## Facts

- The FDA Commissioner issued an amendment to the FDA’s NEPA regulations, 21 C.F.R. § 6.1(a)(3), addressing how the agency would account for environmental considerations in regulatory decisions.
- Environmental Defense Fund, Inc. (EDF), a nonprofit organization, challenged the amendment as unlawfully limiting the FDA’s obligations under the National Environmental Policy Act (NEPA).
- EDF asserted standing based on its members’ direct interests in FDA-regulated products and the effects of FDA decision-making standards on those members.
- EDF initially sought review in the D.C. Circuit, which dismissed for lack of appellate jurisdiction; EDF then filed suit in the U.S. District Court for the District of Columbia.
- The case was presented on cross-motions for summary judgment seeking declaratory and injunctive relief.
- The challenged rule stated, in substance, that FDA would not act solely on environmental considerations and would confine its decision-making to authority conferred by its organic statutes.

## Issues

1. Whether the FDA’s regulation limiting the role of environmental considerations in FDA decisions is consistent with NEPA’s requirement that agencies consider environmental values “to the fullest extent possible.”
2. Whether an agency may, by regulation, treat NEPA as non-operative in the exercise of its statutory powers by asserting that NEPA does not affect the agency’s substantive authority under its organic statutes.

## Decision

- The court granted EDF’s motion for summary judgment and denied defendants’ motion.
- The court held that 21 C.F.R. § 6.1(a)(3) conflicted with NEPA and was invalid.
- The court granted declaratory and injunctive relief barring enforcement of the challenged regulatory limitation.

## Legal Principles

- NEPA imposes a government-wide obligation requiring federal agencies to integrate environmental considerations into decision-making “to the fullest extent possible.”
- NEPA does not supersede an agency’s other statutory duties; it supplements them by requiring environmental values to be incorporated when the agency exercises existing statutory discretion.
- An agency may not adopt regulations that effectively prevent NEPA from meaningfully influencing substantive decisions where the organic statute leaves room for choice or balancing.
- NEPA procedures are not merely formalities; their outputs must be considered in the agency’s substantive weighing of relevant factors.

## Conclusion

The district court invalidated the FDA’s regulation because it unlawfully narrowed NEPA’s effect on FDA decision-making, holding that NEPA supplements an agency’s organic statutes and requires environmental considerations to be integrated into agency actions to the fullest extent possible where discretion exists.


Environmental Defense Fund, Inc. v. Mathews, 410 F. Supp. 336 (D.D.C. 1976)