Who are we? What are we doing? Why are we doing it?

European Food Safety Authority Advising the EU on TSE: A discussion of the way in which the EU seeks scientific advice in relation to TSEs Bart Goossens Scientific Coordinator Panel on Biological Hazards - BSE/TSE Unit European Food Safety Authority Who are we? What are we doing? Why are we doing it?

European Food Safety Authority Who are we? The European Food Safety Authority Is the scientific point of reference for the entire EU regarding food and feed safety.

BSE crisis was one of the reasons for the establishment of EFSA Legislation: White paper on Food Safety, Jan 2000 Implementing Regulation EC 178/2002 Before EFSA Risk Assessment and Risk Management under the same department of DG SANCO of the European Commission. Potential influence by politics, trade, industry and pressure groups.

The Main Principles and Changes Risk assessment (EFSA) separated from risk management (The European Commission) Authority independent from the European Commission Involvement & consideration of stakeholders Risk communication shared with the EC High level of openness and transparency MANAGEMENT BOARD EFSA Structure Office of of the the Executive Director Advisory Forum Instit. Instit. Affairs Affairs Legal Legal Affairs Affairs Finance Finance Human Human Resources Resources Inform Inform Technology Technology Accounts Accounts Science Dep. Scientific Committee & 8 Scientific Panels Panels Scientific Expert Expert Services Communications Press Press Office Office Publications Publications WEB WEB Quality Quality MGMT MGMT

Science department Scientific Committee General coordination and horizontal issues 8 Scientific Expert Panels Scientific Panel on Biological Hazards (incl. TSE) Working with external experts 21 per panel Scientific Expert Services (SES) In house expertise with a variation of tasks supporting the work of the different scientific panels 8 Scientific Panels : 1. Food Additives, Flavourings, Processing Aids, Materials in Contact with Food (AFC) 2. Additives and Products in Animal Feed (FEEDAP) 3. Plant Health, Plant Protection Products (PPR) 4. Genetically Modified Organisms (GMO) 5. Dietetic Products, Nutrition and Allergies (NDA) 6. Biological Hazards (BIOHAZ) 7. Contaminants in the Food Chain (CONTAM) 8. Animal Health and Welfare (AHAW)

European Food Safety Authority What are we doing? EFSA s Role in Risk Analysis Scientific Risk Assessment Risk management Risk Communication

EFSA (In close collaboration with national authorities and in open consultation with its stakeholders): Provides scientific advice and risk assessments Provides clear communication on these Gathers and analyses necessary information Reacts to crises Establishes networks of relevant organisations Monitors specific risk factors (e.g. animal diseases including zoonoses) EFSA s work is carried out with large input from external experts demonstrating the highest level of scientific excellence & independence With assistance of the COM/EFSA Interface Unit Options : invited experts, outsourcing, EFSA SES Mandates leading to Opinions Request from COM-EP-MS EFSA Scientific Secretariat Clarification process Assignment of Mandate to Panel(s) Liaison with Establishment of Panel s Working Groups other Panel(s), as appropriate Meetings to produce Report and draft Opinion Consideration by Panel Adoption (Yes/No/Amend) Opinion Deadline for Completion of Opinion agreed Before deadline

Our place in the Science Group Scientific Panel on Biological Hazard (BIOHAZ) Questions related to Biological Hazards for human health and food safety including Food-borne diseases, BSE/TSE, Microbiology, Food hygiene, Associated waste management (animal byproducts) Independent Scientific Expert Working Groups (WG) WG on TSE Testing WG on Geographical BSE Risk Scientific Panel on Biological Hazards took over the tasks of TSE/BSE ad hoc group of the Scientific Steering Committee (DG Sanco C1-SSC). Scientific Committee on Veterinary Measures related to Public Health (DG Sanco C2-SCVMPH).

