Justice Department Wants FSMA Lawsuit Dismissed

CALIFORNIA The federal government has moved to dismiss a lawsuit that accuses the U.S. Food and Drug Administration (FDA) of unwarranted delay in implementing regulations under the Food Safety Modernization Act (FSMA).

The U.S. Department of Justice has asked federal judge Phyllis J. Hamilton to toss the complaint filed against the FDA and the White House's Office of Management and Budget by the Center for Food Safety and Center for Environmental Health.

The Justice Department argues judicial review is precluded under an executive order plaintiffs have invoked and that FDA's decision to not take enforcement action cannot be reviewed based on U.S. Supreme Court precedent. Government lawyers also contend plaintiffs cannot show the delay in implementing the regulations under the 2011 law is unreasonable.

In a complaint filed over the summer, the Center for Food Safety and Center for Environmental asserted FDA has missed hundreds of deadlines, including the making or so-called promulgation of seven major food-safety regulations.

"Practically speaking we just want to encourage FDA to follow the statutory mandate of promulgating these regulations in a timely fashion," Page Tomaselli, staff attorney with the Center for Food Safety, told FOOD PRODUCT DESIGN in October.

But the Justice Department maintains such a remedy would be unjustified under the circumstances. Government lawyers assert substantial resources have been devoted to implementing the regulations and significant progress has been made.

"The sole remedy available for an unreasonable agency delay claim is for the court to compel agency action, such as by issuing an order requiring the agency to act, without directing the substantive content of the decision," lawyers for the Justice Department wrote. "However, in matters involving rulemaking on complex scientific  and technical issues, courts routinely refuse to intervene to compel agency action by a certain date."

The government doesn't deny deadlines have been missed, but it asserted there's no suggestion Congress was more concerned with the deadlines being met than ensuring the regulations were carefully considered and crafted.

"Although FDA has been unable to meet the aggressive statutory timelines for the seven new rules, there is no indication that Congress believed that strict adherence to those timetables is more important than careful consideration and development of these complex regulations to create an effective and modernized food safety system, provide clear guidance to the industry, and minimize later challenges or revisions to hastily adopted regulations. Accordingly, judicial intervention is not warranted at this time," the Justice Department wrote.

Government lawyers indicated they would appear before the judge at 9 a.m. on Feb. 27, at which time they would ask her to dismiss the case and grant summary judgment in their favor. Plaintiffs will have an opportunity to respond to the motion.

The case is before the U.S. District Court for the Northern District of California, Oakland Division.