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Sanitation and the Food Industry

THE FOOD INDUSTRY enough food each year to feed 128 people.
Even though the number of farms is decreas-
The food system is a complex, concen- ing, overall farm production is increasing,
trated, and dynamic chain of activities that indicating more efficient productivity. This food
begins with the production of raw agricul-tural production efficiency has resulted in a wide
commodities on farms, orchards, and ranches variety of foods being made available to U.S.
and moves to value-added processed and consumers. Proportionally less is spent on food
manufactured products and then to retail food (approximately 10% of disposable income) than
stores and foodservice establish-ments for most consumers in other parts of the world.
(restaurants and institutions) where they are Although the structures of production
merchandised, prepared, and sold to agriculture and farming prac-tices have
consumers. Each sector of the food system is changed dramatically over the years, the result
unique in size, scope, and diversity and has has been a larger, less expen-sive, more
evolved and adapted to changes in demo- diverse, and safer food supply.
graphics and lifestyles, science and technol-
Food Processing and Manufacturing
ogy, and consumer demands. To more fully
comprehend the role of sanitation and food Food and beverage processing facilities
safety in the food industry, it is important to transform raw agricultural materials into
understand the uniqueness of each sector of intermediate foodstuffs or edible products.
the food system. In the United States, there are nearly
29,000 food plants owned by 22,000
Production Agriculture
companies. These plants employ about 1.7
Agriculture is the world’s largest industry million work-ers, which is just over 1% of all
and involves more people than all other U.S. employ-ment.
occupations combined. This industry gener- In recent years, the food processing industry
ates one out of six jobs in the United States. has become more consolidated and concen-
The United States produces more food than trated through mergers and acquisitions. From
any other nation and is the world’s largest 1993 to 2002, there were over 5,800 mergers
exporter of agricultural products. Today, and acquisitions in the food industry. To con-
there are about 2 million farms in the United tinue attracting customers and increase sales,
States and the average farmer produces profits, and market share, food processors are


mergers, acquisitions, divestitures, internal

restructuring and expanding opportunities, growth, and new competitors. There are over
reducing costs, and developing new value- 224,000 food stores in the United States, with
added products. In 2003 there were over grocery stores (including supermarkets,
14,000 new food products developed in the commerce stores, and small grocery stores)
United States. The major focus of this new accounting for more than 96% of food store
product development was on convenience sales. The average retail food store stocks
foods and this trend appears to be continu- between 25,000 and 40,000 food items and
ing with food manufacturers appealing to provides consumers with a wide variety of
on-the-go consumers. products.
Food retailers are striving to increase
Foodservice (Restaurants and Institutions)
customer satisfaction by developing and
There are approximately 878,000 restau-rant expanding prepared and convenience foods
locations in the United States that pro-vide and providing other products and services.
employment for approximately 12 million people Supermarkets are meeting consumer
(almost 9% of the U.S. work-force). demand for convenience by offering a wide
Foodservice outlets account for 84% of variety of products in departments such as
prepared food and meals sold in the United deli foods, prepared for takeout, in-store
States. Since the 1980s, the food serv-ice bakeries, and fresh seafood. Food sanitation
industry has experienced steady growth. plays a very important role in the retail food
Several factors, including demographics, industry because cleanliness is the top factor
organizational issues (labor, outsourcing or that consumers rank as extremely important
contracting of services, and the professional in selecting a supermarket.
attainment of management), culinary trends,
and technology, have driven this growth and
brought about many changes in the food Demographic changes have resulted in an
service industry. The two largest segments of unprecedented shift in the size and structure of
the commercial foodservice industry are full- the U.S. population. Today, there are about 300
service and fast food restaurants. Most eat-ing million people in the United States, with
and drinking establishments are small approximately 3.5 million people being added
businesses, with approximately 70% having each year. The population is also aging. As
fewer than 20 employees. The U.S. restaurant baby boomers reach retire-ment age, the
industry will continue to experience above- proportion of the elderly pop-ulation (65 years
average growth for the foreseeable future due old) is expected to almost double, from 11% in
to favorable demographic trends. Among quick- 1980 to 21% by the year 2030. Hispanics
service restaurants, recruiting and retraining recently became the nation’s largest minority.
employees remains a major chal-lenge. Full- More women are working and postponing
service operators also identified recruiting and marriage and childbearing. There are smaller,
retraining employees in their list of top five less “traditional” families. Today, almost six out
challenges that they will face in the future. of ten women (59.8%) of working age (age 16
and older) are in the workforce. In 2002, U.S.
Food Retailing
consumers spent slightly more than $900 billion
In recent years, the U.S. retail food indus-try on food, and 46% of this was spent on food
has also experienced unprecedented con- away from home. As previously mentioned,
solidations and structural changes through U.S. con-
Sanitation and the Food Industry 3

