Biotechnology Regulation. The United States Approach.
Proceedings of the Occupational Safety and Health Symposium on Biotechnology, The Queen Elizabeth Hotel, Montreal, Quebec, Canada, March 21-22, 1991 1992:75-82
This report reviewed the development of a coordinated framework for biotechnology regulation, identified the primary agencies involved and their areas of expertise. Considerable confusion has resulted from attempts to define biotechnology. It was noted that OSHA considers biotechnology to include products made using classical genetic engineering and/or breeding, and in-vitro modification of genetic material and other novel techniques for modifying genetic material. The first discussion in the United States of potential risks in biotechnology fields occurred in 1973 at the Gordon Research Conference on Nucleic Acids. The most recent discussion involved guidelines for releasing organisms with deliberately modified hereditary traits into the environment for agricultural purposes. A Coordinated Framework for Regulation of Biotechnology was released in December of 1984 and consisted of policy statements from the affected agencies on how they will apply existing regulatory requirements to biotechnology, a scientific advisory mechanism to coordinate scientific review to promote consistent risk assessment within statutory confinements, and an interagency committee to coordinate regulatory activities.
Regulations; Legislation; Genotoxic-effects; Risk-factors; Risk-analysis; Biotechnology-industry; Genetic-engineering; Genetic-factors;
Proceedings of the Occupational Safety and Health Symposium on Biotechnology, The Queen Elizabeth Hotel, Montreal, Quebec, Canada, March 21-22, 1991