On Tuesday (April 5), the Harvard Law School Animal Law & Policy Clinic filed a suit against the United States Department of Agriculture for, it says, evading “its statutory obligation to conduct full annual inspections of research facilities as required under the Animal Welfare Act.”

The lawsuit, which was filed on behalf of the animal welfare organizations Rise for Animals and the Animal Legal Defense Fund, centers around the USDA’s decision to change how it handles inspecting research facilities that house animals for scientific study. Instead of conducting a full annual inspection itself, the agency decided to hire a third-party organization called the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International in February 2019, according to internal documents obtained through the Harvard team’s FOIA requests that were described in the suit and in an interview with The Scientist. But the USDA never publicly announced the change, which involved conducting only partial inspections of AAALAC-accredited facilities. Previous reporting on that documentation suggests the USDA made the decision in order to ease the workload of its inspectors, but the lawsuit suggests that the agency is effectively shirking its responsibilities under the Animal Welfare Act (AWA) while still claiming to perform robust inspections of research sites.

“My perception is that the agency is trying to find a cheaper way, a more efficient way to do inspections,” says David Favre, an animal law expert at Michigan State University who’s not connected to the lawsuit. “And when a lab is already inspected under the other set of codes, they don’t have as much to look at because it’s already being covered by someone else.”

AAALAC International is a private, nonprofit organization that evaluates research institutes to ensure they meet animal treatment standards. Its website claims that the organization has more than 1,000 members, including universities, government agencies, and scientific foundations. Unlike USDA inspections, AAALAC International site visits are announced in advance and, because the organization is a private institution, it’s not specifically beholden to the AWA, its internal documents are protected from FOIA litigation, and it’s not required to publicly disclose its findings. According to the lawsuit, this leaves research animal welfare in the hands of a largely voluntary framework of self-policing.

[The USDA] has sort of been caught with their pants down.

—David Favre, Michgan State University

A 2015 study in the Journal of Applied Animal Welfare Science found that AAALAC International–accredited facilities had a significantly higher number of AWA violations than nonaccredited sites and that accreditation did not increase compliance with animal welfare regulations.

“Peer-reviewed research finding that laboratories accredited by the [AAALAC], an industry trade association, had a higher rate of AWA violations than laboratories it does not accredit is significant because the animal husbandry requirements under the AWA are the bare minimum to give any meaning at all to the concept of ‘animal welfare,’” Taimie Bryant, director of the University of California, Los Angeles, Animal Law and Policy Small Grants Program, tells The Scientist over email. “Attending to animal welfare results in costs such labs do not want to incur, thereby creating a conflict of interest for the industry trade association (the AAALAC) and its inspectors when charged with inspecting for compliance with animal welfare requirements under the AWA.” Bryant and her program are not involved in the lawsuit.

See “Animal Welfare Records Return to USDA Website

“There are a lot of facilities that maintain AAALAC accreditation, even where the USDA has found severe AWA violations,” Max Hantel, a law student at the Harvard Clinic who’s working on the lawsuit, tells The Scientist. And while AAALAC International can put research sites on probation, he says, those institutions’ statuses aren’t disclosed. “It’s all secret. We don’t know who’s on probation, and the USDA treats it all as accredited.”

The Harvard team says that according to the emails it obtained via FOIA requests, the USDA explained to inspectors that a partial inspection for AAALAC International–accredited institutions should involve looking at no more than one of the following every year: the facility, the animals housed there, or the relevant paperwork. In some cases, inspectors need only confirm that some paperwork is on file, which means in practice that years could pass without inspectors examining a single animal at a given facility. Also in the FOIA'd emails, some inspectors asked hypothetical questions like whether they’d be able to perform a full inspection at smaller facilities where doing so would be fairly simple, but were told to refer to the new guidance. Inspectors were also told in the emails that the USDA decided against announcing the change and that they should not disclose the change in policy to the public.

Meanwhile, in its annual budget explanatory notes to Congress for 2022, the USDA uses general language to say that it continues to inspect all animal research sites as required by the AWA, making no mention of the new partial inspection system.

The USDA press office declined to comment for this story, citing the pending litigation. As of this article’s publication, AAALAC International has not responded to The Scientist’s request for an interview.

The Harvard team launched its FOIA investigation in response to what it regarded as suspicious claims from the USDA about a previous case, Hantel explains. In that case, groups including the Harvard Clinic sued the government for failing to mandate that primates used for research be kept in sufficiently engaging and enriching enclosures. The USDA responded to those claims by citing its unannounced annual inspections as proof that the institutes were AWA-compliant, but the subsequently released documents revealed that the agency had already sent out its instructions to perform partial investigations.

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This alleged discrepancy between the USDA’s handling of the inspection process and its legal obligation to conduct thorough investigations under the AWA is at the heart of the lawsuit. AWA-mandated inspections follow a carefully crafted process in which inspectors identify any ways research animals may be mistreated in terms of sanitation, psychological enrichment, husbandry, and overall care.

“If the USDA fails to require AAALAC inspectors to do full inspections and to fully report what they find, as alleged by Plaintiffs, the result is loss of irreplaceable important information,” Bryant says. “There is no other way to get the information about compliance with AWA requirements because only the USDA has inspection and enforcement rights.”

The animal welfare organizations suing the USDA claim damages based on the fact that the unavailability of public inspection records makes it difficult for them to conduct their business. That includes maintaining the Animal Research Laboratory Overview (ARLO) database, which Hantel describes as one of the primary windows into animal research available to anyone outside of those research institutes.

“I think it’s a credible lawsuit,” says Favre. The USDA “has sort of been caught with their pants down.”

“On its face, it’s at least embarrassing” for the USDA, Favre adds about the lawsuit. “And it can also be used as a call to Congress to step up and say something about it in the budget process.”

Hantel says he hopes that the lawsuit will get the organizations behind the litigation “the information they are required to have by law, because it’s critical to their missions.” In the bigger picture, he argues that “these self-policing voluntary measures aren’t doing it if we’re going to have a humane approach to scientific research on animals.” He adds that he wants to “return the USDA inspection regime to what it’s supposed to be under the law, under the Animal Welfare Act.”