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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    CHAPTER TWO: THE NIH GUIDELINES In 1976, the NIH adopted the “Guidelines for Research Involving Recombinant DNA Molecules.” 25 The NIH Guidelines establish containment standards and various degrees of review for certain categories of experiments. They also require the establishment of an Institutional Biosafety Committee (IBC) at any federally-funded institution doing recombinant DNA work. Local IBCs review re- search proposals for compliance with the NIH policy regarding re- combinant DNA research. The NIH/RAC and the director of NIH enforce the NIH Guidelines on the national level. While there have been isolated deviations from the research guidelines,?® the record of safety in recombinant DNA laboratory research is impressive. The NIH Guidelines are used internationally as a commendable ex- ample of self-regulation by the scientific community. Since their inception, the NIH Guidelines have been consistently criticized for three short-comings.?7 First, they are mandatory only for federally funded research; compliance by private companies is voluntary. Second, they do not apply to organisms created by ge- netic engineering methods other than recombinant DNA tech- niques. Finally, the NIH Guidelines were not originally intended to, and in fact do not, adequately address the issue of planned re- leases of genetically-engineered organisms into the environment.?® The increase in proposals for environmental releases of genetically- engineered organisms has underscored these weaknesses in the NIH Guidelines. Despite these criticisms, there is general agree- ment that the NIH Guidelines have successfully promoted safe lab- oratory research in recombinant DNA technology and have set the safety standards utilized by both public and private research insti- tutions and companies. 25 4] Fed. Reg. 27902; Previous reports of this Subcommittee and other Subcommittees have presented thorough discussions of the impetus and evolution of the NIH Guidelines for Research Involving Recombinant DNA Molecules. See reports cited in discussion, infra, at 11-13. 26 In two incidents in the late 1970s, researchers (including one former member of the NIH/ RAC) circumvented the NIH Guidelines and local IBCs failed to take appropriate actions. For a discussion of the incidents, see, “Genetic Engineering, Human Genetics, and Cell Biology: Evolu- tion of Technological Issues, Biotechnology” (Supplemental Report III), Prepared for the Sub- committee on Science, Research and Technology of the Committee on Science and Technology, U.S. House of Representatives, Ninety-Sixth Congress, Second Session, by the Science Policy Re- search Division, Congressional Research Service, Library of Congress, August 1980, Serial DDD. 27 Agriculture's Regulatory System Needs Clarification, General Accounting Office, #GAO/ RCED 86-59, March 1986, at 19. (Hereinafter cited as ‘‘USDA’s Regulatory System’’.) 28 Td.