keep it short and simple and Refined Risk Assessment placed side by side : PEC Groundwater in France

Transcription

1 6 th European Modelling Workshop October 2012 Paris keep it short and simple and Refined Risk Assessment placed side by side : PEC Groundwater in France Arnaud CONRAD ANSES Regulated Product Department (DPR) Ecotoxicology and E-Fate Unit France

2 CONTENT 1. Framework of the European risk assessment 2. National groundwater RA in the context of the zonal assessment 3. Feedback on the refined groundwater RA in FR: Conclusions from FOCUS modelling results compared to conclusions from FROGS modelling results 4. Conclusions and perspectives

3 CONTENT 1. Framework of the European risk assessment 2. National groundwater RA in the context of the zonal assessment 3. Feedback on the refined groundwater RA in FR: Conclusions from FOCUS modelling results compared to Conclusions from FROGS modelling results 4. Conclusions and perspectives

4 Current GW risk assessment scheme Relevant FOCUS (2000) standard scenarios for the intended uses All PECgw < 0.1 µg/l PECgw < 0.1 µg/l for at least one scenario All PECgw Parent, relevant metabolites > 0.1 µg/l non relevant metabolites > 10 µg/l MS should deal with the proposed mitigation measures No safe use Safe use => Decision and risk management at MS level

5 Current GW risk assessment scheme Relevant FOCUS (2000) standard scenarios for the intended uses All PECgw < 0.1 µg/l PECgw < 0.1 µg/l for at least one scenario All PECgw Parent, relevant metabolites > 0.1 µg/l non relevant metabolites > 10 µg/l MS should deal with the proposed mitigation measures No safe use Safe use => Decision and risk management at MS level

6 Tiered assessment scheme for groundwater (FOCUS GW, 2009) Tier 1) Standard FOCUS scenarios with lab. or field degradation studies zms to integrate or not the higher tier (> tier 1) Tier 2a) Modelling with refined parameters Tier 2b) Modelling with refined scenarios = FROGS Tier 3a) Combined modelling refined parameters and scenarios Tier 3b) Advanced spatial modelling Tier 3c) Higher tier leaching experiments set into context by modelling Not evocated in this presentation Tier 3d) Other modelling approaches Tier 4) Groundwater monitoring * Mitigation possible at all tiers

7 CONTENT 1. Framework of the European risk assessment 2. National groundwater RA in the context of the zonal assessment 3. Feedback on the refined groundwater RA in FR: Conclusions from FOCUS modelling results compared to conclusions from FROGS modelling results 4. Conclusions and perspectives

8 National RA in the context of the zonal assessment Tier 1 (Cornerstone of the RA) based on the EU agreed endpoints All FOCUS scenarios: PECgw < 0.1 µg/l for parent and relevant metabolites PECgw < 10 µg/l for non-relevant metabolites Safe use? No Yes Zonal/National registration including mitigation measures Refined RA? zms to integrate or not higher tier (> tier 1)

9 National RA in the context of the zonal assessment Tier 1 (Cornerstone of the RA) based on the EU agreed endpoints All FOCUS scenarios: PECgw < 0.1 µg/l for parent and relevant metabolites PECgw < 10 µg/l for non-relevant metabolites Safe use? No Yes Zonal/National registration including mitigation measures Refined RA? zms to integrate or not higher tier (> tier 1) Tier 2a based on the updated EU endpoints when necessary New studies might be used (or not ) to derive new endpoints All FOCUS scenarios: PECgw < 0.1 µg/l for parent and relevant metabolites PECgw < 10 µg/l for non-relevant metabolites Safe use? No Yes Zonal/National registration including mitigation measures

10 National GW risk assessment Tier 2b/3a Modelling with refined scenarios (EU agreed / updated endpoints) All FOCUS scenarios: PECgw < 0.1 µg/l for parent and relevant metabolites PECgw < 10 µg/l for non-relevant metabolites For the national registration (addendum): Implementation of specific scenarios into the national risk assessment in zonal assessment FROGS MODEL Safe use? Yes identification of relevant mitigation measures No higher tier

