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Administrative Law Keyed to Aman
United States v. Nova Scotia Food Products Corp.
Citation:
568 F.2d 240 (1977)Facts
The Food and Drug Administration, responding to several cases of botulism traced to smoked fish in the early 1960s, issued regulations requiring that hot-process smoked fish be heated to specific minimum temperatures for specified periods depending on salt content. These regulations were designed to destroy Clostridium botulinum Type E spores that can cause botulism. Nova Scotia Food Products Corp., which had been processing smoked whitefish for 56 years without any cases of botulism, argued that the regulations would make their product commercially unmarketable. During the rulemaking process, Nova Scotia and others in the industry submitted comments arguing that the proposed temperature requirements would destroy the product and suggesting that specific processing parameters should be established for each species of fish. The Bureau of Commercial Fisheries also suggested that lower temperatures combined with nitrite and salt additives could safely prevent botulism. The FDA acknowledged these concerns but adopted the regulations anyway, without disclosing the scientific data upon which it relied or adequately addressing the commercial feasibility issue for whitefish.
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