The purpose of this grant is to provide support for the development of an assessment framework addressing environmental and health risks associated with the deliberate release of biotechnology products. Despite rapid growth in biotechnology sales and development, accepted guidelines for evaluating the risks of genetically-altered organisms that are deliberately released into the environment do not exist. As a result, neither government nor private agencies are able to assess adequately whether the analysis of a planned release is thorough and competent, and the public therefore may be unable to place the risks of biotechnology within a realistic perspective. The proposed project requires the researchers to assess a number of important issues that involve both theoretical and applied questions of great interest to the scientific community. For example, what characteristics of the organism are of greatest concern to the public? What features of the environment need to be taken into account? How can the scale and anticipated risks of the release be described in meaningful terms? Answers to these and related questions will be based initially on the assessment of past releases of modified organisms and an analysis of the current risk assessment requirements of regulatory agencies; this initial information base then will be used as the basis for developing an improved risk assessment framework.
