Scientific Panel on Biological Hazards : Approach to Cases John D. Collins Panel Chair

1. Scientific Panel on Biological Hazards : Approach to Cases John D. Collins Panel Chair

2. Scientific Panel on Biological Hazards • Outline • Responsibilities; tasks • Protocol for dealing with mandates and formulation of • Opinions • Opinions: examples relating to • - infant formulae • salmonella in poultry • trichinella in pork • TSE issues • avian influenza (scientific report) • Current activities

4. In addition to its nine Scientific Panels, The EFSA also has • its Scientific Committee (SC) which is responsible for • the provision of scientific advice on • multi-sectorial issues falling within the competence of more • than one Panel, and • on issues which do not fall within the competence of any • of the Panels, • along with the general co-ordination necessary to ensure • Consistency in the scientific opinions of the different Panels.

5. The Scientific Panel on Biological Hazards (BioHaz) deals with questions on biological hazards relating to food safety and food-borne disease, including • food-borne zoonoses and transmissible spongiform encephalopathies, • microbiology, • food hygiene, and • associated waste management.

6. Scientific Panel on Biological Hazards ……took over the tasks of the previous • TSE/BSE ad hoc group previously under the Scientific Steering Committee (DG Sanco C1-SSC). • Scientific Committee onVeterinaryMeasuresrelated toPublicHealth (DG Sanco C2-SCVMPH). • Scientific Committee on Foods (DG Sanco C2-SCF) on Food Microbiology

7. Protocol for Mandates and Opinions EFSA Scientific Secretariat Clarification process Assignment of Mandate to Panel(s) Request from COM EP MS With assistance of the COM/EFSAInterface Unit

8. Protocol for Mandates and Opinions EFSA Scientific Secretariat Clarification process Assignment of Mandate to Panel(s) Establishment of Panel’s WG WG Meetings to produce Report and draft Opinion Request from COM EP MS With assistance of the COM/EFSAInterface Unit Deadline for Completion of Opinion agreed Liaison with other Panel(s), as appropriate Options re invited experts, outsourcing, EFSA SES

9. Protocol for Mandates and Opinions EFSA Scientific Secretariat Clarification process Assignment of Mandate to Panel(s) Establishment of Panel’s Working Group WG Meetings to produce Report and draft Opinion Consideration by Panel Adoption (Yes/No/Amend) Opinion Request from COM EP MS With assistance of the COM/EFSAInterface Unit Deadline for Completion of Opinion agreed Liaison with other Panel(s), as appropriate Options re invited experts, outsourcing, EFSA SciUnit Before deadline

10. BIOHAZ Panel New challenges: See Scientific Committee documents. Include - • Transparency • Emerging risks • Qualified Presumption of Safety (QPS) • Nanotechnology • --------------

11. Composition of the panel • Veterinary • Microbiology • Food Technology • Risk Assessment • Human Medicine

12. Opinions adopted to date by the BIOHAZ Panel May 2003 – May 2006

15. Opinion of BioHaz related to the microbiological risks in infant formulae and follow-on formulae. Adopted on 9 September 2004

16. Opinion of BioHaz related to the microbiological risks in infant formulae and follow-on formulae. 9 September 2004 HAZARD IDENTIFICATION : Salmonella and E. sakazakii - formulation and processing; - isolation and identification HAZARD CHARACTERIZATION - epidemiology and pathogenicity; - dose/response relationships

17. Opinion of BioHaz related to the microbiological risks in infant formulae and follow-on formulae. 9 September 2004 HAZARD IDENTIFICATION : Salmonella and E. sakazakii ·         - formulation and processing; isolation and identification HAZARD CHARACTERIZATION - epidemiology and pathogenicity; dose/response relationships EXPOSURE ASSESSMENT - inactivation and growth of pathogens during processing;          - recontamination, preparation of infant formula after reconstitution; - contamination rate

18. Opinion of BioHaz related to the microbiological risks in infant formulae and follow-on formulae. 9 September 2004 CONTROL MEASURES The most effective control measure to minimise risks in high-risk infants who arenot breast-fed,would be to use commercial sterile liquid formula.

