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Food Safety Regulation Deadline: Court Orders FDA To Propose Regulations By November 30

Jun.27.2013


Recent Happenings in APRM
July 2013

On June 21, 2013, Judge Phyllis J. Hamilton of the United States District Court for the Northern District of California ordered the Food and Drug Administration (FDA) to publish proposed regulations mandated by the Food Safety and Modernization Act of 2010 (FSMA) by November 30, 2013. All of the proposed rules must be finalized by June 30, 2015, although the agency could allow entities covered by the rules additional time to comply with the new requirements before the rules go into effect.

FSMA requires the FDA to propose and finalize regulations in seven major food safety topics by specific deadlines, the latest of which was July 4, 2012. The agency, however, has missed a number of these statutory deadlines, including those concerning a foreign supplier verification program and third-party auditors. In order to compel the agency to begin promulgating the rules as required, two consumer groups filed suit against the FDA in August 2012. The FDA contended that it was working hard to promulgate the necessary regulations, and indeed, while the litigation was ongoing the agency proposed rules on some of the required subjects, such as risk-based preventive controls for food manufacturing, processing, packing, or holding. The agency, however, argued that the statute's deadlines were unachievable given the complexity of the issues and the need to develop them carefully.

In April 2013, the court granted the consumer groups' motion for summary judgment and ruled that the FDA, by its own admission, had violated FSMA by failing to meet the congressionally-mandated deadlines. The court allowed the parties to propose mutually acceptable deadlines for the promulgation of the remaining rules, but the parties were unable to agree on a joint schedule. The FDA's proposed schedule only included "target timeframes" and "goals" for publication of the proposed rules, an open-ended proposal that the court found inadequate under the law and under its previous order. The consumer groups' proposed schedule included hard deadlines, but the court found it to be overly ambitious and instead afforded the agency more time. Because FDA is now required to issue the food safety rules faster than it claims is feasible, the period for public comment after the rules are proposed becomes even more important. The agency may not be able to develop the proposals with as thorough consideration as it would like, and interested parties should review the proposed rules carefully as they are released to ensure that all issues are adequately addressed before the rules are finalized.

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John Fuson
Partner – Washington, D.C.
Phone: +1 202.624.2910
Email: jfuson@crowell.com