1. ANSES’s opinion on microbiological safety and hygiene of pork carcasses refrigerated in chilling rooms and then transported in refrigerated trucks Laurent Guillier French agency for food, environmental and occupational health and safety (ANSES) April 15 th, 2014 U.E.C.B.V. Working group on veterinary issues

2. Outline 2 1.Context: Study conducted by petitioner (with complement of October 2013) and ToR of French Ministry of Agriculture 2.Presentation of ANSES’s opinion 2.1 Critical analysis of petitioner approach 2.2 Complementary approach proposed by ANSES 2.3 Evaluation of different alternative scenarios 3.Conclusion

3. Outline 3 1.Context: Study conducted by petitioner (with complement of October 2013) and ToR of French Ministry of Agriculture 2.Presentation of ANSES’s opinion 2.1 Critical analysis of petitioner approach 2.2 Complementary approach proposed by ANSES 2.3 Evaluation of different alternative scenarios 3.Conclusion

4. Context: Study conducted by the petitioner Just presented by Mariem Ellouze

5. Context: ToRs from French ministry of agriculture ToRs 1.Is the petitioner’s approach pertinent (modelling methods and pathogens) 2.Are petitioner’s conclusion valid ? 3. What would be the maximal temperature increase and transport duration acceptable (acceptable for competent authority = “no significant increase of the consumer’s risk”)

6. Outline 6 1.Context: Study conducted by petitioner (with complement of October 2013) and ToR of French Ministry of Agriculture 2.Presentation of ANSES’s opinion 2.1 Critical analysis of petitioner approach 2.2 Complementary approach proposed by ANSES 2.3 Evaluation of different alternative scenarios 3.Conclusion

7. Outline 7 1.Context: Study conducted by petitioner (with complement of October 2013) and ToR of French Ministry of Agriculture 2.Presentation of ANSES’s opinion 2.1 Critical analysis of petitioner approach 2.2 Complementary approach proposed by ANSES 2.3 Evaluation of different alternative scenarios 3.Conclusion

8. Critical analysis of petitioner approach (2) Petitioner’s study: –Time-temperature integration –4 bacteria : L. monocytogenes, Salmonella, E. coli (for Enterobacteriaceae) Pseudomonas (for total microflora) –Growth estimated on surface (but decision rule based on core temperature) –Fail-safe assumptions : no lag, high aw –Variability integrated (between strains, pH, slaughterhouses, transports, …) –Comparison between scenarios and a reference situation –Lot of data: 2008: transports kinetics (not representative of practices) 2011: slaughterhouse kinetics 2013: Core temperatures when leaving slaughterhouse and at arrival for thousands of carcasses

9. Critical analysis of petitioner approach (2) Critical analysis regarding pathogens and predictive modelling approach -Right approach chosen: Time-temperature integration -Ok for both chosen pathogens (the two others don’t help to give a response to competent authority) -Assumptions (lag, etc.): really fail safe -Variability taken into account: nothing to say -…

10. Critical analysis of petitioner approach (3) Petitioner’s studies relies on three complementary arguments First argument of petitioner -Reference carcasses at slaughterhouse (24h) -Reference versus : carcasses leave when core T is > 7  C (from 10  C to 30  C from no representative data of 2008 at loading) -Results : distribution of differences -Message of petitioner: even for very high initial temperature, increases are “not so big” -ANSES’s view on theses results : ok but don’t help to establish a derogation

11. Critical analysis of petitioner approach (4) Second argument of petitioner -Records of temperature in hundreds of carcasses -Truks can help to decrease temperature -ANSES’s view on theses results : This gives confidence to results on cooling kinetics of 2008 in trucks → temperature decline in transports is possible

12. Critical analysis of petitioner approach (4) Second argument of petitioner Core temperature at loading (  C) Core temperature at arrival to cutting plans (  C)

13. Critical analysis of petitioner approach (5) Third argument of petitioner -For evaluation of alternative scenarios, definition of a reference scenario: but no more cold room (as in argument 1) but conditions corresponding to warm cutting derogation (12 ◦ C-2h) -Reference versus three scenarios (carcasses leave slaughterhouse when core T is 12, 15 or 18  C) -ANSES’s view on this approach : -Reluctant to this reference (petitioner want to gain logistic time and to debone warm carcasses) -Methodology to define scenario: lost of the representativeness (loss of information)

14. Outline 14 1.Context: Study conducted by petitioner (with complement of October 2013) and ToR of French Ministry of Agriculture 2.Presentation of ANSES’s opinion 2.1 Critical analysis of petitioner approach 2.2 Complementary approach proposed by ANSES 2.3 Evaluation of different alternative scenarios 3.Conclusion

15. Complementary approach proposed by ANSES Objective : to complete the petitioner ‘s study in order to help competent authority to appreciate consequences on risk -Representativeness: objective to model of temperature kinetics -Decision rules: objective to define adapted situation(s) of reference (corresponding to actual reg. (CE) 853/2004) versus three possible alternative scenarios (carcasses that leave slaughterhouse when core T is 12, 15 or 18  C)

