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ACROPOLIS Scientific Advisory Board

ACROPOLIS Scientific Advisory Board. Jacob van Klaveren. Contents. EFSA opinion cumulative risk assessment ACROPOLIS (EU funded project) Data access issues Risk management perspective Scientific sound. Deterministic approaches. Advantage IESTI (PRIMo, WHO) Used world-wide

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ACROPOLIS Scientific Advisory Board

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  1. ACROPOLIS Scientific Advisory Board Jacob van Klaveren Jacob van Klaveren

  2. Contents • EFSA opinion cumulative risk assessment • ACROPOLIS (EU funded project) • Data access issues • Risk management perspective • Scientific sound Jacob van Klaveren

  3. Deterministic approaches • Advantage • IESTI (PRIMo, WHO) • Used world-wide • Easy to understand • Disadvantage • One food item at the time • One chemical at the time • Not addressing variability • Not addressing uncertainty • Validity of assumptions not known? Jacob van Klaveren

  4. Different approaches • Short-term intake • PRIMo model used (case 2 a or other cases) Exposure = intake critical RAC + background exposure all other RACs and pesticides CAG - background critical RAC • Is probabilistic assessment possible and can it be used at theinternational level addressing both acute and chronic toxicity Jacob van Klaveren

  5. Probabilistic modeling cumulative exposure RPF index compound residue database consumption database 99, 99.9, and/or 99.99 percentile Jacob van Klaveren

  6. A few recommendations (EFSA opinion) Common Assessment Group should be the same in Europe Draft guidelines are published by EFSA Jacob van Klaveren

  7. Institutes working on ACROPOLIS • National Institute for Public Health and the Environment (RIVM) • The Secretary of State for Environment, Food and Rural Affairs (FERA) • University of Milano • National Research Institute for Food and Nutrition (INRAN) • University of Utrecht • Chemical Regulation Directorate (CRD or former PSD) • National Institute of Public Health (NIPH) • Freshfel Europe • National Food Administration • University of Ghent • Wageningen University (Biometris) Jacob van Klaveren

  8. Aims of EU project ACROPOLIS • Improved cumulative exposure assessment and cumulative hazard assessment; • New models for aggregated exposureassessment addressing different routes of exposure; • Setting up new toxicological testing for identifying possible synergistic effects and developing a strategy for refinement of cumulative assessment groups; Jacob van Klaveren

  9. Important aims of EU project ACROPOLIS • To integrate cumulative and aggregate risk models integrated in a web-based tool, includingaccessible data for all stakeholders • Improving the understanding of cumulative risk assessment methodology of differentstakeholders. Jacob van Klaveren

  10. Project management Jacob van Klaveren

  11. One platform, data and model availability Member States Industry Agrochemicals Regulators ACROPOLIS MODEL Run ACROPLIS Re-run ACROPLIS UK SE NL IT CZ Data access agreed Jacob van Klaveren

  12. Data platform and data sharing • One platform compatible and preferable shared with EFSA • Data owners are Member States • Difficult process for many years • We have to manage this carefully - user groups - confidentiality agreements where needed • A lot of energy (National Food Authorities has already become associated partner of ACROPOLIS to be able to perform cumulative assessment in their own country) Jacob van Klaveren

  13. Influence of uncertainty analyses 95 99 99,9 99,99 • Uncertainty in models, data and assumption • EFSA guideline (qualitatively and quantitatively) • Cooperation RIVM – FERA Jacob van Klaveren

  14. WP6 Stakeholder involvement • Is Science (e.g. Margin of Exposure) understandable • Stakeholder attitudes towards pesticide risk assessment • Is platform in WP5 useful and practical Jacob van Klaveren

  15. Do we help the risk management? Risk managers have to deal with views of different stakeholders Legal obligation (art 14, 396/2005) Keep it simple - exceeding ARfD in deterministic = black-white - variability already difficult to understand - relevance of variability and uncertainty factors as it is part of new and old approaches Starting point is scientific correct model! Jacob van Klaveren

  16. EFSA guideline PPR, 4 approaches needed Assessment of actual exposure using monitoring data acute assessment chronic assessment MRL-setting using Field Trial Data or MRL for one crop-pesticides and monitoring data for all other crops acute assessment (consumer only) chronic assessment Public consultation single chemical (summer 2010) Jacob van Klaveren

  17. Is our concept scientific sound? EFSA request for overview tables Source EFSA Draft guideline for public consultation (no real data filled in) Jacob van Klaveren

  18. Exceeding ARfD or ADI What was the original meaning when ADI was set? Animal versus human Include most sensitive person? Variability or sensitivity? Rest of all uncertainties covered? Original concept addressed the average consumer only How much of the concern has been filled up? variability is well defined in all parameters and included in the model Uncertainty is identified and included Sensitive groups are addressed Jacob van Klaveren

  19. Exceeding ARfD or ADI Once (some) concerns in the original concept have been addressed should we then still use uncertainty factor 10 x 10 in the tails of intake distribution? But new concerns were addressed overtime? New refinements have been proposed e.g. toxicological effect is only relevant for a certain group. Will we have PRIMo data for that group? How to link current deterministic approach results with probabilistic approach? ACROPOLIS will not interfere with Risk Management decision, might provide useful instruments Jacob van Klaveren

  20. Margin of Exposure to put risk in perspective? Jacob van Klaveren

  21. Dissemination activities • Training • Stakeholder conferences • Understanding and acceptance • Variability and uncertainty • Precautionary principle and safety factors • Understanding and acceptance • Desired Level of Protection Jacob van Klaveren

  22. Aim for today • ACROPOLIS is a contract signed by partners and EU Commission and we are obliged to follow that contract. We want to share were we are and what we do! • ACROPOLIS should be useful for risk managers, EFSA, consumers (Greenpeace), trade and industry. • Share information on concepts, data and experience • We want to have feedback how work fits in with your developments • What can be offered from your side • How to organize useful exchange Jacob van Klaveren

  23. acropolis-eu.com Jacob van Klaveren

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