with cleaned and sanitized surfaces.
Following final assembly into either individual trays or into bulk containers, the
food may be held for immediate service or for transportation to another site for service.
This hot holding or cold holding operational step needs to be evaluated in the same manner
as other holding operational steps on the worksheet. Temperature control or using time
as a control measure during transportation and holding and serving at a remote site must
be evaluated and managed as part of your food safety system.
Special consideration should be given to time/temperature controls and the preven-
tion of cross-contamination from equipment and utensils and contamination from employ-
ees’ hands. This process may be adequately controlled through an SOP; however, holding
and transportation should be considered CCPs.
i. Serving. This is the final operational step before the food reaches the customer. When
employees work with food and food-contact surfaces, they can easily spread bacteria,
parasites, and viruses and contamintate these items. Managing employees’ personal hy-
gienic practices is important to controlling these hazards. A management program for
employee personal hygiene includes proper hand washing, the appropriate use of gloves
and dispensing utensils, and controlling bare hand contact with ready-to-eat foods. (See
Table 10.)
Minimizing the growth of bacteria is also a concern at hot and cold holding customer
display areas. Maintaining food products at proper temperature within these display units
will control the growth of microorganisms. Refer to the holding worksheet for additional
information.
Special consideration needs to be given to minimizing contamination from the cus-
tomer. Customer self-service displays, such as salad bars, require specific procedures to
protect the food from contamination. Some suggestions for protecting food on display
include
1. The use of packaging
2. Counter, service line, or salad bar food guards
3. Display cases
Table 9 Set-Up and Packing Worksheet
Corrective
Process 1 Examples: salads, sushi Bacterial growth, micro- Yes or no 41°F
bial contamination No bare-hand contact or
from employees equivalent alternative
Process 2 Examples: hamburgers, Bacterial growth, micro- Yes or no 140°F or 41°F
mahi-mahi bial contamination No bare-hand contact or
Process 3 Example: soups Bacterial growth, micro- Yes or no 140°F or 41°F
bial contamination No bare-hand contact or

Table 10 Serving Worksheet
Corrective
Process 1 Example: salads, sushi Bacterial, parasitic, viral, Yes or no
or physical contami-
nation
Process 2 Examples: hamburgers, Bacterial, parasitic, viral, Yes or no
mahi-mahi or physical contami-
nation
Process 3 Example: soups Bacterial, parasitic, viral, Yes or no
or physical contami-
nation

4. Suitable utensils or effective dispensing methods
5. Not mixing an old product with fresh
6. Having employees monitor self-serve stations
Preventing cross-contamination from soiled utensils and equipment will minimize

the potential for bacterial contamination of ready-to-eat foods.
C. Step 3: Identify CCPs and Critical Limits

The CCPs column identifies places in the flow of food where you can have a significant
impact in controlling food safety hazards. A measurable critical limit has been identified
for each of these CCPs. These critical limits provide the baseline for measuring the effec-
tiveness of your food safety procedures.
For each of your operational steps within your operation, review the CCPs and
critical limits needed to minimize or eliminate significant food safety hazards. Does your
operation currently have control measures in place that are at least equivalent to these
critical limits?
On the worksheet, you will need to decide whether the operational step is a CCP
or whether the hazard is controlled by the SOPs that address the prerequisite program
elements discussed in the Food Code.
In some operational step worksheets, such as for the cooking step, it is recommended
that the step be considered a CCP because there is no practical alternative to ensure control
of the hazard. In other operational steps, you may have a choice as to how you will control
the hazard. For example, in the preparation step for ready-to-eat foods, you will identify
contamination from employees’ hands as a hazard. When controlling that hazard as a
CCP, you must also identify the critical limits, establish monitoring and corrective actions,
verification procedures, and records. Alternatively, you may choose to control that hazard
by instituting an SOP that disallows bare hand contact with ready-to-eat foods, you will
identify contamination from employees’ hands as a hazard. When controlling that hazard
as a CCP, you must also identify the critical limits, establish monitoring and corrective
actions, verification procedures, and records. Alternatively, you may choose to control
that hazard by instituting an SOP that disallows bare-hand contact wtih ready-to-eat food.
You will need to decide the most effective method of controlling the hazard, i.e., as a
CCP or through use of an SOP.
D. Step 4: Monitor Critical Control Points

Use the worksheet to develop procedures, customized to your operation, for monitoring
your CCPs. Consideration should be given to determining answers to the following ques-
tions:
1. What critical limit at the CCP are you measuring?

2. How is it monitored?
3. When and how often will the CCP be monitored?
4. Who will be responsible for monitoring it?
Monitoring is observing or measuring specific operational steps in the food process to

determine if your critical limits are being met. This activity is essential in making sure
your critical food processes are under control. It will identify where a loss of control
occurs or if there is a trend toward a loss of control of a critical food process. Needed
adjustments will then become obvious.
In your food safety management system, certain processes have been identified as
CCPs. What you are going to monitor depends on the critical limits you have established
at each CCP. Minimum critical limits for many CCPs have been established by the Food
Code. For example, cooking hamburger (the CCP) to 155°F (68.3°C) for 15 sec (the
critical limit) will kill most harmful bacteria. Therefore, final temperature and time mea-
surements are very important. You need to determine how you will effectively monitor
the critical limits for each CCP.
Is monitoring equipment needed to measure a critical limit? The equipment you
choose for monitoring must be accurate and routinely calibrated to ensure critical limits
are met. For example, a thermocouple with a thin probe might be the most appropriate
tool for measuring the final product temperature of hamburger patties.
When describing how often you need to monitor, make sure that the monitoring
interval will be reliable enough to ensure the hazard is being controlled. Your procedure
for monitoring should be simple and easy to follow.
Individuals chosen to be responsible for a monitoring activity may be a manager,
line supervisor, or a designated employee. Your monitoring system will only be effective
if employees are given the knowledge, skills, and reponsibility for serving safe food. Train
your employees to carefully follow your procedures, monitor CCPs, and take corrective
action if critical limits are not met.
E. Step 5: Develop Corrective Actions

Decide what type of corrective action you need to take if a critical limit is not met.
1. What measures do you expect employees to take to correct the problem?

2. Is the corrective action understood by your employees?
3. Can the corrective action be easily implemented?
4. Are different options needed for the appropriate corrective actions, depending
on the process and monitoring frequency?
5. How will these corrective actions be documented and communicated to manage-
ment so the system can be modified to prevent the problem from occurring
again?
Whenever a critical limit is not met, a corrective action must be carried out immedi-
ately. Corrective actions may be simply continuing to heat food to the required tempera-
ture. Other corrective actions may be more complicated, such as rejecting a shipment of
raw oysters that does not have the required tags or segregating and holding a product until
an evaluation is done.
In the event that a corrective action is taken, you should reassess and modify, if
necessary, your food safety system based upon the HACCP principles. Despite the best
system, errors occur during food storage and preparation. A food safety system based
upon the HACCP principles is designed to detect errors and correct them before a food
hazard occurs. It is a benefit to industry and regulators to be able to show that immediate
action is taken to ensure that no food product that may be injurious to health is served
to or purchased by a customer. It is important to document all corrective actions in written
records.
F. Step 6: Conduct Ongoing Verification
1. Description
Because HACCP is a system to maintain continuous control of food safety practices,
implementation of the plan needs to be audited or verified. Verification is usually per-
formed by someone other than the person who is responsible for performing the activities
specified in the plan. That person might be a manager, supervisor, designated person, or
the regulatory authority.
There is ongoing verification, which is conducted frequently, such as daily, weekly,
monthly, etc., by designated employees of the establishment. It is important to note that
routine monitoring should not be confused with audit or verification methods or proce-
dures.
There is long-term verification, which is done less frequently. This will be discussed
in Section IV.H. Verification is an oversight auditing process to ensure that the HACCP
plan and SOPs continue to
1. Be adequate to control the hazards is identified as likely to occur
2. Be consistently followed (i.e., a comparison is made regarding observed, actual
practices and procedures with what is written in the plan)
Ongoing verification activities include
1. Observing the person doing the monitoring; is monitoring being done as
planned?
2. Reviewing the monitoring records:
a. Are records completed accurately?
b. Do records show that the predetermined frequency of the monitoring is
followed?
c. Was the planned corrective action taken when the person monitoring found
and recorded that the critical limit was not met?
d. Do records of the calibration of monitoring equipment indicate that the
equipment was operating properly?
2. Procedures
Procedures may include the following activities:
1. Observe the person conducting the activities at the CCPs and recording informa-
tion.
2. Check monitoring records.
3. Check corrective action records.
4. Periodically review the total plan.
5. Test product in process or finished product.
6. Review equipment calibration records.
7. Review recording thermometer accuracy (large operations and some processes
such as large quantity cook and chill operations or smokers, etc.)
3. Frequency
Verification should occur at a frequency that can ensure the HACCP plan is being followed
continuously to
1. Avoid adulterated/unsafe product getting to the consumer
2. Be able to take corrective action without loss of product
3. Ensure prescribed personnel practices are consistently followed
4. Ensure personnel have the tools for proper personal hygiene and sanitary prac-
tices (e.g., hand washing facilities, sanitizing equipment, cleaning supplies, tem-
perature measuring devices, sufficient gloves, etc.)
5. Follow/comply with the control procedures established
6. Conduct calibrations as needed depending upon the type of equipment (some
may be verified daily and others annually)
4. System Verification
a. Receiving. The manager reviews temperature logs of refrigerated products at various
intervals such as daily or weekly. An operation may want its HACCP plan to specify that
the manager checks the monitoring records daily if (1) receiving constitutes a high volume
or (2) products include particular items such as fresh tuna, mahi-mahi, mackerel, etc.
(scombrotoxin-forming species).
b. Chill Step. Weekly, the production manager checks the chilling log that is main-
tained for foods that are either left over or planned for later service. Recorded on the log
sheet are the time the food is placed into the cooler, its temperature, the type of container
used (depth per SOP), and measurements of the time and temperature involved in cooling
the food.
c. Hand Washing Facilities and Practices. Daily, the manager checks the log main-
tained at the hand washing facilities and corrections made in areas where ready-to-eat
food is prepared. Less frequent checks are made in other areas of the operation.
5. Process Verification
The manager checks daily or weekly the time/temperature monitoring records at all CCPs
(receiving, holding, preparation before cooking for scombrotoxin-forming seafood, cook-
ing time/temperature for hamburgers, etc.).
G. Step 7: Keep Records

In order to develop the most effective recordkeeping system for your operation, determine
what documented information will assist you in managing the control of food safety haz-
ards. Some recorded information should already be part of your food safety system, like
shellfish tags, and an additional record may not be needed. Your recordkeeping system can
use existing paperwork, such as delivery invoices, for documenting product temperature.
Another method could be maintaining a log to record the temperatures. A recordkeeping
system can be simple and needs to be designed to meet the needs of the individual estab-
lishment. It can be accomplished in many different ways that are customized to your
operation as long as it provides a system to determine that activities are performed ac-
cording to the HACCP plan.
Accurate recordkeeping is an essential part of a successful HACCP program. Rec-
ords provide documentation that the critical limits at each CCP were met or that appro-
priate corrective actions were taken when the limits were not met. Records also show that
the actions performed were verified.
Involve your employees in the development of your management system. Ask them
how they are currently monitoring CCPs. Discuss with them the types of corrective actions
they take when a critical limit is not met. Employees are an important source for devel-
oping simple and effective recordkeeping procedures. Managers are responsible for de-
signing the system, but effective day-to-day implementation involves every employee.
The simplest recordkeeping system that lends itself to integration into existing opera-
tions is always best. A simple yet effective system is easier to use and communicate to
your employees.
Recordkeeping systems designed to document a process rather than product informa-
tion may be more adaptable within a retail food establishment, especially if you frequently
change items on your menu. Accurately documenting processes like cooking, cooling, and
reheating, identified as CCPs, provides active managerial control of food safety hazards.
Consistent process control by management reduces the risk of foodborne illness.
Simple logs for record refrigeration equipment temperature are perhaps the most
common SOP records currently maintained. However, product temperature records are
commonly CCP records. Other records may include
1. Writing the product temperature on delivery invoices
2. Keeping a log of internal product temperatures of cooked foods
3. Holding shellstock tags for 90 days
Some retail establishments have implemented comprehensive HACCP systems
where records are maintained for each CCP. These records may be quality control logs,
but they can also constitute CCP records if they are designed to monitor activities that
are, in fact, CCPs. The level of sophistication of recordkeeping is dependent upon the
complexity of the food operation. For example, a cook–chill operation for a large institu-
tion would require more recordkeeping than a limited menu, cook–serve operation.
Once a specific process has been shown to work for you, such as an ice bath method
for cooling certain foods, the frequency of recordkeeping may be reduced. In these in-
stances, a recordkeeping system provides a scheduled check (verification) of the process
to ensure that it effectively controls the risk factors. This approach is extremely effective
for labor-intensive processes related to
1. Cooking large volumes of food where a temperature check of each individual
item is impractical
2. Implementing a verified process that will allow employees to complete the pro-
cedure within the course of a scheduled work day
3. Cooling foods or leftovers at the end of the business day
4. Maintaining cold holding temperatures of ready-to-eat potentially hazardous
foods in walk-in refrigeration units
H. Step 8: Conduct Long-Term Verification

Once your food safety system is implemented, you will need to confirm that it is effective
over time, an activity referred to in this chapter as long-term verification. You may benefit
from both internal (quality control) verifications and external verifications that may in-
volve assistance from the regulatory authority or consultants. See Table 11 for a sample
long-term verification worksheet.
Long-term verification is conducted less frequently (e.g., yearly) than ongoing veri-
fication. It is a review or audit of the plan to determine if
1. Any new product/processes/menu items have been added to the menu.
2. Suppliers, customers, equipment, or facilities have changed.
3. The SOPs are current and implemented.
4. The worksheets are still current.
5. The CCPs are still correct or if new CCPs are needed.
6. The critical limits are set realistically and are adequate to control the hazard
(e.g., the time needed to cook turkey to meet the Food Code internal temperature
requirement).
7. Monitoring equipment has been calibrated as planned.
Long-term verification helps the operator
1. Ensure the food safety management system is implemented and the HACCP
plan is being followed.
2. Improve the system and HACCP plan by identifying weaknesses.
3. Eliminate the unnecessary or ineffective controls.
4. Determine if the HACCP plan needs to be modified or updated.
Table 11 Long-Term Verification Worksheet
Name of person responsible for long-term verification:

Title:
Frequency at which the long-term verification is done:
Reason for doing an unscheduled long-term verification:
Date of last long-term verification:

The length of time this record is kept on file:
Question Answer Action Date logged Name logged
1.
a. Has a new prod- No No action
uct, process, or menu
item been added since Yes Go to Question 2
the last verification
and does this change
necessitate a change
on the worksheet?
b. Has the supplier, Yes No action
customer, equipment,
or facility changed No Go to Question 2
since the last verifica-
tion?
2. Do the existing work- No Worksheet information Date: Name:
sheets contain accurate and updated:
current information? Yes Go to Quesion 4

Table 11 Continued
Question Answer Action Date logged Name logged
3. Are the existing CCPs No CCP updated: Date: Name:
correctly identified?
Yes Go to Question 4
4. Are the existing criti- No CLs updated: Date: Name:
cal limits appropriate to
control each hazard? Yes Go to Question 5
5. Do the existing moni- No Monitoring procedures Date: Name:
toring procedures ensure updated:
that the critical limits are Yes Go to Question 6
met?
6. Do the existing correc- No Corrective actions Date: Name:
tive actions ensure that no updated:
injurious food is served or Yes Go to Question 7
purchased?
7. Do the existing ongo- No Ongoing verification Date: Name:
ing verification procedures procedures update:
ensure that the food safety Yes Go to Question 8
system is adequate to con-
trol hazards and is consis-
tently followed?
8. Does the existing rec- No Recordkeeping proce- Date: Name:
ordkeeping system provide dures updated:
adequate documentation Yes Go to Question 9
that the critical limits are
met and corrective actions
are taken when needed?
9. Are the existing SOPs No Does this necessitate a
current and implemented? change in your plan?
Yes If so, start again with
Question 1.
The long-term verification procedure is now complete. The next long-term verification is due
.
The changes made to the food safety management system were conveyed to the line supervisor
or front-line employees on .
Completed by:
Name:
Title:
Date:
REFERENCE
1. Food Code. 2001. Washington, DC: Food and Drug Administration, 2001.

34
Retail Food Processing: Reduced
Oxygen Packaging, Smoking,
and Curing
Y. H. HUI
I. BACKGROUND INFORMATION
The Food Code of 2001 (and also several earlier editions) includes an annex section on
the responsibilities of the retail food industry in the production and sale of foods that are
packaged with reduced oxygen, smoked, or cured. This chapter is a modified version of
the original document [1], Nevertheless, the reader should directly consult the current
edition of the Food Code for official guidance on any particular.
From its inception, the retail segment of the food industry has prepared foods in
consumer-sized portions, using commercially available equipment for cutting, grinding,
slicing, cooking, and refrigeration and applying herbs and spices readily available to con-
sumers at their local grocery. Over the past scores of years, some retail segment operators
have expanded into food manufacturing/processing-type operations, often using sophisti-
cated new technologies and equipment that are sometimes microprocessor controlled.
Many now desire to alter the atmospheres within food packages or apply federally regu-
lated chemical food additives as a method of food preservation. Food processing opera-
tions now being conducted or proposed include cook–chill; vacuum packaging; sous vide;
smoking and curing; brewing, processing, and bottling alcoholic beverages, carbonated
beverages, or drinking water; and custom processing of animals.
The Food Code specifies that a HACCP plan acceptable to the regulatory authority
be the basis for approving food manufacturing/processing operations at retail. The HACCP
plans are to be provided and accepted in two ways as follows.

1. Reduced oxygen packaging. The Food Code provides the criteria that are to
be met in the HACCP plans of those operators who are conducting reduced
oxygen packaging (ROP) operations. Unless prior approval of the HACCP plan
is required by the regulatory authority, the HACCP plan covering this operation
along with the related records documenting monitoring and corrective actions
need only be available and acceptable to the regulatory authority at the time of
inspection.
2. Other food manufacturing/processing operations. The Food Code specifies
that the food establishment operator must obtain a variance from the regulatory
authority for all food manufacturing/processing operations based on the prior
approval of a HACCP plan.
This chapter is designed to provide current preliminary processing criteria for differ-
ent types of food manufacturing/processing operations for use by those preparing and
reviewing HACCP plans and proposals. Criteria for additional processes will be provided
in future editions of the Food Code as they are developed, reviewed, and accepted by
regulatory authorities.
II. REDUCED OXYGEN PACKAGING

A. Introduction
Because ROP provides an environment that contains little or no oxygen, it offers unique
advantages and opportunities for the food industry but also raises many microbiological
concerns. Products packaged using ROP may be produced safely if proper controls are
in effect. Producing and distributing these products with a HACCP approach offers an
effective, rational, and systematic method for the assurance of food safety. This section
provides guidelines for effective food safety controls for retail food establishments cov-
ering the receipt, processing, packaging, holding, displaying, and labeling of food in re-
duced oxygen packages.
B. Definitions
The term ROP is defined as any packaging procedure that results in a reduced oxygen
level in a sealed package. The term is often used because it is an inclusive term and can
include other packaging options such as:
1. Cook–chill. A process that uses a plastic bag filled with hot cooked food from
which air has been expelled and which is closed with a plastic or metal crimp.
2. Controlled atmosphere packaging (CAP). An active system that continuously
maintains the desired atmosphere within a package throughout the shelf-life of
a product by the use of agents to bind or scavenge oxygen or a sachet containing
compounds to emit a gas. Controlled atmosphere packaging is defined as pack-
aging of a product in a modified atmosphere followed by maintaining subse-
quent control of that atmosphere.
3. Modified atmosphere packaging (MAP). A process that employs a gas flushing
and sealing process or reduction of oxygen through respiration of vegetables
or microbial action. Modified atmosphere packaging is defined as packaging of
a product in an atmosphere that has had a one-time modification of gaseous
composition so that it is different from that of air, which normally contains
78.08% nitrogen, 20.96% oxygen, and 0.03% carbon dioxide.
4. Sous vide. A specialized process of ROP for partially cooked ingredients alone
or combined with raw foods that require refrigeration or frozen storage until
the package is thoroughly heated immediately before service. The sous vide
process is a pasteurization step that reduces bacterial load but is not sufficient
to make the food shelf stable. The proces involves the following steps.
a. Preparations of the raw materials (this step may include partial cooking of
some or all ingradients)
b. Packaging of the product, application of vacuum, and sealing of the package
c. Pasteurization of the product for a specified and monitored time/tempera-
ture
d. Rapid and monitored cooling of the product at or below 3°C (37.4°F) or
frozen
e. Reheating of the packages to a specified temperature before opening and
service
5. Vacuum packaging. A process that reduces the amount of air from a package
and hermetically seals the package so that a near-perfect vacuum remains inside.
A common variation of this process is vacuum skin packaging (VSP). A highly
flexible plastic barrier is used by this technology that allows the package to
mold itself to the contours of the food being packaged.
C. Benefits of ROP
Reduced oxygen packaging can create a significantly anaerobic environment that prevents
the growth of aerobic spoilage organisms, which generally are gram-negative bacteria
such as pseudomonads or aerobic yeast and molds. These organisms are responsible for
off-odors, slime, and texture changes—all signs of spoilage.
Reduced oxygen packaging can be used to prevent degradation or oxidative pro-
cesses in food products. Reducing the oxygen in and around a food retards the amount
of oxidative rancidity in fats and oils. It also prevents color deterioration in raw meats
caused by oxygen. An additional effect of sealing food in ROP is the reduction of product
shrinkage by preventing water loss.
These benefits of ROP allow an extended shelf-life for foods in the distribution
chain, providing additional time to reach new geographic markets or longer display at
retail. Providing an extended shelf-life for ready-to-eat convenience foods and advertising
foods as ‘‘Fresh—Never Frozen’’ are examples of economic and quality advantages.
D. Safety Concerns
Use of ROP with some foods can markedly increase safety concerns. Unless potentially
hazardous foods are protected inherently, simply placing them in ROP without regard to
microbial growth will increase the risk of foodborne illnesses. Processors and regulators
of ROP must assume that during distribution of foods or while foods are held by retailers
or consumers, refrigerated temperatures may not be consistently maintained. In fact, a
serious concern is that the increased use of vacuum packaging at retail supermarket deli-
type operations may be followed by temperature abuse in the establishment or by the
consumer. Consequently, at least one barrier or multiple hurdles resulting in a barrier need
to be incorporated into the production process for products packaged using ROP. The
incorporation of several subinhibitory barriers, none of which could individually inhibit
microbial growth but which in combination provide a full barrier to growth, is necessary
to ensure food safety.
Some products in ROP contain no preservatives and frequently do not possess any
intrinsic inhibitory barriers (such as pH, aw , or salt concentrations) that either alone or in
combination will inhibit microbial growth. Thus, product safety is not provided by natural
or formulated characteristics.
An anaerobic environment, usually created by ROP, provides the potential for
growth of several important pathogens. Some of these are psychotrophic and grow slowly
in temperatures near the freezing point of foods. Additionally, the inhibition of the spoilage
bacteria is significant because without these competing organisms telltale signs that the
product is no longer fit for consumption will not occur.
The use of one form of ROP, vacuum packaging, is not new. Many food products
have a long and safe history of being vacuum packaged in ROP. However, the early
use of vacuum packaging for smoked fish had disastrous results, causing a long-standing
moratorium on certain uses of this technology.
E. Refrigerated Holding Requirements for Foods in ROP

Safe use of ROP technology demands that adequate refrigeration be maintained during
the entire shelf-life of potentially hazardous foods to ensure product safety.
Bacteria, with the exception of those that can form spores, are eliminated by pasteur-
ization. However, pathogens may survive in the final product if pasteurization is inade-
quate, poor quality raw materials or poor handling practices are used, or postprocessing
contamination occurs. Even if foods that are in ROP receive adequate thermal processing,
a particular concern is present a retail when employees open manufactured products and
repackage them. This operation presents the potential for postprocessing contamination
by pathogens.
If products in ROP are subjected to mild temperature abuse, i.e., 5–12°C (41–
53.6°F), at any stage during storage or distribution, foodborne pathogens, including Bacil-
lus cereus, Salmonella spp., Staphylococcus aureus, and Vibrio parahaemolyticus, can
grow slowly. Marginal refrigeration that does not facilitate growth may still allow Salmo-
nella spp., Campylobacter spp., and Brucella spp. to survive for long periods of time.
Published surveys indicate that refrigeration practices at retail need improvement.
Some refrigerated products offered in convenience stores were found at or above 7.22°C
(45°F) 50% of the time; in several cases temperature as high as 10°C (50°F) were observed.
Delicatessen display cases have been shown to demonstrate poor temperature control.
Foods have been observed above 10°C (50°F) and above 12.77°C (55°F) in several in-
stances. Supermarket fresh meat cases appear to have a relatively good record of tempera-
ture control. However, even these foods can occasionally be found above 10°C (50°F).
Temperature abuse is common throughout distribution and retail markets. Strict ad-
herence to temperature control and shelf-life must be observed and documented by the
etablishment using ROP. Information on temperature control should also be provided by
the consumer. Currently these controls are not extensively used. Additionally, some com-
mercial equipment is incapable of maintaining foods below 7.22°C (45°F) because of
inadequate refrigeration capacity, insufficient refrigerating medium, or poor maintenance.

Most warehouses and transport vehicles in U.S. distributions chains maintain tem-
peratures in the 0–3.33°C (32–38°F) range. It must be assumed, however, for purposes
of assessing risk that occasionally temperatures of 10°C (50°F) or higher may occur for
extended periods. At retail, further temperature abuse must also be assumed. For instance,
retail display cases can be as high as 13.33°C (56°F) for short periods and some refriger-
ated foods are provided no refrigeration for short periods of time. These realities point
to the need for establishments to implement controls, such as buyer specifications over
refrigerated distribution systems so that better temperature control can be ensured.
F. Control of Clostridium botulinum and Listeria monocytogenes

in ROP Foods
Recently, there has been an increased interest in vacuum packaging or MAP at retail using
conventional refrigeration for holding. Refrigerated foods packaged at retail may be chilled
either after they are physically prepared and repackaged or packaged after a cooking step.
In either case, but primarily the latter, germination of Clostridium botulinum spores must
be inhibited because spores are not destroyed by a heating step. Sanitary safeguards must
be employed to prevent reintroduction of pathogens. Chief among these is Listeria mono-
cytogenes.
Clostridium botulinum is the causative agent of botulism, a severe food poisoning
characterized by double vision, paralysis, and occasionally death. The organism is an
anaerobic, spore-forming bacterium that produces a potent neurotoxin. The spores are
ubiquitous in nature, relatively heat resistant, and can survive most minimal heat treatment
that destroy vegetative cells. Certain strains of C. botulinum (type E and nonproteolytic
types B and F), which have been primarily associated with fish, are psychrotrophic and
can grow and produce toxin at temperature as low as 3.33°C (38°F). Other strains of C.
botulinum (type A and proteolytic types B and F) can grow and produce toxin at tempera-
tures slightly above 10°C (50°F). If present, C. botulinum could potentially grow and
render toxigenic a food packaged and held in ROP because most other competing organ-
isms are inhibited by ROP. Therefore, the food could be toxic yet appear organoleptically
acceptable. This is particularly true of psychrotrophic strains of C. botulinum that do not
produce telltale proteolytic enzymes. Because botulism is potentially deadly, foods held
in anaerobic conditions merit regulatory concern and vigilance.
The potential for botulism toxin to develop also exitst when ROP is used after heat
treatments, such as pasteurization or sous vide processing of foods that do not destroy
the spores of C. botulinum. Mild heat treatments in combination with ROP may actually
select for C. botulinum by killing off its competitors. If the applied heat treatment does
not produce commercial sterility, the food requires refrigeration to prevent spoilage and
ensure product safety. For this reason, sous vide products are frequently flash frozen in
liquid nitrogen and held in frozen storage until use.
There is a further microbial concern with ROP at retail. Processed products such
as meats and cheeses that have undergone an adequate cooking step to kill L. monocyto-
genes can be contaminated when opened, sliced, and repackaged at retail. Thus, a simple
packaging or repackaging operation can present an opportunity for recontamination with
pathogens if strict sanitary safeguards are not in place.
Processors of products using ROP should be cautious if they plan to rely on refrigera-
tion as the sole barrier that ensures product safety. This approach requires very rigorous

temperature controls and monitored refrigeration equipment. If extended shelf-life is
sought, a temperature of 3.33°C (38°F) or lower must be maintained at all times to prevent
outgrowth of C. botulinum and the subsequent production of toxin. Listeria monocytogenes
can grow at even lower temperatures, consequently, appropriate use-by dates must be
established and readily apparent to the consumer. Since refrigeration alone does not guar-
antee safety from pathogenic microorganisms, additional growth barriers must be pro-
vided. Growth barriers are provided by hurdles such as providing for low pH and aw , a short
shelf-lfe, and constant monitoring of the temperature. Any one hurdle, or a combination of
several, may be used with refrigeration to control pathogenic outgrowth.
G. Design of Heat Processes for Foods in ROP

Heat processes for sous vide or cook–chill operations should be designed so that, at a
minimum, all vegetative pathogens are destroyed by a pasteurization process. Special la-
beling of these products is necessary to ensure adequate warning to consumers that these
foods must be refrigerated at 5°C (41°F) and consumed by the date required by the regula-
tory guidance for that particular product.
The National Advisory Committee on Microbiological Criteria for Foods
(NACMCF), chartered by the U.S. Department of Agriculture (USDA) and the Department
of Health and Human Services (DHHS), has provided guidance regarding the microbial
safety of refrigerated foods containing cooked, uncured meat or poultry products that are
packaged for extended refrigerated shelf-life and are ready-to-eat or prepared with little
or no additional heat treatment. The committee recommended guidlines for evaluating
the ability of thermal processes to inactivate L. monocytogenes in extended-shelf-life,
refrigerated foods. Specifically, it recommended a proposed requirement for demonstrating
that ROP processing should include a heat treatment sufficient to achieve a 4 decimal log
reduction (4D) of L. monocytogenes.
Other scientific reports recommend more extensive thermal processing. Thermal
processes for sous vide practiced in Europe are designed to achieve a 12–13 log reduction
(12–13D) of the target organism, Streptococcus faecalis. It is reasoned that thermal inacti-
vation of this organism would ensure destruction of all other vegetative pathogens.
Food manufacturers with adequate in-house research and development programs
may have the ability to design their own thermal processes. However, small retailers and
supermarkets may not be able to perform the microbiological challenge studies necessary
to provide the same level of food safety. If a retail establishment wishes to use an ROP
process, microbiological studies should be performed by, or in conjunction with, an appro-
priate process authority or person knowledgeable in food microbiology who is acceptable
to the regulatory authority.
Finally, if foods are held long enough, even under proper refrigeration, extended
shelf-life may be a problem. A study on fresh vegetables inoculated with L. monocytogenes
conducted to determine the effect of CAP on shelf-life found that CAP lengthened the time
that all vegetables were considered acceptable, but that populations of L. monocytogenes
increased during that extended storage.
H. Consumer Handling Practices and In-Home Refrigerator

Temperatures
Extended shelf-life provided by ROP is cause for concern because of the potential for
abuse by the consumer. Consumers often cannot, or do not, maintain adequate refrigeration
of potentially hazardous foods at home. Foods in ROP that are taken home might not be
eaten before sufficient time/temperature abuse has occurred to allow any pathogens present
to increase to levels which can increase the chance of illness. Under the best of circum-
stances, home refrigerators can be expected to range between 5 and 10°C (41–50°F). One
study reported that home refrigerator temperatures in 21% of the households surveyed
were 10°C (50°F). Another study reported more than one of four home refrigerators are
above 7.22°C (45°F) and almost one of ten are above 10°C (50°F). Thus, refrigeration
alone cannot be relied on for ensuring microbiological safety after foods in ROP leave
the establishment.
Consumers have come to expect that certain packages of foods would be safe without
refrigeration. Low-acid canned foods have been thermally processed, which renders the
food shelf stable. Retort heating ensures the destruction of C. botulinum spores as well
as all other foodborne pathogens. Yet consumers may not understand that most products
that are packaged in ROP are not commercially sterile or shelf stable and must be refriger-
ated. A clear label statement to keep the product refrigerated must be provided to con-
sumers.
I. Safety Barrier Verification

