1Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren ACROPOLIS Scientific Advisory Board Jacob van Klaveren

Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren 2 EFSA opinion cumulative risk assessment ACROPOLIS (EU funded project) Data access issues Risk management perspective Scientific sound Contents

Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren 3 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? Deterministic approaches

Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren 4 Short-term intake –PRIMo model used (case 2 a or other cases) Different approaches 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 the international level addressing both acute and chronic toxicity

Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren 5 consumption database residue database 99, 99.9, and/or percentile RPF index compound Probabilistic modeling cumulative exposure

Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren 6 A few recommendations (EFSA opinion) Common Assessment Group should be the same in Europe Draft guidelines are published by EFSA

Scientific Advisory Board meeting | 31 maart 2011 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)

Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren 8 Aims of EU project ACROPOLIS Improved cumulative exposure assessment and cumulative hazard assessment; New models for aggregated exposure assessment 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;

Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren 9 Important aims of EU project ACROPOLIS To integrate cumulative and aggregate risk models integrated in a web-based tool, including accessible data for all stakeholders Improving the understanding of cumulative risk assessment methodology of different stakeholders.

Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren 10 Project management

Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren 11 One platform, data and model availability Industry Agrochemicals SENLIT ACROPOLIS MODEL Re-run ACROPLIS Run ACROPLIS CZ UK Member States Regulators Data access agreed

Scientific Advisory Board meeting | 31 maart 2011 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)

Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren 13 Influence of uncertainty analyses 99,9999,99995 Uncertainty in models, data and assumption EFSA guideline (qualitatively and quantitatively) Cooperation RIVM – FERA

Scientific Advisory Board meeting | 31 maart 2011 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

Scientific Advisory Board meeting | 31 maart 2011 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!

Scientific Advisory Board meeting | 31 maart 2011 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)

Scientific Advisory Board meeting | 31 maart 2011 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)

Scientific Advisory Board meeting | 31 maart 2011 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? v ariability is well defined in all parameters and included in the model Uncertainty is identified and included Sensitive groups are addressed

Scientific Advisory Board meeting | 31 maart 2011 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

Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren 20 Margin of Exposure to put risk in perspective?

Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren 21 Dissemination activities Training Stakeholder conferences Understanding and acceptance 1.Variability and uncertainty 2.Precautionary principle and safety factors 3.Understanding and acceptance 4.Desired Level of Protection

Scientific Advisory Board meeting | 31 maart 2011 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. 1.Share information on concepts, data and experience 2.We want to have feedback how work fits in with your developments 3.What can be offered from your side 4.How to organize useful exchange

23Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren acropolis-eu.com