FDA Paints Itself Into a Corner with FSMA

A federal judge orders the agency to issue overdue food safety rules by November … which looks unrealistic.

By Eric Lindstrom, Keller and Heckman LLP

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On June 21, a federal judge in California imposed concrete deadlines for the U.S. FDA to publish and finalize all remaining overdue rules to implement provisions of the FDA Food Safety Modernization Act (FSMA).

As background, FSMA was signed into law by President Obama on January 4, 2011. FSMA granted FDA new authority, including a mandate to require science-based preventive controls throughout the food supply chain and enhanced authority regarding inspection, compliance, outbreak response and recalls.

FSMA set specific deadlines for FDA to publish proposed rules or guidance to implement certain provisions of the law, but FDA has failed to meet several of these deadlines. In August 2012, two consumer interest groups – the Center for Food Safety (CFS) and the Center for Environmental Health (CEH) – sued FDA in U.S. District Court for the Northern District of California to compel the agency to publish the overdue rules.

This April 22, the California court granted summary judgment to the consumer groups, stating that FDA had violated FSMA by failing to issue the required regulations in accordance with the deadlines in the law mandated by Congress. Initially, rather than imposing deadlines on FDA, the court ordered FDA to work with CFS and CEH to develop a mutually agreeable proposal setting forth deadlines for FDA's issuance of the overdue rules. But FDA and the consumer groups could not reach agreement on an acceptable timeline; consequently, the parties submitted separate, competing proposals to the court.

The plaintiffs' proposal set May 1, 2014 as the deadline for all final regulations to be issued, with certain limited exceptions. The court found plaintiffs' proposed deadlines to be "overly restrictive in light of the FDA's showing of the complexity of the task ... and its showing of diligence in attempting to discharge its statutory duty to promulgate regulations." In addition, the court was not impressed with plaintiffs' proposal to shorten public comment periods for proposed rules or their proposal to eliminate review by the Office of Management and Budget, which reviews drafts of significant regulatory actions.

On the other hand, FDA proposed that no deadlines be imposed on the agency. Instead, the agency argued that it was more appropriate to impose "target timeframes" with "goals" for publication of the final regulations anywhere from late-2014 to mid-2016. The court found FDA's proposal to be "inadequate," as the court requested the agency to submit proposed deadlines that would form the basis for an injunction.

After balancing the parties' competing concerns and proposals, the court concluded that a compromise deadline roughly in the middle of the two proposals was the correct course. Consequently, the court ordered FDA to publish in the Federal Register by November 30, 2013, all proposed regulations that have not yet been published. For each rule, the public comment period must end by March 31, 2014, and FDA must publish all final regulations no later than June 30, 2015.

FDA now faces the task of publishing proposed rules, by the court-ordered deadlines, to implement the following provisions of FSMA:

  • The foreign supplier verification program (Section 301 of FSMA)
  • Preventive controls for animal feed (Section 103 of FSMA)
  • Protection against intentional adulteration (Section 106 of FSMA)
  • Sanitary transportation of food (Section 111 of FSMA)
  • Accreditation of third-party auditors (Section 307 of FSMA)

Of the proposed rules referenced above, the foreign supplier verification program rules are the longest overdue. Under FSMA, FDA was required to issue the foreign supplier verification program implementing rules by January 5, 2012. Foreign food manufacturers and distributors are still waiting to learn exactly how the agency's proposal will affect imports and trade.

Complying with the court order likely will prove challenging for FDA due to factors such as the complexity of the required rulemaking, the agency's need to consider and respond to public input on rules, the agency's limited resources, and the requirement for the Office of Management and Budget to review drafts of significant regulatory actions.

In addition to the regulations that are the subject of the order, FDA must still finalize currently published proposed FSMA regulations on preventive controls for human food and standards for produce safety; further adding to FDA's burden.

It remains to be seen whether the agency can meet its newly imposed deadlines and avoid being held in contempt of court.

This article originally appeared in our August 2013 issue of Food Processing magazine

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