Higher tier aquatic risk assessment: current and future refinement options

Sarah Priestly and co-chairs have had a session proposal accepted for SETAC Vienna in May 2025 on the topic of ‘Higher tier aquatic risk assessment: current and future refinement options’.

Other co-chairs will be Maike Habekost (BASF; industry), Marinda van Pomeren (Ctgb; government), and Gertie Arts (Wageningen University and Research; academia).

The session topic is outlined below:

Aquatic organisms can potentially be exposed to plant protection products in edge of field water bodies, and thus a risk assessment is required under Regulation (EC) 1107/2009. The current aquatic guidance document used in the European Union and GB is EFSA (2013).

In many cases, Tier I risk assessments following EFSA (2013) do not demonstrate low risks and thus higher tier approaches must be presented for a substance to be authorized for the proposed use(s). Various higher-tier approaches are included in EFSA (2013) e.g. geomean toxicity endpoints, species sensitivity distributions, TWA PECsw, modified exposure studies, effect modelling, mesocosm studies, etc; however, not all higher tier approaches included in EFSA (2013) are currently accepted by regulatory authorities due to uncertainties regarding their implementation and/or protectiveness.

As the EFSA (2013) aquatic guidance is now >10 years old, significant experience has been gained by industry and regulatory authorities in the use and acceptance of the several higher tier options. The aim of this session is to use the experience gained to discuss challenges with the current guidance, regarding issues encountered with existing refinement options in terms of uncertainties in implementation, interpretation and/or protectiveness. Furthermore, presentations are welcomed on new refinement options that are not included in the EFSA (2013) guidance document, together with presentations on horizon issues that may be faced in future revisions of the guidance. Presentations illustrated with case studies are particularly welcomed. Presentations from the point of view of all stakeholders such as practitioners (CROs, consultants), industry, government (regulatory authorities and bodies), and academic researchers are welcome.

The chairs all have sound experience with the use of this GD and are representative of different stakeholders (industry, government, academia, consultants).

Without sufficient abstract submissions, this proposed session will not go ahead. We therefore ask for anyone who currently uses the aquatic guidance document to submit abstracts via the SETAC website within the abstract submission portal. Abstracts submissions start on 11^th October 2024 and close on 20^th November 2024. To find out more about SETAC abstract submissions, click here.

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