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Federal Regulations Advisor Insight and Commentary on U.S. Government Regulatory Affairs

FDA’s Food Safety Regulations – Court Requires Timing Negotiation

Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory Process

The United States District Court for the Northern District of California has found that the Food and Drug Administration (FDA) clearly exceeded the deadlines set by Congress for promulgating regulations under the Food Safety and Modernization Act of 2010 (FSMA).  Rather than impose its own arbitrary deadline, the court sent the parties in Center for Food Safety v. Hamburg  back to the negotiating table over the timing of massive new regulations.  The court’s short and direct opinion reflects a balancing act in the arcane world of regulatory development:  specific statutory commands balanced against insufficient capacity to complete the complex tasks demanded by the statute.  Negotiation must quickly follow.

Background:  Congress enacted and the President (POTUS) signed FSMA on January 4, 2011.  FSMA provided specific deadlines for FDA to promulgate seven sets of substantive regulations – the last of which was in July 2012.  FDA submitted several rules to the Office of Management and Budget (OMB) in November and December 2011, but interagency and executive review consumed a year, and the first two proposed rules were published in January 2013.  The Center for Food Safety sued in August 2012 after FDA missed all seven of the regulatory deadlines in FSMA.

Failure to Act:  Under the Administrative Procedure Act (APA), in a “failure to act” case, such as alleged by the Center for Food Safety, a court can “compel agency action unlawfully withheld or unreasonably delayed.”  The agency “action” must be discrete – such as the failure to promulgate a rule – and be specifically demanded by statute.

The requirement that the agency action be required by statute is carefully circumscribed:  statutory goals that are “mandatory as to the object to be achieved” but leave the agency with “discretion in deciding how to achieve” those goals will not support a “failure to act” claim.  Such discretionary actions are not commanded by the statute.  The remedy is to “compel” agency action but the APA leaves to the agency the substance of that action.  This is a common problem in regulatory deadlines in statutes.

Decision:  The court noted that FDA took pains to establish teams to accomplish the FSMA goals, but FDA responded, the court admits, that “the aggressive timelines set forth in the statute have proven to be unachievable.”  The court recognized the inherent conflict between statutory authorizations and the funds appropriated to achieve those authorizations:

[B]ecause promulgating the new regulations requires the participation and input of individuals with specific expertise – writers, subject matter experts, regulatory counsel, attorneys, economists, program managers, and operations specialists – and because the FDA employs only a limited number of such individuals (particularly those having the relevant subject matter expertise), the FDA has found it difficult to staff the simultaneous development of such a large number of major rules in the same general subject area.

FDA claimed that the two proposed rules published in January represent concrete steps toward achieving three of the seven regulatory requirements.  FDA’s possible extension of the public comment period on those proposed rules, reported Monday, may require further consideration in light of the court’s decision.

The court specifically found that FDA had missed the statutory deadlines and “unlawfully withheld” action.  The APA “unreasonable delay” standards – commonly understood as the balancing of the six part “TRAC factors” did not apply.

At a minimum, it seems clear that by setting deadlines, Congress signaled its intention that the process be closed-ended, rather than open-ended.  Thus, the court finds that imposition of an injunction imposing deadlines for finalization of the regulations would be consistent with the underlying purposes of the [FSMA].

Yet, reason still prevails when the FDA unlawfully withheld action:

Nevertheless, 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.

The judge declined to impose a remedy, but ordered the parties to meet and confer and propose a timetable for the regulations by May 20, 2013, with an admonition:

It will behoove the parties to attempt to cooperate on this endeavor, as any decision by the court will necessarily be arbitrary.

Negotiation:  The Department of Justice (DOJ), representing FDA, must now confer with a number of agencies, including the Office of Management and Budget (OMB), to develop its position for negotiating a timetable with plaintiff’s counsel.  The timing negotiation will likely be complicated by the substance as plaintiffs should be expected to seek concessions on substance in the course of negotiating time.  Counsel may understand the magnitude and complexity of the substance of the regulations, but often may not appreciate the complexities of the rulemaking process and the need to comply with other statutory requirements.  Not understanding the intricacies of the APA and regulatory practice leads to misconstruing the scope of APA compulsion to act authority and the points where substance and process can be leveraged.

The future timetable for the FSMA regulations will certainly not be as short as plaintiffs may wish and will be shorter than FDA and OMB are likely to have comfort.  The court appears, however, to recognize the problem posed by the collision of statute and reality.