FDA Agrees to Deadlines to Issue Final Rules Under the FSMA

March 6, 2014
FDA Agrees to Deadlines to Issue Final Rules Under the FSMA

Manufacturers and food producers may want to take note of a recently settled suit filed against the FDA by the Center for Food Safety (CFS) and the Center for Environmental Health (CEH). The suit alleged that the FDA failed to comply with several requirements under the Food Safety Modernization Act (FSMA).  Specifically, the suit claimed that the FDA violated the FSMA by failing to promulgate and finalize the FSMA's implementing regulations by the required deadlines.  The CFS and CEH sought to require the FDA to issue the regulations pursuant to a court-ordered timeline. 
On February 20, 2014, the parties agreed to resolve the dispute, which was memorialized in  a consent decree.  The table below shows key deadlines for the FDA.
Upcoming FDA Deadlines Under the Food Safety Modernization Act
August 30, 2015 Final rules regarding preventative controls for both human and animal food will be issued.
October 31, 2015 Final rules related to the following will be issued.
·         The foreign supplier verification program
·         Accreditation of third-party auditors
·         Produce safety standards
May 31, 2016 Rules regarding the sanitary transport of food and feed and the intentional adulteration of food will be issued.
Keep in mind that these are the deadlines by which the FDA must submit the final rule to the Federal Register for publication, rather than the dates by which the final rule will be published. 
In the event the FDA believes that, despite its "best efforts," there is good cause to extend these dates, any of the dates may be extended by the parties' written agreement and notice to the court.  If the FDA believes an extension is warranted but fails to reach an agreement on an extension with the CFS and CEH, the FDA may seek modification of any of the dates by filing a motion with the court.  The court will then determine whether the FDA has met its burden warranting the extension.
If you have questions regarding the case, consent decree or other issues, please contact Ice Miller Partner Kevin Murch at kevin.murch@icemiller.com.  

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