1. RISK MANAGEMENT The process of weighing policy alternatives in the light of the results of risk assessment and, if required, selecting and implementing appropriate control options, including regulatory measures

2. Listeria monocytogenes HAZARD Primary production Transformation Distribution Consumption Possible occurrence of “hazardous situations” (situations leading to potential contamination, development, survival of L.m.) Listeriosis in humans“Unwanted event” “Adverse effect” “Harm” PROBABILITY OF OCCURRENCE RISK SEVERITY Consequences: - health effects - other effects

3. RISK ASSESSOR S RISK MANAGERS DECISION STAKEHOL DERS

4. RISK MANAGEMENT PROCESS risk evaluation identification of options choice of option implementation monitoring review

5. RISK EVALUATION risk profiling ranking of hazards identification of goals risk assessment policy initiation of risk assessment

6. RISK PROFILING setting the problem in its context describe the hazard nature and severity of effects economic & trade aspects risk/benefit communication

7. RANKING OF HAZARDS setting priorities severity of the problem complexity of the problem opinion of stakeholders societal/political factors

8. IDENTIFICATION OF GOALS intervention or not appropriate level of protection prevent, reduce, minimise economic, societal, political

9. APPROPRIATE LEVEL OF PROTECTION (SPS) The level of protection deemed appropriate by the Member establishing a sanitary measure to protect human or animal life or health within its territory

10. RISK ASSESSMENT POLICY COMMUNICATION - independence - excellence - integrity - transparency - uncertainties - value judgements - resources

11. RISK MANAGEMENT OPTIONS comparison with other risks magnitude of benefits prevention / control possibilities technical feasibility benefits / “costs” alternate risks consumer perception consumer preference societal and ethical factors

12. CHOICE OF OPTION do nothing communicate the risk adopt an international standard adopt a measure other than an international standard adopt a precautionary measure

13. PRECAUTIONARY PRINCIPLE (SPS) ARTICLE 5(7) : insufficient scientific evidence provisional measure seek to obtain the additional information necessary review measure within a reasonable period of time

14. IMPLEMENTATION regulatory authority or operator increasing tendency to put burden of compliance on operator, with regulatory overview HACCP / animal health Food Safety Objectives

15. MONITOR / REVIEW plan - who, what, when supervision of production disease surveillance repeat assessment

16. Concept of Risk Assessment Index WTO (burden of proof) Risk Profile Uncertainty Risk Policies Zero risk-ADI based model Alara (As Low as Reasonably Achievable) Threshold Approaches/Non threshold Approaches Risk Balancing Policies Procedural Approaches Level of Protection OLF I Extrapolation Sensitivity

17. Risk Management (whole food chain) Decision-making Process Standard Formulation Enforcement / Monitoring Precautionary Principle Risk Communication Assessors Industries Consumers II. III.

18. SUMMARY RISK ANALYSIS SHOULD : provide an integrated approach rely on the best scientific advice involve all stakeholders be flexible and adaptable