Wednesday 24 January 2018

FDA Asks Court To Dismiss Lawsuit Over Delayed FSMA Food Safety Rules

The FDA filed a motion in Federal Court Friday to dismiss a suit brought against the agency in August. Two public interest groups on  sued the FDA in California federal court in an attempt to force the agency to finally implement long-delayed provisions of the Food Safety Modernization Act (read Food Court’s earlier post on the suit here). Reuters reports the FDA claimed creating new rules for food safety is “too complex a task to be completed quickly” and the action should be dismissed.

The FDA argued in its motion that although it was behind schedule in modernizing food safety regulations as set out in the Food Safety Modernization Act passed in January of 2011, the agency’s broad role in regulating a $450 billion domestic and imported food business requires additional time. It emphasized that issuing complex rules that get it right is more important than being on time.

“The enormity and scope of the task given to FDA cannot be overstated,” the FDA said in a motion filed Friday in U.S. District Court for the Northern District of California.

Also from the FDA’s motion:

The enormity and scope of the task given to FDA cannot be overstated,” they say, as the agency is charged with building a new preventative food safety system with rules that have to effectively cover $450 billion worth of domestic and imported foods and hundreds of thousands of food facilities. Because of this complexity, the FDA says, it’s understandable that the rules are taking some time to develop. The agency also asks the court to dismiss the complaint against OMB because the suit does not identify a basis for judicial review.

The FDA also pointed in the motion to the Office of Budget Management (OMB). The OMB is said to have drafts of the rules that it has not finalized, leading the FDA to argue that the agency had not “unreasonably delayed” promulgation of regulations.

Also from the FDA’s motion:

FDA has devoted enormous effort and resources to developing the novel and complex regulations…

Although FDA has been unable to meet the aggressive statutory timelines … 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…

George Kimbrell, senior attorney for the Center for Food Safety, said the FDA is breaking the law and public health needs require swift action.

“They are not disputing that they missed the deadlines Congress set. They are just arguing those deadlines essentially don’t matter,” Kimbrell said. “In addition to being wrong as a matter of law, FDA’s foot-dragging excuse that ‘it’s too hard’ is misdirected and weak. We didn’t set the deadlines – Congress did.”

No date yet for a hearing on the motion. Check back for more updates.

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