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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    B. DISCUSSION 1. INDUSTRY’S EXPERIENCE WITH THE PROPOSED COORDINATED FRAMEWORK At the hearing, industry representatives discussed their experi- ence in seeking federal approval for field tests of genetically-engi- neered organisms. Dr. Ronald Cape, founder and Chief Executive Officer of Cetus Corporation, recounted the problems that Agrace- tus Corp. (a subsidiary) encountered in voluntarily seeking federal authorization to test a genetically-modified plant under field condi- tions. In 1984, the Plant Working Group of the NIH Recombinant DNA Advisory Committee (RAC) had reviewed the Agracetus pro- posal, but a pending law suit prevented RAC from authorizing the field test.® In an effort to obtain official approval of their plan, the company submitted the proposal to the Animal and Plant Health Inspection Service (APHIS), a regulatory division of USDA. Dr. Cape then discussed the difficulties Agracetus encountered in seek- ing authorization from USDA for its proposed field test: Dr. Carr. Agracetus provided additional information to APHIS during this time to further document the RAC review and the protocol to be followed. On June 14, 1985, APHIS wrote to Agracetus indicating that APHIS staff had completed its review of our proposed experiment and found that, based on our protocol, our test did not con- stitute a plant pest risk and would not be subject to further regulation by USDA, APHIS under the Plant Pest Act. . Upon review by our attorneys of the USDA letter, we determined that we did not yet have an actual approval to conduct our test. Although the APHIS determination was favorable, in that it found our test would not constitute a plant pest risk, the agency did not yet have a mechanism to grant us the authority to go ahead. In our view this was because APHIS had not yet publically set forth the policies and proce- dures that would knit together their various authorities detailed in the December 31, 1984, Federal Register notice. Although it was clear that such policies existed at least in prototype form within the Department, we believed that given the novelty of our experiment and given the extent to which the whole regulatory question about biotechnology was being debated, it would be perferable for us to proceed with a test only in circumstances of a generaily known and accepted review mechanism. Thus, as of early July we made the decision to defer beginning experimental tobacco until either the APHIS process was published and opportunity for public review had been provided, or until our original application before the NIH was approved by the NIH director in accordance with the RAC Guidelines.* [Emphasis added. ] In July 1985, it became clear that USDA would not take any reg- ulatory action on the company’s application. Subsequently Agrace- tus submitted its proposal to the NIH/RAC. Dr. CAPE... . as you know, it’s a rather strange situation in that industry is not, strictly speaking, required to adhere to every last sentence including the sign-off from the Director. But there was no way in which we were going to try to short cut the last dot on the last “i” which meant that even though we got the scientific green light from RAC, until Dr. Wyngaarden was willing to give us the same ap- proval that he would give to an NIH-funded lab, we weren’t about to move.? Dr. Kingsbury, chairman of the BSCC, underscored the reliance on voluntary compliance by industry with the NIH Guidelines: Dr. KINGSBURY. There’s no requirement that they teli us anything. The courtesy and the position of the industry in the past has been to voluntarily follow the NIH guidelines and to voluntarily bring those to the NIH prior to the application. As Dr. 5 Foundation on Economic Trends v. Heckler, 587 F.S . 758 (D Cir. 1985); See also, Appendix A, infra. BRR aol aE aaa DU ater Planned Releases”, supra, note 11, Part I, at 215. Id. a :