Food Safety Magazine

eDigest | July 2, 2013

Court to FDA: Deadlines Set For Long Overdue FSMA Rules

By John T. Shapiro

Court to FDA: Deadlines Set For Long Overdue FSMA Rules

When will Food and Drug Administration (FDA) finally issue rules that form the core of the heralded Food Safety Modernization Act (FSMA)? Until recently, the only certainty surrounding issuance is that the rules, and the precise terms encompassed therein that will govern the food industry, remain long overdue. Now, a Federal Court seeks to change that dynamic, ordering the FDA to promulgate final rules by June 30, 2015.

How did FDA, the food industry and consumer get to the point of court intervention given the import of, and attention and resources that have been dedicated to, FSMA? The story is a familiar one. Desire did not meet reality.

In its desire to quickly shift the food safety paradigm from reaction to prevention, Congress sought to put FSMA on a fast track by writing into the law deadlines by which the FDA was to promulgate rules that flesh out FSMA. But, despite sharing Congress’ aspirations, FDA did not meet many of the FSMA-imposed deadlines. Notably, FDA failed to meet the deadline for any of the rules that the FDA indicates form FSMA’s preventative core:

• Hazard analysis and preventative controls for human food
• Preventative controls for animal feed
• Produce safety standards
• Foreign supplier verification
• Accredited third party certification

FDA asserts that those, and many other, FSMA-required rules involve complex processes and issues that warrant additional consideration and time in order to devise meaningful food safety schemes that protect human health and safety.

Two public interest groups did not buy FDA’s excuses, much less FDA’s tacit request for a blank deadline slate. Frustrated by that delay, in August 2012 the Centers for Food Safety and for Environmental Health filed a complaint in the U.S. District Court for the Northern District of California against FDA. In an effort to bring an end to the ongoing delay, the Centers asked the Federal Court to declare that FDA has violated FSMA by failing to promulgate regulations by the statutory deadlines and to enter a judgment directing FDA to promulgate all FSMA regulations as soon as reasonably practicable, in accordance with deadlines to be set by the Court.

In April 2013, the Federal Court sided with the two nonprofits. The Court declared that FDA failed to comply with FSMA’s mandatory rulemaking schedule. Nevertheless, the Court found that “the FDA is correct that the purpose of ensuring food safety will not be served by the issuance of regulations that are insufficiently considered, based on a timetable that is unconnected to the magnitude of the task set by Congress.” (Order, p. 10) Noting that any schedule the Court were to set “will necessarily be arbitrary,” the Court ordered the parties “to meet and confer” and to submit to the Court by May 20, 2013, “a joint written statement setting forth proposed deadlines” by which the regulations will issue. (Id.)

On May 17, the court extended until June 10, 2013, the deadline for submission of the new schedule. FDA and the plaintiffs jointly requested the extension when they realized that they would be unable to resolve by May 20 differences regarding the schedule. The additional time, however, made no difference. Rather, the parties remain at loggerheads because FDA claims that it is unable to agree to specific rule-promulgating deadlines plaintiffs desire and the Court requires. This prompted the parties to file separate proposals, contrary to the Court’s order.

In its court filing dated June 10, the FDA explained that it sought to comply with the Court’s order to set specific deadlines, but nevertheless determined that it could not feasibly do so:

In an effort to comply responsibly with the court’s order, FDA deliberated over the time that will be required to complete the many tasks involved with respect to each rulemaking proceeding for issuing the FSMA regulations. FDA determined that, because there are numerous factors and variables that will affect the length of time required for the development of draft final rules for regulations that have already been proposed, as well as the development of proposed rules that are not yet completed, it is not feasible to predict with anything approaching certainty when the final FSMA regulations will be ready to be published. (FDA Proposal, p. 2)

FDA thus took a tact the Court did not contemplate. That is, FDA proposed a “schedule of target timeframes that the Agency will endeavor to meet in completing its tasks, with the caveat that future developments, such as the need to supplement the administrative records with additional information, or the need to re-open one or more regulations, may render FDA unable to act within all of these timeframes.” (Id.) Were FDA to meet its “target timeframes,” which FDA described as “aggressive but achievable, assuming no new obstacles arise,” final rules, including the rules referenced above, would publish sometime in 2015 or 2016, depending on the length provided for public comment on rule drafts. (Id., p. 6-7)

Not surprisingly, the plaintiffs took FDA to task in their own June 10 filing arguing that FDA’s “proposal consisted of no meaningful deadlines for completion of the rules” and that FDA’s “proposal utterly fails to comply with the Court’s Order and FSMA.” (FDA Proposal, p. 2) Plaintiffs further asserted that “[a] deadline is a deadline, a firm parameter with meaningful consequences, not a ‘target timeframe’ ” and that “[d]eadlines—actual end dates that ensures a closed-ended rulemaking process—are necessary to effectuate the intent of Congress in enacting FSMA, and to comply with this Court’s holding in its Order.” (Id., p. 4.) To that end, the plaintiffs proposed that the Court set May 1, 2014, as the deadline by which FDA drafts, submits for public comment, finalizes and publishes each of the rules FSMA requires. (Id., p. 3)

When FDA and the plaintiffs were unable to agree on deadlines, some thought it would put the Court in a pickle given the delicate balance the Court previously noted between the congressional mandate to expeditiously implement FSMA and the reasonable amount of time FDA requires to address the complex issues at play and promulgate final rules that work. The Court proved those prognostications inaccurate. On June 21, 2013, the Court acted decisively, issuing an “Order Granting Injunctive Relief” in which the Court set the following dates:

• November 30, 2013, by which proposed FSMA regulations must publish for comment;
• March 31, 2014, by which public comments must be submitted; and
• June 30, 2015, by which final rules must publish

The Court found FDA’s “‘target timeframes’ to be an inadequate response to the [Court’s] request that the parties submit a proposal regarding deadlines that can form the basis for an injunction.” (Id.) But the Court rejected the May 1, 2014, deadline plaintiffs proposed because the Court found it “to be overly restrictive in light of FDA’s showing of the complexity of the task, which involves making major modifications to procedures for food inspection and food handling, and its showing of diligence in attempting to discharge its statutory duty to promulgate regulations.” (Id.) Moreover, the Court noted that it “is not inclined to order curtailment of the public comment period, given the varying interests of the public, the health and medical establishment, and farming, business, and industry groups in the content and scope of the FSMA regulations.” (Id.)

There is a silver lining for the food industry that results from the delay in the promulgation of rules and the attendant uncertainty of the playing field. Food companies still have time to review, analyze and comment on key FSMA regulations already proposed and those yet to come. Indeed, the period in which to comment on the preventative controls for human food and produce safety standards has been extended until September 16, 2013. (Information on the proposed rules and the process by which to submit written comments can be found here. By availing themselves of this important opportunity, food companies may play a key role in helping to shape the very rules that will govern their operations and impact their success.

John T. Shapiro is a partner and member of the Food Industry Team at Freeborn & Peters LLP (Chicago).