FDA finalizes three additional FSMA rules; publication imminent.

  • Although FDA’s implementation of the FDA Food Safety Modernization Act (FSMA) is well underway, the Agency has yet to issue several final rules to implement major provisions of the law.  In 2012, two advocacy groups — the Center for Food Safety and the Center for Environmental Health — sued FDA in federal court over the Agency’s failure to ensure timely issuance of major rules required by FSMA.  Under the terms of a settlement agreement in that case, the court imposed staggered deadlines for FDA to issue final rules, running from August 30, 2015 to May 31, 2016.
  • FDA faced a court-imposed deadline of October 31, 2015 to issue final rules to implement the produce safety standards; the foreign supplier verification program (FSVP); and the Agency’s third-party certification program.  On November 2, the Agency announced its submission of all three rules to the Federal Register office, so publication should occur in the very near term.
  • As with the recently-issued final rules to implement the hazard analysis and risk-based preventive control (HARPC) provisions for human and animal food, Keller and Heckman plans to prepare full analyses of all three final rules once they have been published.