568 F.2d 240 (2d Cir. 1977)
United States v. Nova Scotia Food Products is a cornerstone of administrative law on the procedural obligations of agencies engaged in informal rulemaking under the Administrative Procedure Act (APA) § 553.
Did the FDA's informal rulemaking comply with APA § 553 where the agency failed to disclose the scientific data underlying the regulation and did not respond to significant comments regarding feasibility, palatability, and alternative safety measures, such that the rule could properly be enforced against Nova Scotia?
Under APA § 553, an agency engaged in informal rulemaking must: (1) provide adequate notice of the proposed rule and the critical material on which it relies so that affected parties have a meaningful opportunity to comment; and (2) issue a statement of basis and purpose sufficient to enable courts and the public to understand the agency's reasoning, including responses to significant comments and consideration of important alternatives and feasibility concerns. An agency may not base a rule on undisclosed scientific data that deprive interested persons of an opportunity to challenge the assumptions or methodology, and it must address material criticisms to facilitate reasoned decision-making and judicial review.
The Second Circuit held that the FDA's rulemaking did not satisfy APA § 553 because the agency failed to disclose the scientific basis of the rule and failed to respond to significant comments about the rule's feasibility and effects on product palatability. The court therefore set aside enforcement of the regulation against Nova Scotia and remanded for further proceedings consistent with the opinion.
Nova Scotia is a foundational case on the procedural rigor required in informal rulemaking. It establishes that agencies must disclose the critical scientific material underlying proposed rules, respond to significant comments, and provide a statement of basis and purpose that enables meaningful public participation and judicial review. The decision is frequently cited alongside Portland Cement and, later, State Farm, as part of the doctrine requiring a reasoned explanation and a reviewable record. For law students, the case illustrates how courts police the boundary between deference to agency expertise and the insistence on transparent, participatory, and reasoned administrative process.