United States v. Nova Scotia
Defendant violated time-temperature-salinity (T-T-S) regulation while processing hot smoked whitefish. Plaintiff moved to enjoin Defendant from violating the regulation in District Court. The District Court granted the injunction. The defendant has appealed to the United States Court of Appeals, Second Circuit.
Defendant does not contend that the regulation was met. Rather they argue that the regulation is invalid because
- It is beyond the agency's authority delegated by statute
- the agency improperly relied upon "undisclosed evidence in promulgating the regulation and because it is not supported by the record"
- "no adequate statement setting forth the basis of the regulation"
- inadequate record for judicial review
The FDA considered this T-T-S regulation to prevent a dangerous bacteria which sometimes inhabit fish. The Commissioner of the FDA initiated an informal rulemaking to come up with the proper regulation. The defendant and many other organizations attended the informal rulemaking session. The Commissioner issued the final regulations after this session, including regulations from an intervenor (National Fisheries Institute). Further, the intervenor and the Bureau of Commercial Fisheries suggested that there be a species by species determination of the specifications of the T-T-S requirement, because some fish would be commercially not viable if there was one general specification. The commissioner nonetheless decided to impose the requirement on all species of fish although adequate specifications had not been demonstrated for each individual species. The commissioner also did not answer other contentions that certain fisheries did not need high temperatures, the current specifications were not backed with scientific data, and that this would make certain fish not commercially viable.
The court concludes the following:
- no contemporaneous record was made or certified
- the District Court properly excluded information the defendants tried to add during the district court trial (concluding that review has to be made on record made before the agency). There is one exception to this rule, but the district court properly ruled that it did not apply.
- The court ruled that the agency acted improperly when it did not make available to the defendants the data that it relied on when it made its decision. A court can "consider whether the agency has taken account of all relevant factors and whether there has been a clear error of judgment."
- The court ruled that the agency's statement violated APA section 553 in that its "concise general statement" was not adequate because it left vital questions unanswered.
- The could should have addressed the commercial infeasibility of the white fish event though public interest is paramount ("In the regulation of food processing, the worldwide need for food also must be taken into account in formulating measures taken for the protection of health.")