sumers spent 10.1% of their 2002

disposable personal income on food. This microorganisms. Effective sanitation refers
is the smallest proportion of disposable to all the procedures that help accomplish
income spent on food by any nation. these goals.
These dynamic and significant changes in
Sanitation: An Applied Science
all sectors of the food system highlight the
importance of food safety and sanitation in Sanitation is an applied science that incor-
ensuring a safe and wholesome food supply. porates the principles of design, development,
Each sector needs to work together to assure implementation, maintenance, restoration,
a seamless food safety system. and/or improvement of hygienic practices and
As the food industry has become larger conditions. Sanitation applications refer to
and more concentrated and diversified and hygienic practices designed to maintain a clean
as new hazards have emerged to cause con- and wholesome environment for food
cern, food safety and sanitary practices have production, processing, preparation, and
taken on a new importance in protecting storage. However, sanitation is more than just
public health. Many companies are aggres- cleanliness. Done properly it can improve the
sively addressing food safety issues in their aesthetic qualities and hygienic condi-tions of
facilities to prevent biological, chemical, and commercial operations, public facil-ities, and
physical hazards from causing illnesses and homes. Also, applied sanitary science can
injuries to consumers. These issues have improve waste disposal (see Chapter 12),
increased the need for food workers to which results in less pollution and an improved
understand the critical importance of food ecological balance. Therefore, when effectively
safety and sanitary practices and how to applied, food sanitation and general sanitary
attain and maintain hygienic conditions in practices have a beneficial effect on our envi-
food facilities. Those who comprehend the ronment.
biological basis behind these practices and Sanitation is considered to be an applied
the reasons why they are performed will science because of its importance to the pro-
become more effective in assuring the safety tection of human health and its relationship with
of the products that they grow, manufacture, environmental factors that relate to health.
prepare, and sell. Therefore, this applied science relates to
control of the biological, chemical, and physical
hazards in a food environment. San-itarians
WHAT IS SANITATION? must be familiar with all these haz-ards and
thoroughly understand the basic food
The word sanitation is derived from the Latin microbiology and the organisms that are most
word sanitas, meaning “health.” Applied to the likely to affect human health. By identifying,
food industry, sanitation is “the creation and evaluating, and controlling haz-ards and
maintenance of hygienic and healthful through the effective application of sanitary
conditions.” It is the applica-tion of a science to practices, a safe and wholesome food supply
provide wholesome food processed, prepared, can be assured.
merchandised, and sold in a clean environment
by healthy workers; to prevent contamination
with microorgan-isms that cause foodborne WHY SANITATION?
illness; and to minimize the proliferation of food
spoilage More processing is now conducted at
plants near the area of production, a trend

number of significant benefits for both the

that should continue in the years ahead. public and the businesses conducting the
Many of these food plants are hygienically pro-gram. The old adage, “Sanitation
designed; nevertheless, foods can be con- doesn’t cost, it pays,” says it all.
taminated with spoilage microorganisms or Most owners or managers of food facili-ties
those that cause foodborne illness if proper want a clean and sanitary operation.
sanitary practices are not followed. How- However, unsanitary operations frequently
ever, hygienic and safe foods can be pro- result from a lack of understanding of the
duced with sanitary practices, even in older principles of sanitation and the benefits that
plants. Sanitary practices can be as impor- effective sanitation will provide. The follow-
tant to the wholesomeness and safety of ing brief discussion of these benefits shows
food as are the characteristics of the physi- that sanitation is not a “dirty” word.
cal plant.
With increased productivity, convenience Inspection is becoming more strin-gent
foods and other long shelf-life processed because inspectors are using the
foods are affected by problems created Hazard Analysis Critical Control Point
through advanced technology. The major (HACCP) concept to establish compli-
problems have been with food contamination ance. HACCP-based inspections focus
and waste disposal. on the items critical to the safety of
Few programs provide formal training in foods. Thus, an effective sanitation pro-
food sanitation and food safety assurance. gram is essential.
Only a limited number of institutions offer Foodborne illness can be controlled when
even one course related to food sanitation sanitation is properly implemented in all
and limited resource materials are food operations. Common prob-lems
available to sanitarians. A limited amount caused by poor sanitation are food
of educa-tion and training materials and spoilage through off-odor and flavor.
manuals are published through trade Spoiled foods are objectionable to
associations and regulatory agencies. consumers and cause reduced sales,
Gravani (1997) stated that never in recent increased consumer complaints, and
history have Americans been more con-cerned increased claims. Off-condition pro-ducts
about the quality and safety of the food supply. convey the lack of an effective sanitation
Of approximately 76 million people that become program. When consumers think that they
ill from foodborne ill-nesses, 325,000 are have become ill from food, they notify
hospitalized, and approx-imately 5,000 die in regulatory authorities and often seek
the United States each year. The national compensation for their illness and
economic impact of these illnesses is estimated inconvenience.
to be between $10 bil-lion and $83 billion per An effective sanitation program can
year. improve product quality and shelf life
Some food processing, retail food store, and because the microbial population can be
foodservice operators offer excuses for poor reduced. Increased labor, product loss,
sanitation in their establishment(s). Yet, the packaging costs, and reduced pro-duct
reasons for not establishing such a program are value due to poor sanitation can cause a
more compelling, because they relate to the decrease of 5% to 10% of profit of meat
bottom line of a profit and loss statement. A operations in a supermarket. A well-
sanitation program is “a planned way of developed and well-maintained
practicing sanitation.” It results in a
Sanitation and the Food Industry 5

