Animal Legal Defense Fund v. Azar

The federal district court for the Northern District of California denied motions to dismiss a lawsuit challenging the Food and Drug Administration’s (FDA's) approval of a drug intended to reduce releases of ammonia gas from the waste of cattle raised for beef. The plaintiffs’ claims include that FDA failed to consider the drug’s environmental impacts, including impacts from air emissions from concentrated animal feeding operations. The court rejected arguments that the plaintiffs did not have standing or that they failed to exhaust administrative remedies.

Three organizations filed a lawsuit in the federal district court for the Northern District of California alleging that the U.S. Food and Drug Administration (FDA) violated the Federal Food, Drug, and Cosmetic Act and the National Environmental Policy Act when it approved a drug “that allegedly results in less ammonia gas released from the waste produced by cows raised for beef.” In addition to allegations regarding the drug’s safety and effectiveness, the complaint also alleged that the environmental assessment prepared in support of the drug’s approval failed to adequately analyze whether the approval would have a significant adverse impact. The complaint alleged, among other things, that the reduction of ammonia emissions “while confining the same or greater number of cows in [concentrated animal feeding operations (CAFOs)] will do nothing to alleviate the overall air impacts of CAFOS,” including emissions of the greenhouse gases methane and nitrous oxide.