October 3, 2022

Judge Orders FDA to Complete FSMA Rules by June 2015

Federal Judge Phyllis Hamilton of the U.S. District court of Northern California rejected the FDA’s proposed timeline for completion of the Food Safety and Modernization Act (FSMA) timeline and ordered the agency to publish all regulations by June 30, 2015. In her decision, Hamilton wrote, “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.”

GavelsThe FDA was sued by the Center for Food Safety┬áin August 2012, which applauded the Judge’s decision today. George Kimbrell, CFS senior attorney said in a statement, “this is a critical victory for consumers, farmers, and the public health. The Court’s decision will ensure FDA cannot unduly delay these life-saving measures any longer, while also ensuring all interested parties have a meaningful say in their outcome.”

The Food Safety Modernization Act was passed in 2011 to address the fact that 47.8 million people are sickened with food poisoning every year. The cost to the country is $77.7 billion per year in lost wages, productivity, and medical expenses. FSMA improves FDA’s regulation and authority over food production, including more control over imported foods, new controls for food production facilities, and safer production of fruits and vegetables. But some of these rules have been delayed for more than 1-1/2 years.

The rules that have been released include the proposed rule for produce safety, requirements for food facility registration, and the proposed rule for preventative controls in the nation’s food supply. The rules languishing at the Office of Management and Budget (OMB) include new standards for foreign food suppliers, standards requiring the neutrality of third-party audits, and preventative controls for animal feed. The seventh rule mandated by FSMA is the regulation ensuring the safe transport of food; that has not even been submitted to OMB.

The same court ruled in April 2013 that the FDA had violated the law in “unlawfully withholding” FSMA regulations. CFS and the FDA were supposed to submit proposals for new deadlines. While CFS complied with the court order, the FDA did not, saying they would only have ‘target timeframes’ into 2016, which could be changed at any time. The Court found that Congress “indicated that the rule-making process should be close-ended, rather than open-ended.” The Court retains jurisdiction to enforce the terms of the Order.

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