1. Food Safety Risk Assessment - PubH 7100-104 1 of 40 Overview of 3 published risk assessments Don Schaffner, Ph.D. Rutgers, The State University of NJ

2. Food Safety Risk Assessment - PubH 7100-104 2 of 40 Three risk assessments -Salmonella Enteritidis Risk Assessment -Draft Risk Assessment of the Public Health Impact of Escherichia coli O156:H7 in Ground Beef -Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods

3. Food Safety Risk Assessment - PubH 7100-104 3 of 40 Se in eggs -Oldest “full” microbial risk assessment (started 1996, completed in 1998) -Quite complex! -Uses @risk add-in to Microsoft Excel

4. Food Safety Risk Assessment - PubH 7100-104 4 of 40 Se in eggs objectives -Model from farm to table the unmitigated risk of foodborne illness due to SE from the consumption of eggs and egg products; -Identify target areas along the farm-to-table continuum for potential risk reduction activities -Compare the public health benefits accruing from the mitigated risk of SE foodborne illness with the implementation of various intervention strategies -Provide information on risk-effectiveness of mitigation to be utilized by the agency for subsequent cost-effectiveness and cost-benefit analysis -Identify data gaps and guide future research and data collection efforts

5. Food Safety Risk Assessment - PubH 7100-104 5 of 40 Diagram of Se in eggs QRA

6. Food Safety Risk Assessment - PubH 7100-104 6 of 40 Diagrams from production module

7. Food Safety Risk Assessment - PubH 7100-104 7 of 40 Diagram (again)

8. Food Safety Risk Assessment - PubH 7100-104 8 of 40 Shell Eggs Processing and Distribution Module

9. Food Safety Risk Assessment - PubH 7100-104 9 of 40 Yolk membrane breakdown -SE are found in the white -The white contains growth inhibitors -The yolk membrane keeps SE out of the yolk -The yolk membrane degrades with time and temperature

10. Food Safety Risk Assessment - PubH 7100-104 10 of 40 Data used to create model -Unpublished data from Tom Humphreys, UK -Data points represent the time for more than 25% of a group of 9-11 eggs to permit SE growth

11. Food Safety Risk Assessment - PubH 7100-104 11 of 40 Diagram of Se in eggs QRA

12. Food Safety Risk Assessment - PubH 7100-104 12 of 40 Example of LE processing complexity

13. Food Safety Risk Assessment - PubH 7100-104 13 of 40 Diagram of Se in eggs QRA

14. Food Safety Risk Assessment - PubH 7100-104 14 of 40 Preparation and consumption diagram -Pooling (the process of combining eggs together) influences risk

15. Food Safety Risk Assessment - PubH 7100-104 15 of 40 Diagram of Se in eggs QRA

16. Food Safety Risk Assessment - PubH 7100-104 16 of 40 Dose response Salmonella species used in feeding trials appear to be less virulent than SE, based on the epidemiologic data. Morales et al. (1996) proposed Shigella dysenteriae as a surrogate for SE

17. Food Safety Risk Assessment - PubH 7100-104 17 of 40 E. coli O157:H7 -Initiated in 1998 http://www.fsis.usda.gov/OPHS/ecolrisk/home. htm -Draft released in 2001 http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/ 00-023NReport.pdf -Reviewed by National Academy of Science 2002 http://books.nap.edu/books/0309086272/html

18. Food Safety Risk Assessment - PubH 7100-104 18 of 40 E. coli O157:H7 in ground beef objectives -Goal is to produce a baseline risk assessment that Reflects current practices along the farm-to-table continuum Accurately assesses the likelihood of illness and death -The primary use is to assist FSIS in reviewing and refining its risk reduction strategy for E. coli O157:H7 in ground beef -The risk assessment produces scientific support for Development of regulatory impact assessments to support FSIS rulemaking Identification of critical control points and critical control limits in HACCP systems for ground beef Risk-based sampling plans for FSIS inspectors Identification of food safety research on E. coli O157:H7 in ground beef.

19. Food Safety Risk Assessment - PubH 7100-104 19 of 40 E. coli O157:H7 in ground beef diagram

20. Food Safety Risk Assessment - PubH 7100-104 20 of 40 The problem of prevalence -How common is the problem in herds? -In a positive herd, how common is the problem?

