Regulating the Quality and Safety of Foods

1
Regulating the Quality and Safety of Foods
2
The Elements of Food Safety
Law
Safety
Policy
Science
3
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

4
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

5
Food Borne Illness Outbreaks

• Hudson Foods
• Largest recall of beef in U.S. history
• 25 million pounds
• Escherichia coli 0157H7
• Supplier to Burger King and Safeway
• Fined 332,000 by OHSA

6
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

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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

8
Food Safety Regulation

• 12 different federal agencies derive their
  authority over food products from 35 different
  federal statutes
• US spents gt1 billion annually on Food Safety
  Regulation

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Federal Agencies with some jurisdiction over food
products
FDA USDA FTC(Advertising) EPA(Pesticides)
CDC(Foodborne illness) US Customs(Imports) DOT(Transportation) NOAA(Seafood HACCP Training)
CVM(Veterinary Medicine) AMS(Shell Eggs surveillance) CFSAN APHIS(Border quarantines)
DOC BATF(Alcohol and Firearms) FSIS ERS (food safety education)
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Scientific Issues in Food Safety

• Hazard Identification
• Microbiology
• Chemistry
• Toxicology
• Epidemiology
• Risk Assessment
• HACCP /Quality Systems
• Zero tolerance
• Lethal Processing Step

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Regulatory Issues

• Food Additive Regulation
• Labeling
• Novel Food Processing
• Standardization

• Responsibility (liability)
• Food Irradiation
• Genetic Modifications
• Consumer protection

12
Policy Issues

• Risk Assessment
• Centralization (Food Czar)
• Strict Liability
• Global Harmonization and Standardization
• GATT / NAFTA (Fortress Europe)

13
Consumer Expectations

• Consumers expect safe, hazard free food
• Responsibility is shared by
• food producers
• processors
• purveyors
• regulatory agencies

14
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

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Good Manufacturing Practices(GMPs)
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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...

17
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

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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

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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.

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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

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Product specific GMPs

• thermally processed low-acid canned foods
• acidified foods
• bottled drinking water

22
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

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GMPs Regulations

• written as mandatory requirements
• consistent use of shall rather than should
• GMPs used in inspections of plant and warehouses

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GMPs - General Provisions

• provides definitions
• important in understanding implications and
  applications
• personnel
• management has responsibility for performance of
  personnel

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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

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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

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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

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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

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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

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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

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Specific GMPsLow 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

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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

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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

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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

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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

36
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

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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

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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

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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

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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

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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

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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

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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

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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

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Step 5Corrective action

• May be as simple as rejecting a shipment or
  ingredient
• May require adjusting calibration of measuring
  device
• May necessitate shutting down an operation

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Step 6 Record Keeping

• Must have effective record keeping system to
• demonstrate establishment of system
• document its utilization
• verify efficacy

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Step 7Verification 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

48
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

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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

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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?

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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

52
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

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ISO - 9000

• International Food Quality Standards
• Non-prescriptive

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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

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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.