Court Injunction Will Require the FDA to Accelerate the Roll-Out of FSMA Regulations

The Food Safety Modernization Act, known as "FSMA," calls upon the Food and Drug Administration ("FDA") to promulgate extensive new regulations on a broad range of subjects touching upon food safety. FSMA also contains tight deadlines within which the FDA was to propose or implement many of these regulations.

Objecting to the fact that the FDA has missed many of the statutory deadlines, two consumer advocacy groups—the Center for Food Safety and the Center for Environmental Health—filed suit in the United States District Court for the Northern District of California. Among other relief, the plaintiffs sought an injunction "ordering FDA to promulgate all FSMA regulations as soon as reasonably practicable, according to a Court-ordered timeline."

On Monday, April 22, Judge Phyllis J. Hamilton granted summary judgment in favor of the plaintiffs. Judge Hamilton declared that the FDA "has violated the FSMA and the APA [Administrative Procedure Act] by failing to promulgate the FSMA regulations by the statutory deadlines." She also found that the plaintiffs are entitled to injunctive relief, including the imposition of a mandatory schedule. The injunction is not yet in place; the court will determine "the scope of such relief" after May 20, when the parties will make further written submissions.

The court's decision that the plaintiffs were entitled to injunctive relief relied entirely upon the plain language of the statute. Judge Hamilton ruled that it was not necessary to determine whether the underlying statutory deadlines were feasible. Indeed, she deemed the reasonableness of the FDA's delay to be irrelevant and denied discovery on that issue. Although Judge Hamilton stated that an injunction will issue, she indicated that she does not intend to engage in fact-finding in order to craft the injunction. According to Judge Hamilton, "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." She is hoping, however, to receive a stipulated timetable, writing: "It will behoove the parties to attempt to cooperate on this endeavor, as any decision by the court will necessarily be arbitrary."

The interests of the regulated community are not represented in this proceeding, with the exception of one grower who filed an amicus brief that largely supports the plaintiffs' position.

While this lawsuit has commanded little attention from industry, the FDA's steps to implement FSMA have drawn intense scrutiny. The FDA published proposals for two major rules in January. The FDA estimates that the two proposed rules will impose compliance costs exceeding $1 billion per year. So far the FDA has received more than 750 comments on these proposed rules. As a result of numerous requests, the FDA has extended the comment periods on these two proposals from May 16 to September 16.

Barring a reconsideration of Monday's summary judgment ruling (or the intervention of an appellate court), Judge Hamilton will soon decide how long the FDA will be allowed to take when soliciting and considering public comments, both on the pending proposals and on the many more that will follow.

The lawsuit is captioned Center for Food Safety v. Hamburg, No. C 12-4529 PJH (N.D. Cal.).

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