Regulating the Quality and Safety of Foods

The Elements of Food Safety

Law

Safety
Science

Policy

Safety System Basics

Only

marketed

safe and wholesome foods may be

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 CDC USDA US Customs
(Imports) (Advertising)

FTC

(Pesticides)

EPA

(Foodborne illness)

(Transportation)

DOT

(Seafood HACCP Training)

NOAA

(Veterinary Medicine)

CVM

(Shell Eggs surveillance)

AMS

CFSAN FSIS

(Border quarantines)

APHIS ERS

DOC

(Alcohol and Firearms)

BATF

(food safety education)

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 Regulation
Labeling Novel Food Processing

Responsibility (liability)
Food Irradiation Genetic Modifications 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 Subpart B Subpart C Subpart D Subpart E Subpart F Subpart G -

General Provisions Building and Facilities Equipment [Reserved] Production and Process Controls [Reserved] 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

management has responsibility for performance of personnel

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 inspected, analyzed segregated, stored handled

raw materials and ingredients properly

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

Aw greater than 0.85 acid added to lower pH to 4.6 or lower includes beans, cucumbers, cabbage excludes carbonated beverages

Product examples

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 poisonous or deleterious substance (P/D)

microbiological chemical physical

What is a hazard

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 ingredients formula process storage conditions

Knowledgeable person must review:

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

Eli Whitney

History of Standardization

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.