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 0157:H7 • 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

7. 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 >$1 billion annually on Food Safety Regulation

9. Federal Agencies with some jurisdiction over food products

10. Scientific Issues in Food Safety • Hazard Identification • Microbiology • Chemistry • Toxicology • Epidemiology • Risk Assessment • HACCP /Quality Systems • Zero tolerance • Lethal Processing Step

11. Responsibility (liability) Food Irradiation Genetic Modifications Consumer protection Food Additive Regulation Labeling Novel Food Processing Standardization Regulatory Issues:

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

15. Good Manufacturing Practices(GMPs)

16. 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

18. 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

19. 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.

20. 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

21. 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

23. GMPs Regulations • written as mandatory requirements • consistent use of “shall” rather than “should” • GMPs used in inspections of plant and warehouses

24. GMPs - General Provisions • provides definitions • important in understanding implications and applications • personnel • management has responsibility for performance of personnel

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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

37. 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

38. 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

39. 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

40. 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

41. 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

42. 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

43. 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

44. 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

45. 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

46. Step #6:Record Keeping • Must have effective record keeping system to: • demonstrate establishment of system • document its utilization • verify efficacy

47. 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

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

49. 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

50. 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?