Issues in the federal regulation of biotechnology : from research to release : report / prepared by the Subcommittee on Investigations and Oversight, transmitted to the Committee on Science and Technology, House of Representatives, Ninety-ninth Congress, second session.

  • United States. Congress. House. Committee on Science and Technology. Subcommittee on Investigations and Oversight
Date:
1986
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Licence: Public Domain Mark

Credit: Issues in the federal regulation of biotechnology : from research to release : report / prepared by the Subcommittee on Investigations and Oversight, transmitted to the Committee on Science and Technology, House of Representatives, Ninety-ninth Congress, second session. Source: Wellcome Collection.

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    for strong safety and environmental regulations with the need to not be unreasonably restrictive. The OTA report on Commercial Biotechnology was very clear on this point. It concluded, “. . . clarification and modification of cer- tain aspects of U.S. health, safety, and environmental regulation and intellectual property law may be necessary for the mainte- nance of a strong U.S. competitive position in biotechnology.” 2? The implication for Congress is to strive to develop a balanced ap- proach. Rep. Packard explored this approach with Dr. Bernadine Healy, (then) Deputy Director of the Office of Science and Technology Policy, in an April 1985 hearing on “Biotechnology and Agricul- ture’”’: Mr. Packarp. I’m concerned about any set of regulations as to how it will affect the private sector in terms of competition in the world market place, and I don’t think our research can be excluded from this concern. Dr. HEALy. I think there’s no doubt that if we don’t have as a first step a clear regulatory message out there to industry that we are going to have a detrimental effect. And that’s why I quoted the President’s Commission on Industrial Competi- tiveness. Those people said it better than I. That if we don’t have—if we have regu- latory chaos, that is going to be our worst enemy in terms of our economic advantage and our international competitiveness.?* [Emphasis added.] Dr. Ralph Hardy, President of BioTechnica International, Inc. and Chairman of the National Research Council Committee that produced “New Direction in Bioscience and Agriculture: High Reward Opportunities” supports the conclusion reached by Dr. Healy: Dr. Harpy. What will be the impact of regulation? . . . In a broader sense, the United States could lose its competitive edge, as has been previously mentioned. U.S. companies in the extreme could move abroad if regulation becomes excessive: Delays in the prudent development or product development or costly regulatory a would be, I think, catastrophic for start-up companies.24 [Emphasis added. There is no disagreement that the United States must maintain its position as world leader in biotechnology research and commer- cial development. Moreover, there is concern that that position could be jeopardized by excessive regulation. While there is little agreement as to the definition of “excessive” regulation, there is widespread agreement that regulations are necessary to protect health and the environment. The Administration’s Coordinated Framework is intended to balance these concerns. This report dis- cusses the Administration’s efforts and makes recommendations that are intended to improve the regulatory process. | 22 Td., at 5. 23 “Biotechnology and Agriculture”, Hearing before the Subcommittee on Investigations and Oversight of the Committee on Science and Technology, U.S. House of Representatives, 99th oe ae Session, April 16 and 17, 1985, Serial No. 18, at 258. rave a