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Regulating the Quality and Safety of Foods

Regulating the Quality and Safety of Foods. The Elements of Food Safety. Law. Safety. Policy. Science. Safety System Basics. Only safe and wholesome foods may be marketed Regulatory decision-making is science-based Government has enforcement responsibility

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Regulating the Quality and Safety of Foods

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  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?

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