## Facts

- Congress enacted the Food Safety Modernization Act (FSMA) in January 2011 and directed the FDA to issue several major food-safety regulations by date-certain deadlines, generally within 18 months.
- The required rulemakings included preventive controls for human food, produce safety standards, a foreign supplier verification program, and preventive controls for animal food.
- The FDA did not promulgate the required proposed and final rules by the statutory deadlines.
- Public-interest organizations sued the FDA Commissioner (in an official capacity) under the Administrative Procedure Act (APA) and the Mandamus Act to compel issuance of the overdue regulations.
- Plaintiffs sought summary judgment and an injunction imposing a detailed timetable for completion of all FSMA rulemakings.
- The FDA opposed, arguing the claims were not justiciable, the deadlines were not enforceable in the manner plaintiffs asserted, and any remedy should account for rulemaking complexity and constraints.

## Issues

1. Whether the FDA’s failure to meet FSMA’s statutory rulemaking deadlines constituted agency action “unlawfully withheld” under APA § 706(1).
2. Whether a federal court may compel the FDA to complete the overdue FSMA rulemakings and impose a judicially enforceable timetable, including interim deadlines.

## Decision

- The court granted plaintiffs’ summary judgment motion in substantial part.
- The court held the FDA missed mandatory, date-certain FSMA deadlines and therefore “unlawfully withheld” required agency action under APA § 706(1).
- The court rejected the FDA’s justiciability and discretion arguments because FSMA supplied specific deadlines that provided meaningful standards for review.
- The court determined it had authority to compel compliance and to require an enforceable schedule.
- The court did not immediately adopt plaintiffs’ proposed dates; instead, it ordered the parties to meet and confer and submit a joint proposed schedule (or competing proposals) for the court to consider and adopt.

## Legal Principles

- Under APA § 706(1), when Congress imposes a specific statutory deadline for agency action and the agency misses it, the failure is treated as action “unlawfully withheld,” and the court may compel performance.
- “Unlawfully withheld” (missed date-certain deadline) is analytically distinct from “unreasonably delayed” (no fixed deadline), which typically requires a reasonableness assessment.
- Explicit statutory deadlines supply “law to apply,” supporting judicial review and limiting claims that compliance timing is committed solely to agency discretion.
- Courts may order schedule-based injunctive relief to bring an agency into compliance with mandatory rulemaking duties, while allowing reasonable flexibility to account for procedural requirements of rulemaking.

## Conclusion

The court concluded that FSMA imposed mandatory rulemaking deadlines that the FDA failed to meet, constituting agency action unlawfully withheld under APA § 706(1), and it directed the parties to propose a court-enforceable timetable to complete the overdue regulations.


Ctr. for Food Safety v. Hamburg, 954 F. Supp. 2d 965 (N.D. Cal. 2013)