sanitation program can increase the foodborne illnesses and cause injury. In the
shelf life of food. last several years, there have been some
An effective sanitation program includes major food safety incidents that have made
regular cleaning and sanitizing of all headlines and focused attention on poor san-
equipment in a facility including heat-ing, itary practices in all sectors of the food sys-
air conditioning, and refrigeration tem. Some of these incidents are shown in
equipment. Dirty, clogged coils harbor Table 1–1 and explained below.
microorganisms and blowers and fans During the past decade, a large Salmonella
can spread flora throughout the facility. enteritidis outbreak in ice cream was caused by
Clean and sanitized coils lower the risk of the cross-contamination of pasteurized ice
airborne contamination and can reduce cream mix. The pasteurized mix was trans-
energy and maintenance costs by up to ported from premix plants to a freezing oper-
20%. Insurance carriers may reduce rates ation in tanker trucks that had previously been
for clean establishments as a result of used to haul raw liquid eggs. The eggs were
improved working condi-tions as well as contaminated with S. enteritidis. The hauler was
fewer customer com-plaint claims. supposed to wash and sanitize the trucks
Various, less tangible benefits of an before the ice cream mix was loaded, but this
effective sanitation program include: procedure was often bypassed. Inves-tigators
improved product acceptability, found egg residue in one tanker truck after
increased product shelf life, (c) sat- cleaning and noted soiled gaskets, inad-equate
isfied and perhaps even delighted cus- records, and the lack of inspection and
tomers, (d) reduced public health risks, documentation of cleaning and sanitization
increased trust of regulatory agen-cies procedures. There was a nationwide recall of
and their inspectors, (f) decreased over 6.3 million kg of ice cream products before
product waste and removal, and the incident was resolved. It was esti-mated that
improved employee morale. approximately 224,000 people became ill in this
outbreak. The proper clean-ing and sanitization
Sanitation: A Foundation for Food of the tanker trucks could have prevented this
Safety Assurance incident.
Proper sanitation practices provide the In another large outbreak, Escherichia coli
foundation that food safety assurance sys- 0157:H7 in contaminated and undercooked
tems are built upon. Poor hygienic and sani- ground beef patties caused 732 illnesses and 4
tary practices can contribute to outbreaks of deaths in four states. Ground beef con-
taminated at the meat processing plant was
Table 1–1 Major Food Safety Incidents

Agent Food Effect

S. enteritidis Ice cream ~224,000 ill
E. coli 0157:H7 Hamburgers 732 ill, 4 deaths
Benzene Mineral water Worldwide recall of 160 million bottles
L. monocytogenes Hot dogs 101 ill, 21 deaths
Allergens Many foods 35–40% of U.S. population have food allergies;
150–200 people die each year
Glass Bottled beer 15.4 million bottles were recalled, destroyed,
and replaced

Since trace amounts of the offending food

undercooked in the fast food restaurant, trigger reactions, people with food allergies
resulting in this outbreak. Over 225,000 depend on accurate labels on processed
ground beef patties were recalled from the foods, as well as knowledgeable chefs, wait
chains’ restaurants. This was the largest E. staff, and food workers in foodservice
coli 0157:H7 outbreak in U.S. history and was operations and retail food stores.
estimated to cost between $229 million and In the early 1990s a European beer maker
$610 million. The company took bold, inno- inadvertently used defective glass to make
vative steps to develop a state-of-the-art food export beer bottles. When transported or
safety program and improve its reputation opened, glass splinters could fall into the
and brand image. Today, this company beer and cause injury. No one was injured as
enjoys the reputation of being one of the most a result of the glass splinters, but the beer
strin-gent food safety programs in the manufacturer recalled, destroyed, and
foodservice industry. replaced 15.4 million bottles. At the time, the
During the past, a popular brand of company estimated the loss to be between
imported bottled water was contaminated $10 million and $50 million.
with benzene. The natural gas present in the Major food safety incidents have common
spring water source contained a number of characteristics and include biological, chemi-
impurities. The carbon filters that were used cal, or physical hazards. They occur through-
to remove these impurities became clogged. out the food system and have occurred
A faulty warning light on the process con-trol globally and often result from one or a com-
panel went undetected by employees for 6 bination of factors including:
months, allowing the filters to become
clogged. When the benzene-contaminated
contaminated raw materials
water was discovered, the company recalled
errors in transportation, processing,
160 million bottles of water from 120 coun-
preparation, handling, or storage
tries. This incident was estimated to cost the
packaging problems
bottler about $263 million.
food tampering/malicious
An outbreak of Listeria monocytogenes in
frankfurters resulted in 101 cases of illness
changes in formulation or processing
and 21 deaths in 22 states. Although the
inadequate maintenance of
frankfurters were processed, they were con-
equipment or facilities
taminated after processing and before pack-
addition of incorrect ingredient(s)
aging. It was reported that major renovations
were being made in the processing plant These are examples of the importance of
when the contamination occurred. A nation- sanitation during food processing and prepa-
wide recall of frankfurters made in this plant ration, as well as proper cleaning and sani-
was undertaken to prevent additional cases tizing of food manufacturing and food service
of illness. equipment and facilities. The conse-quences
Today, 2% to 3% of the U.S. adult popula- of improper sanitation are severe and include
tion, or about 11 million Americans, have food loss of sales, reduced profits, damaged
allergies and approximately 150 to 200 people product acceptability, loss of trust and
die each year from food-allergic reactions consumer confidence, adverse publicity,
(Bodendorfer et al., 2004). The prevalence of erosion of brand image, loss of market share
food allergies has increased in the last decade and, sometimes, legal action. Sanitary prac-
and this trend will continue in the years ahead.
Sanitation and the Food Industry 7

