A federal court has ordered the U.S. Food and Drug Administration to complete the new food safety regulations of the 2011 Food Safety Modernization Act (FSMA). According to a decision of the U.S. District Court for the Northern District of California, the FDA must publish all proposed FSMA regulations by November 30. District Judge Phyllis Hamilton ordered the comment period for the regulations will not close later than March 31, 2014, and all final regulations shall be published in the Federal Register no later than June 30, 2015.
The FSMA was the first major overhaul of food safety laws since 1938. It improved the FDA's regulation and authority over food production in numerous areas, including preventing contaminated food imports, new preventative controls and hazard analysis requirements for food production facilities, and safer production of fruits and vegetables. The FSMA also granted the FDA new authority to, for the first time, mandate food recalls and suspend facilities, as well as new inspection and enforcement powers. But FDA regulations implementing the statute's mandates were needed before these improvements would take effect.
On April 22, the U.S. District Court for the Northern District of California held that the FDA had violated the law in "unlawfully withholding" the FSMA regulations. The court then ordered the parties to submit remedy proposals for new deadlines to complete the regulations, which the parties did on June 10. After consulting experts, the Center for Food Safety submitted new deadlines to the court. The FDA refused to submit meaningful deadlines, offering only "target timeframes" well into 2016, which it argued it could unilaterally change.
The court's Order Granting Injunctive Relief, issued on June 21, rejected the FDA's proposal. "Congress indicated that the rule-making process should be close-ended, rather than open-ended," according to the order. "Thus, the court finds defendant's 'target timeframes' to be an inadequate response to the request that the parties submit a proposal regarding deadlines that can form the basis of an injunction." The court granted the Center for Food Safety's motion for an injunction, set 2014-2015 deadlines as described above, and retained jurisdiction to enforce the terms of the order.