franz streissl - the revision of the gd on terrestrial ecotoxicology

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The revision of the GD on Terrestrial

Ecotoxicology

ECPA-IBMA workshop – EFSA evaluation of PPPs 26 April 2012

GDs on terrestrial ecotoxicology

Background:

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.

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Background:

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

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The 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)

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The 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

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The 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

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The 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

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The 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

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During 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.

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The 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

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The 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

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The 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

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Deliverables 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.

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franz streissl - the revision of the gd on terrestrial ecotoxicology

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