21. Food Safety Risk Assessment - PubH 7100-104 21 of 40 Why is season important?

22. Food Safety Risk Assessment - PubH 7100-104 22 of 40 E. coli O157:H7 in ground beef diagram

23. Food Safety Risk Assessment - PubH 7100-104 23 of 40 Slaughter module Note that contamination may increase, decrease or stay the same

24. Food Safety Risk Assessment - PubH 7100-104 24 of 40 E. coli O157:H7 in ground beef diagram

25. Food Safety Risk Assessment - PubH 7100-104 25 of 40 Preparation module

26. Food Safety Risk Assessment - PubH 7100-104 26 of 40 Change during storage

27. Food Safety Risk Assessment - PubH 7100-104 27 of 40 Change during cooking

28. Food Safety Risk Assessment - PubH 7100-104 28 of 40 E. coli O157:H7 in ground beef diagram

29. Food Safety Risk Assessment - PubH 7100-104 29 of 40 Dealing with dose response

30. Food Safety Risk Assessment - PubH 7100-104 30 of 40 Risk characterization (picture)

31. Food Safety Risk Assessment - PubH 7100-104 31 of 40 Risk characterization (words) -Most contaminated cooked ground beef servings contain only 1 E. coli O157:H7 organism… and the risk of illness from one E. coli O157:H7 is low. -Few contaminated cooked ground beef servings contain 100,000 E. coli O157:H7 organisms per serving (1.8 × 10-7) but this dose results in the highest risk of illness (1.0 × 10-7) from E. coli O157:H7 in a ground beef serving. -Reducing the number of E. coli O157:H7- contaminated ground beef servings may reduce risk of illness more than reducing the amount of E. coli O157:H7 in contaminated servings.

32. Food Safety Risk Assessment - PubH 7100-104 32 of 40 Listeria monocytogenes in RTE foods -The purpose of the assessment is to examine systematically the available scientific data and information to estimate the relative risks of serious illness and death associated with consumption of different types of ready-to-eat (RTE) foods -This examination of the current science and the models developed from it are among the tools that food safety regulatory agencies will consider when evaluating the effectiveness of current and future policies, programs, and regulatory practices. -A distinction is made between the mild non-invasive illness (referred to as listerial gastroenteritis) and the severe, sometimes life-threatening, disease (referred to as listeriosis). This risk assessment only considers listeriosis.

33. Food Safety Risk Assessment - PubH 7100-104 33 of 40 Listeria monocytogenes in RTE foods -Released plan in 1999 -Released draft in 2001 -Revised in 2003 -Note different FAO/WHO risk assessment ongoing during the same time

34. Food Safety Risk Assessment - PubH 7100-104 34 of 40 What does it do? -Provides analyses and models that… Estimate the potential level of exposure Three age-based population groups and the total United States population to Listeria monocytogenes contaminated foods for 23 food categories Relates this exposure to public health consequences

35. Food Safety Risk Assessment - PubH 7100-104 35 of 40 Diagram of QRA

36. Food Safety Risk Assessment - PubH 7100-104 36 of 40 Interesting features Assumed detected Lm is just the tip of the iceberg

37. Food Safety Risk Assessment - PubH 7100-104 37 of 40 Comparing relative ranks

38. Food Safety Risk Assessment - PubH 7100-104 38 of 40 Risk Characterization -High risk per serving Deli Meats Frankfurters, not reheated Pâté and Meat Spreads Unpasteurized Fluid Milk Smoked Seafood Cooked Ready-to-Eat Crustaceans -High risk per year (cases) Deli Meats (1598.7) Pasteurized Fluid Milk (90.8) High Fat and Other Dairy Products (56.4) Frankfurters, not reheated (30.5)

39. Food Safety Risk Assessment - PubH 7100-104 39 of 40 RC table

40. Food Safety Risk Assessment - PubH 7100-104 40 of 40 Three very different risk assessments -Salmonella Enteritidis in eggs Farm-to-fork, many foods -Draft Risk Assessment of the Public Health Impact of Escherichia coli O156:H7 in Ground Beef Farm-to-fork, single food, still not done! -Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods Limited scope (i.e. not farm-to-fork), many (many!) foods