Heralded as the most sweeping change to food safety laws in half a century, the FDA has struggled to meet the Food Safety Modernization Act’s (FSMA) rulemaking timeline. On February 20, 2014, the FDA obtained an agreement to extend several deadlines.
The agreement settles a lawsuit brought against the FDA in response to delayed rulemaking. The Center for Food Safety and the Center for Environmental Health sued the FDA in a California federal court on August 20, 2012, after the FDA failed to promulgate seven new rules as was required by the statute. The advocacy groups alleged that the FDA’s hesitance violated FSMA, and the organizations sought relief in the form of a court-imposed promulgation schedule.
The federal district judge granted the requested relief, and ordered the FDA to finalize all seven rules by June of 2015. The FDA appealed the decision to the Ninth Circuit. Pursuant to the settlement agreement, the FDA will abandon its appeal in exchange for a new set of deadlines.
The new deadlines for the following rules are staggered, ranging from August 30, 2015, to May 31, 2016:
August 30, 2015:
Preventive Controls for Human Food (FSMA Sections 103(a) and 103(c))
Preventive Controls for Animal Food (FSMA Sections 103(a) and 103(c))
October 31, 2015:
Foreign Supplier Verification Program (FSMA Section 301(a))
Produce Safety Standards (FSMA Section 105(a))
Accreditation of Third Party Auditors (FSMA Section 307)
March 31, 2016:
Sanitary Transport of Food and Feed (FSMA Section 111)
May 31, 2016:
Intentional Contamination (FSMA Section 106(b))
These deadlines are not necessarily set in stone, as the FDA may receive yet another extension upon a showing of good cause or with the written consent of the Centers for Food Safety and for Environmental Health. For now, mark your calendars.