As we advocate for the liberation of the estimated 110 million-plus¹Carbone, L. Estimating mouse and rat use in American laboratories by extrapolation from Animal Welfare Act-regulated species. Sci Rep 11, 493 (2021). https://doi.org/10.1038/s41598-020-79961-0. 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”²Carbone, L. (2004). What animals want: Expertise and advocacy in laboratory animal welfare policy. Oxford University Press., 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%³Goodman J, Chandna A, Roe K. Trends in animal use at US research facilities. J Med Ethics. 2015 Jul;41(7):567-9. doi: 10.1136/medethics-2014-102404. Epub 2015 Feb 25. PMID: 25717142. of those suffering and dying in U.S. laboratories, as well as amphibians, reptiles, insects, aquatic species, and farmed animals used in agricultural research.⁴Monamy, V. (2017). Animal Experimentation: A Guide to the Issues (3rd ed.). Cambridge University Press. (“The mix of public and private regulation may be viewed as a result of the Animal Welfare Act’s failure to give legislative protection to all vertebrates.”)) Adding insult to injury, the federal agencies charged with enforcing this shell law have been captured⁵Kennedy, R. F., The Real Anthony Fauci. Skyhorse Publishing, Inc. (2021), at xv (“[] I also watched how the industry, supposedly being regulated, used its indentured servants on Capitol Hill to systematically hollow out [the idealistic institutions our country built to safeguard public health and democracy] beginning in 1980, disabling their regulatory functions and transforming them, finally, into sock-puppets for the very industry Congress charged them with regulating. My 40-year career as an environmental and public health advocate gave me a unique understanding of the corrupting mechanisms of ‘regulatory capture,’ the process by which the regulator becomes beholden to the industry it’s meant to regulate . . . I was astonished to realize that the pervasive web of deep financial entanglements between Pharma and the government health agencies had put regulatory capture on steroids . . . succeeding in transforming those agencies into subsidiaries of Big Pharma.” (emphasis added)) 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 inspections⁶Congressional Research Service, & Croft, G. K., The Animal Welfare Act: Background and Selected Issues (2022) (reporting that, in 2021, APHIS inspected only about 65% of all AWA licensees and registrants).; that, for those inspections it did undertake, its approach to legal enforcement has equated to, at best, “lax oversight”⁷Person, & Rachael Levy, S. N. L. (2022, December 19). Exclusive: Probe of Musk’s Neuralink to scrutinize long-criticized U.S animal welfare regulator. Reuters. Retrieved December 20, 2022, from https://www.reuters.com/world/us/probe-musks-neuralink-scrutinize-long-criticized-us-animal-welfare-regulator-2022-12-19/ (noting also that the USDA often fails to hold researchers accountable for failing to comply with law). and, at worst, unreasonable deference to the animal research industry⁸Berry, C., Hackett, B. R., Locke, P., & Montanaro, L. (2022). Challenges and Opportunities in Transitioning Away from Using Animals in Research. The Animal Law Conference. In https://www.animallawconference.org/2022-agenda/. Portland. Retrieved December 12, 2022. ; and that, in actuality, the USDA has been working “on the industry’s behalf”.⁹Fobar, R. (2022, December 11). Toothless and ‘paltry’: Critics slam USDA’s fines for animal welfare violations. Animals. Retrieved December 12, 2022, from https://www.nationalgeographic.com/animals/article/toothless-and-paltry-critics-slam-usda-fines-for-animal-welfare-violations. 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.¹⁰At the time of the AWA’s passage in 1966, Senators explicitly rejected the suggestion that AAALAC be allowed to determine AWA compliance in favor of mandating that compliance be determined by employees of the USDA. New England Anti-Vivisection Society, et al. v. Goldentyer, et al., Case No. 8:20-cv-02004-JRR, Document 43 (stating that “‘deferring to AAALAC ‘seems hardly adequate to the problem, especially since the inspectors would be drawn from the same scientific community involved in being inspected, a situation where there would be no serious impartiality’ and because 1) ‘AAALAC is ‘part of the same professional group that today is in charge of the research facilities of most of the research agencies in our various medical schools’ and 2) ‘AAALAC is an industry-dominated organization’.”; describing AAALAC as operating a “‘self-policing coverup of conditions in experimental laboratories.’”). 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.¹¹Grimm, D. (2021, May 5). USDA now only partially inspects some lab animal facilities, internal … Science. Retrieved December 21, 2022, from https://www.science.org/content/article/usda-now-only-partially-inspects-some-lab-animal-facilities-internal- documents-reveal (stating that the USDA decided not to include this policy change in its official inspection guidelines). (The USDA has directed its inspectors not to ask about AAALAC International accreditation status¹²Grimm, D. (2021, May 5). USDA now only partially inspects some lab animal facilities, internal … Science. Retrieved December 21, 2022, from https://www.science.org/content/article/usda-now-only-partially-inspects-some-lab-animal-facilities-internal-documents-reveal (stating that the USDA decided not to include this policy change in its official inspection guidelines). , 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 records¹³Robitzski, D. (2022, April 7). Lawsuit alleges USDA secretly relaxed animal welfare inspections. The Scientist Magazine®. Retrieved December 21, 2022, from https://www.the-scientist.com/news-opinion/lawsuit-alleges-usda-secretly-relaxed-animal-welfare-inspections-69889 (discussing the USDA’s attempt to shield inspection-related information from the public in 2017 by ending public access to an electronic database, which resulted in a U.S. Code amendment requiring the hosting of a publicly searchable database of AWA inspection reports, enforcement records, and research facility annual reports)., 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.¹⁴Grimm, D. (2021, May 5). USDA now only partially inspects some lab animal facilities, internal … Science. Retrieved December 21, 2022, from https://www.science.org/content/article/usda-now-only-partially-inspects-some-lab-animal-facilities-internal-documents-reveal.) Finally, instead of full inspections, USDA inspectors have been directed to undertake “focused” inspections¹⁵Rise for Animals and Animal Legal Defense Fund v. Tom Vilsack, Secretary of the United States Department of Agriculture and Elizabeth Goldentyer, Deputy Administrator of Animal Care, 8:22-cv-00810-TJS, United States District Court for the Southern District of Maryland (2022). 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).¹⁶Garner, R. (2007). Political animals: Animal protection politics in Britain and the United States. Macmillan Press, Ltd., at 205 (noting that AAALAC’s establishment by industry was intended to “show that animal welfare was being voluntarily upheld”).. 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 place¹⁷112 Cong. Rec. 13,893 (1966) by “setting a fox to watch the chicken coop.”¹⁸Animal Dealer Regulation: Hearings Before the Committee on Commerce, United States Senate, 89th Cong. 89-61 (May 25, 1996) at 202 (statement of Senator Clark); see 112 Cong. Rec. 13,893 (1966) (noting that “the inspectors would be drawn from the same scientific community involved in being inspected, a situation where there would be no serious impartiality”).

