UK: disputing boundaries of biotechnology regulation

UK biotechnology regulation has developed 'precautionary controls' for GMO releases. Stringent legislation was drafted and eventually implemented by the Department of Environment (DoE). In parallel, the DoE established a broadly based advisory committee, which included ecologists and an implicit public interest representation. The committee was assigned the task to advise on the release of all 'novel organisms'-a term which implies an analogy between GMOs and non-indigenous organisms. Since 1993 the DoE has called its policy 'risk based regulation'. For trial releases, this means helping applicants to design and justify their experimental design as safe, while deferring uncertainty about which potential effects would be plausible and/or unacceptable. For market approval however, the DoE has been criticized for setting the statutory remit too narrowly, e.g. as regards 'environmental harm', food safety, post-market monitoring, and product labelling. Both at home and abroad, the UK government finds itself in dispute over these regulatory boundaries. The UK government has treated the intentional release of genetically modified organisms as a new problem. It established precautionary controls which could accommodate diverse risk perceptions. This effort has involved a cultural shift in British safety regulation.