Transcript Guidance document food conversion

ACROPOLIS
Scientific Advisory Board
Jacob van Klaveren
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Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
Contents
EFSA opinion cumulative risk assessment
ACROPOLIS (EU funded project)
Data access issues
Risk management perspective
Scientific sound
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Scientific Advisory Board meeting | 31 maart 2011
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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?
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Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
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 the
international level addressing both acute and chronic toxicity
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Scientific Advisory Board meeting | 31 maart 2011
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Probabilistic modeling cumulative exposure
RPF index
residue
database
compound
consumption
database
0.4
0.2
0.0
-3.6
-2.9
-2.2
-1.4
-0.7
0.0
0.7
1.4
2.2
2.9
3.6
99, 99.9, and/or 99.99 percentile
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Scientific Advisory Board meeting | 31 maart 2011
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A few recommendations (EFSA opinion)
Common Assessment Group should be the same in Europe
Draft guidelines are published by EFSA
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Scientific Advisory Board meeting | 31 maart 2011
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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)
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Scientific Advisory Board meeting | 31 maart 2011
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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;
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Scientific Advisory Board meeting | 31 maart 2011
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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.
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Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
Project management
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Scientific Advisory Board meeting | 31 maart 2011
Jacob van Klaveren
One platform, data and model availability
Member
States
Industry
Agrochemicals
ACROPOLIS
MODEL
Run
ACROPLIS
Regulators
0.4
Re-run ACROPLIS
0.2
0.0
-3.6
-2.9
-2.2
-1.4
-0.7
0.0
0.7
1.4
2.2
2.9
3.6
SE
11
NL
IT
CZ
UK
Scientific Advisory Board meeting | 31 maart 2011
Data access
Jacobagreed
van Klaveren
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)
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Scientific Advisory Board meeting | 31 maart 2011
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Influence of uncertainty analyses
95
99
99,9
99,99
Uncertainty in models, data and assumption
EFSA guideline (qualitatively and quantitatively)
Cooperation RIVM – FERA
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Scientific Advisory Board meeting | 31 maart 2011
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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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Scientific Advisory Board meeting | 31 maart 2011
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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!
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Scientific Advisory Board meeting | 31 maart 2011
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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 croppesticides and monitoring data for all other crops
 acute assessment (consumer only)
 chronic assessment
Public consultation single chemical (summer 2010)
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Scientific Advisory Board meeting | 31 maart 2011
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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)
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Scientific Advisory Board meeting | 31 maart 2011
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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
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Scientific Advisory Board meeting | 31 maart 2011
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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
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Scientific Advisory Board meeting | 31 maart 2011
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Margin of Exposure to put risk in perspective?
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Scientific Advisory Board meeting | 31 maart 2011
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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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Scientific Advisory Board meeting | 31 maart 2011
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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
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acropolis-eu.com
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Scientific Advisory Board meeting | 31 maart 2011
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