19. Opinion of BioHaz related to the microbiological risks in infant formulae and follow-on formulae. 9 September 2004 OTHER CONTROL MEASURES Apply - at the manufacturing level; and - during preparation and reconstitution

20. Opinion of BioHaz related to the microbiological risks in infant formulae and follow-on formulae. 9 September 2004 RECOMMENDATIONS • that a Performance Objective (PO) for powdered infant formula and follow-on formula is introduced and that verification of compliance is confirmed by testing for Enterobacteriaceae in the environment and in the product. • that guidelines for preparation, handling, storage and use of infant formula in the home and inhospitals are developed.

21. Pursuant to Article 15 of Regulation (EC) No 2160/2003, The Commission consulted the EFSA on the use of antimicrobials and vaccines for the control of salmonella in poultry.

22. Opinion of BioHaz the use of vaccines for the control ofSalmonella in poultry. Adopted on 21 October 2004

23. Opinion of BioHaz on the use of vaccines for the control of Salmonella in poultry.21 October 2004 ASSESSMENT 1. BACKGROUND INFORMATION 2. VACCINES AVAILABLE FOR POULTRY 3. ADVANTAGES AND DISADVANTAGES OF THE USE OF VACCINES 4. USE OF VACCINES IN CONTROL PROGRAMMES

24. Opinion of BioHaz on the use of vaccines for the control of Salmonella in poultry.21 October 2004 • If a control programme is targeting to eradicate the serovars S. Enteritidis and S. Typhimurium in breeders of layers/broilers or laying hens, vaccination is not an option since it does not eliminate the shedding.

25. Opinion of BioHaz on the use of vaccines for the control of Salmonella in poultry.21 October 2004 • If a control programme is targeting to eradicate the serovars S. Enteritidis and S. Typhimurium in breeders of layers/broilers or laying hens, vaccination is not an option since it does not eliminate the shedding. • If a control programme is targeting serovars other than S. Enteritidis and S. Typhimurium in breeders, layers, broilers or turkeys, vaccination is not an appropriate option since the other serotypes are not covered by commercial vaccines available at the moment.

26. Opinion of BioHaz the use of antimicrobials for the control ofSalmonella in poultry. Adopted on 21 October 2004

27. Opinion of BioHaz the use of antimicrobials for the control ofSalmonella in poultry. Adopted on 21 October 2004 • From a food safety/public health viewpoint, using antimicrobials to control Salmonella spp. in poultry has little justification. • Any use in exceptional circumstances on animal health and welfare grounds must recognize the consequences for public health.

28. Opinion of BioHaz the use of antimicrobials for the control ofSalmonella in poultry. Adopted on21 October 2004 • From a food safety/public health viewpoint, using antimicrobials to control Salmonella spp. in poultry has little justification. • Any use in exceptional circumstances on animal health and welfare grounds must recognize the consequences for public health. • The use of antimicrobials for Salmonella control in poultry should be discouraged. • Their use should be subject to formally defined conditions that would ensure protection of public health.

29. Commission Regulation (EC) No. 1177/2006: requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry

30. Commission Regulation (EC) No 1177/2006 requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry Regarding Antimicrobials: “….Therefore, on the basis of the opinion of the EFSA, it is appropriate to provide that antimicrobials should not be used as part of national control programmes to be adopted pursuant to Article 6 of Regulation (EC) No 2160/2003, other than in the exceptional circumstances referred to by the EFSA in its opinion….”

31. Commission Regulation (EC) No 1177/2006 requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry Regarding Vaccines: On the basis of the opinion of the EFSA, it is appropriate to provide that currently available live vaccines should not be used as part of national control programmes to be adopted pursuant to Article 6 of Regulation (EC) No 2160/2003, in laying hens during production. continued……

32. Commission Regulation (EC) No 1177/2006 requirements for the use of specific control methods in the framework of the national programmes for the control of salmonella in poultry • Regarding Vaccines, continued: • Live vaccines should not be used if the manufacturer does • not provide an appropriate method to distinguish • bacteriologically wild-type strains of salmonella from • vaccine strains. • Based on the current scientific evidence, the use of live or • inactivated vaccines against Salmonella enteritidis should • be mandatory in Member States with a high prevalence in • order to improve public health protection.

