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Registration report : Partim Fate and Behavior in the environment 23 rd October 2006 S. Vanhiesbecq FPS Health, Fo

Registration report : Partim Fate and Behavior in the environment 23 rd October 2006 S. Vanhiesbecq FPS Health, Food Chain Safety and Environment DG Animals, Plants and Food Service Pesticides and Fertilizers. Overview . Registration Report 2 parts to be completed :

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Registration report : Partim Fate and Behavior in the environment 23 rd October 2006 S. Vanhiesbecq FPS Health, Fo

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  1. Registration report : Partim Fate and Behavior in the environment 23rd October 2006 S. Vanhiesbecq FPS Health, Food Chain Safety and Environment DG Animals, Plants and Food Service Pesticides and Fertilizers

  2. Overview • Registration Report • 2 parts to be completed : • PART A : RISK MANAGEMENT • PART B : DETAILED SUMMARY OF THE RISK ASSESSMENT

  3. Part A : Risk Management • Details of the application • Details of the authorization • 2.2 Classification and labelling • Risk Management • 3.1 Reasoned statement of the overal conclusions taken in accordance with the Uniform Principles • 3.2 Conclusions • 3.3 Further information to permit a decision to be made or to support a review of conditions and restrictions associated with the authorisation

  4. Part A - Example of reasoned statetment for F&B

  5. Part B of the Registration Report – General structure • 6. Environmental fate and behavior • 6.0 List of Endpoints from the Review Report • 6.1. Fate and Behavior in Soil • a) New studies/synthesis • b) Risk Assessment • c) Conclusion • 6.2. Fate and Behavior in Water • a) New studies/synthesis b) Risk Assessment • c) Conclusion • 6.3. Fate and Behavior in Air • New studies/synthesis + Conclusion • Note : table with identity of the a.s and its metabolites required

  6. Part B of the Registration Report – General structure • 6. Environmental fate and behavior • 6.0 List of Endpoints from the Review Report • 6.1. Fate and Behavior in Soil • a) New studies/synthesis • b) Risk Assessment • c) Conclusion • 6.2. Fate and Behavior in Water • a) New studies/synthesis b) Risk Assessment • c) Conclusion • 6.3. Fate and Behavior in Air • New studies/synthesis + Conclusion • Note : table with identity of the a.s and its metabolites required

  7. 6.0 List of Endpoints : extract from Review Report Reference of the Review Report ! Source : http://ec.europa.eu/food/plant/protection/evaluation/index_en.htm

  8. Table with identity of the a.s. and metabolites

  9. Part B of the Registration Report – General structure • 6. Environmental fate and behavior • 6.0 List of Endpoints from the Review Report • 6.1. Fate and Behavior in Soil • a) New studies/synthesis • b) Risk Assessment • c) Conclusion • 6.2. Fate and Behavior in Water • a) New studies/synthesis b) Risk Assessment • c) Conclusion • 6.3. Fate and Behavior in Air • New studies/synthesis + Conclusion • Note : table with identity of the a.s and its metabolites required

  10. a) Studies/synthesis (for each compartment) • 1) New submitted studies • What kind of new data ? • New annex II studies required for a national registration • Recalculation of the endpoints following recent guidelines • Detailed description and assessment are required. • What kind of template to be used ? • Name/reference/author of the study • Author • Guideline • GLP status • Materials and methods • Findings • Conclusions & Assessment

  11. a) Studies/synthesis (2) • 2) Synthesis • - summary on the Endpoints characterising the behavior of the a.s. and its metabolites in the Environment • requirement for new data (Annex II studies, recalculation of endpoints) • DT50/DT90 trigger values for higher tier studies •  AIM : Identification of Endpoints used in the Risk Assessment

  12. Part B of the Registration Report – General structure • 6. Environmental fate and behavior • 6.0 List of Endpoints from the Review Report • 6.1. Fate and Behavior in Soil • a) New studies/synthesis • b) Risk Assessment • c) Conclusion • 6.2. Fate and Behavior in Water • a) New studies/synthesis b) Risk Assessment • c) Conclusion • 6.3. Fate and Behavior in Air • New studies/synthesis + Conclusion • Note : table with identity of the a.s and its metabolites required PECsoil and PECgw

