Authorising GMOs and the Resort to EFSA’s Opinions: Space for Other Legitimate Factors?

Abstract

This chapter examines the operation of the revised Deliberate Release framework, as it relies exclusively on the notified technical data, as well as on the EFSA risk assessment conclusions. The chapter illustrates that the resort of the proceduralised licensing framework to a ‘sound-science’ interpretation paradigm has transformed the prescribed information-exchange procedure into a routine set of expert-based administrative actions and steps, where non-scientific considerations play no influential role. The first section examines the structure of the revised Directive as the outcome of the efforts of the Commission to strengthen the scientific dimension but also to elaborate a proceduralised approach towards the assessment of the effects of the deliberate release of GMOs. Special attention is given to the establishment of the European Food Safety Authority (EFSA) as a reflection of the Commission’s determination to separate the risk assessment from the risk management process and to delegate the former to technical experts. The second section focuses on the role of non-scientific factors in the field of the Deliberate Release risk analysis framework and examines the institutional ‘treatment’ of the relevant ethical and socio-economic concerns at the level of risk management.