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Natural Resources Defense Council v. United States Food & Drug Administration

ELR Citation: 42 ELR 20117
Nos. No. 11 Civ. 3562, (S.D.N.Y., 06/01/2012) (Katz, M.J.)

A district court held that the FDA violated the APA and the Food, Drug, and Cosmetic Act (FDCA) when it denied two petitions requesting that it withdraw approval of some uses of certain classes of antibiotics in food-producing animals. The petitions, submitted by environmental groups in 1999 and 2005, requested that the FDA begin withdrawal proceedings for all non-therapeutic uses of medical important antibiotics food producing animals. The FDA failed to offer a reasoned explanation, grounded in the statute, for its refusal to initiate withdrawal proceedings. For over 30 years, the Agency has been confronted with evidence of the human health risks associated with the widespread subtherapeutic use of antibiotics in food-producing animals, and, despite a statutory mandate to ensure the safety of animal drugs, the Agency has done "shockingly little" to address these risks. Denying the petitions on the grounds that it would be too time consuming and resource-intensive to evaluate each individual drug's safety, and withdraw approval if a drug was not shown to be safe, is arbitrary and capricious. Although the FDA intends to adopt a voluntary program outside the FDCA's regulatory scheme, the adoption of voluntary measures does not excuse the agency from its duty to review the petitions on their merits. The agency must evaluate the safety risks of the petitioned drugs and either make a finding that the drugs are not shown to be safe or provide a reasoned explanation as to why it is refusing to make such a finding.