1. United States Department of Agriculture Food Safety and Inspection Service 1 03B Raw Ground Meat Industry FSA Methodology Walk-through December 18, 2008 Washington, DC Janet L. McGinn, DVM Staff Officer Office of Policy and Program Development FSIS, USDA

2. United States Department of Agriculture Food Safety and Inspection Service Overview What information will be collected by the EIAO for the 03B Raw Ground Meat FSA Tool? Review of validation How will this information be used?

3. United States Department of Agriculture Food Safety and Inspection Service Overview Product types will determine which categories of questions the EIAO will seek answers to. –Species other than Beef (general, custom exempt, and miscellaneous questions) –Beef (all questions)

4. United States Department of Agriculture Food Safety and Inspection Service Overview of the 03B Raw Ground Meat FSA Tool Interventions and Validation for E. coli O157:H7 Sampling and Testing Miscellaneous

5. United States Department of Agriculture Food Safety and Inspection Service Interventions and Validation for E. coli O157:H7 EIAO will directly observe the plant’s interventions Purchase specifications –Present? What are they? Verified? Interventions on raw ground beef components and ground beef? CCP? Validated? Validation questions walk the EIAO through the thought process to determine whether validation documents are adequate

6. United States Department of Agriculture Food Safety and Inspection Service Validation Validation includes the HACCP system Initial validation = first 90 days Validation has 2 parts: 1.Scientific or technical support for the HACCP system 2.Initial practical in-plant demonstration proving the HACCP system can perform as expected

7. United States Department of Agriculture Food Safety and Inspection Service 7 Sampling and Testing Raw Ground Beef Components and Ground Beef 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 E. coli O157:H7

8. 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?

9. United States Department of Agriculture Food Safety and Inspection Service Miscellaneous Definition of “lot” # of suppliers of raw ground beef components Product temperature Cleaning and sanitizing Third party audits Retail exemption 9

10. United States Department of Agriculture Food Safety and Inspection Service Miscellaneous Analysis and Summary The point where the EIAO will discuss all findings and analyze the impact of these findings on the plant’s food safety system and its ability to produce safe, wholesome and unadulterated product as it relates to raw ground operations.

11. United States Department of Agriculture Food Safety and Inspection Service Information Use All data, both regulatory and non-regulatory, becomes relevant to inform risk Data used to establish a food safety system’s risk relative to other establishments –prioritizing the scheduling of food safety assessments –Scheduling verification procedures –Scheduling sampling