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Development of an integrated testing strategy to reduce animal testing for plant protection product hazard and risk assessment

Project


Project code: BfR-SiP-08-1322-717
Contract period: 01.01.2019 - 31.12.2019
Purpose of research: Experimental development

The reduction of animal testing is a central aspect in the context of the hazard assessment according to Regulation (EC) No 1272/2008, plant protection product risk assessment based on Regulation (EC) No 1107/2009, and biocidal product risk assessment according to Regulation (EU) No 528/2012. Despite the use of alternatives to in vivo testing, human health and safety standards shall be further optimised. Therefore, the project aim is to develop an integrated testing strategy for the prediciton of pesticide product toxicity. Pesticide formulations differ from other chemical mixtures due to their specific characteristics. Co-formulants are added to augment active substance efficacy, improve its applicability, uptake and distribution, and enhance product stability. However, alternative methods are commonly developed and validated for less complex mixtures. Hence, specific strategies are required to implement alternative methods in the regulatory evaluation of pesticide formulations. Aim of the project is to develope an integrated testing strategy, which initially assesses the need for the conduction of new tests. In this context, active substance and product toxicity shall be compared (using methods developed in the Department Food Safety). This shall be conducted for all endpoints as required by the above regulations as well as for further relevant endpoints, such as genotoxicity or reproductive toxicity. If product toxicity evaluation is required based on this initial testing, available information from in vivo and in vitro studies as well as non-testing methods (i.e. in silico and bridging) shall be integrated in a first step. This requires knowledge on the relevance and reliability of the individual methods. Moreover, result uncertainty shall be analysed. Studies available to BfR shall be used to evaluate the predictability of different methods and derive relevant parameters influencing this predictability. Ultimately, a tool shall be developed which considers the derived parameters and weighs available studies and non-testing information to conclude on the required classification while specifying result uncertainty. In case of unacceptable uncertainty, tests shall be recommended to reduce uncertainty. New in vivo tests shall only be conducted if all other means of assessment have been exhausted. This approach shall guarantee risk assessment quality while substantially reducing animal testing for pescide product regulatory assessment.

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Subjects

Framework programme

BMEL - research cluster

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