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BIOTECHNOLOGY GOOD MANUFACTURING AND LABORATORY PRACTICE GUIDELINES

Executive Summary

BIOTECHNOLOGY GOOD MANUFACTURING AND LABORATORY PRACTICE GUIDELINES would be coordinated by a White House Office of Science and Technology Policy cmte. under a bill introduced March 19 by House Science and Technology Cmte. Chairman Don Fuqua (D-Fla.). The bill, HR 4452, would establish a Biotechnology Science Coordinating Cmte. whose functions would include developing "guidelines to govern good laboratory and good manufacturing practices in the biotechnology sciences." According to the bill, the cmte. is "to serve as a coordinating forum for addressing scientific problems, sharing information, and developing consensus with respect to methods for evaluating potential risks to human health and the environment which are or may be caused by genetically-engineered organisms." The cmte. would "identify gaps in scientific knowledge with respect to such organisms and such risks," and "recommend research priorities to the Board of Governors of the Biotechnology Science Research Program," HR 4452 states. Under the bill, FDA regulatory decisions related to genetically-engineered organisms would not be subject to review by the cmte. "The Committee shall have no authority to review the regulatory decisions of individual Federal agencies for the purpose of approving or disapproving such decisions, nor shall the activities of the Committee have the effect of delaying any regulatory decision by any such agency," the bill states. The Biotechnology Science Coordinating Cmte. was formed last November by the White House to provide interagency coordination of science issues related to research and commercial application of biotechnology. The cmte. in its present form has been criticized by some members of Congress for lacking authority to resolve disputes or establish policy. The bill would establish the cmte. under law. Membership on the cmte. would remain unchanged, consisting of representatives of FDA, National Institutes of Health, Environmental Protection Agency, Department of Agriculture and National Science Foundation. HR 4452 also would establish a Biotechnology Science Research Program within the Office of Science and Technology Policy which would operate "under the supervision of a Board of Governors to be selected from among people outside the Federal Government by the Biotechnology Science Coordinating Cmte." According to the bill, the program would: "coordinate the use of private and public resources to create a data base to support the review and regulation of the biotechnology sciences"; "identify areas of research that will facilitate the development and regulation of biotechnology products"; and "review the research recommendations of the Biotechnology Science Coordinating Committee, and of the Federal Agencies involved in research in biotechnology and in the review and regulation of the biotechnology sciences, for purposes of developing a research agenda."
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