Agreement allows FDA to extend deadline for FSMA final rules

Advocacy groups reached a settlement in Food Safety Modernization Act court case which allows for extended deadlines for final rules.

The Food and Drug Administration, Center for Food Safety, Center for Environmental Health reached a settlement agreement which creates a new timeline for the Food Safety Modernization Act (FSMA) rules. Previously a court-imposed deadline had required all final rules be published by June 2015.

Congress passed the Food Safety and Modernization Act in 2011. Congress ordered FDA to create new safety standards within 18 months. After the agency failed to meet the deadlines, CFS sued. FDA argued that it could take as long as it saw fit to issue the regulations.

In 2013, the federal court ruled in the advocacy groups’ favor, holding that FDA had violated the law. FDA appealed the decision to the Ninth Circuit Court of Appeals.

As part of the settlement agreement, FDA has dropped its appeal and, for the first time, agreed to express deadlines.

The agreement requires FDA to issue the following regulations under new deadlines: preventive controls for human and animal food (8/30/15); imported food and foreign suppliers (10/31/15); produce safety (10/31/15); food transportation (3/31/16); and intentional adulteration of food (5/31/16). The deadlines for the sanitary transportation and intentional food adulteration rules will also be pushed back to 2016.

“We are encouraged that FDA has been allowed to push back the June 2015 deadline for these rules,” said David Gombas, United Fresh Produce Assn. senior vice president of food safety and technology. “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. It’s critical that FDA have the time to ensure that the final rules are right.”

The American Feed Industry Assn. also said it was pleased with the agreement; however, it still poses significant challenges in the near-term to meet current comment period deadlines.

“Giving FDA two more months to finalize human and animal food rules will help the agency, but what the feed industry really needs is two more months to develop our comments. Unfortunately, this agreement does not allow FDA to extend existing comment periods,” explained Richard Sellers, AFIA’s senior vice president of legislative and regulatory affairs.

AFIA said continues to work feverishly with its membership to solicit feedback and input to the comments for the proposed rules.

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 robust public participation throughout the rulemaking process, CFS said in a statement.

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