tices coupled with an effective food safety

assurance program can prevent these individuals are also at a 200 to 300 times
prob-lems. Moreover, consumers have the higher risk to develop listeriosis. As people
right to expect and receive wholesome and age, their immune system function
safe food products. decreases, so people have a decreased
Foodborne illnesses are a real concern to resistance to pathogens as they get older.
public health professionals, food scientists,
Changes in Consumer Practices
microbiologists, and sanitarians. Today there
are more than 200 known diseases transmit-ted U.S. consumers have varied levels of
through foods and many of the pathogens of awareness of specific microbial hazards, risk
greatest concern were not recognized as factors for foodborne illness. The impor-tance of
causes of foodborne illness 20 years ago. Most good personal hygiene during the preparation
cases of foodborne illness involve gas- and serving of foods. Consumers have a
trointestinal symptoms (nausea, vomiting, and relatively poor knowledge of safe food
diarrhea), and are usually acute, self-limiting, preparation practices in their homes. Overall,
and of short duration, and can range from mild some changes in behavior have occurred, but
to severe. Deaths from acute food-borne consumer habits are still fre-quently less than
illnesses are relatively rare and typically occur ideal. A recent study on handwashing habits
in the very young, the elderly, or in per-sons revealed that only 78% of over 7,500 individuals
with compromised immune systems. The U.S. washed their hands after using public restrooms
Food and Drug Administration (FDA) estimates in airports. This was actually an improvement
that 2% to 3% of all acute food-borne illnesses over a previous study that observed 67% of
develop secondary long-term complications individ-uals washed their hands after using
often referred to as chronic sequelae. These public restrooms.
sequelae can occur in any part of the body such
as the heart, kidney, nervous system, or joints
Changes in Food Preferences and
and can be quite debilitating and, in severe
Eating Habits
cases, can cause death.
In 2002, U.S. consumers spent 46.1% of
There are many factors associated with their food dollar away from home. The sheer
the emergence of “new” foodborne volume of meals prepared each day stresses
pathogens and outbreaks of foodborne the need for knowledgeable, well-trained
illnesses. Some of these factors include: foodservice and retail food store employees
who understand the principles of safe food
Demographics preparation. Food preferences have also
The population aged 65 and older was 35 changed, with many people now eating raw
million in 2000 and is expected to more than foods of animal origin or lightly cooked foods
double by 2050. Significant portions of older that can increase the risk of foodborne
Americans suffer from chronic health condi- illnesses.
tions, including heart disease, cancer, dia-
Complexity of the Food System
betes, and this makes them more susceptible to
foodborne illness. For example, persons with As explained earlier, the food system is a
AIDS or late-stage HIV infections have a 20 complex, concentrated, and dynamic chain of
times higher possibility of developing activities that moves food from farm to table.
salmonellosis than healthy people. These When errors occur, major food inci-dents can
result. Multiple handling of foods

surveillance and responses to outbreaks,

(or ingredients) increases the possibility for improved diagnostic techniques, and better
contamination and subsequent temperature medical interventions when illnesses occur.
abuses. The key is to develop close working More rapid microbial tests have been devel-
relationships and strong networks between and oped, and electronic data bases such as
among the different sectors of the system to FoodNet, PulseNet, and ElexNet have been
assure a safe and wholesome food supply. developed to provide better surveillance of
foodborne illnesses, improved information
Globalization of the Food Supply
sharing, and more rapid responses when out-
The international sourcing of food and breaks occur.
food ingredients has enabled U.S.
Changes in Foodborne Pathogens
consumers to enjoy a consistent supply of
a wide variety of products from around the There have been many changes in the
world. The main concern is that the sanitary microorganisms that cause foodborne ill-
standards and safety assurance systems in nesses. Scientists have observed more viru-
some coun-tries may not be as stringent as lent strains of organisms, where a few cells
those in the United States. can cause severe illness. An example is S.
Today, with increasing international enteritidis and E. coli 0157:H7. Adaptive
travel, a microorganism that causes a prob- stress responses have also been observed
lem in one part of the world can be easily where organisms have adapted to environ-
transported to another country very quickly. mental conditions to survive and grow, such
Rapid detection, early intervention, and as psychrotropic pathogens that grow
vigilance are important in preventing the (slowly) at refrigerated temperatures.
spread of foodborne illness from country to Organisms such as Yersinia enterocolitica,
country. monocytogenes, and Clostridium botu-linum
type E are examples of bacteria capa-ble of
growing at refrigerator temperatures. In
Changes in Food Processing Technologies
recent years increased resistance to
As the food industry strives for fresher antibiotics has been observed in Salmonella
products and longer shelf life products, prod-uct typhimurium DT104. A number of out-breaks
developers must be aware of how compo-sition, in produce and unpasturized apple cider
processing parameters, packaging systems, have been caused through the proto-zoan
and storage conditions influence the parasites Cyclospora cayetanensis and
microorganisms that are present. Food safety Cryptosporidium parvum.
must be built into the product while it is being All of these factors have played and con-
developed or reformulated. There has been a tinue to play a role in the emergence of
greater awareness of the environmen-tal food-borne pathogens and foodborne
conditions in processing plants, retail food illnesses. In a discussion of food safety
stores, and foodservice establishments and the issues, a chief executive officer (CEO) of a
need to ensure that biofilms and micro-bial small retail food chain made the following
niches do not develop. comment: “Today, we’re facing a new
enemy; it is not business as usual.” This
statement clearly describes the fact that we
Diagnostic Techniques
live in a changing world and must be
In the last decade, there have been sig- proactive in assuring food safety.
nificant improvements in foodborne disease
Sanitation and the Food Industry 9


