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Legislation and Regulation Keyed to Manning, 5th Ed.
United States v. Nova Scotia Food Products Corp.
Citation:
568 F.2d 240 (1977)Facts
Nova Scotia Food Products Corp. received frozen or iced whitefish in interstate commerce, which it processed by brining, smoking, and cooking before selling as smoked whitefish. The FDA promulgated regulations requiring that hot-process smoked fish be heated to specific temperatures (180°F for 30 minutes with 3.5% salt content or 150°F for 30 minutes with 5% salt content) to prevent the growth of Clostridium botulinum Type E bacteria, which can cause botulism. The regulations were developed following several cases of botulism traced to fish consumption in 1960 and 1963.
During the rulemaking process, Nova Scotia and industry representatives submitted comments arguing that the proposed requirements were not commercially feasible for whitefish and would destroy the product. They suggested that the FDA should establish specific parameters for different species of fish based on research and study. The FDA acknowledged that adequate parameters had not been demonstrated for each individual species but implemented uniform requirements for all species (except chub) without addressing the commercial feasibility concerns. Government inspections later revealed that Nova Scotia was not meeting the minimum T-T-S requirements, leading to the enforcement action. Nova Scotia defended on the grounds that the regulation was invalid because it exceeded statutory authority, relied on undisclosed scientific evidence, and lacked an adequate statement of basis.
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