White Coat Waste Project, Inc. v. U.S. Department of Health and Human Services — D.D.C., No. 1:22-cv-00006 (CJN)

Case summary

White Coat Waste Project, Inc., a watchdog group, sued the U.S. Department of Health and Human Services and others in the U.S. District Court for the District of Columbia, No. 1:22-cv-00006 (CJN). Its amended complaint alleges that the National Institutes of Health violated the Administrative Procedure Act by exempting foreign grant recipients from requirements under section 495 of the Public Health Service Act, 42 U.S.C. § 289d, in particular the requirement to maintain an institutional animal care and use committee, and alternatively that the guidance at issue is rulemaking for which notice-and-comment requirements were disregarded. On August 2, 2023 the court denied the motion to dismiss, holding that at this stage the plaintiff has adequately established organizational standing and that its interests arguably fall within the statute's zone of interests.

Case at a glance

What did the court decide?

It denied the motion to dismiss. The opinion holds that at this stage in the proceedings White Coat has adequately established that it has organizational standing and that its interests arguably fall within the zone of interests protected by the Public Health Service Act, and that the court cannot say its interests are so marginally related to or inconsistent with the statute's purposes that Congress cannot be assumed to have intended to permit the suit.

What does the amended complaint allege?

That NIH enacted contradictory and binding agency rules exempting foreign grant recipients of taxpayer money for animal experiments from maintaining an animal care committee, and that as a result White Coat had to divert and redirect its limited resources to counteract and offset those actions and omissions, including by exhausting alternative repositories of information because the exemption relieves foreign entities of certain record-keeping and reporting obligations.

What is the statutory framework?

The opinion records that section 495 of the Public Health Service Act, 42 U.S.C. § 289d, requires the Secretary of Health and Human Services, acting through the Director of NIH, to establish guidelines for the proper care of animals used in NIH-funded research, that applicants must provide assurances of compliance, and that no entity may receive funding for animal research unless NIH approves its animal welfare assurance. Domestic institutions must set up an animal care committee, while foreign institutions may instead submit evidence that acceptable standards will be met.

Summary written from the documents on this page; every sentence is sourced.