1. GD on Aquatic Ecotoxicology
Stephanie Bopp, Maria Arena, Franz Streissl
ECPA-IBMA workshop – EFSA evaluation of PPPs - 26 April 2012 1
2. Background
• Mandate received in December 2008
• Consultation with Risk Managers via questionnaire end
2008
• Public Consultation on existing SANCO GDs for Aquatic
and Terrestrial Ecotoxicology Oct-Dec 2008
report: EFSA Journal 2009; 7(11):1375 [129 pp.].
• Major needs identified for revision:
– Harmonisation, therefore started in one WG for both mandates
– Before start more detailed specific protection goals are needed,
therefore work on „Opinion on specific protection goals“ (EFSA
Journal 2010; 8(10):1821)
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3. Background (cont.)
Other general suggestions from the public consultation:
– Consider multiple exposure
– Clear definition and harmonisation of triggers
– Consider other organisms not covered by the current scheme
(amphibians, marine organisms), which need to be representative
and sensitive
– Reconsider recovery (time frames, multiple applications)
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4. Analysis of current GD Aquatic
Ecotoxicology (SANCO/3268/2001)
• Update needed due to new Regulation (1107/2009)
• Update needed considering new Data Requirements
• Appropriate linking of exposure and effect assessment
• More detailed guidance on higher tier RA, e.g.
– Incorporating advise on methods to use when data
are available on several species
– Species Sensitivity Distributions (SSDs)
– Refined exposure tests
– Detailed guidance on mesocosm studies (design and
evaluation)
– Effect modelling approaches 4
5. Revision GD Aquatic Ecotoxicology
The need for a modular approach:
• to cope with the complexity of the revision
• start with updating practical guidance on topics
for which “building blocks” are available
• update in a later stage practical guidance on
topics for which the “building blocks” are under
construction
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6. Revision GD Aquatic Ecotoxicology
1. Tiered risk assessment procedure for water organisms
in edge-of-field surface waters
2. Combined exposure and effect modelling approaches
for edge-of-field surface waters
3. Tiered risk assessment procedure for sediment
organisms in edge-of-field surface waters
4. Aquatic ERA procedures to address multiple stress by
PPPs at the edge-of-field and catchment scale
Consultation of SCFCAH on this planning in May 2011
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7. GD Aquatic Ecotoxicology – Module 1
Tiered risk assessment for aquatic organisms
in edge-of-field surface waters
• Major tools for exposure (e.g. FOCUS sw senarios)
and higher-tier effects assessment (e.g. SSDs and
mesocosms) already developed
• Several ERA aspects need an update
e.g. recommendations of recent EFSA opinions and workshops
(such as ELINK; AMRAP)
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8. GD Aquatic Ecotoxicology – Module 2
Combined exposure and effect modelling
approaches for edge-of-field surface waters
• Start with this module when results of EU CREAM
project become available
• Linking exposure and effect models
• Effect assessment requires
- Good modelling practise for regulatory purposes
- Validated/calibrated toxicokinetic/toxicodynamic models for
focal species
- Validated/calibrated population models for focal species
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9. GD Aquatic Ecotoxicology – Module 3
Tiered risk assessment procedure for sediment
organisms in edge-of-field surface waters
• Many insecticides and fungicides show fast
dissipation from water and partition to sediment
• Development of FOCUS-type sediment scenarios
• Predictive value of sediment-spiked Chironomus
riparius toxicity test
• Appropriate sediment organism test battery for PPPs
that differ in toxic mode-of-action
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10. GD Aquatic Ecotoxicology – Module 4
Aquatic ERA procedures to address multiple
stress by PPPs at the edge-of-field and
catchment scale
• Multiple stress assessment
- Consequences of exposure to different PPPs via water and
sediment
- Consequences for ecological recovery in edge-of-field
surface waters
- Consequences for biodiversity and legally protected species
at landscape/watershed level
• Requires catchment scale exposure and effect
scenarios and models and monitoring data
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11. Currently working on Module 1:
GD on tiered RA for aquatic organisms in edge-of-field
surface waters
Chapter 1: Introduction
Chapter 2: Specific Protection Goals for Water
Organisms
Chapter 3: Linking Exposure to Effects
Chapter 4: Exposure Assessment
Chapter 5: Data requirements for active substances
and formulations and tier-1 effect
assessment
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12. Currently working on Module 1:
GD on tiered RA for aquatic organisms in edge-of-field
surface waters
Chapter 6: Higher-tier effect assessment on basis of
laboratory toxicity tests with standard and
additional species
Chapter 7: Higher-tier effect assessment by means of
experimental ecosystems
Chapter 8: Other issues
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13. Related outsourcing activities
Literature reviews outsourced in 2008 for the GD on
Aquatic Ecotoxicology (reports published in 2009 on EFSA
webpage)
• Critical comparison of available and potential higher tier testing
approaches for the risk assessment of plant protection products,
considering at least field and semi-field experimental designs,
extrapolation from dose-response relationships, and increased
dosages (aquatic and terrestrial).
• Evidence of potential long term effects in (aquatic and terrestrial)
invertebrates after short term pulsed exposure
• Available protocols for testing the effects of chemicals against
aquatic invertebrates other than Crustacea
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14. Related outsourcing activities
Literature reviews outsourced 2011 on various topics of
relevance for the GD on Aquatic Ecotoxicology (ongoing)
• Ecological recovery of populations of vulnerable species driving the
risk assessment of pesticides.
• Repeated and multiple stress (exposure to pesticides) on aquatic
organisms.
• Review and comparison of available testing approaches and
protocols for testing effects of chemicals on sediment-dwelling
organisms with potential applicability to pesticides.
• Response of microbial organisms (aquatic and terrestrial) to
pesticides.
• Toxicity of pesticides to aquatic and terrestrial life stages of
amphibians and occurrence, habitat use and exposure of amphibian
species in agricultural environments.
• Literature review on the sensitivity and exposure of marine and
estuarine organisms to pesticides in comparison to corresponding 14
fresh water species
15. Next steps
• WG will work further on
– finalising sections of GD module 1
– developing case studies
• A first complete draft will be presented to the PPR Panel in
the Plenary meeting in June 2012 for information and
commenting
• We plan to go for Public Consultation of the draft GD in
October 2012
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