May 28, 2020

FDA Wants FSMA Lawsuit Dismissed

Timeliness is relative. So says the US Food and Drug Administration (FDA) in its motion to dismiss a lawsuit filed against the agency for its failure to implement and enforce in a timely fashion new regulations outlined in the Food Safety Modernization Act (FSMA). In a motion filed November 30 in US District Court in the Northern District of California, the FDA argues that the suit,  filed August 29, 2012 by the Center for Food Safety, should be dismissed for two reasons: first, that how quickly the FDA and the Office Of Management and Budget act is not for the courts to decide and second that the delay hasn’t been unreasonable.

FDARevamping food safety regulations on a half million food facilities worldwide that produce $417 billion of domestic and $49 billion of imported foods overseen by the FDA, the FSMA was signed into law in January 2011. One month later, the FDA submitted to the Office of Management and Budget a request for additional time on four draft proposals: Hazard Analysis and Risk-based Preventative Controls; Foreign Supplier Verification Program; Current Good Manufacturing Practice and Hazard Analysis and Risk-Benefit Preventative Controls For Food For Animals and Produce Safety Regulation.

A year and a half after the FDA’s request for more time,  the Center for Food Safety filed a lawsuit alleging that the agency had yet to enact any FSMA regulations. “If the Obama Administration has lost the political will to make FSMA a reality, we’re here to help them find it,” Andrew Kimbrell, executive director of Center for Food Safety, said in a statement the day the suit was filed.  “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.”

In its motion to dismiss, the  FDA says it is  “committed to full and timely implementation of FSMA” and that’s  not dragging its feet, it is just working through a huge task.  “As a logistical matter, drafting proposed rules with novel issues is an enormous undertaking that requires extensive resources. Rulemaking in general is a time consumin process, especially when the level of public interest is high.” While the agency works to meet its new obligations, food safety will not fall by the wayside but rather be enforced through existing provisions, the motion states.

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