Regulating the Quality and
Safety of Foods
The Elements of Food Safety
Law
Policy
Safe
ty
Science
Safety System Basics
• Only
safe 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
CDC
US Customs
(Foodborne illness)
CVM
(Veterinary Medicine)
DOC
FTC
EPA
(Advertising)
(Pesticides)
DOT
NOAA
(Imports)
(Transportation)
(Seafood HACCP Training)
AMS
CFSAN
APHIS
BATF
FSIS
(Shell Eggs surveillance)
(Alcohol and Firearms)
(Border quarantines)
ERS
(food safety education)
Scientific Issues in Food Safety

Hazard Identification


Microbiology
Chemistry




Epidemiology
Risk Assessment
HACCP /Quality Systems


Toxicology
Zero tolerance
Lethal Processing Step
Regulatory Issues:
• Food Additive
Regulation
• Responsibility
(liability)
• Labeling
• Food Irradiation
• Novel Food
Processing
• Genetic Modifications
• Standardization
• Consumer protection
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



Product examples



Aw greater than 0.85
acid added to lower pH to 4.6 or lower
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.