CUMULATIVE AND AGGREGATED EXPOSURE TO PESTICIDES (ACROPOLIS PROJECT) Partners: RIVM, FERA, University of Milan, CRD, IRAS, INRAN, NIPH, DLO, NFA, Freshfel Europe p and University y of Ghent Associated partners: DTU (Denmark), CSL (Cyprus), ANSES (France), FVC (Latvia), NIPH (Slovenia), BPI (Greece) AGES (Austria) Jacob van Klaveren [email protected] @ 1 Ai j t ACROPOLIS Aims off EU project Improved cumulative exposure assessment and cumulative hazard assessment; To integrate cumulative and aggregate risk models in a web-based tool, including accessible data for all stakeholders;; Improving the understanding of cumulative risk assessment methodology gy of different stakeholders. EFSA Technical meeting 11-02-2014 2 Internet exchange of models and results EFSA Primo and SAS models - Data collection - Risk assessment Industry (registration new chemical) Partners & associated partners ACROPOLIS higher ti models tier d l DG Sanco DG Research Member States - data owner, - regulators - member of EFSA WG - member of DG Sanco WG EFSA Technical meeting 11-02-2014 3 EFSA Technical meeting 11-02-2014 4 First stakeholders conference DG SANCO expectation from ACROPOLIS p  call for cooperation EFSA and ACROPOLIS  IT tool accessible to all stakeholders Carl Schlyter (European Parliament)  diffi difficult lt tto explain l i th thatt it h has not been regulated since 2005 Go for it, and fix the hole! Trust in ACROPOLIS from (nearly) all stakeholders EFSA Technical meeting 11-02-2014 5 MCRA: How it works acute concentration database consumption database 0.4 Result: distribution of exposure 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 R d Random sampling li ffrom a concentration t ti and d a consumption ti d database t b EFSA Technical meeting 11-02-2014 6 How it works chronic (ETUI project) Observed individual Mean EFSA Guidance 09 0.9 usual intake variance i components t model d l  between individuals  days within individuals  transformation to a log or power (Box-Cox) (Box Cox) scale  remove within persons variation day intake 0 -4 -3 -2 -1 0 1 2 3 EFSA Technical meeting 11-02-2014 4 7 MCRA: Data EFSA Technical meeting 11-02-2014 8 E Platform and get data connected E-Platform EFSA Technical meeting 11-02-2014 9 New or adjusted information EFSA Technical meeting 11-02-2014 10 MCRA: upload focal commodity database EFSA Technical meeting 11-02-2014 11 MCRA: common assessment group EFSA Technical meeting 11-02-2014 12 MCRA: consumer only approach EFSA Technical meeting 11-02-2014 13 MCRA: Model (1) EFSA Technical meeting 11-02-2014 14 MCRA: Model (2) EFSA Technical meeting 11-02-2014 15 MCRA: output requirements % of ARfD EFSA Technical meeting 11-02-2014 16 MCRA: Output (1) EFSA Technical meeting 11-02-2014 17 Output (2): Contribution foods and compounds EFSA Technical meeting 11-02-2014 18 Output O t t (3) (3): Number N b off person-days d per million p EFSA Technical meeting 11-02-2014 19 Output O t t (4) (4): Number N b off person-days d per million ((example) p p ) EFSA Technical meeting 11-02-2014 20 Validation DEEM-FCID is standard of US-EPA Validation result: Good agreement MCRA and DEEM DEEM less precise at low exposures p due to binning Not a problem because upper tail is relevant EFSA Technical meeting 11-02-2014 21 Documentation and help In-line documentation of software, using strict protocols for naming classes, methods and properties User manual, data format manual, reference manual Help function EFSA Technical meeting 11-02-2014 22 ACROPOLIS EXERSICE Use off th U the IT tool t l and dd data t to t calculate l l t cumulative exposure to pesticides  Triazole T i l pesticides ti id Practicality a cumulative P ti lit off performing f i l ti dietary exposure assessment according to th requirements the i t off the th EFSA guidance id on probabilistic modelling Training and user groups EFSA Technical meeting 11-02-2014 23 Experience 1 ACROPOLIS partners Acute and chronic cumulative exposure p modelling g is possible Application of the optimistic model is feasible Performance of the pessimistic model run is very laborious: 1. Determination authorised uses 2. 