FDA Agrees to Firm Deadlines for New Food Safety Rules

Center for Food Safety (CFS) today announced a settlement agreement with the Food and Drug Administration (FDA) that, for the first time, sets firm deadlines for the agency to fully enact the Food Safety Modernization Act.  A Federal Court will maintain supervision to ensure FDA’s compliance with the agreement.

“This is a major victory for the health and safety of the American people. 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.”

Congress passed the Food Safety and Modernization Act in 2011 to combat the epidemic of foodborne illnesses affecting 1 in 6 Americans annually.  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 repeatedly rejected that position and ruled  in CFS’s 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 agency will follow the following court-overseen schedule to implement the 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).

“Our food will soon be safer from e coli and other harms,” continued Kimbrell.  “This is the best possible result, because it provides for robust public participation in the process, yet ensures certainty for its timely conclusion. CFS remains committed to protecting the rights of small farms and organic farms during the process.”

Legal Background:

Until today, FDA refused to agree to a timeline, arguing the rulemaking timeline was up to FDA’s sole discretion.   Siding with CFS, the Court rejected FDA’s arguments, holding that the agency had unlawfully withheld the suite of delayed food safety rules.  The court then issued an injunction mandating the issuance of the draft rules by December 2013, and the completion of the rules by July 2015. 

FDA finally began to issue draft regulations pursuant to the Court’s injunction (PDF), but at the same time 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.  Pursuant to the settlement, FDA agreed to firm deadlines to complete the rules and to drop 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 robust public participation throughout the rulemaking process.

View CFS’s original complaint here
View the court’s April 22, 2013 decision here
View the court’s August 13, 2013 decision here

Food Safety Background:

According to the Centers for Disease Control, every year 47.8 million people (one in six Americans) are sickened as a result of foodborne illness. Tragically, three thousand die annually and nearly 128,000 are hospitalized.  Many suffer serious long-term effects such as kidney failure, chronic arthritis, and nerve and brain damage.  The annual cost to the U.S. economy in medical bills and productivity losses alone is over $77 billion.

In 2011, Congress passed the Food Safety Modernization Act (FSMA) to address the epidemic.  FSMA was the first major overhaul of food safety laws since 1938.  It improved FDA’s regulation and authority over food production in numerous areas, including new preventative controls and hazard analysis requirements for food production facilities, safer production of fruits and vegetables, and preventing contaminated food imports.  FSMA also granted FDA new authority to for the first time mandate food recalls and suspend facilities, as well as new inspection and enforcement powers. 

View a timeline of recent foodborne illness outbreaks