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Content of the presentation CRA / Triazole opinion Probabilistic methodology

Kick-off meeting ACROPOLIS 7/8 June 2010 Cumulative and Aggregate Risk Assessment: EFSA perspective Bernadette Ossendorp (RIVM) on behalf of Luc Mohimont (EFSA PPR Panel Unit). Content of the presentation CRA / Triazole opinion Probabilistic methodology

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Content of the presentation CRA / Triazole opinion Probabilistic methodology

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  1. Kick-off meeting ACROPOLIS7/8 June 2010Cumulative and Aggregate Risk Assessment: EFSA perspectiveBernadette Ossendorp (RIVM) on behalf ofLuc Mohimont (EFSA PPR Panel Unit)

  2. Content of the presentation • CRA / Triazole opinion • Probabilistic methodology • How to apply the methodology in the decision making process

  3. CRA / TRIAZOLE OPINION EFSA Remit regarding CRA (Pesticides) Regulation EC 396/2005 Art 14 (Decision on applications concerning MRLs) “ …Regulation on the setting, modification… of an MRL… shall be prepared by the Commission … account shall be taken of… the possible presence of pesticide residues arising from sources other than current plant protection uses of active substances, and their known cumulative and synergistic effects, when the methods to assess such effects are available…” Whereas (6) “It is also important to carry out further work to develop a methodology to take into account cumulative and synergistic effects. In view of human exposure to combinations of active substances and their possible aggregate and synergistic effects on human health, MRLs should be set after consultation of the European Food Safety Authority…”

  4. Milestones • November 2006: EFSA Colloquium on  Cumulative Risk Assessment of Pesticides in Humans : The way forward  • April 2008: First opinion on the suitability of existing methodologies: Three possible forms of combined toxicity, but only dose-addition is relevant. Integration of methodologies into a tiered approach concept • June 2009: Second opinion on a CRA for triazole fungicides: Exercise aiming at testing the tool Refinement of the tiered approach Identification of needed future developments

  5. MRL setting scenario (Pre-registration): Assessment of the safety of the use and safety of the MRL with regard to cumulative effects One pesticide/commodity combination at a time. • Acute: What happens when the residue is at MRL Level ? MRL level for the combination, monitoring data, consumer only • Chronic: What happens when the pesticide is used according to the critical GAP? STMR level for the combination, monitoring data, whole population

  6. Actual exposure scenario (Post-registration): Purpose: Retrospective evaluation of cumulative risk on the basis of the actual use of pesticides • Acute: What is (has been) the overall acute risk of the population ? Monitoring data, whole population What is the meaning of high exposure events ? HR level for the combination, monitoring data, consumer only • Chronic: What is (has been) the overall chronic risk of the population ? Monitoring data, whole population

  7. Tiered approach 3 main areas of refinement from simple to complex CRA • Establishment of a CAG • Hazard Characterisation • Exposure assessment Combination of these 3 axes depending on needs and resources Standardised tiering process for risk characterisation

  8. Resulting proposed tiering of Risk characterisation • HI (deterministic) • adHI and/or NOAEL-based RPF methodology (deterministic) • BMD-based RPF Methodology (probabilistic) Main recommendations for simplification • Starting with a CAG as refined as the data allow • Restricting assessment to 2 tiers, one deterministic and one probabilistic

  9. Issues • CAGs: Criteria for establishment • UF • BMD determination • Metabolites • Handling of non-detects • Technical issues in probabilistic modelling • Uncertainties • Generation and quality of data • Desired level of protection CRA not yet possible on a routine basis

  10. Next developments at EFSA/EU level • Identification and consensus on CAGs New PPR Panel mandate Terms of reference adopted by the PPR Panel (September 2009) One Art 36 call ongoing CRA will be addressed from a toxicological end point perspective rather than from a chemical class perspective. • Guidance for probabilistic modelling in CRA Future mandate of the PPR Panel • Definition of the desired level of protection

  11. PROBABILISTIC METHODOLOGY Current mandate Guidance document for single compound exposure assessment • Mandate adopted in September 2008 • Different scenarios (pre- and post-registration, acute and chronic effect) • Public consultation early 2010 • Adoption mid 2010

  12. Future mandate Guidance document for cumulative exposure assessment • Mandate to be adopted mid 2010. • Different scenarios (pre- and post-registration, acute and chronic effect) • Public consultation mid 2011 • Adoption end 2011

  13. How to apply the methodology in the decision making process Discussion between Commission and Member States; starting with letter from EFSA to EC on following issues: Definition /confirmation of scenarios Which deterministic approach Which probabilistic approach Desired Level of Protection Uncertainty and desired level of conservatism Prioritisation of end-points to be assessed Aim: Final end 2011

  14. Thank you for your attention

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