FDA Proposes FSMA “Schedule of Target Timeframes”; CFS Demurs

By Ricardo Carvajal –

In previous postings (see here and here),  we reported on the Center for Food Safety’s ("CFS’s") lawsuit seeking to compel FDA to accelerate its implementation of FSMA.  In April, the presiding court ruled that FDA’s delay violated the APA and ordered FDA and CFS to attempt to set a mutually acceptable schedule for implementation.  That negotiation proved fruitless, apparently because CFS insisted on specific deadlines – a nonstarter for FDA.  Thus, the parties submitted their own proposed implementation schedules to the court (see here for FDA's proposal, and here for the CFS proposal).

FDA explained its disinclination to set specific deadlines as follows:

FDA determined that, because there are numerous factors and variables that will affect the length of time required for the development of draft final rules for regulations that have already been proposed, as well as the development of proposed rules that are not yet completed, it is not feasible to predict with anything approaching certainty when the final FSMA regulations will be ready to be published. Therefore, FDA developed a schedule of target timeframes that the Agency will endeavor to meet in completing its tasks, with the caveat that future developments, such as the need to supplement the administrative records with additional information, or the need to re-open one or more regulations, may render FDA unable to act within all of these timeframes.

The “factors and variables” referred to above include coordination of policy issues based on comments received on the five “foundational” FSMA rules (Preventive Controls for Human Food, Produce Safety, Foreign Supplier Verification, Preventive Controls for Animal Food, and Third Party Accreditation), accommodation of public input and response to comments, OMB and interagency review, and the agency’s limited resources.  The agency therefore proposed the following “aggressive but achievable” schedule for submitting final rules to the Federal Register:

• Preventive controls for human food – 19 months after the close of the comment period (currently set for September 16) 
• Produce Safety – 21 months after the close of the comment period (currently set for September 16)
• FSVP and Accreditation of 3rd party auditors – the proposed rule would publish in Summer 2013 with a 120-day comment period; the final rule would be submitted 19 months after the close of the comment period
• Preventive controls for animal feed – the proposed rule would publish in Fall 2013; the final rule would be submitted 19 months after the close of the comment period
• Sanitary transportation – the proposed rule would publish in the 2nd quarter of 2014; the final rule would be submitted 15 months after the close of the comment period
• Intentional contamination – an ANPRM would publish in the 2nd quarter of 2014; the proposed rule would publish 15 months after the close of that comment period; the final rule would be submitted 15 months after the close of the comment period for the proposed rule

CFS strongly objected to FDA’s proposal:

Defendants’ proposal utterly fails to comply with the Court’s Order and FSMA…  A deadline is a deadline, a firm parameter with meaningful consequences, not a “target timeframe.”  Contrary to Defendants’ mischaracterization, Defendants’ Proposal provides nothing remotely resembling a closed-ended process, not in accordance with the Court’s Order and congressional intent in setting firm deadlines for rulemaking in FSMA.

CFS proposed its own implementation schedule with much tighter timeframes.  With the exception of the rule for accreditation of third party auditors (for which the comment period would close on November 30 with submission of the rule to follow by December 31, 2013), all comment periods would close on December 31, 2013, and final rules would be submitted by May 1, 2014.  In part, CFS’s timeframes count on foregoing OMB review, which CFS contends is “not required where, as here, rulemaking requirements are governed by FSMA’s statutory deadlines and the pending court-imposed injunction.”

Stay tuned.  We will be monitoring the court’s response.