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Deadlines for FSMA Final Rules Pushed Back

The court-ordered deadlines by which FDA is required to issue final rules under the Food Safety Modernization Act (FSMA) have been pushed back pursuant to a consent decree between FDA and two consumer groups.

The two consumer groups, the Center for Food Safety and the Center for Environmental Health, had sued FDA (Center for Food Safety v. Hamburg) for failure to meet the statutory deadlines in FSMA for seven rulemakings.  The U.S. District Court for the Northern District of California decided for the plaintiffs and set deadlines for those rulemakings, and FDA appealed.  The parties have now reached a settlement agreement, which the court is expected to approve.  Pursuant to the settlement, the new deadlines will be as follows:

Final Rule

Deadline

Preventive controls for human food

August 30, 2015

Preventive controls for animal food

August 30, 2015

Produce safety standards

October 31, 2015

Foreign Supplier Verification Program

October 31, 2015

Accreditation of third-party auditors

October 31, 2015

Sanitary transportation of food

March 31, 2016

Intentional adulteration/food defense

May 31, 2016

FDA agrees “in good faith” to issue the final rules by the above deadlines.  If, however, FDA believes that good cause exists to seek further extensions, any of the deadlines may be extended by written agreement of the parties and notice to the court.  If the parties are unable to agree on an extension, FDA may seek an extension by filing a motion with the court.  FDA would have the burden to prove “good cause and/or exceptional circumstances warranting the delay, and address the effect of the delay on the public health and safety.”

The consent decree also provides that the comment period deadlines previously set by the court “are no longer operative.”  Thus, if FDA wishes to, it may grant extensions of the comment periods that remain open (or reopen comment periods that have closed), as long as FDA meets the deadlines for issuing the final rules.  The remaining comment period deadlines are: March 31, 2014 for preventive controls for animal food and intentional adulteration/food defense; and May 31, 2014 for sanitary transportation of food.  In addition, FDA has indicated it plans to re-propose parts of the produce safety standards and preventive controls for human food rules this summer, at which time it will provide an opportunity to comment on the re-proposed provisions.

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