The safety barriers for all processed foods held in ROP at retail must be verified in writing.
This can be accomplished through written certification from the product manufacturer.
Independent laboratory analysis using methodology approved by the regulatory authority
can also be used to verify incoming product and should be used to verify the barriers in
a product that is packaged within the establishment by an ROP method. The multiple
barrier or hurdle efficacy should be validated by inoculated pack or challenge studies. A
product should be tested under abuse temperatures to demonstrate product safety during
the food shelf-life. Any changes in product formulation or processing procedures are cause
for notification of the regulatory authority and a required approval of the revised ROP
process. A record of all safety barrier verifications should be updated every 12 months.
This record must be available to the regulatory authority for review at the time of inspec-
tion.
J. USDA Process Exemption

Meat and poultry products cured at a food processing plant regulated by the U.S. Depart-
ment of Agriculture using substances specified in 9 CFR 318.7 (approval of substances
for use in the preparation of products) and 9 CFR 381.147 (restrictions on the use of
substances in poultry products) are exempt from the safety barrier verification require-
ments. Other ROP operations may be developed if prior approval is obtained from the
regulatory authority.
K. Recommendations for ROP Without Multiple Barriers

1. Employee training. If ROP is used, employees assigned to packaging of the
foods must have documented proof that demonstrates familiarity with ROP
guidelines in the Food Code and the potential hazards associated with these
foods. At the discretion of the regulatory authority, a description of the training
and course content provided to the employees must either be available for re-
view or have prior approval by the regulatory authority.
2. Refrigeration requirements. Foods in ROP that have only one barrier, i.e., re-
frigeration, to C. botulinum must be refrigerated to 5°C (41°F) or below and
marked with a use-by date within either the manufacturer’s labeled use-by date
or 14 days after preparation at retail, whichever comes first. Alternatively, food
packaged by ROP may be kept frozen if freezing is used as the declared primary
safety barrier. Any extension of shelf-life past 14 days will require a further
variance that considers lower refrigeration temperatures. Foods that are intended
for refrigerated storage beyond 14 days must be maintained at or below 3.33°C
(38°F).
3. Labeling—refrigeration statements. All foods in ROP which rely on refrigera-
tion as a barrier to microbial growth must bear the statement ‘‘Important—must
be kept refrigerated at 5°C (41°F)’’ or ‘‘Important—must be kept frozen’’ in
the case of foods which rely on freezing as a primary safety barrier. The state-
ment must appear on the principal display panel in bold type on a contrasting
background. Foods held under ROP that have lower refrigeration requirements
as a condition of safe shelf-life must be monitored for temperature history and
must be offered for retail sale if the temperature and time specified in the vari-
ance are exceeded.
4. Labeling—use-by date. Each container of food in ROP must bear a use-by
date. This date cannot exceed 14 days from retail packaging or repackaging
without a further variance granted by the regulatory authority. The date assigned
by a repacker cannot extend beyond the manufacturer’s recommended pull date
for the food. The use-by date must be listed on the principal display panel in
bold type on a contrasting background. Any label must contain a combination
of a sell-by date and use-by instructions which makes it clear that the product
must be consumed within 14 days of retail packaging or repackaging, as an
acceptable alternative to a 14-day use-by date, e.g., for product packaged on
November 1, 2001—‘‘Sell by November 10, 2001’’—use within 4 days of sell-
by date. Foods that are frozen before or immediately after packaging and remain
frozen until use should bear a ‘‘Keep frozen, use within 4 days after thawing’’
statement.
5. Foods which require a variance.
a. Processed fish and smoked fish may not be packed by ROP unless establish-
ments are approved for the activity and inspected by the regulatory author-
ity. Establishments packaging such fish products, and smoking and packing
establishments, must be licensed in acoordance with applicable law. Caviar
may be packed on the premises by ROP if the establishment is approved
by the regulatory authority and has an approved scheduled process estab-
lished by a processing authority acceptable to the regulatory authority.
b. Soft cheese such as ricotta, cottage cheese, cheese spreads, and combina-
tions of cheese and other ingredients such as vegetables, meat, or fish at
retail must be approved for ROP and inspected by the regulatory authority.
c. Meat or poultry products which are smoked or cured at retail—except raw
food of animal origin which is cured in a USDA-regulated processing plant
or establishment approved by the regulatory authority to cure these foods—
may be smoked in accordance with approved time/temperature require-
ments and packaged in ROP at retail if approved by the regulatory authority.
6. Hazard analysis and critical control point (HACCO) Operation. All food es-
tablishments packaging food in a reduced oxygen atmosphere must develop a
HACCP plan and maintain the plan at the processing site for review by the
regulatory authority. For ROP operations the plan must include
a. A complete description of the processing packaging, and storage procedures
designated as critical control points, with attendant critical limits, corrective
action plans, monitoring and verification schemes, and records required
b. A list of equipment and food-contact packaging supplies used, including
compliance standards required by the regulatory authority, i.e., USDA or
a recognized third party equipment by the evaluation organization such as
NSF International
c. A description of the lot identification system acceptable to the regulatory
authority
d. A description of the employee training program acceptable to the regulatory
authority
e. A listing and proportion of food-grade gasses used
f. A standard operating procedure for method and frequency of cleaning and
sanitizing food-contact surfaces in the designated processing area
7. Precaution against contamination at retail. Only unopened packages of food
products obtained from sources that comply with the applicable laws relating
to food safety can be used to package at retail in a reduced oxygen atmosphere.
If it is necessary to stop packaging for a period in excess of one-half hour,
the remainder of that product must be diverted for another use in the retail
establishment.
8. Disposition of expired product at retail. Processed reduced oxygen foods that
exceed the use-by date or manufacturer’s pull date cannot be sold in any form
and must be disposed of in a proper manner.
9. Dedicated area/restricted access. All aspects of reduced oxygen packaging
shall be conducted in an area specifically designated for this purpose. There
shall be an effective separation to prevent cross-contamination between raw and
cooked foods. Access to processing equipment shall be restricted to responsible,
trained personnel who are familiar with the potential hazards inherent in food
packaged by an ROP method. Some ROP procedures such as sous vide may
require a sanitary zone or dedicated room with restricted access to prevent con-
tamination.
III. SMOKING AND CURING

A. Introduction
Meat and poultry are cured by the addition of salt alone or in combination with one or
more ingredients such as sodium nitrite, sugar, curing accelerators, and spices. These are
used for partial preservation, flavoring, color enhancement, tenderizing, and improving
yield of meat. The process may include dry curing, immersion curing, direct addition, or
injection of the curing ingredients. Curing mixtures are typically composed of salt (sodium
chloride), sodium nitrite, and seasoning. the preparation of curing mixtures must be care-
fully controlled. Several proprietary mixtures of uniform composition are available. The
maximum residual sodium nitrite in the finished product is limited to 200 ppm by the
USDA. A sodium nitrite concentration of 120 ppm is usually sufficient for most purposes.
Specific requirements for added nitrite may be found in USDA regulations 9 CFR 318
and 381. It is important to use curing methods that achieve uniform distribution of the
curing mixture in the meat or poultry product.
B. Definitions
Cured meat and poultry can be divided into three basic categories: (1) uncomminuted
smoked products, (2) sausages, and (3) uncomminuted unsmoked processed meats.
1. Uncomminuted smoked products. These include bacon, beef jerky, hams, pork
shoulders, turkey breasts, and turkey drumsticks.
2. Sausages. These include both finely ground and coarse ground products.
Finely ground sausages include bologna, frankfurters, luncheon meats and
loaves, sandwich speads, and viennas. Coarse ground sausages include chorizos,
kielbasa, pepperoni, salami, and summer sausages.
Cured sausages may be categorized as
Raw, cured
Cooked, smoked
Cooked, unsmoked
Dry, semidry, or fermented
3. Uncomminuted, unsmoked processed products. These include corned beef,
pastrami, pig’s feet, and corned tongues. This category of products may be sold
as either raw ready-to-cook or ready-to-eat.
C. Incorporation of Cure Ingredients

Regardless of preparation method, cure ingredients must be distributed throughout the
product. Cure ingredients may be introduced into sausage products during mixing or com-
minution. Proper and thorough mixing is necessary whether the cure is added to the formu-
lation in dry or solution form. Muscle cuts may be cured by immersion into a curing
(pickling) solution. These methods depend on slow diffusion of the curing agents through
the product. Products must be properly refrigerated during immersion curing.
Several methods may be used to shorten curing times. These include hot immersion
curing greater than 49.2°C (120°F), injection by arterial pumping (e.g., hams), and stitch
pumping by a series of hollow needles. If the injection method is used, injection needles
must be frequently monitored during processing to ensure that they are not fouled or
plugged.
Tumbling or massaging may also be used as an aid to hasten curing. Proper sanitation
must be observed to prevent contamination during this operation.
The dry curing method, a similar process, may also be used. In this case, curing
ingredients are rubbed over cuts and surfaces of meat held under refrigeration. Precautions
must include wearing sanitary gloves when meat is handled. Product temperature mainte-
nance is critical.
D. Smoking
Smoking is the process of exposing meat products to wood smoke. Depending on the
method, some products may be cooked and smoked simultaneously, smoked and dried
without cooking, or cooked without smoking. Smoke may be produced by burning wood
chips or by using an approved liquid smoke preparation. Liquid smoke preparations may
also be substituted for smoke by addition directly onto the product during formulation in
lieu of using a smokehouse or another type of smoking vessel. As with curing operations,
a standard operating procedure must be established to prevent contamination during the
smoking process.
E. Fermentation and Dehydration

Meat may be fermented or dehydrated for preservation. The purpose of fermentation is
to reduce the pH to below 4.6 and inhibit bacteria harmful to health as well as bacteria
that can cause spoilage. Meat products may also be cured and then dehydrated to prevent
germination and growth of bacterial spores. Many fermented and dehydrated meats are
made without a cooking step. Sanitary practices in the production of these products are
extremely important because Staphylococcus aureus can be introduced; S. aureus produces
an enterotoxin that is heat stable and thus will not be inactivated by subsequent cooking.
Processed pork products require treatment to destroy Trichinella spiralis. At retail
products that contain raw pork and that are not subsequently cooked must be produced
from certified trichina-free pork or treated to destroy trichinae. USDA regulation 9 CFR
318.10(c)(3) establishes various requirements for destroying trichinae in pork by heating,
freezing, drying, or smoking.
Some fermented and dry-cured products are processed without cooking. The labeling
for these products should include instructions to the consumer to cook thoroughly before
consumption.
F. Recommendations for Safe Curing of Meat and Poultry

1. Posting of acceptable products. A list of products approved by the regulatory
authority, or by an approved knowledgeable authority on curing acceptable to
the regulatory authority, must be posted in the processing area of the establish-
ment.
2. Employee training. Employees assigned to cure meat or poultry must demon-
strate familiarity with these guidelines and the potential hazards associated with
curing foods. A description of the training and course content provided to the
employees must be available for review by the regulatory authority.
3. HACCP. A HACCP plan is needed for all curing operations. The following
recommendations must be met to cure meat and poultry products in the estab-
lishment:
a. Critical control points. The following are critical control points to be ad-
dressed:
Purchase of prepared cure mixes or, if cure mixes are blended on the prem-
ises instead, carefully controlled mixing using calibrated weighing devices.
Storage of cure ingredients in a dry location. Cure must be discarded if the
package is wet or appears to have been wetted.
b. Raw material handling. Thawing must be monitored and controlled to
ensure thoroughness and to prevent temperatute abuse. Improperly thawed
meat could cause insufficient cure penetration. Temperature abuse can
cause spoilage or growth of pathogens. Meat must be fresh. Curing may
not be used to salvage meat that has excessive bacterial growth or spoilage.
c. Formulating, preparation, and curing.
A formulation and preparation procedure must be documented.
All equipment and utensils must be cleaned and sanitized.
Pieces must be prepared to uniform sizes to ensure uniform cure penetration.
This is extremely critical for dry and immersion curing.
Calibrated scales must be used to weigh ingredients.
A schedule or recipe must be established for determining the exact amount
of curing formulation to be used for a specified weight of meat or meat
mixture.
Methods and procedures must be strictly controlled to ensure uniform cure.
Mixing of curing formulation with comminuted ingredients must be con-
trolled and monitored.
All surfaces of meat must be rotated and rubbed at intervals of sufficient
frequency to ensure cure penetration when a dry curing method is used.
Immersion curing requires periodic mixing of the batch to facilitate uniform
curing.
The application of salt during dry curing of muscle cuts requires that the
temperature of the product be strictly controlled between 35°F (1.67°C) and
45°F (7.22°C). The lower temperature is set for the purpose of ensuring
cure penetration and the upper temperature is set to limit microbial growth.
Refer to USDA regulation 9 CFR 318.10(c)(3)(iv) for specific details on
dry curing.
Curing solutions must be discarded daily unless they remain with the same
batch of products during its entire curing process.
Injection needles must be inspected for plugging when such pumping or
artery pumping of muscle cuts is performed.
Sanitary casings must be provided for sausage, chub, or loaf forming.
Casings may not be stripped for reuse in forming additional chubs or sau-
sage from batch to batch.
Hot curing of bacon bellies, hams, or any other products must be performed
at ⬎120°F (48.89°C), as specified in 9 CFR 318.
d. Cooking and/or smoking.
When smokehouses are initially installed or structurally modified, cali-
bration of product heating characterisitics must be ascertained by competent
food technologists. Tests should be run with full range of anticipated prod-
uct loading. Verification of even airflow and moisture should be recorded
in operational records of the smokehouse for these various loads. Proce-
dures should be documented for opening and closing combinations of vents
and drains which are required during each specific smokehouse opera-
tion.
Procedures for delivering the appropriate thermal treatment of cooked
meats in conformance with the Food Code must be developed and used
(also see 9 CFR 318.17 and 318.23 for USDA requirements for meat prod-
ucts). A minimum of 165°F (73.89°C) should be used for cured poultry
products.
• Cooking equipment that provides even temperature control of the heat-
ing medium must be used.
• Products must be adequately separated to prevent overlap in the cooking
media whether immersed in hot water, sprayed with hot water, steamed,
or oven heated.
• Calibrated temperature measuring devices must be used for determining
internal product temperatures.
• Temperature measuring device probes must be sanitized to prevent con-
taminating products when internal temperature are measured.
• Calibrated temperature measuring devices must be used for measuring
temperatures of the heating medium.
• Raw products must be separated from cooked products.
• Time/temperature parameters of the cooking process must be monitored
and recorded. In some processes the heating medium temperature should
also be monitored.
e. Cooling.
Cooling must be done in accordance with recommendations in the Food
Code or under a variance. USDA Cooling Guideline, FSIS Directive 7110.3
(special procedures for cured products), provides specific guidance.
Written cooling procedures must be established.
Chill water used in water sprays or immersion chilling which is in direct
contact with products in casings or products cooked in an impervious pack-
age must be properly chlorinated.
Chill water temperature must be monitored and controlled.
Chill water may not be reused until properly chlorinated. Reclaimed chill
water must be discarded daily.
Product must be placed in a manner that allows chilled water or air to uni-
formly contact the product for assurance of uniform cooling.
Internal temperatures must be monitored during cooling by using calibrated
temperature measuring devices.
Adequate cooling medium circulation must be maintained and monitored.
Temperature of the cooling medium must be monitored and recorded in
accordance with a written procedure.
Handling of product must be minimized during cooling, peeling of casing,
and packaging. Sanitary gloves must be used in these procedures.
f. Fermentation and drying.
Temperature and time must be controlled and logs must be maintained that
record the monitoring of this process.
Humidity must be controlled by use of a humidistat. Monitoring of the
process must be recorded in a written log.
Product must be kept separated to allow adequate air circulation during the
process.
Use of an active and pure culture must be ensured to effect a rapid pH drop
of the product. Use of commercially produced culture is necessary and the
culture must be used according to the manufacturer’s instructions.
Determination of the pH of fermented sausages at the end of the fermenta-
tion cycle must be recorded.
Handling of products must be minimized and only done with sanitary gloves
or sanitized utensils.
Dry (unfermented) products may not be hot smoked until the curing and
drying procedures are completed.
Semi-dry fermented sausage must be heated after fermentation to a time/
temperature sufficient to control growth of pathogenic and spoilage organ-
isms of concern.
4. Dedicated area restricted access. All aspects of curing operations must be con-
ducted in an area specifically designated for this purpose. There must be an
effective separation to prevent cross-contamination between raw and cooked
foods or cured and uncured foods. Access to processing equipment shall be
restricted to responsible trained personnel who are familiar with the potential
hazards inherent in curing foods.
5. Equipment cleaning and sanitizing. The procedure for cleaning and sanitiza-
tion must be accomplished according to instructions given in the Food Code.
REFERENCE
1. FDA. Food Code, 2001. Recommendations of the United States Public Health Service. Wash-
ington, DC: U.S. Department of Health and Human Services, 2001.

35
FDA Enforcement and Food
Plant Sanitation
PEGGY STANFIELD
I. BACKGROUND
The U.S. Food and Drug Administration (FDA) is charged with protecting American con-
sumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public
health laws. What does it do when there is a health risk associated with a food product?
When a problem arises with a product regulated by FDA, the agency can take a number
of actions to protect the public health. Initially, the agency works with the manufacturer
to correct the problem voluntarily. If that fails, legal remedies include asking the manufac-
turer to recall a product, having federal marshals seize products if a voluntary recall is
not done, and detaining imports at the port of entry until problems are corrected. If war-
ranted, FDA can ask the courts to issue injunctions or prosecute those that deliberately
violate the law. When warranted, criminal penalties—including prison sentences—are
sought.
However, the FDA is aware that it has legal responsibility to keep the public in-
formed of its regulatory activities. To do so, the FDA uses press releases and fact sheets.
The FDA uses this tool before, during, and after an event of health hazard related to
a food product. Some of these are briefly described herein, emphasizing the sanitation
deficiencies of affected food products.
A. Press Releases and Fact Sheets

FDA Talk Papers are prepared by the press office to guide FDA personnel in responding
with consistency and accuracy to questions from the public on subjects of current interest.
Talk Papers are subject to change as more information becomes available.
For example, on April 27, 2001, the FDA issued the following press release and
talk paper:
Solgar vitamin and herb company recalls Solgar’s Digestive Aid 100’s dietary supplements
because of possible salmonella contamination.
Solgar Vitamin and Herb Company of Leonia, New Jersey, is recalling 754 bottles
of Solgar’s Digestive Aid 100’s dietary supplements, because they have the potential to be
contaminated with Salmonella, an organism which can cause serious and sometimes fatal
infections in young children, frail or elderly people, and others with weakened immune sys-
tems. Healthy persons infected with salmonella often experience fever, diarrhea (which may
be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with sal-
monella can result in the organism getting into the bloodstream and producing more severe
illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.
Bottles of Solgar’s Digestive Aid 100’s were distributed from March 30, 2001, to April
20, 2001, to retail stores nationwide and in some foreign countries, including the United
Kingdom, France, and Israel.
The product comes in brown bottles with yellow labels that have an orange stripe on
the bottom. The bottles being recalled are marked with lot numbers 31993 or 30957 that are
printed above the expiration date on the bottle neck. The label reads in part ‘‘Solgar Digestive
Aid—Dietary Supplement—100 Tablets—Sugar and Starch Free.’’
No illnesses from this product have been reported to date.
The recall was the result of a routine sampling program by American Laboratories
Inc., of Omaha, Nebraska, which detected Salmonella in the raw material, pepsin, that was
used in Solgar’s dietary supplement. FDA’s investigation of the situation continues.
Consumers who purchased this product are urged to not consume it and should instead
destroy it or return it to the place of purchase for a full refund.
The regulatory tools used by the FDA are described in the following sections.
II. DATA ON INSANITARY PRACTICES

For the FDA to enforce its laws and regulations, it must have specific data regarding the
sanitary practices of a food processing plant. The FDA has a number of ways to ascertain
or determine if a food product is associated with unsanitary conditions in a food processing
plant or if a food processing plant has sanitary deficiencies. They include
1. Product monitoring
2. Activities based on reports from the public
3. Activities based on reports from other government agencies
4. Establishment inspection reports
A. Product Monitoring
Product monitoring is as old as when modern food processing first started. At present,
local, county, state, and federal health authorities conduct market food product sampling
and analyses to determine the wholesomeness of food. Such monitoring is restricted by
the availability of allocated budget and resources. However, the FDA has the most re-
sources and its monitoring effort produces the most results.
When products are found to be unsanitary (from pathogens, rats, insects, glass,
metal, etc.) by the FDA, it will implement standard procedures to warn the public, remove
such products from the market, and take a variety of other actions it can do and which
will be discussed later in this chapter.
B. Activities Based on Reports from the Public

The FDA has a website and an 800 number for the public to report health hazards, includ-
ing sanitation of food products. Since the establishment of such communication conve-
nience, there is an increasing number of consumers reporting products posing health risks,
such as glass in baby food, dead insects in frozen dinners, and so on. Occasionally, so-
called whistle blowers, i.e., employees of food companies, inform the FDA of products
with contaminants from unsanitary practices. Based on the data provided by the public,
the FDA implements standard procedures to handle any potential health hazards related
to the products reported.
C. Activities Based on Reports from Other Government Agencies

Health care providers frequently are the source of information that eventually leads to
unsanitary practices of food companies. These people include physicians, pharmacists,
nurses, dentists, public health personnel, and others. Most of these reports involve injury
such as food poisoning or decomposed or spoiled product contents. Their reports become
a vital source of leads for the FDA to enforce its laws and regulations.
D. Establishment Inspection Reports

Inspection of a food processing plant by a government authority is the basis on which the
government can decide if the food manufactured in the plant is wholesome and poses no
economic fraud. The frequency and intensity of the inspection process will depend on
resources and budgets, especially for the nonfederal agencies. The FDA, as a federal
agency, has more authority, greater resources, and a larger budget.
The framework for inspecting a plant covers the following:
1. Basics
a. Preparation and references
b. Inspectional authority
2. Personnel
3. Plants and grounds
4. Raw materials
5. Equipment and utensils
6. Manufacturing process
a. Ingredient handling
b. Formulas
c. Food additives
d. Color additives
e. Quality control
f. Packaging and labeling
After an inspection is completed, the inspector gives the plant management a copy
of the report. If there are sanitation deficiencies, the management will be expected to
correct them.
The data collected from this inspectional procedure and other sources discussed
earlier become the central operation base on which the FDA will enforce its legal responsi-
bility to make sure that all deficiencies are corrected to reduce any hazard to the health
of the consuming public.
The interesting part is the enforcement and compliance of the equation that concerns
this chapter. We have seen the manner in which the FDA compiles data on the sanitation
of a food product and a food processing plant. We will now proceed on the regulatory
activities the FDA usees to assure compliance.
III. RECALLS
The FDA Consumer magazine has published several articles on the recalls of food products
in this country. The following information has been compiled from these public docu-
ments.
A. Misunderstanding
Recalls are actions taken by a firm to remove a product from the market. Recalls may be
conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory
authority.
The recall of a defective or possibly harmful consumer product often is highly publi-
cized in newspapers and on news broadcasts. This is especially true when a recall involves
foods, drugs, cosmetics, medical devices, and other products regulated by FDA. Despite
this publicity, FDA’s role in conducting a recall often is misunderstood not only by con-
sumers, but also by the news media and occasionally even by the regulated industry. The
following headlines, which appeared in two major daily newspapers, are good examples
of that misunderstanding: ‘‘FDA Orders Peanut Butter Recall’’ and ‘‘FDA Orders 6,500
Cases of Red-Dyed Mints Recalled.’’ The headlines are wrong in indicating that the
agency can order a recall. The FDA has no authority under the Federal Food, Drug, and
Cosmetic Act to order a recall, although it can request a firm to recall a product.
Most recalls of products regulated by FDA are carried out voluntarily by the manu-
facturers or distributors of the product. In some instances, a company discovers that one
of its products is defective and recalls it entirely on its own. In others, FDA informs a
company of findings that one of its products is defective and suggests or requests a recall.
Usually, the company will comply; if it does not, then FDA can seek a court order authoriz-
ing the federal government to seize the product.
This cooperation between FDA and its regulated industries has proven over the years
to be the quickest and most reliable method to remove potentially dangerous products
from the market. This method has been successful because it is in the interest of FDA,
as well as industry, to get unsafe and defective products out of consumer hands as soon
as possible.
The FDA has guidelines for companies to follow in recalling defective products
that fall under the agency’s jurisdiction. These guidelines make clear that FDA expects
these firms to take full responsibility for product recalls, including follow-up checks to
assure that recalls are successful. Under the guidelines, companies are expected to notify
FDA when recalls are started, to make progress reports to FDA on recalls, and to undertake
recalls when asked to do so by the agency. The guidelines also call on manufacturers and
distributors to develop contingency plans for product recalls that can be put into effect if
and when needed. The FDA’s role under the guidelines is to monitor company recalls
and assess the adequacy of a firm’s action. After a recall is completed, FDA makes sure
that the product is destroyed or suitably reconditioned and investigates why the product
was defective.
The FDA has stated the following guidelines several times in its magazine FDA
Consumer.
B. Categories
The guidelines categorize all recalls into one of three classes according to the level of
hazard involved.
Class I recalls are for dangerous or defective products that predictably could cause
serious health problems or death.
Class II recalls are for products that might cause a temporary health problem or
pose only a slight threat of a serious nature.
Class III recalls are for products that are unlikely to cause any adverse health reac-
tion, but that violate FDA regulations.
The FDA develops a strategy for each individual recall that sets forth how exten-
sively it will check on a company’s performance in recalling the product in question. For
a Class I recall, for example, FDA would check to make sure that each defective product
has been recalled or reconditioned. In contrast, for a Class III recall the agency may decide
that it only needs to spot check to make sure the product is off the market. Detailed
regulations have been promulgated on FDA recalls in the U.S. Code of Federal Regula-
tions.
Even though the firm recalling the product may issue a press release, FDA seeks
publicity about a recall only when it believes the public needs to be alerted about a serious
hazard. For example, if a canned food product purchased by a consumer at a retail store
is found by FDA to contain botulinum toxin, an effort would be made to retrieve all the
cans in circulation, including those in the hands of consumers. As part of this effort the
agency also could issue a public warning via the news media to alert as many consumers
as possible to the potential hazard.
The FDA also issues general information about all new recalls it is monitoring
through a weekly publication titled ‘‘FDA Enforcement Report.’’
Before taking a company to court, FDA usually notifies the responsible person of
the violation and provides an opportunity to correct the problem. In most situations, a
violation results from a mistake by the company rather than from an intentional disregard
for the law.
There are several incentives for a company to recall a product, including the moral
duty to protect its customers from harm and the desire to avoid private lawsuits if injuries
occur. In addition, the alternatives to recall are seizures, injunctions, or criminal actions.
These are often accompanied by adverse publicity, which can damage a firm’s reputation.
A company recall does not guarantee that FDA will not take a company to court.
If a recall is ineffective and the public remains at risk, FDA may seize the defective
products or obtain an injunction against the manufacturer or distributor.
The recalling firm is always responsible for conducting the actual recall by con-
tacting its purchasers by telegram, mailgram, or first-class letter with information including
1. The product being recalled
2. Identifying information such as lot numbers and serial numbers
3. The reason for the recall and any hazard involved
4. Instructions to stop distributing the product and what to do with it
The FDA monitors the recall, assessing the firm’s efforts.
C. Initiating a Recall
A firm can recall a product at any time. Firms usually are under no legal obligation even
to notify FDA that they are recalling a defective product, but they are encouraged to notify
the agency, and most firms seek FDA’s guidance. FDA may request a recall of a defective
product, but it does so only when agency action is essential to protect the public health.
When a firm undertakes a recall, the FDA district office in the area immediately
sends a ‘‘24 Hour Alert to Recall Situation’’ notifying the relevant FDA center (responsi-
ble for foods and cosmetics, drugs, devices, biologics, or veterinary medicine) and the
FDA’s Division of Emergency and Epidemiological Operations (DEEO) of the product,
recalling firm, and reason for the recall. FDA also informs state officials of the product
problem, but for routine recalls the state does not become actively involved.
After inspecting the firm and determining whether there have been reports of inju-
ries, illness, or other complaints to either the company or to FDA, the district documents
its findings in a recall recommendation (RR) and sends it to the appropriate center’s recall
coordinator. The RR contains the results of FDA’s investigation, including copies of the
product labeling, FDA laboratory worksheets, the firm’s relevant quality control records,
and when possible a product sample to demonstrate the defect and the potential hazard.
The RR also contains the firm’s proposed recall strategy.
D. The Strategy
The FDA reviews the firm’s recall strategy (or, in the rare cases of FDA-requested recalls,
drafts the strategy), which includes three things: the depth of recall, the extent of public
warnings, and effectiveness check levels.
The depth of recall is the distribution chain level at which the recall will be aimed.
If a product is not hazardous, a recall aimed only at wholesale purchasers may suffice.
For more serious defects, a firm will conduct a recall to the retail level. And if the public
health is seriously jeopardized, the recall may be designed to reach the individual con-
sumer, often through a press release.
But most defects don’t present a grave danger. Most recalls are not publicized be-
yond their listing in the weekly Enforcement Report mentioned earlier. This report lists
the product being recalled, the degree of hazard (called ‘‘classification’’), whether the
recall was requested by FDA or initiated by the firm, and the specific action taken by the
recalling firm.
A firm is responsible for conducting ‘‘effectiveness checks’’ to verify—by personal
visits, by telephone, or with letters—that everyone at the chosen recall depth has been
notified and has taken the necessary action. An effectiveness check level of A (check of
100% of people that should have been notified) through E (no effectiveness check) is
specified in the recall strategy, based on the seriousness of the product defect.
E. The Health Hazard Evaluation
When the center receives the RR from the district office, it evaluates the health hazard
presented by the product and categorizes it as Class I, II, or III. The classification is
determined by an ad hoc Health Hazard Evaluation Committee made up of FDA scientists
chosen for their expertise. Classification is done on a case-by-case basis, considering the
potential consequences of a violation.
A class I recall involves a strong likelihood that a product will cause serious adverse
health consequences or death. A very small percentage of recalls are Class I. In December
of 2000, Schneider Cheese, Inc. (Waldo, WI) recalled several kinds of cheese including
Schneider String Cheese (mozzarella cheese). This was a Class I recall because the product
was contaminated with Listeria monocytogenes.
A class II recall is one in which use of the product may cause temporary or medically
reversible adverse health consequences or in which the probability of serious adverse
health consequences is remote. An example of Class II is the following. In March 2001,
Alpete Meats (Muncie, IN) recalled meat-free/veggie corn dogs because the products may
have been manufactured using an ingredient which appeared to contain the genetic material
(DNA) necessary for the production in corn (trade name StarLink) of the pesticide Cry9C
protein derived from Bacillus thuringiensis subspecies tolworthi. The pesticide is not al-
lowed for use in foods for human consumption.
A Class III recall involves a product not likely to cause adverse health consequences.
In March 2001, H. R. Davis Candy Company (Canton, OH) recalled Coconut Dips milk
chocolate, sugar-free candy because they contained undeclared sulfites.
For Class I and II, and infrequently for class III, FDA conducts audit checks to
ensure that all customers have been notified and are taking appropriate action. The agency
does this by personal visits or telephone calls.
A recall is classified as ‘‘completed’’ when all reasonable efforts have been made
to remove or correct the product. The district notifies a firm when FDA considers its recall
completed.
F. Planning Ahead
The FDA recommends that firms maintain plans for emergency situations requiring recalls.
Companies can minimize the disruption caused by the discovery of a faulty product if
they imprint the date and place of manufacture on their products and keep accurate and
complete distribution records.
A ‘‘market withdrawal’’ is a firm’s removal or correction of a distributed product
that involves no violation of the law by the manufacturer. A product removed from the
market due to tampering, without evidence of manufacturing or distribution problems, is
one example of a market withdrawal.
A ‘‘stock recovery’’ is another action that may be confused with a recall. A stock
recovery is a firm’s removal or correction of a product that has not yet been distributed.
Even though the firm recalling the product may issue a press release, FDA seeks
publicity about a recall only when it believes the public needs to be alerted about a serious
hazard. For example, if a canned food product purchased by a consumer at a retail store
is found by FDA to contain botulinum toxin, an effort would be made to retrieve all the
cans in circulation, including those in the hands of consumers. As part of this effort the
agency also could issue a public warning via the news media to alert as many consumers
as possible to the potential hazard.
G. Examples of Recalls
The following describes three examples of recalls.
1. Class I Recall
Product: cold smoked sea bass, air-packed in cardboard boxes; recall #F-313-1
Code: sb 0110
Manufacturer: Haifa Smoked Fish Inc., Jamaica, NY
Recalled by: manufacturer, by telephone and letter on 2/15/01; FDA-initiated recall
complete
Distribution: Rego Park, NY (Queens)
Quantity: 231.4 lb
Reason: product contaminated with Listeria monocytogenes
Reference: April 4, 2001, FDA Weekly Enforcement
2. Class II Recall
Product: Kraft EasyMac Microwavable Single Servings Macaroni & Cheese Dinner;
3/4 cup individual serving laminate twin-packets, packaged in 6-count boxes,
UPC 21000-67148, and 18-count boxes, UPC 21000-67149; recall #F-306-1
Code: code dates SEP-05-01 through SEP-26-01. These dates are followed by either
a 1 or 2, then XCN and military time
Manufacturer: Cloud Corp., Des Plaines, IL
Recalled by: Kraft Foods, Inc., Northfield, IL, by fax/e-mail on 2/6/01; firm initiated
recall complete
Distribution: Nationwide
Quantity: 142,181.5 case equivalents
Reason: product contaminated with a compressed air system lubricant
Reference: April 4, 2001, FDA Weekly Enforcement
3. Class III Recall

