ABSTRACT

Since the 1980s, there has been a public controversy over the risks of biotechnology. In response to this legitimacy problem, the European Community adopted uncertainty-based legislation; the Deliberate Release Directive 90/220 provided a common framework for regulating releases of genetically modified organisms (GMOs). The Directive aimed to 'establish harmonized procedures and criteria', especially for Europe-wide approval of commercial products. In practice, however, member states have given different interpretations to key statutory terms, e.g. 'risk', 'adverse effects', and the 'step-by-step' principle.

Moreover, each marketing application has led to disputes over which potential effects must be prevented, as well as over product labelling. Often at issue is the prospect that transgenic crops may adversely pre-empt or encourage changes in agrochemical usage. In that regard, risk assessment rests upon normative judgements about what modes of crop protection are acceptable or even desirable. Presumed benefits of products have no agreed criteria, yet may influence working definitions of environmental harm.

In all these ways, safety decisions cannot avoid an implicit technology assessment on product design, and thus on the R&D trajectory of agricultural biotechnology. Such implicit judgements give rise to European disharmonies of environmental risk. Thus precautionary regulation bears the difficult burden of the legitimacy problems which it was designed to overcome.