Not So Fast
Those protections were short-lived, however, at least with respect to the 95 percent of animals used in research, i.e., birds, rats, and mice. In one of the more bizarre episodes of AWA enforcement, in 1971, the U.S. Department of Agriculture (USDA), in its regulations implementing the 1970 amendments, misinterpreted Congress’ intent and declared that birds, rats, and mice are not animals for purposes of AWA protections. This ushered in decades of legal challenges, as discussed below.
More legal protections for research animals would be enacted—though, again, none would apply to birds, rats, mice, or cold-blooded animals. The 1976 amendments required, among other things, that all federal agencies using laboratory animals—including the Army, Air Force, and National Institutes of Health—show full compliance with the Act.
In 1985, the Food Security Act—an omnibus farm bill—included The Improved Standards for Laboratory Animals Act (ISLAA), which amended the AWA to minimize pain and distress of animals in laboratories. It established an information service—the Animal Welfare Information Center—within the National Agricultural Library, in cooperation with the National Library of Medicine, to provide data on alternatives to using animals in research, help prevent unintended duplication of experiments and tests, and supply information to institutions for training scientists and other personnel in humane laboratory practices.
As a result of these amendments, each registered research facility must appoint an Institutional Animal Care and Use Committee, which must include a veterinarian and an unaffiliated person to represent the general community interest in the welfare of animals. The committee must inspect the facility’s animal laboratories twice a year and report any deficiencies. If the deficiencies are not corrected promptly, the USDA must be notified for enforcement action, and any funding agency involved must be informed so they can decide whether grants should be suspended or revoked.
ISLAA also requires investigators to consider alternatives and to consult with a veterinarian before beginning any experiment that could cause pain. They must adhere to standards set by the Secretary of Agriculture for pre- and post-surgical care, including in the administration of pain-relieving drugs, euthanasia, against the use of paralytics without anesthesia, and the unnecessary use of the same animal for more than one major operation. Exceptions are only provided when the procedures are required by a research protocol and an explanation is provided for any deviation. After proper adjudication, in addition to license suspension or revocation, civil penalties may be ”not more than” $10,000 for an AWA violation; criminal penalties may include fines and jail time; and a fine of $1,500 may be assessed for failure to obey a cease-and-desist order. Each day that such violations continue is considered a separate offense.
The 1985 amendment also required registered research facilities to provide exercise opportunities for dogs and psychological enrichment for primates in laboratory settings.
Of course, none of these changes—including these steps toward minimizing pain and unnecessary use of animals—benefit birds, rats, or mice.
Going to Court
It was at the behest of the research industry that birds, rats, and mice were unceremoniously excluded from the definition of “animal” in the 1971 regulations, and they turned up the heat in response to lawsuits aimed at restoring coverage for these species.
In 1991, the Animal Legal Defense Fund, Humane Society of the U.S., and two individuals from those organizations sued the USDA over its exclusion of birds, mice, and rats from the definition of animal under the AWA. DC Circuit Court Judge Charles Ritchey, ruling on the USDA’s motion to dismiss, found not only that the plaintiffs had standing to sue but also had stated a claim inasmuch as the Court found that “the Secretary was not necessarily acting within the discretionary authority delegated by Congress when he determined that birds, mice and rats are not covered by the FLAWA.” Judge Richey noted that the discretion accorded to the USDA was limited, and that Congress’ failure to respond to the department’s action was “not sufficient to prove” that the plaintiffs wouldn’t prevail.
In 1992, then hearing the case on its merits, Judge Ritchey granted the plaintiffs’ request for summary judgment, calling out the perversity of the USDA’s 1971 action, and finding that “the agency's exclusion of the animals is arbitrary and capricious and not in accordance with the law.”
That victory was short-lived. In 1994, the Court of Appeals for the District of Columbia reversed, ruling that the plaintiffs didn’t have standing.
But all was not lost! Afterwards, the Washington Post reported the following:
Louis Sibal, director of the Office of Laboratory Animal Research at the National Institutes of Health, said the ruling does not mean that laboratory animals can be abused with impunity; he said federally funded researchers are encouraged to follow animal-care recommendations published by the Public Health Service [(PHS)], which are strict enough to ensure that such animals are not mistreated.
