The Sordid Self-Policing of the Animal Research Industry

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The Sordid Self-Policing of the Animal Research Industry

Rise for Animals, March 21, 2024

As we advocate for the liberation of the estimated 110 million-plus¹ other-than-human animals commodified, brutalized, and killed in the name of science each year in the U.S., the research industry claims, over and over again, that its practices are highly regulated. That its laboratories must meet stringent federal standards. That its employees are legally required to prioritize the well-being of the other-than-human animals subjected to their research efforts. And, that research on other-than-human animals continues because it benefits humans.

Unfortunately, these claims are as disingenuous as they are inaccurate.

The Misconceptions and Reality of Animal Welfare in Research

Minimum care standards for animals incarcerated in research facilities are promulgated through the federal Animal Welfare Act (the “AWA”), and, though the animal research industry would have you believe that this Act requires their consistently conscientious and compassionate treatment of other-than-human research subjects, the AWA sets the barest of life-sustaining standards, does not prohibit a single type of harm to a nonhuman (no matter how egregious), and applies at best to approximately 5% of the other-than-human animals subjugated by researchers. (Building upon Congress’ emphasis that none of the AWA’s provisions were intended to “interfere with the design or conduct of research experiments”², the animal research industry has been successful in exempting from the AWA’s minimal coverage rats, mice, and birds bred for research, who together comprise 95-98%³ of those suffering and dying in U.S. laboratories, as well as amphibians, reptiles, insects, aquatic species, and farmed animals used in agricultural research.⁴) Adding insult to injury, the federal agencies charged with enforcing this shell law have been captured⁵ by the very industry they are responsible for regulating. Apparently, for the animal research industry, even the most minimal standards of animal welfare that, at best, apply to 1 out of 20 other-than-human animals in their care are too onerous and must be circumvented.

The USDA: Failing to Perform its Required Compliance Inspections

Though the system of regulating animal research is most aptly categorized as self-regulatory, an oversight role was carved out for the federal government: the United States Department of Agriculture (the “USDA”) is charged with enforcing the AWA against all institutions subject to its mandates. By the USDA’s own design in shaping its regulatory undertakings, the USDA’s Animal and Plant Health Inspection Service (“APHIS”) is supposed to conduct yearly, unannounced inspections of research facilities to ensure compliance with federal animal welfare standards – but this has not happened. In fact, criticism of the USDA’s efficacy in this regulatory role has been biting and has included incontrovertible evidence that the USDA has failed to perform its required compliance inspections⁶; that, for those inspections it did undertake, its approach to legal enforcement has equated to, at best, “lax oversight”⁷ and, at worst, unreasonable deference to the animal research industry⁸; and that, in actuality, the USDA has been working “on the industry’s behalf”.⁹ And, though the USDA has denied these staunch allegations, its actions leave no room for doubt about its allegiance: the USDA has partnered directly with the animal research industry itself to regulate – well – the animal research industry.

AAALAC International: A Private, “Industry-Dominated” Organization

Since 2019, the USDA has deferred to an industry trade group – the Association for Assessment and Accreditation of Laboratory Animal Care (“AAALAC”) International – in regulating and considering the legal compliance of animal research facilities. A wholly private, non-governmental organization, AAALAC International “accredits” animal research facilities that voluntarily apply and pay for its “accreditation”, and the USDA has allowed AAALAC-accredited institutions to avoid the AWA mandate that they be inspected by the federal government yearly.¹⁰ In fact, the USDA quietly changed its inspection policy to prohibit its inspectors from conducting full annual inspections of any research facility that claims AAALAC International accreditation.¹¹ (The USDA has directed its inspectors not to ask about AAALAC International accreditation status¹², and, because AAALAC International is incorporated as a non-profit entity, the USDA has no right-of-access to AAALAC International’s records. The confidentiality of AAALAC International records is worth emphasizing, because the USDA has historically tried but failed to restrict public access to its regulatory records¹³, finally succeeding by shifting significant regulatory oversight to a non-governmental operation (i.e., AAALAC International). In making this move, the USDA knowingly denied the public and itself access to AAALAC International records.¹⁴) Finally, instead of full inspections, USDA inspectors have been directed to undertake “focused” inspections¹⁵ that consider a sampling of either a laboratory’s facilities, records, or other-than-human animals – meaning that years could go by without the USDA setting eyes on a single other-than-human animal at any given registered laboratory.

By way of important background, AAALAC International was founded in 1965 by animal research trade associations that sought to prevent the passage of the 1966 Laboratory Animal Welfare Act (the first Act to affect the use of other-than-human animals for research).¹⁶ Since its inception, AAALAC’s existence as an animal research industry trade group has been widely known and even recognized by Congress itself: in considering a proposal to have AAALAC, instead of the USDA, regulate AWA compliance, Congress concluded that AAALAC oversight would serve only to repeat the “shocking failures of self-policing” that had motivated enactment of the AWA in the first place¹⁷ by “setting a fox to watch the chicken coop.”¹⁸

