1. Interagency Retail Listeria monocytogenes Risk Assessment Background, Scope, and Purpose Janell Kause Food Safety and Inspection Service June 23, 2009

2. What is risk assessment? Risk assessment is the scientifically based process of estimating the likelihood (probability) of exposure to a hazard and the resulting pubic health impact from this exposure. It is used to facilitate the application of science to policy. 2

3. 3 Risk Assessment Evaluate data and information Estimate exposure and risk Risk Analysis Risk Management Weigh and select policy options Education/Outreach Risk Communication Exchange information

4. 4 Scientific basis for food safety decisions integrates data and information systematically address food safety issues focus resources to improve food safety Predicts public health benefits of changes in policies, practices, or interventions Why use risk assessment?

5. 5 FDA-FSIS Quantitative Risk Assessment for Listeria monocytogenes in Ready-to-Eat Foods (2003) FSIS Listeria Risk Assessment for Deli Meats (2003) Risk-based Listeria monocytogenes Verification (2004) FSIS Comparative Risk Assessment for Listeria monocytogenes in Ready-to-Eat Meat and Poultry Products (2009) Past Listeria monocytogenes Risk Assessments

6. 6 2003 FDA/FSIS Listeria monocytogenes Risk Assessment Estimated the relative risks of serious illness and death associated with the consumption of 23 types of ready-to-eat foods Retail-to-table probabilistic risk assessment Developed through close collaboration between USDA/FSIS and DHHS/FDA Which foods pose the greatest risk of listeriosis? Source: http://www.foodsafety.gov/~dms/lmr2-toc.html

7. 7 Predicted Cases of Listeriosis per Serving–Total Population Deli meats Frankfurters (not-reheated) Deli salads Frankfurters (heated)

8. 8 Predicted Cases of Listeriosis per Annum–Total Population Deli meats Frankfurters (not-reheated) Deli salads Frankfurters (heated)

9. 9  2003 FSIS Listeria risk assessment Plant-to-table probabilistic risk assessment Built in a few months by adding a module to the prior Listeria monocytogenes risk assessment developed by FDA and FSIS Evaluated the number of illnesses prevented and lives saved annually based on the adoption of various interventions during manufacturing Source: http://www.fsis.usda.gov/PDF/Lm_Deli_Risk_Assess_Final_2003.pdf Which processing interventions effectively control Listeria monocytogenes?

10. 10 50 100 150 200 4-2-18-4-2 10-10-10 16-8-4 32-16-8 40-20-1060-60-60 PP-95%PP-99% Growth Inhibitor (GI) PP-95% & GI Scenario Number of annual lives saved among elderly: Median prediction Sampling Effectiveness Process Control Effectiveness *Proposed mandatory testing: 4 tests/line/month 2 tests/line/month 1 test/line/month * Proposed testing for Listeria monocytogenes (66 FR 12589; 2001) post-lethality interventions; antimicrobial agent/processes Comparing Listeria monocytogenes Processing Controls

11. 11 Interim Final Rule (9 CFR 430) Alternative 1: Use of post-lethality treatment AND antimicrobial agent/process (growth inhibitor) Alternative 2: Use of post-lethality treatment OR antimicrobial agent/process (growth inhibitor) Alternative 3: Use of sanitation procedures only Result: Industry Adoption of more Effective Interventions

12. 12 Reduction of Listeria monocytogenes in Deli Meats From Manufacturer Why a plateau in listeriosis?

13. 13 Compare the risk of listeriosis from prepackaged vs. retail-sliced deli meat Analysis using 2003 FDA/FSIS Listeria monocytogenes Risk Assessment NFPA Data (Gombas, 2003), AMI consumer behavior data (2003) NAFSS Data (Draughon, 2006), RTI consumer behavior data (2006) FSIS Comparative Listeria monocytogenes Risk Assessment (2009) Source: http://www.fsis.usda.gov/PDF/Comparative_RA_Lm_Report.pdf

14. 14 Statistical difference in prevalence by slicing source –Prepackaged prevalence: 0.2% –Retail-sliced prevalence: 1.4% Retail-sliced product has higher concentrations of Lm than prepackaged product Listeria monocytogenes contamination in prepackaged versus retail-sliced deli meats

15. 15 Listeria monocytogenes prevalence in retail- sliced vs. prepackaged deli meat by state Source: National Food Processors Association (Gombas, 2003); National Alliance for Food Safety and Security (USDA/ARS Funded; Lead: Ann Draughon, 2006)

16. 16 Consumer Storage Times Consumers tend to use retail-sliced product more quickly than prepackaged. This limits the amount of growth of Listeria monocytogenes in retail-sliced product prior to consumption. Data: RTI International, www.FoodRisk.orgwww.FoodRisk.org

17. 17 Results of the 2009 Comparative Listeria monocytogenes Risk Assessment: Attributable Listeriosis Cases and Deaths Category Public Health Impact Retail-sliced Deli Meat Pre-packaged Deli MeatTotal Illnesses/De aths With Growth Inhibitor Deaths26.510.537.1 Illnesses14658205 Without Growth Inhibitor Deaths140.323.6163.9 Illnesses773130904 Total Deaths 166.934.1201.0 Illnesses 9201891108 Note: Approximately 83% of listeriosis cases and deaths attributed to deli meats are associated with those sliced at retail.

18. 18 Why would retail-sliced products be more contaminated than prepackaged ones? Major hypothesis: additional contamination –More than one kind of product manipulated at a given time or place Meat, Poultry, Vegetables, Seafood, … –More than one process at a given time and place Slicing, Cutting, Mixing, … Additional consideration: potential growth of Listeria monocytogenes (e.g. storage time and temperature abuse)

19. Objective Ascertain the impact on public health of current practices and potential interventions that reduce or prevent Listeria monocytogenes contamination in ready-to-eat food sliced, prepared and/or packaged in retail facilities

20. Risk Management Questions “What is the exposure to Listeria monocytogenes from consuming ready-to- foods prepared in retail facilities?” “What are the key processes that increase ready-to-foods contamination at retails?” “How much is the relative risk per serving reduced according to specific risk management options?”

21. 21 New: Interagency Retail Listeria monocytogenes Risk Assessment Interagency collaboration: USDA/FSIS and DHHS/FDA New approach: retail cross-contamination model Develop data specifically for the risk assessment model Involve scientists from academia: VA Tech, University of Maryland, and Cornell University Stakeholder participation early in the process

22. Thank you