Court Dismisses Lawsuit Challenging Perchlorate in Food Packaging

A New York federal judge ruled in favor of the U.S. Food and Drug Administration (FDA) concerning the agency’s denial of a citizen petition to revoke the Threshold of Regulation (TOR) exemption allowing the inclusion of perchlorate in plastic food-contact articles. In the April 12, 2022 ruling, Judge Vernon Broderick found that FDA’s decision to deny the plaintiffs’ citizen petition was neither arbitrary nor capricious in violation of the Administrative Procedure Act (APA) and did not violate the Federal Food, Drug, and Cosmetic Act, as the plaintiffs had argued, in National Resources Defense Council, Inc. et al v. U.S. Food and Drug Administration et al.

By way of background, the Natural Resources Defense Council and other nongovernmental groups petitioned FDA in 2014 to revoke the TOR exemption and promulgate a rule to ban the use of perchlorate in food-contact materials. On May 4, 2017, FDA denied the petition, and the next month the plaintiffs filed objections to FDA’s denial. On April 24, 2019, FDA sent the plaintiffs a letter explaining its reasons for denying their petition. The plaintiffs filed a lawsuit in the United States District Court for the Southern District of New York on October 29, 2019, alleging that FDA 1) ignored data from the Total Diet Study samples and its own analyses of that data; 2) failed to consider the cumulative effects of perchlorate in the diet; 3) failed to account for food contacting multiple perchlorate-containing food-contact articles.

“If the FDA were required to consider the total dietary concentration, it would be forced to deny every TOR exemption for a substance if it expects any molecule at level 0.5 ppb to migrate into the food supply, which is significantly below the toxicity level and clearly an absurd result,” wrote Judge Broderick.

With respect to the Plaintiffs’ argument that FDA should consider the cumulative exposure of multiple uses of perchlorate in the food supply chain, FDA stated that the single-use migration protocol is more protective than the Plaintiffs’ proposal to calculate exposure when a substance is used in both single- and repeated-use articles. The judge concurred and stated, “I will not second guess this well-reasoned and articulated agency conclusion based on its expertise.”