This document outlines the background and plans for revising the Guidance Document on Aquatic Ecotoxicology. It discusses the need to update the current guidance to align with new regulations and data requirements. The revision will take a modular approach, beginning with practical guidance on topics where "building blocks" already exist. The first module will focus on a tiered risk assessment for aquatic organisms in edge-of-field surface waters. Further modules will address topics like combined exposure/effect modelling, sediment organisms, and multiple stress assessment. The working group is currently drafting the first module and plans to seek public comment on the draft guidance in October 2012.

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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