Structured analysis of broader GMO impacts inspired by technology assessment to inform policy decisions

If genetically modified organisms (GMOs) are approved in the EU for experimental release or marketing authorization (placing on the market), a risk assessment (RA) is carried out beforehand to determine whether this may be associated with negative effects on human health, nature or the environment. Applications are reviewed by the European Food Safety Authority (EFSA) and the national Competent Authorities of the Member States. However, the potential ramifications of the GMOs that are systematically addressed in the current RA context are limited. Broader consideration can include environmental and health aspects beyond the scope of the statutory RA, as well as societal, ethical and cultural impacts. These other levels of impact may be considered during the comitology process of authorisation, but how this is done is typically not made explicit in a systematic way. However, with the dynamic developments of new kinds of GMOs, these considerations as well as transparency regarding the role of broader considerations in political decision-making become more and more relevant. Against this backdrop, we identified the requirements and suggest the main elements for such a broader assessment. We use insights from the field of Technology Assessment (TA) to explore the requirements for operationalising a rapid but still systematic, transparent and broad case-by-case GMO assessment compatible with the existing legislative framework.