Appeals Court Tells FDA To Stick With FSMA Deadlines

By Sam Lewis

FDA says government shutdown affected new food safety rule making process

The FDA was denied a motion to delay issuing a draft rule required by the Food Safety Modernization Act (FSMA) by the Ninth Court of Appeals late on Monday, Nov 4. The FDA has been failing to meet deadlines set forth by Congress, leading to the Center for Food Safety (CFS) has sued the agency. The court ruled in favor of CFS, re-establishing deadlines for FSMA’s rules, with Nov 30, 2013 being the deadline for all drafts of the legislation to be issued.

The decision was appealed by the FDA, and it pursued a halt of the injunction dependent upon the outcome of the agency’s appeals. Even though the Ninth Circuit didn’t grant the FDA’s motion for an extension, it was granted additional time for another proposed FSMA rule to compensate for lost time due to the federal government shutdown. “Congress passed the Food Safety Modernization Act (FSMA) to end the preventable foodborne illness epidemic in this country,” says lead attorney George Kimberly. “But without its implementing rules, the statute is an empty vessel. Congress knew this was literally an issue of life or death, which is why it included mandatory deadlines in the law for its regulations.”

On Nov 4, The FDA said it would be announcing a 60-day extension of the commenting period of two proposed rules. First is the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals. Second is the Accreditation of Third-Party Auditors/Certification bodies to Conduct Food Safety Audits to Issuer Certifications. The move for an extension was put into motion by those in the feed industry, attempting to allow the latest rules on animal feed to be contemplated along with previously announced rules. The public comment period for both pieces of proposed legislation is scheduled to end Nov. 26.

The FDA has already taken advantage of an extension. The most recent 60-day extension was granted to proposed rules for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventative for Human Food and Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption. This extension is set to expire on Nov 15.

The FDA has had some problems conforming to the set deadlines, and it’s easy to see why. The rules are very complex, requiring many levels of review before being put into effect. In addition, public review of proposed legislature is a time-eating endeavor, and extensions are often needed. However, the courts seems to have put its foot down, forcing the FDA to get the ball rolling on FMSA guidelines, or else face penalties of being held in contempt of federal court.