Judge orders FDA to publish outstanding FSMA regs by November 30 deadline

30-Jun-2013 - Last updated on 01-Jul-2013 at 14:04 GMT

A judge in a federal court in California has ordered the Food & Drug Administration (FDA) to publish all outstanding proposed regulations under the Food Safety Modernization Act (FSMA) by November 30 this year.

In a June 21 court order in a case brought against the FDA by the Center for Food Safety, US district judge Phyllis Hamilton said that all remaining FSMA regulations - notably the Foreign Supplier Verification Program, Accreditation of Third Party Auditors, Preventive Controls for Animal Foods, Intentional Contamination, and Sanitary Transport of Food and Feed - must be published by November 30, 2013.

Rejecting FDA’s proposed deadlines as “inadequate” and the Center for Food Safety’s proposal as “overly restrictive,” the court also ordered that, for each proposal, the close of the comment period shall be no later than March 31, 2014.

It also mandated that all final regulations shall be published in the Federal Register no later than June 30, 2015.

Writing in the FDA law blog about the move, Hyman, Phelps & McNamara attorney Ricardo Carvajal said: "In essence, these publication dates show deference to FDA’s 'target timeframes' – an indication of the court’s reluctance to take too strong a hand in driving FSMA implementation."

Click here to read the order in full.