ELR Citation: 52 ELR 20046
No(s). 19-CV-10005 (VSB) (S.D.N.Y. Apr 12, 2022) (Broderick, J.)

A district court denied nonprofit groups' motion for summary judgment in a challenge to FDA's denial of the group's petition concerning a threshold of regulation (TOR) exemption that allowed the inclusion of sodium perchlorate monohydrate in food-contact materials. The groups argued FDA violated the Food Act and the APA by failing to consider its own studies concerning perchlorate, failing to consider the cumulative effects of perchlorate in the diet, and failing to account for foods contacting multiple perchlorate-containing items. The court found that because the groups had not included the studies in their petition, it was neither arbitrary nor capricious for FDA not to have considered them, that neither FDA regulations nor the Food Act required the agency to consider cumulative effects when issuing a TOR exemption, and that the agency reasonably concluded that application of the single-use migration protocol was more protective than the groups' proposal to calculate exposure when a substance was used in both single- and repeated-use articles. It denied the groups' motion for summary judgment and granted FDA's cross-motion.