1. United States Department of Agriculture Food Safety and Inspection Service 11 ISSUES FOR FUTURE DISCUSSION: E. coli O157:H7 DANIEL ENGELJOHN, Ph.D. Deputy Assistant Administrator Office of Policy and Program Development Food Safety and Inspection Service, USDA

2. United States Department of Agriculture Food Safety and Inspection Service 22 Chaired by Secretaries of HHS and USDA 3 Principles Preventing harm to consumers is our first priority Effective food safety inspections and enforcement depend upon good data and analysis Outbreaks of foodborne illness should be identified quickly and stopped FSWG

3. United States Department of Agriculture Food Safety and Inspection Service 3 19972008*2010 Cases per 100,000 (Baseline)(Target) E. coli O157:H7 (STEC 0157) 2.11.1**1.0 Lm.500.29***0.24**** Salmonella spp 13.716.2*****6.8 Campylobacter spp 24.612.712.3 Data sources: Chapter 10 - http://www.healthypeople.gov/document/pdf/Volume1/10Food.pdfhttp://www.healthypeople.gov/document/pdf/Volume1/10Food.pdf *Preliminary FoodNet Data on the Incidence of Infection with Pathogens Transmitted Commonly Through Food --- 10 States, 2008 -- goal met only in 2004 **FSIS estimates 0.34 cases/100,000 are from ground beef in 2007, volume adjusted ***FSIS estimates 0.14 cases/100,000 are from RTE meat and poultry in 2007, volume adjusted ****Changed to year 2005 by E.O. (President Clinton *****FSIS estimates 0.84 cases/100,000 are from broilers in 2007, volume adjusted HEALTHY PEOPLE 2010

4. United States Department of Agriculture Food Safety and Inspection Service 44  1994: FSIS declares E. coli O157:H7 an adulterant  Stemmed from illnesses from food service preparation  Successful court challenge (TX Food Industry Association, et al.; Civ. No. A-94—CA-748 JN.)  Ordinary cooking by consumers is less than that required for food safety  The pathogen is particularly virulent  The pathogen renders the product adulterated  Collect 5,000 samples of raw ground beef from federally inspected establishments and from retail to spur industry to control for this pathogen  1997:  Healthy People 2010 goal established to cut infections by half  FSIS changes its analytical sample size from 25 g to 325 g  1999:  FSIS adopts a new selection and detection laboratory method  FSIS clarifies that non-intact products, not just ground beef, are adulterated if contaminated with E coli O157:H7  2002:  FSIS creates STEPs and begins in-depth assessments at suppliers E. coli O157:H7: Policy Milestones

5. United States Department of Agriculture Food Safety and Inspection Service 55  2004:  FSIS begins testing trim to supplement ground beef testing 1997:  2007:  FSIS issues a checklist/survey (FSIS Notice 65-07) to catalog industry practices related to raw beef operations and controls for E coli O157:H7  2008:  FSIS issues draft compliance guidelines for beef trim, introducing the need to establish criteria for high event periods (i.e., indication that microbiological independence may no longer be a valid assumption; primal cuts not intended for non-intact use also may be adulterated)  2009:  FSWG - Verification procedures for slaughter dressing issued  FSWG - Bench trim program initiated E. coli O157:H7: Policy Milestones (continued)

6. United States Department of Agriculture Food Safety and Inspection Service 66 Develop new N60 sampling instructions for FSIS Focus on proper excision sampling: Ensure that 60 pieces of exterior surface tissue are excised of a specific size/thickness for a weight of 325 g Develop Federal Register notices on compliance guidelines Availability of compliance guidelines for public comment Pre-harvest controls Interpreting N60 test results - high event periods Laboratory test kit validation Validation Policy Considerations

7. United States Department of Agriculture Food Safety and Inspection Service 77 Develop Federal Register Policy Documents Record keeping to facilitate traceback at retail and into the Federal system (follow-up to the December public meeting on product traceback) Hold-and-test Labeling of non-intact meat subjected to mechanical tenderization Policy Considerations

8. United States Department of Agriculture Food Safety and Inspection Service 88 Baselines Consider an approach to address process control capability of the industry, similar to poultry and hog carcasses Collect at least two related samples One sample immediately post-hide removal but prior to decontamination interventions and evisceration One sample post-chill after all decontamination interventions but prior to fabrication Consider on-going baselines for trim, other components, bench trim, ground beef Policy Considerations

9. United States Department of Agriculture Food Safety and Inspection Service 99 Thank You