incredible: USDA Secretly Curtails Oversight of AAALAC-Accredited Laboratories

“What you have to do to lose your accreditation is basically give them the finger and say we’re not doing that. Otherwise they will work with you for years.”

So stated, under oath, veterinarian Peggy Danneman during a 2011 deposition in a whistleblower lawsuit against The Jackson Laboratory. At the time, she was on the board of trustees—the governing body—of the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International. 

Nothing appears to have changed since Danneman’s sworn assertion. Despite AAALAC’s mission statement that voluntary accreditation “enhances the quality of research, testing and education by promoting humane and responsible research animal care and use,” the USDA record shows that animal suffering and death has occurred repeatedly for years at accredited facilities. 

This situation has taken on added significance recently, because the USDA has secretly changed its inspection system, enabling facilities with AAALAC accreditation to avoid the mandate of the Animal Welfare Act (AWA) for complete annual compliance inspections. Full compliance inspections will now occur only once every three years. The implied justification for this move pushed by industry (not that the USDA has offered any) is that AAALAC accreditation is an indication that the institution is more likely to be in compliance with the AWA—hence, no need for routine, thorough inspections. 

An examination of the record, however, demonstrates how far removed this is from reality. AAALAC merely “visits” (AAALAC’s term) its accredited facilities once every three years, and makes clear that such visits are not inspections. They are scheduled in advance, allowing plenty of opportunity for the facility to prepare. But the starkest indication that this new USDA scheme is wrong-headed involves the relationship between AAALAC accreditation and AWA compliance—or rather, the lack thereof. 

In 2014, the Journal of Applied Animal Welfare Science published a paper from Goodman et al. that found higher citation rates for AWA noncompliant items (NCIs) at AAALAC-accredited facilities than at non-accredited facilities. This paper prompted a response from AAALAC, published in Science (Newcomer, 2015). AAALAC’s primary argument was that all NCIs are not equal, with many lacking “demonstrable relevance to animal care, health, or well-being outcomes.” Last year, as industry lobby groups touted AAALAC while pushing for this new USDA policy, they further claimed that NCIs deemed “non-critical” by the USDA do “not pose a direct risk to animal welfare.” This is simply not true.

The USDA defines a “critical” NCI as one that has “had a serious or severe adverse effect on the health and well-being of the animal.” A “direct” NCI is a critical NCI that is currently adversely affecting health and well-being. “Non-critical” citations supposedly don’t involve either, with the implication that these non-critical citations shouldn’t be part of the discussion.

But a brief examination of instances involving non-critical citations shows just how hollow this argument is. Examples abound of citations at accredited facilities that the USDA deemed non-critical but nevertheless have caused tremendous animal suffering: A University of Wisconsin Madison inspection documented three monkeys who suffered dehydration after their water line became disconnected for days. They required IV fluids; nonetheless, one had to be euthanized. The inspector also found 12 instances of primates escaping enclosures due to hardware failure or human error, resulting in lost portions of tongues and other injuries requiring sutures or amputation of digits. Absorption Systems—which has had 16 citations in three separate inspections since 2016—failed to ensure that a study director had an advanced degree or proof of qualifications or training for surgery. Yet the Institutional Animal Care and Use Committee (IACUC) allowed him to conduct an acute surgical procedure on the very first sheep used under the protocol. The sheep died during the procedure. At Wake Forest University, a pig died after surgical complications. The necropsy showed a surgical towel had been left in his abdomen; he suffered from acute peritonitis. Colorado State University failed to provide any scientific justification for withholding painkillers or anesthetics for a protocol in which dogs and cats could experience unrelieved pain or distress, with the facility writing “N/A” in the space where the justification was mandated. Similarly, at Cincinnati Children’s Hospital Medical Center, four separate protocols did not contain any scientific justification for withholding painkillers or anesthetics.

The fact that these incidents—which quite obviously had serious and severe effects on animal health and well-being—were deemed non-critical is a clear indication that the USDA is underreporting critical/direct NCIs. But even if we indulge the pretense that these egregious incidents can be swept under the rug and limit ourselves solely to NCIs the USDA did designate as critical or direct (­as the industry would have us do), ­the numbers are still damning: From January 1, 2016, through July 31, 2019, of 92 registered research facilities with critical and/or direct citations, 60 were AAALAC accredited. Of 24 facilities with two or more separate inspections having critical and/or direct citations, 17 were AAALAC accredited. All nine facilities with three or more separate inspections having critical and/or direct citations were AAALAC accredited.

Here are just some of the examples taken from inspections of these facilities, all of which also have a history of USDA fines:

At the University of Washington ($10,893 USDA fine in 2011 and warning letter in 2014), a June 2019 inspection documented a monkey dying after surgery. He had not been fasted properly but surgery proceeded anyway, with a one-hour “abbreviated” fast. The monkey went into respiratory arrest during the recovery period. During CPR, he vomited and aspirated food, and later died. A November 2018 inspection found that a monkey died after the chain on an improperly installed enrichment device became entangled with his jaw. An April 2017 inspection documented that during a one-week period, more blood was removed than was approved from four monkeys. Moreover, unapproved blood draws were performed on a monkey who had already been identified as anemic (he was pale, with altered respiration). A January 2017 inspection documented an 8-year-old monkey who died from dehydration; the water line had been disconnected, but no one had noticed until this monkey was found lethargic during “unrelated rounds and treatments.” He died during veterinary treatment. Daily care logs indicated that the water bottles had been checked twice per day in the days prior to the death; clearly, that couldn’t be the case. 

