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When the basis for a proposed rule is a scientific decision, the scientific material which is believed to support the rule should be exposed to the view of interested parties for their comment.
Appellee United States, through the Food and Drug Administration, passed 21 C.F.R. pt. 122, which prevented the processing of whitefish unless it was in accordance with the regulation. Appellants, food processor and trade association, challenged the regulation because it would have been impossible to commercially process the fish under the regulation. Appellee obtained an injunction from the trial court to prevent further processing without compliance with the regulation.
Is the regulation preventing the processing of whitefish valid?
The court reversed and directed that appellee's complaint be dismissed because the regulation was arbitrary and capricious and, therefore, invalid. Because of concerns regarding public safety, even though the Food, Drug, and Cosmetic Act, 21 U.S.C.S. § 371(a), stated that it covered only unsanitary conditions, the court read § 371(a) broadly so as to apply to micro-organisms found in food. However, the court found that the agency record failed to disclose the basis of the regulation. As a result, appellants were unable to respond to the evidence upon which the agency relied in the promulgation of the regulation, and appellee did not have to respond to appellants' concerns.