33. Opinion of BIOHAZ on the “Risk assessment of a revised inspection of slaughter animals in areas with low prevalence of Trichinella”. Adopted on 10 March 2005.

34. Opinion of BIOHAZ on the “Risk assessment of a revised inspection of slaughter animals in areas with low prevalence of Trichinella”. Adopted 10 March 2005. • INTERPRETATION OF TERMS OF REFERENCE • HAZARD IDENTIFICATION and CHARACTERISATION In humans and in pigs and other species • EXPOSURE ASSESSMENT • RISK CHARACTERISATION OF TRICHINELLA INFECTION Suggested semi-quantification of probabilities • DETECTION OF INCREASED TRICHINELLA RISK OR EXPOSURE Reservoir surveillance; emerging trichinellosis • CONCLUSIONS AND RECOMMENDATIONS

35. Opinion of BIOHAZ on the “Risk assessment of a revised inspection of slaughter animals in areas with low prevalence of Trichinella”. Adopted 10 March 2005. • The request for opinion refers only to Trichinella-free farms complying with the requirements in the SCVPH opinion • Since the risk of Trichinella infections is negligible in pigs originating from farms classified as Trichinella-free, the additional risk reduction contributed by individual Trichinella testing is also negligible.

36. Opinion of BIOHAZ on the “Risk assessment of a revised inspection of slaughter animals in areas with low prevalence of Trichinella”. Adopted 10 March 2005. • The request for opinion refers only to Trichinella-free farms complying with the requirements in the SCVPH opinion • Since the risk of Trichinella infections is negligible in pigs originating from farms classified as Trichinella-free, the additional risk reduction contributed by individual Trichinella testing is also negligible. • Compliance with the regulations for Trichinella -free farms is crucial for maintaining this negligible risk level

37. Opinion of BIOHAZ on the “Risk assessment of a revised inspection of slaughter animals in areas with low prevalence of Trichinella”. Adopted 10 March 2005. “….The problem as to how to define the geographical regions or areas in which there is Trichinella absence or negligible prevalence in wildlife reservoirs is not trivial…..” See also: Opinion of the Scientific Panel BIOHAZ on the “Request for an opinion on the feasibility of establishing Trichinella-free areas, and if feasible, on the risk increase to public health of not examining pigs from those areas for Trichinella spp.” Adopted 26 October 2005

38. Annex to the Opinion on the assessment of the age limit in cattle for the removal of certain Specified Risk Materials (SRM). Report of the Working Group The EFSA Journal (2005) 220, 1-21 Procedure adopted 1. Assessment 1.1. Experimental studies 1.2. Epidemiological data 2. Conclusions Justification to eventually change the age limit on the basis of the results of pathogenesis studies and epidemiological data 3. Recommendations

39. Quantitative Assessment of the Residual BSE Risk in Bovine-Derived ProductsEFSA QRA Report 2004* While Quantitative Risk Assessment of food-borne pathogens is a powerful methodology for estimating how likely, and at what level, an individual or population will be exposed to a microbial hazard, the output of risk models is relatively complex. QRA methodology based on concurrent data is applied in the context of the quantitative assessment of residual BSE risk on an ongoing basis. *The EFSA Journal (2005) 307: 1-135. See also “Risk assessment of food-borne bacterial pathogens: quantitative methodology relevant for human exposure assessment”. (EC SSC Preliminary Report, February 21-22nd, 2002).

40. EFSA QRA REPORT, 2004. • Background data required included - • input data needed for quantitative BSE risk assessments • Species barrier for oral transmission • The infectious load of cattle by-products • Assumptions regarding the total infectious load of the cattle by-products • Assumptions regarding the yield per animal of certain by-products, • viz. gelatine from bones, di-calcium phosphate from bones, tallow • Probability of material from an infected animal being present • Infectivity reduction by processing • Human and animal consumption of certain cattle-derived products

41. Annex to the Opinion on the assessment of the age limit in cattle for the removal of certain Specified Risk Materials (SRM). Report of the Working Group The EFSA Journal (2005) 220, 1-21 1. Assessment 1.1. Experimental studies 1.1.1. Assessment of spread of infectivity and/or PrPsc in relation to time (pathogenesis studies) and the earliest detectable infectivity in the Central Nervous System of cattle PrPsc 1.1.2. Experimental data from mouse and hamster models of pathogenesis involving infection in the oral cavity 1.1.3. Infectivity in tonsil and intestine 1.1.4. Conclusion on pathogenesis studies

