J. Skelly Wright

“ To reiterate, NIH must first complete a far more adequate environmental assessment of the possible environmental impact of the deliberate release experiment than it has yet undertaken. That assessment must "provide sufficient evidence and analysis for determining whether to prepare an environmental impact statement or a finding of no significant impact," 40 C.F.R. § 1508.9 (a) (1) . Ignoring possible environmental consequences will not suffice. Nor will a mere conclusory statement that the number of recombinant-DNA-containing organisms will be small and subject to processes limiting survival. ”

“ 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:
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. ”

“ The ultimate goal was to protect the crops from frost and thus to extend their growing season. Such non-frost-triggering bacteria occur in nature as products of natural mutation, but Lindow and Panopoulos apparently hoped that the genetically engineered organisms would be more stable than the natural mutants. They sought to treat crops at six sites; the workers applying the recombinant-DNA-containing bacteria would wear respirators to reduce the risk of inhalation. ”

“ Recombinant DNA technology has been limited primarily to small organisms, usually bacteria. This production of new bacteria through altering genetic material has been confined to the laboratory; organisms with recombinant DNA have never been released into the general environment. ”

“ An environmental assessment that fails to address a significant environmental concern can hardly be deemed adequate for a reasoned determination that an EIS is not appropriate. See Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 553, 98 S.C.t. 1197, 1216, 55 L. Ed. 2d 460 (1978) ("NEPA places upon an agency the obligation to consider every significant aspect of the environmental impact of a proposed action") . ”

“ Broad claims are made about both the potential benefits and the potential hazards of genetically engineered organisms. Use of recombinant DNA may lead to welcome advances in such areas as food production and disease control. ”

“ NEPA thus stands as landmark legislation, requiring federal agencies to consider the environmental effects of major federal actions, empowering the public to scrutinize this consideration, and revealing a special concern about the environmental effects of new technology. ”

“ In short, we vacate the part of the injunction enjoining NIH approval of all deliberate release experiments, but we stress that NIH's attention to important issues regarding deliberate release experiments will continue to influence whether its individual decisions may be found to reflect the "rule of reason," Committee for Auto Responsibility v. Solomon, supra, 603 F.2d at 1003, that measures the adequacy of environmental review. ”

“ We thus conclude that, if NIH does not at least consider the advisability of a programmatic EIS, its approval of individual deliberate release experiments is likely to violate established principles of reasoned decisionmaking. See State Farm, supra, 104 S.C.t. at 2867 (agency may not "entirely fail [] to consider an important aspect of the problem") . And, unlike NIH's completely conclusory statement that it would not prepare a programmatic EIS, 49 Fed. ”

“ Neither the government nor the University seriously disputes that an environmental assessment is necessary. The government has conceded that the approval is a "major action" and that it does not fall into a categorical exclusion to the EIS requirements, Federal Defendants' Response to Plaintiffs' Second Set of Interrogatories at 17, JA 50 ”