July 01, 2021

Leaders at a Harvard University–based legal clinic are questioning whether a federal agency is risking the welfare of research animals by conducting partial, focused inspections, rather than full inspections, of certain research facilities.

In response, officials with the Department of Agriculture Animal and Plant Health Inspection Service contend that far from weakening the inspection process, the risk-based inspection system makes the best use of agency resources by focusing attention on those facilities that need it the most.

In early May, Science magazine published an article that describes a policy at APHIS of allowing focused inspections under the Animal Welfare Act of research facilities that have been accredited by AAALAC International, a private nonprofit organization that includes the AVMA among its member organizations.

Full versus focused inspections

Officials with APHIS and the Harvard University Animal Law & Policy Clinic disagree on whether full inspections are required under the AWA and whether focused inspections can provide sufficient guarantees that research animals are treated well.

Katherine Meyer, director of the Harvard legal clinic, said in a message to JAVMA that the law requires full inspections each year to ensure laboratories comply with minimum standards of humane treatment.

 The animals already sacrifice their lives, she said, and they deserve protections that guarantee their care.

The Harvard clinic provided a copy of a USDA memorandum, labeled as “for internal use only,” that indicates APHIS enacted a policy in February 2019 that mandated performing only focused inspections at AAALAC-accredited research facilities unless the facilities requested full inspections. The document states that, of the first 322 inspections performed since the policy was enacted, 151 involved AAALAC-accredited facilities, and 91 of those facilities underwent focused inspections.

“We heard that some facilities requested a full inspection because they were concerned about the appearance of a ‘focused inspection’ (since such inspections have historically occurred to follow up on complaints involving animal welfare or direct noncompliance),” the USDA memo states. “We also heard that facilities and inspectors appreciate the ability to focus the inspection, and inspectors remain confident with the animal welfare at the facilities.”

APHIS spokesperson Lyndsay Cole provided a statement that AAALAC accreditation is one factor considered in determining whether a facility will receive a focused inspection, as is a facility’s previous compliance with the AWA. Inspections remain unannounced, laboratory facility officials don’t know whether they will receive a focused inspection, inspectors may decide at any time to instead conduct a full inspection, and the agency keeps the information on how it determines which facilities will receive focused versus full inspections confidential.

Inspection standards and practices

Dr. Kathryn Bayne, CEO of AAALAC International, said in a statement that the organization strives to ensure responsible animal care and use and that AAALAC’s accreditation program is complementary to USDA inspections. A USDA policy of conducting focused inspections by default at all AAALAC-accredited facilities would be impractical as the USDA and AAALAC International have substantial differences in their oversight programs, she said.

Dr. Bayne noted that AAALAC’s accreditation standards exceed federal requirements and its accreditation program is part of a matrix of animal research oversight that includes APHIS and the National Institutes of Health Office of Laboratory Animal Welfare. AAALAC has promoted humane and responsible care and use of research animals for more than 50 years, she said.

Dr. Stuart Leland, chair of the Veterinary Consortium for Research Animal Care and Welfare and director of research integrity and assurance at Princeton University, believes federal law gives APHIS discretion on how to conduct its investigations and decide how best to ensure animal welfare. Dedicating resources where they are most needed could help improve animal welfare at institutions that lack resources or haven’t proven their ability to comply with the AWA and its regulations, he said.

He and counterparts from other research institutions have been aware for years that APHIS could conduct focused inspections in one of three areas regulated under the AWA: animals, facilities, or records. His facilities’ two most recent AWA-related inspections were both focused ones, the first on the animals and the second on records.

Dr. Leland also said the focused inspections may let APHIS officials conduct deeper dives into certain aspects of a facility, rather than taking a broad look at all AWA-regulated activities during each inspection.

Asked whether the focused inspections are good policy, Dr. Leland said he would wait to see agency data that would allow comparisons across years in terms of violations found and citations issued. Finding similar numbers of violations and citations would suggest the inspection system at least meets the quality of the previous system, he said, although he acknowledged other variables could affect those figures.

Public notice

The Science article and a related announcement from the Harvard Law School Animal Law & Policy Clinic both suggested that APHIS officials adopted the policy without public announcement, meaning the public may not have been aware of the change. A researcher with the legal clinic discovered the policy in documents obtained through a public records request filed on behalf of two advocacy organizations, Rise for Animals and the Animal Legal Defense Fund.

Still, Dr. Donna Matthews Jarrell, president of the American College of Laboratory Animal Medicine, said in a statement that ACLAM leaders and other members of the laboratory animal community had been aware of the changes in USDA policy and that those changes had been major discussion points at meetings, gatherings, and webinars in 2019. She noted that discussions at one of those meetings, the Public Responsibility in Medicine and Research’s annual conference on animal care and use, included discussions of the topic that were open to the public.