Harmonization difficulties of European biotechnology regulation: EC directive 90/220 on the deliberate release of genetically modified organisms (GMOS)

In recent years, 'risk' debate has become a means for adjudicating the legitimacy of contentious technologies (U. Beck, 1992). Often such debate centres upon 'unacceptable risk', implying that the extent (and even type) of risk may not be scientifically known. As a response to the problems of reflexive modernization, discursive forms of technology assessment have been conceptualized for democratising the policy process (R. Von Schomberg, 1995). In the case of genetically modified organisms (GMOs), or 'the new biotechnology', a 'risk' debate erupted prior to the commercial stage. For their intentional release into the environment, debate has centered upon 'hazard identification', amidst scientific disagreements over how to identify cause-effect pathways of potential harm from GMOs. Meanwhile GMO releases have undergone safety precautions, albeit often voluntary controls, starting from the earliest R&D trials. Early US regulation deepened the original controversy, as regards whether all GMOs warrant 'additional [statutory] regulation', and with what expertise for risk assessment. This conflictual outcome illustrates how safety regulation implicitly becomes a social assessment of a new technology, involving diverse social actors (C. Limoges et al., 1990) Unlike the USA, the European Community enacted legislation specially for regulating all GMO releases in 1990. The paper analyses difficulties in implementing that Directive, especially in reconciling its various aims.