GOVERNMENT
House Panel Attempts To Unravel Confusion in Biotech Regulations Science & Technology panel recommends retaining current laws but urges more research to fill information gaps, clearer definitions of terms David J. Hanson, C&EN Washington
In its first major report on biotechnology in nearly two years, the House Science & Technology Subcommittee on Investigations & Oversight has tried to sort through the happenings of the past year and determine what has been accomplished. It has been a significant period, during which several events have occurred that will shape the future for biotechnology in the U.S. Among them are the creation of a coordinated biotechnology regulatory framework within the government and the highly contentious "release" of two biotechnology products into the environment. There appears to be an overall theme of confusion running through the detailed descriptions of regulatory problems and Congressional hearings that make up most of the report. Industrial developers of biotechnology are confused over what the government will require for commercial use of a product; government regulators don't seem to be able to make it clear where their authority or responsibility lies; and Congress is having trouble getting a handle on the fine distinctions separating the various forms of biotechnology. Central to the issue has been the Administration's attempt at regulation. This is embodied in the framework for biotechnology regulations, which tries to use current laws to regulate the different uses of bio-
Bedell: a terrible deficiency technology. First proposed in December 1984, and revised in June 1986, this framework draws together the sundry responsibilities of the Environmental Protection Agency, Food & Drug Administration, Department of Agriculture, and National Institutes of Health to regulate research and commercialization of biotechnology. By applying different laws to the diverse expected products of genetic engineering and other recombinant DNA methods, the Administration believes it can cover most, if not all, situations. But clarity in the system is coming slowly. Two incidents in the past year caused some anguish as researchers butted heads with the regulators over what can and cannot be done. In the first incident, Advanced Genetic Sciences Inc., a California biotechnology company trying to commercialize bacteria that would slow frost formation on certain plants, ran afoul of EPA regulations by testing the plant pathogenicity of the genetically engi-
neered bacteria by injection into tree limbs. EPA requirements are that any experiment with genetically altered bacteria must be done without release of the bacteria into the environment. AGS injected its product into trees on the roof of its building, open to the air. Scientists at the company believed that this test, which was monitored (although there is some disagreement as to how well), did not constitute a release because the bacteria were confined to the trees. EPA disagreed and told AGS to stop work until the situation could be straightened out. The second incident also involved the question of what constitutes a release. In this instance, a Baylor college of medicine researcher developed a vaccine for swine pseudorabies using recombinant DNA techniques and tested it on an experimental animal farm. In this case the scientist believed that the technique used (deletion of a single gene) did not fall under the regulations as set up, and, additionally, that injection of vaccines into animals was not considered by USDA to be a release into the environment. NIH, which apparently funded a small part of the work, reviewed the case and concluded that the researcher had overreached in his assumptions and should have obtained permission to do the test. In the meantime, of course, other legitimate proposals for doing recombinant DNA field experiments have been delayed as each of these "releases" are examined in detail. EPA has not approved a field test of a pesticide-like bacteria even though its special scientific review panel said that it was probably safe under the proposed conditions. A primary reason for the delay could well be the agency's concern about adverse public and Congressional reaction December 1, 1986 C&EN
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Government to any release of genetically altered bacteria, despite the evidence of safety. The upshot of these incidents is that Congress, in particular, has become suspicious of the regulatory agencies' ability to adequately monitor the growing use of genetic engineering. At hearings held over the past year on the formation of the coordinated framework of federal regulations, the AGS experiment, and the pseudorabies vaccine, Administration officials were repeatedly asked if they could do the job. Harold L. Volkmer (D.-Mo.), chairman of the Subcommittee on Investigations & Oversight, for instance, questioned EPA assistant administrator for pesticides and toxic substances John A. Moore on the Toxic Substances Control Act. U n d e r TSCA, Volkmer asked, "If EPA allows the release of an intergeneric pathogen on 1 acre of land, the organism goes into the TSCA inventory and anyone can release it anywhere?" Moore replied: "Unless some restriction is made when we put it in the inventory, once it is on the inventory, it is totally unrestricted." Volkmer wondered if such apparent gaps in the ability to regulate releases were appropriate. Volkmer was equally concerned about practices at USDA. In the case of the swine vaccine, Alan Tracy, acting assistant secretary for marketing and inspection services, was taken to task for USDA's trusting that scientists would get all the proper approvals before testing a biotechnology-produced organism. "Don't you require proof that [researchers] have followed the g u i d e l i n e s ? " Volkmer asked. The answer was essentially no. Tracy also said USDA had no statutory authority to regulate intrastate shipments of a recombinant DNA-produced vaccine. Volkmer replied, "It's amusing to me that EPA can tell AGS that they [AGS] can't do what they did in California, but you can't do anything [in this case] when it's all in Texas . . . until we pass a law saying you can." Another Congressman nonplussed by this situation was Berkley Bedell (D.-Iowa). Under the Virus Serum Toxin Act, which is supposed to regulate vaccines, Bedell had trouble 20
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believing that USDA did not have the power to make a scientist comply with the NIH guidelines for recombinant DNA research when doing research toward licensing a vaccine product. When this was confirmed by Tracy, Bedell commented: "If that is the case, I think this is a terrible deficiency." From testimony presented at several hearings, the subcommittee has distilled some of the recurring problems and has made recommendations that might help bring some order to the confusion. One major obstacle in the government's oversight, it finds, is the lack of ways to assess accurately potential risks of altered organisms in the environment. The subcommittee would like to see the Biotechnology Science Coordinating Committee (BSCC)—the oversight group formed under the coordinated framework—set up research priorities to fill in the information gaps in this area. Science funding agencies should cooperate in this regard and expand appropriate research efforts. BSCC also could help by publishing and distributing research results so the individual agencies' biotechnology committees would have the data at hand. BSCC must make sure that such key terms as "release into the environment," "contained facility," and "intergeneric organisms" are unambiguously defined, because inconsistencies have hampered progress in research and testing up to this point. It also should consider imposing user fees on biotechnology companies because of the fiscal burden being put on the regulatory agencies to review recombinant DNA projects. Although BSCC has not considered this up to now, there is concern that smaller companies might lose competitiveness if user fees were required. At the individual agencies, the subcommittee sees the need for consistency and clarity. It recommends that USDA better coordinate the activities of the science and education division and its marketing and inspection division so that products such as the pseudorabies vaccine do not slip through the cracks. This could be accomplished by working through the department's Agricul-
Volkmer:gaps in ability to regulate tural Recombinant DNA Research Committee, or some other future central committee within USDA. EPA has boldly stepped forward with its regulations under TSCA and the pesticide laws, but the subcommittee recommends that EPA promulgate new regulations defining significant new uses for organisms, removing the premanufacture notification exemption for research and development activities, imposing reporting requirements for certain field experiments, and redefining "small business." The report does not recommend new legislation from Congress to control biotechnology research and application. Two bills introduced in the 99th Congress, one by Sen. David Durenberger (R.-Minn.) and one by Rep. Don Fuqua (D.-Fla.), gained very little support last year, and Congress still doesn't seem very interested in the idea. The general feeling seems to be that BSCC should be allowed to try its program for a while and see if it works. If new problems arise, such as happened with recent releases of recombinant DNA organisms in Argentina and New Zealand, Congress' interest may solidify. But, barring a serious problem from a release in the U.S., either approved or unapproved, it seems that the current government regulations are going to be used to regulate these new products for some time to come. G
