1. United States Department of Agriculture Food Safety and Inspection Service 1 03G Fully Cooked Not Shelf Stable Tool Industry FSA Methodology Walk-through December 18, 2008 Washington, DC William K. Shaw, Jr., PhD Senior Food Technologist Office of Policy and Program Development FSIS, USDA

2. United States Department of Agriculture Food Safety and Inspection Service Overview Whether the plant produces products which contain beef determines which categories of questions the EIAO will seek answers to -Contains beef (general, E. coli O157:H7, Salmonella, sampling questions, product stabilization, and product processing) -Does not contain beef (general, Salmonella, product stabilization, product processing and sampling questions)

3. United States Department of Agriculture Food Safety and Inspection Service Overview Also, whether the plant produces post-lethality exposed RTE products determines which categories of questions the EIAO will seek answers to AMAP, PLT, and Sanitation sections should not be completed if plant does not produce post lethality exposed products. AMAP, PLT, and Sanitation questions are derived from the LM Validation Checklist

4. United States Department of Agriculture Food Safety and Inspection Service Overview Finally, the Alternative the plant uses determines which categories of questions the EIAO will seek answers to ___Alternative 1 (AMAP, PLT, and Sanitation) ___Alternative 2a (PLT and Sanitation) ___Alternative 2b (AMAP and Sanitation) ___Alternative 3 (Sanitation)

5. United States Department of Agriculture Food Safety and Inspection Service The Sections Pathogen Reduction and Validation For Escherichia coli O157:H7 Pathogen Reduction and Validation For Salmonella Sampling and Testing Product Stabilization Processing Practices

6. United States Department of Agriculture Food Safety and Inspection Service The Sections cont’d Post-lethality Treatment Antimicrobial Agents and Processes Sanitation PLE RTE

7. United States Department of Agriculture Food Safety and Inspection Service Pathogen Reduction and Validation For Escherichia coli O157:H7 These questions are aimed at looking at whether the plant has validation data and how strong the validation is.

8. United States Department of Agriculture Food Safety and Inspection Service Pathogen Reduction and Validation For Escherichia coli O157:H7 Process validated to reduce E. coli O157:H7 by at least 5 logs Validation documented? How was the validation done? Same critical variables and product or product formulation? If not, was additional validation done?

9. United States Department of Agriculture Food Safety and Inspection Service Pathogen Reduction and Validation For Escherichia coli O157:H7 If no additional validation was done, was there rationale to explain why the intervention is effective? Did the plant initially test the adequacy of the process to reduce E. coli O157:H7?

10. United States Department of Agriculture Food Safety and Inspection Service Pathogen Reduction and Validation For Salmonella Validated cooking process for Salmonella? Validation documented? How was the validation done? Same critical variables and product or product formulation? If not, was additional validation done?

11. United States Department of Agriculture Food Safety and Inspection Service Pathogen Reduction and Validation For Salmonella If no additional validation was done, was there rationale to explain why the intervention is effective? Did the plant initially test the adequacy of the process to reduce Salmonella?

12. United States Department of Agriculture Food Safety and Inspection Service Sampling and Testing Sampling –Is it done? Method? –Testing –Method? –EIAO will evaluate for weaknesses in program, i.e. fit for use, adequate frequency, test portion, method validated, method being followed as written –Compare to FSIS Method Adequate to detect low levels of pathogens

13. United States Department of Agriculture Food Safety and Inspection Service Sampling and Testing EIAO will report on results from in-plant testing and review FSIS results Corrective actions Hold lot pending results? Recall?

14. United States Department of Agriculture Food Safety and Inspection Service Product Stabilization Validated procedure for cooling? Source of validation? Apply the validated time/temp? If not, did the plant conduct additional validation? Verify the adequacy of cooling procedure?

15. United States Department of Agriculture Food Safety and Inspection Service Product Stabilization Deviations from the cooling procedures? Corrective actions?

16. United States Department of Agriculture Food Safety and Inspection Service Processing Practices Product temps Is product PLE? If not, is it cook-in-the bag or hot-filled? If PLE, what Alternative?

17. United States Department of Agriculture Food Safety and Inspection Service Post-lethality Treatment Validated and documented the PLT? How was the validation done? Same critical variables and product or product formulation? If not, was additional validation done?

18. United States Department of Agriculture Food Safety and Inspection Service PLT If no additional validation was done, was there rationale to explain why the intervention is effective? Did the plant initially test the adequacy of the process? Rational basis/data to show that the reduction of LM by the PLT sufficient to control the level of contamination of Lm?

19. United States Department of Agriculture Food Safety and Inspection Service PLT If excess contamination, does the establishment have documentation that the PLT is still effective? If rework is used, does the plant have documentation that the level of contamination below that for which the intervention is designed?

20. United States Department of Agriculture Food Safety and Inspection Service PLT Is the PLT a pre-packaging treatment? If so, does the plant have validated control measures in place to prevent recontamination after treatment and before re-packaging

21. United States Department of Agriculture Food Safety and Inspection Service Antimicrobial Agents and Processes (AMAP) Is the AMAP GRAS? Validation questions Did the validation study include a shelf-life study? Is the refrigerated shelf life (use by date on the label) the same or longer than the recommended shelf life in the validation?

22. United States Department of Agriculture Food Safety and Inspection Service Sanitation PLE RTE Evaluate potential cross contamination issues –Traffic patterns b/t raw and RTE –Physical separation b/t raw and RTE –Garments and utensils –Maintenance equipment and tools –Trash and waste -equipment properly broken down and cleaned -cleaning and sanitizing

23. United States Department of Agriculture Food Safety and Inspection Service Sanitation PLE RTE Evaluate potential cross contamination issues –Construction –Plant conditions

24. United States Department of Agriculture Food Safety and Inspection Service Sanitation PLE RTE Evaluate FCS program –Compliance with 430 –Selected sites most probable sources of contamination? –Are all sites identified?  Evaluate results from plant’s program  Was adequate follow-up testing in response to a positive FCS done?