The Food and Drug Administration has officially broken the law by failing to release regulations needed to implement the Food Safety Modernization Act (FSMA), the 2011 legislation meant to overhaul the nation's food safety system.
That was the key finding in the case of Center for Food Safety v. Hamburg, released Monday by U.S. District Judge Phyllis Hamilton of the Northern District of California. The Center for Food Safety had sued Margaret Hamburg, the FDA commissioner, after the agency failed to release seven key regulations by July 2012, which the FSMA had set as the deadline for their release.
The Center for Food Safety asked the court to order the FDA to release the regulations in a timely manner. The FDA responded that the rules were complicated and technical, and that releasing them prematurely would compromise their efficacy. (The agency didn't directly address widespread accusations that the regulations were held up by the White House for political reasons.)
It looked like the lawsuit took a hit this January when the FDA released the two most important draft rules for public comment. But those two proposals weren't enough for the judge.
Hamilton ruled Monday that the seven food safety regulations were being "unlawfully withheld" and that "the FDA has violated the FMSA and the [Administrative Procedure Act] by failing to complete the regulations by the statutory deadlines." She ordered the FDA's food safety officials to meet with representatives from the Center for Food Safety to draw up a concrete timeline for the release and finalization of the regulations and to present it to the court no later than May 20. She will use the proposed timeline as the basis for a judicial injunction with the force of law.
George Kimbrell, senior attorney at the Center for Food Safety, described the decision as a "comprehensive victory" in a phone call with The Huffington Post.
"We think it's an important case," Kimbrell said. "It's literally life or death. One in six Americans contract a food-borne illness every year and, tragically, thousands of them die. Congress knew that when they passed the statute. It was their intent with the Food Safety Modernization Act to fix it. But without its regulations, the statute is an empty vessel, which is why I'm so glad the court decided in our favor."
FDA spokeswoman Shelly Burgess said that the FDA could not comment on pending litigation. Kimbrell noted that the agency could appeal the decision to the U.S. Court of Appeals for the 9th Circuit.
Barring that, however, the next step in the case is the meeting to set a timeline. Kimbrell wouldn't say how soon the Center for Food Safety would ask the FDA to release the rules, though it wouldn't be "tomorrow." In her decision, Hamilton agreed with the FDA that "the purpose of ensuring food safety will not be served by the issuance of regulations that are insufficiently considered." And any proposed regulation will be subject to a public comment period of at least 30 days. So the FSMA won't be implemented over night.
But Kimbrell insisted that the regulations' release would be "way way sooner than it would have been without this litigation."
The seven regulations could conceivably be released by July, one year after the deadline in the FSMA.
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