A June 2019 inspection of a Covance dealer site in Alice, Texas, ($31,500 USDA fine in 2016) documented 25 monkeys who were not fed for six days, resulting in two requiring euthanasia. In September 2016, the USDA documented three monkeys who had suffered limb fractures that had been undiagnosed, and apparently unobserved, for days. A May 2019 inspection at Covance’s research site in Madison, Wisconsin, documented two instances of non-repairable orthopedic injuries in monkeys, requiring euthanasia. A May 2016 inspection documented a monkey who had diarrhea and baldness, collapsed twice and was given fluids by a technician, yet there was no documentation showing that the monkey was being treated for baldness or diarrhea, and he had not been seen by a veterinarian for over two weeks. An August 2017 inspection of Covance’s breeding site in Denver, Pennsylvania, documented multiple dogs suffering from not receiving adequate veterinary care, including a female beagle with an orange-sized mammary mass, and another with a bleeding paw wound. (Despite eight dogs described as not receiving adequate veterinary care, the USDA deemed this a single non-critical citation.) Insects/insect larvae were found in feed in all buildings, with some areas having insects in over 50 percent of self-feeders. Mold was also observed. 

A June 2019 report at Vanderbilt University ($8,156 USDA fine in 2010) documented multiple instances of major changes to protocols without IACUC approval, including 14 pigs used when 12 had been approved, and 23 gerbils used in a pilot study where only 10 had been approved. Anesthesia protocols involving the gerbils were not approved. Of the 23 gerbils used, 17 died, but none were reported to the IACUC. A September 2016 report documented a rabbit kicking his hind legs and screaming loudly during anesthesia induction; Vanderbilt proceeded with the surgery, and five hours after the surgery the rabbit’s legs were noted as “paralyzed.” Vanderbilt failed to contact a veterinarian until the next day. A galago (small nocturnal primate) recovered sooner than expected from general anesthesia after a 12-hour study procedure that included a craniotomy. Awake after this highly invasive and painful procedure, the galago became agitated and aggressive after researchers gave him a post-surgical injection—but they failed to give him the required painkiller. For eight hours, Vanderbilt failed to contact a veterinarian and allowed this animal to suffer. The veterinarian who finally examined him stated that there were no health or well-being issues.

At Oregon Health & Science University ($11,676 USDA fine in 2012), a June 2019 inspection documented that a lab group was using poor sterile technique for surgery on a ferret. The pilot surgery resulted in unexpected anatomical complications necessitating euthanasia. The euthanasia method was not approved. The same lab group had a ferret in restraint for training and skull cap care, yet the ferret had a “strong, foul” odor, with pus oozing from the skull cap, while another ferret was rubbing his head cap on a mattress, indicating distress. Neither of these ferrets had been reported to the attending veterinarian. An August 2018 report documented a young monkey who had been trapped by PVC pipes on a perch. After exhibiting neurological symptoms, the monkey was euthanized. Another monkey did not receive painkillers or antibiotics the morning after surgery. A February 2018 report documented a juvenile monkey dying after becoming trapped behind a cage. A baboon fractured his hand, caused by a guillotine door. A January 2016 report documented a monkey dying after entrapment in the chain of an obsolete enrichment device. 

The last administrative complaint filed against a research facility for failure to comply with the AWA was September 2016, against SNBL USA. The complaint described 38 monkey deaths. Weeks later, a November 2016 inspection documented multiple monkey deaths as well as stereotypical behavior (see AWI Quarterly, winter 2016). In response to the complaint, SNBL signed a consent agreement on December 2, 2016, mandating a $185,000 fine, 30-day dealer license suspension, and an order to cease and desist from violating the AWA. Yet a May 2017 inspection of SNBL documented 40 guinea pigs with open wounds and substantial swelling caused by irradiation; only 10 of the guinea pigs were provided painkillers. A monkey suffered two broken bones in his arm arising from the protocol, possibly from restraint, but SNBL waited 20 hours after observing the trauma before contacting a veterinarian. The monkey was euthanized. Despite this disturbing record, AAALAC continued to accredit SNBL USA until it was sold in September 2018. 

Clearly, AAALAC accreditation does not equate to AWA compliance. And yet, the USDA’s new system will exempt accredited research facilities from the full annual compliance inspections mandated by law. Instead, for each of the first two years, accredited labs will have a greatly abbreviated “focused” inspection of either the records, the physical facilities, or the animals—who, at accredited labs, could end up being inspected by USDA veterinarians only once every three years.

A couple of years ago, the USDA proposed to reduce oversight of accredited facilities regulated under the AWA. The department received more than 35,500 comments on this proposal—the vast majority opposed. The USDA withdrew the proposal and announced that it “will not recognize third-party inspections and certifications.” Flying in the face of that announcement is the USDA’s decision to reduce oversight of accredited labs. 

Industry will no doubt claim that the USDA’s risk-based inspection system will still result in closer monitoring of problem facilities like the University of Washington and Oregon Health & Science University. But such a defense—as well as the USDA’s secret adoption of this new system—ignores this fundamental truth: AAALAC accreditation simply does not ensure animal welfare compliance. As the years-long USDA record shows, accreditation did not prevent significant animal suffering and death at multiple labs. No amount of industry or USDA spin can obviate this incontrovertible fact. In short, the USDA cannot be allowed to “give the finger” to animal welfare, compliance with the law, and public accountability. 

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