WASHINGTON – A federal judge has ordered the US Food and Drug Administration to move forward with releasing regulations needed to implement the 2011 Food Safety Modernization Act (FSMA).

The Center for Food Safety, an advocacy group, in August sued FDA commissioner Margaret Hamburg after the agency failed to issue seven major regulations by the statutory deadline of July 2012. The FDA had argued that rules of “such magnitude and complexity” require time and care to develop.

In an April 22 decision, US District Judge Phyllis J. Hamilton of the Northern District of California said the agency should work with the plaintiffs to establish a new timeline for the release and finalization of the rules by May 20.

“The court agreed with the plaintiffs and ruled that the law is clear on deadlines for the regulations, and that this is a health and safety regulation, so timeliness matters,” said Joe Levitt, a partner with Hogan Lovells and former director of the FDA’s Center for Food Safety and Applied Nutrition. “On the other hand, the judge also agreed with the FDA that getting it right is also really important.”

The FDA in January released two proposals related to risk-based inspection for produce farms and manufacturing plants, but the White House Office of Management and Budget (OMB) had received the drafts for review at the end of 2011.

“It strikes people as unusual that it took OMB so long to review the proposed rules,” Levitt said. “I suspect that one of the things this lawsuit is about is not just pushing FDA but pushing the entire political process.”
Although the FDA may appeal the decision, the ruling reinforces that the regulations development process under FSMA should be close-ended, Levitt said.

“The food industry has been wanting the proposed regulations to be issued, to have a public comment period and to get them done,” Levitt said. “So long as there’s no rush to judgment, but a considered judgment, and provided FDA seriously considers and responsibly addresses comments, I think the industry will be satisfied.”

In response to the ruling, George Kimbrell, senior attorney for the Center for Food Safety, said, “Every day without the FSMA regulations is another day where consumers are at unnecessary risk. Because of this decision our food will soon be safer from E. coli and other threats.”