Between uncertainty and controversy: has the European Union actually responded to the challenges of GMO regulation?

Abstract

The legal regime applicable to Genetically Modified Organisms (GMOs) in the European Union is an important witness to the central position assumed by risk in European regulatory and institutional reform over the last years. At the European level, the GMO regime provides an archetypical response by the regulator to the challenges raised by scientific uncertainty, social controversy and the weakening of national frontiers. The need to act in situations where knowledge about relevant facts is insufficient or uncertain presents a test to the regulator and more generally to a legal system in which the verification or proof of the truth has traditionally been the requirement for both activating the law and for determining their possible violation. The precautionary principle provides the primary EU response to this challenge. Its inclusion in EU legislation on GMOs entails the recognition of the actual lack of conclusive evidence of harm which may be caused by the experimental use, the cultivation or industrial application of GMOs. At the same time, the extent of the public controversy surrounding this biotechnology led the EU to reconsider and possibly reinforce mechanisms for involving the civil society in the regulatory process. Yet, at the end of the day, the GMO regime structures the whole system for the assessment and management of the risk on the use of science and scientific opinions. This article seeks to examine this apparent paradox and the way in which the GMO regime attempts to resolve it. This analysis will lead us in the end to questioning whether by meeting the risk raised by the development and use of GMOs in the way it does, the EU is not generating a sort of regulatory failure.