Regulating the Quality and

Safety of Foods
 The Elements of Food Safety

Law Safety
Policy Science
Safety System Basics
• Onlysafe and wholesome foods may be
marketed
• Regulatory decision-making is science-based
• Government has enforcement responsibility
• Manufacturers, distributors, importers, and other
are expected to comply and face liability for
noncompliance
• Regulatory process is transparent and accessible
to the public
National Food Safety Initiative

• Food safety from farm to table

• New interagency strategy to prevent
food borne disease
• Assesses current system of regulation
• Recommends actions to improve food
safety
Food Borne Illness Outbreaks
Hudson Foods
• Largest recall of beef in U.S. history
• 25 million pounds
• Escherichia coli 0157:H7
• Supplier to Burger King and Safeway
• Fined $332,000 by OHSA
Scope of Regulatory Responsibility

• 6,100 meat and poultry processing facilites

• 50,000 food establishments
• 537,000 commercial restaurants
• 172,000 institutional food programs
• 190,000 retail stores
• 70,000 separately labeled food products
The Problem

• Resistance and virulence of emerging pathogens

• Patchwork system of food safety regulation
• Lack of an effective, low cost method of ensuring
safety of food
products
• Lack of regulatory oversight beyond commercial
facilities
• Lack of effective consumer education programs
Food Safety Regulation

 12 different federal agencies

derive their authority over food
products from 35 different federal
statutes
 US spents >$1 billion annually on

Food Safety Regulation

 Federal Agencies with some
jurisdiction over food products

FDA USDA FTC EPA

(Advertising) (Pesticides)

CDC US Customs DOT NOAA

(Foodborne illness) (Imports) (Transportation) (Seafood HACCP Training)

CVM AMS CFSAN APHIS

(Veterinary Medicine) (Shell Eggs surveillance) (Border quarantines)

DOC FSIS ERS

BATF (food safety education)
(Alcohol and Firearms)
Scientific Issues in Food Safety
 Hazard Identification
 Microbiology
 Chemistry
 Toxicology
 Epidemiology
 Risk Assessment
 HACCP /Quality Systems
 Zero tolerance
 Lethal Processing Step
Regulatory Issues:

• Food Additive • Responsibility

Regulation (liability)
• Labeling • Food Irradiation
• Novel Food • Genetic Modifications
Processing
• Consumer protection
• Standardization
Policy Issues

• Risk Assessment
• Centralization (Food Czar)
• Strict Liability
• Global Harmonization and
Standardization
• GATT / NAFTA (Fortress Europe)
Consumer Expectations
 Consumers expect safe, hazard free
food
 Responsibility is shared by:
 food producers
 processors
 purveyors
 regulatory agencies
Safety:
• Freedom from danger, risk or injury
• Any of the various devices designed to
prevent accident such as a gun lock
• A play in which a member of the offensive
team is forced to down the football in his
own end zone
Good Manufacturing Practices
(GMPs)
Regulation vs Cooperation
 FDCA gave authority and responsibility to
FDA for ensuring safety in food supply
 FDCA prohibits poisonous or deleterious
substances in food
 GMPs reference in FDCA states:
 food is adulterated if it may have been
rendered injurious to health by conditions
under which it was prepared, packed or held...
Food borne illness
 24 million people per year
 cost of $7 billion
 10,000 deaths
 mishandling at retail level is a factor
 12 million workers in 1 million establishments
 regulatory agencies alone cannot prevent
 cooperation with industry required
Adulteration under the FDCA

 Food MAY be adulterated if-

 prepared under insanitary conditions
 proof of actual adulteration not

necessary
 proof of illness not necessary

 conditions under which food is

prepared, packed, or held is
determinant
Good Manufacturing Practices

 Procedures developed to ensure production

of safe, wholesome foods and to provide safe
working environment
 Not "process specific", relate to entire
operation
 GMPs include facilities/grounds, equipment
pest control, receiving and storage, process
control, product recall and personnel training.
First proposal for GMPs:
 proposed rule December, 1968
 final rule April, 1969
 original GMPs regulation very broad
 FDA then attempted to develop specific
industry GMPs
 FDA concluded it was more effective to
strengthen “umbrella” GMPs
 revisions to GMPs in 1986
Product specific GMPs

 thermally processed low-acid

canned foods
 acidified foods
 bottled drinking water
GMPs Regulations
 21CFR Part 110
 Subpart A - General Provisions
 Subpart B - Building and Facilities
 Subpart C - Equipment
 Subpart D - [Reserved]
 Subpart E - Production and Process Controls
 Subpart F - [Reserved]
 Subpart G - Defect Action Levels
GMPs Regulations

 written as mandatory requirements

 consistent use of “shall” rather than
“should”
 GMPs used in inspections of plant
and warehouses
GMPs - General Provisions

 provides definitions
 important in understanding implications and
applications
 personnel
 management has responsibility for
performance of personnel
GMP’s - Buildings and Facilities

 buildings must be designed and

constructed to facilitate effective
maintenance and sanitation
 results specified rather than
method for achieving
 detailed expectations in sanitation
of operations
GMPs - Equipment
 equipment and utensils
 designed and constructed to be easily and
properly cleaned
 temperature measuring and recording on
refrigerators and freezers
 measurement of critical parameters
GMP’s:
Production and Process Controls
 end results emphasized
 ensuring that no adulterated food enters
marketplace
 terms used subject to variation in
interpretation
 raw materials and ingredients properly
 inspected, analyzed
 segregated, stored
 handled
Production and Process Controls:

 manufacturing operations must be

monitored
 pH, water activity, temperatures
 elimination of metal from product
 personnel should be trained and
aware of GMP requirements
GMP’s - Defect Action Levels
 natural or unavoidable defects may be in
food
 not harmful at levels present
 present even with GMPs
 FDA establishes DALs when necessary and
possible
 defect level may not be reduced by
blending
Summary of General GMPs