REGULATIONS AND GUIDELINES ments, and training for positions that
require certification.
Since thousands of laws, regulations, and Regulation development is a multistep
guidelines are currently in effect to control the process. For example, in the federal process,
production, processing, and preparation of food the relevant agency prepares the proposed
in the United States, it would be impossible to regulation, which is then published as a pro-
address all of these rules in this book. Thus, it posed rule in the Federal Register. The Federal
is not the intent of this chap-ter or this book to Register is the official daily publication for rules,
emphasize the specific details of food proposed rules, and notices of federal agencies
processing, or preparation, regulations. Only and organizations as well as execu-tive orders
the major agencies involved with food safety and other presidential documents.
and their primary respon-sibilities are Accompanying the proposal is information
discussed. The reader should consult related to background. Any comments, sug-
regulations available from various jurisdictions gestions, or recommendations are to be
to determine specific require-ments for the food directed to the agency, usually within 60 days
operation and area where it is located. It is after proposal publication, although time
inappropriate to discuss regulatory extensions are frequently provided. The regu-
requirements for cities and coun-tries because lation is published in final form after com-ments
they have designated govern-mental entities on the proposal have been reviewed, with
with their own food safety criteria (Bauman, another statement of how the comments were
1991), which often differ from one area to handled and specifying effective dates for
another and can change periodically. compliance. This statement suggests that
comments on matters not previously consid-
Sanitation requirements developed by leg- ered in the regulations may be submitted for
islative bodies and regulatory agencies in further review. Amendments may be initiated by
response to public demands are detailed in any individual, organization, other govern-ment
laws and regulations. They are not static but office, or by the agency itself. A petition is
change in response to sanitation, pub-lic necessary, with appropriate documents that
health, and new scientific and technical justify the request.
information regarding biological, chemical, There are two types of regulations: sub-
and physical hazards and other important stantive and advisory. Substantive regula-
issues brought to public attention. tions are more important because they have
Laws are passed by legislators and must be the power of law. Advisory regulations are
signed by the chief executive. After a law has intended to serve as guidelines. Sanitation
been passed, the agency responsible for its regulations are substantive because food
enforcement prepares regulations designed to must be made safe for the public. In regula-
implement the intention of the law or the act. tions, the use of the word shall means a
Regulations are developed to cover a wide requirement, whereas should implies a rec-
range of requirements and are more specific ommendation. Several regulations impor-tant
and detailed than are laws. Regulations for food to sanitation by various governmental
provide standards for building design, agencies will now be addressed.
equipment design, commodities, tolerances for
Food and Drug Administration Regulations
chemical or other food additives, sanitary
practices and qualifications, labeling require- The FDA, responsible for enforcing the
Food, Drug, and Cosmetic Act, as well as

