Court Dismisses Lawsuit Challenging FDA’s Inaction on Mercury Labeling

A federal court has granted summary judgment for the U.S. Food and Drug Administration (FDA) in a lawsuit brought by the Center for Science in the Public Interest (CSPI) and Mercury Policy Project (MPP) alleging that the agency has egregiously delayed a response to the organizations’ 2011 petition urging FDA to require the labeling of mercury levels in seafood. CSPI v. FDA, No. 14-0375 (D.D.C., order entered November 21, 2014). Additional information about the complaint appears in Issue 517 of this Update.

Assessing precedent, the court noted six considerations relevant in evaluating agency delay and found that three were in question here. CSPI and MPP argued that FDA’s delay was unreasonable because statutorily, the agency has six months to approve, deny or tentatively respond to citizen petitions; while FDA technically complied with this regulation, they argued, the deadline “provides a framework within which to gauge FDA’s delay in issuing a final response.” The court disagreed, finding that the regulations do not dictate when an ultimate response is issued, but rather the time frame is guided by the Administrative Procedures Act’s requirement of action “within a reasonable
time.” Further, the court noted, FDA has been actively working on the subject of mercury levels in seafood, resulting in the agency issuing draft guidance in June 2014 on recommended seafood intake for children and pregnant women. Additional information on the draft guidance appears in Issue 525 of this Update.

The court also examined the effects of the delay on human health and welfare. CSPI and MPP successfully argued that the delay affected the health and welfare of U.S. citizens, but the court held that this consideration alone was insufficient to support a finding of egregious delay. FDA’s mission is to preserve human health and welfare, the court noted, so the argument would be more persuasive against an agency that does not prioritize health so highly.

Finally, the court considered how a court-ordered expedited action would affect FDA’s other priorities. MPP and CSPI argued that mercury in seafood is a high priority for FDA, so expediting a response would not detract from the agency’s other concerns. FDA acknowledged the high priority of the issue but argued that “rushing a decision on Plaintiff’s detailed labeling recommendations at this juncture would force it to take action without due deliberation and would thereby draw resources from actually resolving issues related to mercury consumption.” The court agreed, and concluding that the delay did not yet warrant judicial intervention, granted summary judgment for FDA.

Issue 547