Product: Colonial Kitchen Bacon Bits; recall #F-271-1
Code: 08K3080, 06W3060, 09K3110, 09W3110, 08W3080, 08K3090, 09K3150,
09W3150
Manufacturer: Feaster Foods, Omaha, NE
Recalled by: Dollar Tree Stores, Inc., Chesapeake, VA, by phone on/about 12/5/
2000; completed recall resulted from follow-up by the New York State Depart-
ment of Agriculture and Markets
Distribution: PA, IL, MS, and VA
Quantity: 42552 bottles
Reason: product contained undeclared FD&C Red No. 40 and is not identified as
an imitation bacon product
Reference: March 7, 2001, FDA Weekly Enforcement
IV. WARNING LETTERS

Under FDA regulations, a prior notice is a letter sent from FDA to regulated companies
about regulatory issues. One such notice is the warning letter. If the establishment inspec-
tion report includes a list of sanitary deficiencies, the FDA may send a warning letter to
the food company to ask for proper correction of such deficiencies.
Two such letters are provided here. However, the following premise must be real-
ized. Matters described in FDA warning letters may have been subject to subsequent
interaction between FDA and the recipient of the letter that may have changed the regula-
tory status of the issues discussed in the letter.
A. Insanitary Practices in a Potato Plant

On June 7, 2001, the FDA issued a warning letter to a potato processing plant. The major
contents of the letter are presented here.
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility
located at May 3, 4, and 9, 2001.
The inspection revealed significant insanitary practices and conditions which cause
your foods to be adulterated within the meaning of Section 402(a)(4) of the Federal Food,
Drug, and Cosmetic Act (the Act) because they have been prepared, packed, or held under
insanitary conditions whereby they may have been contaminated with filth.
You are responsible for ensuring that your facility has the proper construction and
design and that your processes, controls, and procedures are adequate to store and process
food under sanitary conditions.
The following is a list of the insanitary practices, conditions, and findings observed
by FDA:
1. Sanitary operations
a. Pest control: You are not taking effective measures to exclude pests from your
plant, as evidenced by the following:
i. A decomposed rat, approximately 10 inches long, was found near bags of
sodium metabisulfite.
ii. Sixteen (16) rodent pellets, confirmed by FDA laboratory analysis, were
found at various locations in the raw ingredients room.
iii. Six (6) decomposed mice were found near a pallet holding an opened box
of food-packaging poly bags in your miscellaneous materials room (called
junk room by the FDA investigator).
iv. Approximately twenty (20) rodent pellets, eight of which were confirmed
by FDA laboratory analysis, were found at the west side of the miscellane-
ous materials room.
b. General Maintenance: You are not taking effective measures to maintain the
building, fixtures, and other physical facilities of the plant in a sanitary condition,
as evidenced by the following:
i. Two live spiders were found in the northeast corner of the raw ingredient
room, next to an uncovered wooden bin filled with raw potatoes.
ii. An uncovered wooden bin of raw potatoes and bagged raw ingredients
were stored over wooden ceiling, piping, and lighting that were covered
with dustlike debris and spider webbing in the raw ingredient room.
iii. Scraps of wood and empty cans, covered with dustlike debris and spider
webbing, were piled against the walls on the south side of the raw ingredi-
ent room.
iv.Uncovered plastic bins of boiled potatoes were exposed to ceiling, walls,
and flooring that had a build-up of brown-black moldlike material in the
walk-in refrigerator.
v. The metal casing around the light bulb suspended over bins of uncovered
boiled potatoes bore a gray, crustlike material in the walk-in refrigerator.
vi. Uncovered plastic bins of cooled potatoes were exposed to moldy ceilings
and walls in the shredding/dicing room.
vii. Three fans with dusty grills were blowing onto exposed raw potatoes as
they were hauled up a conveyor belt in the processing room.
viii. There is a build-up of dried potato residue, dust, and debris along the peeled
potato line in the processing room.
ix. The lighting unit directly above the hand-sorting table was covered with
dust and spider webs in the processing room.
x. Two cigarette butts and spilled raw ingredients were found behind contain-
ers of raw ingredients in the processing room.
2. Plant and grounds
a. Plant Construction: Your plant is not constructed in such a manner that floors,
walls, and ceiling may be adequately cleaned and kept clean and in good repair,
i. The walls and ceiling in the shredding/dicing room bear a black moldlike
substance.
ii. The processing room floor is heavily pitted.
iii. The south of the room, formerly known as the french-fry room, has missing
concrete and the metal framing is exposed and bears rustlike debris.
b. Plant Design: The combination of activities that take place in the processing room
increases the potential for contamination of food and food-contact surfaces. Spe-
cifically, the employees’ microwave oven and coffee pot are next to the grill used
to test browning of hash browns; employees’ food and drink items were found
on the same table as the scale used to weigh finished product; and employees’
shoes and a box of recycled cans were found directly underneath this table.
c. Placement of Equipment and Storage of Materials:
i. You do not provide sufficient space for such placement of equipment and
storage of materials as is necessary for the maintenance of sanitary opera-
tions. Specifically, bins of uncovered raw potatoes, miscellaneous equip-
ment, wooden shelving, and pallets of raw ingredients were flush against
the walls, preventing access to cleaning and maintaining rodent traps.
ii. You do not take proper measures to ensure that drip or condensate from
fixtures, ducts, and pipes does not contaminate food-contact surfaces. Spe-
cifically, the food shredder was stored beneath a refrigeration unit that was
leaking condensation.
3. Sanitary facilities and controls
a. Plumbing: You do not provide adequate floor drainage in areas where normal
operations discharge water on the floor, as evidenced by the following:
i. In the raw ingredient room, a five-gallon bucket filled with water and a
floating cigarette butt was observed overflowing into the channel drain that
leads to a drain underneath wooden bins used to store raw potatoes. The
drain had 2 inches of standing dark-colored, sewage-smelling water. An
employee identified the water as condensate from the freezer.
ii. In the processing room, there is a channel drain that contained rotten potato
peels and up to 1 inch of standing dark-colored water.
iii. In the room, formerly known as the french-fry room, the ‘‘sump’’ system
was overflowing, causing water to back up through the drain channel into
the production room. The flooded floor had a sewage odor. Employees
were observed tracking the standing water back and forth from the french-
fry room and the production room.
4. Equipment and utensils
a. Design and Material: Equipment and utensils should be so designed and of such
material and workmanship as to be adequately cleanable and should be properly
maintained. Specifically,
i. The wooden ceiling, walls, and floor bear a build-up of brown-black mold-
like material.
ii. The bins used for storing raw potatoes are wooden and have moldlike mate-
rial on the interior and exterior sides as well as the interior base.
5. Maintenance
a. Equipment should be maintained so as to facilitate cleaning.
b. Specifically, the walk-in refrigerator’s forced air cooling unit had peeling paint
chips and was blowing debris near uncovered plastic bins of boiled potatoes.
c. Seams on food-contact surfaces should be smoothly bonded or maintained so as
to minimize accumulation of food particles, dirt, and organic matter. Specifically,
the conveyor belt in the processing room had uneven seams and had a dark-
colored, moldlike build-up.
d. Proper Cleaning: Your food equipment is washed using a sodium hypochlorite
solution, but there is no water rinse afterwards. Proper cleaning includes a final
rinse with clean water.
6. Processes and controls
a. Potential for Contamination of Food and Food-Contact Surfaces: You do not take
proper precautions to reduce the potential for contamination of food and food-
contact surfaces with filth or other extraneous material, as evidenced by the fol-
lowing:
i. In the walk-in refrigerator, uncovered plastic bins of boiled potatoes were
stored approximately 2 feet from the forced air cooling unit, which was
blowing rustlike debris. There were also two drums overflowing with wa-
ter, which an employee identified as condensate, underneath the unit.
ii. In the walk-in refrigerator, a fan grill covered with rustlike debris was
stored in a plastic bin designated to store boiled potatoes for cooling.
iii. The maintenance room, where the forklift, lubricants, tools, and other mis-
cellaneous equipment are stored, directly opens to the hand-sorting table
in the production room.
iv. You are not taking effective measures to protect against the inclusion of
metal or other extraneous material in the raw potatoes or finished pro-
duct.
b. Temperature of Walk-In Refrigerator: You are neither performing routine temper-
ature checks nor maintaining records of the temperature of the walk-in refrigera-
tor. Also, there is no automatic regulating control of the temperature.
7. Personnel
a. Cleanliness: You do not assure that your employees conform to hygienic practices
while on duty to the extent necessary to protect against contamination of food,
i. Employees did not wash their hands after eating or drinking and returning
to the production line.
ii. No hand sanitizers are installed in the production area.
iii. An employee was observed driving the forklift, doing general plant mainte-
nance, and blowing his nose, but not washing his hands prior to unloading/
loading finished product into delivery vans.
At the conclusion of the inspection, the insanitary practices and conditions were
listed on Form FDA 483 (Inspectional Observations) and discussed with you. A copy of
this form is enclosed for your ready reference. This list is not meant to be an all-inclusive
list of violations.
You should take prompt action to correct the violations. Failure to promptly correct
these violations may result in regulatory action without further notice. These include sei-
zure and/or injunction.
Please advise FDA in writing, within fifteen (15) working days of receipt of this
letter, of the specific steps you have taken to correct the noted violations. If corrective
action cannot be completed within 15 days, state the reasons for the delay and the time
at which the corrections will be completed.
Your response should be directed to .
B. Unsanitary Prepackaged Sandwiches

On June 1, 2001, the FDA issued a warning letter to a food plant that produces prepackaged
sandwiches. The major contents of this letter are presented here.
During an inspection of your manufacturing facility, located at con-

ducted May 14 and 15, 2001, we found that you manufacture and distribute ready-to-eat
food products, including prepackaged sandwiches. During the inspection, we collected a
number of samples including unopened ingredients, sliced meats and cheeses, and finished
products. Our analysis of these samples revealed Listeria monocytogenes (L. mono) con-
tamination as follows:
1. We isolated L. mono from finished retail units of turkey and chedder cheese
submarine sandwiches (FDA Sample Number 133746) and turkey, ham, and
cheese submarine sandwiches (FDA sample number 133745).
2. We isolated L. mono from ham (FDA Sample Number 133739), chedder cheese
(FDA Sample Number 133740), and provolone cheese (FDA Sample Number
133741), which were sliced at your facility to be used in the preparation of your
finished sandwiches.
3. Our analysis of bulk, unopened units of ham (FDA Sample Number 133742),
chedder cheese (FDA Sample Number 133743), and provolone cheese (FDA
Sample Number 133744), in storage at your facility, showed no L. mono con-
tamination. Listeria monocytogenes is a pathogenic organism that can cause
serious and sometimes fatal infections in young children, frail or elderly people,
and others with weakened immune systems. Although healthy individuals may
suffer only short-term symptoms such as high fever, severe headache, stiffness,
nausea, abdominal pain, and diarrhea, Listeria infection can cause miscarriages
and stillbirths among pregnant women. Therefore, the products listed in items
1 and 2 above are adulterated under section 402(a)(1) of the Food, Drug, and
Cosmetics Act (the Act) because they are contaminated with the pathogenic
bacteria Listeria monocytogenes, which may render the product injurious to
health. We note that you are conducting a recall of products from the market-
place and acknowledge your action in this regard.
We further note that the U.S. Army notified you in May 2001 that they had isolated
L. monocytogenes from your ham and turkey and turkey and cheddar sandwiches sampled
in April 2001. You were also recently notified that L. mono was isolated from several
other sandwiches collected by the U.S. Army in May 2001, including your ham and cheese,
ham and turkey, pastrami and cheese, French dip, roasted turkey croissant, tuna salad
croissant, chicken pesto pita, tuna pita, and turkey pita. The repeat nature of the Listeria
monocytogenes contamination of your food products, as evidenced by the U.S. Army and
FDA test results, along with the negative sample results associated with the incoming
food ingredients used to manufacture your products, indicates that you have a widespread
problem with Listeria monocytogenes.
In addition, we also observed inappropriate food handling and sanitation prac-
tices as outlined at the conclusion of the inspection on the Form FDA-483 issued to
. Based on these insanitary practices, along with the U.S. Army test results from
April and May 2001, and the FDA sample results describing Listeria monocytogenes con-
tamination of your sandwiches described above, we regard all products prepared, packed,
or held at your facility to be adulterated within the meaning of Section 402(a)(4) of
the Act.
Among the significant findings described on the Form FDA-483 is the observa-
tion that the temperature of your cold storage room fluctuated from 48 to 50°F from
11:30 a.m. to 3:30 p.m. on May 14, 2001. This high temperature may not prevent the
rapid growth of undesirable microorganisms. Test results supplied to you by the U.S.
Army in May 2001 indicate that some of your products are not only contaminated with
L. mono, but also have high levels of aerobic bacteria (⬎600,000,000 cfu/g), coliforms
(50,000 cfu/g), and/or E. coli (up to 11,000 cfu/g), which are further indications of insani-
tary practices and/or conditions at your facility.
The above identification of violations is not intended to be an all-inclusive list of
deficiencies at your facility. It is your responsibility to assure that your establishment
is in compliance with all requirements of the federal regulations. Moreover, it is your
responsibility to produce safe products. You should take prompt action to prevent further
violation of the Act.
Further violation of the Act may result in regulatory action without further notice,
which can include seizure of your products and/or injunction of your firm.
Please notify this office in writing within 15 working days of receipt of this letter
of the specific actions taken to correct the noted violations and prevent their recurrence.
If corrective actions cannot be completed within 15 working days, state the reason for
the delay and the time within which corrections will be completed. Your written response
should be directed to the attention of .
Additionally, due to the serious concerns we have over the repeat nature of the
listeria contamination, we request that you contact this office to schedule a meeting within
five (5) days of receipt of this letter. You may schedule this meeting by calling the district
office at and arranging a mutually agreeable date and time.
V. SUMMARIES OF COURT ACTIONS
Summaries of court actions are given pursuant to Section 705 of the Federal Food, Drug,
and Cosmetic Act. Summaries of court actions report cases involving seizure proceedings,
criminal proceedings, and injunction proceedings. Seizure proceedings are civil actions
taken against goods alleged to be in violation, and criminal and injunction proceedings
are against firms or individuals charged to be responsible for violations. The cases gener-
ally involve foods, drugs, devices, or cosmetics alleged to be adulterated or misbranded
or otherwise violative of the law when introduced into and while in interstate commerce
or while held for sale after shipment in interstate commerce.
Summaries of court actions are prepared by the Office of the Chief Counsel, Food
and Drug Administration and published by direction of the Secretary of Health and Human
Services.
The September–October issue of the FDA Consumer magazine reported the follow-
ing summaries of court actions regarding foods that were seized because of unsanitary
conditions.
A. Case 1
Product: Articles of food, dusting starch, seized at Norfolk, VA (E.D. Va.); Civil
Action No. 2:99cv1130.
Charged 7-16-99: While held for sale after shipment in interstate commerce at
Golden Fields Enterprises, Inc. (Norfolk, VA), the articles of food were adulter-
ated in that they had been prepared, packed, and held under insanitary conditions
whereby they might have become contaminated with filth—402(a)(4).
Disposition: Pursuant to default decree of condemnation, forfeiture, and destruction,
the articles of food were destroyed December 17, 1999. (F.D.C. No. 67278; S.
No. 48739 et al.; S.J. No. 1.)
B. Case 2
Product: Beef trachea, three cases more or less, seized at Greeley, CO (D. Colo.);
Civil Action No. 99-Z-2398.
Charged 12-16-99: While held for sale after shipment in interstate commerce at Old
West Treat Company, in (Greeley, CO), the article of food was adulterated in
that it bore or contained Salmonella, a poisonous and deleterious substance which
might have rendered it injurious to health—402(a)(1).
Disposition: The article of food was destroyed. (F.D.C. No. 67296; S. No. 57883;
S.J. No. 2.)
C. Case 3
Product: Frozen shrimp, 1192 cases more or less, seized at Jacksonville, FL (M.D.
Fla.); Civil Action No. 98-236-Civ-J-20B.
Charged 3-16-98: While held for sale after shipment in interstate commerce at Indus-
trial Cold Storage, Inc. and stored at the account of King and Prince Seafood
Corporation (Brunswick, GA), the articles of food were all adulterated in that
they consisted in whole or in part of a decomposed substance by reason of the
presence therein of decomposed shrimp—402(a)(3).
Disposition: Pursuant to an order amending the consent decree, a portion of the
defendant lot of decomposed frozen shrimp was satisfactorily reconditioned. The
rejected portion of the reconditioned product had been destroyed under the super-
vision of the United States Marshals Service. (F.D.C. No. 67224; S. No. 98-712-
573; S.J. No. 5.)
D. Case 4
Product: Frozen shrimp, 302 cases more or less, seized at Tampa, FL (M.D. Fla.);
Civil Action No. 98-476-CIV-T-17C.
Charged 3-4-98: While held for sale after shipment in interstate commerce at Ameri-
cold Corporation, stored to the account of Central Seaway Company, Inc. (Tampa,
FL), all of the defendant shrimp were adulterated in that they consisted in whole
or in part of a decomposed substance by reason of the presence therein of decom-
posed shrimp—402(a)(3). Furthermore, certain defendant shrimp (420 cases more
or less) were also adulterated in that they consisted in whole or in part of a filthy
substance by reason of the presence therein of insect and bird filth—402(a)(3).
Disposition: The condemned defendant shrimp was exported to Zhejiang Foreign
Economic Relations and Trade Development Corporation (Hangzhou, China).
(F.D.C. No. 67223; S. No. 98-768-226/228; S.J. No. 6.)
E. Case 5
Product: Preserved turnip, 60 cases more or less, seized at Brooklyn, NY (E.D.
N.Y.); Civil Action No. 98-CV-0181.
Charged 1-14-98: While held for sale after shipment in interstate commerce at Yick
Cheung Corporation, doing business as Goodworld Trading (Brooklyn, NY), the
articles of food were adulterated in that the articles (60 case lots of preserved
turnips) consisted in part of a filthy substance, by reason of having been rodent-
gnawed and by reason of the presence therein of rodent urine—402(a)(3). The
articles were further adulterated in that they (all lots) had been held under insani-
tary conditions whereby they very likely became contaminated with filth—
402(a)(4).
Disposition: The condemned articles of food were successfully reconditioned.
(F.D.C. No. 67222; S. No. 98-751-473; S.J. No. 7.)
F. Case 6
Product: Soybeans and Mung Beans, seized at San Lorenzo, CA (N.D. Calif.); Civil
Action No. 99-4799.
Charged 11-1-99: While held for sale after shipment in interstate commerce at Dong
Ling Sprout and Produce Co. (San Lorenzo, CA), the articles of food were adulter-
ated in that certain articles of food consisted in part of a filthy substance, including
350 50-lb bag lots of soybeans, by reason of being rodent gnawed; 720 55-lb bag
lots of mung beans, by reason of the presence therein of insects and rodent excreta
pellets; 1190 110-lb bag lots of mung beans, by reason of the presence therein
of rodent hairs; and 2320 55-lb bag lots of mung beans, by reason of the presence
therein of mammalian urine—402(a)(3). The articles were further adulterated in
that all articles of food (all lots) had been held under insanitary conditions
whereby they might have become contaminated with filth—402(a)(4).
Disposition: The articles were destroyed. (F.D.C. No. 67290; S. No. 38938 et al.;
S.J. No. 8.)
VI. INVESTIGATORS’ REPORTS

The Food and Drug Administration Investigators’ Reports refer to selected cases published
in FDA Consumer magazine illustrating regulatory and administrative actions—such as
inspections, recalls, seizures, and court proceedings—by FDA’s regional and district of-
fices across the country. Four such reports are described here.
A. ‘‘Food Seized at Warehouse Overrun with Rodents’’

The July–August 1998 issue of FDA Consumer magazine carried the above-headlined
article by Carol Lewis on legal action against a food warehouse with unsanitary conditions.
More than 200 kinds of Oriental food products with a retail value of $280,000 were
seized in January of 1998 at a New York City warehouse because of rodent contamination.
At FDA’s request, the U.S. District Court for the Eastern District of New York
issued a seizure warrant January 26, 1998, for the food—about 5488 cases of imported
rice cakes, candies, dried vegetables, and other assorted products—after the food’s owner
and distributor, Yick Cheung Corp., doing business as Goodworld Trading Co., refused
to rid the Brooklyn warehouse of rodents.
‘‘A seizure can give substantial motivation to those responsible for cleaning up their
act,’’ said Lillian Aveta, a compliance officer in FDA’s New York district office. ‘‘They
want to get their facility back into business.’’
Goodworld’s poor sanitary practices were first identified in February 1995 when,
as part of a crackdown on misbranded products, New York State authorities inspected the
storage facility. In addition to sanitation violations, state chemists detected staphylococcal
bacteria in mushrooms Goodworld had for sale. The state seized more than 1000 cases
of mushrooms and cited Goodworld for sanitation violations.
Subsequent inspections later that year found continuing sanitation problems and
resulted in further seizures and fines of more than $1500.
But the violations continued. As part of a routine schedule, FDA inspected Good-
world in October. In repeated visits through December, FDA investigators Cornelius Gal-
lagher, Peter Caparelli, Kwong Lee, and Donald Ullstrom observed a dog roaming freely
within the food storage area, fresh rodent pellets ‘‘too numerous to count’’ throughout
the walk-in refrigerator, cases of food that looked like they had been gnawed, and gnawed
holes through the base of the north and west walls of the warehouse. Food samples col-
lected and later analyzed by FDA indicated rodent contamination.
Company president Wing Chan told FDA that garbage was picked up once weekly
and that the company acted as its own exterminator, using a BB gun and placing unen-
closed rodenticide on the floor throughout the warehouse.
On November 7, FDA investigators, along with FDA chemist Nariman Ayyad, met
New York State inspector Sonia Morales at the warehouse. New York State is under
contract with FDA to assist with some inspections. Morales placed all food lots sampled

by FDA under state embargo to ensure that the food items in question would not be
distributed while the seizure was being processed.
At a December 3 follow-up inspection, agency investigators noted that previously
documented building deficiencies had not been corrected. Company president Chan told
FDA that he rented the warehouse from the owner who, he said, was looking to sell the
property. He also said that if the property was not sold within 6 months, he ‘‘may make
the building corrections’’ himself. Until then, he said, he intended to leave the building
deficiencies ‘‘as is’’ for financial reasons, Aveta said.
The agency can order a warrant for mass seizure based on six violative lots of food,
Aveta said. She added that Goodworld was in violation with a total of nine lots of food.
The seizure on January 26, 1998, only affected products in soft packaging because
other types of containers used had not been found to be contaminated.
At press time, the company was allowed to distribute only products packaged in
rigid containers, such as metal and hard plastic, as well as in soft packages received after
the seizure date.
B. ‘‘Imported Fruit Blamed for Rare Typhoid Outbreak’’

The July–August 1999 issue of FDA Consumer magazine carried the above-headlined
article by John Henkel on legal action against imported fruit responsible for typhoid out-
break in this country.
A tropical fruit popular in Hispanic American homes was the source of a recent
outbreak of a disease rarely seen in the United States: typhoid fever.
Health officials believe that frozen mamey fruit from Central America contaminated
with potentially dangerous bacteria caused 14 cases of typhoid in the Miami area between
December 1998 and February 1999. All of the sickened people, who required hospitaliza-
tion, reportedly recovered.
Though the products also were sold elsewhere in the United States, no other related
typhoid cases were reported. Federal and state officials removed the fruit from circulation
in February and March, preventing any further sickness.
Typhoid, a primarily waterborne infection caused by the bacterium Salmonella typhi,
produces persistent and high fever, abdominal cramps, loss of appetite, and fatigue.
Though potentially life threatening, the disease normally can be cured if treated promptly
with antibiotics.
Hispanic households use frozen mamey (pronounced mam-may) to make a shakelike
drink called batidos de mamey. The products have not caused any reported problems in
the past.
In Florida, the clustered cases puzzled health officials because the disease is rare
in the United States. When it shows up, it is usually in travelers returning from a visit
abroad. But an investigation by state authorities and the national Centers for Disease Con-
trol and Prevention showed that those sickened had not traveled.
‘‘There were just too many clustered cases to attribute to travelers,’’ says Mike
Chappell, investigations director in FDA’s Florida district office. ‘‘Those numbers of clus-
tered cases could be explained by a traveling group: for example, a group of firefighters
who travel to Guatemala. After drinking contaminated water, some of them come back
and then develop typhoid fever. But that wasn’t the case with this outbreak.’’
So in early February, Florida Health Department and CDC officials focused their

efforts on finding the common elements of the cluster of cases showing up in the Miami
area. They determined that in all the cases the people had consumed frozen mamey either
at home, where it had been bought from a food store, or in a restaurant. Florida officials
immediately embargoed the fruit to keep it from being distributed.
Having pinpointed the outbreak cause, officials set out to trace the origin of the
contaminated fruit. The FDA joined the investigation on February 18 and, by evaluating
data provided by state health officials and CDC, identified El Sembrador brand frozen
mamey produced in Guatemala and possibly Honduras as the most likely source. Epidemi-
ological data from South Florida showed that this brand was in homes and in restaurants
where those exposed ate the product.
On February 20, FDA publicly warned consumers not to eat the El Sembrador brand
of frozen mamey.
The FDA and Florida officials collected samples for laboratory analysis but were
unable to isolate the S. typhi bacterium. FDA’s southeast regional laboratory in Atlanta
did, however, find high concentrations of both fecal coliform and E. coli bacteria in the
samples, signs that the products had heavy bacterial contamination and possibly harbored
the typhoid bacteria.
In late February, FDA officials inspected a frozen mamey production plant in Guate-
mala that health officials there had closed down weeks earlier because of the outbreak.
‘‘Even though we got there after the facility was closed,’’ says Chappell, ‘‘it was obvious
that the product was produced under [substandard] sanitation conditions.’’
Also, the contamination could have occurred as a result of Hurricane Mitch, which
hit Guatemala hard in late 1998, possibly polluting the water supply used to make the
fruit product.
On March 8, FDA announced the voluntary recall of El Sembrador frozen mamey,
along with two other brands also suspected of being contaminated: La Fe and a product
with no brand name produced by Agrodex in Guatemala. At press time, these products
were awaiting destruction. Other brands of frozen mamey not associated with the outbreak
are still available.
C. ‘‘Juice Maker Fined Record Amount for E. Coli –Tainted Product’’

The May–June 1997 issue of FDA Consumer magazine carried the above-headlined article
on legal action against E. coli contaminated fruit (by John Henkel).
A California juice company was fined $1.5 million after pleading guilty to 16 mis-
demeanor criminal charges related to a 1996 outbreak of dangerous Escherichia coli
O157:H7 bacteria. One child died and 14 other children were seriously sickened after
drinking the company’s fresh, unpasteurized apple juice.
The fine is one of the largest ever imposed in FDA history for a food injury case,
and the criminal conviction by federal prosecutors is one of the first ever obtained in a
large-scale outbreak of infectious pathogens.
Odwalla Inc., of Half Moon Bay, agreed in a criminal plea bargain in July to pay
the fine and serve 5 years of court-supervised probation. The plea agreement, filed in U.S.
District Court for the Eastern District of California, also requires Odwalla to implement
a Hazard Analysis and Critical Point (HACCP) plan in its facility. A HACCP plan is a
food safety system that identifies potential food safety hazards and specifies controls for
preventing these hazards.
A $250,000 portion of the fine will be divided between a charitable organization,
Safe Tables Our Priority (STOP), and the food safety research centers of the University
of Maryland and Pennsylvania State University. The funds will be used to raise consumer
food safety awareness and research the safety of fresh produce.
The tainted juice affected consumers in Colorado, California, Washington State,
and British Columbia. Fifteen children who drank the juice developed the life-threatening
condition hemolytic uremic syndrome (HUS), a leading cause of kidney failure in children.
One of the children, a 16-month-old Colorado girl, died from HUS-related multiple organ
failure. At least 51 others were sickened but to a lesser degree. Food safety experts say
survivors of this strain of E. coli may have significant health problems for years.
In late October 1996, FDA received word that the health departments from the three
affected states had identified an E. coli O157:H7 outbreak. Washington State health offi-
cials also told FDA that using DNA fingerprinting methods, they had clustered 15 related
cases of E. coli infection in which all the victims had reported drinking Odwalla apple
juice.
When notified of these findings, Odwalla began a recall on October 31 of all its
apple juice products. At the same time, FDA launched a 14-month investigation. An inves-
tigator with FDA’s San Francisco district office, Helen Hamaoka, inspected the Odwalla
plant and collected apple juice samples, which were shipped to FDA’s analytical labora-
tory in Seattle. Tests showed the samples were negative for E. coli O157:H7. Hamaoka
noted, however, that the company had ignored safety standards by centering its product
testing more on shelf-life than bacterial contamination.
On November 5, 1996, FDA’s Seattle district laboratory analyzed samples of juice
found in an Odwalla warehouse in Washington State. One sample that came from juice
processed around October 7, 1996, tested positive for E. coli O157:H7. The laboratory
analysis enabled FDA to link the E. coli outbreak to Odwalla juice.
As part of its criminal investigation of Odwalla, FDA’s Office of Criminal Investiga-
tions (OCI) began interviewing former Odwalla employees, suppliers, and others familiar
with company operations. Their comments indicated that Odwalla had in the past had
numerous deficiencies in its sanitation procedures. For example, accepted industry practice
calls for use of a chlorine solution for washing and sanitizing fruit, but Odwalla had
stopped using chlorine and was instead using phosphoric acid, which may not be effective
as a fruit wash.
The OCI also learned that the U.S. Army had rejected a contract with Odwalla in
June 1996 after Army analysis identified a high bacterial count in an Odwalla product.
The OCI also discovered that a consultant hired by the company had uncovered
Listeria and other bacterial contamination in the processing plant during weekly microbio-
logical tests he conducted between May 1994 and December 1995. The OCI learned that
Odwalla initially tried to identify and eliminate the source of the Listeria contamination
but ultimately focused on extending shelf-life without ever conclusively solving the con-
tamination problem. Records showed that Odwalla had used an inferior grade of apples,
which may have made the juice more prone to contamination.
After determining that Odwalla’s operations created an environment within which
E. coli O157:H7 could exist, OCI’s investigation centered on determining the source of
the contamination. Though officials could not pinpoint the exact source, several theories
emerged. Among them are
The apples used to make the juice were contaminated with animal fecal material.
The wooden crates used to ship the apples were contaminated.
Odwalla employees failed to wash their hands properly after using the bathroom
and before returning to production areas.
As part of the consent decree, Odwalla implemented a HACCP plan whose pro-
visions included
1. Maintaining sanitary conditions to avoid food contamination

2. A written sanitation control program run by a qualified manager
3. A comprehensive employee training program in areas such as proper food han-
dling and personal hygiene.
In June 1997, Hamaoka inspected Odwalla again and took juice samples and swabs
from the company’s equipment for analysis. The samples proved negative for E. coli, and
Hamaoka noted that the company had begun using more effective sanitation methods.
The FDA will continue to inspect Odwalla regularly to ensure HACCP compliance.
D. ‘‘Sandwich Maker Fined for Consent Decree Violation’’

The May–June 1997 issue of FDA Consumer magazine carried the above-headlined article
by John Henkel on legal action against a sandwich maker for sanitation violation.
A breach in a court-ordered consent decree by a New Orleans food company has
resulted in a $2500 fine against the company.
Finest Foods Inc., maker of Mrs. Drake’s Sandwiches, violated the decree when it
resumed operations without FDA permission after being closed by the agency for unsani-
tary conditions. The 1993 consent decree requires Finest Foods to get FDA’s approval
before resuming operations.
Finest Foods, which makes about 11,000 sandwiches a day for retail sale, signed
the consent decree in the U.S. District Court for the Eastern District of Louisiana after
FDA found recurring problems. A 1994 amendment to the consent decree allows FDA
to shut down Finest Foods’s sandwich operation if the company violates the decree pro-
visions.
The FDA found such violations in February 1996 when investigators inspected the
facility and found L. monocytogenes contamination and other conditions, such as filth in
the processing plant and unsanitary food handling procedures. Listeria monocytogenes
can be fatal to infants, older adults, and people with weakened immune systems. The
conditions FDA found were similar to those that led to the 1993 consent decree.
Following the February inspection, FDA sent a letter saying the plant must cease
operations until the violations are corrected. Under the consent decree, if FDA orders the
facility to shut down, the company, with written documentation of corrections, can request
reconsideration and stay open until FDA confirms that the shutdown is necessary. On
April 23, 1996, FDA delivered another letter to Finest Foods saying the company had
failed to address its deficiencies and that it should suspend its operations immediately.
That day the company met with FDA and agreed to the ordered suspension.
The FDA told the company that to reopen it must
1. Shut down and clean the plant and equipment.

