1. Regulating the Quality and Safety of Foods

2. Law Science Policy Safe ty The Elements of Food Safety

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 12 different federal agencies derive their authority over food products from 35 different federal statutes US spents >$1 billion annually on Food Safety Regulation US spents >$1 billion annually on Food Safety Regulation

9. Federal Agencies with some jurisdiction over food products FDAUSDA 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) FSISERS (food safety education)

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

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

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 Consumers expect safe, hazard free food Responsibility is shared by: Responsibility is shared by: food producers food producers processors processors purveyors purveyors regulatory agencies 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 gave authority and responsibility to FDA for ensuring safety in food supply FDCA prohibits poisonous or deleterious substances in food FDCA prohibits poisonous or deleterious substances in food GMPs reference in FDCA states: 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 24 million people per year cost of $7 billion cost of $7 billion 10,000 deaths 10,000 deaths mishandling at retail level is a factor mishandling at retail level is a factor 12 million workers in 1 million establishments 12 million workers in 1 million establishments regulatory agencies alone cannot prevent regulatory agencies alone cannot prevent cooperation with industry required cooperation with industry required

18. Adulteration under the FDCA Food MAY be adulterated if- Food MAY be adulterated if- prepared under insanitary conditions prepared under insanitary conditions proof of actual adulteration not necessary proof of actual adulteration not necessary proof of illness not necessary proof of illness not necessary conditions under which food is prepared, packed, or held is determinant 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 Procedures developed to ensure production of safe, wholesome foods and to provide safe working environment Not "process specific", relate to entire operation Not "process specific", relate to entire operation GMPs include facilities/grounds, equipment pest control, receiving and storage, process control, product recall and personnel training. 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 proposed rule December, 1968 final rule April, 1969 final rule April, 1969 original GMPs regulation very broad original GMPs regulation very broad FDA then attempted to develop specific industry GMPs FDA then attempted to develop specific industry GMPs FDA concluded it was more effective to strengthen “umbrella” GMPs FDA concluded it was more effective to strengthen “umbrella” GMPs revisions to GMPs in 1986 revisions to GMPs in 1986

21. Product specific GMPs thermally processed low-acid canned foods thermally processed low-acid canned foods acidified foods acidified foods bottled drinking water bottled drinking water

22. GMPs Regulations 21CFR Part 110 21CFR Part 110 Subpart A -General Provisions Subpart A -General Provisions Subpart B -Building and Facilities Subpart B -Building and Facilities Subpart C -Equipment Subpart C -Equipment Subpart D -[Reserved] Subpart D -[Reserved] Subpart E -Production and Process Controls Subpart E -Production and Process Controls Subpart F -[Reserved] Subpart F -[Reserved] Subpart G -Defect Action Levels Subpart G -Defect Action Levels

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

24. GMPs - General Provisions provides definitions provides definitions important in understanding implications and applications important in understanding implications and applications personnel personnel management has responsibility for performance of 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 buildings must be designed and constructed to facilitate effective maintenance and sanitation results specified rather than method for achieving results specified rather than method for achieving detailed expectations in sanitation of operations detailed expectations in sanitation of operations

26. GMPs - Equipment equipment and utensils equipment and utensils designed and constructed to be easily and properly cleaned designed and constructed to be easily and properly cleaned temperature measuring and recording on refrigerators and freezers temperature measuring and recording on refrigerators and freezers measurement of critical parameters measurement of critical parameters

27. GMP’s: Production and Process Controls end results emphasized end results emphasized ensuring that no adulterated food enters marketplace ensuring that no adulterated food enters marketplace terms used subject to variation in interpretation terms used subject to variation in interpretation raw materials and ingredients properly raw materials and ingredients properly inspected, analyzed inspected, analyzed segregated, stored segregated, stored handled handled

28. Production and Process Controls: manufacturing operations must be monitored manufacturing operations must be monitored pH, water activity, temperatures pH, water activity, temperatures elimination of metal from product elimination of metal from product personnel should be trained and aware of GMP requirements personnel should be trained and aware of GMP requirements

29. GMP’s - Defect Action Levels natural or unavoidable defects may be in food natural or unavoidable defects may be in food not harmful at levels present not harmful at levels present present even with GMPs present even with GMPs FDA establishes DALs when necessary and possible FDA establishes DALs when necessary and possible defect level may not be reduced by blending defect level may not be reduced by blending

30. Summary of General GMPs Intended to prevent adulteration Intended to prevent adulteration Opportunity for considerable judgment in defining and interpreting regulations 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 “spirit” of GMPs is to do what is reasonable and necessary to ensure safe and unadulterated food supply

31. Specific GMPs: L ow acid canned foods Life threatening risk if improperly processed Life threatening risk if improperly processed Requires supervision of personnel who have been trained Requires supervision of personnel who have been trained Regulations quite detailed for equipment design and operation Regulations quite detailed for equipment design and operation Extensive record keeping requirements Extensive record keeping requirements

32. Acidified foods: Defined as a low acid food with Defined as a low acid food with A w greater than 0.85 A w greater than 0.85 acid added to lower pH to 4.6 or lower acid added to lower pH to 4.6 or lower Product examples Product examples includes beans, cucumbers, cabbage includes beans, cucumbers, cabbage excludes carbonated beverages excludes carbonated beverages Personnel trained under approved program Personnel trained under approved program

33. Bottled Drinking Water: All water sealed in bottles, packages for human consumption All water sealed in bottles, packages for human consumption Regulations are general and similar to umbrella GMPs Regulations are general and similar to umbrella GMPs Source of water must be approved Source of water must be approved Sanitation, equipment designed, personnel emphasized Sanitation, equipment designed, personnel emphasized Extensive record keeping Extensive record keeping

