2. FSIS Enforcement of Animal Drug Tolerances in Imported Meat and Poultry Products Food Safety and Inspection Service Veterinary Medicine Advisory Committee January 22, 2002 1

3. USDA - Food Safety and Inspection Service INTRODUCTION John C. Prucha D.V.M., M.S., M.P.H., D.A.C.V.P.M. Assistant Deputy Administrator Food Safety and Inspection Service 2

4. USDA - Food Safety and Inspection Service IMPORT RE INSPECTION Foreign Inspection Service Inspected Passed Certified Food Safety and Inspection Service RE-inspected Passed Released 3

5. USDA - Food Safety and Inspection Service EXPORTING COUNTRIES Argentina Australia Austria Belgium Brazil Canada Costa Rica Croatia Denmark Finland France Germany Honduras Hong Kong Hungary Iceland Ireland Israel Italy Japan Mexico Netherlands New Zealand Nicaragua Poland Spain Sweden Switzerland United Kingdom Uruguay 4

6. USDA - Food Safety and Inspection Service EXPORTING COUNTRIES 5

7. USDA - Food Safety and Inspection Service EQUIVALENCE Equivalent inspection SYSTEM Not an establishment-based decision Reliance on foreign Competent Authority to certify establishments for export to the United States 6

8. USDA - Food Safety and Inspection Service EQUIVALENCE Trust... But Verify 7

9. USDA - Food Safety and Inspection Service 8

10. DOCUMENT ANALYSIS Full-system analysis initially Animal husbandry practices Government residue control program Focused on sanitary measures later “As needed event” 9

11. USDA - Food Safety and Inspection Service ON-SITE AUDIT Full-system audit initially Farm and feedlot visits Veterinary drug use Laboratory capabilities Focused on key elements later “An annual event” 10

12. USDA - Food Safety and Inspection Service PORT-OF-ENTRY REINSPECTION Conducted every day Every shipment Residue sampling Ports-of-entry around the U.S. “A daily event” 11

13. USDA - Food Safety and Inspection Service PORT-OF-ENTRY REINSPECTION Billions of Pounds Reinspected Each Year 12

14. USDA - Food Safety and Inspection Service PORT-OF-ENTRY REINSPECTION Types of Inspection Shipping documents Container, packaging, labeling Organoleptic product reinspection Microbial sampling, lab analysis Formulation sampling, lab analysis Residue sampling, lab analysis 13

15. USDA - Food Safety and Inspection Service PORT-OF-ENTRY RESIDUE SAMPLING Veterinary drugs Pesticides Environmental contaminants 14

16. USDA - Food Safety and Inspection Service VETERINARY DRUGS FSIS: Draws samples at import reinspection ports-of-entry Analyzes samples for marker residues Takes action if residue tolerance established by FDA is exceeded 15

17. USDA - Food Safety and Inspection Service RESIDUE ENFORCEMENT REGULATION Animal drug residues are permitted in meat and meat food products if such residues are from drugs which have been approved by the Food and Drug Administration and any such drug residues are within tolerance levels approved by [FDA], unless otherwise determined by the [FSIS] Administrator and listed herein. (9 CFR 318.20) 16

18. USDA - Food Safety and Inspection Service RESIDUE ENFORCEMENT POLICY If the residue is from a veterinary drug that is not approved by FDA for use in the United States, FSIS would consider its tolerance to be: zero 17

19. USDA - Food Safety and Inspection Service RESIDUE ENFORCEMENT POLICY FSIS enforces the zero tolerance policy at U.S. ports-of-entry for imported meat and poultry products 18

20. USDA - Food Safety and Inspection Service RESIDUE ENFORCEMENT POLICY FSIS enforcement includes: Refused entry Recall Destruction of adulterated product 19

21. USDA - Food Safety and Inspection Service National Residue Program (NRP) Enforce U.S. laws and regulations Consumer confidence Deter misuse Assess and communicate human exposure Verify HACCP systems 20

22. USDA - Food Safety and Inspection Service National Residue Program (NRP) Components Monitoring Plan Special Projects Surveillance Enforcement Testing Import Residue Plan 21

23. USDA - Food Safety and Inspection Service National Residue Program (NRP) Resource Allocations in Year 2000 Domestic samples: 84% (40,250) Imported samples: 16% (7,395) 22

24. USDA - Food Safety and Inspection Service National Residue Program (NRP) NRP Planning Phases Phase I: Identify and rank compounds Phase II: Select compounds Phase III: Identify product classes Phase IV: Allocate sampling resources 23

25. USDA - Food Safety and Inspection Service National Residue Program (NRP) Surveillance Advisory Team USDA (FSIS, AMS, APHIS, ARS) FDA (CVM, CFSAN) EPA CDC 24

26. USDA - Food Safety and Inspection Service National Residue Program (NRP) NRP Planning Phases Phase I: Identify and rank compounds Phase II: Select compounds Phase III: Identify product classes Phase IV: Allocate sampling resources 25

27. USDA - Food Safety and Inspection Service IMPORT RE INSPECTION Foreign Inspection Service Inspected Passed Certified Food Safety and Inspection Service RE-inspected Passed Released 26

28. USDA - Food Safety and Inspection Service National Residue Program (NRP) NRP Planning Phases Phase I: Identify and rank compounds Phase II: Select compounds Phase III: Identify product classes Phase IV: Allocate sampling resources 27

29. USDA - Food Safety and Inspection Service National Residue Program (NRP) NRP Planning Phases Phase I: Identify and rank compounds Phase II: Select compounds Phase III: Identify product classes Phase IV: Allocate sampling resources 28

30. USDA - Food Safety and Inspection Service National Residue Program (NRP) Import Residue Plan COUNTRY PRODUCT COMPOUND NO. SAMPLES 29

31. USDA - Food Safety and Inspection Service National Residue Program (NRP) Import Residue Plan COUNTRY 30 countries in the 2000 plan Active importers 30

32. USDA - Food Safety and Inspection Service National Residue Program (NRP) Import Residue Plan PRODUCT Classes of product per country As few as one As many as seventeen 31

33. USDA - Food Safety and Inspection Service National Residue Program (NRP) Import Residue Plan PRODUCT Fresh Beef=61% Fresh Pork=19% Other Fresh=05% ______ 85% Fresh Product 32

34. USDA - Food Safety and Inspection Service National Residue Program (NRP) Import Residue Plan COMPOUND Same as the domestic plan in 2000 Not included are drugs used legally in other countries but neither approved nor banned in the U.S. 33

35. USDA - Food Safety and Inspection Service National Residue Program (NRP) Import Residue Plan NUMBER OF SAMPLES Allocated by formula As few as 8 annually per compound, per product class, per country As many as 220 34

36. USDA - Food Safety and Inspection Service Equivalent 35

37. USDA - Food Safety and Inspection Service FSIS Enforcement of Animal Drug Tolerances in Imported Meat and Poultry Products Food Safety and Inspection Service Dr. John C. Prucha 36

38. USDA - Food Safety and Inspection Service FSIS Enforcement of Animal Drug Tolerances in Imported Meat and Poultry Products Food Safety and Inspection Service Dr. John C. Prucha 37