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U.S. Court Declares that FDA has Violated FSMA and the APA by Failing to Promulgate the FSMA Regulations by the Statutory Deadlines

On April 22, 2013, the U.S. District Court for the Northern District of California (Hon. Phyllis J. Hamilton, District Judge, case No. C 12-4529 PJH) ruled that the U.S. Food and Drug Administration (FDA) violated the Food Safety Modernization Act (FSMA) and ordered the agency to agree upon new dates for issuance of the regulations by May 20th.  This ruling is in response to a legal complaint filed on August 29, 2012 by the Center for Food Safety and Center for Environmental Health. The results of this hearing are of vast importance to the food and beverage industry. Registrar Corp will monitor the implementation of the regulations and help industry comply with the new regulations.

The Complaint

In the complaint, the Center for Food Safety and Center for Environmental Health allege that certain proposed and final regulations have not been issued by FDA pursuant to the Administrative Procedures Act (“APA”), within the time frame set forth by FSMA. These regulations include:

1. Regulations regarding the establishment of science-based minimum standards for conducting hazard analysis, documenting hazards, implementing preventing controls, and documenting implementation of preventive controls.
2. Regulations regarding (a) activities that constitute on-farm packing or holding of food not raised or consumed on such farm or another under the same ownership and (b) activities that constitute on-farm manufacturing or processing of food not consumed on that farm or on another farm under common ownership as required by provision that FDA must clarify activities included as part of definition of “facility.”
3. Regulations establishing science-based minimum standards for safe production and harvesting of fruits and vegetables.
4. Regulations protecting against intentional adulteration of food subject to FSMA.
5. Regulations regarding FDA requirement that shippers, carriers by motor vehicle or rail, receivers, and other persons engaged in transportation of food use sanitary transportation practices to ensure that food is not transported under conditions that might render it adulterated.
6. Regulations regarding foreign supplier verification program (FSVP).
7. Regulations ensuring the neutrality and independence of third-party audits.
The Center for Food Safety and Center for Environmental Health sought an order ordering FDA to issue the regulations as soon as reasonably possible, in accordance with the establishment of a court-ordered timeline. In addition, the Center for Food Safety and Center for Environmental Health requested that the court retain jurisdiction over the case to ensure compliance with the order.

The Hearing

During a hearing on March 27, 2013, FDA argued that FDA has been working on the new regulations. FDA asserted that the aggressive timelines set forth in FSMA have proven to be unachievable. In addition, FDA argued that it has been difficult to staff the simultaneous development of such a large number of major rules in the same general subject area.

The court found that, given that the FDA has admittedly failed to comply with the mandatory rulemaking schedule, declaratory relief was proper. Because FSMA included specific deadlines, failure to comply with those deadlines constituted a “failure to act” under APA.

The Court’s Opinion

The question then became whether the court had discretion in the Center for Food Safety and Center for Environmental Health’s order compelling the FDA to complete the rule making process by a date certain. And, if so, should the court grant injunctive relief, and, what form that relief should take. The court reasoned that, by setting deadlines, Congress signaled its intention that the process be closed-ended, rather than open-ended. Thus, the court found that the imposition of an injunction imposing deadlines for finalization of the regulations would be consistent with the underlying purposes of FSMA.

The Court’s Order

In an effort to prevent the issuance of regulations that are insufficiently considered, based on a timetable that is unconnected to the magnitude of the task set by Congress, the court ordered the parties to meet and confer, and prepare a joint written statement setting forth proposed deadlines, in detail sufficient to form the basis of an injunction. The joint statement shall be submitted no later than May 20, 2013.

FDA has the right to appeal the court’s decision. If FDA wants to appeal, the appeal would go to the U.S. Court of Appeals for the Ninth Circuit, considered the most liberal appellate court. Otherwise, FDA will have to meet with the Center for Food Safety and Center for Environmental Health to determine new deadlines.

Impact of the Decision

Both sides of the case kept FSMA’s original motive in mind–to ensure food safety. On one hand, the Center for Food Safety and the Center for Environmental Health argued that the delay was endangering the public. And on the other, FDA voiced that it needs time to craft these essential regulations. Judge Hamilton’s ruling will force the FDA to act quickly but hopefully not rashly. FSMA presents a paradigm shift for the food industry. No longer will FDA act retroactively to food crisis. With these new regulations, FDA hopes to prevent crises before they begin. As Registrar Corp’s Executive Director, Russell K. Statman, observed, “Implementation of all of FSMA’s requirements will impose numerous costs across broad segments of industry. One special interest group will benefit: people who eat food.”

On May 17th, both parties submitted a joint stipulation to the court requesting an extension to the deadline to June 10, 2013. FDA, the Center for Food Safety and the Center for Environmental Health were granted an extension to continue discussions of a proposed timeline.

As a FDA regulatory compliance firm assisting companies with Food Facility Registrations, Renewals, and U.S. Agent requirements, Registrar Corp will continue to monitor the developments of FDA’s FSMA regulations. Meanwhile, Registrar Corp can help companies with the FDA FSMA regulations that have been set including Food Facility Registration Renewal and the mandatory increase in Inspection. If your company missed FDA’s Registration Renewal deadline, Registrar Corp can help your company Re-register with the FDA. Registrar Corp’s Food Safety Department also performs Mock FDA Inspections of facilities to help companies prepare for U.S. FDA inspections. FSMA requires FDA to inspect foreign food facilities and to double the number of inspections every year until 2015. This year alone, FSMA requires FDA to perform a minimum of 2400 inspections of foreign facilities. Prepare now for a U.S. FDA inspection.

Registrar Corp will continue to keep you updated on the implementation of FSMA. For more information on how the Food Safety Modernization Act may affect you, Registrar Corp is available by phone at +1-757-224-0177 or 24/7 via online Live Help. To receive regulatory updates, visit: FDA Regulatory Updates by Registrar Corp.