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FDA files motion to dismiss suit, defends FSMA implementation record

By Hank Schultz , 12-Dec-2012
Last updated on 21-Jan-2013 at 19:08 GMT

FDA has filed a motion to dismiss a lawsuit that sought to prod the agency into faster implementation of the Food Safety Modernization Act (FSMA).  But regardless of whether full implementation is accelerated, FSMA has already significantly altered the regulatory landscape for food and dietary supplement companies, said attorney Ricardo Carvajal.

“It’s not as if FSMA hasn’t already had effects. There is the expanded access to records, that’s already under effect.  We have worked on any number of cases where FDA has used that authority to gain access to records that they previously couldn’t have,” Carvajal told NutraIngredients-USA.

“There is the expanded enforcement authority.  We just saw for the first time (in the recent case of a peanut butter plant in New Mexico) FDA use that authority under FSMA to suspend a facility’s registration,” said Carvajal, who is with the firm Hyman, Phelps and McNamara.

In addition, another facet of FSMA is also active;  all food faciilties operating in the US or producing food or supplements for sale here are required to file updated facility registrations before Dec. 31.

Agency sued over implementation

In August, FDA was sued by the Center for Food Safety and the Center for Environmental Health in the Northern District of California to compel FDA and the Office of Management and Budget (OMB) to implement several major facets of FSMA.

In FDA’s motion to dismiss, the agency cited the enormity of the task that FSMA set before it.  The agency noted that the new regulations “are novel and complex, and that complexity is increased by the need to build a cohesive system of regulatory controls integrating different regions and countries, as well as different food types.”

In addition, the agency went to say that the agency is called on regulate $450 billion worth of domestic and imported food, and the effort includes hundreds of thousands of registered food facilities.  FDA’s motion said, “the enormity of the task cannot be overstated” and went on to say, “through FSMA, Congress directed FDA, for the first time, to develop comprehensive, science-based preventive controls across the entirety of the food supply.”

Divided resources

The motion details the management structure FDA has put into place to implement FSMA.  It goes on to state the timelines written into the law have proved to be unachievable, even with the “several hundred employees” the agency has assigned to the task.

“One of the concerns about FSMA was the extent to which it would draw resources away from other programs within the agency.  I think there has been some sign of that,” Carvajal said. 

“So the idea that FDA could have or should have done it any faster or that having a judge put pressure on FDA to adapt to a faster timetable (doesn’t make much sense),” he said.

“If you really try to ram these things through you significantly increase the likelihood of litigation on the back end.  If you try to speed it through and you make significant mistakes you will have any number of people willing to sue you on the back end,” he said.

Major rules already written

In a blog posting on the motion to dismiss, Carvajal noted that there are four major FSMA rules that have been written are now in the review process at OMB. They are: preventive controls for human food; produces safety standards, the foreign supplier verification program and preventive controls for animal food.

A second wave of major rules includes rules on intentional adulteration, sanitary transport and third party accreditation. This last is also under review at OMB, while the others are at earlier stages of the process.

Carvajal said the whole process is complex enough that he doesn’t foresee full implementation of the law before sometime in 2014 at the earliest.  Nevertheless, he said significant progress has already been made including behind the scenes meetings with other agencies at the state level and overseas to lay the groundwork for full implementation.

As for the outcome of the lawsuit and the motion to dismiss, Carvajal wasn’t willing to speculate, except to say that “I’d be hard pressed to think that a federal court will be willing to jump into this in any significant way."

Check out FDA Imports' new infographic on FSMA below: 

FSMA and Santa Infographic


Courtesy of: FDAImports.com