1. United States Department of Agriculture Food Safety and Inspection Service 1 New FSA Tools EIAO Methodology Industry Walkthrough December 18, 2008 Washington, DC William K. Shaw, Jr. Senior Food Technologist Office of Policy and Program Development FSIS, USDA

2. United States Department of Agriculture Food Safety and Inspection Service 2 Background Project began in February 2007 Team represents members from OPPD, OPHS, OFO, OPEER, OOEET, OFDER Pilots took place in Philly and Albany Districts The HQ working group conducted FSAs in Alameda, Albany and Chicago districts.

3. United States Department of Agriculture Food Safety and Inspection Service Goals of New FSA Tools Build consistency of data in FSA reports Structured process flow for FSAs Electronic FSA reports in an analyzable format to feed into FSIS data infrastructure improvements Streamline background data accessibility for EIAOs Learn plant practices to develop better guidance documents and assess current policies More user friendly format which would assist plant’s to improve their food safety systems 3

4. United States Department of Agriculture Food Safety and Inspection Service OIG Recommendations 1.Implement an action plan with specific milestone dates for capturing the results of food safety assessments in appropriate configuration that allows for further analysis. 2.Determine how the results of food safety assessments will be used by FSIS in estimating establishment risk.

5. United States Department of Agriculture Food Safety and Inspection Service OIG Recommendations 3.Develop and implement a criteria for prioritizing the scheduling of food safety assessments. 4.Develop and implement a system to track changes at an establishment over time and determine which changes would trigger FSIS to conduct a food safety assessment at an establishment prior to its periodic evaluation.

6. United States Department of Agriculture Food Safety and Inspection Service OIG Recommendations 5.Develop and implement procedures to ensure sufficient, timely follow-up work is performed in response to findings in food safety assessments. Data is need in an electronic format to satisfy these recommendations

7. United States Department of Agriculture Food Safety and Inspection Service 7 What is staying the same? EIAOs will still conduct FSAs FSAs will be comprehensive and most likely even more so There will be narrative analysis sections supporting decisions but more focused

8. United States Department of Agriculture Food Safety and Inspection Service 8 The Most Important New Aspects The new FSA will capture the data EIAOs now collect in order to do their analysis so FSIS can do critical overall program analyses to improve public health protection Pass/Fail vs. A,B,C,D,F Establishments Gives FSIS the opportunity to be more proactive than reactive Potentially reduce recalls and enforcement actions by providing valuable information to plants about their food safety systems

9. United States Department of Agriculture Food Safety and Inspection Service ALL DATA BECOMES RELEVANT IN THIS NEW SYSTEM: BOTH REGULATORY AND NON-REGULATORY All data contributes to the larger picture of the plant’s food safety system 9

10. United States Department of Agriculture Food Safety and Inspection Service Data Supports 2 Functions 1.Data used to determine adequacy of food safety system (compliance or out of compliance) 2.Data used to establish a food safety system’s risk relative to other establishments

11. United States Department of Agriculture Food Safety and Inspection Service 11 The Sections

12. United States Department of Agriculture Food Safety and Inspection Service 5100-1 Replaces 5000-8 Contains all the information that 5000-8 captures but more data:  Parent Corporation  Reason for FSA  Pre-filled background data for verification  Executive Summary 12

13. United States Department of Agriculture Food Safety and Inspection Service 03 Category Sections 03J Slaughter Meat/Poultry 03B Raw Ground Meat/Poultry 03C Raw Not Ground Meat/Poultry 03D Thermally Processed/Commercially Sterile 03E Not Heat Treated-Shelf Stable 03F Heat Treated-Shelf Stable 03G Fully Cooked-Not Shelf Stable 03H Heat Treated-Not Fully Cooked-Not Shelf Stable 03I Product with Secondary Inhibitors-Not Shelf Stable 13

14. United States Department of Agriculture Food Safety and Inspection Service Additional Sections General Sanitation (SPS/SSOP) Dual Jurisdiction Food Defense 14

15. United States Department of Agriculture Food Safety and Inspection Service FSA Prioritized Scheduling Federal/State/Local positive E. coli O157:H7 sample in raw non-intact beef or beef intended for non-intact Federal/State/Local positive LM, Salmonella, E. coli O157:H7 in RTE product Failed PR/HACCP Set At least once every 4 years New Establishment Shipment of SRM 15

16. United States Department of Agriculture Food Safety and Inspection Service FSA Prioritized Scheduling Enforcement action (other than from FSA) Outbreak Investigation Link Establishment supplier of E. coli O157:H7 positive product more than once in 120 days Repetitive Salmonella serotypes of human health concern and PFGE matches (future) Establishment sustains structural damage from natural disaster Accumulation of public health related NRs 16

17. United States Department of Agriculture Food Safety and Inspection Service Additional Criteria District directed FSA scheduling based on events on the ground Inspector generated with FLS concurrence alert to case specialist HQ Directed