Citation. United States v. Nova Scotia Food Products Corp., 568 F.2d 240, 1977)
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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.
Facts.
When the Commissioner employed notice-and-comment procedures for the proposed T-T-S requirement, the Bureau of Commercial Fisheries (Bureau) objected on the ground that the application of a uniform standard to all species was not commercially feasible, and suggested an alternative using a lower temperature with suitable concentrations of nitrate and salt. The Commissioner did not respond to the Bureau’s suggestion. Nova Scotia wrote a letter to the Commissioner stating that the high temperature would destroy its product. The Commissioner disregarded these comments, and adopted a uniform standard to all species. Nova Scotia refused to comply.
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>
