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GD on Aquatic Ecotoxicology

Stephanie Bopp, Maria Arena, Franz Streissl

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

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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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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Analysis of current GD Aquatic Ecotoxicology (SANCO/3268/2001)

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• 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

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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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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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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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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GD Aquatic Ecotoxicology – Module 2

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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GD Aquatic Ecotoxicology – Module 3

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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GD Aquatic Ecotoxicology – Module 4

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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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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Currently working on Module 1: GD on tiered RA for aquatic organisms in edge-of-field surface waters

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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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 fresh water species

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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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