FSMA Implementation Suit Unlikely to Speed Matters

The Center for Food Safety has filed suit in federal court against the Office of Management and Budget and the FDA for their failure to implement key provisions of the Food Safety Modernization Act of 2010 according to the prescribed schedule.

The lawsuit asks the court to order the FDA to enact the FSMA regulations by a deadline the court itself would impose and to enjoin OMB from delaying compliance.

“It’s a disgrace that a crucial, lifesaving law sits idle while the bureaucracies of FDA and OMB grind along without a hint of results. The American people shouldn’t have to wait another second for safer food policies that are already law,” said Andrew Kimbrell, executive director of Center for Food Safety.

But David Acheson, MD, the FDA’s former chief medical officer who now heads up the food and import safety practice at the health care consulting firm Leavitt Partners, predicts that the lawsuit will achieve “absolutely nothing.”

“You can sue all you want and it will have zero impact on the speed with which this moves out the door,” he said. “What it will do is create churn in the agency; someone will have to respond to this, and from that respect, it will have a negative impact.”

Dr. Acheson speculated that several factors have combined to create the surprising delays in implementing FSMA. “If it’s true, as has been said, that the four regulations they are preparing to issue are interconnected in such a way that it means publish four or publish none, that more than quadruples the challenge. Just one part of one may be causing the angst and the holdup.”

That “part of one” may be found within foreign supplier verification requirements. “The EU has stated publicly that they don’t like pieces of this, that it’s overburdensome and they don’t see it as helpful,” Dr. Acheson said. “I suspect the EU is pushing back hard.”

Another potential holdup, Dr. Acheson suggested, may be some significant cost to small business that the administration is trying to grapple with. “This is all speculation, of course, but, overall, I think it’s partly political, partly trade, partly budget, and partly the fact that they made it complex for themselves if they truly can’t publish one without the others.”

If he were in charge, Dr. Acheson said, he would get the preventive controls out first, at least for processed food. “Why? It’s the underpinning of the foreign supply verification, and it will at least move the ball forward. That would be my highest priority. Then preventive controls for produce next, and foreign supplier verification could follow.”

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