The FDA does not approve cleaning com-

other statutes, has wide-ranging authority. It pounds and sanitizers for food plants by their
is under the jurisdiction of the U.S. trade names. However, the FDA regula-tions
Department of Health and Human Services. indicate approved sanitizing compounds by
This agency has had a profound impact on their chemical names. For example, sodium
the food industry, especially in the control of hypochlorite is approved for “bleach-type”
adulterated foods. Under the Food, Drug, and sanitizers, sodium or potassium salts of
Cosmetic Act, food is considered to be isocyanuric acid for “organic chlorine” sani-
adulterated if it contains any filth or putrid tizers, n-alkyldimethylbenzyl ammonium
and/or decomposed material or if it is other- chloride for quaternary ammonium products,
wise unfit as food. This act states that food sodium dodecylbenzenesulfonate as an acid
prepared, packed, or held under unsanitary anionic sanitizer component, and oxypoly-
conditions that may cause contamination ethoxy–ethanol–iodine complex for iodophor
from filth or that is injurious to health is sanitizers. A statement of maximum allow-able
adulterated. The act gives the FDA inspector use concentrations for these compounds
authority, after proper identification and without a potable water rinse on product con-
presentation of a written notice to the per-son tact surfaces after use is also provided.
in charge, to enter and inspect any estab-
lishment where food is processed, packaged, Good Manufacturing Practices
or held for shipment in interstate commerce On April 26, 1969, the FDA published the
or after shipment. Also, the inspector has the first Good Manufacturing Practice (GMP)
authority to enter and inspect vehicles used regulations, commonly referred to as the
to transport or hold food in interstate com- umbrella GMPs. These regulations deal pri-
merce. This official can check all pertinent marily with sanitation in manufacturing,
equipment, finished products, containers, processing, packing, or holding food.
and labeling. The sanitary operations section establishes
Adulterated or misbranded products that basic minimum rules for sanitation in a food
are in interstate commerce are subject to establishment. General requirements are pro-
seizure. Although the FDA initiates action vided for the maintenance of physical facili-ties;
through the federal district courts, seizure cleaning and sanitizing of equipment and
is performed by the U.S. Marshal’s office. utensils; storage and handling of clean
Legal action can also be taken against equipment and utensils; pest control; and the
an organization through an injunction. This proper use and storage of cleaning com-
form of legal action is usually taken when pounds, sanitizers, and pesticides. Minimum
serious violations occur. However, the FDA demands for sanitary facilities are included
can prevent interstate shipments of through requirements for water, plumbing
adulter-ated or misbranded products by design, sewage disposal, toilet and hand
requesting a court injunction or restraining washing facilities and supplies, and solid waste
order against the involved firm or disposal. There is also a short section on
individual. This order is effective until the education and training of employees. Spe-cific
FDA is assured that the violations have GMPs supplement the umbrella GMPs and
been corrected. To correct flagrant emphasize wholesomeness and safety of
violations, the FDA has taken legal steps several manufactured products.
against finished products made from Each regulation covers a specific industry
interstate raw materials, even though they or a closely related class of foods. The criti-
were never shipped outside the state.
Sanitation and the Food Industry 11

cal steps in the processing operations are

U.S. Department of Agriculture Regulations
addressed in specific detail, including time-
and-temperature relationships, storage con- The U.S. Department of Agriculture
ditions, use of additives, cleaning and (USDA) has jurisdiction over three areas of
sanitizing, testing procedures, and special- food processing, based on the following
ized employee training. laws: the Federal Meat Inspection Act, the
According to Marriott et al. (1991), Poultry Products Inspection Act, and the
inspections are used by regulatory agencies Egg Products Inspection Act. The agency
to assure compliance with food safety regu- that administers the area of inspection is
lations. However, this approach has limita- the Food Safety and Inspection Service
tions because laws that are supposed to be (FSIS), established in 1981.
enforced by inspectors are frequently not By design, federal jurisdiction usually
clearly written, and what constitutes compli- involves only interstate commerce. However,
ance is questionable. Furthermore, it is the three statutes on meat, poultry, and eggs
sometimes difficult to distinguish between have extended USDA jurisdiction to the
requirements critical to safety and those intrastate level if state inspection programs
related to aesthetics. In recent years, regula- are unable to provide proper enforcement as
tory agencies have recognized these required by federal law. Products shipped
problems and revised their inspection from official USDA-inspected plants into
procedures and forms. Now, many agencies distribution channels and subsequently iden-
have two major categories to differentiate tified as adulterated or misbranded come
between food safety items and aesthetic under the jurisdiction of the Food, Drug, and
issues. There are critical deficiencies that Cosmetic Act. The FDA can take legal steps
address items that when left unattended to remove this product from the mar-ket.
could lead to food-borne illness and general Normally, the product is referred back to the
deficiencies related to aesthetic items. USDA for disposition.
In 1995, the FDA issued the procedures In 1994, the FSIS began an evaluation,
for the Safe and Sanitary Processing and review, and revision of existing food safety
Import of Fish and Fishery Products; Final regulations for meat and poultry. This review
Rule, which is the Seafood HACCP led to the 1996 publication of the Pathogen
regulation. This first HACCP regulation in Reduction; Hazard Analysis and Critical
the United States requires processors of Control Points (PR/HACCP) Final Rule. The
fish and fishery products to develop and objective of this new regulation was to reduce
implement HACCP systems for their oper- foodborne illnesses associated with meat
ations. and poultry products. The meat and poultry
As a consequence of several large food- HACCP regulation requires all meat and
borne outbreaks related to raw juices poultry slaughter and processing estab-
processed in commercial facilities, the FDA lishments to design and implement an
published a final rule in 2001 mandating HACCP system for their operations.
that all juices processed for inter- or As a consequence of several large food-
intrastate sale be produced under an borne outbreaks related to raw juices
HACCP plan. This rule was designed to processed in commercial facilities, FDA pub-
improve the safety of fruit and vegetable lished a final rule in 2001 mandating that all
juice and juice prod-ucts and is known as juices processed for inter- or intrastate sale
the Juice HACCP regulation. be produced under an HACCP plan. This rule
was designed to improve the safety of

