PLANNED RELEASES OF GENETICALLY-MODIFIED ORGANISMS INTO THE ENVIRONMENT - THE EVOLUTION OF SAFETY CONSIDERATIONS

Issues of safety and risk have taken the foreground in discussions on the deliberate release of genetically modified organisms. In most case s, the organisms being introduced into the environment are modified ve rsions of familiar organisms with a long history of safe use and are e xpected to have no direct adverse effects for human health or for the environment. However, there is legitimate concern about the environmen tal fate of these organisms, in particular, about the genetic informat ion which they carry. In the past, discussions of technological risk h ave often been based on the terminology and logic of the familiar risk -assessment strategy developed for characterizing risks from hazardous chemical processes. While the direct transfer of this assessment mode l to evaluating contained biotechnological processes has been successf ul, attempts at molding the model to the requirements of open systems have been unsatisfactory. To be meaningful, the safety evaluation for environmental releases must accomodate the distinguishing features of this open system: the lack of an intrinsic hazardous property, the lac k of quantitative thresholds for adverse effects, and the lack of a co mmon currency in which to express potential damages. A survey of risk- assessment strategies in the chemical and biotechnological sectors is presented here. This will provide the necessary background to understa nding the current situation of assessing and communicating the risks a ssociated with the reintroduction of familiar organisms into environme nts where they were already naturally present.