Abstract
In late 1984, the Reagan administration proposed a Coordinated Framework for Regulation of Biotechnology. Its proposed regulatory approach appears less constraining than the deep concerns of the 1970s concerning the risk of biotechnology would have suggested. Several distinctive characteristics of the early period of biotechnology, particularly the role of the research community in developing the initial regulatory system and the extent of federal funding, explain this development. The administration’s proposal may attract substantial support. However, implementation may lead to conflicts and problems, especially concerning human germ-line gene therapy and environmental release of viable genetically engineered organisms.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
49 Fed. Reg. 50,856 (Dec. 31, 1984).
Foundation on Economic Trends et al. v. Margaret M. Heckler et al.,587 F. Supp. 753 (DDC, 1984).
42 USC § 4331et seq.
Dept. of Health and Human Services, Natl. Institutes of Health,Guidelines for Research Involving Recombinant DNA Molecules. The current version is at49 Fed. Reg. 46,266 (Nov. 23, 1984).
For examples of industry support for regulation,see, e.g., speech of H. P. Green,A Regulatory Overview, presented at an October 18, 1984, meeting of the Industrial Biotechnology Association (IBA); letters to OSTP, EPA, FDA, and USDA dated March 29, 1985, from Harvey Price, Executive Director of the IBA responding to the Administration notice. The IBA is a trade association representing major companies engaged in biotechnology.
Ref. 1supra.
17 USC §§ 136–139y.
Environmental Protection Agency,Interim Policy on Small Scale Field Testing of Microbial Pesticides,49 Fed. Reg. 40,659 (Oct. 17, 1984).
5 USC §§ 2601–2929.
Letter from Maxine Singer and Dieter Soll, reprinted in Science181, 1114 (1973).
Committee on Recombinant DNA,Potential Biohazards of Recombinant DNA Molecules, Proc. Natl. Acad. Sci. 71, 2593 (1974).
RAC Charter, October 7, 1974.
P. Berg et al.,Summary Statement of the Asilomar Conference on Recombinant DNA Molecules, Proc. Natl. Acad. Sci. 72, 1981 (1975).
See Dept. of Health, Education, and Welfare, Natl. Institutes of Health,Decision of the Director, NIH, to Release Guidelines for Research on Recombinant DNA Molecules,41 Fed. Reg. 27,902, 27,903 (July 7, 1976).
Dept. of Health, Education, and Welfare, Natl. Institutes of Health,Guidelines for Research Involving Recombinant DNA Molecules,41 Fed. Reg. 27,911 (July 7, 1976).
Ref. 14supra at 27,902. The final Environmental Impact Statement was published in late 1977. See Dept. of Health, Education, and Welfare, Natl. Institutes of Health, Publications No. (NIH) 1489, 1490 (Oct. 1977).
Ref. 15supra at 27,915.
Ref. 4supra.
Id. § III-A-1.
Id. § III-A-3.
Id. § III-A-2. See also Dept. of Health and Human Services, Natl. Institutes of Health,Proposed Points to Consider for Environmental Testing of Microorganisms,50 Fed. Reg. 12,456 (Mar. 28, 1985).
Id. §§ III-B-1 and III-B-2.
Id. § III-B-5.
Id. § III-D-5 and Appendix C.
Occupational Safety and Health Administration,Agency Guidelines on Biotechnology,50 Fed. Reg. 14,468 (April 12, 1985).
Natl. Science Foundation,University-Industry Research Relationships, 13 (1982).
See, e.g. J. Ferguson,National Security Controls on Technological Knowledge: A Constitutional Perspective, Science, Technology, and Human Values 10, 87 (1985); R. Greenstein,Federal Contractors and Grantees: What Are Your First Amendment Rights?Jurimetrics 24, 197 (1984).
45 Fed. Reg. 6,718, 6,746 (Jan. 29, 1980).
Office of Pesticides and Toxic Substances, Environmental Protection Agency,Listing Genetically Engineered Products on the Toxic Substances Control Act Chemical Substance Inventory (Preliminary Draft, Dec. 1984.)
48 Fed. Reg. 24,549 (June 1, 1983).
Ref. 2supra.
Ref. 2supra, Memorandum and Order.
Foundation on Economic Trends, et al. v. Margaret M. Heckler, et al., 756 F.2d 143 (D.C. Cir. 1985).
50 Fed. Reg. 14,794 (Apr. 15, 1985).
50 Fed. Reg. 30,016 (July 23, 1985).
Ref. 8supra.
US Congress, Office of Technology Assessment, Human Gene Therapy— Background Paper, 7 (Dec. 1984).
50 Fed. Reg. 2940 (Jan. 22, 1985).
Id. at 2944.
Ref. 37supra at 31–33.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Greenstein, R.L. Controlling the bugs. Appl Biochem Biotechnol 11, 489–506 (1985). https://doi.org/10.1007/BF02798643
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/BF02798643
Index Entries
- Biotechnology, the first decade
- biotechnology, regulation of by the administration
- research community, role of in regulation of biotechnology
- biotechnology and federal funding
- human germ-line gene therapy, conflicts and problems of
- genetically engineered organisms, release of into environment
- biotechnology, regulation of by public