Hazard, risk and responsibility in the current regulation of biotechnology

Recent events have shown that the release of genetically modified crops and their use as food is increasingly controversial. The confusion over the issues involved displayed by the public, the media and governments across Europe is symptomatic of deficiencies in the current regulation of biotechnology. These deficiencies have been explained in terms of the differences between "product-based" and "process-based" models of regulation. These supposedly reflect the characteristics of, respectively, the United States and European regulatory frameworks. It has been claimed that the "process-based" model is functionally unable to distinguish real from conjectural risks. It is therefore dismissed as irrational and perpetuating the confusion experienced by the public whilst unnecessarily burdening the emerging biotechnology industry. This dichotomy, however convenient, does not accurately reflect or explain the characteristics of current regulations and does not inform the debate over the acceptability of biotechnology. The adequacy of a regulatory framework, i. e. the legislative policy rather than the efficiency or effectiveness of its application, in an international comparative context, must be established with regard to the principles of proportionality and precaution. As well as being the only available internationally- accepted references for this task, these two emerging principles of international law offer clear guidance for the understanding of the concepts of "risk" and "hazard", and help establish the corresponding legal responsibilities in the context of biotechnology. They allow a fair and adequate evaluation of all the points of view present in the biotechnology debate. Accordingly, both regulatory frameworks present defects, but these are not insurmountable. The frameworks are neither equivalent nor mutually exclusive, and cannot be treated as alternatives. Their differences illustrate the sovereign right of States to choose appropriate levels of safety for their jurisdictions, as long as this choice is adequately justified. This right is not a barrier to trade or to scientific understanding.