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Administrative Law Keyed to Koch
United States v. Nova Scotia Food Products Corp.
Citation:
568 F.2d 240 (1977)Facts
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. These regulations were developed following several botulism cases in the early 1960s linked to vacuum-packed whitefish. Nova Scotia Food Products Corp., which had been processing smoked whitefish for 56 years without a single case of botulism, challenged these regulations, arguing they would render their product commercially unmarketable. During the rulemaking process, Nova Scotia and other industry members submitted comments warning about commercial infeasibility and suggesting species-specific parameters. The FDA did not disclose the scientific data upon which it relied to the interested parties during the comment period, nor did it adequately address the concerns about commercial feasibility in its final rule. Government inspections revealed Nova Scotia was not complying with the regulations, leading to enforcement action six years after the regulations were promulgated.
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