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United States Court of Appeals for the Second Circuit - 568 F.2d 240
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This case involves an appeal against an injunction that prohibited the appellants from processing hot smoked whitefish in violation of T-T-S regulations. The court found that the smoked whitefish processed in violation of the T-T-S regulation is "adulterated" under the Food, Drug and Cosmetics Act. The court invalidated the regulation as applied to the appellants due to inadequacies in the procedure followed in its promulgation. The FDA proposed regulations to control the risk of Clostridium botulinum Type E spores in fish, which can cause botulism. The final regulation accepted the intervenor's suggestion of an alternative procedure of cooking fish at 150°F for 30 minutes with 5% salt in the water phase, which was made a permanent part of the regulation. The Commissioner proposed regulations to prevent the outgrowth and toxin formation of C. botulinum Type E in fish, which Nova Scotia Food Products Corp. failed to comply with, leading to an injunctive relief action by the United States Attorney. The court held that the regulation is reasonably related to the purposes of the enabling legislation and that food can be rendered injurious to health by inadequate sanitary conditions or prevention. However, there is an argument that treating the regulations in question as supported by § 342(a)(4) would result in a different agency rulemaking procedure.
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