1. Janell R. Kause, MPH/MPP U.S. Department of Agriculture Food Safety and Inspection Service Conducting Risk Assessments to Guide Food Safety Decisions Addressing L. monocytogenes Interagency Risk Assessment - L. monocytogenes in Retail Delicatessens Public Meeting Washington, DC - May 22 nd, 2013

2. Role of Risk Analysis in Food Safety Powerful Public Health Tool –Scientific basis for food safety policies and allocation of resources –Allows for transparency and stakeholder involvement to ensure credibility and scientific accountability –Facilitates the application of science to policy – “ informational bridge” between data and decisions 2 May 22 nd, 2013 Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens Public Meeting

3. 2003 FDA/FSIS Quantitative Risk Ranking of Ready-to-Eat Foods Which RTE foods pose the greatest risk of listeriosis? Highest risk:  Deli meats (67% of listeriosis cases)  Other RTE foods: soft cheeses, hot dogs, deli salads Deli meats (1599 cases/yr) Hot dogs (not- reheated) (31 cases/yr) Hot dogs (heated) (0.4 case/yr) Deli salads (<0.1 case/yr) Predicted Annual Cases of Listeriosis Hard cheeses (<0.1 case/yr) Soft cheeses (8 cases/yr) 3 May 22 nd, 2013 Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens Public Meeting

4. 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 Increased product testing: 4 tests/line/month 2 tests/line/month 1 test/line/month post-lethality interventions and/ antimicrobial agent/growth inhibitors 2003 FSIS Listeria Risk Assessment: Comparing Processing Controls Source: http://www.fsis.usda.gov/PDF/Lm_Deli_Risk_Assess_Final_2003.pdf May 22 nd, 2013 Interagency Retail Listeria monocytogenes Risk Assessment Public Meeting 4

5. Interim Final Rule (9 CFR 430) 1)use both a growth inhibiting agent and a post-processing lethality 2)use either a growth inhibiting agent or a post- processing lethality step 3)sampling only - use neither a growth inhibitor nor a post-processing lethality step Industry Implementation of Stronger Lm Controls During Processing 5 May 22 nd, 2013 Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens Public Meeting

6. Reduction of Listeria monocytogenes in Deli Meats From Manufacturer 6 FSIS RTE verification testing, 2001-2011 http://www.fsis.usda.gov/Science/Micro_Testing_RTE/ May 22 nd, 2013 Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens Public Meeting

7. Incidence of Listeriosis Why a plateau in listeriosis? 7 May 22 nd, 2013 Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens Public Meeting

8. Lm prevalence higher for deli-sliced products than for prepackaged deli meats* –Prepackaged prevalence: 0.2% –Retail-sliced prevalence: 1.4% Deli-sliced product has higher concentrations of Lm than prepackaged product Retail Surveys: Listeria monocytogenes Contamination in Prepackaged & Retail- Sliced Deli Meats Surveys by Industry & Academia: 1.National Food Processors Association (Gombas et al., Journal of Food Protection, 2003); 2.National Alliance for Food Safety and Security (Draughon et al., 2006) 8 May 22 nd, 2013 Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens Public Meeting

9. 83% of all deli- meat related listeriosis cases are from product sliced and sold in retail delis Cornell University risk assessment had similar findings* Comparative Listeria monocytogenes Risk Assessment: Attributable Listeriosis Cases and Deaths 9 FSIS Comparative Lm Risk Assessment Results* Source: Endrikat et al. (2010). A Comparative Risk Assessment for Listeria monocytogenes in Prepackaged versus Retail-Sliced Deli Meat. Journal of Food Protection, 2010. 73(4): p. 612-619. * Pradhan et al. (2010). Quantitative Risk Assessment of Listeriosis- Associated Deaths Due to Listeria monocytogenes Contamination of Deli Meats Originating from Manufacture and Retail. Journal of Food Protection, 2010. 73(4): p. 620-630. May 22 nd, 2013 Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens Public Meeting

10. Why would retail-sliced products be more contaminated than prepackaged ones? Very little was known about the transmission of Lm in retail delis and how cross contamination occurs Contributing factors: –Retail environment/sanitary conditions –More than one product prepared at a given time Meat, Poultry, Vegetables, Seafood, … –More than one process at a given time and place Slicing, Cutting, Mixing, … Other factors: incoming contamination, temperature control 10 May 22 nd, 2013 Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens Public Meeting

11. The risk managers’ questions can’t be answered through experiments –Example: What is the impact of growth vs. cross contamination? –Some risk scenarios are not practicable –The impact is not measurable The risk is too low A model is a simplification of the reality –Shares important characteristics with the system –Without the “noise” that could lead to misleading conclusions Interpretation –Better in relative effects than in absolute ones Why must we use a model? 11 May 22 nd, 2013 Interagency Risk Assessment--Listeria monocytogenes in Retail Delicatessens Public Meeting