Balancing Regulatory Control, Scientific Knowledge, and Public Understanding
The commercial application of the modern biotechnologies or “New Biotechnology” (recombinant DNA, monoclonal antibodies, and advanced micro-chemical analysis and synthesis) has been in progress for slightly more than a decade. The initial products that resulted were monoclonal antibodies for disease diagnosis and new drugs resulting from the large-scale fermentation of microorganisms that had been genetically modified. In each case, the living cells were not the products themselves, but were simply the means by which the end product was produced. Production was done in carefully controlled, contained facilities, and product regulation was almost independent of the mode of manufacture.
KeywordsEnvironmental Protection Agency International Coordination Register Policy Statement Notification Requirement National Science Foundation Program
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