standards have been developed specific to

fruit and vegetable juice and juice prod- industry groups or product groups. Regu-
ucts and is known as the Juice HACCP reg- lations for meat products and selected
ulation. seafood products, grain and cereal products,
dairy products, selected fruit and vegetable
Environmental Regulations
products, and beet and cane sugar refining
The Environmental Protection Agency are published by the EPA.
(EPA) enforces provisions for numerous
statutes related to the environment, many of
Clean Air Act
which affect food establishments. Environ- This act, devised to reduce air pollution,
mental regulations that affect sanitation of the gives the EPA direct control over polluting
food facility include the Federal Water sources in the industry, such as emission con-
Pollution Control Act; Clean Air Act; Fed-eral trols on automobiles. Generally, state and local
Insecticide, Fungicide, and Rodenticide Act agencies set pollution standards based on EPA
(FIFRA); and the Resource Conserva-tion recommendations and are responsi-ble for their
and Recovery Act. enforcement. This statute is of concern to the
The EPA is involved in the registration of food operation that may dis-charge air
sanitizers by both their trade and chemical pollutants through odors, smoke-stacks,
names. Sanitizing compounds are recognized incineration, or other methods.
through federal regulators as pesticides; thus,
their uses are derived from the FIFRA. The EPA Federal Insecticide, Fungicide,
requires environmental impact, antimicrobial and Rodenticide Act
efficacy, and toxicologic pro-files. Furthermore, The FIFRA authorized EPA control of the
specific label information and technical manufacture, composition, labeling, clas-
literature that detail recom-mended use of sification, and application of pesticides.
applications and specific directions for use are Through the registration provisions of the act,
required. Disinfectants must be identified by the the EPA must classify each pesticide either
phrase: “It is a vio-lation of federal law to use for restricted use or for common use, with
this product in a manner inconsistent with its periodic reclassification and registra-tion as
labeling.” necessary. A pesticide classified for
restricted use must be applied only by or
under the direct supervision and guidance of
Federal Water Pollution Control Act
a certified applicator. Those who are certi-
This act is important to the food industry fied, either by the EPA or by a state, to use or
because it provides for an administrative per- supervise the use of restricted pesticides
mit procedure for controlling water pollu-tion. must meet certain standards, demonstrated
The National Pollutant Discharge Elimination through written examination and/or per-
System (NPDES), which is under this permit formance testing. Commercial applicators
system, requires that industrial, municipal, are required to have certain standards of
and other point-source dischargers obtain competence in the specific category in which
permits that estab-lish specific limitations on they are certified.
the discharge of pollutants into navigable Current EPA regulations permit the use of
waters. The pur-pose of this permit is to effect certain residual insecticides for crack and
the gradual reduction of pollutants crevice treatment in food areas of food estab-
discharged into streams and lakes. Effluent lishments. The EPA lists residual pesticides
guidelines and
Sanitation and the Food Industry 13

that are permitted in crack and crevice treat-

ment during an interim period of 6 months, fishery products, juice, and meat and poul-
while registrants apply for label modification. try). Because of the importance of HACCP
this subject is be discussed in detail in
Resource Conservation and Recovery Act
Chapter 7.
Through the Resource Conservation and
Recovery Act, a national program was
designed to control solid waste disposal. ESTABLISHMENT OF SANITARY
The act authorizes the EPA to recommend PRACTICES
guide-lines in cooperation with federal,
state, and local agencies for solid waste Sanitation, good manufacturing practices,
management. It also authorizes funds for and other environmental and operating con-
research, con-struction, disposal, and ditions necessary for the production of safe,
utilization projects in solid waste wholesome food are known as prerequisite
management at all regulatory levels. programs. These prerequisite programs pro-
vide the foundation for HACCP and are a vital
Hazard Analysis Critical Control Points component in a company food safety
Although other voluntary programs have assurance system. So, the design and devel-
been developed in the United States and opment of this entire system in a food facil-ity
throughout the world, the HACCP concept is the begins with the establishment of basic
approach that is being emphasized. After this sanitary practices.
concept was developed jointly through the The employer is responsible for establish-
Pillsbury Company, the National Aeronautics ing and maintaining sanitary practices to
and Space Administration (NASA) and the U.S. protect public health and maintain a positive
Army Natick Labora-tories in the late 1960s image. The problem of establishing, imple-
adopted this concept for use in the space menting, and maintaining sanitary practices
program. Recognizing its application in other within the food industry is certainly a chal-
areas, the HACCP con-cept was shared with lenge. The sanitarian or person in charge of
the food industry at the 1970 Conference for this important area must assure that the san-
Food Protection. Since then it has been itary practices keep low-risk potential haz-
adopted as a voluntary or mandatory program ards from becoming serious hazards that
to assure food safety through the identification, could cause illness or injury. The sanitarian is
evaluation, and control of biological, chemical, both the guardian of public health and the
and physical hazards in a food facility. A large counselor to company management on qual-
number of these hazards are clearly affected by ity and safety issues that are influenced by
the effectiveness of sanitary measures sanitary practices.
adopted. Although HACCP was initially A large food processing company should
voluntary, several regulations that have been have a separate food safety department on the
previously mentioned were developed by FDA same organizational level as production. It
and USDA that require HACCP plan develop- should have a separate food safety depart-ment
ment, implementation, and maintenance in on the same organizational level, as production
specific sectors of the food industry and have or research, that is responsible for food safety
changed the status of this program from at all operating plants. A san-itation department
voluntary to mandatory (seafoods and or team should exist in a plant on a level with
other departments. In a large organization,
sanitation should be

