European biotechnology regulation: contested boundaries of environmental risk

In response to the legitimacy problems of biotechnology, the European Community adopted the Deliberate Release Directive 90/220/EEC, as the statutory 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, each marketing application has led to disputes among member states, e.g. regarding whether to consider secondary effects, how to define adverse effects, and whether to require product labelling. Some member states exclude secondary effects, arguing that the Directive encompasses only product safety, i.e. direct ecological effects of the GMO or its inserted genes. Other member states emphasize the Directive's requirement that all appropriate measures be taken 'to avoid adverse effects on human health and the environment' - which may be interpreted to encompass agricultural practices in using the product. This issue has proven contentious because of the prospect that transgenic crops may ultimately pre-empt, encourage or force changes in crop-protection methods. In excluding such considerations, some regulators have acknowledged that their decisions leave a 'regulatory gap' between environmental protection and agricultural policy. Yet the problem also lies within risk assessment, which rests upon judgements about what modes of crop protection are acceptable or even desirable. Safety decisions necessarily involve an implicit technology assessment on product design, with its contentious assumptions about natural resources and human practices. Moreover, these concerns have been displaced to the consumer stage, where the labelling issue compounds the dispute over the statutory relevance of pesticide implications. In sum, the contested boundaries of risk regulation arise from its origins in the legitimacy problems of biotechnology