Training session File Note and Registration Report, 23 rd October 2006
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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
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Overview
Registration Report
2 parts to be completed :
PART A : RISK MANAGEMENT
PART B : DETAILED SUMMARY OF THE RISK ASSESSMENT
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Part A : Risk Management
1. Details of the application
2. Details of the authorization
2.2 Classification and labelling
3. 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
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Part A - Example of reasoned statetment for F&B
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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
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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
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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
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Table with identity of the a.s. and metabolites
Code number
IUPAC name
Metabolite
found
ZZ 142
Dummy X
(active
substance)
-
ZZ 1421
Dummy XY
(met 1)
Sediment (21%)
Chemical
Structure
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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
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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
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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
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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 PECsoil and PECgw
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
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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
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Estimation of PECsoil - initial, short and long term
Which kinetic has been used to derive degradation parameter ? (SFO,…)
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Estimation of PECsoil - initial, short and long term
(2)
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Estimation of PECsoil - accumulation
Plateau average Plateau maximum
concentration
concentration
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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)
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Estimation of PECgw - Example of presentation for study
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Estimation of PECgw - Example of presentation for study
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Conclusion for the Compartment Soil
Does the product comply with the Uniform Principles ?
especially for
- persistence
- leaching to groundwater
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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
PECsw and PECsed
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
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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
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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
Training session File Note and Registration Report, 23 rd October 2006
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Estimation of PECsw/sed- Example of presented results
Training session File Note and Registration Report, 23 rd October 2006
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Estimation of PECsw/sed- Example of presented results
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Conclusion for the Compartment Water
Does the product comply with the Uniform Principles ?
especially for
- water organisms
See Ecotox for TERvalues
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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
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6.3 fate & behavior in Air
Details of the evaluation :
- Concise summary on the Endpoints (behavior in the Environment)
Conclusion :
Summary
Training session File Note and Registration Report, 23 rd October 2006
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Thank you for your attention