568 F.2d 240 (2d Cir. 1977)
United States v. Nova Scotia Food Products Corp.
Did the FDA's smoked fish processing rule comply with APA § 553's procedural requirements when the agency did not disclose key scientific material during rulemaking, failed to respond to significant comments, and provided an inadequate statement of basis and purpose?
Under APA § 553, an agency engaged in informal rulemaking must: (1) provide notice of the proposed rule with sufficient detail to permit meaningful comment; (2) disclose the critical material on which it relies—especially scientific or technical data—so interested persons have a meaningful opportunity to comment; (3) consider and respond to significant comments that, if credited, would require a change in the rule; and (4) publish a statement of basis and purpose that explains the agency's reasoning on the major issues, enabling both public understanding and judicial review. An agency may not rely on undisclosed data or post-comment material as a basis for the final rule without affording an opportunity for comment, and a conclusory basis-and-purpose statement is inadequate.
The Second Circuit held that the FDA's rulemaking was procedurally deficient under the APA. Because the agency failed to disclose critical scientific data in time for meaningful comment, did not adequately respond to significant industry comments, and issued an insufficient statement of basis and purpose, the court set aside the rule to the extent challenged and remanded to the FDA for further proceedings consistent with the APA.
Nova Scotia is a bedrock case for: (1) the duty to disclose critical scientific material to enable meaningful comment; (2) the obligation to respond to significant, outcome-determinative comments; and (3) the requirement to publish a statement of basis and purpose that addresses the major issues and explains the agency's reasoning. It strengthens judicial review by ensuring a transparent administrative record. After Vermont Yankee, courts continue to rely on Nova Scotia because its requirements flow from § 553's text and purpose, not from judicially invented add-ons. For law students, it frames exam analysis on adequacy of notice, comment responsiveness, record disclosure, and reasoned decision-making in informal rulemaking.