11 Previous talks on specific scenarios (FROGS model) FROGS model was presented by Klaus Hammel at the 5 th European Modelling Workshop, 14/15 Oct 2010, Capri, Italy Software can be downloaded on the website and documentation is available on internet : FROGS (2011) French Refinement Of Groundwater Scenarios Report of the UIPP Environmental Methodology Working Group version 2.0

12 Tier 2b scenarios describing realistic conditions National approach based on variety of representative conditions rather than worstcases Realistic environmental conditions in terms of climate, soils and management derived from readily available data National scenarios only needed if standard European FOCUS scenarios show exceedances and no relevant mitigation measure can be defined Causal analysis of PECgw exceedances enable implementation of mitigation options Analysis of PECgw as a function of - sand content - OC content - available water content of the whole profile - soil ID - specific weather and typical rotation of each AU Tool developed for 8 major field crops in France (winter wheat, winter barley, oilseed rape, maize fodder, maize grain, sugar beet, potato and sunflower)

13 CONTENT 1. Framework of the European risk assessment 2. National groundwater RA in the context of the zonal assessment 3. Feedback on the refined groundwater RA in FR: Conclusions from FOCUS modelling results compared to Conclusions from FROGS modelling results 4. Conclusions and perspectives

14 Number of dossiers (%) Feedback on the refined groundwater RA in FR: Conclusions from FOCUS modelling results compared to conclusions from FROGS modelling results Total: 500 dossiers since 2011 For active substance and/or metabolites Case 1: FOCUS modelling sufficient to conclude (majority of situations) _ 1 example Case 2: FROGS modelling used to refine the RA (only 10 dossiers; 2 active substances) _ 1 example Case 3: FROGS modelling used to refine the RA, but conclusion was similar to FOCUS run _ 2 examples Case 4: RA based on mitigation measures unapplicable (Results of the FROGS model not correctly used to finalise the RA) _ 1 example Cases Case 5: the representative crop selected did not correspond to the intended uses (1 dossier)

15 Case 1: FOCUS modelling sufficient to finalise the RA Majority of cases FOCUS modelling performed at a higher rate than the intended uses (risk envelope) PECgw > 0.1 µg/l for one location -> RA not acceptable for FR FROGS modelling available to refine the RA -> RA acceptable ANSES position : Approach not accepted; FROGS modelling not assessed FOCUS-PECgw < 0.1 µg/l for all locations when the intended applied rate was considered FROGS modelling only considered to refine the RA. => Use to avoid mitigation measures (suggested from FOCUS modelling) considered as not justified : - Adequated rate - Application dates - Number of applications - Application every other year, every third year

16 Principes généraux de l évaluation du risque pour les eaux souterraines Case 2: FROGS modelling used to refine the RA Active substance (AS) 1 on Maize EU agreed endpoints DT50 (days) 20 Koc (cm 3 /g) Variable; related to the soil clay content 1/n (-) 0.9 Crop uptake factor (-) 0.5 Application rate (g/ha) X on Maize Application date/stage BBCH FOCUS-PECgw: calculated at 1m depth monoculture (Maize) FROGS-PECgw: calculated at the bottom of the soil profile (40 to 140 cm) Maize (primary crop, rotational crop, monoculture considered (conservative approach)

17 Case 2: AS 1 on Maize Tier 1: 80 th centile average PEC gw (µg/l) at 1 m depth for AS 1 Uses Maize; every year Maize; every other year FOCUS Scenarios PECgw > 0.1 µg/l for one scenario PECgw < 0.1 µg/l for all scenarios National restriction based on FOCUS modelling : «SPe 2: Do not apply on maize a product containing SA1 on soil having less than 10% of clay, and not more than every other year»