2 Supplementation or replacement of RACs with insufficient data   Borrowing data from other countries MRLs or field trial data EFSA Technical meeting 11-02-2014 24 E i 2 ACROPOLIS partners Experience IInclusion l i off MRL MRLs off animal i l commodities diti resulted lt d in  U Unrealistic regarding the contribution off animal li ti conclusions l i di th t ib ti i l commodities to the dietary exposure. Which number of person-days exceeding the ARfD/ADI is associated with an unacceptable health risk is an open issue  should be decided by risk managers  ACROPOLIS IT tool is open for all stakeholders y decision taken by y the tool,, it just j follows the  there is not any EFSA guidance EFSA Technical meeting 11-02-2014 25 E i 3 user group regulators l t Experience More experience M i is i needed d d with ith the th EFSA guidance and the model with other (larger) CAGs  Proof P f off principle, i i l plan l to t upscale l performance f Need for ‘realistic’ scenario that combines the optimistic and pessimistic model run  still be argued to be conservative (precautionary principle) but not over-conservative EFSA Technical meeting 11-02-2014 26 Experience 4 user group food authorities Pessimistic scenario: replacement LoR  Look at historical use  If not detected in the past nd (or < LoR) = 0  If detected in certain percentage uses insert 1/2/ LoD or fraction of LoD (or LoR) SSD data easy to use A i l products d t Animal are measured and can be made available EFSA Technical meeting 11-02-2014 27 Experience 5 user group industry (a) Scenario 1: existing situation  run with monitoring data Scenario Scena io 2: 2 100% of use se on food A is replaced eplaced by b new agricultural use M Measure 1 or more chemicals h i l in i FT off new agricultural i lt l use  Implication is that monitoring data for food A are no longer relevant  Run with FT data instead of monitoring g data for food A Exposure can be higher, equal or lower e.g. high conc. Tebuconazole may still be lower than RPF*low conc. Flusilazole when RPF=40 EFSA Technical meeting 11-02-2014 28 Experience 5 user group industry (b) Scenario 3: p% of use on food A is replaced  run where in p% of Monte Carlo draws FT data are sampled, sampled and in (100-p)% the monitoring data Scenario 4: the new agricultural use is additional to all existing uses S Scenario i 5: 5 the th new agricultural i lt l use with ith compound C is additional to all existing uses without compound C C, and replaces existing uses with compound C ( (replacement l t scenarios i nott iin EFSA guidance) id ) EFSA Technical meeting 11-02-2014 29 Second stakeholders conference Training g was well-received by y nearly y all stakeholders (NGO ( did not attend training, although they were invited) Pesticide industry was able to connect focal commodity to monitoring and consumption data More transparent use of data through the use of the ACROPOLIS IT tool Easy-to-use Easy to use software One uniform tool for discussing the level op protection, but no direction or decision has been taken (objective tool) EFSA Technical meeting 11-02-2014 30 DG SANCO and ACROPOLIS The European Commission sets the level of protection  all member states are trained  European investment should be used  involvement of stakeholders responsible for pesticide risk assessment  linking innovation with practical needs of DG SANCO EFSA Technical meeting 11-02-2014 31 C d ffuture t i ti Currentt and organization New conceptt requires time tto di digestt N i ti ACROPOLIS follow-up follow up initiative Agreement to share data and to use it DG SANCO and EFSA cooperation  Form ‘proof of principle’ to a full production server  Still a lot of issues to be solved Open debate also with NGOs EFSA Technical meeting 11-02-2014 32 Thanks to all the people involved EFSA Technical meeting 11-02-2014 33