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.
The basis and purpose statement must, enable us to see what major issues of policy were ventilated by the informal proceedings and why the agency reacted to them as it did.View Full Point of Law