Opinion ID: 448992
Heading Depth: 2
Heading Rank: 3

Heading: Federal Oversight of Genetic Engineering

Text: 14 Spurred by scientists involved in genetic research, NIH began efforts to oversee genetic engineering in the mid-1970's. Federal oversight of deliberate release experiments falls into four periods: (1) NIH's 1976 standards, which prohibited deliberate release of organisms containing recombinant DNA; (2) NIH's 1978 revision, which gave the NIH Director power to approve deliberate release experiments; (3) the NIH Director's approval of three such experiments in the early 1980's; and (4) the District Court's injunction prohibiting the University of California experiment and enjoining NIH approval of all other deliberate release experiments. 2 15 1. NIH's 1976 standards: prohibition on deliberate release. In 1976 the NIH Director issued Guidelines for Research on Recombinant DNA Molecules. 41 Fed.Reg. at 27902, JA 230. The Guidelines were an historic development, representing the first major federal effort to oversee genetic research and the culmination of intense scientific attention to the possible hazards of genetic research. 16 In 1974 scientists working in genetic research voluntarily called for a moratorium on certain kinds of experiments until an international meeting could be convened to consider the potential hazards of recombinant DNA molecules. Id. On October 7, 1974 NIH established the Recombinant DNA Advisory Committee (RAC) to consider genetic research issues. And in February 1975 NIH, the National Science Foundation, and the National Academy of Sciences sponsored an international conference at the Asilomar Conference Center in Pacific Grove, California to review the questions posed by the possibility of genetic engineering. 17 Finally, in the summer of 1976 the NIH Director announced the Guidelines that would govern NIH-supported genetic research experiments. In broad terms, the Guidelines permitted certain laboratory experiments to go forward under carefully specified conditions; certain other types of experiments were flatly prohibited. Deliberate release--[d]eliberate release into the environment of any organism containing a recombinant DNA molecule--was one of five categories explicitly banned. 41 Fed.Reg. at 27915, JA 243. In announcing the Guidelines the Director noted that deliberate release of organisms with recombinant DNA was not yet feasible and that, if it became feasible, the ban could be reconsidered. Id. at 27907, JA 235. But he stressed that, if such reconsideration occurred, environmental concerns should be paramount: It is most important that the potential environmental impact of the release be considered. Id. 18 Significantly, NIH prepared an EIS to accompany its Guidelines, JA 244--the only EIS NIH has ever completed on the subject of genetic engineering. The EIS did not specifically refer to deliberate release experiments; such experiments were banned. The EIS did, however, note that dispersion of organisms with recombinant DNA molecules loomed as a potential environmental hazard from the permitted experiments: 19 Should organisms containing recombined DNA be dispersed into the environment, they might, depending on their fitness relative to naturally occuring [sic] organisms, find a suitable ecological niche for their own reproduction. A potentially dangerous organism might then multiply and spread. Subsequent cessation of experiments would not stop the diffusion of the hazardous agent. 20 JA 357. 21 Thus in 1976 the NIH Guidelines prohibited deliberate release; the Director emphasized the importance of full environmental consideration of any possible future release; and the EIS identified dispersion of organisms with recombinant DNA as a possible environmental hazard. 22 2. The 1978 revision: permission to waive the prohibition against deliberate release. In 1978 the NIH Director undertook an effort to revise the Guidelines in light of NIH's experience operating under them and in light of [NIH's] increasing knowledge about the potential risks and benefits of this research technique. 43 Fed.Reg. 33042 (July 28, 1978), JA 433. Proposed in July and adopted in December, the revision changed the Guidelines in several respects. Most importantly for this appeal, the 1978 revision allowed the NIH Director authority to grant exceptions to the five absolute prohibitions in the Guidelines--including the prohibition on deliberate release of organisms containing recombinant DNA into the environment. 43 Fed.Reg. 60108 (December 22, 1978), JA 478. 23 NIH announced that the standard governing the use of this waiver authority would be the standard generally applicable to the Director's exercise of his duties: [T]he Director shall weigh each proposed action, through appropriate analysis and consultation, to determine that it complies with the Guidelines and presents no significant risk to health or the environment. Id. at 60126, JA 496. NIH also declared that the Director would exercise his authority with the advice of the Recombinant DNA Advisory Committee after appropriate notice and opportunity for public comment. Id. at 60108, JA 478. The Director further stated that his waiver decisions [would] include a careful consideration of the potential environmental impact, and certain decisions may be accompanied by a formal assessment or statement. This must be determined on a case-by-case basis. 43 Fed.Reg. at 33051, JA 442. 24 On the subject of deliberate release experiments in particular, the Director suggested that clear standards might be necessary to guide his waiver discretion: Recognizing the need expressed by    commentators for more definitive standards [to govern deliberate release waiver decisions], I will refer the matter to the Recombinant Advisory Committee (RAC) for its consideration.    [T]he RAC will be asked to address conditions under which exceptions to various prohibited categories of experiments may be granted. 43 Fed.Reg. at 60083, JA 471. Thus the Director perceived a possible need for more definitive standards and suggested that such standards might be forthcoming. 25 NIH did not prepare an EIS to accompany its 1978 revision. It prepared two Environmental Assessments--one for the revision as proposed, 43 Fed.Reg. at 33111, JA 467, and one for the revision as adopted, 43 Fed.Reg. at 60101, JA 471. The assessments said little about the Director's new waiver authority for deliberate release experiments. The first simply declared, Waiver decisions will include a careful consideration of potential environmental impact, 43 Fed.Reg. at 33111, JA 466; the second did not mention the waiver authority. 26 The 1978 revision also extended the coverage of the Guidelines to all experiments at institutions receiving NIH funds for recombinant DNA research, whether or not the particular experiment had received NIH funds. 43 Fed.Reg. at 60123, JA 493. 27 3. Approval of deliberate release experiments. The 1978 revision was the last significant revision of NIH's guidelines regarding deliberate release experiments. A 1982 revision was largely semantic, 47 Fed.Reg. 17186-17187 (April 21, 1982), JA 503-504; a 1983 revision establishing slightly different procedures for deliberate release involving certain plants, 48 Fed.Reg. 24580 (June 1, 1983), is not part of this appeal. The more definitive standards suggested by the Director never emerged. 28 Although the guidelines have not changed, NIH's role has begun to change dramatically. For, with the maturation of genetic engineering technology, NIH has been faced with applications for approval of deliberate release experiments. 29 The NIH Director, acting on the advice of RAC, has approved three deliberate release experiments at institutions receiving NIH funds for recombinant DNA research. On August 7, 1981 the Director approved a request by Dr. Ronald Davis of Stanford University to field-test corn plants containing recombinant DNA molecules. 46 Fed.Reg. 40331 (August 7, 1981). The goal was to increase the corn's dietary value by improving its ability to store protein. However, the field tests were never conducted because feasibility problems developed. Genetic Engineering Report at 17, JA 171. 30 On April 15, 1983 the Director approved a request by Dr. John Sanford of Cornell University to field-test tomato and tobacco plants with recombinant DNA. 48 Fed.Reg. 16459 (April 15, 1983). The goal was to prove that pollen could serve as a vector for insertion of recombinant DNA. Again, however, due to feasibility problems, the experiment never went forward. Genetic Engineering Report at 17, JA 171. 31 On June 1, 1983 the Director gave final approval to the experiment at issue on appeal--the request by Drs. Nickolas Panopoulos and Steven Lindow of the University of California at Berkeley to apply genetically altered bacteria to plots of potatoes, tomatoes, and beans in northern California. 48 Fed.Reg. 24549 (June 1, 1983), JA 522. As discussed in greater detail below, the goal was to increase the crops' frost resistance. Because of the cancellation of the previous two experiments, the Panopoulos-Lindow experiment would be the first NIH-approved deliberate release experiment actually to be conducted. 3 32 In February 1984 a congressional subcommittee report sharply criticized NIH's method of reviewing deliberate release experiments. The report concluded that the current regulatory framework does not guarantee that adequate consideration will be given to the potential environmental effects of a deliberate release. Genetic Engineering Report at 10, JA 168. In particular, the RAC's ability to adequately evaluate the environmental hazards posed by deliberate releases is limited by both its expertise and its jurisdiction. Id. The subcommittee report recommended a moratorium on deliberate release approvals until an interagency review panel was established to consider the potential environmental effects of each deliberate release experiment. Each [deliberate release experiment] could result in major environmental damage or adverse public health effects. Id. at 43-44, JA 176-177. 4 33 4. The injunction. In September 1983 three public interest organizations and two individuals filed suit against the three federal officials ultimately responsible for NIH deliberate release decisions; they later added Regents of the University of California as a defendant. The University of California experiment was scheduled to begin on or about May 25, 1984. On May 18 the District Court issued an injunction enjoining the University of California experiment and NIH approval of other deliberate release experiments. The District Court found that plaintiffs were likely to succeed in showing that NIH should have completed at least a more complete environmental assessment, and perhaps an EIS, before approving the University of California experiment; it also found them likely to succeed in showing that NIH should have completed an Environmental Impact Statement in connection with both its 1978 policy change and its imminent program of deliberate release approvals. 5 34 Both the federal defendants and the University of California Regents have filed appeals; the appeals were consolidated and the case heard by this court on an expedited basis.