2. Hire an independent expert to ensure that the company makes the required cor-
rections and to provide FDA with a written statement certifying compliance.
3. Test the plant and products for contamination.
According to court records, the company said it fulfilled all three requirements on
April 24, the day after the shutdown. But FDA learned that the company reopened the
facility before receiving test results, without providing a written statement from the expert,
and without getting FDA’s permission.
On April 30, FDA told the company it had violated the consent decree by reopening.
Finest Foods again suspended operations until May 2, when FDA inspected the facility
and allowed the company to reopen. FDA took the consent decree breach to district court,
where on December 18 Judge Peter Beer found that the company’s actions were a ‘‘willful
violation’’ of the decree. In ordering the $2500 fine, Beer cited only the company for
contempt, not the individual defendants, company owners James and Timothy Ganus. He
found that their actions ‘‘were mitigated by their overall efforts to comply with the consent
decree.’’
Finest Foods has since resumed operation and, FDA officials say, the company has
taken measures to stay in compliance with the consent decree.
ACKNOWLEDGMENT
Most data provided in this chapter have been obtained from documents prepared by Sci-
ence Technology System, West Sacramento, CA. Permission to use the materials has been
granted by Science Technology System.

36
A Review of U.S. Food Safety Policies
and Programs
Tin Shing Chao

I. INTRODUCTION
All previous chapters have introduced you to the laws, regulations, and practices concern-
ing sanitation, safety, and other aspects of the operations of an establishment to produce
a safe and wholesome food. This chapter summarizes the government policies and pro-
grams that make it possible to have a safe food supply.
The production of the nation’s food supply has long been an important part of the
U.S. Food and Drug Administration’s (FDA) public health mission. Throughout the years,
the U.S. government has established different food regulations and employed food inspec-
tors to enforce its laws.
As we are entering the 21st century, new technology has emerged, and there are
always new ways in manufacturing and producing food supplies. For the consumer, the
challenges facing the food safety system are constantly changing as technology changes.
Foodborne illness in the United States is a major cause of personal distress, prevent-
able death, and avoidable economic burden. In 1994, the Council for Agriculture Science
and Technology estimated 33 million people become ill from microorganism in food,
resulting in as many as 9,000 needless deaths every year. For many victims, foodborne
illness results only in discomfort or lost time from job. For some, especially preschool age
children, older adults in health care facilities, and those with impaired immune systems,
foodborne illness is more serious and may be life threatening.
The Centers for Disease Control and Prevention has consistently stated that where
reported foodborne illness outbreaks were caused by mishandling of food, most of the
time the mishandling occurs within the retail segment of the food industry (restaurants,

markets, schools, churches, camps, institutions, and vending locations), where ready-to-
eat food is prepared and provided to the public for consumption [1].
II. OVERVIEW OF FEDERAL LAWS AND REQUIREMENTS

Those who are responsible for food processing of any kind in the United States are all
subject to some rather complicated laws, many of which can sometimes be contradictory
on some points, but in general they all have similar objectives.
In general, an overview of the agencies and laws pertaining to food processing is
as follows:
A. Food and Drug Administration

The Food, Drug, and Cosmetic Act provides guidelines for the food processors how to
deal with (1) adulteration of foods; (2) unsanitary conditions in plants; and (3) good manu-
facturing practices. In addition, defect action levels deal with rodent droppings and insect
parts in specific raw materials.
B. Environmental Protection Agency

The Federal Insecticides, Fungicide, and Rodenticide Act (FIFRA) covers the use of insec-
ticides, rodenticides, and sanitizing solutions used by everyone in the nation, not merely
food processors.
C. United States Department of Agriculture

This agency executes the laws applied to food processors that offer products containing
meat and poultry. Food processors such as bakers who use eggs in their finished products
are not covered by these rules.
D. Hazard Analysis and Critical Control Points System

At present, FDA has introduced regulation to implement an industry-wide system called
the hazard analysis and critical control point (HACCP) plan for seafood processing and
fruit and vegetable juices. The U.S. Department of Agriculture (USDA) is implementing
HACCP plans for some aspects of meat and poultry processing. It is expected that over
the next decade or so, most categories of food manufacturing will be covered by the
HACCP program.
E. State and Local Regulations

State and local governments usually have their specific laws pertaining to food processing,
storage, and sale. These laws generally go hand in hand with the Food, Drug, and Cosmetic
Act and the good manufacturing practices. In many states, some of these laws are more
specific and stringent. Many states are under contract with the Food and Drug Administra-
tion to conduct FDA regulatory inspections of food processors in their areas. Roving FDA
teams often follow, on a random basis, inspections performed by state inspectors.
F. Military Standards
Food processors who produce products for military installations including commissaries
can expect inspections by the military once every 6 months. Military standards are very
similar to good manufacturing practices, but certain specifics are included. If you are a
food processor dealing with the military, make certain you have a copy of these laws.
Regardless of the agency or agencies, these laws are all designed to eliminate the
possibility of foodborne illness and or personal injury that comes about from the patho-
genic microbes or their toxins, pests and pest evidences, and foreign materials.
III. HISTORY OF FOOD CODES

Previous editions of food codes recommended by the United States Public Health Services
for regulating operations for providing food directly to the consumer [2] are summarized
as follows:
1934: Restaurant Sanitation Regulations. Proposed by the U.S. Public Health
Service (PHS) in cooperation with the Conference of State and Territorial Health
Officers and the National Restaurant Code Authority.
1935: An Ordinance Regulating Food and Drink Establishment. Recom-
mended by U.S. Public Health Service, December 1935 (Mimeographed).
1938: Ordinance and Code Regulating Eating and Drinking Establish-
ment. Recommended by the U.S. Public Health Service, March 1938 (Mimeo-
graphed).
ments. Recommended by the U.S. Public Health Service, June 1940 (Mimeo-
graphed).
ments. Recommended by the U.S. Public Health Service. FSA/Public Health
Bulletin No. 280 (republished in 1955 as DHEW/PHS Publication No. 37).
1957: The Vending of Foods and Beverages—A Sanitation Ordinance and
Code. Recommendations of the Public Health Service. DHEW/PHS Publica-
tion No. 546.
1962: Food Service Sanitation Manual Including a Model Food Service Sanita-
tion Ordinance and Code. Recommendations of the Public Health Service.
DHEW/PHS Publication No. 934.
1965: The Vending of Food and Beverages—A Sanitation Ordinance and
Code. Recommendations of the Public Health Service. DHEW/PHS Publica-
tion 1965, No. 546.
1976: Food Service Sanitation Manual Including a Model Food Service Sanita-
tion Ordinance. Recommendations of the Food and Drug Administration
(DHEW/PHS/FDA). DHEW Publication No. (FDA) 78-2091.
1978: The Vending of Food and Beverages Including a Model Sanitation Ordi-
nance. Recommendations of the Food and Drug Administration (DHEW/PHS/
FDA). DHEW Publication No. (FDA) 78-2091.
1982: Retail Food Store Sanitation Code. Recommendations of the Association
of Food and Drug Officals and U.S. Department of Health and Human Services/
Public Health Service/Food and Drug Administration.
1993: Food Code. Recommendations of the U.S. Public Health Service, Food and
Drug Administration. National Technical Information Service Publication PB94-
113941.
265492.
133656.
1999: Food Code. Recommendations of the U.S. Public Health Services, Food
and Drug Administration. National Technical Information Services Publication
PB-99-115925.
2001: Food Code. Recommendations of the U.S. Public Health Services, Food
and Drug Administration. National Technical Information Services Publication
PB-2002100819.
The 2001 Food Code is the most current; numerous editing changes were made
throughout the document for internal consistency. The 2001 Food code incorporated cor-
rections and clarification to the 1999 Food Code. To view the summary of changes for the
2001 Food Code see the following web site: http://cfsan.fda.gov/⬃dms/fc01-sum.html.
IV. PUBLIC HEALTH AND CONSUMER EXPECTATIONS

It is a shared responsibility of the food industry and the government to ensure that food
provided to the consumer is safe and does not become a vehicle in a disease outbreak or
in the transmission of communicable disease. This shared responsibility extends to ensur-
ing that consumer expectations are met and that food is unadulterated, prepared in a clean
environment, and honestly presented.
Under FDA’s 1997 mission statement the agency is responsible for ensuring that
foods are safe, wholesome, and sanitary; regulated products are honestly, accurately, and
informatively represented; these products are in compliance with the law and FDA regula-
tions; noncompliance is identified and corrected; and any unsafe or unlawful products are
removed from the market place [3].
V. NATIONAL FOOD SAFETY INITIATIVES

To protect consumers from foodborne disease, the United States must strengthen the na-
tion’s capacity to predict and prevent foodborne hazards and to monitor and rapidly react
to outbreaks of foodborne diseases. To achieve the public health goal of reducing food-
borne illness to the fullest extent possible, steps must be taken at each point in the farm-
to-table chain where hazards can occur. Important progress has been made in the efforts
to monitor and prevent foodborne disease and ensure that consumers are provided with
the safest possible foods. These activities encompass the entire continuum of food produc-
tion, food processing and manufacture, retail food stores, and food services to consumers.
Former President Clinton’s National Food Safety Initiative recommended the adop-
tion and implementation of the Food Code that, corresponding with congressional appro-
priations, authorized the following initiatives:
1. A provision to ensure the safety of domestic and imported fresh fruits and vege-
tables
2. The creation of the Foodborne Outbreak Response Coordination Group (FORC-
G) to improve federal and state agencies’ response to foodborne disease out-
breaks
3. The initiation of PulseNet, a public health laboratory network that ‘‘finger-
prints’’ bacteria and permits more rapid and accurate detection of foodborne
illness outbreaks
4. The expansion of FoodNet, the collaboration Foodborne Disease and Active
Surveillance Network, which measures the burden and sources of foodborne
disease in the United States
5. The establishment of the Joint Institute for Food Safety Research to coordinate
food safety research and priority setting
6. The formation of the President’s Council on Food Safety that will develop a
strategic plan for federal food safety activities and recommend ways to enhance
coordination and improve effectiveness in the food safety system.
The FDA, USDA-Food Safety and Inspection Service (FSIS), and Centers for Disease
Control (CDC) endorse the Food Code because the code provides public health and regula-
tory agencies with practical science-based advice and manageable, enforceable provisions
for mitigating risk factors known to contribute to foodborne disease [4].
VI. REGULATORY PROGRAMS

The FDA’s Office of Regulatory Affairs (ORA) mission statement is ‘‘Achieve effective
and efficient compliance products through high quality, science-based work that results
in maximizing consumer protection.’’
The ORA is responsible that FDA-regulated products (food, drugs, medical devices,
cosmetics, radiation-emitting products such as microwave ovens, and feed and drugs for
pets and farm animals) comply with the consumer protection laws and regulations and
agency enforcement. Approximately 900 investigators and 100 compliance officers in
FDA offices around the United States are assigned to the Office of Regulatory Affairs.
Dennis Baker, the associate commissioner for regulatory affairs, said in the FY 1999
annual report:
FDA inspects all food (except meat and poultry products) of domsestic and foreign origin
either directly or through contracts with state agencies. We want to make sure the food is
wholesome and not misbranded. That responsibility includes food production, processing,
distribution and sale at the retail level. We also investigate issues related to drug residues
and pesticides in the food supply We provide training to state health and agriculture official
and work for passage of the Food Code.
We are targeting inspections to identify those products that have the highest level of
contaminants and the highest level of food safety concern, such as low-acid canned foods or
sanitation in the seafood, fruit and vegetable juices industry.
VII. FOOD SAFETY INITIATIVE PROGRESS AND PERSPECTIVE

Dr. Robert Buchanan, senior science advisor to the Center for Food Safety and Applied
Nutrition (CFSAN), shared his thoughts about advances in food science research and
where science will lead us into the next century. The following is an excerpt from his
report:
In 1906 with the passage of the Pure Food and Drug Act, the government was able to gain
control over the economic adulteration of food and inappropriate use of chemicals. From
there, the entire discipline of food science developed to the point today where there is a
system in place that identifies risks in foods. We have moved from a system that began as
‘‘buyer beware’’ to HACCP—hazard analysis critical control points, which is based on the
producer anticipating hazards and preventing them. There is now a safety net under the entire
food system.
Microbiology was a new science at the turn of the century. Chemistry and toxicology
had not been around too long. Here is a good example of progress we are making: During
the last 25 years the standard technique for isolating low acid level of Listeria in food took
one month. Now, gene-based system can identify Listeria in six hours. This has helped reduce
by 60% the incidence of listeriosis in the last 10 years.
Nothing in the food industry stays the same. Food changes, the marketplace changes, and
the demographics of the population changes. This results in new challenges in new food
safety problems. Science will provide us with an ability to anticipate and rapidly respond
to threats to public health. The translation of knowledge we’ve gained in the last 10 years
will turn into practical solutions in the next 10 years. For example, in the 1990s it became
apparent that foodborne pathogens start on the farm. It is now the job of science to identify
those pathogens and identify methods for reducing or eliminating them.
Not all research is conducted in a laboratory. As part of the President’s Food Safety
Initiative, FDA and USDA’s National Agriculture Services were directed to work together
to establish a baseline description of current agriculture practices used in the production
of fresh fruits and vegetables in the United States, and to conduct a survey every two
years to measure changes in agriculture practices [5].
VIII. THE JOINT INSTITUTE FOR FOOD SAFETY RESEARCH

On July 3, 1998, President Clinton directed the Department of Health and Human Services
(DHHS) and the U.S. Department of Agriculture to develop a plan to create the Joint
Institute for Food Safety Research ( JIFSR). The goal of JIFSR is to (1) coordinate planning
and priority setting for food safety research among the two departments, other government
agencies, and the private sector and (2) foster effective translation of research results into
practices along the farm-to-table continuum [6].
IX. SURVEILLANCE AND OUTBREAK RESPONSE

Detecting and responding to emerging pathogens in food supply quickly and effectively
is essential to preventing widespread illness. PulseNet—a collaborative project between
CDC, FDA, USDA, and state health departments—uses dedicated, high-speed Internet
connections for the rapid comparison of DNA fingerprints of foodborne bacteria with
those in an ever-growing database at CDC. When the system detects a match between
fingerprints of bacteria isolated from different areas, an automated e-mail massage is sent
to all the participants alerting them of a possible multistate outbreak.
Dr. Farukh M. Khambaty, the microbiologist in charge of PulseNet at CFSAN, stated
[7]:
Using the method of pulsed-field gel electrophoresis (PFGE) to general DNA fingerprints of
bacteria has proved to be the most reproducible and discriminatory solution for linking spo-
radic cases of foodborne illness with larger foodborne outbreaks. With the advances in the

speed of computers and the development of the Internet, we can rapidly analyze and transfer
huge files of information.
In 1999, an important case stands out as illustrative of the benefits of PulseNet.

PulseNet proved useful in linking cases of shigella infections in Minnesota, Massachusetts,
California, and Canada to fresh parsely from a single operation in Mexico.
In 1999, PulseNet capability was expended to FDA labs in Los Angeles; Brooklyn,
NY; Atlanta; Denver; Seattle; and Jefferson, AK [7].
X. THE NATIONAL FOOD SAFETY SYSTEM PROJECT

The FDA is leading an effort to improve coordination and communication among public
health and food regulatory officials, particularly around foodborne illness outbreaks. This
effort, known as the National Food Safety System (NFSS) project, contributes significantly
to more effective implementation of existing food safety programs. Work began in Sep-
tember 1998 with an FDA-hosted meeting of food safety and agriculture officials from
all 50 states, Puerto Rico, and the District of Columbia; epidemiologist and laboratory
staff from state and local health departments; and colleagues from CDC, USDA, and EPA.
Discussions from that meeting led to the creation, in 1999, of a nationwide coordinat-
ing commitee and workgroups to generate ideas for activities that would promote an inte-
grated national food safety system. Workgroups were established in six areas: role and
responsibilities; outbreak coordination and investigations; laboratory operations and coor-
dination; national uniform criteria; information sharing and data collection; and communi-
cation.
In 1999, two laboratory accreditation training programs were held. The first, in
March of 1999, was for workgroup members. The second, in June of 1999, was held in
conjunction with the Association of Food and Drug Officials (AFDO) and preceded
AFDO’s annual meeting. Over 70 federal, state, university, and private laboratory person-
nel attended the workshop.
The outbreak coordination and investigations workgroup made progress in 1999; a
draft outline of a guidelines manual for coordinating foodborne outbreak and traceback
investigation was completed. One course focused on conducting a traceback investigation
using the procedures outlined in the ‘‘FDA Guide to Traceback Fruits and Vegetables
Implicated in Epidemiological Investigations.’’ The training also covered the deci-
sionmaking process for initiating tracebacks and the roles of producers, distributors, im-
porters, and investigators and how they fit into the overall traceback investigation. A
foodborne illness course provided an opportunity to learn how to develop and maintain
a surveillance system and how to apply epidemiological principles to an investigation [8].
XI. NATIONAL ANTIMICROBIAL RESISTANCE MONITORING

SYSTEM
The United States now has in place a system that allows FDA to tell when foodborne
bacteria that cause disease in humans begin to develop resistance to antimicrobials used in
food animals. The system is called National Antimicrobial Resistance Monitoring System
Enteric Bacteria (NARMSEB). It combines the resources of FDA, CDC, and USDA to
create a nationalwide monitoring system.
Informed public health officials, responsible animal producers, drug manufacturers,
and veterinarians can use this information to control and prevent harm from the use of
antimicrobials in food animals through prudent antibiotic use practices. The system tests
the susceptibility of gram-negative bacteria for susceptibility to 17 different antibiotics
and the susceptibility of gram-positive Enterococci to 27 antibiotics. The human isolates
are tested by CDC, and the animal isolates by the Agriculture Research Services of USDA.
The FDA initiated the program in 1996 and significantly expanded it under the Food
Safety Initiative in 1999 to collect more isolates from more locations and more types of
bacteria from animals and humans [9].
XII. FDA-FUNDED STATE FOOD SAFETY TASK FORCES

Working to improve coordination among state and local regulatory, industry, legislative,
and consumer organizations, FDA funded the establishment of 23 food safety task forces.
Richard Barnes, Director of Federal–States Relations in FDA’s Office of Regulatory Af-
fairs stated ‘‘The goal of funding the 23 state food safety task forces is to create a better
food safety system from local level all the way up to the state level’’ [10].
XIII. MAKING PROGRESS TOWARD A SAFER FOOD SUPPLY

While the American food supply is among the safest in the world, we can always do more.
We are eating a greater variety of foods thoughout the year from all over the country and
all around the world. Statistics have shown we are eating more and more food prepared
outside our homes. Nearly a quarter of our population is considered at-risk for developing
foodborne illness. Research has shown there are more than five times the number of food-
borne pathogens in 1999 than there were 50 years ago. The most critical element of our
nation’s food safety system is a strong science base to underpin decisionmaking from
research and risk assessment to surveillance, inspection, training, and education.
Susan Alpert, Director of Food Safety for the Center for Food Safety and Applied
Nutrition stated ‘‘Bacteria are smarter than people. We will never totally eliminate them
from food supply. Where we can reasonably improve food safety by decreasing bacterial
contamination we should. The challenge is to evaluate the entire farm-to-table process
and find the places where we can take steps to decrease pathogens. I expect to see accom-
plishment in the areas of technology, science, risk assessment, and education.’’
XIV. OPERATIONAL AND ADMINISTRATIVE SYSTEM FOR IMPORT

SUPPORT
The Operational and Administrative System for Import Support (OASIS) is a national
computer database on imports, enforcement activities, and findings. This system not only
supports FDA field personnel in carrying out their day-to-day activities, but also provides
headquarters personnel and program staff within the FDA centers with vital information
on FDA compliance program and enforcement accomplishments. FDA uses OASIS to
decide the admissibility and to ensure the safety, efficacy, and quality of the foreign prod-
ucts for which the FDA has regulatory responsibility under the Federal Food, Drug, and
Cosmetic Act. According to FDA the OASIS computer system enables them to handle
the burgeoning volume of shipments of imported products more efficiently and more effec-
tively, despite the decreasing agency resources [12].
According to another report provided by FDA the OASIS system has significantly
sped up processing time compared to the manual system used previously. OASIS routes
admissibility decisions electronically to the computer of the importer’s agents within min-
utes when the importer electronically transmits shipment data to FDA. Therefore, 85%
of the shipments are cleared without submission of paper by the importers [13].
Automated screening functions enhance FDA’s ability to detect problems, thereby
helping to keep violative goods from entering the country. When OASIS identifies there
is a problem with certain imported goods, FDA’s district office will issue a ‘‘Notice of
Detention and Hearing’’ to the owner or the consignee. In the import detention report
(IDR) it specifies the nature of the violation to the owner or consignee. The owner is
entitled to an informal hearing to provide testimony regarding the admissibility of the
product. Each month, FDA will post the IDR on the FDA web site. People can view IDR
report either by country or by product and view the violation charge code at the following
site: http://www.fda.gov/ora/oasis.
By having national data on imports, enforcement activities, and findings, FDA man-
agement is better able to spot emerging trends, identify emergency situations, and alert
all field personnel quickly, allocate resources more effectively, and effect greater unifor-
mity in enforcement activities throughout the country.
XV. U.S. CUSTOMS AND SAFE FOOD IMPORTS

American consumers enjoy one of the safest food supplies in the world. In enhancing the
safety of the U.S. food supply, the Clinton administration funded the requests for food
safety initiatives, the establishment of the Food Safety Council, and directives to improve
the safety of the food supply [14]. On July 3, 1999, President Clinton expanded his safe
food directive to the Secretary of Health and Human Services and the Secretary of the
Treasury to take additional action to further protect consumers from unsafe imported
foods. While most imported food is safe and most importers comply with U.S. food safety
requirements, a few importers try to sidestep U.S. laws to bring unsafe or contaminated
food into the country. While FDA is responsible for the safety of most imported foods,
the U.S. Customs Services works hand in hand with FDA to [15]
1. Prevent distribution of imported unsafe food by means such as requiring food
to be held until reviewed by FDA
2. Destroying imported food that poses a serious public health threat
3. Prohibiting the reimportation of food that has been previously refused admission
and has not been brought into compliance with U.S. laws and regulations, and
requiring the marking of shipping containers and/or papers of imported food
that is refused admission for safety reasons
4. Setting standards for private laboratories for the collection and analysis of sam-
ples of imported food for the purpose of gaining entry into the United States
5. Increasing the amount of the bond posted for imported foods when necessary
to deter premature and illegal entry into the United States
6. Enhancing enforcement against violations of U.S. laws related to the importa-
tion of foods, including through the imposition of civil monetary penalties.
Many of the mentioned activities represent significant changes in the FDA import program.
FDA and customs have conducted a series of public meetings to present and discuss those
activities to both the industry and the public before implementing changes in these six
areas. One could find the final rules on the appropriate agency’s internet website. The
development and implementation of the planned activity in the six areas will increase the
tools available to FDA and customs to protect American consumers from unsafe imported
foods. FDA and customs will use these tools to focus on problem importers who try to
sidestep U.S. laws to bring unsafe or contaminated food into the country. FDA and customs
anticipate continuation of working together in cooperation with the U.S. Department of
Agriculture, Environmental Protection Agency, Food Safety Inspection Service, Animal
and Plant Health Inspection Service, Foreign Agriculture Service, U.S. trade representa-
tives, and the Food Safety Council to protect consumers from unsafe imported food [16].
XVI. SAFE TRANSPORTATION OF FOODS

The American food system provides consumers with an abundant supply of convenient,
economical, high-quality, and safe food products. This system is built on the enterprise
and innovative capacities of those who produce and market food in the United States, and
it is driven by the high expectations of American consumers for the foods they purchase
for their families. The Secretary of Transportation introduced the Sanitary Food Tranporta-
tion Act of 1990, which prohibits certain food transportation practices. It also safeguards
food and certain other products from contamination during motor or rail transportation
[17]. Food being transported in interstate commerce is subjected to federal and state regula-
tions. Customs also plays an important role in safeguarding and prohibiting contaminated
food items from entering the United States. Customs also works in conjunction with FDA,
USDA, EPA, etc., to regulate domestic food as well. If an imported food is suspected, it
can be tested for contamination and its entry into the United States can be denied. Food
safety is an important public health issue. The Sanitary Food Transportation Act of 1990
only covers a limited area in food transportation. Former president Clinton’s administra-
tion developed and implemented some major steps toward reinventing food regulations
after the Vice President’s National Performance Review in 1993, and as a result a blueprint
for reinventing our nation’s food safety system was issued [18]. Other U.S food safety
initiatives and inspection programs, such as USDA’s Food Safety Inspection Service,
which oversees importation of food from foreign countries ensure that imported food meets
U.S. regulations. FDA also issued regulations that require the meat, poultry, and seafood
industries to follow hazard analysis and critical control point plans. This HACCP standards
calls for food industries to implement measures at each critical control point. The indus-
tries are also responsible for controlling their own safety assurance actions. The HACCP
standards bring regulation of meat, poultry, and seafood in line with state-of-the-art scien-
tific procedures [19]. These regulations also help regulate food safety during transportation
as part of the critical control point. From farm to table is a long journey; Food items pass
through a lot of hands before reaching consumers. It is not easy to accomplish this task;
many different trades and the government have to work hand in hand in order to achieve
the delivery of safe food to our table. The combined efforts of domestic and international
food importers working with different government agencies will ensure that safe and
wholesome food can reach consumers’ tables.
XVII. CONCLUSION
In conclusion, a quote from then President Clinton’s December 11, 1999, radio address:
‘‘Food Safety is part of our citizens’ basic contract with the government.’’ The FDA
together with other agencies are working hard to achieve and maintain this goal [11].
REFERENCES
1. www.fda.gov
2. www.fda.gov
3. www.fda.gov
4. www.fda.gov
5. www.fda.gov
6. www.fda.gov
7. www.fda.gov
8. www.fda.gov
9. www.fda.gov
10. www.fda.gov
11. www.fda.gov
12. www.fda.gov
13. www.fda.gov
14. www.customs.ustreas.gov
17. www.fda.gov
18. www.fda.gov
19. www.fda.gov

APPENDIX A
U.S. Food and Drug Administration
Good Manufacturing Practices
U.S. Code of Federal Regulations
The following is excerpted from 21 CFR 110, last revised April 1, 2001.
TITLE 21—FOOD AND DRUGS
PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN

MANUFACTURING, PACKING, OR HOLDING
Subpart A—General Provisions
Sec. 110.3 Definitions.
The definitions and interpretations of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act (the act) are applicable to such terms when used in this part. The follow-
ing definitions shall also apply:
(a) Acid foods or acidified foods means foods that have an equilibrium pH of 4.6
or below.
(b) Adequate means that which is needed to accomplish the intended purpose in
keeping with good public health practice.
(c) Batter means a semifluid substance, usually composed of flour and other ingredi-
ents, into which principal components of food are dipped or with which they are coated,
or which may be used directly to form bakery foods.
(d) Blanching, except for tree nuts and peanuts, means a prepackaging heat treatment
of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely
inactivate the naturally occurring enzymes and to effect other physical or biochemical
changes in the food.
(e) Critical control point means a point in a food process where there is a high
probability that improper control may cause, allow, or contribute to a hazard or to filth
in the final food or decomposition of the final food.
(f) Food means food as defined in section 201(f) of the act and includes raw materi-
als and ingredients.
(g) Food-contact surfaces are those surfaces that contact human food and those sur-
faces from which drainage onto the food or onto surfaces that contact the food ordinarily
occurs during the normal course of operations. ‘‘Food-contact surfaces’’ includes utensils
and food-contact surfaces of equipment.
(h) Lot means the food produced during a period of time indicated by a specific
code.
(i) Microorganisms means yeasts, molds, bacteria, and viruses and includes, but is
not limited to, species having public health significance. The term ‘‘undesirable microor-
ganisms’’ includes those microorganisms that are of public health significance, that subject
food to decomposition, that indicate that food is contaminated with filth, or that otherwise
may cause food to be adulterated within the meaning of the act. Occasionally in these
regulations, FDA used the adjective ‘‘microbial’’ instead of using an adjectival phrase
containing the word microorganism.
( j) Pest refers to any objectionable animals or insects including, but not limited to,
birds, rodents, flies, and larvae.
(k) Plant means the building or facility or parts thereof used for or in connection
with the manufacturing, packaging, labeling, or holding of human food.
(1) Quality control operation means a planned and systematic procedure for taking
all actions necessary to prevent food from being adulterated within the meaning of the
act.
(m) Rework means clean, unadulterated food that has been removed from processing
for reasons other than insanitary conditions or that has been successfully reconditioned
by reprocessing and that is suitable for use as food.
(n) Safe-moisture level is a level of moisture low enough to prevent the growth
of undesirable microorganisms in the finished product under the intended conditions of
manufacturing, storage, and distribution. The maximum safe moisture level for a food is
based on its water activity, a w . An a w will be considered safe for a food if adequate data
are available that demonstrate that the food at or below the given a w will not support the
growth of undesirable microorganisms.
(o) Sanitize means to adequately treat food-contact surfaces by a process that is
effective in destroying vegetative cells of microorganisms of public health significance,
and in substantially reducing numbers of other undesirable microorganisms, but without
adversely affecting the product or its safety for the consumer.
(p) Shall is used to state mandatory requirements.
(q) Should is used to state recommended or advisory procedures or identify recom-
mended equipment.
(r) Water activity (a w ) is a measure of the free moisture in a food and is the quotient
of the water vapor pressure of the substance divided by the vapor pressure of pure water
at the same temperature.
Sec. 110.5 Current good manufacturing practice.
(a) The criteria and definitions in this part shall apply in determining whether a food
is adulterated (1) within the meaning of section 402(a)(3) of the act in that the food has
been manufactured under such conditions that it is unfit for food or (2) within the meaning
of section 402(a)(4) of the act in that the food has been prepared, packed, or held under
insanitary conditions whereby it may have become contaminated with filth, or whereby
it may have been rendered injurious to health. The criteria and definitions in this part also
apply in determining whether a food is in violation of section 361 of the Public Health
Service Act (42 U.S.C. 264).
(b) Food covered by specific current good manufacturing practice regulations also
is subject to the requirements of those regulations.
Sec. 110.10 Personnel.
The plant management shall take all reasonable measures and precautions to ensure
the following:
(a) Disease control. Any person who, by medical examination or supervisory obser-
vation, is shown to have, or appears to have, an illness, open lesion, including boils, sores,
or infected wounds, or any other abnormal source of microbial contamination by which
there is a reasonable possibility of food, food-contact surfaces, or food-packaging materi-
als becoming contaminated, shall be excluded from any operations which may be expected
to result in such contamination until the condition is corrected. Personnel shall be in-
structed to report such health conditions to their supervisors.
(b) Cleanliness. All persons working in direct contact with food, food-contact sur-
faces, and food-packaging materials shall conform to hygienic practices while on duty to
the extent necessary to protect against contamination of food. The methods for maintaining
cleanliness include, but are not limited to:
(1) Wearing outer garments suitable to the operation in a manner that protects against
the contamination of food, food-contact surfaces, or food-packaging materials.
(2) Maintaining adequate personal cleanliness.
(3) Washing hands thoroughly (and sanitizing if necessary to protect against contam-
ination with undesirable microorganisms) in an adequate hand-washing facility before
starting work, after each absence from the work station, and at any other time when the
hands may have become soiled or contaminated.
(4) Removing all unsecured jewelry and other objects that might fall into food,
equipment, or containers, and removing hand jewelry that cannot be adequately sanitized
during periods in which food is manipulated by hand. If such hand jewelry cannot be
removed, it may be covered by material which can be maintained in an intact, clean, and
sanitary condition and which effectively protects against the contamination by these ob-
jects of the food, food-contact surfaces, or food-packaging materials.
(5) Maintaining gloves, if they are used in food handling, in an intact, clean, and
sanitary condition. The gloves should be of an impermeable material.
(6) Wearing, where appropriate, in an effective manner, hair nets, headbands, caps,
beard covers, or other effective hair restraints.
(7) Storing clothing or other personal belongings in areas other than where food is
exposed or where equipment or utensils are washed.
(8) Confining the following to areas other than where food may be exposed or where
equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using
tobacco.
(9) Taking any other necessary precautions to protect against contamination of food,
food-contact surfaces, or food-packaging materials with microorganisms or foreign sub-
stances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and
medicines applied to the skin.
(c) Education and training. Personnel responsible for identifying sanitation failures
or food contamination should have a background of education or experience, or a combina-
tion thereof, to provide a level of competency necessary for production of clean and safe
food. Food handlers and supervisors should receive appropriate training in proper food
handling techniques and food-protection principles and should be informed of the danger
of poor personal hygiene and insanitary practices.
(d) Supervision. Responsibility for assuring compliance by all personnel with all
requirements of this part shall be clearly assigned to competent supervisory personnel.
Sec. 110.19 Exclusions.
(a) The following operations are not subject to this part: Establishments engaged
solely in the harvesting, storage, or distribution of one or more ‘‘raw agricultural commod-
ities,’’ as defined in section 201(r) of the act, which are ordinarily cleaned, prepared,
treated, or otherwise processed before being marketed to the consuming public.
(b) FDA, however, will issue special regulations if it is necessary to cover these
excluded operations.
Subpart B—Buildings and Facilities
Sec. 110.20 Plant and grounds.
(a) Grounds. The grounds about a food plant under the control of the operator shall
be kept in a condition that will protect against the contamination of food. The methods
for adequate maintenance of grounds include, but are not limited to:
(1) Properly storing equipment, removing litter and waste, and cutting weeds or
grass within the immediate vicinity of the plant buildings or structures that may constitute
an attractant, breeding place, or harborage for pests.
(2) Maintaining roads, yards, and parking lots so that they do not constitute a source
of contamination in areas where food is exposed.
(3) Adequately draining areas that may contribute contamination to food by seepage,
foot-borne filth, or providing a breeding place for pests.
(4) Operating systems for waste treatment and disposal in an adequate manner so
that they do not constitute a source of contamination in areas where food is exposed.
If the plant grounds are bordered by grounds not under the operator’s control and
not maintained in the manner described in paragraph (a) (1) through (3) of this section,
care shall be exercised in the plant by inspection, extermination, or other means to exclude
pests, dirt, and filth that may be a source of food contamination. (b) Plant construction
and design. Plant buildings and structures shall be suitable in size, construction, and design
to facilitate maintenance and sanitary operations for food-manufacturing purposes. The
plant and facilities shall:
(1) Provide sufficient space for such placement of equipment and storage of materi-
als as is necessary for the maintenance of sanitary operations and the production of safe
food.
(2) Permit the taking of proper precautions to reduce the potential for contamination
of food, food-contact surfaces, or food-packaging materials with microorganisms, chemi-
cals, filth, or other extraneous material. The potential for contamination may be reduced
by adequate food safety controls and operating practices or effective design, including
the separation of operations in which contamination is likely to occur, by one or more of
the following means: location, time, partition, air flow, enclosed systems, or other effective
means.
(3) Permit the taking of proper precautions to protect food in outdoor bulk fermenta-
tion vessels by any effective means, including:
(i) Using protective coverings.
(ii) Controlling areas over and around the vessels to eliminate harborages for pests.
(iii) Checking on a regular basis for pests and pest infestation.
(iv) Skimming the fermentation vessels, as necessary.
(4) Be constructed in such a manner that floors, walls, and ceilings may be ade-
quately cleaned and kept clean and kept in good repair; that drip or condensate from fix-
tures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging
materials; and that aisles or working spaces are provided between equipment and walls
and are adequately unobstructed and of adequate width to permit employees to perform
their duties and to protect against contaminating food or food-contact surfaces with cloth-
ing or personal contact.
(5) Provide adequate lighting in hand-washing areas, dressing and locker rooms,
and toilet rooms and in all areas where food is examined, processed, or stored and where
equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, skylights,
or other glass suspended over exposed food in any step of preparation or otherwise protect
against food contamination in case of glass breakage.
(6) Provide adequate ventilation or control equipment to minimize odors and vapors
(including steam and noxious fumes) in areas where they may contaminate food; and
locate and operate fans and other air-blowing equipment in a manner that minimizes the
potential for contaminating food, food-packaging materials, and food-contact surfaces.
(7) Provide, where necessary, adequate screening or other protection against
pests.
Sec. 110.35 Sanitary operations.
(a) General maintenance. Buildings, fixtures, and other physical facilities of the plant
shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent
food from becoming adulterated within the meaning of the act. Cleaning and sanitizing
of utensils and equipment shall be conducted in a manner that protects against contamina-
tion of food, food-contact surfaces, or food-packaging materials.
(b) Substances used in cleaning and sanitizing; storage of toxic materials. (1) Clean-
ing compounds and sanitizing agents used in cleaning and sanitizing procedures shall be
free from undesirable microorganisms and shall be safe and adequate under the conditions
of use. Compliance with this requirement may be verified by any effective means including
purchase of these substances under a supplier’s guarantee or certification, or examination
of these substances for contamination. Only the following toxic materials may be used
or stored in a plant where food is processed or exposed:
(i) Those required to maintain clean and sanitary conditions;
(ii) Those necessary for use in laboratory testing procedures;
(iii) Those necessary for plant and equipment maintenance and operation; and
(iv) Those necessary for use in the plant’s operations.
(2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be
identified, held, and stored in a manner that protects against contamination of food, food-
contact surfaces, or food-packaging materials. All relevant regulations promulgated by
other Federal, State, and local government agencies for the application, use, or holding
of these products should be followed.
(c) Pest control. No pests shall be allowed in any area of a food plant. Guard or
guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely
to result in contamination of food, food-contact surfaces, or food-packaging materials.
Effective measures shall be taken to exclude pests from the processing areas and to protect
against the contamination of food on the premises by pests. The use of insecticides or
rodenticides is permitted only under precautions and restrictions that will protect against
the contamination of food, food-contact surfaces, and food-packaging materials.
(d) Sanitation of food-contact surfaces. All food-contact surfaces, including utensils
and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to
protect against contamination of food.
(1) Food-contact surfaces used for manufacturing or holding low-moisture food shall
be in a dry, sanitary condition at the time of use. When the surfaces are wet-cleaned, they
shall, when necessary, be sanitized and thoroughly dried before subsequent use.
(2) In wet processing, when cleaning is necessary to protect against the introduction
of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized be-
fore use and after any interruption during which the food-contact surfaces may have be-
come contaminated. Where equipment and utensils are used in a continuous production
operation, the utensils and food-contact surfaces of the equipment shall be cleaned and
sanitized as necessary.
(3) Non-food-contact surfaces of equipment used in the operation of food plants
should be cleaned as frequently as necessary to protect against contamination of food.
(4) Single-service articles (such as utensils intended for one-time use, paper cups,
and paper towels) should be stored in appropriate containers and shall be handled, dis-
pensed, used, and disposed of in a manner that protects against contamination of food or
food-contact surfaces.
(5) Sanitizing agents shall be adequate and safe under conditions of use. Any facility,
procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if
it is established that the facility, procedure, or machine will routinely render equipment
and utensils clean and provide adequate cleaning and sanitizing treatment.
(e) Storage and handling of cleaned portable equipment and utensils. Cleaned and
sanitized portable equipment with food-contact surfaces and utensils should be stored in
a location and manner that protects food-contact surfaces from contamination.
Sec. 110.37 Sanitary facilities and controls.
Each plant shall be equipped with adequate sanitary facilities and accommodations
including, but not limited to:
(a) Water supply. The water supply shall be sufficient for the operations intended
and shall be derived from an adequate source. Any water that contacts food or food-
contact surfaces shall be safe and of adequate sanitary quality. Running water at a suitable
temperature, and under pressure as needed, shall be provided in all areas where required
for the processing of food, for the cleaning of equipment, utensils, and food-packaging
materials, or for employee sanitary facilities.
(b) Plumbing. Plumbing shall be of adequate size and design and adequately installed
and maintained to:
(1) Carry sufficient quantities of water to required locations throughout the plant.
(2) Properly convey sewage and liquid disposable waste from the plant.
(3) Avoid constituting a source of contamination to food, water supplies, equipment,
or utensils or creating an unsanitary condition.
(4) Provide adequate floor drainage in all areas where floors are subject to flooding-
type cleaning or where normal operations release or discharge water or other liquid waste
on the floor.
(5) Provide that there is not backflow from, or cross-connection between, piping
systems that discharge waste water or sewage and piping systems that carry water for
food or food manufacturing.
(c) Sewage disposal. Sewage disposal shall be made into an adequate sewerage
system or disposed of through other adequate means.
(d) Toilet facilities. Each plant shall provide its employees with adequate, readily
accessible toilet facilities. Compliance with this requirement may be accomplished by:
(1) Maintaining the facilities in a sanitary condition.
(2) Keeping the facilities in good repair at all times.
(3) Providing self-closing doors.
(4) Providing doors that do not open into areas where food is exposed to airborne
contamination, except where alternate means have been taken to protect against such con-
tamination (such as double doors or positive air-flow systems).
(e) Hand-washing facilities. Hand-washing facilities shall be adequate and conve-
nient and be furnished with running water at a suitable temperature. Compliance with this
requirement may be accomplished by providing:
(1) Hand-washing and, where appropriate, hand-sanitizing facilities at each location
in the plant where good sanitary practices require employees to wash and/or sanitize their
hands.
(2) Effective hand-cleaning and sanitizing preparations.
(3) Sanitary towel service or suitable drying devices.
(4) Devices or fixtures, such as water control valves, so designed and constructed
to protect against recontamination of clean, sanitized hands.
(5) Readily understandable signs directing employees handling unprotected food,
unprotected food-packaging materials, of food-contact surfaces to wash and, where appro-
priate, sanitize their hands before they start work, after each absence from post of duty,
and when their hands may have become soiled or contaminated. These signs may be posted
in the processing room(s) and in all other areas where employees may handle such food,
materials, or surfaces.
(6) Refuse receptacles that are constructed and maintained in a manner that protects
against contamination of food.
(f) Rubbish and offal disposal. Rubbish and any offal shall be so conveyed, stored,
and disposed of as to minimize the development of odor, minimize the potential for the
waste becoming an attractant and harborage or breeding place for pests, and protect against
contamination of food, food-contact surfaces, water supplies, and ground surfaces.
Subpart C—Equipment
Sec. 110.40 Equipment and utensils.
(a) All plant equipment and utensils shall be so designed and of such material and
workmanship as to be adequately cleanable, and shall be properly maintained. The design,
construction, and use of equipment and utensils shall preclude the adulteration of food
with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All
equipment should be so installed and maintained as to facilitate the cleaning of the equip-
ment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when
in contact with food. They shall be made of nontoxic materials and designed to withstand
the environment of their intended use and the action of food, and, if applicable, cleaning
compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect
food from being contaminated by any source, including unlawful indirect food addi-
tives.
(b) Seams on food-contact surfaces shall be smoothly bonded or maintained so as
to minimize accumulation of food particles, dirt, and organic matter and thus minimize
the opportunity for growth of microorganisms.
(c) Equipment that is in the manufacturing or food-handling area and that does not
come into contact with food shall be so constructed that it can be kept in a clean condition.
(d) Holding, conveying, and manufacturing systems, including gravimetric, pneu-
matic, closed, and automated systems, shall be of a design and construction that enables
them to be maintained in an appropriate sanitary condition.
(e) Each freezer and cold storage compartment used to store and hold food capable
of supporting growth of microorganisms shall be fitted with an indicating thermometer,
temperature-measuring device, or temperature-recording device so installed as to show
the temperature accurately within the compartment, and should be fitted with an automatic
control for regulating temperature or with an automatic alarm system to indicate a signifi-
cant temperature change in a manual operation.
(f) Instruments and controls used for measuring, regulating, or recording tempera-
tures, pH, acidity, water activity, or other conditions that control or prevent the growth
of undesirable microorganisms in food shall be accurate and adequately maintained, and
adequate in number for their designated uses.
(g) Compressed air or other gases mechanically introduced into food or used to
clean food-contact surfaces or equipment shall be treated in such a way that food is not
contaminated with unlawful indirect food additives.
Subpart E—Production and Process Controls
Sec. 110.80 Processes and controls.
All operations in the receiving, inspecting, transporting, segregating, preparing,

manufacturing, packaging, and storing of food shall be conducted in accordance with
adequate sanitation principles. Appropriate quality control operations shall be employed
to ensure that food is suitable for human consumption and that food-packaging materials
are safe and suitable. Overall sanitation of the plant shall be under the supervision of one
or more competent individuals assigned responsibility for this function. All reasonable
precautions shall be taken to ensure that production procedures do not contribute contami-
nation from any source. Chemical, microbial, or extraneous material testing procedures
shall be used where necessary to identify sanitation failures or possible food contamina-
tion. All food that has become contaminated to the extent that it is adulterated within the
meaning of the act shall be rejected or, if permissible, treated or processed to eliminate
the contamination.
(a) Raw materials and other ingredients.
(1) Raw materials and other ingredients shall be inspected and segregated or other-
wise handled as necessary to ascertain that they are clean and suitable for processing
into food and shall be stored under conditions that will protect against contamination and
minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove
soil or other contamination. Water used for washing, rinsing, or conveying food shall be
safe and of adequate sanitary quality. Water may be reused for washing, rinsing, or con-
veying food if it does not increase the level of contamination of the food. Containers and
carriers of raw materials should be inspected on receipt to ensure that their condition has
not contributed to the contamination or deterioration of food.
(2) Raw materials and other ingredients shall either not contain levels of microorgan-
isms that may produce food poisoning or other disease in humans, or they shall be pasteur-
ized or otherwise treated during manufacturing operations so that they no longer contain
levels that would cause the product to be adulterated within the meaning of the act. Com-
pliance with this requirement may be verified by any effective means, including purchasing
raw materials and other ingredients under a supplier’s guarantee or certification.
(3) Raw materials and other ingredients susceptible to contamination with aflatoxin
or other natural toxins shall comply with current Food and Drug Administration regula-
tions, guidelines, and action levels for poisonous or deleterious substances before these
materials or ingredients are incorporated into finished food. Compliance with this require-
ment may be accomplished by purchasing raw materials and other ingredients under a
supplier’s guarantee or certification, or may be verified by analyzing these materials and
ingredients for aflatoxins and other natural toxins.
(4) Raw materials, other ingredients, and rework susceptible to contamination with
pests, undesirable microorganisms, or extraneous material shall comply with applicable
Food and Drug Administration regulations, guidelines, and defect action levels for natural
or unavoidable defects if a manufacturer wishes to use the materials in manufacturing
food. Compliance with this requirement may be verified by any effective means, including
purchasing the materials under a supplier’s guarantee or certification, or examination of
these materials for contamination.
(5) Raw materials, other ingredients, and rework shall be held in bulk, or in contain-
ers designed and constructed so as to protect against contamination and shall be held at
such temperature and relative humidity and in such a manner as to prevent the food from
becoming adulterated within the meaning of the act. Material scheduled for rework shall
be identified as such.
(6) Frozen raw materials and other ingredients shall be kept frozen. If thawing is
required prior to use, it shall be done in a manner that prevents the raw materials and
other ingredients from becoming adulterated within the meaning of the act.
(7) Liquid or dry raw materials and other ingredients received and stored in bulk
form shall be held in a manner that protects against contamination.
(b) Manufacturing operations.
(1) Equipment and utensils and finished food containers shall be maintained in an
acceptable condition through appropriate cleaning and sanitizing, as necessary. Insofar as
necessary, equipment shall be taken apart for thorough cleaning.
(2) All food manufacturing, including packaging and storage, shall be conducted
under such conditions and controls as are necessary to minimize the potential for the
growth of microorganisms, or for the contamination of food. One way to comply with
this requirement is careful monitoring of physical factors such as time, temperature, hu-
midity, a w , pH, pressure, flow rate, and manufacturing operations such as freezing, dehy-
dration, heat processing, acidification, and refrigeration to ensure that mechanical break-
downs, time delays, temperature fluctuations, and other factors do not contribute to the
decomposition or contamination of food.
(3) Food that can support the rapid growth of undesirable microorganisms, particu-
larly those of public health significance, shall be held in a manner that prevents the food
from becoming adulterated within the meaning of the act. Compliance with this require-
ment may be accomplished by any effective means, including:
(i) Maintaining refrigerated foods at 45°F (7.2°C) or below as appropriate for the
particular food involved.
(ii) Maintaining frozen foods in a frozen state.
(iii) Maintaining hot foods at 140°F (60°C) or above.
(iv) Heat treating acid or acidified foods to destroy mesophilic microorganisms when
those foods are to be held in hermetically sealed containers at ambient temperatures.
(4) Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating,
controlling pH, or controlling a w that are taken to destroy or prevent the growth of undesir-
able microorganisms, particularly those of public health significance, shall be adequate
under the conditions of manufacture, handling, and distribution to prevent food from being
adulterated within the meaning of the act.
(5) Work-in-process shall be handled in a manner that protects against contamina-
tion.
(6) Effective measures shall be taken to protect finished food from contamination
by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or
refuse are unprotected, they shall not be handled simultaneously in a receiving, loading,
or shipping area if that handling could result in contaminated food. Food transported by
conveyor shall be protected against contamination as necessary.
(7) Equipment, containers, and utensils used to convey, hold, or store raw materials,
work-in-process, rework, or food shall be constructed, handled, and maintained during
manufacturing or storage in a manner that protects against contamination.
(8) Effective measures shall be taken to protect against the inclusion of metal or
other extraneous material in food. Compliance with this requirement may be accomplished
by using sieves, traps, magnets, electronic metal detectors, or other suitable effective
means.
(9) Food, raw materials, and other ingredients that are adulterated within the mean-
ing of the act shall be disposed of in a manner that protects against the contamination of
other food. If the adulterated food is capable of being reconditioned, it shall be recondi-
tioned using a method that has been proven to be effective or it shall be reexamined and
found not to be adulterated within the meaning of the act before being incorporated into
other food.
(10) Mechanical manufacturing steps such as washing, peeling, trimming, cutting,
sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whip-
ping, defatting, and forming shall be performed so as to protect food against contamina-
tion. Compliance with this requirement may be accomplished by providing adequate physi-
cal protection of food from contaminants that may drip, drain, or be drawn into the food.
Protection may be provided by adequate cleaning and sanitizing of all food-contact sur-
faces, and by using time and temperature controls at and between each manufacturing
step.
(11) Heat blanching, when required in the preparation of food, should be effected
by heating the food to the required temperature, holding it at this temperature for the
required time, and then either rapidly cooling the food or passing it to subsequent manufac-
turing without delay. Thermophilic growth and contamination in blanchers should be mini-
mized by the use of adequate operating temperatures and by periodic cleaning. Where the
blanched food is washed prior to filling, water used shall be safe and of adequate sanitary
quality.
(12) Batters, breading, sauces, gravies, dressings, and other similar preparations shall
be treated or maintained in such a manner that they are protected against contamination.
Compliance with this requirement may be accomplished by any effective means, including
one or more of the following:
(i) Using ingredients free of contamination.
(ii) Employing adequate heat processes where applicable.
(iii) Using adequate time and temperature controls.
(iv) Providing adequate physical protection of components from contaminants that
may drip, drain, or be drawn into them.
(v) Cooling to an adequate temperature during manufacturing.
(vi) Disposing of batters at appropriate intervals to protect against the growth of
microorganisms.
(13) Filling, assembling, packaging, and other operations shall be performed in such
a way that the food is protected against contamination. Compliance with this requirement
may be accomplished by any effective means, including:
(i) Use of a quality control operation in which the critical control points are identified
and controlled during manufacturing.
(ii) Adequate cleaning and sanitizing of all food-contact surfaces and food con-
tainers.
(iii) Using materials for food containers and food-packaging materials that are safe
and suitable, as defined in Sec. 130.3(d) of this chapter.
(iv) Providing physical protection from contamination, particularly airborne contam-
ination.
(v) Using sanitary handling procedures.
(14) Food such as, but not limited to, dry mixes, nuts, intermediate moisture food,
and dehydrated food that relies on the control of a w for preventing the growth of undesir-
able microorganisms shall be processed to and maintained at a safe moisture level. Compli-
ance with this requirement may be accomplished by any effective means, including em-
ployment of one or more of the following practices:
(i) Monitoring the a w of food.
(ii) Controlling the soluble solids/water ratio in finished food.
(iii) Protecting finished food from moisture pickup, by use of a moisture barrier or
by other means, so that the a w of the food does not increase to an unsafe level.
(15) Food such as, but not limited to, acid and acidified food, that relies principally
on the control of pH for preventing the growth of undesirable microorganisms shall be
monitored and maintained at a pH of 4.6 or below. Compliance with this requirement
may be accomplished by any effective means, including employment of one or more of
the following practices:
(i) Monitoring the pH of raw materials, food in process, and finished food.
(ii) Controlling the amount of acid or acidified food added to low-acid food.
(16) When ice is used in contact with food, it shall be made from water that is safe
and of adequate sanitary quality, and shall be used only if it has been manufactured in
accordance with current good manufacturing practice as outlined in this part.
(17) Food-manufacturing areas and equipment used for manufacturing human food
should not be used to manufacture nonhuman food-grade animal feed or inedible products,
unless there is no reasonable possibility for the contamination of the human food.
Sec. 110.93 Warehousing and distribution.
Storage and transportation of finished food shall be under conditions that will protect
food against physical, chemical, and microbial contamination as well as against deteriora-
tion of the food and the container.
Subpart G—Defect Action Levels
Sec. 110.110 Natural or unavoidable defects in food for human use that present no health
hazards.
(a) Some foods, even when produced under current good manufacturing practice,
contain natural or unavoidable defects that at low levels are not hazardous to health. The
Food and Drug Administration establishes maximum levels for these defects in foods
produced under current good manufacturing practice and uses these levels in deciding
whether to recommend regulatory action.
(b) Defect action levels are established for foods whenever it is necessary and feasi-
ble to do so. These levels are subject to change upon the development of new technology
or the availability of new information.
(c) Compliance with defect action levels does not excuse violation of the require-
ment in section 402(a)(4) of the act that food not be prepared, packed, or held under
unsanitary conditions or the requirements in this part that food manufacturers, distributors,
and holders shall observe current good manufacturing practice. Evidence indicating that
such a violation exists causes the food to be adulterated within the meaning of the act,
even though the amounts of natural or unavoidable defects are lower than the currently
established defect action levels. The manufacturer, distributor, and holder of food shall
at all times utilize quality control operations that reduce natural or unavoidable defects
to the lowest level currently feasible.
(d) The mixing of a food containing defects above the current defect action level
with another lot of food is not permitted and renders the final food adulterated within the
meaning of the act, regardless of the defect level of the final food.
(e) A compilation of the current defect action levels for natural or unavoidable de-
fects in food for human use that present no health hazard may be obtained upon request
from the Center for Food Safety and Applied Nutrition (HFS-565), Food and Drug Admin-
istration, 200 C St. SW, Washington, DC 20204.

APPENDIX B
Hazard Analysis and Critical
Control Point Principles and
Application Guidelines
The following is excerpted from a document issued by the National Advisory Committee
on Microbiological Criteria for Foods in August 1997.
EXECUTIVE SUMMARY
The National Advisory Committee on Microbiological Criteria for Foods (Committee)
reconvened a Hazard Analysis and Critical Control Point (HACCP) Working Group in
1995. The primary goal was to review the Committee’s November 1992 HACCP docu-
ment, comparing it to current HACCP guidance prepared by the Codex Committee on
Food Hygiene. Based upon its review, the Committee made the HACCP principles more
concise; revised and added definitions; included sections on prerequisite programs, educa-
tion and training, and implementation and maintenance of the HACCP plan; revised and
provided a more detailed explanation of the application of HACCP principles; and pro-
vided an additional decision tree for identifying critical control points (CCPs).
The Committee again endorses HACCP as an effective and rational means of assur-
ing food safety from harvest to consumption. Preventing problems from occurring is the
paramount goal underlying any HACCP system. Seven basic principles are employed in
the development of HACCP plans that meet the stated goal. These principles include
hazard analysis, CCP identification, establishing critical limits, monitoring procedures,
corrective actions, verification procedures, and record-keeping and documentation. Under
such systems, if a deviation occurs indicating that control has been lost, the deviation is
detected and appropriate steps are taken to reestablish control in a timely manner to assure
that potentially hazardous products do not reach the consumer.
In the application of HACCP, the use of microbiological testing is seldom an effec-
tive means of monitoring CCPs because of the time required to obtain results. In most
instances, monitoring of CCPs can best be accomplished through the use of physical and

chemical tests, and through visual observations. Microbiological criteria do, however, play
a role in verifying that the overall HACCP system is working.
The Committee believes that the HACCP principles should be standardized to pro-
vide uniformity in training and applying the HACCP system by industry and government.
In accordance with the National Academy of Sciences recommendation, the HACCP sys-
tem must be developed by each food establishment and tailored to its individual product,
processing and distribution conditions.
In keeping with the Committee’s charge to provide recommendations to its sponsor-
ing agencies regarding microbiological food safety issues, this document focuses on this
area. The Committee recognizes that in order to assure food safety, properly designed
HACCP systems must also consider chemical and physical hazards in addition to other
biological hazards.
For a successful HACCP program to be properly implemented, management must
be committed to a HACCP approach. A commitment by management will indicate an
awareness of the benefits and costs of HACCP and include education and training of
employees. Benefits, in addition to enhanced assurance of food safety, are better use of
resources and timely response to problems.
The Committee designed this document to guide the food industry and advise its
sponsoring agencies in the implementation of HACCP systems.
DEFINITIONS
CCP decision tree: A sequence of questions to assist in determining whether a control
point is a CCP.
Control: (a) To manage the conditions of an operation to maintain compliance with
established criteria. (b) The state where correct procedures are being followed and criteria
are being met.
Control measure: Any action or activity that can be used to prevent, eliminate or
reduce a significant hazard.
Control point: Any step at which biological, chemical, or physical factors can be
controlled.
Corrective action: Procedures followed when a deviation occurs.
Criterion: A requirement on which a judgement or decision can be based.
Critical control point: A step at which control can be applied and is essential to
prevent or eliminate a food safety hazard or reduce it to an acceptable level.
Critical limit: A maximum and/or minimum value to which a biological, chemical
or physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an
acceptable level the occurrence of a food safety hazard.
Deviation: Failure to meet a critical limit.
HACCP: A systematic approach to the identification, evaluation, and control of food
safety hazards.
HACCP plan: The written document which is based upon the principles of HACCP
and which delineates the procedures to be followed.
HACCP system: The result of the implementation of the HACCP Plan.
HACCP team: The group of people who are responsible for developing, implement-
ing and maintaining the HACCP system.
Hazard: A biological, chemical, or physical agent that is reasonably likely to cause
illness or injury in the absence of its control.
Hazard analysis: The process of collecting and evaluating information on hazards
associated with the food under consideration to decide which are significant and must be
addressed in the HACCP plan.
Monitor: To conduct a planned sequence of observations or measurements to assess
whether a CCP is under control and to produce an accurate record for future use in verifi-
cation.
Prerequisite programs: Procedures, including Good Manufacturing Practices, that
address operational conditions providing the foundation for the HACCP system.
Severity: The seriousness of the effect(s) of a hazard.
Step: A point, procedure, operation or stage in the food system from primary produc-
tion to final consumption.
Validation: That element of verification focused on collecting and evaluating scien-
tific and technical information to determine if the HACCP plan, when properly imple-
mented, will effectively control the hazards.
Verification: Those activities, other than monitoring, that determine the validity of
the HACCP plan and that the system is operating according to the plan.
HACCP PRINCIPLES
HACCP is a systematic approach to the identification, evaluation, and control of food
safety hazards based on the following seven principles:
Principle 1: Conduct a hazard analysis.

