Theoretical issues in the regulation of genetically engineered organisms: the case of deliberate release

At the cutting edge of research in biotechnology is the production of special genetically engineered organisms for use in an open, agricultural environment. We argue that the standard approaches to risk assessment and management employed by regulatory agencies are inadequate to the task of properly assessing the advisability of such experiments, as well as the even more significant prospect of widespread commercial use of genetically engineered organisms in agriculture. Given the current lack of sufficient information with which to make competent assessments of the risks involved and the attempts to gain such information in a timely fashion, we conclude that a compelling case for deliberate release programs has not been made.