The international gold standard of laboratory animal care may have lost a bit of its luster. Labs accredited by the United States’ only independent certifier of research animal welfare violate national animal welfare guidelines more frequently than do unaccredited facilities, a study conducted by an animal rights organization has found. As both the National Institutes of Health (NIH) and the Department of Defense (DOD) waive certain inspection requirements for labs vetted by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International, the findings may force a rethink of how lab animal welfare is overseen in the United States and other countries.
“Funders, journal editors, and the general public should be reevaluating whether AAALAC accreditation is a meaningful distinction,” says the study’s lead author, Justin Goodman, the director of the Laboratory Investigations Department at People for the Ethical Treatment of Animals (PETA). But AAALAC’s executive director, Christian Newcomer, disputes that conclusion, saying the report is based on biased data collected by the U.S. Department of Agriculture (USDA). Still, he adds, “I can guarantee this study will generate discussion within AAALAC. It won’t be discounted just because it was conducted by PETA.”
AAALAC was founded in 1965 by leading scientists and veterinarians who wanted to provide rigorous independent oversight to the burgeoning use of lab animals. The United States was about to pass the Animal Welfare Act (AWA), which regulates the use of animals in research, but AAALAC’s creators felt it could be more nimble and knowledgeable than the USDA inspectors tasked with enforcing the minimal standards of the AWA, Newcomer says.
Today, more than 900 institutions in 38 countries have earned AAALAC accreditation, including the top 100 NIH-funded labs, and all major pharmaceutical companies, commercial laboratory animal breeders, and biotech companies. Although accreditation is voluntary, many granting agencies, including DOD, require it. Labs are subject to triennial inspections and must pay a yearly fee ranging from $2600 to more than $9000, depending on their size. “We have chosen to meet standards that go above and beyond the animal research regulations required by law,” reads a poster sold by AAALAC to accredited labs. Newcomer says that many labs have become accredited to combat growing public anxiety about animal testing.
But PETA’s Goodman notes that AAALAC keeps all of its inspections confidential. “There’s a lot of stock being put into this seal of approval, but what it actually means in terms of animal welfare has been unknown.”
So Goodman and colleagues turned to the only data they could get: the yearly on-site inspection reports USDA conducts at every government-funded lab that does animal research. In all, the researchers analyzed the 2010 and 2011 records from 823 facilities, 315 of which were AAALAC-accredited and 508 of which were not. On average, when controlling for the number of animals, accredited facilities were cited with 2.13 violations of animal welfare guidelines, or about one per year, whereas unaccredited facilities were cited for 1.56 violations, or about 0.75 per year, the team will report next month in the Journal of Applied Animal Welfare Science. (When the article is online, it will be available here.) The researchers also presented their findings Monday in Prague at the 9th World Congress on Alternatives and Animal Use in the Life Sciences.
“AAALAC accreditation has become more of a PR tool than a meaningful oversight mechanism,” Goodman says. He speculates that accredited facilities have become less vigilant about animal welfare. At the very least, he says, “you certainly can’t say that animals are better off in these facilities.”
But in an e-mail to Science, NIH’s Office of Laboratory Animal Welfare says the study’s implications are unclear. One complication is that Goodman’s team was unable to ascertain the specifics of each violation's actual impact on animal welfare. USDA has historically issued violations for everything from failing to anesthetize 50 goats during highly invasive surgical procedures to simple errors in paperwork. NIH also notes that AAALAC accreditation is just one of the many criteria it uses to evaluate an institution’s animal program. “For these reasons,” it writes, “it is difficult to concur with the authors’ conclusion.”
Newcomer says the USDA data on which the study is based is flawed. While noncertified labs tend to be smaller operations, performing simpler tasks such as using rabbits to create antibodies, AAALAC labs tend to be large and complex operations performing cutting-edge animal research, he contends. “These complex environments are disorienting to the USDA,” he says, and that makes the agency’s inspectors more likely to find violations. (A USDA spokesman responds: “Our inspectors are trained professionals with the knowledge and capacity to inspect regulated research facilities.”)
“It’s a really interesting report, and I applaud the effort to take a look at these data,” says Larry Carbone, the associate director of the Laboratory Animal Resource Center at the University of California, San Francisco. But Carbone, who has spent most of his career taking care of lab animals and who authored a book on the history of the AWA, agrees with NIH that the implications for animal welfare are murky. He also notes that in his experience, AAALAC inspections tend to be more rigorous than USDA inspections. Nevertheless, Carbone says, “If I were AAALAC, I would put together a task force to figure out if there really is a problem with their accreditation process. If there is, they should figure out a way to fix it.”
