USDA DRAFT, March 2005 Risk Assessment of the Impact of Lethality Standards on Salmonellosis from Ready-to-Eat RTE Mea

1. USDA DRAFT, March 2005Risk Assessment of the Impact of Lethality Standards on Salmonellosis from Ready-to-Eat (RTE) Meat and Poultry Products

2. Risk Management Issue: USDA/FSIS has proposed regulations for processors to achieve a specified level of lethality in the processing of RTE meats and poultry Specification in terms of probability of survival of Salmonella (log reductions) when present in raw materials

3. The proposed RTE rule has a minimum lethality of a 6.5 log reduction of Salmonella in meat for all categories (cooked, fermented, salt-cured, dried). Question for Risk Assessment: What would be the public health impact of alternative lethality standards of 5.0-log and 6.5 log of Salmonella (7.0-log for products containing poultry)?

4. Scope Estimation of cases of salmonellosis only (although other pathogens affected also) Sources other than raw material contamination not measured (i.e., post-processing contamination during packaging, retail or home handling Given the charge other pathways of contamination do not significantly alter the determination of the lethality standard

5. A first step Many products/processes to consider Categorization/groupings of products needed

6. Risk category assignment Fully cooked, uncured, non-shelf-stable Fully cooked, cured, non-shelf-stable Fermented, uncooked, shelf-stable Dried (including heat treatment) Dried, no heat treatment (salt-cured)

7. Risk factors 1. Primary Control Mechanism Thermal processing Fermentation (direct acidification) + thermal processing Fermentation (direct acidification) Thermal process + water activity Water activity

8. Risk factors 2. Controllability degree of control in ability to manage the primary control mechanism 3. Role of formulation in lethality E.g., not critical in fully cooked product, critical in uncooked, fermented product 4. Relative margin of safety Large for cooked product, variable or small for uncooked 5. Re-growth of pathogens Growth, controlled, no growth

9. Risk factors 4. Relative margin of safety - Large for cooked product, variable or small for uncooked 5. Re-growth of pathogens Growth, controlled, no growth

10. Product risk categories Roast beef, corned beef Fully cooked beef patties Cooked pork (ham, barbecued) Cooked turkey – non-deli Cooked chicken –non-deli Cooked poultry deli Cooked chicken patties Beef/pork frankfurters

11. Product categories Beef/pork bologna Poultry frankfurters Semi-dry fermented sausage Dry fermented sausage Meat sticks Beef jerky Country ham Prosciutto, Cappicola, Pancetta, Basturma

12. Risk Estimation Evidence Factors: Level of contamination of raw materials Required level of lethality standard Extent of compliance with standard Thermal processing safety factors (re: any thermal lethality process) Storage of product and potential growth of surviving organisms Frequency and extent of consumer re-heating of product Amount of consumption of product

13. Data sources Microbiological baseline surveys Raw material pathogen burden Prevalence and concentration Industry practices Formulation, safety factors, etc. Consumer surveys Expert opinion Predictive growth models Economic census (production volumes)

14. Exposure Pathway

15. Hazard Characterization Dose-Response model from FAO/WHO risk assessments for Salmonella in broiler chickens and eggs Beta-Poisson model

16. Salmonella D-R Model Based on Outbreak Data

17. Risk characterization Surviving pathogens from raw materials (including expected growth after processing) + Probability of illness from surviving pathogens Consideration of sensitivity of model to assumptions about risk factors and data inputs

18. Results Risk of illness per 1000 Kg To identify products of highest risk per unit of food Number of cases per year Influenced by amount of each product category that is consumed each year in the USA % contribution of each product category to total number of cases

19. Rationale A product of highest risk per unit of food may cause only a small number of cases if total amount consumed by population is small A product of low risk per unit may cause many more cases if a very large amount of product consumed

20. Results: Cases per year 5-log lethality standard applied to all products 66,000 case of illness Split processing lethality standard Cooked (6.5 logs for beef, pork; 7.0 logs if contains poultry) Other (5.0 log logs) 1,900 cases of illness All 6.5 (7.0 for poultry) lethality 1,100 cases of illness

21. Limitations and Uncertainties Categorization Pathogen Burden in Raw Materials Thermal Process Safety Factors Storage and Growth Consumer Reheating Dose-Response Relationship Measure Units for Consumption

22. Risk management considerations for selecting a standard What is the acceptable level of risk? 66,000 cases vs. 1,900 cases vs. 1,100 cases Feasibility of achieving risk reduction, including Ability of industry to achieve Maintaining product characteristics Ensuring compliance What is the cost to society? What is the cost to industry? Is more research/surveys needed to reduce uncertainty?

23. Comments Available via internet USDA, Food Safety Inspection Service (FSIS) Office of Public Health Service, Risk Assessment Division Risk assessment model developed using software Analytica® (Enterprise version 3.0). Model can be reviewed using Analytica ® Player downloadable from www.lumina.com (free-of-charge)

24. Comments Revisions to draft risk assessment may be done after public comment All risk assessments should be considered dynamic New research, technology changes, new knowledge will help to improve