  13. Estimation of PECsoil • a) Formulation • Initial PEC values (excelsheets www.phytoweb.fgov.be) • b) Active substance/metabolites (if needed) • Initial, short and long term PECsoil • (actual and time weighted average values) • - Accumulation (plateau concentration determined by soil accumulation studies or modelling • «Soil persistence models and EU registration» 7617/VI/96

  14. Estimation of PECsoil - initial, short and long term • Which kinetic has been used to derive degradation parameter ? (SFO,…)

  15. Estimation of PECsoil - initial, short and long term (2)

  16. Estimation of PECsoil - accumulation Plateau average concentration Plateau maximum concentration

  17. Estimation of PECgw • PECgw calulated with : • - FOCUS Models (like PEARL or PELMO) with the most relevant European FOCUS scenarii for Belgium (Châteaudun, Hamburg, Okehampton, Kremsmünster) • - FOCUS Model PEARL with the Belgian scenarii • - PELEP (actually : revision of soils parameters) • Note : • Input parameters in line with the FOCUS recommendations • Metabolites with PECgw exceeding 0,1 µg/L : evaluation of their relevance with guideline Sanco/221/2000 (limit : 10 µg/L)

  18. Estimation of PECgw - Example of presentation for study

  19. Estimation of PECgw - Example of presentation for study

  20. Conclusion for the Compartment Soil • Does the product comply with the Uniform Principles ? • especially for • - persistence • - leaching to groundwater

  21. Part B of the Registration Report – General structure • 6. Environmental fate and behavior • 6.0 List of Endpoints from the Review Report • 6.1. Fate and Behavior in Soil • a) New studies/synthesis • b) Risk Assessment • c) Conclusion • 6.2. Fate and Behavior in Water • a) New studies/synthesis b) Risk Assessment • c) Conclusion • 6.3. Fate and Behavior in Air • New studies/synthesis + Conclusion • Note : table with identity of the a.s and its metabolites required PECsw and PECsed

  22. Estimation of PECsw and PECsed • a) Formulation (drift) • PECsw calculated with excel sheets avalaible on www.phytoweb.fgov.be • in accordance with ‘ordinary’ national registration • anti-drift measure (list of drift reducing equipments) • initial PECvalues • b) Active substance/metabolites (drift + drainage/run-off) • PECsw calculated with FOCUS Models STEP 1 – 4 (D3, D4 and R1) • European models are needed for a mutual recognition. • initial, short and long term values • needed if not present in the DAR

  23. The tiered FOCUS surface water system • Step 1 : single application, single fixed scenario • FOCUS STEP 1-2 Calculator • Step 2 : multiple applications, regional scenarios • FOCUS STEP 1-2 Calculator • Step 3 : Advanced modelling, multiple regional scenarios • SWASH, MACRO, PRZM, TOXSWA • Step 4 : Refined modelling • field scale : SWASH, MACRO, PRZM, TOXSWA • Only the most suitable Step is required to assess the risk for water organisms

  24. Estimation of PECsw/sed- Example of presented results

  25. Estimation of PECsw/sed- Example of presented results

  26. Conclusion for the Compartment Water • Does the product comply with the Uniform Principles ? • especially for • - water organisms • See Ecotox for TERvalues

  27. Part B of the Registration Report – General structure • 6. Environmental fate and behavior • 6.0 List of Endpoints from the Review Report • 6.1. Fate and Behavior in Soil • a) New studies/synthesis • b) Risk Assessment • c) Conclusion • 6.2. Fate and Behavior in Water • a) New studies/synthesis b) Risk Assessment • c) Conclusion • 6.3. Fate and Behavior in Air • New studies/synthesis + Conclusion • Note : table with identity of the a.s and its metabolites required

  28. 6.3 fate & behavior in Air • Details of the evaluation : • - Concise summary on the Endpoints (behavior in the Environment) • Conclusion : • Summary

  29. Thank you for your attention

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