BIOHAZ Panel Expertise food hygiene food technology food microbiology public health animal health parasitology virology zoonoses meat inspection TSE (epidemiology, neuropathology, testing, exposure) 21 experts Opinions Biohaz : TSE/BSE Quantitative assessment of the residual BSE risk in a number of bovine-derived products (e.g. tallow, gelatine, MBM..) Interpretation of results of EU TSE surveillance Assessment of the age limit in cattle for the removal of certain Specified Risk Materials (SRM). Qualitative Assessment of the risks posed to humans by goat meat and goat meat products related to BSE Chronic Wasting Disease

TSE/BSE related Geographical BSE Risk (GBR) Assessment of GBR I and II countries BSurvE Update of the GBR methodology Validation of diagnostic tests: EC call for application of interest: - post mortem BSE tests- cattle - scrapie tests small ruminants - Ante mortem tests European Food Safety Authority Why are we doing it?

The risk assessor provides a scientific basis for decision making by the [risk] manager Mutual understanding of the complementary roles of the RA and the RM is essential as is Communication. EFSA s clients European Commission European Parliament Member States Self-tasking issues Consumers

Opinions and Scientific Reports Background Explanation of the ToR Assessment (science based report of Working Group) Qualitative Semi-quantitative Quantitative risk assessments Conclusions Recommendations Data gaps and research needs identified Publication Publication (1) Conclusions: Communicated to originator of question (EC, MS, EP) supporting changes of legislation or impose/ease import restrictions (e.g. GBR) etc by EC (DG Sanco et al.) and turned into Proportionate risk management decisions Recommendations: Points of attention, further data collection, additional surveillance etc...

EC - DG Sanco - Risk Management significant decrease in the number of positive BSE cases in the EU, due to stringent risk reducing measures and new developments in science and technology the TSE Roadmap considers possible amendments to certain BSE measures TSE Roadmap Amendments in the short and medium term (2005-2009) Specified Risk Material (SRM) Opinion of the Biohaz Panel on the assessment of the age limit in cattle for the removal of certain SRM. Proposal COM at 24 M Monitoring programmes: bovines, small ruminants Opinion of the Biohaz Panel on the results of EU surveillance of TSEs in small ruminants, culling strategies and the TSE-related safety of certain small ruminant products. Opinion of the Biohaz Panel on a surveillance programme for Chronic Wasting Disease in the EU.

TSE Roadmap Alternative scenarios BSE in small ruminants If, following the intensive surveillance in goats, BSE would be confirmed at large scale within the sheep and goat population stringent measures should be taken which would include the full testing of small ruminants and consequently discriminatory testing of the TSE cases and an extensive list of SRM based on the scientific opinions which could lead in the worst scenario to the complete destruction of the carcass. This will also enforce the need for a breeding programme for resistance within the sheep population. Publication (2) Recommendations for further research Identification of data gaps and research needs : used by DG RTD (research) to include in framework contracts, calls for proposals etc

EC - DG RTD - Research Ongoing research projects currently funded Sixth and Seventh framework program-proposals Network of excellence Neuroprion Regular funding of conferences on BSE/TSE Regular meetings DG RTD, DG Sanco, EFSA Commercial break

EFSA Scientific Colloquium: Principles of Risk Assessment for Health and Welfare of Food Producing Animals: Current and future approaches 1-2 December 2005, Parma, Italy EFSA Newsletter circulation ca 4700 EFSA Highlights Subscribe via EFSA website

EFSA renewal of scientific panels May 2006 : end of three year mandate of the EFSA scientific panels. Renewal of mandates Call for expression of interest Early 2006 Experts in field related to Biohazards and TSE 8 day-meetings a year several working group meetings Most meetings in Parma, Italy Conclusion

EFSA BSE EC/EU Science based Risk Assessments Proportionate Risk Management measures Possible reduction of the costs for BSE control and surveillance Acknowledgements BioHaz Panel TSE Part Herbert Budka John D. Collins Christian Ducrot James Hope Ernst Lücker Riitta Liisa Maijala Ivar Vågsholm Emmanuel Vanopdenbosch Some 100 external ad hoc experts for working groups on: TSE surveillance CWD SRM in cattle BSE in goats BSE culling TSE test evaluation UK Moderate Risk Atypical scrapie.

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