December 6, 2021

Volume XI, Number 340

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December 06, 2021

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December 03, 2021

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FDA’s Implementation of Food Safety and Modernization Act of 2010 (FSMA) Continues, Now with Judicial Encouragement

In August 2012, the Center for Food Safety filed suit under the Administrative Procedures Act to force the U.S. Food and Drug Administration (FDA) to propose and implement a number of food safety regulations within the time frame that Congress set in the Food Safety and Modernization Act of 2010 (FSMA). In April 2013, the U.S. District Court for the Northern District of California, granted the Center for Food Safety’s request for a judicial declaration that FDA had violated FSMA by failing to promulgate the required regulations within the deadlines mandated by Congress. However, the court acknowledged FDA’s arguments against a rushed or arbitrary rulemaking timeline and required that the parties propose a joint timeline. Not surprisingly, the Center for Food Safety and FDA were unable to agree to a joint proposed timeline so the court decided to set its own timeline that provided FDA with more time than the Center for Food Safety had requested but with less flexibility than the “target” timelines that FDA desired. Thus, on June 21, 2013, the court ordered FDA to:

  • Publish all proposed FSMA regulations by November 30, 2013;

  • Close the comment period for each proposed regulation no later than March 31, 2014; and

  • Publish all final regulations in the Federal Register no later than June 30, 2015.

It is not yet clear whether FDA will appeal the court’s decision. Michael Best & Friedrich LLP’s Agribusiness, Food and Beverage team continues to monitor FDA’s implementation of FSMA.

©2021 MICHAEL BEST & FRIEDRICH LLPNational Law Review, Volume III, Number 220
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About this Author

Leah Hurgten Ziemba, Michael Best Law Firm, Agribusiness and Energy Attorney
Partner, Industry Group Chair

Leah takes a big-picture approach in advising clients as they face challenges on environmental, food safety, and regulatory compliance issues. She draws on experience gained in cases involving the EPA, FDA, and other public agencies.

Leah’s success as a counselor, litigator and negotiator reflects her combination of subject matter expertise, industry knowledge, and creativity. Her work includes:

  • Investigating, assessing, and remediating vapor intrusion issues at sites with historic solvent contamination...

608-283-4420
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