Natural Resources Defense Council, Inc. v. U.S. Food and Drug Administration

Background

The plaintiffs—Natural Resources Defense Council, Inc., Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Environmental Defense Fund, and Environmental Working Group—sought declaratory and injunctive relief against the U.S. Food and Drug Administration and Robert M. Califf, M.D., in his official capacity as FDA Commissioner. The dispute concerned the FDA’s denial of the plaintiffs’ citizen petition seeking revocation of a threshold-of-regulation exemption and a rule banning sodium perchlorate monohydrate in food-contact materials.

Sodium perchlorate monohydrate is used in plastic packaging and other food-contact articles as an antistatic agent for dry foods. The FDA’s threshold-of-regulation process exempts a substance from food-additive regulation when its expected dietary concentration is at or below 0.5 parts per billion. The FDA issued an exemption in 2005 authorizing perchlorate’s use in certain antistatic agents and finished articles contacting dry foods.

The plaintiffs petitioned the FDA in 2014 to reconsider and revoke the exemption and to prohibit perchlorate’s use in food-contact materials. The FDA denied the petition in 2017 and denied the plaintiffs’ objections in 2019. The plaintiffs then filed this action and moved for summary judgment, arguing that the FDA violated the Administrative Procedure Act and the Food Act. The FDA filed a cross-motion for summary judgment.

Issues and Analysis

The plaintiffs raised three principal challenges. First, they argued that the FDA ignored its own 2008 and 2016 studies and a related 2017 report concerning perchlorate levels in food. The court noted that the plaintiffs had relied on the 2008 study in their petition but had not submitted the 2016 study or 2017 report before the petition decision. Under the FDA’s regulations, the administrative record closed when the FDA decided the petition. The plaintiffs could have supplemented the petition or submitted the later materials with a new petition, but they did not do so.

The court held that the FDA was not required to consider the 2016 study or 2017 report merely because the agency knew about them. The materials were not part of the administrative record for the citizen petition. The court also found that the FDA had addressed the issues raised by the 2008 study and had made a rational connection between the information before it and its decision. The FDA therefore did not act arbitrarily or capriciously by failing to consider the later materials.

Second, the plaintiffs argued that the FDA violated the Food Act and its own regulation by failing to consider the cumulative effects of perchlorate exposure from multiple sources and related substances. The court relied on precedent recognizing the FDA’s discretion to treat a substance as outside food-additive regulation when its migration into food is so small that it presents no public-health or safety concern. The court concluded that the FDA could use the 0.5-parts-per-billion threshold as the basis for the exemption and was not required to apply the Food Act’s cumulative-effects provision to the threshold-of-regulation exemption.

The court also rejected the plaintiffs’ argument that the FDA’s threshold regulation itself required cumulative-exposure analysis. The regulation refers to the dietary concentration resulting from the “use in question,” and its provision allowing the FDA to reevaluate an exemption upon receiving significant new information is permissive rather than mandatory. The court further stated that a challenge to the threshold regulation itself should have been brought when the regulation was adopted or through a petition to modify it, rather than through this challenge to the denial of the plaintiffs’ citizen petition.

Third, the plaintiffs argued that the FDA underestimated exposure because food could contact multiple perchlorate-containing plastics, including both single-use and repeated-use articles. The court found that the FDA had reasonably explained its use of a single-use migration protocol. According to the FDA’s explanation, that method assumed contact with all food in a consumer’s diet, use of the maximum permitted perchlorate level, and other assumptions that produced a more protective exposure estimate. The court deferred to the FDA’s scientific judgment and concluded that the agency had adequately considered the relevant issue.

The court assumed, without analyzing, that the plaintiffs had standing because the FDA did not contest standing. It also did not address the portion of the FDA’s decision declining to propose a separate regulation prohibiting perchlorate use because the plaintiffs did not raise arguments specifically directed to that portion.

Disposition

The court held that the FDA’s denial of the citizen petition was neither arbitrary nor capricious under the Administrative Procedure Act and did not violate the Food Act. Judge Vernon S. Broderick denied the plaintiffs’ motion for summary judgment and granted the FDA’s cross-motion for summary judgment. The Clerk was directed to terminate the relevant docket entries and close the case.