Regulating the Quality and

Safety of Foods

The Elements of Food Safety

Law

Polic
y

Safet
y
Scienc
e

Safety System Basics

Only safe and wholesome foods may be

marketed
Regulatory decision-making is sciencebased
Government has enforcement
responsibility
Manufacturers, distributors, importers,
and other are expected to comply and face
liability for noncompliance
Regulatory process is transparent and

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

(Imports)

AMS

FTC

(Advertising)

DOT

(Transportation)

CFSAN

(Shell Eggs surveillance)

BATF

(Alcohol and Firearms)

EPA

(Pesticides)

NOAA

(Seafood HACCP Training)

APHIS

(Border quarantines)

FSIS

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 lowacid 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 Controls

Production and Process

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

GMPs - 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

GMPs:
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

GMPs - 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.