FDA Earns More Time For Food Safety Rule Implementation

FDA agrees to firm deadline on Food Safety Modernization Act implementation, but gets extra time

Published on: Feb 24, 2014

The Food and Drug Administration on Thursday agreed to 2015 and 2016 deadlines for implementing the Food Safety and Modernization Act, the Center for Food Safety said.

CFS sued the FDA after it did not deliver on its 18-month deadline to create new food safety guidelines as stipulated in the FSMA in 2011.

FDA argued that it could take as long as it saw fit to issue the regulations, but a federal court last year ruled in CFS's favor, holding that FDA had violated the law. The court issued an injunction mandating the issuance of the draft rules by December 2013, and the completion of the rules by July 2015.

FDA agrees to firm deadline on Food Safety Modernization Act implementation, but gets extra time
FDA agrees to firm deadline on Food Safety Modernization Act implementation, but gets extra time

Meanwhile, FDA appealed the decision. In late 2013, the appeals court denied FDA’s initial motion for relief, but the agency’s broader appeal was still pending.

As part of the settlement agreement, however, FDA has dropped its appeal and has agreed to specific deadlines for final rules:
• preventative 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 first major update to our food safety laws since 1938 must now be implemented in a close-ended, timely fashion," said George Kimbrell, CFS senior attorney, who led the case. "That means safer food for American families."

Related: Court Requires FDA To Determine FSMA Deadline

The settlement does extend the court’s deadlines for the final rules.  It also removes the upcoming March 2014 deadline for public comment periods, allowing more extended public participation throughout the rulemaking process.

Implementation of the FSMA has been fraught with several issues, including technical difficulties that limited the public's ability to comment on the produce safety and preventative controls rules. There was also significant industry pushback on the two rules.

Farm and produce groups at the front of the debate supported attention to advanced food safety in the FSMA, but said the rules were too restrictive, instituting new requirements that conflict with existing conservation and environmental standards.

In response, FDA withdrew the rules in December in favor of re-working them based on what comments were received. New language for the produce safety and preventative controls rules are expected to roll out this summer, FDA said.

FDA has released draft rules for each of the facets of the Food Safety Modernization Act, successfully unveiling its final proposal on the transport rule last month.