Registration report :

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

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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

• 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

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Part A - Example of reasoned statetment for FB
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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
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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
• 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
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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 concentration
Plateau maximum 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 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
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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

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Estimation of PECsw/sed- Example of presented
results

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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

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• Thank you for your attention