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Foundation on Economic Trends v. Heckler

ELR Citation: 14 ELR 20467
Nos. No. 83-2714, 587 F. Supp. 753/21 ERC 1829/(D.D.C., 05/16/1984)

The court rules that the National Institutes of Health (NIH) amended its regulations to allow approval of releases of recombinant deoxyribonucleic acid (DNA), embarked on an ad hoc program of approving such releases, and approved a specific release by the University of California, all without undertaking the environmental review required by the National Environmental Policy Act (NEPA). In reviewing NIH's decisions not to prepare environmental impact statements (EISs), the court applies a rule of reason, inquiring whether the agency took a hard look at environmental problems, identified areas of concern, and made convincing findings of no significant impact or acted so as to reduce impacts to a minimum.

The court first considers NIH's 1978 amendment of its guidelines controlling federally supported recombinant DNA research. Because NEPA requires the environmental analysis to be collected into a single document, the court limits its review to examination of the environmental assessments accompanying the guideline amendments. It is uncontested that the amendments, which for the first time allowed NIH to approve deliberate releases of recombinant DNA, were a major federal action. The court holds that the sparse discussion of environmental issues associated with releases would not satisfy NEPA if releases would have significant environmental impact. NIH did not make a finding concerning significance of potential environmental impacts, but suggested it would develop standards for allowing releases and decide environmental significance on a case-by-case basis. Without deciding whether releases could have significant impact, the court holds that the record suggests that plaintiffs will prevail on their claim of a violation of NEPA's hard look requirement.

The court then holds that plaintiffs are likely to prevail on their claim that NIH should have prepared a programmatic EIS on its release approvals. The court agrees with NIH that in 1978 when the guidelines were amended, there was no program for approving releases. Since then, NIH has approved three releases and undoubtedly will receive requests for others. The court holds that while there is no rigid test for determining when a programmatic EIS is required, NIH's role in controlling releases now is sufficiently well-defined as to benefit from and require a progammatic EIS.

The court rejects NIH's defense of laches, finding neither unreasonable delay by plaintiffs nor prejudice to the defendants. The court also rejects NIH's argument that its actions were functionally equivalent to a NEPA inquiry. NIH as an agency is probably not "engaged primarily in an examination of environmental questions," and its "substantive and procedural standards" do not "ensure full and adequate consideration of environmental issues." Substantive standards are nonexistent. Procedurally, NIH does consult with a Recombinant DNA Advisory Committee, but the committee guidance is not environmentally focused or recorded in an environmental document, and the committee might not provide the interdisciplinary perspective required by NEPA. In short,NIH review does not satisfy the aims of NEPA. The court agrees with NIH, however, that NEPA does not apply to the nonbinding review that NIH offers as a service to private researchers not under NIH's regulatory authority.

The court holds that plaintiffs probably will prevail on their claim that NIH's NEPA review for approval of a specific release by the University of California was inadequate. NIH's finding of no gignificant impact was based on an informal environmental review, not the careful, written document that NEPA requires. Also, the review apparently failed to consider several areas of environmental concern. The court rejects the defense of laches; holds that the Environmental Protection Agency's potential jurisdiction over the experiment under the Federal Insecticide, Fungicide, and Rodenticide Act is immaterial and would not provide the functional equivalent of NEPA compliance; and holds that plaintiffs' failure to seek relief from NIH prior to its approval of the experiment is no bar to this suit.

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

Counsel for Defendants
Judith Bartnoff, Ass't U.S. Attorney
2800 U.S. Cthse., 3d & Constitution Ave. NW, Washington DC 20001
(202) 633-4953

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