In 2011, Congress charged the U.S. Food and Drug Administration (FDA) with implementing the Food Safety Modernization Act (FSMA) — the most comprehensive and significant updating of the country’s food safety laws in decades. FSMA is aimed at reducing threats ranging from foodborne illness to food supply terrorism, by shifting regulatory focus from reaction to prevention.

The legislation also mandated an aggressive — and perhaps unrealistic — implementation schedule. The FDA was “required” to promulgate regulations in seven key areas by 2012. That didn’t happen. In 2013, much of the FDA’s FSMA work is still incomplete. Of course, as the FDA is quick to point out, in a time of sequesters and cutbacks, it cannot pour all its resources into developing a new food safety paradigm while simultaneously discharging its existing obligations to protect America’s food supply. Thus, the FDA counsels patience.

Those clamoring for FSMA implementation are out of patience, and recently handed the FDA a major defeat in a California federal district court. In August 2012, the Center for Food Safety (CFS) filed suit under the Administrative Procedure Act (APA) to force the FDA to propose and implement FSMA food safety regulations in seven key areas within the time limits set by Congress. [1] These areas include a foreign supplier verification program, protection against intentional adulteration and safe food transportation. CFS sought a declaration that the agency had violated the APA and FSMA and an injunction requiring the FDA to promulgate rules pursuant to a court-ordered timeline.

In that lawsuit, the FDA acknowledged that it had not complied with the deadlines set forth by Congress, but argued that declaratory or injunctive relief was not appropriate under the APA because it had not “unreasonably” withheld or delayed action. Instead, the FDA maintained that it was necessarily balancing the burden of creating a complex and expansive new regulatory food safety framework with its existing responsibility for safeguarding much of the nation’s food supply pursuant to the Federal Food, Drug, and Cosmetics Act — all with finite fiscal and human resources. CFS countered that because Congress has set specific deadlines for the promulgation and implementation of the various rules and regulations, the reasonableness of the FDA’s delay was no defense and it was entitled to summary judgment.

The court ultimately sided with CFS, granted summary judgment in its favor and denied summary judgment to the FDA. However, the court also found that the FDA had presented credible arguments against a hasty or arbitrary rulemaking timeline and ordered the parties to submit a joint proposed timeline by May 20, 2013, that could form the basis for an injunction. In its order, the court noted that “[i]t will behoove the parties to attempt to cooperate on this endeavor, as any decision by the court will necessarily be arbitrary.” The court later extended the joint proposal deadline to June 10, 2013. Despite the extension, the parties were unable to reach an accord, and instead submitted separate proposals. Under those proposals, CFS sought specific and aggressive deadlines while the FDA sought later and less specific “goals” and “targets.”

On June 21, 2013, the court issued a final order disposing of the case and resolving the impasse. In that order, the court chastised the FDA for providing only “targets” and “goals” as opposed to true deadlines. However, it also found CFS’s proposed deadlines too restrictive and refused CFS’s requests to limit the public comment period on proposed rules or discontinue the Office of Management and Budget analysis of proposed rules. Thus, the court rejected both parties’ proposals and, as promised, imposed its own framework for the promulgation and implementation of regulations that have not yet been published in the Federal Register.

Specifically, the court ordered that:

  1. The FDA must publish all proposed regulations by Nov. 30, 2013;
  2. For each regulation, the close of the public comment period shall be no later than March 31, 2014; and,
  3. All final regulations shall be published in the Federal Register no later than June 30, 2015.

Thus, having failed to meet the congressionally mandated statutory requirements for the proposal and enactment of new food safety regulations under FSMA, the FDA is once again on the clock — this time the clock of the Northern District of California. While the court-imposed framework is more compact and concrete than FDA requested, it is also substantially less hurried than CFS sought.