It should come as no surprise, then, that AAALAC International remains brazenly transparent in its allegiance to industry – indeed, it is, and always has been, the industry itself. AAALAC International is funded by the same institutions that pay it for “accreditation”, and AAALAC has structured its operations in complete deference to these institutions’ interests. By ways of example, in undertaking its “accreditation” function–which the USDA treats as a stand-in for its own duties–AAALAC International relies on pre-scheduled “visits” to (not “inspections of”) research facilities once every three three years; has ad hoc consultants, peers based at other research institutions¹⁹ (i.e., individuals invested in the very industry they are supposedly assessing), undertake these “visits”; and describes accreditation as a “partnership” between the research facility and AAALAC International.²⁰

Further, AAALAC International utilizes, as its principal standard in evaluating research facilities, the Public Health Service’s Guide for the Care and Use of Laboratory Animals (known as the “Guide”): a set of guidelines lacking the general force of law but constituting the “most influential document in the field . . . the document of reference” for the federal government’s Public Health Service Policy on Humane Care and Use of Animals.²¹ AAALAC International utilizes these guidelines instead of the legally-binding federal law (the AWA) that the USDA is charged with enforcing. Unlike the AWA, a “congressional law” that was “imposed upon scientific research from the outside”²² and that applies to all research facilities, the Guide grew from a set of “self-regulatory standards and guidance” that was created “almost exclusively” by “scientists and laboratory animal veterinarians”²³ to emphasize “flexible self-regulation by research facilities”²⁴; remains “closed to outsiders, both in its authorship and in its enforcement”²⁵; explicitly avoids setting any restrictions on researchers’ investigative freedoms²⁶; and applies only to those research facilities receiving funding from the National Institutes of Health (the “NIH”).

The NIH: The World’s Leading Funder of Animal Research

The NIH, part of the Public Health Service and the single largest funder of animal research in the world²⁷, supported AAALAC International both at its founding and through its formative years (recognizing AAALAC International accreditation as assurance of compliance with the Guide since 1971²⁸), and contracted indirectly with AAALAC International (through its parent entity) to compile the Guide – meaning that AAALAC International drafted, and continues to interpret through the publishing of position papers, the very federal guidelines that it gets paid to help enforce.²⁹ Put differently, the research industry, of which AAALAC International is a key component, has from inception defined and continues to define the regulations that govern its industry’s operation and is, effectively, allowed to “enforce” these regulations against itself. Should there be any doubt, one need only recognize that both the USDA and the NIH have decided that non-governmental (i.e., AAALAC International) accreditation serves as prima facie evidence of compliance with applicable federal law (such as the AWA), federal regulations (such as the Guide), or both; and that AAALAC-accredited facilities receive preferential treatment when seeking animal research funding – much of such funding coming directly from the USDA and the NIH, which subsidize a great number of the very research undertakings they are tasked with evaluating. (The NIH itself spends at least 50% of its $40B+ budget on animal research each year.³⁰)

It seems self-apparent that allowing research facilities to skirt federal laws and regulations is irresponsible, at best, and nefarious, at worst. And this paradigm would be alarming enough without the immeasurable direct harm that results from it: on average, AAALAC-accredited institutions violate the AWA more often than non-accredited entities – put differently, AAALAC-accredited labs satisfy the most minimal standards of care for nonhuman animals less often than non-accredited labs.³¹ Tragically, this makes cents (pun intended): because attention to animal welfare implicates financial costs that research facilities strongly resist, there exists a strong incentive for AAALAC International, as the animal research industry’s premier trade association, to skirt the AWA’s animal welfare requirements.”³²

The Disconnect: Public Trust and Animal Welfare

So, even though the animal research industry and the federal government tout AAALAC-accreditation as some kind of gold seal for animal welfare commitment³³, and even though the USDA allows AAALAC International accreditation to stand in place of federally-mandated and -undertaken inspections (hollowly claiming that compliance with animal welfare standards is, thereby, improved³⁴), AAALAC International does not improve institutional compliance with federal law AND is associated with worse, legally-inadequate animal welfare for animals in labs.³⁵ Indeed, as research scientists themselves have testified before Congress, AAALAC accreditation is a ‘farce’”³⁶ and the interests of the industry do not align with those of the public at large.³⁷

Further, because AAALAC-accredited facilities receive preferential treatment when seeking animal research funding, the effect of this paradigm is almost assuredly to place greater numbers of animals in greater numbers of research facilities that commit greater (both in number and severity) violations of the U.S.’s most minimal animal welfare standards. Indeed, it has been argued that this form of “regulation” is worse than no regulation at all because it allows “cruelty” to be “protected by public confidence in a legal supervision that [does] not sufficiently supervise and restr[ai]n.”³⁸

Rise for Animals, in partnership with the Animal Legal Defense Fund and the Harvard Animal Law & Policy Clinic, has sued the USDA over its impermissible “partnership” with the animal research industry (which it is charged with overseeing), specifically, and its dereliction of duty, generally. In response, the USDA falsely asserted that AAALAC-accredited facilities have better compliance records.³⁹ The USDA also lied to Congress in a 2022 budget explanatory note, wherein it asserted that it continues to inspect all animal research facilities as required by the AWA.⁴⁰

Everyone deserves to know the truth. Help expose the sordid realities of the animal research industry by sharing this investigative report among your network now.

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