ABSTRACT

It is accepted that most rDNA products will be of low or negligible risk and therefore legislation must be flexible enough not to constrain diffusion of the technology. This can be achieved by a precautionary structure that permits reclassification of organisms in the light of scientific progress on a case-bycase basis, and by ensuring that the institutional supervisory structures are efficient, thus avoiding product approval delays and excessive costs. This can be thought of as “guilty until innocent with parole for good behaviour”. At least in principle, the European Directives 90/219 and 90/220 were framed with this in mind, allowing clearance of products and provisions for technical amendment throughout the European Union. On these grounds alone, the process-based precautionary legislation adopted by the EU can be justified. Arguments that there should be a wholesale reversal of this approach remain unconvincing, even in the light of scientific and technological advance.