16. ANSES proposal to model of temperature kinetics -First: core temperature modelling in slaughterhouse Complementary approach proposed by ANSES Core temperature (  C) Time (h)

17. ANSES proposal to model of temperature kinetics -Second: core temperature modelling in trucks. -Comparison between cooling kinetics rate Complementary approach proposed by ANSES Rate of exponential decease (h-1))

18. ANSES proposal to model of temperature kinetics -Third: link between core temperature and surface (the same in trucks and cold rooms) Complementary approach proposed by ANSES Core temperature (  C) Core temperature minus surface temperature (  C)

19. ANSES proposal to model of temperature kinetics -Finally: distribution are available for every important parameters (exponential rate in cold rooms in trucks and parameters for linking Tc to Ts): Representativeness solve Complementary approach proposed by ANSES Time (h) Surface temperature (  C)

20. Outline 20 1.Context: Study conducted by petitioner (with complement of October 2013) and ToR of French Ministry of Agriculture 2.Presentation of ANSES’s opinion 2.1 Critical analysis of petitioner approach 2.2 Complementary approach proposed by ANSES 2.3 Evaluation of different alternative scenarios 3.Conclusion

21. Evaluation of different alternative scenarios Objective : to complete the petitioner ‘s study in order to help competent authority to appreciate consequences on risk -Representativeness: objective to model of temperature kinetics -Decision rules: objective to define adapted situation(s) of reference (corresponding to actual reg. (CE) 853/2004) versus three possible alternative scenarios (carcasses that leave slaughterhouse when core T is 12, 15 or 18  C)

22. Evaluation of different alternative scenarios First how to define scenarios (in a stochastic context) -Example for Scenario 12  C: what does that mean? -All carcasses leave when 12  C is reached: non sense because of variability (why the first should leave after 10h, another one after 13h etc.) -Define a time in cold room where a percentage (95%) of carcasses is below 12  C -12  C (95% below) = 15 h -15  C (95% below) = 10 h -18  C (95% below) = 8 h

23. Evaluation of different alternative scenarios What is(are) the situation(s) of reference ? -Ref A: warm cutting (15h in slaughterhouse = 95% of carcasses <12 + 2 hours of transport -Ref B: 24 h in cold rooms (carcasses are below 7) + transport (at a temperature randomly chosen in [2,7] range for [3-20] hours -Ref C: 24 h in cold rooms (carcasses are below 7) + transport (at a temperature randomly chosen in [2,7] range for [3-20] hours + cold rooms of cutting plants (total time = 72h)

24. 2.3 Third part: Evaluation of different alternative scenarios Ref 1A versus scenarios (scenario 15 – Lm 1 example out of 10,000) -Example Time(h)

25. Evaluation of different alternative scenarios Ref 1A versus scenarios -Results expressed in Nfinal scenario – Nfinal reference (in log10)

26. Evaluation of different alternative scenarios Ref 1B versus scenarios (scenario 15 – Salmonella 1 example out of 10,000) -Example Time(h)

27. Evaluation of different alternative scenarios Ref 1B versus scenarios -Results expressed in Nfinal scenario – Nfinal reference (in log10)

28. Evaluation of different alternative scenarios Ref 1C versus scenarios (scenario 18 – Lm 1 example out of 10,000) -Example Time(h)

29. Evaluation of different alternative scenarios Ref 1B versus scenarios -Results expressed in Nfinal scenario – Nfinal reference (in log10)

30. Outline 30 1.Context: Study conducted by petitioner (with complement of October 2013) and ToR of French Ministry of Agriculture 2.Presentation of ANSES’s opinion 2.1 Critical analysis of petitioner approach 2.2 Complementary approach proposed by ANSES 2.3 Evaluation of different alternative scenarios 3.Conclusion

31. Conclusion ANSES focused on petitioner study (as asked by competent authority) -Petitioner’s conclusions not complete enough to evaluate safety consequences -ANSES proposed a complementary approach to solve main limits -Definition of acceptable scenario (what is the “reference situation”) is of competent authority‘s responsibility -It’s possible to not comply the “7ºC” while maintaining an acceptable risk level

32. Conclusion: differences between ANSES and EFSA ? Similarities ANSES and EFSA general approaches are similar (TTE, growth on surface, variability) ANSES and EFSA used the same reference situation (24h in slaughterhouse+48h of transport) ANSES and EFSA’s conclusions are the same: “it’s possible to define alternative chilling process and transport regimes… without increasing the risk” ANSES and EFSA’s conclusions opens the way to possible derogations Differences Surface temperature modelling is more “complex” in ANSES’s opinion EFSA recommends to establish a process criteria based on a limit of surface temperature and a transport time /ANSES doesn’t define the nature of process criteria (surface temperature, a core temperature, a percentage of carcasses above a value etc.)