Lawsuit on Deadlines for FSMA Regs Ends as FDA Agrees to Timetable
The Food and Drug Administration reached a settlement with the Center for Food Safety on deadlines for its Food Safety Modernization Act regulations, ending a contentious lawsuit in the U.S. Court of Appeals for the 9th Circuit. The agency had been operating under deadlines ordered by the Northern California U.S. District Court in 2013 that required all seven of FDA’s final rules implementing FSMA by June 30, 2015 (see 13062412). The agreement extends the deadlines, some by nearly a year, in return for FDA dropping its appeal.
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According to court documents posted on the Center for Food Safety’s website (here), the new deadlines under the settlement for FDA’s FSMA final rules are as follows:
- Preventive Controls for Human Food: Aug. 30, 2015
- Preventive Controls for Animal Food: Aug. 30, 2015
- Foreign Supplier Verification Program (FSVP): Oct. 31, 2015
- Produce Safety Standards: Oct. 31, 2015
- Accreditation of Third Party Auditors: Oct. 31, 2015
- Sanitary Transport of Food and Feed: March 31, 2016
- Intentional Contamination: May 31, 2016
Under the settlement, the Court of Appeals will oversee implementation of the deadlines. FDA may request extensions, but must show good cause. The Appeals Court would then decide whether the extension should be granted.
“This is a major victory for the health and safety of the American people,” said Center for Food Safety lawyer George Kimbrell (here). “The first major update to our food safety laws since 1938 must now be implemented in a close-ended, timely fashion.” The food safety advocacy group had originally brought the lawsuit because FDA missed deadlines ordered by Congress in FSMA for issuing implementing regulations. “Our food will soon be safer from e coli and other harms,” said Kimbrell. “This is the best possible result, because it provides for robust public participation in the process, yet ensures certainty for its timely conclusion.” FDA did not immediately respond for comment.