United States v. Nova Scotia Food Products Corp.
United States Court of Appeals for the Second Circuit
568 F.2d 240 (1977)
The FDA adopted time-temperature-salinity (T-T-S) requirements for hot-smoked fish after botulism outbreaks, without disclosing the underlying scientific data, and without responding to industry and government agency comments arguing the T-T-S rule would render certain fish species commercially unprocessable and suggesting an alternative brining method instead. Nova Scotia Food Products Corporation (defendant), later found violating the T-T-S requirements while processing whitefish, was sued by the government for injunctive relief; the district court granted the injunction, and Nova Scotia appealed.
Whether an agency promulgating a rule through informal notice-and-comment rulemaking must provide a concise general statement identifying the major policy issues considered and the agency's rationale for addressing them.