Franz Streissl - The revision of the GD on terrestrial ecotoxicology

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Franz Streissl - The revision of the GD on terrestrial ecotoxicology

  1. 1. The revision of the GD on Terrestrial Ecotoxicology ECPA-IBMA workshop – EFSA evaluation of PPPs 26 April 2012 1
  2. 2. GDs on terrestrial ecotoxicologyBackground:In 2006, EFSA has taken over the responsibility from the European Commission to revise existing Guidance Documents under Council Directive 91/414/EEC and to elaborate new ones where necessary.The PPR panel is tasked with the update of the Guidance Document on Terrestrial Ecotoxicology under mandate M-2009-0002. The Guidance Documents which are still in place were developed under Directive 91/414/EEC. 2
  3. 3. GDs on terrestrial ecotoxicologyBackground:A public consultation was held end of 2008 where stakeholders were consulted on major needs for improvement of the existing SANCO Guidance Documents to be considered in the revision process.A survey on the needs and priorities regarding Guidance Documents was conducted among Member States Authorities and a final list was compiled in the Pesticide Steering Committee meeting in November and December 2010 3
  4. 4. GDs on terrestrial ecotoxicologyThe following points were most often mentioned for updating the terrestrial Guidance Documents:• Considerations of the revision of Annexes II and III of Directive 91/414/EEC,• Consideration of the new Regulation (EC) 1107/2009• Harmonisation with other directives and regulations (biocides, REACH)• Clearly defined protection goals• Multiple exposure• Inclusion of additional species in the risk assessment (e.g. amphibians, reptiles, bats, molluscs, ferns, mosses, lichens, butterflies, grasshoppers and moths) 4
  5. 5. GDs on terrestrial ecotoxicologyThe following points were most often mentioned for updating the terrestrial Guidance Documents:• More guidance on statistical analysis• Preference of ECx over NOEC values in the risk assessment• To consider all available information from workshops (EUFRAM, ESCORT, PERAS and other SETAC workshops)• Endocrine disruption• Consideration of all routes of exposure• Bee risk assessment• Non-target arthropods risk assessment• Soil organism risk assessment 5
  6. 6. GDs on terrestrial ecotoxicologyThe survey among Member States resulted in the following list of topics of high priority:• Assessment of impacts on non-target organisms including the ongoing behaviour• Impact on biodiversity• Impact on the ecosystem• Effects on bees• Effects on amphibians and reptiles• Linking exposure to effects and ecological recovery• The use of field studies in the risk assessment and guidance for interpretation of field studies 6
  7. 7. GDs on terrestrial ecotoxicologyThe survey among Member States resulted in the following list of topics of high priority:• Revision of non-target arthropod risk assessment (ESCORT II)• Guidance for risk assessment in greenhouses• Definitions of environmental hazard criteria (POP, PBT, vPvB) which will serve as a cut-off criteria according to the new regulation. Guidance on what studies, test conditions and endpoints should be used in determining whether the cut-off values have or have not been met.• Definition of hazard criteria in relation to endocrine disruption 7
  8. 8. GDs on terrestrial ecotoxicologyThe mandate for the update of the terrestrial GD comprises:• Development of Guidance on risk assessment for non-target arthropods• Development of Guidance on in-soil risk assessment• Development of Guidance on risk assessment for non-target terrestrial plants• Development of Guidance on risk assessment for amphibians and reptiles• Good modelling practice in effect modelling 8
  9. 9. GDs on terrestrial ecotoxicologyDuring the ongoing revision several major areas for which harmonisation between the aquatic and terrestrial field as well as between the Risk Assessment approaches for different organism groups were identified. 9
  10. 10. GDs on terrestrial ecotoxicologyThe following issues have been identified as overarching issues:• Spatial boundaries (definitions for in-field and off-field areas to be considered for defining Specific Protection Goals)• Uncertainties arising from non-compliance with authorized use• Protection of endangered species• Considering multiple pesticide use / exposure in Risk Assessment (tank mixes, exposure from sequential applications and simultaneous or sequential applications form adjacent fields, multiple stress, etc.)• Common way to consider/address uncertainties• Definition of SPGs 10
  11. 11. GDs on terrestrial ecotoxicologyThe following issues have been identified as overarching issues:• Tiered Approach (consistency in the different schemes e.g. concerning what is considered refinement, what is considered higher tier)• Exposure issues and better linking between exposure and effect• Recovery: how can it be assessed, conditions under which it should be considered or not• Validation of triggers, common principles of procedure 11
  12. 12. GDs on terrestrial ecotoxicologyThe mandate for the update of the terrestrial GD comprises:• Development of Guidance on risk assessment for non-target arthropods• Development of Guidance on in-soil risk assessment• Development of Guidance on risk assessment for non-target terrestrial plants• Development of Guidance on risk assessment for amphibians and reptiles• Good modelling practice in effect modelling 12
  13. 13. GDs on terrestrial ecotoxicologyDeliverables for the Guidance Documents on non-target arthropods, in-soil risk assessment, non-target plants, amphibians and reptiles:• Opinion addressing the state of the science• Guidance of EFSA• Public consultation on the draft Guidance of EFSA• Public consultation on the draft opinion (in-soil risk assessment and amphibians and reptiles)Good modelling practice in effect modelling:• Opinion on good modelling practice in the context of mechanistic effect models for risk assessment of plant protection products. 13

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