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Administrative Law Keyed to Breyer
United States v. Nova Scotia Food Products Corp.
Citation:
568 F.2d 240 (1977)Facts
The FDA promulgated regulations requiring that hot-process smoked fish be heated to specific temperatures (180°F or 150°F) for a minimum of 30 minutes, depending on salt concentration. These regulations aimed to prevent botulism caused by Clostridium botulinum Type E bacteria. Nova Scotia Food Products Corp. processed whitefish by brining, smoking, and cooking, but failed to meet the FDA’s requirements. The company argued that compliance would destroy the commercial viability of their product. During the rulemaking process, Nova Scotia and others submitted comments arguing that the regulations were not commercially feasible and that parameters should be established on a species-by-species basis. The FDA did not disclose the scientific data upon which it relied to interested parties during the rulemaking process. In its final rule, the FDA acknowledged that adequate parameters had not been demonstrated for each individual species but concluded that the proposed requirements were the safest known to prevent botulism. After several inspections and warnings, the government sought and obtained an injunction against Nova Scotia.
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