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Administrative Law Keyed to Mawshaw
United States v. Nova Scotia Food Products Corp.
Citation:
568 F.2d 240 (1977)Facts
In 1969, the FDA proposed regulations to control Clostridium botulinum Type E bacteria in smoked fish following several botulism cases in the early 1960s. The final regulations required that hot-process smoked fish be heated to at least 180°F for 30 minutes with 3.5% salt content, or alternatively, 150°F for 30 minutes with 5% salt content. Nova Scotia and other industry members submitted comments arguing that these requirements would destroy the commercial viability of whitefish products and suggesting that species-specific standards should be developed instead. The FDA acknowledged that “adequate times, temperatures and salt concentrations have not been demonstrated for each individual species of fish” but implemented the regulations anyway, stating they were “the safest now known.” The FDA did not disclose the scientific data it relied upon to interested parties during the rulemaking process. When Nova Scotia failed to comply with the regulations, the government sought and obtained an injunction. Nova Scotia appealed, arguing the regulations were beyond statutory authority, procedurally defective, and not supported by the administrative record. The historical record showed that between 1899 and 1964, only eight cases of botulism were attributed to hot-smoked whitefish, all involving vacuum-packed products (a practice the industry had abandoned), and no cases had been reported since 1963.
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