| Abstract: | Summary By combining hazard assessment of effects of a potential biotechnology product with exposure assessments based on study of the genetically engineered organism's fate, conclusions may be reached about the risk involved in release of the product to the environment. In order to make this risk assessment, criteria (including regulatory endpoints) must be established and then developed further against a data base from well-accepted tests. Other aspects requiring research and development include test evaluation, quality assurance, statistical procedures, and methods of identifying and monitoring not only the nominal organism(s) in the products, but also any contaminating material or organisms to which the genetically engineered components may be transferred in the environment.Application of microcosm technology to testing of genetically engineered organisms is expected to be important, since these systems may be used safely to understand fate and effects prior to (or in place of) testing the product in the environment. Limitations in the use of microcosms may be offset by the cost-effectiveness and incisiveness of results, as has been shown for other pollutants.Risk management for biotechnology products currently lacks an adequate background, but components of the process exist or can be developed. New resources, in terms of personnel, training, facilities, and funding, will be needed in order to apply the risk assessment paradigm used for toxic chemicals and pesticides. We will need to know: |
