Gene splicing: 'final' federal plan.

The latest White House proposal to involve itself in regulating genetic engineering in the United States was met this week with skepticism from scientists. Bernadine Healy of the President's Office of Science and Technology Policy (OSTP) presented the "final iteration" of a plan to coordinate biotechnology decisions of different federal agencies. She described the proposed mechanism to a meeting in Bethesda, Md., of the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC), the original, and most prestigious, group that sets policy on gene splicing. At that meeting the RAC also prepared itself to receive imminent proposals for human genetic engineering; the committee unanimously approved its document called "Points to consider in the design and submission of human somatic-cell gene therapy protocols."

The new White House proposal outlines a two-tiered system for consideration of genetic engineering. Each of the agencies that funds or regulates gene splicing work would maintain or set up its own scientific review mechanism, such as NIH's RAC. These groups would review the detailed applications submitted by researchers and commercial groups.

In a change from a previous OSTP proposal, the top tier of the system would include a new interagency committee under the auspices of OSTP's Federal Coordinating Council for Science, Engineering and Technology (FCCSET, pronounced "fix-it"). The committee would be composed of "high-level" administrators from each relevant agency: NIH, the National Science Foundation, the Food and Drug Administration (FDA), the Environmental Protection Agency and the Department of Agriculture.

The FCCSET committee would develop scientific policy to be used by all the agencies, Healy says. But it would not have any authority to force agencies to abide by its recommendations, nor would it decide jurisdictional disputes among the agencies. Its power would derive, Healy says, from "the clout of science, and science alone."

The RAC members expressed two objections to the proposal. First, they were concerned that public confidence would be undermined because the deliberations of the FCCSET committee would not be open to the public. Second, they felt little need for a higher advisory body. "This FCCSET might not have a lot to do," says Bernard Davis of Harvard Medical School.

One area where jurisdictional disputes are expected is human gene therapy. At the meeting the RAC approved its "Points to consider ...," which include a statement that the document applies only to work at institutions receiving NIH support for recombinant DNA research and a footnote that the FDA has jurisdiction over drug products to be used in clinical trials (SN: 8/31/85, p. 141). The first proposals will probably need approval by both the RAC and FDA. Bernard Talbot of NIH says, "The RAC is set to go."