Abstract

Regulated products such as genetically modified organisms (GMOs), plant protection products (PPPs) or feed additives for livestock are subject to an environmental risk assessment before they can be approved for use in agriculture. This assessment aims to evaluate any possible risk that the deployment of such products may pose to the environment. Robust environmental risk assessments require an explicit formulation of potential problems to identify plausible and relevant exposure scenarios and potential adverse effects from predicted exposures. The actual risk is then characterised by testing specific hypotheses about the likelihood and severity of these adverse effects [1], [2], [3], [4]. The ultimate decision on what is an acceptable level of risk, and thus whether a GMO, PPP or feed additive can be commercialised, is taken by risk managers—policymakers and regulators—who have to weigh different policy options to accept, minimise or reduce the risks that were characterised through the environmental risk assessment. The first step of an environmental risk assessment is to establish the context for the assessment by identifying which components of the environment—species, habitats, services, etc.—are valued by civil society and/or protected by relevant laws or policies. This exercise establishes the so‐called environmental policy protection goals: environmental components that should be protected and taken into account when conducting environmental risk assessments to support regulatory decision‐making. These protection goals can vary between jurisdictions, but their overall aim is to minimise harm to the environment, including biodiversity and ecosystems, caused by human activities. However, policy protection goals, such as protecting biodiversity, are often too generic and vague to be useful for scientific risk assessment, and need to be translated into specific, operational ones. Because protecting everything, everywhere, forever is not always tenable, operational protection goals, also termed specific protection goals, have to delineate …

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