Animal Legal Defense Fund v. Azar

Background

Animal Legal Defense Fund, Food & Water Watch, and Food Animal Concerns Trust challenged the FDA’s approval of Experior for use in cattle feedlots. Elanco Animal Health, the manufacturer, intervened as a defendant. Experior contains lubabegron and was approved for reducing ammonia gas emissions per pound of live weight and hot carcass weight in beef cattle confined for slaughter during the last 14 to 91 days on feed.

The plaintiffs brought claims under the Administrative Procedure Act and the National Environmental Policy Act. They argued that Experior had not been shown to be safe and effective and that the FDA failed to adequately consider environmental effects. The parties filed cross-motions for summary judgment. The opinion notes that the plaintiffs’ claim concerning the FDA’s denial of a request to stay the approval did not need to be reached because the parties agreed it was unnecessary.

Standing

The court rejected the defendants’ renewed standing challenge. The plaintiffs relied on associational standing, meaning an organization seeks relief based on injuries to its members. The court concluded that the members’ alleged injuries were sufficiently connected to the FDA’s approval because Elanco could market Experior, cattle producers could purchase and use it, and members could encounter the resulting effects. The court found that the plaintiffs’ prior declarations continued to support standing.

Evidence outside the administrative record

The court explained that review of agency action under the Administrative Procedure Act generally focuses on the administrative record that existed when the agency made its decision. Extra-record evidence is allowed only in narrow circumstances, such as when it is needed to determine whether the agency considered relevant factors, explain technical subjects, address documents on which the agency relied, or show bad faith.

The court excluded a 43-page declaration from Dr. John Tegzes and the FDA’s rebuttal declarations. It found that the Tegzes declaration was not necessary under the recognized exceptions, included improper legal conclusions and opinions, and would improperly invite the court to substitute its scientific judgment for the FDA’s. The plaintiffs remained free to make attorney arguments based on the alleged deficiencies identified in the declaration.

Deference to the FDA

The court rejected the plaintiffs’ argument that the FDA deserved less deference because the approval involved environmental effects. It held that evaluating the safety, effectiveness, and environmental effects of a new animal drug fell within the FDA’s statutory responsibilities and expertise. The court also stated that its conclusions did not depend on any particularly heightened level of deference.

Effectiveness

The court held that the FDA reasonably found substantial evidence that Experior would reduce ammonia gas emissions on the approved per-animal basis. The agency relied on five adequate and well-controlled studies involving 536 animals, conducted at Michigan State University and the University of California, Davis. The court rejected the plaintiffs’ arguments that the studies were inconclusive, did not establish the drug’s mode of action, failed to measure herd- or farm-scale emissions, or contained significant methodological problems.

The court emphasized that the approved claim concerned emissions per pound of live weight and hot carcass weight, not reductions in emissions at the herd, farm, or larger scale. The label disclaimed reliable predictions at those larger scales. The court also concluded that the FDA reasonably addressed concerns about feed and water intake, weight gain, environmental variables, nitrogen studies, and software used to collect data. The FDA’s effectiveness finding was not set aside.

Safety

The court held that the FDA reasonably evaluated human food safety, including through pharmacology, toxicology, residue chemistry, laboratory-animal studies, human studies, and a calculated safety factor. The court rejected the plaintiffs’ argument that the agency was required to conduct bladder-function testing to assess possible effects on a particular beta-3 receptor.

The court also found that the FDA considered risks to farmworkers by reviewing warnings about eye burns, organ damage, cardiovascular risks, and protective equipment. The possibility that workers might misuse the product or fail to use protective equipment did not establish that the product was too unsafe for approval. The court likewise found that the FDA reasonably addressed the plaintiffs’ concerns about risks to cattle. The FDA’s safety finding was not set aside.

National Environmental Policy Act

The National Environmental Policy Act requires an Environmental Impact Statement for major federal actions significantly affecting the human environment. The FDA instead prepared an Environmental Assessment and issued a Finding of No Significant Impact.

The court held that the FDA took the required “hard look” at environmental consequences, considered relevant factors, and provided a convincing explanation for its finding. The agency evaluated potential effects on soil microorganisms, plants, earthworms, algae, water fleas, rainbow trout, manure, soil, and surface water. Its risk-quotient analysis found values below one for the organisms studied, and the FDA concluded there was little or no potential for significant adverse effects on terrestrial and aquatic organisms.

The court rejected the plaintiffs’ argument that the FDA’s finding was inconsistent with approving Experior based on its environmental effects. It explained that the FDA’s effectiveness determination under the animal-drug statute and the significance determination under the National Environmental Policy Act use different standards. The court found no basis to remand the matter for further proceedings under the National Environmental Policy Act.

Sealing motions and disposition

The court denied the sealing motions as to all briefs supporting or opposing the substantive motions. For the administrative record, declarations, and exhibits supporting the motions, the court granted the sealing motions to the extent proposed by Elanco in Docket Nos. 138-2 and 136-2, and otherwise denied them.

The court denied the plaintiffs’ motion for summary judgment and granted the defendants’ cross-motions for summary judgment. It denied the motions to consider extra-record materials and granted the motions to strike the declarations offering those materials. The sealing motions were granted to the specified extent and otherwise denied. The order states that a separate judgment would enter.