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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    ment. As this new chapter unfolds, a federal regulatory system for biotechnology is unfolding as well. | The Federal regulation of biotechnology is now in its third stage. The first stage began with the “Guidelines for Research Involving Recombinant DNA Molecules”’ (“NIH Guidelines”) adopted by the National Institutes of Health (NIH) in 1976.° These guidelines took a cautious stance, emphasizing containment standards and prelimi- nary review by committees at each research institute of proposed experiments involving recombinant DNA technology. The guide- lines have been gradually relaxed as scientists obtained more infor- mation about the safety of the organisms involved.’ The second stage of biotechnology regulation began on December 31, 1984, when the Office of Science and Technology Policy (OSTP) published a “Proposal for a Coordinated Framework for Regulation of Biotechnology.” * The purpose of the proposal was to “provide a concise index of U.S. laws related to biotechnology, to clarify the policies of the major regulatory agencies that will be involved in reviewing research and products of biotechnology, to describe a sci- entific advisory mechanism for assessment of biotechnology issues, and to explain how the activities of the federal agencies in biotech- nology will be coordinated.” ° The Proposed Coordinated Framework served as guidelines for the review of biotechnology products until June 26, 1986, when the Office of Science and Technology Policy published the “Coordinated Framework for Regulation of Biotechnology.” 1° This ‘Coordinated Framework’ incorporated the comments received on the December 1984 Proposed Coordinated Framework and contained revised and expanded agency policy statements regarding the regulation of bio- technology products. This began the third and present stage of gov- ernment regulation of biotechnology. Although nearly a score of bills specifically designed to regulate biotechnology have been in- troduced in the House and Senate in the past 16 years, none have become law. From December 1985 through July 1986, the Investigations and Oversight Subcommittee of the House Committee on Science and Technology held a series of hearings which, taken as a whole, chronicle the journey from the NIH Guidelines to the Coordinated Framework. The first hearing, which was held one year after the publication of the Proposed Coordinated Framework, examined the status of government research into, and regulation of, planned re- leases of genetically-engineered organisms.1! The next two hear- ings investigated review and regulation under the Proposed Coordi- nated Framework of two genetically-engineered products, “‘ice- Re er pe: Reg. 131, Part II, at 27902-27943, July 7, 1976. (Hereinafter cited as “NIH Guide- 7 The most recent revision is found in 51 Fed. Reg. 1695 . Reg. 8, May 7, 1986. ® 49 Fed. Reg. 252, Monday, December 31, 1984 - i i “Pro- See edinet Reels er 31, 1984, at 50856-50907. (Hereinafter cited as “Pro : de: at 50856. s% cena 123, Thursday, June 26, 1986, at 23302-23393. (Hereinafter cited as “Coordinat- 11 “Planned Releases of Genetically-Altered Organi : od AX : ganisms: The Status of Government Research ee , Hearing before the Subcommittee on Investigations and Oversight of the Com- oe e a ; ee and Technology, U.S. House of Representatives, 99th Congress, First Session, ecember 4, 1985, Serial No. 99-72. (Hereinafter cited as “Hearing: Planned Releases’”’.)