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Biotechnology is a rapidly developing field. Concerns for the health and safety of workers, for the safety and efficacy of the biotechnically derived products, and for potential environmental contamination have been expressed. With the development of a consistent government-wide policy for the regulation of products derived from new biotechnologies, the United States government has taken steps at agency and interagency levels to dispel these concerns. Under the authority of the Food, Drug, and Cosmetic Act of 1938, the U.S. Food and Drug Administration (FDA) evaluates and regulates the safety of biotechnology-derived products in the same way that it does for conventionally manufactured products. Scientific, safety, and regulatory issues are considered prior to approval for commercial production. Once a product receives approval, enforcement of the laws and regulations at the manufacturing level is accomplished by FDA's field personnel. The individual firm's manufacturing and quality control procedures are reviewed and evaluated to determine if they are in compliance with the Current Good Manufacturing Practice regulations. The FDA believes the current laws provide adequate regulatory protection and are sufficiently comprehensive to regulate products regardless of whether they are manufactured by traditional processes or are the products of biotechnology.
bioprocessing, biotechnology, enforcement, genetic engineering, inspection, safety, recombinant DNA, regulations
Director of investigations, U.S. Food and Drug Administration, Chicago, IL