United States v. Nova Scotia Food Products Corp.
Citation: 568 F.2d 240 (2d Cir. 1977)
Facts
The FDA promulgated regulations requiring specific time and temperature controls for smoked whitefish to prevent botulism. Nova Scotia argued the rule was arbitrary and capricious because the FDA had failed to disclose the scientific data on which it relied during the notice-and-comment process, preventing meaningful comment.
Issue
Does the APA’s notice-and-comment requirement obligate an agency to disclose the technical data and methodology underlying a proposed rule so that commenters may meaningfully respond?
Holding
Yes. Notice-and-comment is meaningless if agencies can withhold the technical basis for a rule. The FDA’s failure to disclose the scientific data on which its time-temperature regulations were based violated APA notice requirements and rendered the rule arbitrary and capricious.
Rule
Meaningful comment requirement: Under APA § 553, the notice-and-comment obligation requires that the agency disclose the data and methodology on which it relies in the rulemaking. Commenters must have access to the factual and technical basis for a proposed rule to provide meaningful input. Failure to disclose renders a rule arbitrary and capricious under § 706(2)(A).
Significance
- A leading Second Circuit case on the substantive content of notice-and-comment obligations
- Agencies cannot “hide the ball” on technical data — meaningful participation requires meaningful access to the agency’s factual basis
- Influenced Vermont Yankee’s rejection of judicially created procedural requirements (but Vermont Yankee was decided by the Supreme Court the same year on different grounds — courts cannot impose additional procedural requirements beyond what APA provides)
- Still good law on the APA notice requirements