Principle 2: Determine the critical control points (CCPs).
Principle 3: Establish critical limits.
Principle 4: Establish monitoring procedures.
Principle 5: Establish corrective actions.
Principle 6: Establish verification procedures.
Principle 7: Establish record-keeping and documentation procedures.
GUIDELINES FOR APPLICATION OF HACCP PRINCIPLES

Introduction
HACCP is a management system in which food safety is addressed through the analysis
and control of biological, chemical, and physical hazards from raw material production,
procurement and handling, to manufacturing, distribution and consumption of the finished
product. For successful implementation of a HACCP plan, management must be strongly
committed to the HACCP concept. A firm commitment to HACCP by top management
provides company employees with a sense of the importance of producing safe food.
HACCP is designed for use in all segments of the food industry from growing,
harvesting, processing, manufacturing, distributing, and merchandising to preparing food
for consumption. Prerequisite programs such as current Good Manufacturing Practices
(cGMPs) are an essential foundation for the development and implementation of success-
ful HACCP plans. Food safety systems based on the HACCP principles have been success-
fully applied in food processing plants, retail food stores, and food service operations.
The seven principles of HACCP have been universally accepted by government agencies,
trade associations and the food industry around the world.
The following guidelines will facilitate the development and implementation of ef-
fective HACCP plans. While the specific application of HACCP to manufacturing facilities
is emphasized here, these guidelines should be applied as appropriate to each segment of
the food industry under consideration.
Prerequisite Programs
The production of safe food products requires that the HACCP system be built upon a
solid foundation of prerequisite programs. Examples of common prerequisite programs
are listed in Appendix A. Each segment of the food industry must provide the conditions
necessary to protect food while it is under their control. This has traditionally been accom-
plished through the application of cGMPs. These conditions and practices are now consid-
ered to be prerequisite to the development and implementation of effective HACCP plans.
Prerequisite programs provide the basic environmental and operating conditions that are
necessary for the production of safe, wholesome food. Many of the conditions and prac-
tices are specified in federal, state and local regulations and guidelines (e.g., cGMPs and
Food Code). The Codex Alimentarius General Principles of Food Hygiene describe the
basic conditions and practices expected for foods intended for international trade. In addi-
tion to the requirements specified in regulations, industry often adopts policies and proce-
dures that are specific to their operations. Many of these are proprietary. While prerequisite
programs may impact upon the safety of a food, they also are concerned with ensuring
that foods are wholesome and suitable for consumption (Appendix B.1). HACCP plans
are narrower in scope, being limited to ensuring food is safe to consume.
The existence and effectiveness of prerequisite programs should be assessed during
the design and implementation of each HACCP plan. All prerequisite programs should
be documented and regularly audited. Prerequisite programs are established and managed
separately from the HACCP plan. Certain aspects, however, of a prerequisite program may
be incorporated into a HACCP plan. For example, many establishments have preventive
maintenance procedures for processing equipment to avoid unexpected equipment failure
and loss of production. During the development of a HACCP plan, the HACCP team may
decide that the routine maintenance and calibration of an oven should be included in the
plan as an activity of verification. This would further ensure that all the food in the oven
is cooked to the minimum internal temperature that is necessary for food safety.
Education and Training

The success of a HACCP system depends on educating and training management and
employees in the importance of their role in producing safe foods. This should also include
information on the control of foodborne hazards related to all stages of the food chain.
It is important to recognize that employees must first understand what HACCP is and
then learn the skills necessary to make it function properly. Specific training activities
should include working instructions and procedures that outline the tasks of employees
monitoring each CCP.
Management must provide adequate time for thorough education and training. Per-
sonnel must be given the materials and equipment necessary to perform these tasks. Effec-
tive training is an important prerequisite to successful implementation of a HACCP plan.
Developing a HACCP Plan

The format of HACCP plans will vary. In many cases the plans will be product and process
specific. However, some plans may use a unit operations approach. Generic HACCP plans
can serve as useful guides in the development of process and product HACCP plans;
however, it is essential that the unique conditions within each facility be considered during
the development of all components of the HACCP plan.
In the development of a HACCP plan, five preliminary tasks need to be accom-
plished before the application of the HACCP principles to a specific product and process.
1. Assemble the HACCP team.
2. Describe the food and its distribution.
3. Describe the intended use and consumers of the food.
4. Develop a flow diagram that describes the process.
5. Verify the flow diagram.
Assemble the HACCP Team
The first task in developing a HACCP plan is to assemble a HACCP team consisting of
individuals who have specific knowledge and expertise appropriate to the product and
process. It is the team’s responsibility to develop the HACCP plan. The team should
be multidisciplinary and include individuals from areas such as engineering, production,
sanitation, quality assurance, and food microbiology. The team should also include local
personnel who are involved in the operation as they are more familiar with the variability
and limitations of the operation. In addition, this fosters a sense of ownership among those
who must implement the plan. The HACCP team may need assistance from outside experts
who are knowledgeable in the potential biological, chemical and/or physical hazards asso-
ciated with the product and the process. However, a plan which is developed totally by
outside sources may be erroneous, incomplete, and lacking in support at the local level.
Due to the technical nature of the information required for hazard analysis, it is
recommended that experts who are knowledgeable in the food process should either partic-
ipate in or verify the completeness of the hazard analysis and the HACCP plan. Such
individuals should have the knowledge and experience to correctly: (a) conduct a hazard
analysis; (b) identify potential hazards; (c) identify hazards which must be controlled; (d)
recommend controls, critical limits, and procedures for monitoring and verification; (e)
recommend appropriate corrective actions when a deviation occurs; (f ) recommend re-
search related to the HACCP plan if important information is not known; and (g) validate
the HACCP plan.
Describe the Food and Its Distribution
The HACCP team first describes the food. This consists of a general description of the
food, ingredients, and processing methods. The method of distribution should be described
along with information on whether the food is to be distributed frozen, refrigerated, or at
ambient temperature.
Describe the Intended Use and Consumers of the Food
Describe the normal expected use of the food. The intended consumers may be the general
public or a particular segment of the population (e.g., infants, immunocompromised indi-
viduals, the elderly, etc.).
Develop a Flow Diagram which Describes the Process
The purpose of a flow diagram is to provide a clear, simple outline of the steps involved
in the process. The scope of the flow diagram must cover all the steps in the process
which are directly under the control of the establishment. In addition, the flow diagram
can include steps in the food chain which are before and after the processing that occurs
in the establishment. The flow diagram need not be as complex as engineering drawings.
A block type flow diagram is sufficiently descriptive (see Appendix B.2). Also, a simple
schematic of the facility is often useful in understanding and evaluating product and pro-
cess flow.
Verify the Flow Diagram

The HACCP team should perform an on-site review of the operation to verify the accuracy
and completeness of the flow diagram. Modifications should be made to the flow diagram
as necessary and documented.
After these five preliminary tasks have been completed, the seven principles of
HACCP are applied.
Conduct a Hazard Analysis (Principle 1)

After addressing the preliminary tasks discussed above, the HACCP team conducts a haz-
ard analysis and identifies appropriate control measures. The purpose of the hazard analy-
sis is to develop a list of hazards which are of such significance that they are reasonably
likely to cause injury or illness if not effectively controlled. Hazards that are not reasonably
likely to occur would not require further consideration within a HACCP plan. It is impor-
tant to consider in the hazard analysis the ingredients and raw materials, each step in the
process, product storage and distribution, and final preparation and use by the consumer.
When conducting a hazard analysis, safety concerns must be differentiated from quality
concerns. A hazard is defined as a biological, chemical or physical agent that is reasonably
likely to cause illness or injury in the absence of its control. Thus, the word hazard as
used in this document is limited to safety.
A thorough hazard analysis is the key to preparing an effective HACCP plan. If the
hazard analysis is not done correctly and the hazards warranting control within the HACCP
system are not identified, the plan will not be effective regardless of how well it is fol-
lowed.
The hazard analysis and identification of associated control measures accomplish
three objectives: Those hazards and associated control measures are identified. The analy-
sis may identify needed modifications to a process or product so that product safety is
further assured or improved. The analysis provides a basis for determining CCPs in Princi-
ple 2.
The process of conducting a hazard analysis involves two stages. The first, hazard
identification, can be regarded as a brain storming session. During this stage, the HACCP
team reviews the ingredients used in the product, the activities conducted at each step in
the process and the equipment used, the final product and its method of storage and distri-
bution, and the intended use and consumers of the product. Based on this review, the
team develops a list of potential biological, chemical or physical hazards which may be
introduced, increased, or controlled at each step in the production process. Appendix B.3
lists examples of questions that may be helpful to consider when identifying potential
hazards. Hazard identification focuses on developing a list of potential hazards associated
with each process step under direct control of the food operation. A knowledge of any
adverse health-related events historically associated with the product will be of value in
this exercise.
After the list of potential hazards is assembled, stage two, the hazard evaluation, is
conducted. In stage two of the hazard analysis, the HACCP team decides which potential
hazards must be addressed in the HACCP plan. During this stage, each potential hazard
is evaluated based on the severity of the potential hazard and its likely occurrence. Severity
is the seriousness of the consequences of exposure to the hazard. Considerations of severity
(e.g., impact of sequelae, and magnitude and duration of illness or injury) can be helpful
in understanding the public health impact of the hazard. Consideration of the likely occur-
rence is usually based upon a combination of experience, epidemiological data, and infor-
mation in the technical literature. When conducting the hazard evaluation, it is helpful to
consider the likelihood of exposure and severity of the potential consequences if the hazard
is not properly controlled. In addition, consideration should be given to the effects of short
term as well as long term exposure to the potential hazard. Such considerations do not
include common dietary choices which lie outside of HACCP. During the evaluation of
each potential hazard, the food, its method of preparation, transportation, storage and
persons likely to consume the product should be considered to determine how each of
these factors may influence the likely occurrence and severity of the hazard being con-
trolled. The team must consider the influence of likely procedures for food preparation
and storage and whether the intended consumers are susceptible to a potential hazard.
However, there may be differences of opinion, even among experts, as to the likely occur-
rence and severity of a hazard. The HACCP team may have to rely upon the opinion of
experts who assist in the development of the HACCP plan.
Hazards identified in one operation or facility may not be significant in another
operation producing the same or a similar product. For example, due to differences in
equipment and/or an effective maintenance program, the probability of metal contamina-
tion may be significant in one facility but not in another. A summary of the HACCP team
deliberations and the rationale developed during the hazard analysis should be kept for
future reference. This information will be useful during future reviews and updates of the
hazard analysis and the HACCP plan.
Appendix B.4 gives three examples of using a logic sequence in conducting a hazard
analysis. While these examples relate to biological hazards, chemical and physical hazards
are equally important to consider. Appendix B.4 is for illustration purposes to further
explain the stages of hazard analysis for identifying hazards. Hazard identification and
evaluation as outlined in Appendix B.4 may eventually be assisted by biological risk
assessments as they become available. While the process and output of a risk assessment
(NACMCF, 1997) [1] is significantly different from a hazard analysis, the identification
of hazards of concern and the hazard evaluation may be facilitated by information from
risk assessments. Thus, as risk assessments addressing specific hazards or control factors
become available, the HACCP team should take these into consideration.
Upon completion of the hazard analysis, the hazards associated with each step in
the production of the food should be listed along with any measure(s) that are used to
control the hazard(s). The term control measure is used because not all hazards can be
prevented, but virtually all can be controlled. More than one control measure may be
required for a specific hazard. On the other hand, more than one hazard may be addressed
by a specific control measure (e.g., pasteurization of milk).
For example, if a HACCP team were to conduct a hazard analysis for the production
of frozen cooked beef patties (Appendices B.2 and B.4), enteric pathogens (e.g., Salmo-
nella and verotoxin-producing Escherichia coli) in the raw meat would be identified as
hazards. Cooking is a control measure which can be used to eliminate these hazards. The
following is an excerpt from a hazard analysis summary table for this product.
Hazard to be
addressed
in plan? Control
Step Potential hazard(s) Justification Y/N measure(s)
5. Cooking Enteric pathogens: e.g., Enteric pathogens have Y Cooking
Salmonella verotox- been associated with
igenic-E. coli outbreaks of food-
borne illness from un-
dercooked ground beef
The hazard analysis summary could be presented in several different ways. One
format is a table such as the one given above. Another could be a narrative summary of
the HACCP team’s hazard analysis considerations and a summary table listing only the
hazards and associated control measures.
Determine Critical Control Points (CCPs) (Principle 2)

A critical control point is defined as a step at which control can be applied and is essential
to prevent or eliminate a food safety hazard or reduce it to an acceptable level. The poten-
tial hazards that are reasonably likely to cause illness or injury in the absence of their
control must be addressed in determining CCPs.
Complete and accurate identification of CCPs is fundamental to controlling food
safety hazards. The information developed during the hazard analysis is essential for the
HACCP team in identifying which steps in the process are CCPs. One strategy to facilitate
the identification of each CCP is the use of a CCP decision tree (examples of decision
trees are given in Appendices B.5 and B.6). Although application of the CCP decision
tree can be useful in determining if a particular step is a CCP for a previously identified
hazard, it is merely a tool and not a mandatory element of HACCP. A CCP decision tree
is not a substitute for expert knowledge.
Critical control points are located at any step where hazards can be either prevented,
eliminated, or reduced to acceptable levels. Examples of CCPs may include: thermal pro-
cessing, chilling, testing ingredients for chemical residues, product formulation control,
and testing product for metal contaminants. CCPs must be carefully developed and docu-
mented. In addition, they must be used only for purposes of product safety. For example,
a specified heat process, at a given time and temperature designed to destroy a specific
microbiological pathogen, could be a CCP. Likewise, refrigeration of a precooked food
to prevent hazardous microorganisms from multiplying, or the adjustment of a food to a
pH necessary to prevent toxin formation could also be CCPs. Different facilities preparing
similar food items can differ in the hazards identified and the steps which are CCPs. This
can be due to differences in each facility’s layout, equipment, selection of ingredients,
processes employed, etc.
Establish Critical Limits (Principle 3)

A critical limit is a maximum and/or minimum value to which a biological, chemical or
physical parameter must be controlled at a CCP to prevent, eliminate or reduce to an
acceptable level the occurrence of a food safety hazard. A critical limit is used to distin-
guish between safe and unsafe operating conditions at a CCP. Critical limits should not
be confused with operational limits which are established for reasons other than food
safety.
Each CCP will have one or more control measures to assure that the identified haz-
ards are prevented, eliminated or reduced to acceptable levels. Each control measure has
one or more associated critical limits. Critical limits may be based upon factors such as:
temperature, time, physical dimensions, humidity, moisture level, water activity (a w ), pH,
titratable acidity, salt concentration, available chlorine, viscosity, preservatives, or sensory
information such as aroma and visual appearance. Critical limits must be scientifically
based. For each CCP, there is at least one criterion for food safety that is to be met. An
example of a criterion is a specific lethality of a cooking process such as a 5D reduction
in Salmonella. The critical limits and criteria for food safety may be derived from sources
such as regulatory standards and guidelines, literature surveys, experimental results, and
experts.
An example is the cooking of beef patties (Appendix B.2). The process should be
designed to ensure the production of a safe product. The hazard analysis for cooked meat
patties identified enteric pathogens (e.g., verotoxigenic F. coli such as E. coli O157:H7,
and salmonellae) as significant biological hazards. Furthermore, cooking is the step in the
process at which control can be applied to reduce the enteric pathogens to an acceptable
level. To ensure that an acceptable level is consistently achieved, accurate information is
needed on the probable number of the pathogens in the raw patties, their heat resistance,
the factors that influence the heating of the patties, and the area of the patty which heats
the slowest. Collectively, this information forms the scientific basis for the critical limits
that are established. Some of the factors that may affect the thermal destruction of enteric
pathogens are listed in the following table. In this example, the HACCP team concluded
that a thermal process equivalent to 155°F for 16 seconds would be necessary to assure
the safety of this product. To ensure that this time and temperature are attained, the
HACCP team for one facility determined that it would be necessary to establish critical
limits for the oven temperature and humidity, belt speed (time in oven), patty thickness
and composition (e.g., all beef, beef and other ingredients). Control of these factors enables
the facility to produce a wide variety of cooked patties, all of which will be processed to
a minimum internal temperature of 155°F for 16 seconds. In another facility, the HACCP
team may conclude that the best approach is to use the internal patty temperature of 155°F
and hold for 16 seconds as critical limits. In this second facility the internal temperature
and hold time of the patties are monitored at a frequency to ensure that the critical limits
are constantly met as they exit the oven. The example given below applies to the first
facility.
Process step Yes Critical limits

5. Cooking Yes Oven temperature: °F
Time; rate of heating and cooling (belt speed in ft/min): ft/min
Patty thickness: in.
Patty composition: e.g., all beef
Oven humidity: % RH
Establish Monitoring Procedures (Principle 4)

Monitoring is a planned sequence of observations or measurements to assess whether a
CCP is under control and to produce an accurate record for future use in verification.
Monitoring serves three main purposes. First, monitoring is essential to food safety man-
agement in that it facilitates tracking of the operation. If monitoring indicates that there
is a trend towards loss of control, then action can be taken to bring the process back into
control before a deviation from a critical limit occurs. Second, monitoring is used to deter-
mine when there is loss of control and a deviation occurs at a CCP, i.e., exceeding or not
meeting a critical limit. When a deviation occurs, an appropriate corrective action must
be taken. Third, it provides written documentation for use in verification.
An unsafe food may result if a process is not properly controlled and a deviation
occurs. Because of the potentially serious consequences of a critical limit deviation, moni-
toring procedures must be effective. Ideally, monitoring should be continuous, which is
possible with many types of physical and chemical methods. For example, the temperature
and time for the scheduled thermal process of low-acid canned foods is recorded continu-
ously on temperature recording charts. If the temperature falls below the scheduled temper-
ature or the time is insufficient, as recorded on the chart, the product from the retort is
retained and the disposition determined as in Principle 5. Likewise, pH measurement may
be performed continually in fluids or by testing each batch before processing. There are
many ways to monitor critical limits on a continuous or batch basis and record the data
on charts. Continuous monitoring is always preferred when feasible. Monitoring equip-
ment must be carefully calibrated for accuracy.
Assignment of the responsibility for monitoring is an important consideration for
each CCP. Specific assignments will depend on the number of CCPs and control measures
and the complexity of monitoring. Personnel who monitor CCPs are often associated with
production (e.g., line supervisors, selected line workers and maintenance personnel) and,
as required, quality control personnel. Those individuals must be trained in the monitoring
technique for which they are responsible, fully understand the purpose and importance of
monitoring, be unbiased in monitoring and reporting, and accurately report the results of
monitoring. In addition, employees should be trained in procedures to follow when there
is a trend towards loss of control so that adjustments can be made in a timely manner to
assure that the process remains under control. The person responsible for monitoring must
also immediately report a process or product that does not meet critical limits.
All records and documents associated with CCP monitoring should be dated and
signed or initialed by the person doing the monitoring.
When it is not possible to monitor a CCP on a continuous basis, it is necessary to
establish a monitoring frequency and procedure that will be reliable enough to indicate
that the CCP is under control. Statistically designed data collection or sampling systems
lend themselves to this purpose.
Most monitoring procedures need to be rapid because they relate to on-line, “real-
time” processes and there will not be time for lengthy analytical testing. Examples of
monitoring activities include: visual observations and measurement of temperature, time,
pH, and moisture level.
Microbiological tests are seldom effective for monitoring due to their time-consum-
ing nature and problems with assuring detection of contaminants. Physical and chemical
measurements are often preferred because they are rapid and usually more effective for
assuring control of microbiological hazards. For example, the safety of pasteurized milk
is based upon measurements of time and temperature of heating rather than testing the
heated milk to assure the absence of surviving pathogens.
With certain foods, processes, ingredients, or imports, there may be no alternative
to microbiological testing. However, it is important to recognize that a sampling protocol
that is adequate to reliably detect low levels of pathogens is seldom possible because of
the large number of samples needed. This sampling limitation could result in a false sense
of security by those who use an inadequate sampling protocol. In addition, there are techni-
cal limitations in many laboratory procedures for detecting and quantitating pathogens
and/or their toxins.
Establish Corrective Actions (Principle 5)

The HACCP system for food safety management is designed to identify health hazards
and to establish strategies to prevent, eliminate, or reduce their occurrence. However, ideal
circumstances do not always prevail and deviations from established processes may occur.
An important purpose of corrective actions is to prevent foods which may be hazardous
from reaching consumers. Where there is a deviation from established critical limits, cor-
rective actions are necessary. Therefore, corrective actions should include the following
elements: (a) determine and correct the cause of non-compliance; (b) determine the dispo-
sition of non-compliant product and (c) record the corrective actions that have been taken.
Specific corrective actions should be developed in advance for each CCP and included
in the HACCP plan. As a minimum, the HACCP plan should specify what is done when
a deviation occurs, who is responsible for implementing the corrective actions, and that
a record will be developed and maintained of the actions taken. Individuals who have a
thorough understanding of the process, product and HACCP plan should be assigned the
responsibility for oversight of corrective actions. As appropriate, experts may be consulted
to review the information available and to assist in determining disposition of non-compli-
ant product.
Establish Verification Procedures (Principle 6)

Verification is defined as those activities, other than monitoring, that determine the validity
of the HACCP plan and that the system is operating according to the plan. The NAS
(1985) [2] pointed out that the major infusion of science in a HACCP system centers on
proper identification of the hazards, critical control points, critical limits, and instituting
proper verification procedures. These processes should take place during the development
and implementation of the HACCP plans and maintenance of the HACCP system. An
example of a verification schedule is given in the table.
Activity Frequency Responsibility Reviewer

Verification activitiesYearly or upon HACCP HACCP coordinator Plant manager
scheduling system change
Initial validation of Prior to and during ini- Independent ex- HACCP team
HACCP plan tial implementation of pert(s) a
plan
Subsequent validation When critical limits Independent ex- HACCP team
of HACCP plan changed, significant pert(s) a
changes in process,
equipment changed,
after system failure,
etc.

Activity Frequency Responsibility Reviewer
Verification of CCP According to HACCP According to HACCP According to HACCP
monitoring as de- plan (e.g., once per plan (e.g., line su- plan (e.g., quality
scribed in the plan shift) pervisor) control)
(e.g., monitoring of
patty cooking tem-
perature)
Review of monitor- Monthly Quality assurance HACCP team
ing, corrective ac-
tion records to
show compliance
with the plan
Comprehensive Yearly Independent ex- Plant manager
HACCP system pert(s) a
verification
a
Done by others than the team writing and implementing the plan. May require additional technical expertise
as well as laboratory and plant test studies.
One aspect of verification is evaluating whether the facility’s HACCP system is

functioning according to the HACCP plan. An effective HACCP system requires little
end-product testing, since sufficient validated safeguards are built in early in the process.
Therefore, rather than relying on end-product testing, firms should rely on frequent reviews
of their HACCP plan, verification that the HACCP plan is being correctly followed, and
review of CCP monitoring and corrective action records.
Another important aspect of verification is the initial validation of the HACCP plan
to determine that the plan is scientifically and technically sound, that all hazards have
been identified and that if the HACCP plan is properly implemented these hazards will
be effectively controlled. Information needed to validate the HACCP plan often include
(a) expert advice and scientific studies and (b) in-plant observations, measurements, and
evaluations. For example, validation of the cooking process for beef patties should include
the scientific justification of the heating times and temperatures needed to obtain an appro-
priate destruction of pathogenic microorganisms (i.e., enteric pathogens) and studies to
confirm that the conditions of cooking will deliver the required time and temperature to
each beef patty.
Subsequent validations are performed and documented by a HACCP team or an
independent expert as needed. For example, validations are conducted when there is an
unexplained system failure; a significant product, process or packaging change occurs; or
new hazards are recognized.
In addition, a periodic comprehensive verification of the HACCP system should be
conducted by an unbiased, independent authority. Such authorities can be internal or exter-
nal to the food operation. This should include a technical evaluation of the hazard analysis
and each element of the HACCP plan as well as on-site review of all flow diagrams and
appropriate records from operation of the plan. A comprehensive verification is indepen-
dent of other verification procedures and must be performed to ensure that the HACCP
plan is resulting in the control of the hazards. If the results of the comprehensive verifica-
tion identifies deficiencies, the HACCP team modifies the HACCP plan as necessary.
Verification activities are carried out by individuals within a company, third party
experts, and regulatory agencies. It is important that individuals doing verification have
appropriate technical expertise to perform this function. The role of regulatory and industry
in HACCP was further described by the NACMCF (1994) [3].
Examples of verification activities are included as Appendix B.7.
Establish Record-Keeping and Documentation Procedures (Principle 7)
Generally, the records maintained for the HACCP System should include the following:
1. A summary of the hazard analysis, including the rationale for determining haz-
ards and control measures.
2. The HACCP Plan
Listing of the HACCP team and assigned responsibilities.
Description of the food, its distribution, intended use, and consumer.
Verified flow diagram.
HACCP Plan Summary Table that includes information for:
Steps in the process that are CCPs
The hazard(s) of concern.
Critical limits
Monitoring*
Corrective actions*
Verification procedures and schedule*
Record-keeping procedures*
The following is an example of a HACCP plan summary table:
Critical Corrective
CCP Hazards limit(s) Monitoring Actions Verification Records
3. Support documentation such as validation records.

4. Records that are generated during the operation of the plan.
Examples of HACCP records are given in Appendix B.8.
IMPLEMENTATION AND MAINTENANCE OF THE HACCP PLAN

The successful implementation of a HACCP plan is facilitated by commitment from top
management. The next step is to establish a plan that describes the individuals responsible
for developing, implementing and maintaining the HACCP system. Initially, the HACCP
coordinator and team are selected and trained as necessary. The team is then responsible
for developing the initial plan and coordinating its implementation. Product teams can be
appointed to develop HACCP plans for specific products. An important aspect in devel-
oping these teams is to assure that they have appropriate training. The workers who will
be responsible for monitoring need to be adequately trained. Upon completion of the
HACCP plan, operator procedures, forms and procedures for monitoring and corrective
action are developed. Often it is a good idea to develop a timeline for the activities involved
in the initial implementation of the HACCP plan. Implementation of the HACCP system
* A brief summary of position responsible for performing the activity and the procedures and frequency should
be provided.

involves the continual application of the monitoring, record-keeping, corrective action
procedures and other activities as described in the HACCP plan.
Maintaining an effective HACCP system depends largely on regularly scheduled
verification activities. The HACCP plan should be updated and revised as needed. An
important aspect of maintaining the HACCP system is to assure that all individuals in-
volved are properly trained so they understand their role and can effectively fulfill their
responsibilities.
REFERENCES
1. National Advisory Committee on Microbiological Criteria for Foods. 1997. The principles of
risk assessment for illness caused by foodborne biological agents. Adopted April 4, 1997.
2. An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients. 1985.
National Academy of Sciences, National Academy Press, Washington, DC.
3. National Advisory Committee on Microbiological Criteria for Foods. 1994. The role of regula-
tory agencies and industry in HACCP. Int. J. Food Microbiol. 21:187–195.
APPENDIX B.1
Examples of Common Prerequisite Programs
The production of safe food products requires that the HACCP system be built upon a solid founda-
tion of prerequisite programs. Each segment of the food industry must provide the conditions neces-
sary to protect food while it is under their control. This has traditionally been accomplished through
the application of cGMPs. These conditions and practices are now considered to be prerequisite to
the development and implementation of effective HACCP plans. Prerequisite programs provide the
basic environmental and operating conditions that are necessary for the production of safe, whole-
some food. Common prerequisite programs may include, but are not limited to:
Facilities. The establishment should be located, constructed and maintained according to
sanitary design principles. There should be linear product flow and traffic control to mini-
mize cross-contamination from raw to cooked materials.
Supplier control. Each facility should assure that its suppliers have in place effective GMP
and food safety programs. These may be the subject of continuing supplier guarantee and
supplier HACCP system verification.
Specifications. There should be written specifications for all ingredients, products, and pack-
aging materials.
Production equipment. All equipment should be constructed and installed according to sani-
tary design principles. Preventive maintenance and calibration schedules should be estab-
lished and documented.
Cleaning and sanitation. All procedures for cleaning and sanitation of the equipment and
the facility should be written and followed. A master sanitation schedule should be in place.
Personal hygiene. All employees and other persons who enter the manufacturing plant
should follow the requirements for personal hygiene.
Training. All employees should receive documented training in personal hygiene, GMP,
cleaning and sanitation procedures, personal safety, and their role in the HACCP program.
Chemical control. Documented procedures must be in place to assure the segregation and
proper use of non-food chemicals in the plant. These include cleaning chemicals, fumi-
gants, and pesticides or baits used in or around the plant.
Receiving, storage, and shipping. All raw materials and products should be stored under
sanitary conditions and the proper environmental conditions such as temperature and hu-
midity to assure their safety and wholesomeness.

Traceability and recall. All raw materials and products should be lot-coded and a recall
system in place so that rapid and complete traces and recalls can be done when a product
retrieval is necessary.
Pest control. Effective pest control programs should be in place.
Other examples of prerequisite programs might include quality assurance procedures; standard op-
erating procedures for sanitation, processes, product formulations and recipes; glass control; proce-
dures for receiving, storage and shipping; labeling; and employee food and ingredient handling
practices.
APPENDIX B.2
Example of a flow diagram for the production of frozen cooked beef patties:
1. Receiving (Beef )
2. Grinding
3. Mixing
4. Forming
5. Cooking
6. Freezing
7. Boxing
8. Distributing
9. Reheating
10. Serving
APPENDIX B.3
Examples of Questions to be Considered When Conducting a Hazard
Analysis
The hazard analysis consists of asking a series of questions which are appropriate to the process
under consideration. The purpose of the questions is to assist in identifying potential hazards.
A. Ingredients
1. Does the food contain any sensitive ingredients that may present microbiological
hazards (e.g., Salmonella, Staphylococcus aureus); chemical hazards (e.g., aflatoxin,
antibiotic or pesticide residues); or physical hazards (stones, glass, metal)?
2. Are potable water, ice and steam used in formulating or in handling the food?
3. What are the sources (e.g., geographical region, specific supplier)?
B. Intrinsic Factors—Physical characteristics and composition (e.g., pH, type of acidulants,
fermentable carbohydrate, water activity, preservatives) of the food during and after pro-
cessing.
1. What hazards may result if the food composition is not controlled?
2. Does the food permit survival or multiplication of pathogens and/or toxin formation
in the food during processing?
3. Will the food permit survival or multiplication of pathogens and/or toxin formation
during subsequent steps in the food chain?
4. Are there other similar products in the market place? What has been the safety
record for these products? What hazards have been associated with the products?
C. Procedures used for processing
1. Does the process include a controllable processing step that destroys pathogens? If
so, which pathogens? Consider both vegetative cells and spores.
2. If the product is subject to recontamination between processing (e.g., cooking, pas-
teurizing) and packaging, which biological, chemical or physical hazards are likely
to occur?
D. Microbial content of the food
1. What is the normal microbial content of the food?
2. Does the microbial population change during the normal time the food is stored
prior to consumption?
3. Does the subsequent change in microbial population alter the safety of the food?
4. Do the answers to the above questions indicate a high likelihood of certain biological
hazards?
E. Facility design
1. Does the layout of the facility provide an adequate separation of raw materials from
ready-to-eat (RTE) foods if this is important to food safety? If not, what hazards
should be considered as possible contaminants of the RTE products?
2. Is positive air pressure maintained in product packaging areas? Is this essential for
product safety?
3. Is the traffic pattern for people and moving equipment a significant source of con-
tamination?
F. Equipment design and use
1. Will the equipment provide the time-temperature control that is necessary for safe
food?
2. Is the equipment properly sized for the volume of food that will be processed?
3. Can the equipment be sufficiently controlled so that the variation in performance
will be within the tolerances required to produce a safe food?
4. Is the equipment reliable or is it prone to frequent breakdowns?
5. Is the equipment designed so that it can be easily cleaned and sanitized?

6. Is there a chance for product contamination with hazardous substances; e.g.,
glass?
7. What product safety devices are used to enhance consumer safety?
• metal detectors
• magnets
• sifters
• filters
• screens
• thermometers
• bone removal devices
• dud detectors
8. To what degree will normal equipment wear affect the likely occurrence of a physi-
cal hazard (e.g., metal) in the product?
9. Are allergen protocols needed in using equipment for different products?
G. Packaging
1. Does the method of packaging affect the multiplication of microbial pathogens and/
or the formation of toxins?
2. Is the package clearly labeled “Keep Refrigerated” if this is required for safety?
3. Does the package include instructions for the safe handling and preparation of the
food by the end user?
4. Is the packaging material resistant to damage thereby preventing the entrance of
microbial contamination?
5. Are tamper-evident packaging features used?
6. Is each package and case legibly and accurately coded?
7. Does each package contain the proper label?
8. Are potential allergens in the ingredients included in the list of ingredients on the
label?
H. Sanitation
1. Can sanitation have an impact upon the safety of the food that is being processed?
2. Can the facility and equipment be easily cleaned and sanitized to permit the safe
handling of food?
3. Is it possible to provide sanitary conditions consistently and adequately to assure
safe foods?
I. Employee health, hygiene and education
1. Can employee health or personal hygiene practices impact upon the safety of the
food being processed?
2. Do the employees understand the process and the factors they must control to assure
the preparation of safe foods?
3. Will the employees inform management of a problem which could impact upon
safety of food?
J. Conditions of storage between packaging and the end user
1. What is the likelihood that the food will be improperly stored at the wrong tempera-
ture?
2. Would an error in improper storage lead to a microbiologically unsafe food?
K. Intended use
1. Will the food be heated by the consumer?
2. Will there likely be leftovers?
L. Intended consumer
1. Is the food intended for the general public?
2. Is the food intended for consumption by a population with increased susceptibility
to illness (e.g., infants, the aged, the infirmed, immunocompromised individuals)?
3. Is the food to be used for institutional feeding or the home?

APPENDIX B.4 Examples of How the Stages of Hazard Analysis Are Used to Identify and Evaluate Hazards a
Hazard Analysis Stage Frozen cooked beef patties Product containing eggs prepared Commercial frozen pre-cooked,
produced in a manufacturing for foodservice boned chicken for further
plant processing
Stage 1 Determine potential hazards as- Enteric pathogens (i.e., E. coli Salmonella in finished product. Staphylococcus aureus in fin-
Hazard sociated with product O157:H7 and Salmonella) ished product.
Identifi-
cation
Stage 2 Assess severity of health conse- Epidemiological evidence indi- Salmonellosis is a foodborne in- Certain strains of S. aureus pro-
Hazard quences if potential hazard is cates that these pathogens fection causing a moderate to duce an enterotoxin which can
Evaluation not properly controlled. cause severe health effects in- severe illness that can be cause a moderate foodborne ill-
cluding death among children caused by ingestion of only a ness.
and elderly. Undercooked beef few cells of Salmonella.
patties have been linked to dis-
ease from these pathogens.
Determine likelihood of occur- E. coli O157:H7 is of very low Product is made with liquid eggs Product may be contaminated
rence of potential hazard if probability and salmonellae is which have been associated with S. aureus due to human
not properly controlled. of moderate probability in raw with past outbreaks of salmo- handling during boning of
meat. nellosis. Recent problems with cooked chicken. Enterotoxin
Salmonella serotype Enteriti- capable of causing illness will
dis in eggs cause increased only occur as S. aureus multi-
concern. Probability of Salmo- plies to about 1,000,000/g. Op-
nella in raw eggs cannot be erating procedures during bon-
ruled out. ing and subsequent freezing
If not effectively controlled, prevent growth of S. aureus,
some consumers are likely to thus the potential for entero-
be exposed to Salmonella toxin formation is very low.
from this food.

Using information above, deter- The HACCP team decides that HACCP team determines that if The HACCP team determines
mine if this potential hazard is enteric pathogens are hazards the potential hazard is not that the potential for entero-
to be addressed in the for this product. properly controlled, consump- toxin formation is very low.
HACCP plan. Hazards must be addressed in tion of product is likely to re- However, it is still desirable
the plan. sult in an unacceptable health to keep the initial number of
risk. S. aureus organisms low. Em-
Hazard must be addressed in the ployee practices that minimize
plan. contamination, rapid carbon di-
oxide freezing and handling in-
structions have been adequate
to control this potential
hazard.
Potential hazard does not need to
be addressed in plan.
a
For illustrative purposes only. The potential hazards identified may not be the only hazards associated with the products listed. The responses may be different for different
establishments.