 Intended to prevent adulteration

 Opportunity for considerable
judgment in defining and interpreting
regulations
 “spirit” of GMPs is to do what is
reasonable and necessary to ensure
safe and unadulterated food supply
Specific GMPs:
Low acid canned foods
 Life threatening risk if improperly
processed
 Requires supervision of personnel who
have been trained
 Regulations quite detailed for
equipment design and operation
 Extensive record keeping requirements
Acidified foods:
 Defined as a low acid food with
 Aw greater than 0.85
 acid added to lower pH to 4.6 or lower
 Product examples
 includes beans, cucumbers, cabbage
 excludes carbonated beverages
 Personnel trained under approved
program
Bottled Drinking Water:
 All water sealed in bottles, packages for
human consumption
 Regulations are general and similar to
umbrella GMPs
 Source of water must be approved
 Sanitation, equipment designed,
personnel emphasized
 Extensive record keeping
The History of HACCP
 HACCP initiated in early 1960s as
cooperative effort
 Pillsbury
 NASA
 Natik labs of U.S. Army
 U.S. Air Force Space Laboratory
 Purpose was to produce zero defect food
for astronauts
HACCP History:
 NASA asked Pillsbury to design products
for use in outer space
 Pillsbury presented HACCP plan at 1971
Conference on Food Protection
 FSIS asked NAS to evaluate inspection
process and recommend modernization
 HACCP recommended by NAS to FSIS in
1985
HACCP
 Sec. 342 of FDCA is basis for HACCP
(Adulteration provisions)
 By adopting HACCP, companies share
in responsibility for safety
 GMPs and HACCP are increasingly
important as more and more food is
produced, processed, and handled by
others
HACCP Basics:

 Defects always possible with less than

100% testing
 Detection of hazards by end product
testing is only as good as statistics behind
sampling and testing protocols
 HACCP prevents rather than detects
HACCP Basics

 Seven elements
 Science based system of food safety
 Made mandatory in EU
 Mandatory for seafood first (1995)
 Meats (beef, pork, poultry) in 1996
 Voluntary for other products
Seven Steps of HACCP:
 Assess Potential Hazards
 Determine Critical Control Points
 Establish requirements for each CCP
 Establish procedure to monitor each CCP
 Establish corrective action if deviation
 Establish record keeping procedures
 Establish procedure to monitor effectiveness
Step #1:
Determine Potential Hazards
 First step in developing program
 what hazards might exist
 What is a hazard
 poisonous or deleterious substance (P/D)
 microbiological
 chemical
 physical

 Hazard more specific than adulterant b/c

product may be adulterated without
being hazardous
Sources of hazards
 Review of operation to determine where
hazard might occur
 ingredients and other raw materials
 breakdown in some part of process
 Knowledgeable person must review:
 ingredients
 formula
 process
 storage conditions
Step #2:
Identify Critical Control Points (CCPs)

 CCP is a point at which a hazard might

develop
 if hazard results from loss of control, point is
critical
 QCP is point where quality might be
affected
 if reduction in quality occurs, point is a quality
control point
Step #3:
Establishing Control Limits
 Hazard may develop if CCP out of
control
 Determine how much out of control
results in a hazard
 Limits must be set for each CCP
 Knowledge of both hazards and the
process is important
Step #4:
Establish System to Monitor CCPs
 Monitoring system to determine when process
exceeds limits
 Continuous monitoring preferred with immediate
correction
 Periodic sampling and testing may be only
reasonable alternative
 Continuous or frequent monitoring used to
establish trends
Step #5:
Corrective action

 May be as simple as rejecting a

shipment or ingredient
 May require adjusting calibration of
measuring device
 May necessitate shutting down an
operation
Step #6:
Record Keeping

 Must have effective record keeping

system to:
 demonstrate establishment of system
 document its utilization

 verify efficacy
Step #7:
Verification of Program - HACCP Plan
 Written plan to describe system
 May be shown to FDA as evidence that
plan has been developed
 Monitoring data and records of actions
may be reviewed by:
 company management
 regulatory officials
HACCP Plan
 Section 123.6 requires that every processor
shall have implemented a written HACCP
plan specific to the process and the
product
 FSIS has developed "Generic HACCP
Models" for major process categories
 Must be signed by "responsible
establishment individual"
 HACCP training big business
Flow Charts
 Step by step path traveled by food during
processing
 Shows CCPs
 Shows where to take corrective action
 Can use to monitor CCPs
 Helps verify effectiveness
HACCP Issues:

 Should HACCP be voluntary or

mandatory?
 Should small businesses be exempt?
 Should foreign exporters be exempt?
 What records should be available?
 What training should be required?
GMPs and HACCP

 Prior to the development of HACCP plan,

establishment should verify that all GMPs are
in place and effective
 Effective GMP programs ensure that HACCP
plans focus specifically on the critical control
points necessary to ensure product safety
GMPs and HACCP
 GMPs establish guidelines, requirements,
and expectation for reducing
adulteration
 GMPs along cannot guarantee safety
 HACCP represents joint effort
 Policies, procedures, regulations are
evolving
ISO - 9000
 International Food Quality Standards
 Non-prescriptive
Standardization
 GATT and NAFTA
 Harmonization of trade restrictions
 Fortress Europe Concept
 Single Europe Act
 Free movement of goods and services
 History of Standardization
 Eli Whitney
ISO-9000

 Non-prescriptive standard that does not

specify how a company's quality
assurance must occur, but mandates
that a company define appropriate
quality standards, document its
processes, and prove that it consistently
adheres to both.