WP2: Cumulative dietary exposure and hazard assessment Bernadette Ossendorp en Polly Boon

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 2 Contents What is probabilistic modeling Build upon previous work done for and by EFSA What need to be done in WP2 -Exposure -Effect modeling

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 3 consumption database residue database 99, 99.9, and/or percentile RPF index compound Probabilistic modeling cumulative exposure

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 4 Performed by RIKILT (RIVM), NFA, NIPH, CRD, AFSSA, INRAN, EVIRA Is probabilistic assessment possible and can it be used at the international level addressing both acute and chronic toxicity. -actual exposure using monitoring results -exposure using MRLs or STMRs -acute toxicity corresponds with short-term exposure -chronic toxicity corresponds with long-term exposure EFSA contract probabilistic assessment

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 5 NL IT SE UK MCRA-software E-platform of databases (food and residue) CZ FR

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 6 Short-term acute intake in different countries Residue per country All residues pooled

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 7 Models and bimodal distributions No real cumulative model available Two alternative approaches were used Serious limitations

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 8 Other limitation in models for MRL setting BBN do not handle bimodal distributions properly Observed Individual Mean model as alternative Further model development will be done in WP5

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 9 Alternative model Observed Individual Mean OIM is conservative which is allowed in Risk Assessment Real cumulative models are not used

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 10 Main conclusions in EFSA opinion, RIKILT report Common Assessment Groups should be clear and the same over Europe Lot of work to solve compatibility issues and to organize data More understanding and model development regarding cumulative probabilistic modelling (EFSA works on opinion on probabilistic modeling)

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 11 Is MoE or level of protection adequate? Is Margin of Exposure (or safety) acceptable Hazard assessment (tiers) Exposure assessment (tiers)

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 12 Tasks WP2 Description of the work to be performed in WP2, including -Deliverables -Milestones Tasks are to be performed by all WP2 partners including AFSSA, unless stated otherwise Case studies

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 13 Task 2.1 Input data organisation Food consumption and pesticide monitoring data for use in case studies: -Organophosphates, conazoles, synthetic pyrethroids RPFs (NFA) Processing, variability factors and unit weights (CRD) All data will be linked in such to allow for cumulative assessments by M12 (ms. 2.2) Paper on availability and quality input data by M12 (del. 2.1) NL IT SE UK MCRA-software CZ FR

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 14 Task 2.2 Harmonising input data Link between foods consumed and products (RACs) analysed -Guidance document by M9 (del. 2.2) + training (RIVM) -Conversion own food consumption data using national recipes by M15 Pooling of food consumption data: vulnerable groups -Development of a methodology to merge different food surveys into a common database (RIVM) -Harmonisation food coding and compound coding -M24 -Paper by M36, including uncertainties (del 2.5)

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 15 Task 2.3 Benchmark dose modeling, RPFs Summarise toxicological studies relevant for cumulative effects (NFA/UMIL + EPA member advisory board) by M12 (ms 2.1) BMD modelling by M18 (NFA) : needed for Task 2.4. What has been done: -SAFE FOODS -EFSA opinion

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 16 Task 2.4 Cumulative exposure and risk modelling (1) Guidance document on (RIVM) -Usage of the models developed in WP5 -Performance of cumulative exposure calculations 4 scenario’s Acute and chronic exposure, actual (monitoring results) Acute and chronic exposure, MRL setting Use of model (exposure) by M18 -Case studies -Chlorpyrifos: results are input for quantitative link with biomarker measurements WP4 (ms 2.3) -Vulnerable groups -Scientific paper by M18 (del 2.3)

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 17 Task 2.4 Cumulative exposure and risk modelling (2) After integration exposure with BMD modelling -Estimating cumulative margin of exposure (MoE) using integrated model -Uncertainty analyses -User and reference guideline integrated model + uncertainty analysis by M30 (ms 5.5) Scientific paper by M36 (del. 2.4) MoE

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 18 Task 2.5. Identification uncertainties Identification uncertainties expected to affect cumulative exposure and effect + qualitative importance (ms 5.1) -M1-6 -Based on an approach developed in WP5 Providing input (data + expert knowledge) for WP5 to develop models to assess most important uncertainties quantitatively Reviewing approaches developed in WP5 Inclusion of uncertainties in cumulative assessments (Task 2.4)

Kick-off meeting ACROPOLIS, 7-8 June 2010, Utrecht, The Netherlands 19 Work to be done in coming months Discuss quality of data to be used Discuss data organisation based on previous work Both for exposure as for BMD modelling

Thanks Bernadette Ossendorp en Polly Boon