## Facts

- Public-interest organizations and individuals sued federal health officials to stop NIH support for certain genetic, AIDS, and cancer research until NIH prepared a new or supplemental Environmental Impact Statement (EIS) under NEPA.
- NIH had issued recombinant DNA (rDNA) safety guidelines in 1976 and completed an EIS in 1977 evaluating environmental consequences of research conducted under those guidelines.
- After 1977, NIH periodically modified (generally relaxed) the rDNA guidelines based on accumulated experience, continued oversight, and scientific developments.
- Plaintiffs argued that NIH-funded research had changed in ways not adequately analyzed in 1977, triggering NEPA’s duty to supplement, particularly regarding:
  - use of oncogenic viral material in *E. coli*;
  - genetic engineering work involving HIV in new host cells; and
  - engineering AIDS-related agents in mice.
- NIH maintained that these activities posed no materially greater environmental risk than research already assessed, and that risks were controlled through guideline-based containment and review procedures.
- Defendants moved for summary judgment.

## Issues

1. Whether NIH’s post-1977 guideline changes and approvals of the challenged research constituted substantial changes or major federal actions requiring a supplemental EIS under NEPA.
2. Whether significant new circumstances or information relevant to environmental concerns arose after the 1977 EIS, requiring supplementation.
3. Whether NIH’s decision not to prepare a supplemental EIS was arbitrary or capricious under the APA.

## Decision

- The court granted defendants’ motion for summary judgment.
- The court denied injunctive relief to halt NIH-supported research pending preparation of a supplemental EIS.
- The court held NIH did not violate NEPA by declining to supplement the 1977 EIS.
- The court held NIH’s no-supplement decision was not arbitrary or capricious, given the existing EIS, the guideline framework, and the administrative record of review.

## Legal Principles

- NEPA is primarily procedural; courts review whether the agency took a “hard look” at environmental consequences rather than selecting environmental outcomes.
- An agency must supplement an EIS when it makes substantial changes relevant to environmental concerns, or when significant new circumstances or information arise that bear on impacts.
- Under the APA, a court generally defers to reasonable agency judgments, particularly on technical scientific matters, when supported by an administrative record and reasoned explanation.
- NEPA does not require a new or supplemental EIS for each new experiment or technique if the activity remains within the scope of prior analysis and risk controls.

## Conclusion

The court upheld NIH’s determination that the challenged biotechnology research and related guideline modifications did not present substantial changes or significant new information requiring a supplemental EIS, and it deferred to NIH’s technical judgments and ongoing oversight as satisfying NEPA’s procedural demands.


Found. on Econ. Trends v. Bowen, 722 F. Supp. 787 (D.D.C. 1989)