42. Annex to the Opinion on the assessment of the age limit in cattle for the removal of certain Specified Risk Materials (SRM). Report of the Working Group The EFSA Journal (2005) 220, 1-21 • Assessment, continued • 1.2. Epidemiological data. • 1.2.1. Age dependent susceptibility at infection • 1.2.2. Age distribution of BSE cases in the EU • 1.2.3. Age distribution of young BSE cases outside the EU • 1.2.4. Probability for the presence of BSE infected cattle with an age • under 30 months covering the EU-25 • 1.2.5. Possible epidemiological approaches • 1.2.7. Conclusions on epidemiological data

43. Annex to the Opinion on the assessment of the age limit in cattle for the removal of certain Specified Risk Materials (SRM). Report of the Working Group The EFSA Journal (2005) 220, 1-21 2. Conclusions • On the basis of pathogenesis studies it can be assumed that in Central Nervous System (CNS) the likely detectable PrPSc, and consequently the likely detectable infectivity, appears at about ¾ of the incubation time. • Based on the earliest clinical manifestation seen in pathogenesis studies and assuming that the last quarter of the incubation period would be positive for infectivity, the earliest infectivity would have to be assumed at 26 months. However, this would reflect uptake of the BSE agent via the gut only.

44. Annex to the Opinion on the assessment of the age limit in cattle for the removal of certain Specified Risk Materials (SRM). Report of the Working Group The EFSA Journal (2005) 220, 1-21 • 3. Recommendations • • The main issue that needs to be addressed with respect to • options for estimation of the age limit for the removal of • Specified Risk Materials (SRM) is the likelihood of the • infectivity in SRM derived from infected cattle at different • age groups. • Estimation of this likelihood of infectivity would require • back calculation modelling with further assessment of • experimental and epidemiological data.

45. Public Consultations, 2005-2006 • Draft Opinion on Microbiological Testing, Criteria • and other Objectives . Under discussion, October, 2006 • Joint AFC/BIOHAZ Draft Guidance Document on • antimicrobial treatments for the removal of microbial • surface contamination of foods of animal origin

46. Draft opinion on microbiological testing, criteria and other objectives 12 stakeholders submitted comments: • Commission (DG-SANCO) • National Food Authorities and Institutes • AFSSA-France, FASFC-Belgium, RIVM-the Netherlands • Industry and associations • CIAA, CLITRAVI, EDA, UNILEVER • Scientific associations • ILSI Europe, ICMSF • Private experts on risk assessment

47. Draft opinion on microbiological testing, criteria and other objectives Some examples of comments: • The relation between ALOP, FSO, PO, PC and MC/microbiological testing • The examples on ALOP and the assessment whether an ALOP is met • The role of food business to set POs and PCs • The use and establishment of microbiological criteria by the regulatory authorities and the industry

48. Joint AFC/BIOHAZ guidance document on antimicrobial treatments 7 stakeholders submitted comments: • National Food Authorities and Institutes • AFSSA-France, FASFC-Belgium • Industry, associations and producers • Danisco A/S, ECOLAB, CLITRAVI • Private experts on risk assessment

49. Joint AFC/BIOHAZ guidance document on antimicrobial treatments Some examples of comments: • The need of harmonisation of terminology • The requirement of the rinse step • The definition of the efficacy of the treatment See: Joint AFC/BIOHAZ guidance document on the submission of data for the evaluation of the safety and the efficacy of substances for the removal of microbial surface contamination of foods of animal origin. Adopted on 13 July and 28 August 2006.

50. REPORT BioHaz Panel’s scientific report on food as a vehicle for Avian Influenza virus* * See “Food as a possible source of infection with highly pathogenic avian influenza viruses for humans and other mammals” 30 June 2006. The EFSA Journal (2006) 74: 1 – 29. Also, see “Opinion of the Scientific Panel on Animal Health and Welfare on the possible role of migratory birds in the spread of highly pathogenic avian influenza”. 12 May 2006. The EFSA Journal (2006) 357: 1 – 46.