Training session File Note and Registration Report, 23 rd October 2006 1 Registration report : Partim Fate and Behavior in the environment 23 rd October

Training session File Note and Registration Report, 23rd October 2006

1

Registration report : Partim Fate and Behavior in the

environment

23rd October 2006 S. Vanhiesbecq

FPS Health, Food Chain Safety and EnvironmentDG 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

1. Details of the application2. Details of the authorization

2.2 Classification and labelling

3. Risk Management3.1 Reasoned statement of the overal conclusions taken in accordance with the Uniform Principles3.2 Conclusions3.3 Further information to permit a decision to be made or to support a review of conditions and restrictions associated with the authorisation

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

5Part B of the Registration Report – General structure6. Environmental fate and behavior

6.0 List of Endpoints from the Review Report6.1. Fate and Behavior in Soil

a) New studies/synthesisb) Risk Assessmentc) Conclusion

6.2. Fate and Behavior in Watera) New studies/synthesis

b) Risk Assessmentc) Conclusion

6.3. Fate and Behavior in Air New studies/synthesis + Conclusion

Note : table with identity of the a.s and its metabolites required








76.0 List of Endpoints : extract from Review Report

Source : http://ec.europa.eu/food/plant/protection/evaluation/index_en.htm

Reference of the Review Report !

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

Code number IUPAC name Metabolite found

Chemical Structure

ZZ 142 Dummy X (active

substance)

-

ZZ 1421 Dummy XY(met 1)

Sediment (21%)








10 a) Studies/synthesis (for each compartment)

1) New submitted studiesWhat 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 studyAuthorGuidelineGLP statusMaterials and methodsFindingsConclusions & Assessment

11a) 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








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,…)

15Estimation 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)

18Estimation of PECgw - Example of presentation for study

19Estimation 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








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 registrationanti-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 valuesneeded if not present in the DAR

23 The tiered FOCUS surface water system

Step 1 : single application, single fixed scenarioFOCUS STEP 1-2 Calculator

Step 2 : multiple applications, regional scenariosFOCUS STEP 1-2 Calculator

Step 3 : Advanced modelling, multiple regional scenariosSWASH, MACRO, PRZM, TOXSWA

Step 4 : Refined modellingfield scale : SWASH, MACRO, PRZM, TOXSWA

Only the most suitable Step is required to assess the risk for water organisms


24Estimation of PECsw/sed- Example of presented results


25Estimation of PECsw/sed- Example of presented results

26 Conclusion for the Compartment Water

Does the product comply with the Uniform Principles ? especially for

- water organismsSee Ecotox for

TERvalues








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

Documents

Training session File Note and Registration Report, 23 rd October 2006 1 Registration report : Partim Fate and Behavior in the environment 23 rd October