ELR Citation: ELR 20248
No(s). s. 84-5314, -5419 (D.C. Cir. Feb 27, 1985)

The court rules that the National Institutes of Health (NIH) did not adequately assess whether to prepare an environmental impact statement (EIS) under the National Environmental Policy Act (NEPA) before approving an experimental deliberate release of genetically engineered, recombinant-DNA-containing organisms. The court reviews NIH's decision not to prepare an EIS to see if the decision accords with the norms of reasoned decisionmaking and if the agency has taken a hard look at environmental consequences. The court first holds that the environmental review that NIH gave the proposed project was not sufficiently thorough to support a decision not to perform an EIS. NIH completely failed to address a major environmental concern, that of dispersion of the organisms beyond the release area. The Director's final approval of the project is merely a bald conclusion that the project will have no impact and is not self-supporting. Also, NIH's various evaluations of the project never directly addressed what should be the central question of an environmental assessment under NEPA—whether an EIS is necessary. Unless NIH can show in its assessment why dispersion is not a serious concern, the facts would seem to weigh heavily in favor of preparing an EIS.

Turning to procedural questions, the court first holds that the trial court had the power to enjoin the experimenters even though they are not part of a federal agency. NEPA extends to private parties where their activity requires federal approval to be lawful, and federal approval in violation of NEPA cannot discharge the experimenters' obligation to obtain valid approval. Second, the district court did not abuse its discretion in not invoking the doctrine of exhaustion of administrative remedies, since the question was of great public importance and there was no real unfairness to the defendants. The suggestion that failure to comment in response to a Federal Register notice should bar subsequent judicial review is repugnant to the public participation purposes of a statute like NEPA. Third, the district court neither improperly limited its review of the administrative record nor shifted the burden of proof onto the agency. And fourth, the court's balancing of injunction criteria, including the weight it gave to the harm of not complying with NEPA, was not an abuse of discretion.

The circuit court disagrees with the district court's conclusions that plaintiffs are likely to succeed in proving that NIH must complete EISs covering its 1978 experimentation Guidelines revisions and its program for reviewing deliberate releases. The 1978 revisions did not irrevocably commit NIH to any decision; also, at the time, no deliberate release was imminent. As for the need for a programmatic EIS, the circuit court holds that, on the record before it, it cannot conclude that plaintiffs are likely to prove that the absence of such an EIS unreasonably obstructs NIH's environmental review. However, given the stream of applications NIH is likely to soon face, the court notes that it would be unreasonable for NIH not to formally consider whether to prepare a programmatic EIS.

A concurring opinion states that plaintiffs should have exhausted administrative remedies first; however, since the majority is effectively remanding the controversy to NIH anyway, the judge declines to dissent.

[The opinion of the district court appears at 14 ELR 20467.]

Counsel for Appellants
J. Carol Williams
Land and Natural Resources Division
Department of Justice, Washington DC 20530
(202) 633-2757

William A. Anderson III
Bracewell & Peterson
1825 I St. NW, Washington DC 20006
(202) 828-5800

Counsel for Appellees
Edward Lee Rogers
1718 P St. NW, Washington DC 20036
(202) 387-1600

Before WRIGHT and MIKVA, Circuit Judges, and MacKINNON, Senior Circuit Judge.