## Facts

- The FDA issued a rule for hot-process smoked fish intended to prevent Type E botulism by prescribing uniform time-temperature-salinity (T-T-S) processing requirements.
- The rule required, among other options, a continuous internal temperature of at least 180°F for 30 minutes at 3.5% water-phase salt, or 150°F for 30 minutes at 5% water-phase salt.
- During notice-and-comment rulemaking, the Bureau of Commercial Fisheries objected that a uniform standard for all species was not commercially feasible and proposed an alternative using lower temperatures combined with nitrate and salt.
- Nova Scotia Food Products Corp., a processor of smoked whitefish, submitted comments asserting the required temperatures would destroy the product’s marketability.
- The FDA did not disclose the scientific studies and data it relied on to justify the specific T-T-S values and did not meaningfully address the feasibility objections or proposed alternative in the statement of basis and purpose.
- After inspections, the United States brought an enforcement action alleging Nova Scotia’s smoked whitefish, processed contrary to the T-T-S rule, was adulterated under the FDCA.
- A district court enjoined Nova Scotia and its officers from processing hot-smoked whitefish except in compliance with the T-T-S regulation; Nova Scotia and an industry intervenor appealed.

## Issues

1. Whether, under APA § 553, an agency must disclose the critical scientific materials underlying a proposed technical rule to permit meaningful public comment.
2. Whether APA § 553(c) requires an agency to respond to significant comments and proposed alternatives in its statement of basis and purpose.
3. Whether the FDA could enforce the T-T-S regulation through an FDCA adulteration injunction when the regulation was challenged as procedurally invalid in the enforcement action.

## Decision

- The Second Circuit vacated the injunction and held the T-T-S regulation unenforceable against Nova Scotia because it was not validly promulgated under APA § 553.
- The court concluded the FDA’s notice-and-comment process was deficient because the agency failed to make available the scientific basis for the rule during the comment period.
- The court also found the FDA failed to provide an adequate statement of basis and purpose because it did not answer significant feasibility objections or explain why it rejected a concrete alternative proposal.
- The court permitted regulated parties to raise APA procedural defects as a defense in an enforcement action seeking injunctive relief.

## Legal Principles

- For rules resting on complex scientific judgments, APA notice-and-comment requires disclosure of the critical factual and scientific materials relied upon so commenters can participate meaningfully.
- APA § 553(c)’s “concise general statement” must address significant comments and substantial objections and must explain the agency’s resolution of major issues raised in the proceeding.
- A conclusory or skeletal statement of basis and purpose may be inadequate where the rule has major economic impact and depends on technical determinations, because it prevents effective judicial review.
- In enforcement litigation premised on a regulation, defendants may challenge the regulation’s procedural validity under the APA; a procedurally defective rule cannot support an injunction.

## Conclusion

The Second Circuit set aside enforcement of the FDA’s smoked-fish T-T-S standard because the agency failed to disclose the scientific basis for the rule and failed to respond to significant comments and alternatives, rendering the rule procedurally invalid under APA § 553 and insufficient to support an FDCA injunction.


United States v. Nova Scotia Food Prods. Corp., 568 F.2d 240 (2d Cir. 1977)