Regulating agricultural biotechnology in Europe: harmonisation difficulties, opportunities, dilemmas

The EC Deliberate Release Directive 90/220 responded to a wide-ranging risk debate on the intentional release of GMOs. It was to integrate environmental precaution with market harmonisation. New networks have offered opportunities for influencing the expertise and concepts which would guide its implementation. In particular, ‘familiarity’ has been promoted as a euphemism for acknowledging and clarifying uncertainty about biotechnological risk. The Directive provided a flexible framework for evaluating potential effects of GMOs — their statutory relevance, acceptability, causality and plausibility. Regulators have had to devise normative judgements, for which divergent norms have arisen from national differences in regulatory style and institutional framework. Only by learning from these differences can the regulatory procedure accommodate the wider risk debate and thus address the legitimacy problems of biotechnology.