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 institutions¹⁹Carbone, L. (2004). What animals want: Expertise and advocacy in laboratory animal welfare policy. Oxford University Press. (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.²⁰AAALAC International. (2006). Preparing for an AAALAC International Site Visit.

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.²¹Thomas L. Wolfle, 50 Years of the Institute for Laboratory Animal Research (ILAR): 1953-2003, ILAR Journal, Volume 44, Issue 4, 2003, Pages 324–337, https://doi.org/10.1093/ilar.44.4.324. 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”²²Carbone, L. (2004). What animals want: Expertise and advocacy in laboratory animal welfare policy. Oxford University Press. 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”²³Carbone, L. (2004). What animals want: Expertise and advocacy in laboratory animal welfare policy. Oxford University Press. to emphasize “flexible self-regulation by research facilities”²⁴Carbone, L. (2004). What animals want: Expertise and advocacy in laboratory animal welfare policy. Oxford University Press (also describing the Guide as the “centerpiece of the NIH’s self-regulatory approach to laboratory animal welfare” and as the “professionals’ corrective and resistance to what they saw as ill-informed agendas of protectionists and legislators”).; remains “closed to outsiders, both in its authorship and in its enforcement”²⁵Carbone, L. (2004). What animals want: Expertise and advocacy in laboratory animal welfare policy. Oxford University Press (also describing the Guide as the “centerpiece of the NIH’s self-regulatory approach to laboratory animal welfare” and as the “professionals’ corrective and resistance to what they saw as ill-informed agendas of protectionists and legislators”).; explicitly avoids setting any restrictions on researchers’ investigative freedoms²⁶ Carbone, L. (2004). What animals want: Expertise and advocacy in laboratory animal welfare policy. Oxford University Press.; 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 world²⁷Nuwer, R. (2022). US agency seeks to phase out animal testing. Nature. Available at https://www.nature.com/articles/d41586-022-03569-9. , supported AAALAC International both at its founding and through its formative years (recognizing AAALAC International accreditation as assurance of compliance with the Guide since 1971²⁸Carbone, L. (2004). What animals want: Expertise and advocacy in laboratory animal welfare policy. Oxford University Press.), 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.²⁹See Carbone, L. (2004). What animals want: Expertise and advocacy in laboratory animal welfare policy. Oxford University Press (nothing that authorship by “technically nongovernmental” agencies (i.e, the Animal Care Panel and the Institute for Laboratory Animal Research) exempted the Guide from the government’s rules-writing regulations). 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.³⁰Greek, R., Greek, J. Is the use of sentient animals in basic research justifiable?. Philos Ethics Humanit Med 5, 14 (2010). https://doi.org/10.1186/1747-5341-5-14.)

