The EFSA guidance document on risk assessment for birds and mammals published in 2009 will soon be replaced by a new version. In November 2021, EFSA closed the public consultation on the new guidance, which will likely have similar principles to the 2009 version, but with more detailed, improved and generally more conservative data. Please find access to the consultation here.
The new document retained the surrogate protection goals, but the more conservative tone was emphasized due to the provision of more details. Thus, in the acute risk assessment scheme for birds and mammals the current operational protection goal is to avoid mortality due to direct toxicity of exposed individuals of birds and mammals that (temporarily) occur in treated crops, while in the long term reproductive risk assessment scheme this goal is defined as negligible population-level effects due to direct toxicity on pesticide-exposed bird and mammal species that (temporarily) occur in pesticide-treated crops.
Some aspects that the new guidance is considering are (i) the new regulatory framework, (ii) any new scientific developments; (iii) feedback received from Member States and stakeholders on existing guidelines with a view to clarifying and correcting them where necessary; (iv) possible harmonization of higher-level methodologies and (v) development of a calculation tool.
Therefore, one of the improvements that can be expected tackles the harmonisation and transparency in the evaluation of higher tier studies. Evaluation tools were developed for the most commonly available refinements (i.e. residue decline, effect field studies and ecological field studies for the identification of focal species, PT and PD). The working group also recommended an approach to considering the implications of other available data to refined risk assessment (e.g. literature data or data not owned by the applicant).
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