WASHINGTONA federal judge on Friday ordered the U.S. Food and Drug Administration (FDA) to publish final regulations no later than two years from now under the FDA Food Safety Modernization Act (FSMA). The order was released two months after U.S. District Judge Phyllis Hamilton ruled FDA had violated the sweeping food-safety law by missing deadlines imposed by Congress.
Although Hamilton specified three deadlines, she stated that FDA "shall have the discretion to prioritize other matters relating to the rulemaking process."
Last year, the Center for Food Safety and Center for Environmental Health sued the agency, contending the delayed regulations put Americans at further risk of contracting foodborne illness. FDA has acknowledged missing deadlines, but it has cited the complexity of implementing the regulations under the law's aggressive timelines. The plaintiffs and FDA were ordered to confer and devise a proposed schedule of new deadlines under FSMA. The parties, however, couldn't come to an agreement and submitted different proposed timelines. Hamilton found both FDA's "target timeframes" and plaintiffs' proposals untenable.
FDA was ordered to publish all proposed regulations by Nov. 30, 2013, and all comment periods cannot extend past March 31, 2014. The agency must publish the final regulations in the Federal Register by June 30, 2015.
"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," George Kimbrell, senior attorney of the Center for Food Safety, said in a statement.