On February 20, 2014, the Food & Drug Administration (FDA) agreed to firm deadlines for implementing the Food Safety Modernization Act (FSMA). By doing so, FDA withdrew its appeal of the of the U.S. District Court for the Northern District of California’s decision in the Center for Food Safety et al. v. Hamburg case filed against FDA by the Center for Food Safety in August 2012. FDA’s entry into the consent decree with the Center for Food Safety modifies the deadlines previously summarized in our articles here and here.
While the Northern District of California initially ordered that FDA publish all final regulations in the Federal Register no later than June 30, 2015, the consent decree that FDA just entered into with the Center for Food Safety gives FDA almost another year – until May 31, 2016 – to publish the last FSMA rule.
Specifically, the consent decree requires FDA publish the final issue:
- Preventive Controls for Human and Animal Food rules no later than August 30, 2015;
- Foreign Supplier Verification Program rule by October 31, 2015;
- Produce Safety Standards rule by October 31, 2015;
- Accreditation of Third Party Auditors rule by October 31, 2015;
- Sanitary Transport of Food and Feed rules (just released in draft on January 31, 2014) by March 31, 2016; and
- Intentional Contamination rules (just released in draft on December 24, 2013) by May 31, 2016.
The court will oversee the schedule for FDA to issue all of its final rules. The consent decree does allow FDA to seek modification of the final implementation dates upon a showing of good cause and/or exceptional circumstances that warrant such a delay but any final decision about an extension of the implementation deadlines rest with the Northern District of California.
Michael Best & Friedrich LLP’s Agribusiness, Food and Beverage and FDA Regulatory teams continue to monitor FDA’s implementation of FSMA and are available to answer specific questions regarding how FSMA impacts your business.