## Facts

- The National Institutes of Health (NIH), within the Department of Health and Human Services, regulated and approved certain recombinant DNA research under NIH guidelines.
- The Regents of the University of California proposed a field experiment involving the deliberate environmental release of genetically engineered bacteria.
- NIH approved the proposed field test after internal review and issuance of an environmental assessment (EA).
- The Foundation on Economic Trends (FOET) and related plaintiffs opposed the experiment, alleging environmental and health risks from the release.
- Plaintiffs sued to block the approval, alleging NIH violated the National Environmental Policy Act (NEPA) by approving the experiment without an adequate EA and without preparing an environmental impact statement (EIS) if required.
- The district court ruled for plaintiffs, invalidated NIH’s approval, and enjoined the experiment pending NEPA compliance; NIH and the Regents appealed.

## Issues

1. Whether FOET and associated plaintiffs had Article III standing to challenge NIH’s approval under NEPA.
2. Whether NIH’s approval of the field test constituted final agency action reviewable under the Administrative Procedure Act (APA).
3. Whether NIH complied with NEPA by taking a sufficient “hard look” at environmental consequences through its EA, and whether an EIS was required.

## Decision

- The court held plaintiffs had standing to enforce NEPA’s procedural protections tied to alleged environmental and health harms from the proposed release.
- The court held NIH’s approval was final, reviewable agency action because it consummated the agency’s decisionmaking and authorized the experiment to proceed.
- The court held NIH’s EA was inadequate under NEPA because it did not meaningfully analyze possible environmental consequences of the proposed action.
- The court affirmed the district court’s judgment invalidating the approval and requiring adequate NEPA review before the experiment could proceed.

## Legal Principles

- NEPA applies to agency approvals involving emerging scientific research; novelty or technical complexity does not exempt federal decisionmaking from environmental review.
- A plaintiff may establish standing in a NEPA case by alleging concrete environmental interests and seeking enforcement of procedural rights intended to protect those interests, including where the threatened harm is probabilistic.
- Agency authorization that permits a project to proceed after completion of internal review constitutes final agency action subject to APA review for NEPA compliance.
- An EA must contain sufficient analysis of potential environmental effects to support a reasoned determination whether an EIS is necessary; conclusory statements of no significant impact are insufficient.
- NEPA’s “hard look” requirement demands identification and evaluation of relevant environmental risks and an explanation that permits judicial review, including consideration of uncertainty where risks may be unknown but potentially serious.

## Conclusion

The court required NIH to comply with NEPA before authorizing a field release of genetically engineered organisms, holding that NIH’s approval was final and reviewable and that its environmental assessment was legally insufficient because it failed to analyze potential environmental consequences.


Found. on Econ. Trends v. Heckler, 756 F.2d 143 (D.C. Cir. 1985)