Animal Legal Defense Fund v. Azar

Background

The plaintiffs brought an action under the Administrative Procedure Act challenging the Food and Drug Administration’s approval of Experior for use in cattle feedlots. In such cases, review generally is limited to the administrative record—the materials the agency considered when making its decision.

To support their motion for summary judgment, the plaintiffs offered a 43-page declaration from a proposed expert witness. They said the declaration could help the court determine whether the agency had considered all relevant factors and explained its decision, or could explain technical terms and complex subject matter. The plaintiffs filed a separate motion concerning whether the declaration should be considered.

Motion and analysis

The defendants asked the court to advance the hearing on the declaration-related motion and adjust the schedule for briefing on the parties’ summary-judgment motions. The defendants wanted the declaration issue decided before their summary-judgment opposition was due. The parties had been unable to agree on that timing.

The court explained that questions about whether an agency produced a complete administrative record generally should be decided before and separately from summary judgment. But when a party offers material outside the administrative record for one of the limited permissible purposes identified in prior cases, there is no fixed rule requiring the issue to be decided at a particular time.

The court tentatively viewed the declaration as largely addressing technical issues. To that extent, it appeared similar to explanations and arguments that counsel could provide in briefing. The defendants could challenge the declarant’s explanations, submit their own declarations if necessary, and contest the factual basis and reasoning of assertions that the agency had failed to consider relevant factors. The court also stated that legal conclusions in the declaration would not be treated as evidence.

Ruling

The court denied the defendants’ request to advance the hearing on the declaration-related motion. It was not prepared to decide before the summary-judgment briefing how much, if any, of the declaration should be considered, noting that such declarations can prove largely immaterial to the analysis. The parties could stipulate to further adjustments of the briefing schedules.

This order addressed the timing of the declaration-related hearing and the briefing schedule; it did not decide the merits of the challenge to the FDA’s approval of Experior.