1. 1 Audit Entrance Conference China May 11, 2004 U.S. Department of Agriculture Food Safety and Inspection Service

2. 2 Introduction

3. 3 Introduction Introduction of Presentation Introduction Objective of Audit Scope of Audit Audit Standards Audit Procedures Security of Auditors Conflict of Interest Issues Communications Conclusion

4. 4 Introduction Introduction of Audit Team Members Todd Furey, Team Leader, FSIS Oto Urban, FSIS Margaret O’Keefe, FSIS Victor Cook, FSIS AJ Ogundipe, FSIS

5. 5 Objective of Audit

6. 6 Objective of the Audit To begin the process to determine if China’s poultry inspection system is equivalent to that of the United States.

7. 7 Objective of the Audit Initial Equivalence Initial equivalence evaluations of foreign meat and poultry regulatory systems are a prerequisite for trade. This is a legal requirement that FSIS is required to obey. Any country can apply for eligibility to export meat or poultry products to the U.S.

8. 8 Objective of the Audit Initial Equivalence (Standard Process) FSIS responds to a request with a standard package that contains: – Questionnaires designed to collect detailed information about the foreign food regulatory system – Examples of completed questionnaires that demonstrate how FSIS would answer them – Copies of pertinent U.S. laws, FSIS regulations and other documents that set forth meat and poultry food regulatory policy

9. 9 Objective of the Audit Initial Equivalence (Standard Process) Applications from foreign countries must contain sufficient technical and scientific evidence for FSIS to evaluate whether sanitary measures of the foreign food regulatory system are equivalent to the U.S. system The evaluation involves: Document Review On-Site Review

10. 10 Objective of the Audit Initial Equivalence (Standard Process) FSIS publishes a proposed rule in the Federal Register that announces results of the first two steps and proposes to add the country to its list of eligible exporters in the Code of Federal Regulations

11. 11 Objective of the Audit Initial Equivalence (Standard Process) After a country is determined to be equivalent FSIS relies on it to carry out daily inspection the country’s chief inspection official certifies establishments that meet U.S. import requirements Countries must also be certified periodically as continuing to operate an equivalent residue control program

12. 12 Objective of the Audit Initial Equivalence (Streamlined Process)

13. 13 Scope of Audit

14. 14 Scope of Audit Government Oversight Five Risk Areas 1. Animal Disease 2. Sanitation 3. Slaughter/Processing 4. Residues 5. Enforcement

15. 15 Scope of Audit FSIS will audit a sample of establishments that China says meet our regulations. Must include slaughter as well as processing establishments.

16. 16 Scope of Audit Headquarters

17. 17 Scope of Audit Laboratories for microbiological and residue that will be product exported to the United States

18. 18 Audit Standards

19. 19 Audit Standards FSIS laws, regulations, and requirements. For example: Daily inspection, control of inedible product, Sanitation Standard Operating Procedures (SSOP), Salmonella testing, HACCP, check sample programs, and turnaround times for lab results.

20. 20 Audit Standards Government Oversight 1. Central Competent Authority (CCA) has the organizational structure and staffing to ensure uniform implementation of U.S. requirements. 2. CCA has ultimate control and supervision over official activities of all employees and certified establishments. 3. CCA ensures the assignment of competent qualified inspectors. 4. CCA has authority and responsibility to enforce U.S. requirements. 5. CCA has adequate administrative and technical support to operate inspection system.

21. 21 Audit Standards Five Risk Areas: 1. Animal Disease 2. Sanitation 3. Slaughter/Processing 4. Residues 5. Enforcement

22. 22 Audit Procedures

23. 23 Audit Procedures Audit Protocol All decisions made as a result of audit findings are made after results are analyzed by FSIS after the auditors return to the U.S.

24. 24 Audit Procedures Audit Protocol Results will be summarized by government oversight and five risk areas, not on an establishment-by-establishment basis.

25. 25 Security of Auditors

26. 26 Security of Auditors FSIS requests that any personnel in establishments, laboratories, or government offices who have expressed any hostility toward Americans, FSIS, or FSIS employees, NOT be on the premises when the FSIS auditor is present. Again, audit findings will be discussed with government officials only after leaving the premises and meeting on neutral territory.

27. 27 Conflict of Interest

28. 28 Conflict of Interest Federal law prohibits FSIS personnel from accepting anything of value from any establishment or inspection personnel, with the exception of transportation to and from the individual audits, and coffee and snacks. The auditor must pay his or her fair share of any activities.

29. 29 Communications

30. 30 Communications Please provide, in advance of activities in the various regions of the country in which audit activities are planned, emergency numbers that can be used in the event that they are needed. I can be reached immediately, at any time, at this number: 202 409 2537. Please provide this contact number to all officials with whom I will have contact.

31. 31 Conclusion

32. 32 Conclusion Summary of Entrance Conference Introduction Objective of audit Scope of audit Audit Standards Audit Procedures Security of Auditors Conflict of Interest Issues Communications Conclusion