FDA, Food Safety Advocates Settle Rulemaking Litigation

The Center for Food Safety (CFS) and the FDA Commissioner have agreed to settle the rulemaking litigation, setting a schedule for the FDA to complete the development and publication of seven sets of regulations required under the Food Safety Modernization Act (FSMA) (P.L. 111-353). Under the proposed Consent Decree, the FDA must file the final rules with the Federal Register on the following schedule:

  • Preventive Controls for Human Food and Preventive Controls for Animal Food: August 30, 2015
  • Foreign Supplier Verification Program: October 31, 2015
  • Produce Safety Standards: October 31, 2015
  • Accreditation of Third Party Auditors: October 31, 2015
  • Sanitary Transport of Food and Feed: March 31, 2016
  • Intentional Contamination: May 31, 2016

Background

The FSMA was enacted January 4, 2011. The statute required that rulemaking be completed within a specified time, the latest of which was18 months of the date of enactment, i.e., July 4, 2012. None of the final rules had been published by that date, so on July 29, 2012, CFS and the Center for Environmental Health (CEH) sued under the Administrative Procedure Act, asking for a declaratory judgment that the FDA had violated the law and for an injunction ordering compliance by a date certain. On April 22, 2013, Judge Phyllis Hamilton granted summary judgment to CFS and CEH on the issue of violation of the law. The court did not set deadlines or order other relief at that time, but directed the parties to submit a joint statement within four weeks.

In June 2013, the court rejected the FDA’s proposal for “target time frames” and ordered the agency to publish proposed rules by November 30, 2013, close all comment periods by March 31, 2014, and publish final rules by June 30, 2015. The FDA’s request to modify the order was denied in August. The FDA appealed and moved for a stay pending appeal. On October 23, 2013, the Ninth Circuit Court of Appeals denied the FDA’s request for a stay. Because of the government shutdown, the court ruled that the compliance period had been tolled. However, it did order the agency to publish a notice of proposed rulemaking on intentional adulteration by December 20, 2013. The court also ruled that oral argument on the appeal would be set for the week of March 10, 2014.

Other Settlement Terms

In addition to the deadlines, the parties have agreed that the court will retain jurisdiction to enforce or modify the order. They dispensed with interim deadlines for the close of comment periods. The FDA agreed to make every effort in good faith to comply with the order. If, after doing so, the agency believes it cannot comply, it must first ask for a written extension from CFS and CEH. If they cannot agree, the FDA may ask the court for an extension. A detailed procedure is provided, placing the burden of proof on the agency and requiring advance notice to the plaintiffs before it presents a motion to modify the order. The question of attorney’s fees under the Equal Access to Justice Act has been reserved for later resolution.