18 Cumulative areal distribution (-) Principes généraux de l évaluation du risque pour les eaux souterraines Case 2: AS 1 on Maize Tier 2b: FROGS 80th/90th centile PEC gw and FOCUS 80 th percentile PEC gw 1,0 0,8 0,6 0,4 Chateaudun Kremsmuster Sevilla Thiva Okehampton Porto Hamburg FOCUS PECgw: 0.16 µg/l 0,2 FROGS 90th PECgw: µg/l Piacenza 0,0 0,000 0,005 0,010 0,015 0, th centile PECgw (µg/l)

19 Case 2: AS 1 on Maize Principes généraux de l évaluation du risque pour les eaux souterraines Tier 2b : Distribution of FROGS-PECgw (temporal 80 th centile) for SA1 related to clay content of soil (%) National restriction based on FROGS modelling : None

20 Case 3a: Principes généraux de l évaluation du risque pour les eaux souterraines AS 2 on Sugar beets EU agreed endpoints FOCUS-PECgw: monoculture (sugar beets) FROGS-PECgw: sugar beets (primary crop, rotational crop) Tier 1: 80 th percentile average PEC gw (µg/l) at 1 m depth for SA2 Mitigation measures Application every year Application every other year Application every third year FOCUS Scenarios PECgw > 0.1 µg/l for at least one scenario PECgw > 0.1 µg/l for at least one scenario PECgw < 0.1 µg/l for all scenarios National restriction based on FOCUS modelling : SPe1: To protect groundwater, do not apply this or any other product containing SA2 more than once every third year. in agreement with the agricultural practices

21 Case 3a: AS 2 on Sugar beets Principes généraux de l évaluation du risque pour les eaux souterraines Tier 2b: National approach based on variety of representative conditions Substance PECgw, min (µg/l) PECgw, max (µg/l) % of area with PECgw > 0.1 µg/l 90 th percentile PECgw = µg/l AS 2 < % National restriction based on FROGS modelling : Application on primary crop only - Acceptable for application rotational crop every third year on primary crop - Similar conclusion compared to results obtained from FOCUS model

22 Case 3b: Uses : Oil seed rape; 1000 g/ha; Treatment every third year FOCUS modelling (PEARL v4 + PELMO v4) FROGS modelling (FROGS v2) Metabolites X 80 th centile >> 10 µg/l X1 : (max µg/l ; 2 scenarios/6) X2 : (max µg/l ; 1 scenario/6) X3 : (max µg/l, 1 scenario/6) X4, X5 X6 <10µg/L X1: (13.6 µg/l) X2: (11.3 µg/l). X3, X4, X5 X6 Metabolites X 90 th centile >> 10 µg/l <10µg/L National restriction based on both FOCUS and FROGS modellings : => no safe use

23 Case 4: Unapplicable mitigation measures Proposed mitigation measure based on the FROGS modellings can be scientifically acceptable, BUT not applicable for the risk manager e.g., 90 th centile PECgw < 0.1 µg/l if soil clay content < 10%, and available water capacity ranged from X and X % Fortunately, not observed since the guidance document FROGS (2011) exists

24 CONTENT 1. Framework of the European risk assessment 2. National groundwater RA in the context of the zonal assessment 3. Feedback on the refined groundwater RA in FR: Conclusions from FOCUS modelling results compared to conclusions from FROGS modelling results 4. Conclusions and perspectives

25 Conclusions Specific scenarios improve the realism of EU modellings, however results from specific scenarios do not lead to very different conclusions than those obtained using the FOCUS tool. Modellings using FROGS model: few cases proposed in the framework of the zrr Specific scenarios permit to conclude without mitigation measures, but not all the time (no magic answer) In the context of the zonal assessment, mitigation measures should be preferably proposed in the core assessment based on EU models (time optimisation.) -> Risk assessment kept simple

26 Limits, Perspectives Crop not supported in FROGS model: surrogate not acceptable Evolution/adaptation of scenario implemented into the model (i.e., rotational crop ) e.g., rotational crops as oil seed rape

27 Thank you for your attention