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Legislation and Regulation Keyed to Eskridge, 1st Ed.
United States v. Nova Scotia Food Products Corp.
Citation:
568 F.2d 240 (1977)Facts
In response to several cases of botulism traced to smoked fish in the early 1960s, the FDA promulgated regulations establishing time-temperature-salinity requirements for processing hot-smoked fish. These regulations required fish to be heated to either 180°F for 30 minutes with 3.5% salt content or 150°F for 30 minutes with 5% salt content. Nova Scotia Food Products Corp., which had been processing whitefish for over 50 years without any cases of botulism, argued that these requirements would destroy the commercial marketability of whitefish. During the rulemaking process, Nova Scotia and others in the industry submitted comments arguing that the regulations should be species-specific rather than applied uniformly to all smoked fish. 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. The FDA did not disclose the scientific data upon which it relied, nor did it adequately address concerns about commercial feasibility. After several inspections revealed Nova Scotia’s non-compliance, the government sought and obtained an injunction.
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