contamination. All phases of food produc-tion

separated from production and mechanical and plant sanitation should be included in the
maintenance, an arrangement that will program to supplement the cleaning and
enable the sanitation department team to sanitizing procedures for equipment in the
exercise company-wide surveillance of facility. A safety assurance program should
sanitary prac-tices and maintain a high level start with compliance inspection and audit of
of activity. Production practices, quality the entire facility.
control, and sanitary practices are not always The inspection and audit should be com-
compatible when administered by a single prehensive and critical. As each item is con-
department or individual; but all of these sidered, the ideal solution should be noted,
functions are complementary and are best irrespective of cost. When the audit is com-
performed when properly coordinated and pleted, all items should be reevaluated and
synchro-nized. more practical and/or economic solutions
Ideally, an organization should have a full- determined. All items that need attention should
time sanitarian with assistants, but this is not be prioritized and an action plan for completion
always practical. Instead, a trained individ-ual should be established. Attention should be
who was originally employed as a quality clearly focused on critical deficien-cies
control technician, a production foreman, a throughout the facility. Aesthetic sani-tary
superintendent, or some other individual practices should not be adopted without clear
experienced in production can be charged evidence of their ability to pay divi-dends in
with the responsibility of the sanitation increased sales or because they are necessary
operation. This situation is common and to meet competitive sales pressure.
usually effective. However, unless the sani-
tarian has an assistant to take care of some
of the routine tasks and is given sufficient SUMMARY
time for proper attention to sanitary details,
the program may not succeed. Large-volume food processing, retail, and
one-person safety assurance depart- preparation operations have increased the
ment with a full schedule of control work will need for sanitary practices and hygienic
be generally inadequate to assume the tasks conditions in the food industry. Even in
of a sanitarian. However, with proper hygienically designed plants, foods can be
assistance, quality assurance and sanitation contaminated with spoilage microorgan-isms
supervision can be successfully conducted or those causing foodborne illness if proper
through a qualified individual that can divide sanitary practices are not properly followed.
his or her effort between sanitation and
quality assurance. It is beneficial for this Sanitation is the creation and maintenance of
person to have the advice and service of an hygienic and healthful conditions. It is an
outside agency, such as a university, trade applied science that incorporates principles
association, or private consultant, to avoid regarding the design, development, imple-
becoming submerged in the conflicting inter- mentation, and maintenance of hygienic
ests of different departments. The extra practices and conditions. Sanitation is also
expense can be a worthwhile investment. considered to be a foundation for food safety
planned sanitation maintenance pro- assurance systems.
gram is essential to meet legal requirements The Food, Drug, and Cosmetic Act covers
and protect brand and product reputation, food commodities, except meat and poultry
product safety, quality, and freedom from
Sanitation and the Food Industry 15

products, from harvest through processing

and distribution channels. Meat and poultry What is a substantive regulation?
products are under the jurisdiction of the What is the significance of HACCP?
USDA. GMP regulations are specific require- What are examples of how micro-
ments developed to establish minimum crite- organisms can mutate?
ria for sanitation practices. A number of Which acts affect environmental
statutes related to pollution control of the air, regu-lations in the food industry?
water, and other resources are enforced What are prerequisite programs?
through the EPA. Which U.S. agency administers the
The progressive company, including food Clean Air Act?
processors, food retailers, and foodservice
operators, should take responsibility for REFERENCES
establishing and maintaining sanitary prac-
tices. An effective sanitation program that is the Bauman, H.E. 1991. Safety and regulatory aspects. In Food
foundation of a food safety assurance system is product development, ed. E. Graf and I.S. Saguy, 133.
essential to meet regulatory require-ments; New York: Van Nostrand Reinhold.
Bodendorfer, C., Johnson, J., and Hefle, S. 2004. Got
protect brand, image, and product reputation; (hidden) food allergies? Natl Provisioner 218: 52.
and ensure product safety, qual-ity, and Gravani, R.B. 1997. Coordinated approach to food safety
edu-cation is needed. Food Techol 51, no. 7: 160.
freedom from contamination.
Marriott, N.G. et al. 1991. Quality assurance manual for the
food industry. Virginia Cooperative Extension, Virginia
Polytechnic Institute and State University, Blacksburg.
Publication No. 458-013.


What is sanitation? National Restaurant Association Educational Foundation.

What is a law? 1992. Applied foodservice sanitation. 4th ed., New York:
John Wiley & Sons. In cooperation with the Education
What is a regulation? Foundation of the National Restaurant Association,
What is an advisory regulation? Chicag