NRDC v. US FDA, No. 12-2106 (2d Cir. 2014)Annotate this Case
Plaintiffs contend that the FDA is required by 21 U.S.C. 360b(e)(1) to proceed with hearings to determine whether to withdraw approval for the use of penicillin and tetracyclines in animal feed, and that the FDA's denial of two citizen petitions demanding such hearings was arbitrary or capricious within the meaning of 5 U.S.C. 706(2). Based on the court's survey of the text, the context, the regulations, and the background legal principles, the court concluded that Congress has not required the FDA to hold hearings whenever FDA officials have scientific concerns about the safety of animal drug usage, that the FDA retains the discretion to institute or terminate proceedings to withdraw approval of animal drugs by issuing or withdrawing notices of opportunity for hearing (NOOHs), and that the statutory mandate contained in section 360b(e)(1) applies to limit the FDA's remedial discretion by requiring withdrawal of approval of animal drugs or particular uses of such drugs only when the FDA has made a final determination, after notice and hearing, that the drug could pose a threat to human health and safety. The court also concluded that it is not arbitrary or capricious for the FDA to pursue policies intended to reduce the use of animal feed containing antibiotics through a variety of steps short of withdrawing approval for the use of antibiotics in feed via a protracted administrative process and likely litigation. Accordingly, the court reversed the district court's judgment to the contrary and remanded for further proceedings.