“Encouraged” to follow the PHS standards? The research community’s chief argument against AWA coverage for these species was that animals in labs are sufficiently protected thanks to guidance under NIH, AAALAC, and Institutional Animal Care and Use Committees (IACUCs), and this “redundant” oversight would only increase the cost of using these animals, to the detriment of life-saving research. While the PHS Policy on Humane Care and Use of Animals (including the establishment of IACUCs) does in fact extend to all vertebrate animals (thus including birds, mice, rats, and cold-blooded animals), it is only a policy, and it applies only to PHS-supported research. Even if Mr. Sibel was right, encouragement is a long way from a requirement. Although facilities that violate PHS policy risk loss of funding, the PHS Policy and other guidelines do not have the force of law and do not require inspection by USDA Veterinary Medical Officers.
Going Back to Court
The 1994 appeals court decision was not the end either. In 1999, the Alternatives Research and Development Foundation (ARDF) sued the USDA over the definitional exclusions. In June 2000, Judge Ellen Huvelle of the U.S. District Court for the District of Columbia rejected the USDA’s arguments that the plaintiffs didn’t have standing, and that “the Secretary’s discretion to exclude certain animals from the Act is committed by law to his discretion and is not subject to judicial review.” With respect to the extent of the Secretary’s discretion, Judge Huvelle wrote—quoting Judge Ritchey from the prior cases—the following:
“this provision limits the Secretary’s discretion to determining whether a warm-blooded animal is used, or intended for use for those purposes specified in the definition,” it does not confer upon the Secretary the unbridled discretion to conclude that animals which are being used for research are not “animals” with the meaning of the Act.
Later that summer, the National Association for Biomedical Research (NABR) and Johns Hopkins University filed motions to intervene in the ARDF lawsuit. But the USDA settled the case in October and agreed to begin the process of extending AWA coverage to birds, rats, and mice. In 2001, the court denied the NABR’s motion to dismiss the ARDF/USDA settlement.
That same year, in response to continuing arguments that the USDA’s definitional exclusions were consistent with Congressional intent, former Senate Majority Leader Bob Dole (R-KS), who had been instrumental in strengthening the AWA, wrote a letter to ARDF saying, in part, “As someone deeply involved with the process of revising and expanding the AWA, I assure you that the AWA was meant to include birds, mice, and rats.”
In May of 2002, before the USDA could get to work on new regulations as required under the agreement with ARDF, Sen. Jesse Helms (R-NC), at the behest of researchers, succeeded in amending the Farm Security and Rural Investment Act, another an omnibus farm bill, to change the definition of “animal” in the AWA itself to specifically exclude birds, rats of the genus Rattus, and mice of the genus Mus, bred for use in research.
However, the amendment was not as all-encompassing as intended with respect to birds. Thanks to a punctuation error, the USDA wound up having to promulgate standards for the use of birds in the wholesale pet trade. That took a mere 21 years.
What Next?
“As it stand[s] now, the rats, mice[,] and birds who constitute the vast majority of the animals in research have no legal protection.” It is crucial to distinguish the legal protection afforded by AWA regulations from compliance with PHS Policy. “Basic standards for their housing and care are not overseen by USDA veterinary inspectors. The number of these animals in research is not reported. There is no legal mandate to consider alternatives to the use of these animals, or to devise means to alleviate or reduce pain and distress.”
Efforts will again be made to reverse this perversity in the law. In the meantime, a step has been taken to address another glaring omission. In 2023, Rep. Betty McCollum introduced The Cold-Blooded Animal Research and Exhibition (CARE) Act to extend Animal Welfare Act protections to animals currently excluded from the law, including fish, reptiles, amphibians, and cephalopods. Written in response to concerns about “cruel and dangerous” conditions for these animals in exhibits and breeding facilities, the bill would also bring about “a broad, positive impact on the conditions of both cold-blooded and warm-blooded animals in exhibition, research, and pet breeding facilities.”
