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Office of Recombinant DNA Activities
Office of Science Policy
National Institutes of Health
6000 Executive Boulevard, Suite 302
Bethesda, MD 20892
The American Society for Microbiology (ASM) wishes to submit the following written comments in response to the Notice of Intent to Propose Amendments to the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules Regarding Enhanced Mechanisms for NIH Oversight of Recombinant DNA Activities, published in the July 8 Federal Register. The ASM is the largest single life science society in the world, with over 43,000 members, including scientists in academe, industry, clinical laboratories and government, who are experienced in molecular biology and genetics, environmental microbiology, microbial physiology, agricultural and industrial microbiology. The ASM membership includes many past members of the NIH Recombinant DNA Advisory Committee (RAC) as well as RAC past chairs.
In view of the pivotal role that the NIH Recombinant DNA Advisory Committee has played in the public and scientific debate over the safety of recombinant DNA and gene therapy, it is not surprising that the proposal to discontinue RAC is controversial. The RAC has earned a reputation for thoughtfulness, integrity, independence and scientific validity. For over twenty years it has been constituted to have the breadth of knowledge, experience and prestige necessary to deal effectively with issues raised by molecular genetics and its applications.
On the one hand, the elimination of the RAC is reassuring that there is now an adequate regulatory process in place to ensure the future safe development of research and applications of genetic engineering and gene therapy. Certainly, there is no need for duplication with gene therapy and approval processes by the Food and Drug Administration (FDA) and other agencies. On the other hand, however, the elimination of the RAC removes an historically important and time tested means of ensuring future progress and public scrutiny of recombinant DNA research. RAC activities have taken a careful approach to public participation and understanding, and RAC's sensitivity to public as well as scientific opinion has contributed to the confidence scientists who conduct genetic research and the lay public have in the NIH Guidelines, and in the RAC's capacity to modify the Guidelines as dictated by advances in knowledge. The RAC has greatly increased the visibility of how science contributes to the development of recombinant DNA technologies. In so doing, it has improved public confidence in ways that the normal regulatory review process does not. Since it was established to provide guidance rather than regulatory oversight, the RAC has been able to involve the most able and best qualified scientists and members of the laity in the continued review and development of the NIH Guidelines for Recombinant DNA Research. This is especially important because the Guidelines serve as a model for the rest of the world and, in some cases, the legal framework for biosafety related to recombinant DNA activities.
Questions and issues related to the emerging field of gene therapy and new techniques in molecular genetics will arise in the future. While it is true that ad hoc bodies can review individual cases, there will be a lack of continuity of action based on past experience needed for the forward thinking which has been characteristic of RAC. The RAC has traditionally directed its attention to areas of public concern and possible hazard, and has dealt with topics through an effective system of work groups. The open forum of the RAC, which has allowed for scientific and public input into proposed modifications of the Guidelines, has the highest credibility for decision-making of any government body. Care needs to be taken that such credibility is not jeopardized or lost. Retention of the RAC would be reassuring to both the public and scientific communities that recombinant DNA technologies will continue to develop in a manner that ensures careful scrutiny and the highest levels of quality and safety.