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FDA agrees to new deadlines on FSMA final rules

By Hank Schultz , 24-Feb-2014
Last updated on 24-Feb-2014 at 18:22 GMT

The Food and Drug Administration has agreed to new deadlines for final rules detailing the implementaiton of the Food Safety Modernization Act (FSMA). The agreement comes as part of a settlement in a lawsuit brought by advocacy groups claiming that FDA was moving too slowly.

Signed into law in 2011, FSMA is the most sweeping change to the way food safety is regulated in the United States since the adoption of the Food Drug and Costmetic act itself in 1938.  FDA has struggled to meet deadlines for the implementation of the sweeping legislation, with the first having been missed in 2012.

While FDA’s performance did prompt a lawsuit, consultant Ben England, a principal in the firm FDAimports.com LLC, doesn’t see it as a case of deliberate stonewalling by the agency.

“Congress tells government agencies to do all sorts of things and gives them deadlines and then does not give them the money to do it. They can’t force people to work overtime to meet a deadline that is not funded,” England said.

Staggered deadlines

In coming to a settlement of the lawsuit filed by the Center for Food Safety (CFS) and the Center for Enviornmental Health, FDA agreed to a new set of staggered deadlines for issuing final rules that run from Aug. 30, 2015 to May 31, 2016.

 The two advocacy groups sued FDA for failing to deliver seven rules required by FSMA by the 2012 deadline set in the law. FDA missed the deadline as it worked with the affected industries to design final regulations for the most significant update of the American food system in 70 years. The federal district court in Oakland had ruled that all seven proposed rules must be issued by Nov. 30, 2012 and final rules by June 2015. FDA appealed that ruling, but has dropped its appeal after agreeing to a new set of deadlines . Under the new agreement, FDA must issue the following regulations under the following court-overseen schedule: 

 • Aug. 30, 2015 - preventative controls for human and animal food; 

 • Oct. 31, 2015 - imported food and foreign suppliers; 

 • Oct. 31, 2015 - produce safety; 

 • March 31, 2016 - food transportation; and 

 • May 31, 2016 - intentional adulteration of food.

Michael McGuffin, presdient of the American Herbal Products Association, welcomed the new deadline structure, saying it will give FDA enough time to get the final rules right.  FDA has issued draft versions of all of the proposed rules already.

"AHPA views the proposed FSMA Rules as a complex new set of regulations with large and broad economic and cultural consequences," McGuffin said. "Given the significant potential impact of these rules, it is critical for FDA to draft effective rules and these new deadlines give the administration more time to address the numerous and significant concerns voiced by impacted industries."  

No enforcement teeth

But even this new timetable is not set in stone, England said.  While the agreement represents a good-faith effort on the part of the agency and there is at this point no reason to assume that the agency can’t meet these goals, the settlement has no real enforcement teeth behind it.

“What are they going to do? Not fund the agency? I think it’s mostly posturing. I think FDA will try to meet these deadlines.  But if they try too hard we might end with final rules that are not workable for industry,” England said.

And England said the sheer size of FSMA means effective enforcement is still years away, regardless of what the new deadlines might imply. England cites a precedent from his time as an FDA employee.

“When FDA issued the seafood HAACP regulations it was five to seven years after the final regs were out and we were still writing warning letters to seafood importers about the basic provisions of the regulation,” he said. “The government is going to have the same problem with FSMA. It is so big they are not going to be able to enforce it right away.”

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