Center for Food Safety Wants Court Order Compelling FDA to Issue FSMA Regs
The Center for Food Safety moved for judgment Jan. 11 in its action to compel the Food and Drug Administration to issue seven long-overdue regulations required by the Food Safety Modernization Act.1 The non-profit is seeking court orders from the Northern California District Court mandating a timetable for FDA implementation of FSMA provisions on produce safety, Hazard Analysis and Risk-Based Preventative Controls, the Foreign Supplier Verification Program, and third-party auditing, among other things. “Congress enacted FSMA to end the ongoing epidemic of food contamination in our country and its concomitant harms to our nation’s health and economy,” CFS said. “Yet, without its implementing regulations, the statute is an empty vessel.”
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CFS originally filed its three-claim complaint in August, arguing that (1) FDA violated FSMA and the Administrative Procedures Act by failing to enforce the “self-executing” provisions of FSMA; (2) OMB delayed issuance of the FSMA rules, in violation of Executive Order 12866 requiring review of regulations within 120 days; and (3) FDA violated FSMA and the APA by failing to adhere to Congress’ timetable for the rulemakings. FDA responded in November with a motion to dismiss the claims related to “self-executing” provisions and the claim against OMB. Enforcement discretion is unreviewable by courts, FDA said, and the executive order relied upon in the claim against OMB also explicitly prohibits judicial review. A joint stipulation filed alongside CFS’ Jan. 11 motion for summary judgment requested dismissal of the claims against FDA’s failure to enforce and OMB’s regulatory review delays.
FDA in November also moved for judgment against CFS’ claim that the agency unlawfully exceeded FSMA’s statutory deadlines. The D.C. circuit in Telecommunications Research & Action Center (TRAC) v. FCC outlined a six-part test on whether agency delays are reasonable.2 According to FDA, the motion to compel agency action did not meet the TRAC test’s definition of unreasonable. “In matters involving rulemaking on complex scientific and technical issues, courts routinely refuse to intervene to compel agency action by a certain date,” FDA said. “Although FDA has been unable to meet the aggressive statutory timelines for the seven new rules, there is no indication that Congress believed that strict adherence to those timetables is more important than careful consideration and development of these complex regulations.”
But according to CFS, this case should not be decided on the TRAC reasonableness standard. When an agency misses an express Congressional deadline, the agency has violated a law, it said. The court does not have discretion to declare that delay reasonable. CFS pointed to past precedent to back its argument, including a case where the Tenth Circuit distinguished between “unlawfully withheld” and “unreasonably delayed” regulations. “When Congress by organic statute sets a specific deadline for agency action, neither the agency nor any court has discretion,” the circuit held in Forest Guardians v. Babbitt. “The agency must act by the deadline. If it withholds such timely action, a reviewing court must compel the action unlawfully withheld,” said the Tenth Circuit in the 1999 case.
Even if the TRAC factors apply, FDA’s delay was not reasonable, CFS said. FDA has missed all seven deadlines for FSMA rules, not just one or two, it said. The regulations also affect the health and welfare of U.S. citizens, and Congress repeatedly stressed the imperative nature of the provisions, CFS said.
The government's reply is due Feb. 15, and the CFS reply brief March 8. The district court scheduled a hearing on the cross-motions for March 27.
1The seven rules and their statutory deadlines are: (1) preventative controls (HARPC), due July 4, 2012; (2) registration requirements for farms, due in proposed form by Oct. 4, 2011; (3) produce safety, due in proposed form by Jan. 4, 2012; intentional contamination, due July 4, 2012; food transportation, due July 4, 2012; Foreign Supplier Verification Program, due Jan. 4, 2012; and third-party audits, due July 4, 2012.
2The six factors of the TRAC test include (1) a “rule of reason,” which governs the analysis; (2) any timetable or other indication of the speed provided by statute; (3) implications for human health and welfare; (4) higher or competing agency priorities; (5) interests prejudiced by the delay; and (6) impropriety.
Email ITTNews@warren-news.com for a copy of the complaint, government motion to dismiss and motion for judgment, and/or CFS motion for judgment.