Brief Fact Summary. The Food and Drug Administration (FDA) issued a regulation to prevent botulism that applied a uniform time-temperature-salinity (T-T-S) regulation on all species of fish. Nova Scotia Food Products Corp., a seller of smoked whitefish, refused to comply with the regulation, claiming that heating certain types of fish to high temperatures destroys the product.
Synopsis of Rule of Law. APA Section:553 requires agencies to issue a “concise general statement,” which was inadequate in this case. When the basis for a proposed rule is a scientific decision, the scientific material believed to support the rule should be exposed to the view of interested parties for their comment.
Issue. Was the T-T-S regulation valid?
Held. No, the regulation was invalid. The Commissioner failed to notify the interested parties of the scientific research upon which it was relying in its proposal; failed to address the Bureau’s suggested alternative; and failed to answer the comment that the proposed T-T-S requirements would destroy whitefish. Dissent. None. Concurrence. None.
Discussion. This case involved a scientific decision, and the Commission’s notice-and- comment procedure was insufficiently executed./br>