April 26, 2018

FDA Motion to Delay FSMA Rules Denied by Court of Appeals

The Ninth Circuit Court of Appeals denied an FDA motion yesterday to delay issuing a rule required by the Food SAfety Modernization Act of 2011. FDA did not meet deadlines set by Congress, so the Center for Food Safety sued.

GavelsThe court agreed with CFS that delaying the rules was unacceptable, and re-established deadlines, starting with all drafts issued by November 30, 2013. FDA appealed that decision and sought a stay of the injunction. Yesterday’s decision rejected the appeal for an extension, but let the agency have an extra 16 days to make up for the government shutdown last month.

George Kimbrell, lead attorney for CFS, said in a statement, “Congress passed FMSA to end the preventable foodborne illness epidemic in this country. But without its implementing rules, the statute is an empty vessel. After FDA utterly failed to meet even a single deadline, we sued them. Unfortunately, instead of focusing its resources on complying with Congress’s orders, the agency has stubbornly continued to fight in court, now asking the court of appeals to relieve them of their obligations.”

The ruling states that FDA failed to show that it would be irreparably injured absent a stay. The court said, “the FDA must merely promulgate a notice of proposed rulemaking (NPRM) by November 30 that meets minimum APA requirements, or that provides notice to interested parties, or that discloses information bearing on the NPRM that the FDA currently possesses.” The FDA simply has to use public comment to collect more information before issuing a final rule.

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