On April 22, 2013, a federal judge issued an order ruling that the U.S. Food and Drug Administration (FDA) had violated the Food Safety and Modernization Act of 2010 (FSMA) by “failing to promulgate the FSMA regulations by the statutory deadlines.” The case, Ctr. for Food Safety v. Hamburg, No. 12-4529 (U.S. Dist. Ct., N.D. Cal., filed August 29, 2012), had been brought by the Center for Food Safety and the Center for Environmental Health, who jointly filed a complaint in California federal court against the FDA seeking declaratory and injunctive relief for “failure to act” and to compel FDA to promulgate and finalize the required regulations by certain dates (e.g., stipulated deadlines or expedited dates).
In their motion, Plaintiffs contend that FDA has missed seven of FSMA’s statutory deadlines, thereby “failing to implement FSMA’s major food safety regulations” and putting millions of lives at risk from contracting food-borne illnesses. Those seven rules include:
- Preventive Controls for Human Food
- Produce Safety Standards
- Foreign Supplier Verification Program
- Preventive Controls for Animal Food
- Intentional Adulteration
- Sanitary Transport
- Accredited Third Parties
In fact, as we reported previously, FDA has already issued two major proposed rules—Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” and “Standards for Growing, Harvesting, Packing and Holding of Produce for Human Consumption”—which implement some of these statutory requirements, but the rest of these required rules remain outstanding.
Despite FDA’s contention that it had been working diligently to develop the required regulations, and the issuance of the two aforementioned proposed rules, the court found declaratory relief proper in light of FDA’s admitted failure to comply with the statutorily-imposed rulemaking schedule. The court also found that the imposition of an injunction imposing deadlines for finalization of regulations “would be consistent with the underlying purposes of the FMSA,” but agreed with FDA that “the purpose of ensuring food safety will not be served by the issuance of regulations that are insufficiently considered, based on a timetable that is unconnected to the magnitude of the task set by Congress.”
Therefore, the judge ordered the parties to meet and confer, and prepare a joint written statement setting forth proposed deadlines that must be submitted no later than May 20, 2013. By that date, we expect that implementation of FSMA rules will change from an open-ended process to a closed-ended one. We continue to monitor and provide updates regarding FDA’s implementation of these proposed rules and are anxiously awaiting the joint statement from the two parties.