34. The History of HACCP HACCP initiated in early 1960s as cooperative effort HACCP initiated in early 1960s as cooperative effort Pillsbury Pillsbury NASA NASA Natik labs of U.S. Army Natik labs of U.S. Army U.S. Air Force Space Laboratory U.S. Air Force Space Laboratory Purpose was to produce zero defect food for astronauts Purpose was to produce zero defect food for astronauts

35. HACCP History: NASA asked Pillsbury to design products for use in outer space NASA asked Pillsbury to design products for use in outer space Pillsbury presented HACCP plan at 1971 Conference on Food Protection Pillsbury presented HACCP plan at 1971 Conference on Food Protection FSIS asked NAS to evaluate inspection process and recommend modernization FSIS asked NAS to evaluate inspection process and recommend modernization HACCP recommended by NAS to FSIS in 1985 HACCP recommended by NAS to FSIS in 1985

36. HACCP Sec. 342 of FDCA is basis for HACCP (Adulteration provisions) Sec. 342 of FDCA is basis for HACCP (Adulteration provisions) By adopting HACCP, companies share in responsibility for safety 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 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 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 Detection of hazards by end product testing is only as good as statistics behind sampling and testing protocols HACCP prevents rather than detects HACCP prevents rather than detects

38. HACCP Basics Seven elements Seven elements Science based system of food safety Science based system of food safety Made mandatory in EU Made mandatory in EU Mandatory for seafood first (1995) Mandatory for seafood first (1995) Meats (beef, pork, poultry) in 1996 Meats (beef, pork, poultry) in 1996 Voluntary for other products Voluntary for other products

39. Seven Steps of HACCP: Assess Potential Hazards Assess Potential Hazards Determine Critical Control Points Determine Critical Control Points Establish requirements for each CCP Establish requirements for each CCP Establish procedure to monitor each CCP Establish procedure to monitor each CCP Establish corrective action if deviation Establish corrective action if deviation Establish record keeping procedures Establish record keeping procedures Establish procedure to monitor effectiveness Establish procedure to monitor effectiveness

40. Step #1: Determine Potential Hazards First step in developing program First step in developing program what hazards might exist what hazards might exist What is a hazard What is a hazard poisonous or deleterious substance (P/D) poisonous or deleterious substance (P/D) microbiological microbiological chemical chemical physical physical Hazard more specific than adulterant b/c product may be adulterated without being hazardous 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 Review of operation to determine where hazard might occur ingredients and other raw materials ingredients and other raw materials breakdown in some part of process breakdown in some part of process Knowledgeable person must review: Knowledgeable person must review: ingredients ingredients formula formula process process storage conditions storage conditions

42. Step #2 : Identify Critical Control Points (CCPs) CCP is a point at which a hazard might develop CCP is a point at which a hazard might develop if hazard results from loss of control, point is critical if hazard results from loss of control, point is critical QCP is point where quality might be affected QCP is point where quality might be affected if reduction in quality occurs, point is a quality control point 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 Hazard may develop if CCP out of control Determine how much out of control results in a hazard Determine how much out of control results in a hazard Limits must be set for each CCP Limits must be set for each CCP Knowledge of both hazards and the process is important 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 Monitoring system to determine when process exceeds limits Continuous monitoring preferred with immediate correction Continuous monitoring preferred with immediate correction Periodic sampling and testing may be only reasonable alternative Periodic sampling and testing may be only reasonable alternative Continuous or frequent monitoring used to establish trends Continuous or frequent monitoring used to establish trends

45. Step #5: Corrective action May be as simple as rejecting a shipment or ingredient May be as simple as rejecting a shipment or ingredient May require adjusting calibration of measuring device May require adjusting calibration of measuring device May necessitate shutting down an operation May necessitate shutting down an operation

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

47. Step #7: Verification of Program - HACCP Plan Written plan to describe system Written plan to describe system May be shown to FDA as evidence that plan has been developed May be shown to FDA as evidence that plan has been developed Monitoring data and records of actions may be reviewed by: Monitoring data and records of actions may be reviewed by: company management company management regulatory officials 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 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 FSIS has developed "Generic HACCP Models" for major process categories Must be signed by "responsible establishment individual" Must be signed by "responsible establishment individual" HACCP training big business HACCP training big business

49. Flow Charts Step by step path traveled by food during processing Step by step path traveled by food during processing Shows CCPs Shows CCPs Shows where to take corrective action Shows where to take corrective action Can use to monitor CCPs Can use to monitor CCPs Helps verify effectiveness Helps verify effectiveness

50. HACCP Issues: Should HACCP be voluntary or mandatory? Should HACCP be voluntary or mandatory? Should small businesses be exempt? Should small businesses be exempt? Should foreign exporters be exempt? Should foreign exporters be exempt? What records should be available? What records should be available? What training should be required? What training should be required?

51. GMPs and HACCP Prior to the development of HACCP plan, establishment should verify that all GMPs are in place and effective 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 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 establish guidelines, requirements, and expectation for reducing adulteration GMPs along cannot guarantee safety GMPs along cannot guarantee safety HACCP represents joint effort HACCP represents joint effort Policies, procedures, regulations are evolving Policies, procedures, regulations are evolving

53. ISO - 9000 International Food Quality Standards International Food Quality Standards Non-prescriptive Non-prescriptive

54. Standardization GATT and NAFTA GATT and NAFTA Harmonization of trade restrictions Harmonization of trade restrictions Fortress Europe Concept Fortress Europe Concept Single Europe Act Single Europe Act Free movement of goods and services Free movement of goods and services History of Standardization History of Standardization Eli Whitney Eli Whitney

55. 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. 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.