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Legislative Process Keyed to Bressman, 4th Ed.
United States v. Nova Scotia Food Products Corp.
Citation:
568 F.2d 240 (1977)Facts
The FDA issued regulations requiring that hot-process smoked fish be heated to specific minimum temperatures (180°F for 30 minutes with 3.5% salt content, or 150°F for 30 minutes with 5% salt content) to kill Clostridium botulinum Type E bacteria, which can cause deadly botulism. These regulations were prompted by several botulism cases in the early 1960s linked to vacuum-packed whitefish. Nova Scotia Food Products, which had been processing whitefish for 56 years without any cases of botulism, argued that the regulations would destroy the commercial marketability of their product. During the rulemaking process, Nova Scotia and others in the industry submitted comments arguing that the regulations were not commercially feasible for whitefish 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, and its final statement of basis and purpose did not adequately address the concerns about commercial feasibility or species-specific regulation.
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