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.³¹Goodman JR, Chandna A, Borch C. Does accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) ensure greater compliance with animal welfare laws? J Appl Anim Welf Sci. 2015;18(1):82-91. doi: 10.1080/10888705.2014.948625. Epub 2014 Aug 30. PMID: 25174609. 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.”³²Robitzski, D. (2022, April 7). Lawsuit alleges USDA secretly relaxed animal welfare inspections. The Scientist Magazine®. Retrieved December 21, 2022, from https://www.the-scientist.com/news-opinion/lawsuit-alleges-usda-secretly-relaxed-animal-welfare-inspections-69889 (citing Taimie Bryant, UCLA).

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 Monamy, V. (2017). Animal Experimentation: A Guide to the Issues (3rd ed.). Cambridge University Press. (stating that the National Science Foundation recognizes AAALAC accreditation as “evidence of exemplary standards of laboratory animal care”)., 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, improved³⁴Congressional Research Service, & Croft, G. K., The Animal Welfare Act: Background and Selected Issues (2022).), AAALAC International does not improve institutional compliance with federal law AND is associated with worse, legally-inadequate animal welfare for animals in labs.³⁵See Goodman JR, Chandna A, Borch C. Does accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) ensure greater compliance with animal welfare laws? J Appl Anim Welf Sci. 2015;18(1):82-91. doi: 10.1080/10888705.2014.948625. Epub 2014 Aug 30. PMID: 25174609. Indeed, as research scientists themselves have testified before Congress, AAALAC accreditation is a ‘farce’”³⁶Animal Dealer Regulation: Hearings Before the Committee on Commerce, United States Senate, 89th Cong. 89-61 (May 25, 1996) at 312. and the interests of the industry do not align with those of the public at large.³⁷Rudacille, D. (2001). The Scalpel and the Butterfly: The Conflict Between Animal Research and Animal Protection. University of California Press, at 222 (quoting Erwin Chargaff, “a new renowned genetics researcher” as saying that: “ . . . I have been too long a scientist to say certain kinds of experimentation should be forbidden by the authorities. But they should be controlled and I would not leave it to the scientists themselves to control themselves to ensure safe operations. Who will watch the watchers?’” (emphasis added)); Rudacille, D. (2001). The Scalpel and the Butterfly: The Conflict Between Animal Research and Animal Protection. University of California Press, at 222-223 (quoting Liebe Cavalieri, “another esteemed scientist” as asserting that “‘the evaluation of benefits and risks and the guiding rules of the game have been made by scientists, with only token input by nonscientists. Is it not the public to whom the results, good or bad, will accrue? It is presumptuous of the scientific community to assume that its interests coincide with those of society as a whole. Furthermore, in acting on this assumption, they have preempted a public function, that of decision making where its own fate is concerned. Scientists must obviously play a role in the progress, but not the only role.’” (emphasis added)).

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.”³⁸Leffingwell, A., MD (1916). An Ethical Problem. London G. Bell and Sons Ltd. Retrieved January 24, 2022, from https://www.gutenberg.org/cache/epub/20222/pg20222.html (stating that, “[f]or the prevention of cruelty it may be right to permit certain persons always to have the right to enter any laboratory whatever without previous notice; the fact that they may come at any time constitutes the safeguard to a limited degree. But such men must be persons unpaid by the State, of intelligence sufficient to comprehend all peculiarities of experimentation, and of a probity that no bribe can disturb. It would be far better to allow things to go on as they are than to have cruelty protected by public confidence in a legal supervision that did not sufficiently supervise and restrian [sic].”)

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.³⁹Congressional Research Service, & Croft, G. K., The Animal Welfare Act: Background and Selected Issues (2022). 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.⁴⁰Robitzski, D. (2022, April 7). Lawsuit alleges USDA secretly relaxed animal welfare inspections. The Scientist Magazine®. Retrieved December 21, 2022, from https://www.the-scientist.com/news-opinion/lawsuit-alleges-usda-secretly-relaxed-animal-welfare-inspections-69889.

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