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
Catalogue details

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.

    17/128 (page 11)
    CHAPTER FOUR: THE COORDINATED FRAMEWORK FOR REGULATION OF BIOTECHNOLOGY, JUNE 26, 1986 On June 26, 1986, the Office of Science and Technology Policy published a ‘‘Coordinated Framework for Regulation of Biotechnol- ogy” that describes the Administration’s policy for the regulation of biotechnology, defines which organisms would be subject to full, and which to abbreviated review, and contains specific policy state- ments from FDA, EPA, USDA, NIH, and the Occupational Safety and Health Administration (OSHA).** The Coordinated Framework establishes a regulatory scheme for both commercial and research releases of genetically-engineered organisms. This scheme is sum- marized in Charts I and II in Appendix C of this report. The Coordinated Framework was compiled by the interagency committee entitled the Biotechnology Science Coordinating Com- mittee (BSCC) under the direction of the DPC Working Group on Biotechnology.4® The BSCC comprises representatives from NIH, National Science Foundation (NSF), EPA, FDA, and USDA. The charter authorizes the BSCC to: Serve as a coordinating forum for addressing scientific problems, sharing informa- tion, developing consensus; Promote consistency in the development of federal agen- cies’ review, procedures, and assessment; Facilitate continuing cooperation among 4451 Fed. Reg. 23302. 45 The government-wide effort to coordinate the regulation of research involving, and prod- ucts using, biotechnology was first directed by the interagency Cabinet Council Working Group on Biotechnology, who developed The Proposed Coordinated Framework for Regulation of Bio- technology. The Cabinet Council Working Group on Biotechnology, established in April 1984, included as member agencies the Departments of: Interior, Justice, State, Agriculture, Com- merce, Defense, Energy, Health and Human Services, and Labor; the Environmental Protection Agency; the Council on Environmental Quality; the Council of Economic Advisors; the Office of Management and Budget; the Office of Policy Development; the National Science Foundation, the Office of the U.S. Trade Representative, and the Office of Science and Technology Policy. [49 Fed. Reg. 252 at 50857.] This working group was succeeded by the Domestic Policy Council Working Group on Biotech- nology, which was responsible for the development of the Coordinated Framework for Regula- tion of Biotechnology. The Domestic Policy Council Working Group on Biotechnology also con- siders policy matters related to biotechnology, including jurisdiction, commercialization, and international aspects. [51 Fed. Reg. 123 at 23306.] It monitors developments in biotechnology and is ready to identify problems and make appropriate recommendations for their solution. [51 Fed. Reg. 123 at 23306.] The Domestic Policy Council Working Group on Biotechnology proposed creation of the Bio- technology Science Coordinating Committee (BSCC) as the committee responsible for coordina- tion and consistency of scientific policy and scientific reviews. The BSCC, established October 31, 1985, as part of the Federal Coordinating Council for Science, Engineering and Technology (FCCSET) within OSTP, consists of senior policy officials involved in the oversight of biotechnol- ogy research and products. [51 Fed. Reg. 123 at 23306.] Its seven members represent the Depart- ment of Agriculture (two members), the Department of Health and Human Services, the Envi- ronmental Proteciton Agency (two members), the Food and Drug Administration, and the Na- tional Science Foundation. One of the primary activities of the BSCC has been the development of definitions essential to a coordinated Federal framework. [51 Fed. Reg. 123 at 23306.] The BSCC was also helpful in the formulation of two underlying principles of the Coordinated Framework: 1) that agencies should seek to adopt consistent definitions of those genetically-engi- neered organisms subject to review to the extent permitted by their respective statutory au- sosonr” and 2) that agencies should utilize reviews of comparable rigor. [51 Fed. Reg. 123 at