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Administrative Law Keyed to Popper
United States v. Nova Scotia Food Products Corp.
Citation:
568 F.2d 240 (1977)Facts
The Food and Drug Administration promulgated regulations establishing time-temperature-salinity (T-T-S) requirements for processing hot-smoked fish to prevent the growth of Clostridium botulinum Type E bacteria, which can cause botulism. These regulations required that hot-processed smoked fish be heated to a minimum internal temperature of 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 smoked whitefish for over 50 years without any cases of botulism, claimed that these requirements would render their product commercially unmarketable. During the rulemaking process, Nova Scotia and other industry members submitted comments arguing that the regulations should be species-specific rather than applied uniformly to all types of fish, and that the proposed parameters were not commercially feasible for whitefish. The FDA did not disclose the scientific data upon which it relied in formulating the regulations, nor did it specifically address the concerns about commercial feasibility in its final rule.
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