The New Schedule for FSMA Rules

FDA recently entered into a consent decree with the Center for Food Safety (CFS) that sets firm deadlines for the agency’s submission of final rules implementing the Food Safety Modernization Act (FSMA) to the Federal Register for publication.

Congress ordered FDA to create new safety standards within 18 months after FSMA was passed in 2011. After the agency failed to meet the deadlines, CFS sued. FDA didn’t agree to a timeline, arguing the rulemaking timeline was up to FDA’s sole discretion. In 2013, the federal court rejected that position and ruled in CFS’s favor, holding that FDA had violated the law. After attempts to appeal the decision, FDA agreed to firm deadlines to complete the rules—dropping its appeal. In return, the settlement briefly extends the court’s deadlines for the final rules. It also removes the upcoming March 2014 deadline for public comment periods, allowing more public participation throughout the rulemaking process.

United Fresh Produce Association is in support of FDA’s new timeline for FSMA. “Each rule represents major changes to the industry and FDA in how the safety of human and animal food is controlled and regulated, both domestically and imported,”  said United’s David Gombas, senior vice president of food safety and technology. “It’s critical that FDA have the time to ensure that the final rules are right.”

A Federal Court will maintain supervision to ensure FDA’s compliance with the agreement. The following are the new rule deadlines:

August 30, 2015: Preventive Controls for Human and Animal Food

October 31, 2015: Foreign Supplier Verification Program and the Produce Safety Standards

March 31, 2016: Sanitary Transport of Food and Feed

May 31, 2016: Intentional Contamination


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