training session file note and registration report, 23 rd october 2006 1 registration report :...
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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
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
6Part 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%)
9Part 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
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
12Part 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
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,…)
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)
20 Conclusion for the Compartment Soil
Does the product comply with the Uniform Principles ? especially for
- persistence- leaching to groundwater
21Part 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
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
Training session File Note and Registration Report, 23rd October 2006
24Estimation of PECsw/sed- Example of presented results
Training session File Note and Registration Report, 23rd October 2006
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
27Part 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
28 6.3 fate & behavior in Air
Details of the evaluation :- Concise summary on the Endpoints (behavior in the Environment)
Conclusion :Summary