On August 29, 2012, the Center for Food Safety (CFS) and the Center for Environmental Health filed an action against the U.S. Food and Drug Administration (FDA) alleging that the agency had violated the Food Safety Modernization Act (FSMA) and the Administrative Procedure Act (APA) by unlawfully withholding FSMA regulations beyond the required statutory deadlines. The plaintiffs sought declaratory and injunctive relief requiring FDA to issue the regulations pursuant to a court-ordered timeline.
Yesterday, the U.S. District Court for the Northern District of California issued a consent decree whereby the parties agreed to extend and stagger the final rule deadlines beyond the June 2015 deadline initially set by the court last year. In exchange, the FDA has agreed to drop its Ninth Circuit appeal in the dispute with the two consumer advocacy groups.
The regulations required under FSMA were originally scheduled to be promulgated in 2012. However, due to significant delays and budgetary concerns, the FDA failed to meet those deadlines which prompted CFS to file its lawsuit.
According to the consent decree, the new deadlines are as follows:
|Preventive controls for human food||August 30, 2015|
|Preventive controls for animal food||August 30, 2015|
Produce safety standards
|October 31, 2015|
|Foreign Supplier Verification Program||October 31, 2015|
|Accreditation of third-party auditors||October 31, 2015|
|Sanitary transportation of food||March 31, 2016|
|Intentional adulteration/food defense||May 31, 2016|
The FDA agreed “in good faith” to issue the final rules by the above deadlines. The dates provided are dates by which FDA will submit the final rule to the Federal Register for publication, rather than the dates by which the final rule will be published. However, the ruling permits FDA to seek further extensions of any of the above deadlines through written agreement of the parties and notice to the court if the agency believes in good faith that it cannot meet them. If the parties are unable to agree on an extension, FDA may seek an extension by filing a motion with the court. FDA would have the burden to prove “good cause and/or exceptional circumstances warranting the delay, and address the effect of the delay on the public health and safety.”