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Transcript of 1Scientific Advisory Board meeting | 31 maart 2011 Jacob van Klaveren ACROPOLIS Scientific Advisory...
1 Scientific 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
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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
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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 theinternational level addressing both acute and chronic toxicity
Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
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consumptiondatabase
residuedatabase
0.0
0.2
0.4
0.0 0.7 1.4 2.2 2.9 3.6-0.7-1.4-2.2-2.9-3.6
99, 99.9, and/or 99.99 percentile
RPF index
compound
Probabilistic modeling cumulative exposure
Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
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A few recommendations (EFSA opinion)
Common Assessment Group should be the same in EuropeDraft guidelines are published by EFSA
Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
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Institutes working on ACROPOLISNational 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
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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;
Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
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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.
Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
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Project management
Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
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One platform, data and model availability
IndustryAgrochemicals
SE NL IT
0.0
0.2
0.4
0.0 0.7 1.4 2.2 2.9 3.6-0.7-1.4-2.2-2.9-3.6
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
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Data platform and data sharingOne 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
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Influence of uncertainty analyses
99,9999,99995
Uncertainty in models, data and assumptionEFSA guideline (qualitatively and quantitatively)Cooperation RIVM – FERA
Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
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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
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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
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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
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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
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Exceeding ARfD or ADIWhat 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
Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
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Exceeding ARfD or ADIOnce (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
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Margin of Exposure to put risk in perspective?
Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
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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
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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
23 Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
acropolis-eu.com