U.S. Food and Drug Administration

1. U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

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

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

5. 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 EXPORTING COUNTRIES 4

6. EXPORTING COUNTRIES 5

7. 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. EQUIVALENCE Trust . . . But Verify 7

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

11. 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. PORT-OF-ENTRYREINSPECTION • Conducted every day • Every shipment • Residue sampling • Ports-of-entry around the U.S. “A daily event” 11

13. PORT-OF-ENTRYREINSPECTION Billions of Pounds Reinspected Each Year 12

14. PORT-OF-ENTRYREINSPECTION 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. PORT-OF-ENTRY RESIDUE SAMPLING • Veterinary drugs • Pesticides • Environmental contaminants 14

16. 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. 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. 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. RESIDUE ENFORCEMENT POLICY FSIS enforces the zero tolerance policy at U.S. ports-of-entry for imported meat and poultry products 18

20. RESIDUE ENFORCEMENT POLICY FSIS enforcement includes: • Refused entry • Recall • Destruction of adulterated product 19

21. National Residue Program (NRP) • Enforce U.S. laws and regulations • Consumer confidence • Deter misuse • Assess and communicate human exposure • Verify HACCP systems 20

22. National Residue Program (NRP) Components • Monitoring Plan • Special Projects • Surveillance • Enforcement Testing • Import Residue Plan 21

23. National Residue Program (NRP) Resource Allocations in Year 2000 Domestic samples: 84% (40,250) Imported samples: 16% (7,395) 22

24. 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. National Residue Program (NRP) Surveillance Advisory Team • USDA (FSIS, AMS, APHIS, ARS) • FDA (CVM, CFSAN) • EPA • CDC 24

26. 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. IMPORT REINSPECTION Foreign Inspection Service • Inspected • Passed • Certified Food Safety and Inspection Service • RE-inspected • Passed • Released 26

28. 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. 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. National Residue Program (NRP)Import Residue Plan COUNTRY PRODUCT COMPOUND NO. SAMPLES 29

31. National Residue Program (NRP)Import Residue Plan COUNTRY • 30 countries in the 2000 plan • Active importers 30

32. National Residue Program (NRP)Import Residue Plan PRODUCT • Classes of product per country • As few as one • As many as seventeen 31

33. National Residue Program (NRP)Import Residue Plan PRODUCT • Fresh Beef= 61% • Fresh Pork= 19% • Other Fresh= 05% ______ 85% Fresh Product 32

34. 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. 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. Equivalent 35

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

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