APPENDIX B.5
Example I of a CCP Decision Tree
Important considerations when using the decision tree:
The decision tree is used after the hazard analysis.
The decision tree then is used at the steps where a hazard that must be addressed in the
HACCP plan has been identified.
A subsequent step in the process may be more effective for controlling a hazard and may be
the preferred CCP.
More than one step in a process may be involved in controlling a hazard.
More than one hazard may be controlled by a specific control measure.
Q1. Does this step involve a hazard of sufficient likelihood of occurrence and
severity to warrant its control?
↓ ↓
YES NO → Not a CCP
↓
Q2. Does a control measure for the hazard exist at this step?
↓ ↓ ↑
YES NO Modify the step,
↓ ↓ process or product
↓ Is control at this step ↑
↓ necessary for safety? → YES
↓ ↓
↓ NO → Not a CCP → STOP*
Q3. Is control at this step necessary to prevent, eliminate, or reduce the risk
of the hazard to consumers?
↓ ↓
YES NO → Not a CCP → STOP*
↓
CCP
* Proceed to next step in the process.
APPENDIX B.6
Example II of a CCP Decision Tree
Q1. Do control measure(s) exist for the identified hazard?

↓ ↓ ↓ ↑
YES NO Modify step, process or product
↓ ↓ ↑
↓ Is control at this step necessary for safety? → YES
↓ ↓
↓ NO → Not a CCP → STOP*
Q2. Does this step eliminate or reduce the likely occurrence of a hazard to an acceptable level?
↓ ↓
NO YES
↓ ↓

Q3. Could contamination with the identified hazard(s) occur in excess ↓
of acceptable level(s) or could it increase to an unacceptable level(s)? ↓
↓ ↓ ↓
YES NO → Not a CCP → STOP* ↓
↓ ↓
↓
Q4. Will a subsequent step eliminate the identified hazard(s) or
reduce its likely occurrence to an acceptable level? ↓
↓ ↓ ↓
YES → Not a CCP → STOP* NO ↓
↓ ↓
CRITICAL CONTROL POINT
* Proceed to next step in the described process.
APPENDIX B.7
Examples of Verification Activities
A. Verification procedures may include:
1. Establishment of appropriate verification schedules.
2. Review of the HACCP plan for completeness.
3. Confirmation of the accuracy of the flow diagram.
4. Review of the HACCP system to determine if the facility is operating according to the
HACCP plan.
5. Review of CCP monitoring records.
6. Review of records for deviations and corrective actions.
7. Validation of critical limits to confirm that they are adequate to control significant hazards.
8. Validation of HACCP plan, including on-site review.
9. Review of modifications of the HACCP plan.
10. Sampling and testing to verify CCPs.
B. Verification should be conducted:
1. Routinely, or on an unannounced basis, to assure CCPs are under control.
2. When there are emerging concerns about the safety of the product.
3. When foods have been implicated as a vehicle of foodborne disease.
4. To confirm that changes have been implemented correctly after a HACCP plan has been
modified.
5. To assess whether a HACCP plan should be modified due to a change in the process,
equipment, ingredients, etc.
C. Verification reports may include information on the presence and adequacy of:
1. The HACCP plan and the person(s) responsible for administering and updating the
HACCP plan.
2. The records associated with CCP monitoring.
3. Direct recording of monitoring data of the CCP while in operation.
4. Certification that monitoring equipment is properly calibrated and in working order.
5. Corrective actions for deviations.
6. Sampling and testing methods used to verify that CCPs are under control.
7. Modifications to the HACCP plan.
8. Training and knowledge of individuals responsible for monitoring CCPs.
9. Validation activities.

APPENDIX B.8
Examples of HACCP Records
A. Ingredients for which critical limits have been established.
1. Supplier certification records documenting compliance of an ingredient with a critical limit.
2. Processor audit records verifying supplier compliance.
3. Storage records (e.g., time, temperature) for when ingredient storage is a CCP.
B. Processing, storage and distribution records
1. Information that establishes the efficacy of a CCP to maintain product safety.
2. Data establishing the safe shelf life of the product; if age of product can affect safety.
3. Records indicating compliance with critical limits when packaging materials, labeling or
sealing specifications are necessary for food safety.
4. Monitoring records.
5. Verification records.
C. Deviation and corrective action records.
D. Employee training records that are pertinent to CCPs and the HACCP plan.
E. Documentation of the adequacy of the HACCP plan from a knowledgeable HACCP expert.

APPENDIX C
Food Code 2001
Recommendations of the U.S. Public Health
Service Food and Drug Administration
The following is excerpted from the FDA’s Food Code Recommendations 2001.
The Food Code is a model for safeguarding public health and ensuring food is unadulter-
ated and honestly presented when offered to the consumer. It represents FDA’s best advice
for a uniform system of provisions that address the safety and protection of food offered
at retail and in food service.
This model is offered for adoption by local, state, and federal governmental jurisdic-
tions for administration by the various departments, agencies, bureaus, divisions, and other
units within each jurisdiction that have been delegated compliance responsibilities for
food service, retail food stores, or food vending operations. Alternatives that offer an
equivalent level of public health protection to ensure that food at retail and foodservice
is safe are recognized in this model.
This guidance represents FDA’s current thinking on safeguarding public health and
ensuring food is unadulterated and honestly presented when offered to the consumer. It
does not create or confer any rights for or on any person and does not operate to bind
FDA or the public. This guidance is being issued in accordance with FDA’s Good Guid-
ance Practices regulation (21 CFR 10.115; 65 FR 56468; September 19, 2000).
TABLE OF CONTENTS
Chapter 1 Purpose and Definitions
1-1 TITLE, INTENT, SCOPE
1-101 Title
1-102 Intent
1-103 Scope

1-2 DEFINITIONS
1-201 Applicability and Terms Defined
Chapter 2 Management and Personnel

2-1 SUPERVISION
2-101 Responsibility
2-102 Knowledge
2-103 Duties
2-2 EMPLOYEE HEALTH
2-201 Disease or Medical Condition
2-3 PERSONAL CLEANLINESS
2-301 Hands and Arms
2-302 Fingernails
2-303 Jewelry
2-304 Outer Clothing
2-4 HYGIENIC PRACTICES
2-401 Food Contamination Prevention
2-402 Hair Restraints
2-403 Animals
Chapter 3 Food
3-1 CHARACTERISTICS
3-101 Condition
3-2 SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS
AND RECORDS
3-201 Sources
3-202 Specifications for Receiving
3-203 Original Containers and Records
3-3 PROTECTION FROM CONTAMINATION AFTER RECEIVING
3-301 Preventing Contamination by Employees
3-302 Preventing Food and Ingredient Contamination
3-303 Preventing Contamination from Ice Used as a Coolant
3-304 Preventing Contamination from Equipment, Utensils, and Linens
3-305 Preventing Contamination from the Premises
3-306 Preventing Contamination by Consumers
3-307 Preventing Contamination from Other Sources
3-4 DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN
3-401 Cooking
3-402 Freezing
3-403 Reheating
3-404 Other Methods
3-5 LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC
HEALTH CONCERN
3-501 Temperature and Time Control
3-502 Specialized Processing Methods

3-6 FOOD IDENTITY, PRESENTATION, AND ON-PREMISES LABELING
3-601 Accurate Representation
3-602 Labeling
3-603 Consumer Advisory
3-7 CONTAMINATED FOOD
3-701 Disposition
3-8 SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE POPULATIONS
3-801 Additional Safeguards
Chapter 4 Equipment, Utensils, and Linens

4-1 MATERIALS FOR CONSTRUCTION AND REPAIR
4-101 Multiuse
4-102 Single-Service and Single-Use
4-2 DESIGN AND CONSTRUCTION
4-201 Durability and Strength
4-202 Cleanability
4-203 Accuracy
4-204 Functionality
4-205 Acceptability
4-3 NUMBERS AND CAPACITIES
4-301 Equipment
4-302 Utensils, Temperature Measuring Devices, and Testing Devices
4-4 LOCATION AND INSTALLATION
4-401 Location
4-402 Installation
4-5 MAINTENANCE AND OPERATION
4-501 Equipment
4-502 Utensils and Temperature and Pressure Measuring Devices
4-6 CLEANING OF EQUIPMENT AND UTENSILS
4-601 Objective
4-602 Frequency
4-603 Methods
4-7 SANITIZATION OF EQUIPMENT AND UTENSILS
4-701 Objective
4-702 Frequency
4-703 Methods
4-8 LAUNDERING
4-801 Objective
4-802 Frequency
4-803 Methods
4-9 PROTECTION OF CLEAN ITEMS
4-901 Drying
4-902 Lubricating and Reassembling
4-903 Storing
4-904 Handling

Chapter 5 Water, Plumbing, and Waste
5-1 WATER
5-101 Source
5-102 Quality
5-103 Quantity and Availability
5-104 Distribution, Delivery, and Retention
5-2 PLUMBING SYSTEM
5-201 Materials
5-202 Design, Construction, and Installation
5-203 Numbers and Capacities
5-204 Location and Placement
5-205 Operation and Maintenance
5-3 MOBILE WATER TANK AND MOBILE FOOD ESTABLISHMENT
WATER TANK
5-301 Materials
5-302 Design and Construction
5-303 Numbers and Capacities
5-304 Operation and Maintenance
5-4 SEWAGE, OTHER LIQUID WASTE, AND RAINWATER
5-401 Mobile Holding Tank
5-402 Retention, Drainage, and Delivery
5-403 Disposal Facility
5-5 REFUSE, RECYCLABLES, AND RETURNABLES
5-501 Facilities on the Premises
5-502 Removal
5-503 Facilities for Disposal and Recycling
Chapter 6 Physical Facilities

6-1 MATERIALS FOR CONSTRUCTION AND REPAIR
6-101 Indoor Areas
6-102 Outdoor Areas
6-2 DESIGN, CONSTRUCTION, AND INSTALLATION
6-201 Cleanability
6-202 Functionability
6-3 NUMBERS AND CAPACITIES
6-301 Handwashing Facilities
6-302 Toilets and Urinals
6-303 Lighting
6-304 Ventilation
6-305 Dressing Areas and Lockers
6-306 Service Sinks
6-4 LOCATION AND PLACEMENT
6-401 Handwashing Facilities
6-402 Toilet Rooms
6-403 Employee Accommodations
6-404 Distressed Merchandise
6-405 Refuse, Recyclables, and Returnables
6-5 MAINTENANCE AND OPERATION
6-501 Premises, Structures, Attachments, and Fixtures—Methods
Chapter 7 Poisonous or Toxic Materials

7-1 LABELING AND IDENTIFICATION
7-101 Original Containers
7-102 Working Containers
7-2 OPERATIONAL SUPPLIES AND APPLICATIONS
7-201 Storage
7-202 Presence and Use
7-203 Container Prohibitions
7-204 Chemicals
7-205 Lubricants
7-206 Pesticides
7-207 Medicines
7-208 First Aid Supplies
7-209 Other Personal Care Items
7-3 STOCK AND RETAIL SALE
7-301 Storage and Display
Chapter 8 Compliance and Enforcement

8-1 CODE APPLICABILITY
8-101 Use for Intended Purpose
8-102 Additional Requirements
8-103 Variances
8-2 PLAN SUBMISSION AND APPROVAL
8-201 Facility and Operating Plans
8-202 Confidentiality
8-203 Construction Inspection and Approval
8-3 PERMIT TO OPERATE
8-301 Requirement
8-302 Application Procedure
8-303 Issuance
8-304 Conditions of Retention
8-4 INSPECTION AND CORRECTION OF VIOLATIONS
8-401 Frequency
8-402 Access
8-403 Report of Findings
8-404 Imminent Health Hazard
8-405 Critical Violation
8-406 Noncritical Violation
8-5 PREVENTION OF FOODBORNE DISEASE TRANSMISSION
BY EMPLOYEES
8-501 Investigation and Control

Annex 1 Compliance and Enforcement
1. PURPOSE
2. EXPLANATION
3. PRINCIPLE
4. RECOMMENDATION
5. PARTS
8-6 CONSTITUTIONAL PROTECTION
8-7 NOTICES
8-8 REMEDIES
Annex 2 References
PART I UNITED STATES CODE AND CODE OF FEDERAL REGULATIONS
PART II BIBLIOGRAPHY
PREFACE
CHAPTER 1 PURPOSE AND DEFINITIONS
CHAPTER 2 MANAGEMENT AND PERSONNEL
CHAPTER 3 FOOD
CHAPTER 4 EQUIPMENT, UTENSILS, AND LINENS
CHAPTER 5 WATER, PLUMBING, AND WASTE
CHAPTER 6 PHYSICAL FACILITIES
PART III FDA SUPPORTING DOCUMENTS
A—DRAFT RECOMMENDED VOLUNTARY NATIONAL RETAIL FOOD REGU-
LATORY PROGRAM STANDARDS
B—PROCEDURES FOR THE STANDARDIZATION AND CERTIFICATION OF
RETAIL FOOD TRAINING/INSPECTION OFFICERS (2000)
C—DRAFT MANAGING FOOD SAFETY: A HACCP PRINCIPLES GUIDE FOR OP-
ERATORS OF FOOD SERVICE, RETAIL FOOD STORES, AND OTHER FOOD
ESTABLISHMENTS AT THE RETAIL LEVEL (1998)
D—PLAN REVIEW GUIDELINES (2000)
E—PRE-OPERATIONAL GUIDE FOR TEMPORARY FOOD ESTABLISHMENTS
(2000)
F—FDA RETAIL FOOD PROGRAM DATABASE OF FOODBORNE ILLNESS RISK
FACTORS (2000)
Annex 3 Public Health Reasons/Administrative Guidelines

CHAPTER 1 PURPOSE AND DEFINITIONS
CHAPTER 2 MANAGEMENT AND PERSONNEL
CHAPTER 3 FOOD
CHAPTER 4 EQUIPMENT, UTENSILS, AND LINENS
CHAPTER 5 WATER, PLUMBING, AND WASTE
CHAPTER 6 PHYSICAL FACILITIES
CHAPTER 7 POISONOUS OR TOXIC MATERIALS
Annex 4 Food Establishment Inspection

1. INTRODUCTION
2. PROGRAM PLANNING
3. STAFF TRAINING
4. CONDUCTING THE INSPECTION
5. INSPECTION DOCUMENTATION
6. INSPECTION REPORT
7. ADMINISTRATIVE PROCEDURES BY THE STATE/LOCAL AUTHORITIES
8. TEMPERATURE MEASURING DEVICES
9. CALIBRATION PROCEDURES
10. HACCP INSPECTION DATA FORM
11. FOOD ESTABLISHMENT INSPECTION REPORT
12. FDA ELECTRONIC INSPECTION SYSTEM
13. ESTABLISHMENT SCORING
Annex 5 HACCP Guidelines

1. INTRODUCTION
2. HACCP PRINCIPLES
3. SUMMARY
4. ACKNOWLEDGEMENTS
5. BIBLIOGRAPHY
6. OTHER SOURCES OF HACCP INFORMATION
TWO TYPICAL FLOW DIAGRAMS
Annex 6 Food Processing

1. INTRODUCTION
2. REDUCED OXYGEN PACKAGING
3. SMOKING AND CURING
Annex 7 Model Forms, Guides, and Other Aids

1) Employee health information
a) Form 1-A Applicant and Food Employee Interview
b) Form 1-B Food Employee Reporting Agreement
c) Form 1-C Applicant and Food Employee Medical Referral
d) Guide 1-D Exclusions and Restrictions
e) Guide 1-E Removal of Exclusions and Restrictions
f ) List 1-F Worldwide Status of Salmonella Typhi, Shigella spp., Escherichia
coli O157:H7, and Hepatitis A Virus by Geographical Area
2) Adoption information
a) Form 2-A Adoption by Reference
b) Form 2-B Adoption by Section-by-Section Reference
3) Inspection information
a) Form 3-A HACCP Inspection Data
b) Form 3-B Food Establishment Inspection Report
c) Guide 3-C Inspectional Guide
4) Summary information
a) Chart 4-A Summary Chart for Minimum Cooking Food Temperatures
and Holding Times Required by Chapter 3
b) Chart 4-B Summary Chart for Minimum Food Temperatures and Holding
Times Required by Chapter 3 for Reheating Foods for Hot Holding
c) Chart 4-C Summary Chart—Date Marking and Disposing Ready-to-Eat,
Potentially Hazardous Food
d) Chart 4-D FDA Food Code Mobile Food Establishment Matrix
e) Summary Summary of Changes in the FDA Food Code

APPENDIX D
The Handbook of Food Defect Action
Levels
Levels of Natural or Unavoidable Defects in
Foods that Present No Health Hazards
for Humans
The following is from the FDA/CFSAN Defect Action Level Handbook.
INTRODUCTION
Title 21, Code of Federal Regulations, Part 110.110 allows the Food and Drug Administra-
tion (FDA) to establish maximum levels of natural or unavoidable defects in foods for
human use that present no health hazard. These “Food Defect Action Levels” listed in
this booklet are set on this premise—that they pose no inherent hazard to health.
Poor manufacturing practices may result in enforcement action without regard to
the action level. Likewise, the mixing of blending of food with a defect at or above the
current defect action level with another lot of the same or another food is not permitted.
That practice renders the final food unlawful regardless of the defect level of the finished
food.
The FDA set these action levels because it is economically impractical to grow,
harvest, or process raw products that are totally free of non-hazardous, naturally occurring,
unavoidable defects. Products harmful to consumers are subject to regulatory action
whether or not they exceed the action levels.
It is incorrect to assume that because the FDA has an established defect action level
for a food commodity, the food manufacturer need only stay just below that level. The
defect levels do not represent an average of the defects that occur in any of the products—
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, May 1995; Revised March
1997; Revised May 1998.

the averages are actually much lower. The levels represent limits at which FDA will regard
the food product “adulterated”; and subject to enforcement action under Section 402(a)(3)
of the Food, Drug, and Cosmetics Act.
As technology improves, the FDA may review and change defect action levels on
this list. Also, products may be added to the list. The FDA publishes these revisions as
Notices in the Federal Register. It is the responsibility of the user of this booklet to stay
current with any changes to this list.
PRODUCTS WITHOUT DEFECT LEVELS

If there is no defect action level for a product, or when findings show levels or types of
defects that do not appear to fit the action level criteria, FDA evaluates the samples and
decides on a case-by-case basis. In this procedure, FDA’s technical and regulatory experts
in filth and extraneous materials use a variety of criteria, often in combination, in determin-
ing the significance and regulatory impact of the findings.
The criteria considered is based on the reported findings (e.g., lengths of hairs, sizes
of insect fragments, distribution of filth in the sample, and combinations of filth types
found). Moreover, FDA interprets the findings considering available scientific information
(e.g., ecology of animal species represented) and the knowledge of how a product is grown,
harvested, and processed.
USE OF CHEMICAL SUBSTANCES TO ELIMINATE DEFECT LEVELS

It is FDA’s position that pesticides are not the alternative to preventing food defects. The
use of chemical substances to control insects, rodents and other natural contaminants has
little, if any impact on natural and unavoidable defects in foods. The primary use of pesti-
cides in the field is to protect food plants from being ravaged by destructive plant pests
(leaf feeders, stem borers, etc.).
A secondary use of pesticides is for cosmetic purposes—to prevent some food prod-
ucts from becoming so severely damaged by pests that it becomes unfit to eat.
USING THIS FOOD DEFECT ACTION LEVEL BOOKLET

This edition of The Food Defect Action Level includes the source of each defect and the
significance of it (i.e., how the defect affects the food). Food processors may find this
information helpful as a quality control tool in their operation.
Food commodities (Product) are listed alphabetically. Each listing indicates the ana-
lytical methodology (Defect Method) used, as well as the parameters for the defect (Defect
Action Level).
GLOSSARY
The glossary describes terms used throughout this booklet.
ABUSE Improper handling.
AESTHETIC Offensive to the senses.
CONTAMINATION Addition of foreign material, (e.g., dirt, hair, excreta, non-inva-
sive insects, machinery mold) to a product.
COPEPODS Small free-swimming marine crustaceans, many of which are fish para-
sites. In some species the females enter the tissues of the host fish and may form pus
pockets.
DAMAGE Refers to the condition of the product which shows the evidence of the pest
habitation or feeding, (e.g., tunneling, gnawing, egg cases, etc.).
DECOMPOSED Consists of the bacterial breakdown of the normal product tissues and
the subsequent enzyme induced chemical changes. These changes are manifested by ab-
normal odors, taste, texture, color, etc.
DECOMPOSITION METABOLITES Compounds such as histamines and diamines,
etc.
ECONOMIC ADULTERATION Intentional failure to remove inedible materials from
the finished product, or the intentional addition or substitution of cheaper food or ingredi-
ent to a product.
EXTRANEOUS MATERIALS Any foreign matter in a product associated with objec-
tionable conditions or practices in production, storage, or distribution. Includes: objection-
able matter contributed by insects, rodents, and birds; decomposed material; and miscella-
neous matter such as sand, soil, glass, rust, or other foreign substances.
FOREIGN MATTER Includes objectionable matter such as sticks, stones, burlap bag-
ging, cigarette butts, etc. Also includes the valueless parts of the raw plant material, such
as stems.
GUMMY A resinous glaze on an almond kernel that is induced by an insect injury or
mechanical damage.
HARVEST Occurs during the harvesting process.
HISTAMINE A chemical compound formed by the bacterial decomposition of seafood.
INDOLE A chemical compound formed by the bacterial decomposition of seafood.
INFECTION A condition due to the growth of an organism in a host, (e.g., rot or decay,
visible mold mycelia).
INFESTATION The presence of any live or dead life cycle stages of insects in a host
product, (e.g., weevils in pecans, fly eggs and maggots in tomato products); or evidence
of their presence (i.e., excreta, cast skins, chewed product residues, urine, etc.); or the
establishment of an active breeding population, (e.g., rodents in a grain silo).
MILDEW Refers to downy mildew which is a fungus infection that causes yellow-
brown spots on the leaves of edible greens in the mustard family.
MOLD COUNT Refers to the results of the Howard mold count method which is re-
ported as the percentage of positive microscopic fields that have been scored as either
positive or negative based on the presence or absence of a minimum amount of mold
hyphae. Performed only on comminuted fruits and vegetables, and some ground spices.
The source of the mold hyphae is rotten raw material that is processed along with sound
raw material but is no longer visible due to the comminution process.
MOLDY Evidenced by the presence of mold (mold hyphae and/or spore forming struc-
tures) that are visible to the unaided eye. Microscopic examination may be used to confirm
the presence of characteristic hyphal filaments and fruiting structures.
POST HARVEST Occurs after harvest, for example:
1. field holding of the harvested crop prior to transit
2. farm storage of harvested crop
3. during transit by truck, ship, rail, etc.
4. at the processing facility, awaiting processing or proper storage
PREHARVEST Occurs while product is in the field, during growth or awaiting harvest.
PROCESSING Occurs while in the processing facility, in storage or during processing
RANCID A condition where a product has a disagreeable odor or taste of decomposed
oils or fat. For example, rancid nuts frequently are soft, with a yellow, dark, or oily appear-
ance, a bitter taste and a stale odor.
ROT Plant tissue that is visibly decomposed, usually discolored with disagreeable odors
and taste. The plant tissue has been invaded and is being digested by microorganisms.
Although rot can also be caused by bacteria and yeasts, these organisms are secondary
invaders. Molds are the primary organisms of decomposition and the presence of mold
hyphae in the tissue is used to confirm rot.
SHRIVELED A condition where the nut kernel is shrunken and not fully developed,
commonly a result of climatic stress or infection by certain molds.
SIGNIFICANCE OF DEFECT Refers to the real or potential impact on the consumer
due to the presence of a particular defect. A listed defect can have more than one signifi-
cance to the consumer (e.g., the mold defect of whole cassia has an aesthetic significance,
whereas the mold defect of green coffee beans has a potential health hazard significance
due to the threat of mold toxins produced by the mold species known to infect coffee
beans).
SOUR In fruits, consists of the bacterial breakdown of the product and the formation
of lactic acid and subsequent sour taste.
WATER INSOLUBLE INORGANIC MATTER A contaminant of the finished prod-
uct that consists of fine grit that originates from the sand, dirt, and stones that contaminate
the raw agricultural product at the time of harvest.
WHOLE OR EQUIVALENT INSECT A whole insect, separate head, or body por-
tions with head attached.
WORTHLESS Any condition where the product has been affected by organisms or the
environment that it has no food value.

Commodities and Defect Action Levels
Product Defect (Method) Action level
ALLSPICE, GROUND Insect Filth Average of 30 or more insect fragments per 10 grams
(AOAC 981.21)
Rodent filth Average of 1 or more rodent hairs per 10 grams
(AOAC 981.21)
DEFECT SOURCE: Insect fragments—pre/postharvest and processing insect infestation. Rodent hair—postharvest and/or processing contamination with
animal hair or excreta
SIGNIFICANCE: Aesthetic
ALLSPICE, WHOLE Mold Average of 5% or more berries by weight are moldy

(MPM-V32)
DEFECT SOURCE: Preharvest and/or postharvest infection
SIGNIFICANCE: Potential health hazard—may contain mycotoxin producing fungi
APPLE BUTTER Mold Average of mold count is 12% or more

(AOAC 975.51)
Rodent filth Average of 4 or more rodent hairs per 100 grams of apple butter
(AOAC 945.76)
Insects Average of 5 or more whole or equivalent insects (not counting mites, aphids, thrips, or scale insects)
(AOAC 945.76) per 100 grams of apple butter
DEFECT SOURCE: Mold—postharvest infection. Rodent hair—postharvest and/or processing contamination with animal hair. Whole or equivalent in-
sects—preharvest, and/or postharvest and/or processing insect infestation
APRICOTS, CANNED Insect filth Average of 2% or more by count has been damaged or infected by insects
(MPM-V51)
DEFECT SOURCE: Preharvest insect infestation

Commodities and Defect Action Levels Continued

ASPARAGUS, Insect filth 10% by count of spears or pieces are infested with 6 or more attached asparagus beetle eggs and/or
CANNED OR (MPM-V93) sacs
FROZEN
Insects Asparagus contains an average of 40 or more thrips per 100 grams
(MPM-V93) OR
Insects (whole or equivalent) of 3 mm or longer have an average aggregate length of 7 mm or longer
per 100 grams of asparagus
BAY (LAUREL) Mold Average of 5% or more pieces by weight are moldy

LEAVES (MPM-V92)
Insect filth Average of 5% or more pieces by weight are insect-infested
(MPM-V32)
Mammalian excreta Average of 1 mg or more mammalian excreta per pound after processing
(MPM-V32)
DEFECT SOURCE: Mold—preharvest infection. Insect infestation—preharvest and/or postharvest and/or processing insect infestation. Mammalian ex-
creta—postharvest and/or processing animal contamination
BEETS, CANNED Rot Average of 5% or more pieces by weight with dry rot
DEFECT SOURCE: Preharvest mold infection
BERRIES
Drupelet, Canned and Fro- Mold Average mold count is 60% or more
zen (blackberries, rasp- (AOAC 955.47)
berries, etc.) Insects and larvae
Average of 4 or more larvae per 500 grams
(AOAC 981.20) OR
Average of 10 or more whole insects or equivalent per 500 grams (excluding thrips, aphids and mites)
DEFECT SOURCE: Insects and larvae—preharvest insect infestation. Mold—postharvest infection

Lingon, Canned (Euro- Insect larvae Average of 3 or more larvae per pound in a minimum of 12 subsamples
pean cranberry) (MPM-V64)
DEFECT SOURCE: Insects—preharvest insect infestation
Multer, Canned Insects Average of 40 or more thrips per No. 2 can in all subsamples and 20% of subsamples are materially in-
(MPM-V64) fested
DEFECT SOURCE: Insects—preharvest insect infestation
BROCCOLI, FROZEN Insects and mites Average of 60 or more aphids and/or thrips and/or mites per 100 grams
(AOAC 945.82)
BRUSSELS SPROUTS, Insects Average of 30 or more aphids and/or thrips per 100 grams
FROZEN (MPM-V95)
CAPSICUM:
Pods Insect filth and/or Average of more than 3% of pods by weight are insect-infested and/or moldy
mold
(MPM-V32)
Mammalian excreta Average of more than 1 mg mammalian excreta per pound
(MPM-V32)
DEFECT SOURCE: Insect infested—preharvest and/or postharvest insect infestation. Mold—preharvest and/or postharvest infection. Mammalian ex-
SIGNIFICANCE: Aesthetic, Potential health hazard—mold may contain mycotoxin producing fungi


Ground Capsicum (ex- Mold Average mold count is more than 20%
cluding paprika) (AOAC 945.94)
Insect filth Average of more than 50 insect fragments per 25 grams
(AOAC 978.22)
Rodent filth Average of more than 6 rodent hairs per 25 grams
(AOAC 978.22)
DEFECT SOURCE: Mold—preharvest and/or postharvest mold infection. Insect fragments—preharvest and/or postharvest and/or processing insect infes-
tation. Rodent hair—preharvest and/or postharvest and/or processing contamination with animal hair or excreta
SIGNIFICANCE: Aesthetic, Mold may contain mycotoxin producing fungi
Ground Paprika Mold Average mold count is more than 20%
(AOAC 945.94)
Insect filth Average of more than 75 insect fragments per 25 grams
(AOAC 977.25B)
Rodent filth Average of more than 11 rodent hairs per 25 grams
(AOAC 977.25B)
DEFECT SOURCE: Mold—pre and/or postharvest mold infection. Insect fragments—pre and/or postharvest and/or processing insect infestation. Rodent
hair—pre and/or postharvest and/or processing contamination with animal hair or excreta
CASSIA (OR) CINNA- Mold Average of 5% or more pieces by weight are moldy
MON BARK, WHOLE (MPM-V32)
Insect filth Average of 5% or more pieces by weight are insect-infested
(MPM-V32)
Mammalian excreta Average of 1 mg or more mammalian excreta per pound
(MPM-V32)
DEFECT SOURCE: Mold—postharvest mold infection. Insect infestation—postharvest and/or processing. Mammalian excreta—postharvest and/or pro-
cessing animal contamination.

