1. The revision of the GD on Terrestrial
Ecotoxicology
ECPA-IBMA workshop – EFSA evaluation of PPPs
26 April 2012
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2. 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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3. GDs on terrestrial ecotoxicology
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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4. GDs on terrestrial ecotoxicology
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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5. GDs on terrestrial ecotoxicology
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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6. GDs on terrestrial ecotoxicology
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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7. GDs on terrestrial ecotoxicology
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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8. GDs on terrestrial ecotoxicology
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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9. GDs on terrestrial ecotoxicology
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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10. GDs on terrestrial ecotoxicology
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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11. GDs on terrestrial ecotoxicology
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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12. GDs on terrestrial ecotoxicology
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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13. GDs on terrestrial ecotoxicology
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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