ACROPOLIS Scientific Advisory Board

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


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


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


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


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


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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)


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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;


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.


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Project management


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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


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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)


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


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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


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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!


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)


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)


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


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


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Margin of Exposure to put risk in perspective?


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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


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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

Documents

ACROPOLIS Scientific Advisory Board