CINNAMON, GROUND Insect filth Average of 400 or more insect fragments per 50 gram
(AOAC 968.38b)
(AOAC 968.38b)
DEFECT SOURCE: Insect fragments—postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing contamination with an-
imal hair or excreta
CHERRIES
Brined and Maraschino Insect filth Average of 5% or more pieces are rejects due to maggots
(MPM-V48)
Fresh, Canned, or Frozen Rot Average of 7% or more pieces are rejects due to rot
(MPM-V48)
Insect filth Average of 4% or more pieces are rejects due to insects other than maggots
(MPM-V48)
DEFECT SOURCE: Insect reject—Preharvest and/or postharvest insect infestation. Rot reject—preharvest mold infection
CHERRY JAM Mold Average mold count is 30% or more

(MPM-V61)
DEFECT SOURCE: Preharvest mold infection

CHOCOLATE AND Insect filth Average is 60 or more insect fragments per 100 grams when 6 100-gram subsamples are examined
CHOCOLATE (AOAC 965.38) OR
LIQUOR Any 1 subsample contains 90 or more insect fragments
Rodent filth Average is 1 or more rodent hairs per 100 grams in 6 100-gram subsamples examined
(AOAC 965.38) OR
Any 1 subsample contains 3 or more rodent hairs
Shell For chocolate liquor, if the shell is in excess of 2% calculated on the basis of alkali-free nibs
(AOAC 968.10–
970.23)
imal hair or excreta. Shell—processing contamination
CITRUS FRUIT JUICES, Mold Average mold count is 10% or more

CANNED (AOAC 970.75)
Insects and insect 5 or more Drosophila and other fly eggs per 250 ml or 1 or more maggots per 250 ml
eggs
(AOAC 970.72)
DEFECT SOURCE: Mold—processing contamination, Fly eggs and/or maggots—postharvest insect infestation
CLOVES Stems Average of 5% or more stems by weight

(MPM-V32)
DEFECT SOURCE: Harvest
SIGNIFICANCE: Aesthetic, economic adulteration

COCOA BEANS Mold More than 4% of beans by count are moldy
(MPM-V18)
Insect filth More than 4% of beans by count are insect-infested including insect-damaged
(MPM-V18)
Insect filth and/or More than 6% of beans by count are insect-infested or moldy
mold NOTE: Level differs when both filth and mold are present
(MPM-V18)
DEFECT SOURCE: Mold—postharvest infection. Insect infested/damaged—postharvest and/or processing insect infestation. Mammalian excreta—post-
harvest and/or processing animal contamination
SIGNIFICANCE: Aesthetic, Potential health hazard—may contain mycotoxin producing fungi
COCOA POWDER Insect filth Average of 75 or more insect fragments per subsample of 50 grams when 6 subsamples are examined
PRESS CAKE (AOAC 965.38) OR
Any 1 subsample contains 125 or more insect fragments
Rodent filth Average in 6 or more subsamples is 2 or more rodent hairs per subsample of 50 grams
(AOAC 965.38) OR
Any 1 subsample contains 4 or more rodent hairs
Shell 2% or more shell calculated on the basis of alkali-free nibs.
(AOAC 968.10–
970.23)
imal hair or excreta. Shell—processing contamination
COFFEE BEANS, Grade defects Beans are poorer than Grade 8 of the New York Green Coffee Association
GRADED GREEN (MPM-V6)
DEFECT SOURCE: Quality—processing
SIGNIFICANCE: Aesthetic, economic adulteration


COFFEE BEANS, Insect filth and Average 10% or more by count are insect-infested or insect-damaged
GREEN insects Note: If live external infestation is present use the Compliance Policy Guide (CPG) titled “Food Stor-
(MPM-V1) age and Warehousing-Adulteration-Filth” (CPG 580.100) in accordance with “Interpretation of In-
sect Filth” (CPG 555.600)
Mold Average of 10% or more beans by count are moldy
(MPM-V1)
DEFECT SOURCE: Insect infested/damaged—preharvest and/or postharvest and/or processing insect infestation. Mold—postharvest and/or processing in-
fection
CONDIMENTAL Mammalian excreta Average of 3 mg or more of mammalian excreta per pound

SEEDS OTHER (MPM-V32)
THAN FENNEL
SEEDS AND SES-
AME SEEDS
DEFECT SOURCE: Postharvest and/or processing animal contamination
CORN: SWEET CORN, Insect larvae Insect larvae (corn ear worms, corn borers) 2 or more 3 mm or longer larvae, cast skins, larval or cast
CANNED (AOAC 973.61) skin fragments of corn ear worms or corn borer and the aggregate length of such larvae, cast skins,
larval or cast skin fragments exceeds 12 mm in 24 pounds (24 No. 303 cans or equivalent)
CORN HUSKS FOR Insect filth Average of 5% or more husks by weight are insect-infested (including insect-damaged)
TAMALES (MPM-V115)
Mold Average of 5% or more husks by weight are moldy
(MPM-V115)
DEFECT SOURCE: Insect infested—preharvest and/or processing insect infestation. Mold—preharvest and/or postharvest and/or processing infection

CORNMEAL Insects Average of 1 or more whole insects (or equivalent) per 50 grams
(AOAC 981.19)
Insect filth Average of 25 or more insect fragments per 25 grams
(AOAC 981.19)
(AOAC 981.19) OR
Average of 1 or more rodent excreta fragment per 50 grams
DEFECT SOURCE: Insects and insect fragments—preharvest and/or postharvest and/or processing insect infestation. Rodent hair and excreta frag-
ments—postharvest and/or processing contamination with animal hair or excreta
CRANBERRY SAUCE Mold Average mold count is more than 15%

(AOAC 970.76) OR
The mold count of any 1 subsample is more than 50%
CUMIN SEED Sand and grit Average of 9.5% or more ash and/or 1.5% or more acid insoluble ash
(AOAC 975.48)
DEFECT SOURCE: Harvest contamination
CURRANT JAM, Mold Average mold count is 75% or more

BLACK (MPM-V61)
DEFECT SOURCE: Postharvest and/or processing infection
CURRANTS Insect filth 5% or more, by count, wormy in the average of the subsamples
(MPM-V53)


CURRY POWDER Insect filth Average of 100 or more insect fragments per 25 grams
(AOAC 975.48)
(AOAC 975.48)
DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing insect infestation. Rodent hair—postharvest and/or processing con-
tamination with animal hair or excreta
DATE MATERIAL Insects 10 or more dead insects (whole or equivalent) in 1 or more subsamples
(CHOPPED, SLICED, (MPM-V53) OR
(OR) MACERATED) 5 or more dead insects (whole or equivalent) per 100 grams
Pits 2 or more pits and/or pit fragments 2 mm or longer measured in the longest dimension per 900 grams
(MPM-V53)
DEFECT SOURCE: Insects—preharvest and/or postharvest and/or processing insect infestation. Pits—processing
SIGNIFICANCE: Insects—Aesthetic. Pits—mouth/tooth injury
DATES, PITTED Multiple Average of 5% or more dates by count are rejects (moldy, dead insects, insect excreta, sour, dirty,
(MPM-V53) and/or worthless) as determined by macroscopic sequential examination
Pits Average of 2 or more pits and/or pit fragments 2 mm or longer in the longest dimension per 100 dates
(MPM-V53)
DEFECT SOURCE: Insects, insect excreta, & mold—preharvest and/or postharvest and/or processing. Sour & worthless—preharvest. Dirt—harvest con-
tamination. Pits—processing
SIGNIFICANCE: Insects, insect excreta, mold, sour & worthless, dirt—Aesthetic. Pits—mouth/tooth injury
DATES, WHOLE Multiple Average of 5% or more dates by count are rejects (moldy, dead insects, insect excreta, sour, dirty,
(MPM-V53) and/or worthless) as determined by macroscopic sequential examination
DEFECT SOURCE: Insects, insect excreta, & mold—preharvest and/or postharvest and/or processing. Sour & worthless—preharvest. Dirt—harvest con-
tamination

EGGS AND OTHER Decomposition 2 or more cans decomposed and at least 2 subsamples from decomposed cans have direct microscopic
EGG PRODUCTS, (AOAC 939.14, counts of 5 million or more bacteria per gram
FROZEN 940.36, 940.37)
DEFECT SOURCE: Processing (incubator rejects)
SIGNIFICANCE: Economic
FENNEL SEED Insects 20% or more of subsamples contain insects

(MPM-V32)
Mammalian excreta
20% or more of subsamples contain mammalian excreta
(MPM-V32) OR
average of more than 3 mg of mammalian excreta per pound
DEFECT SOURCE: Insects—preharvest and/or postharvest insect infestation, Excreta—postharvest and/or processing animal contamination
FIG PASTE Insects Contains 13 or more insect heads per 100 grams of fig paste in each of 2 or more subsamples
(AOAC 964.23)
DEFECT SOURCE: Preharvest and/or postharvest and/or processing insect infestation
FIGS Insect filth and/or Average of 10% or more by count are insect-infested and/or moldy and/or dirty fruit or pieces of fruit
mold and/or
dirty fruit or
pieces of fruit
(MPM-V53)
DEFECT SOURCE: Insect infested—Preharvest and/or postharvest infestation, Moldy—preharvest infection. Dirt—harvest contamination


FISH, FRESH (OR) FRO- Decomposition Decomposition in 5% or more of the fish (or fillets) show Class 3 decomposition over at least 25% of
ZEN (APPLIES TO their areas in 2 or more subsamples
FISH (OR) FILLETS OR
WEIGHING 3 20% or more of the fish (or fillets) show Class 2 decomposition over at least 25% of their areas in 2
POUNDS (OR) LESS) or more subsamples
OR
The percentage of fish (or fillets) showing Class 2 decomposition plus 4 times the percentage of those
showing Class 3 decomposition as above equals at least 20% in 2 or more subsamples
ORGANOLEPTIC DECOMPOSITION CLASSES:
Class 1—No odors of decomposition
Class 2—First definite odor of decomposition
Class 3—Odors of advanced decomposition
DEFECT SOURCE: Postharvest time/temperature abuse
SIGNIFICANCE: Potential health hazard from decomposition metabolites
Tullibees, Ciscoes, Incon- Parasites (cysts) 50 parasitic cysts per 100 pounds (whole or fillets), provided that 20% of the fish examined are in-
nus, Chubs, and White- (MPM-V28) fested
fish
DEFECT SOURCE: Preharvest infection
Blue Fin and other Fresh Parasites (cysts) 60 parasitic cysts per 100 fish (fish averaging 1 pound or less) or 100 pounds of fish averaging over 1
Water Herring (MPM-V28) pound), provided that 20% of the fish examined are infested
Red Fish and Ocean Parasites (cope- 3% of the fillets examined contain 1 or more copepods accompanied by pus pockets
Perch pods)
(MPM-V28)

GINGER, WHOLE Insect filth and/or Average of 3% or more pieces by weight are insect-infested and/or moldy
mold
(MPM-V32)
Mammalian excreta Average of 3 mg or more of mammalian excreta per pound
(MPM-V32)
DEFECT SOURCE: Insect infestation—postharvest and/or processing. Mold—postharvest and/or processing infection. Mammalian excreta—postharvest
and/or processing animal contamination
SIGNIFICANCE: Aesthetic. Potential health hazard—may contain mycotoxin producing fungi
GREENS, CANNED Mildew Average of 10% or more of leaves, by count or weight, showing mildew over 1/2″ in diameter
(AOAC 967.23)
HOPS Insects Average of more than 2,500 aphids per 10 grams

(AOAC 967.23)
DEFECT SOURCE: Preharvest infestation
MACARONI AND NOO- Insect filth Average of 225 insect fragments or more per 225 grams in 6 or more subsamples
DLE PRODUCTS (AOAC 969.41)
Rodent filth Average of 4.5 rodent hairs or more per 225 grams in 6 or more subsamples
(AOAC 969.41)
DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing infestation. Rodent hair—postharvest and/or processing contamina-
tion with animal hair or excreta
MACE Insect filth and/or Average of 3% or more pieces by weight are insect-infested and/or moldy
mold
(MPM-V32)
Mammalian excreta Average of 3 mg or more of mammalian excreta per pound
(MPM-V32)
Foreign matter Average of 1.5% or more of foreign matter through a 20-mesh sieve
(MPM-V32)
DEFECT SOURCE: Insect infestation—preharvest and/or postharvest and/or processing. Mold—preharvest and/or postharvest infection. Mammalian ex-
creta—postharvest and/or processing animal contamination. Foreign matter—postharvest contamination


MARJORAM, WHOLE Insect filth and/or Average of 5% or more pieces by weight are insect-infested or moldy
PLANT, UNPRO- mold
CESSED (MPM-V32)
(MPM-V32)
DEFECT SOURCE: Insect infestation—preharvest and/or postharvest and/or processing. Mold—postharvest and/or processing infection. Mammalian ex-
MARJORAM, GROUND Insect filth Average of 1175 or more insect fragments per 10 grams
(AOAC 975.49)
(AOAC 975.49)
MARJORAM, UN- Insect filth Average of 250 or more insect fragments per 10 grams
GROUND (AOAC 985.39)
(AOAC 985.39)
DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing insect infestation. Rodent hair—processing contamination with ani-
mal hair or excreta

MUSHROOMS, Insects Average of over 20 or more maggots of any size per 100 grams of drained mushrooms and proportion-
CANNED AND DRIED (AOAC 967.24) ate liquid or 15 grams of dried mushrooms
OR
Average of 5 or more maggots 2 mm or longer per 100 grams of drained mushrooms and proportion-
ate liquid or 15 grams of dried mushrooms
Mites Average of 75 mites per 100 grams drained mushrooms and proportionate liquid or 15 grams of dried
(AOAC 967.24) mushrooms
Decomposition Average of more than 10% of mushrooms are decomposed
(MPM-V100)
DEFECT SOURCE: Insects—preharvest insect infestation. Mites—preharvest and/or postharvest infestation. Decomposition—preharvest infection
NECTARS, APRICOT, Mold Average mold count is 12% or more

PEACH AND PEAR
NUTMEG, WHOLE Insect filth and/or Average of 10% or more pieces by count are insect-infested and/or moldy
mold
(MPM-V41)
DEFECT SOURCE: Insect infestation—preharvest and/or postharvest and/or processing. Mold—preharvest and/or postharvest infection
SIGNIFICANCE: Aesthetic. Potential health hazard—may contain mycotoxin producing fungi
NUTMEG, GROUND Insect filth Average of 100 or more insect fragments per 10 grams
(AOAC 979.26)
(AOAC 979.26)


NUTS, TREE Multiple Defects Reject nuts (insect-infested, rancid, moldy, gummy, and shriveled or empty shells) as determined by
(MPM-V81) macroscopic examination at or in excess of the following levels:
NUT TYPE UNSHELLED % SHELLED %

Almonds 5 5
Brazils 10 5
Cashew — 5
Green chestnuts 15 —
Baked chestnuts 10 —
Dried chestnuts — 5
Filberts 10 5
Lichee nuts 5 —
Pecans 10 5
Pili nuts 15 10
Pistachios 10 5
Walnuts 10 5
DEFECT SOURCE: Insect infested—preharvest and/or postharvest and/or processing. Mold—preharvest and/or postharvest and/or processing infection.
Gummy & shriveled—preharvest physiological condition, Rancidity—postharvest
OLIVES
Pitted olives Pits Average of 1.3 percent or more by count of olives with whole pits and/or pit fragments 2 mm or
(MPM-V67) longer measured in the longest dimension
DEFECT SOURCE: Processing
SIGNIFICANCE: Mouth/tooth injury
Imported Green olives Insect damage 7% or more olives by count showing damage by olive fruit fly
(MPM-V67)

Salad olives Pits Average of 1.3 or more olives by count of olives with whole pits and/or pit fragments 2 mm or longer
(MPM-V67) measured in the longest dimension
Insect damage 9% or more olives by weight showing damage by olive fruit fly
(MPM-V67)
DEFECT SOURCE: Pits—processing, Insect damage—preharvest insect infestation
SIGNIFICANCE: Pits—mouth/tooth injury, Insect damage—Aesthetic
Salt-cured olives Insects Average of 10% or more olives by count with 10 or more scale insects each
(MPM-V67)
Mold Average of 25% or more olives by count are moldy
(MPM-V67)
DEFECT SOURCE: Scale insects—preharvest infestation. Mold—postharvest and/or processing infection
Imported Black olives Insect damage 10% or more olives by count showing damage by olive fruit fly
(MPM-V67)
OREGANO, WHOLE Insect filth and/or Average of 5% or more insect infested and/or moldy pieces by weight
PLANT, UNPRO- mold weight
CESSED (MPM-V32)
(MPM-V32)
DEFECT SOURCE: Insect infested—preharvest and/or postharvest and/or processing. Mold—postharvest and/or processing infection. Mammalian ex-
OREGANO, GROUND Insect filth Average of 1250 or more insect fragments per 10 grams
(AOAC 975.49)
(AOAC 975.49)

OREGANO, CRUSHED Insect filth Average of 300 or more insect fragments per 10 grams
(AOAC 969.44)
(AOAC 969.44)
PEACHES, CANNED Mold/Insect Average of 3% or more fruit by count are wormy or moldy
AND FROZEN damage
(MPM-V51)
Insects In 12 1-pound cans or equivalent, one or more larvae and/or larval fragments whose aggregate length
(MPM-V51) exceeds 5 mm
DEFECT SOURCE: Mold—preharvest and/or postharvest infection. Insect damage—preharvest insect infestation. Larvae—preharvest insect infestation
PEANUT BUTTER Insect filth Average of 30 or more insect fragments per 100 grams
(AOAC 968.35)
(AOAC 968.35)
Grit Gritty taste and water insoluble inorganic residue is more than 25 mg per 100 grams
(AOAC 968.35)
tamination with animal hair or excreta. Grit—harvest contamination

PEANUTS, SHELLED Multiple defects Average of 5% or more kernels by count are rejects (insect-infested, moldy, rancid, otherwise decom-
(MPM-V89) posed, and dirty)
Insects Average of 20 or more whole insects or equivalent in 100-pound bag siftings
(MPM-V89)
DEFECT SOURCE: Insect infested—postharvest and/or processing infestation. Moldy—preharvest and/or postharvest and/or processing infection. Ran-
cid & decomposed—postharvest abuse. Dirty—harvest contamination
PEANUTS, UN- Multiple defects Average of 10% or more peanuts by count are rejects (insect-infested, moldy, rancid, otherwise decom-
SHELLED (MPM-V89) posed, and dirty)
DEFECT SOURCE: Insect infested—postharvest and/or processing infestation. Mold—preharvest and/or postharvest and/or processing infection. Ran-
cid & decomposed—postharvest abuse
PEAS: BLACK-EYED, Insect damage Average of 10% or more by count of class 6 damage or higher in minimum of 12 subsamples
COWPEAS, FIELD (MPM-V104)
PEAS, DRIED
DEFECT SOURCE: Preharvest and/or postharvest insect infestation
PEAS, COWPEAS, Insect larvae Average of 5 or more cowpea curculio larvae or the equivalent per No. 2 can
BLACK-EYED PEAS (MPM-V104)
(SUCCULENT),
CANNED
DEFECT SOURCE: Preharvest and/or postharvest insect infestation
PEAS AND BEANS, Insect filth Average of 5% or more by count insect-infested and/or insect-damaged by storage insects in a mini-
DRIED (MPM-V104) mum of 12 subsamples
DEFECT SOURCE: preharvest and/or postharvest and/or processing infestation


PEPPER, WHOLE Insect filth and/or Average of 1% or more pieces by weight are infested and/or moldy
(BLACK & WHITE) insect-mold
(MPM-V39)
(MPM-V39)
Foreign matter Average of 1% or more pickings and siftings by weight
(MPM-V39)
DEFECT SOURCE: Insect infested—postharvest and/or processing infestation. Moldy—postharvest and/or processing infection. Mammalian excreta—
postharvest and/or processing animal contamination. Foreign material—postharvest contamination
SIGNIFICANCE: Aesthetic. Potential health hazard—mammalian excreta may contain salmonella
PEPPER, GROUND Insect filth Average of 475 or more insect fragments per 50 grams
(AOAC 972.40)
(AOAC 972.40)
PINEAPPLE, CANNED Mold Average mold count is 20% or more

(AOAC 970.75, OR
MPM-V73) The mold count of any 1 subsample is 60% or more
DEFECT SOURCE: Processing mold contamination
PINEAPPLE JUICE Mold Average mold count is 15% or more

(AOAC 970.75) OR
The mold count of any 1 subsample is 40% or more
DEFECT SOURCE: Processing mold contamination

PLUMS, CANNED Rot Average of 5% or more plums by count with rot spots larger than the area of a circle 12 mm in diam-
(MPM-V51) eter
POPCORN Rodent filth 1 or more rodent excreta pellets are found in 1 or more subsamples, and 1 or more rodent hairs are
(AOAC 950.91) found in 2 or more other subsamples
OR
2 or more rodent hairs per pound and rodent hair is found in 50% or more of the subsamples
OR
20 or more gnawed grains per pound and rodent hair is found in 50% or more of the subsamples
Field corn 5% or more by weight of field corn
DEFECT SOURCE: Rodent excreta—postharvest and/or processing animal contamination. Rodent hair—postharvest and/or processing contamination with
animal hair or excreta. Rodent gnawing—postharvest and/or processing damage. Field corn—harvest contamination
POTATO CHIPS Rot Average of 6% or more pieces by weight contain rot

(MPM-V113)
PRUNES DRIED AND Multiple defects Average of a minimum of 10 subsamples is 5% or more prunes by count are rejects (insect-infested,
DEHYDRATED, (MPM-V53) moldy or decomposed, dirty, and/or otherwise unfit)
LOW-MOISTURE
DEFECT SOURCE: Insect infested—preharvest infestation, Moldy & decomposed—preharvest infection, Dirty—harvest contamination, Otherwise unfit—
preharvest condition
PRUNES, PITTED Pits Average of 2% or more by count with whole pits and/or pit fragments 2 mm or longer and 4 or more
(MPM-V53) of 10 subsamples of pitted prunes have 2% or more by count with whole pits and/or pit fragments 2
mm or longer
DEFECT SOURCE: Processing
SIGNIFICANCE: Mouth/tooth injury

PUREE, APRICOT, Mold Average mold count is 12% or more
PEACH AND PEAR (AOAC 982.33)
DEFECT SOURCE: preharvest and/or postharvest and/or processing infection
RAISINS, NATURAL & Mold Average of 10 subsamples is 5% or more, by count, moldy raisins
GOLDEN (MPM-V76)
Sand and Grit Average of 40 mg or more of sand and grit per 100 grams of natural or golden bleached raisins
(MPM-V76)
DEFECT SOURCE: Mold—postharvest and/or processing infection. Sand—postharvest contamination
RAISINS, GOLDEN Insects and insect 10 or more whole or equivalent insects and 35 Drosophila eggs per 8 oz.
eggs
(AOAC 969.42 &
MPM-V76)
DEFECT SOURCE: Postharvest and/or processing infestation
SAGE, WHOLE PLANT, Insect filth Average of 5% or more pieces by weight are insect infested
UNPROCESSED (MPM-V32)
Mammalian excreta Average of 1 mg or more per pound after processing
(MPM-V32)
DEFECT SOURCE: Insect infested—preharvest and/or postharvest and/or processing infestation. Mammalian excreta—postharvest and/or processing ani-
mal contamination

SAGE, GROUND Insect filth Average of 200 or more insect fragments per 10 grams
(AOAC 985.38)
(AOAC 985.38)
DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing infestation. Rodent hair—postharvest and/or processing contamina-
SALMON, CANNED Decomposition 2 or more Class 3 defective cans, regardless of lot or container size
OR
2 to 30 Class 2 and/or Class 3 defective cans as required by sampling plan based on lot size and con-
tainer size
NOTE: A defective can is defined as one that contains Class 2 or Class 3 decomposition—see FISH
product listing. Sampling plan tables are available on request from FDA
DEFECT SOURCE: Postharvest and/or processing temperature abuse
SAUERKRAUT Insects Average of more than 50 thrips per 100 grams

(AOAC 955.45)
SESAME SEEDS Insect filth Average of 5% or more seeds by weight are insect-infested or damaged
(MPM-V32)
Mold Average of 5% or more seeds by weight are decomposed
(MPM-V32)
Mammalian excreta Average of 5 mg or more mammalian excreta per found
(MPM-V32)
Foreign matter Average of 0.5% or more foreign matter by weight
(MPM-V32)
DEFECT SOURCE: Insect infested—preharvest and/or postharvest and/or processing infestation. Mold—preharvest infection. Mammalian excreta—post-
harvest and/or processing animal contamination. Foreign matter—post processing and/or processing contamination


SHRIMP: UNPRO- Decomposition 5% or more are Class 3 or 20% or more are Class 2 decomposed as determined by organoleptic exami-
CESSED, FRESH nation in 2 or more subsamples
(OR) FROZEN OR
If percentage of Class 2 shrimp plus 4 times percent of Class 3 equals or exceeds 20% in 2 or more
subsamples
Indole levels of 25 µg/100 gm to 49 µg/100 gm for both original and check analysis confirm Class 2
decomposition; levels equal or greater than 50 µg/100 gm confirm Class 3 decomposition. The ab-
sence of indole, however, does not prove the absence of decomposition.
SHRIMP: PROCESSED, Decomposition 2 or more subsamples classified as decomposed

COOKED (OR) FRO-
ZEN, (CANNED) Subsamples are classified by organoleptic examination as Acceptable (Passed) or decomposed (Failed)
based on the presence or absence of odors of decomposition.
Subsamples may also be classified as decomposed if they contain indole equal or greater than 25 µg/
100 gm. for both original and check analysis
SPICES, LEAFY, Insect filth and/or Average of 5% or more pieces by weight are insect-infested and/or moldy
OTHER THAN BAY mold
LEAVES (MPM-V32)
Mammalian excreta Average of 1 mg or more of Mammalian excreta per pound after processing
(MPM-V32)
DEFECT SOURCE: Insect infested—preharvest and/or postharvest and/or processing infestation. Mold—preharvest and/or postharvest and/or processing
infection. Mammalian excreta—postharvest and/or processing animal contamination

SPINACH, CANNED Insects and mites Average of 50 or more aphids, thrips and/or mites per 100 grams
OR FROZEN (AOAC 974.33) OR
2 or more 3 mm or longer larvae and/or larval fragments or spinach worms (caterpillars) whose aggre-
gate length exceeds 12 mm are present in 24 pounds
OR
Leaf miners of any size average 8 or more per 100 grams or leaf miners 3 mm or longer average 4 or
more per 100 grams
DEFECT SOURCE: Preharvest infestation
STRAWBERRIES: FRO- Mold Average mold count of 45% or more and mold count of at least half of the subsamples is 55% or
ZEN WHOLE OR (AOAC 952.22) more
SLICED
Grit Berries taste gritty
DEFECT SOURCE: Mold—postharvest and/or processing infection. Grit—harvest contamination
THYME, WHOLE Insect filth Average of 5% or more pieces by weight are insect infested and/or moldy
PLANT, UNPRO- (MPM-V32)
CESSED
Mammalian excreta Average of 1 mg or more mammalian excreta per pound after processing
(MPM-V32)
DEFECT SOURCE: Insect infested—preharvest and/or postharvest and/or processing infestation. Mold—preharvest and/or postharvest and/or processing
infection. Mammalian excreta—postharvest and/or processing animal contamination
THYME, GROUND Insect filth Average of 925 or more insect fragments per 10 grams
(AOAC 975.49)
(AOAC 975.49)
DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing infestation Rodent hair—postharvest and/or processing contamina-


THYME, UNGROUND, Insect filth Average of 325 insect fragments or more per 10 grams
PROCESSED (AOAC 975.49)
Rodent filth Average of 2 rodent hairs or more per 10 grams
(AOAC 975.49)
DEFECT SOURCE: Insect fragments—preharvest and/or postharvest and/or processing insect infestation, Rodent hair—postharvest and/or processing con-
TOMATOES, CANNED Drosophila fly Average of 10 or more fly eggs per 500 grams

(AOAC 955.46) OR
5 or more fly eggs and 1 or more maggots per 500 grams
OR
2 or more maggots per 500 grams
TOMATOES, CANNED, Mold Average mold count in 6 subsamples is 15% or more and the counts of all of the subsamples are more
WITH (OR) WITH- (AOAC 945.90) than 12%
OUT JUICE (BASED
ON DRAINED JUICE)
DEFECT SOURCE: Preharvest and/or postharvest and/or processing infection
TOMATOES, CANNED Mold Average mold count in 6 subsamples is 29% or more and the counts of all of the subsamples are more
PACKED IN TO- (AOAC 945.90) than 25%
MATO PUREE
(BASED ON
DRAINED LIQUID)

TOMATO JUICE Drosophila fly Average of 10 or more fly eggs per 100 grams
(AOAC 955.46) OR
OR
2 or more maggots per 100 grams, in a minimum of 12 subsamples
Mold Average mold count in 6 subsamples is 24% or more and the counts of all of the subsamples are more
(AOAC 965.41) than 20%
DEFECT SOURCE: Fly eggs & maggots—preharvest and/or postharvest and/or processing insect infestation. Mold—preharvest and/or postharvest and/or
processing infection
TOMATO PASTE, Drosophila fly Average of 30 or more fly eggs per 100 grams

PIZZA AND OTHER (AOAC 955.46) OR
SAUCES 15 or more fly eggs and 1 or more maggots per 100 grams
OR
2 or more maggots per 100 grams in a minimum of 12 subsamples
TOMATO PUREE Drosophila fly Average of 20 or more fly eggs per 100 grams

(AOAC 955.46) OR
OR
2 or more maggots per 100 grams in a minimum of 12 subsamples
TOMATO PASTE (OR) Mold Average mold count in 6 subsamples is 45% or more and the mold counts of all of the subsamples are
PUREE (AOAC 955.46) more than 40%


PIZZA AND OTHER TO- Mold Average mold count in 6 subsamples is 34% or more and the counts of all of the subsamples are more
MATO SAUCES (AOAC 945.92) than 30%
TOMATO SAUCE, UN- Mold Average mold count in 6 subsamples is 45% or more and the mold counts of all of the subsamples are
DILUTED (AOAC 965.41) more than 40%
TOMATO CATSUP Mold Average mold count in 6 subsamples is 55% or more

(AOAC 965.41)
TOMATO POWDER, Mold Average mold count in 6 subsamples is 45% or more and the mold counts of all of the subsamples are
EXCEPT SPRAY- (AOAC 972.42) mold than 40%
DRIED
TOMATO POWDER, Mold Average mold count in 6 subsamples is 67% or more

SPRAY-DRIED (AOAC 972.42)
TOMATO SOUP AND Mold Average mold count in 6 subsamples is 45% or more and the mold counts of all of the subsamples are
TOMATO PROD- (AOAC 945.91) more than 40%
UCTS

TUNA, CANNED Decomposition Odors of decomposition
(AOAC 957.07, OR
977.13) honey-combed tissue
OR
histamine equal to or greater than 5 mg/100 gm in 2 or more cans
TUNA, FRESH, Decomposition Odors of decomposition

FROZEN (AOAC 957.07, OR
977.13) histamine equal to or greater than 5 mg/100 gm
DEFECT SOURCE: Postharvest and/or processing temperature abuse.
WHEAT Insect damage Average of 32 or more insect-damaged kernels per 100 grams
(MPM-V15)
Rodent filth Average of 9 mg or more rodent excreta pellets and/or pellet fragments per kilogram
(MPM-V15)
DEFECT SOURCE: Insect damage—preharvest and/or postharvest and/or processing infestation. Excreta—postharvest and/or processing animal contami-
nation.
WHEAT FLOUR Insect filth Average of 75 or more insect fragments per 50 grams
(AOAC 972.32)
(AOAC 972.32)
tamination with animal hair or excreta.

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FOOD

Marcel Dekker, Inc. New York • Basel

Copyright © 2002 by Marcel Dekker, Inc. All Rights Reserved.

© 2003 by Marcel Dekker, Inc.

This book is printed on acid-free paper.

Eastern Hemisphere Distribution

World Wide Web

Copyright  2003 by Marcel Dekker, Inc. All Rights Reserved.

Current printing (last digit):

PRINTED IN THE UNITED STATES OF AMERICA

© 2003 by Marcel Dekker, Inc.

© 2003 by Marcel Dekker, Inc.

As food professionals, we have noticed the monumental increase in awareness of food

© 2003 by Marcel Dekker, Inc.

PART I. PRINCIPLES OF FOOD PLANT SANITATION

1. An Overview of FDA’s Food Regulatory Responsibilities

2. Foodborne Diseases in the United States

3. The FDA’s GMPs, HACCP, and the Food Code

4. Food Plant Inspections

PART II. FOOD CONTAMINANTS

5. Hard or Sharp Foreign Objects in Food

© 2003 by Marcel Dekker, Inc.

7. Food Defect Action Levels

8. Analysis of Drug Residues in Food

PART III. CLEANING A FOOD PLANT

9. Cleaning and Sanitizing a Food Plant

10. Water in Food Processing

11. Water and HACCP Programs

12. Water Use in the Beverage Industry

13. Sanitation of Food Processing Equipment

PART IV. WORKERS IN A FOOD PROCESSING PLANT

14. Workers’ Personal Hygiene

15. Worker Safety and Regulatory Requirements

16. Worker Training in Sanitation and Personal Safety

17. Worker Safety and Types of Food Establishments

PART V. HOUSEKEEPING IN A FOOD PROCESSING PLANT

18. Rodent Pest Management

003 by Marcel Dekker, Inc.

20. Pest Birds: Biology and Management at Food Processing Facilities

21. Stored-Product Insect Pest Management and Control

PART VI. QUALITY ASSURANCE PROGRAMS

22. An Informal Look at Food Plant Sanitation Programs

23. Sanitation and Warehousing

24. Metal Detection

PART VII. HACCP AND PRODUCT PROCESSING

26. Beverage Plant Sanitation and HACCP

27. Cereal Food Plant Sanitation

28. Plant Sanitation and HACCP for Fruit Processing

29. Sanitation in Grain Storage and Handling

31. Poultry Processing, Product Sanitation, and HACCP

32. Seafood Processing: Basic Sanitation Practices

33. Retail Foods Sanitation: Prerequisites to HACCP

34. Retail Food Processing: Reduced Oxygen Packaging, Smoking,

PART IX. FEDERAL ENFORCEMENT AND FOOD SAFETY PROGRAMS

35. FDA Enforcement and Food Plant Sanitation

36. A Review of U.S. Food Safety Policies and Programs

Appendix A: U.S. Food and Drug Administration Good Manufacturing Practices

© 2003 by Marcel Dekker, Inc.

Daniel W. Bena PepsiCo Beverages International, Purchase, New York, U.S.A.

Henry C. Carsberg Henry C. Carsberg & Associates, Anacortes, Washington, U.S.A.

T. C. Chen Poultry Science Department, Mississippi State University, Mississippi State,

Robert M. Corrigan RMC Pest Management Consulting, Richmond, Indiana, U.S.A.

P. Michael Davidson Department of Food Science and Technology, University of Ten-