Reuters reported on December 2. 5 that the USDA’s watchdog, the Office of Inspector General, is investigating Neuralink, a medical device company that develops brain implants, for possible animal welfare violations. A federal prosecutor in the Civil Division of the U.S. Attorney’s Office for the Northern District of California has requested the investigation, people familiar with the matter said.
Reuters was unable to determine which potential violations are being investigated. Dec. 5 reports identified four experiments over the past few years involving 86 pigs and two monkeys that were marred by human error. Errors weakened the research value of experiments and necessitated repeat testing, leading to the death of more animals.
Given that the USDA has cleared Neuralink’s facilities during eight visits over the past three years, federal investigators believe it is worth reviewing the USDA’s oversight of the company as it considers the potential animal welfare violations, people familiar with the investigation said.
Those sources said federal investigators’ decision to look into the USDA was bolstered by criticism from the USDA’s Office of Inspector General, which for years described the agency as overwhelmed and ineffective.
In 2014, the watchdog noted in a report that the department’s enforcement office “had a backlog of over 2,000 cases, a volume so large that (animal inspectors) couldn’t deal with serious violations quickly. “.
A USDA spokesperson told Reuters the agency could not comment on anything related to Neuralink and referred all inquiries to the inspector general, whose office declined to comment. The agency did not respond to requests for comment on its research experiences with animal surveillance nationwide.
The Department of Justice and the U.S. Attorney’s Office for the Northern District of California declined to comment. Spokespersons for Neuralink and Musk did not respond to requests for comment.
The USDA’s handling of a recent high-profile case involving Envigo, a dog breeding and research facility, also factored into federal investigators’ decision to review the agency’s oversight of Neuralink. the sources told Reuters.
In this case, law enforcement officials eventually stepped in, filing suit against the company this year, which resulted in a civil consent decree requiring Envigo to surrender approximately 4,000 beagles to the Humane Society of the United States. United.
Envigo’s parent company said in a statement to Reuters that it did not need to pay fines or admit wrongdoing in its agreement with the Justice Department.
LARGE WALKING MARGIN
A Reuters review of government records and interviews with two current and former USDA employees, a lawmaker and more than a dozen animal welfare experts paint a picture of an overwhelmed agency struggling to regulate the animal testing.
The USDA Animal Care Unit employs only 122 inspectors nationwide. They are responsible for monitoring 11,785 facilities, including laboratories, breeders and zoos, the Congressional Research Service, which conducts analysis for the US Congress, reported in July.
The USDA inspector general has issued at least three reports since 2014 criticizing the agency’s lax oversight, though his criticisms date back to the 1990s.
Lack of resources means the agency is often unable to hold researchers accountable when they fail to comply with the law, the inspector general found in his 2014 audit.
USDA lab inspectors operate separately from the agency’s inspector general, which audits the USDA and investigates animal welfare crimes to assist US prosecutors.
The law gives animal researchers wide latitude to conduct various tests, although companies can be penalized when they fail to conduct experiments in the manner approved by their committees, according to three regulatory experts interviewed by Reuters.
Some supporters of the current system – many of whom work in medical research – say it gives researchers the freedom they need to advance lifesaving medical treatments.
Naomi Charalambakis, associate director of science policy at the Federation of American Societies for Experimental Biology, said animal research was already “highly regulated, highly scrutinized” and no further regulation is needed.
She said she doesn’t believe what Reuters reported to Neuralink is representative of the vast majority of research labs.
The Animal Welfare Act, which governs animal testing, kills mice and rats. This is despite making up the vast majority of all animals used, including at Neuralink, according to more than a dozen current and former employees of the company.
The law states that research facilities form committees to review the use and care of animals in experiments. Only one committee member should be unaffiliated with the research institution. In human trials, all panel members involved in monitoring should be independent to avoid undue corporate pressure and other conflicts of interest.
Autumn Sorrells, Neuralink’s director of animal care, leads the company’s committee, which is made up of more than half a dozen Neuralink employees and three outsiders, according to internal company documents reviewed. by Reuters.
Sorrells did not respond to a request for comment. Neuralink states on its website that it champions animal welfare and tries to reduce animal testing where possible.
Two university studies conducted in 2009 and 2012 found that animal research committees approved between 98% and 99% of experiments proposed by researchers.
The USDA was particularly accommodating under former US President Donald Trump, when the agency allowed researchers to avoid violations if they reported them first.
In 2019, Neuralink and then-research partner University of California Davis self-reported an incident in which a Neuralink surgeon used sealant on a monkey monkey to fill a gap between two brain implants without the glue was approved by the research committee, according to emails and public documents obtained by the advocacy group Physicians Committee for Responsible Medicine (PCRM).
A university spokesperson declined to comment.
The USDA decided there was no violation due to the rule change introduced in 2018 under the Trump administration, Robert Gibbens, an agency official, told PCRM on Dec. 13. 6 in an email seen by Reuters.
“The facility discovered the non-compliance using its own compliance monitoring program and immediately took appropriate corrective action and established measures to prevent recurrence,” Gibbens wrote in the statement. ‘E-mail. “Therefore…there were no citations on the inspection report.”
Last year, the USDA changed its policy so that self-declaration of a violation no longer avoids a citation.
Gibbens referred Reuters to a USDA spokesperson, who did not respond to a request for comment.
LIMITED CONSEQUENCES
Two animal researchers told Reuters that USDA penalties for any infractions they may have committed would be minor compared to their institutions’ resources and funding.
The maximum fine of $12,771 per day per animal imposed by the USDA is rarely imposed, and the usual fines, potentially on the order of a few thousand dollars, are considered by violators to be “a normal cost of business “, said the inspector general in a report published in 2014.
The Inspector General audits the animal inspection program sporadically and the maximum penalties have not changed since.
What’s more, the vast majority of violations result in warnings or no action at all, according to a 2017 analysis by Delcianna Winders, animal rights expert at Vermont Law and Graduate School. His research found that issuing more warnings often failed to induce compliance with the law.
The Winders and Inspector General analyzes are the most recent found by Reuters. This year, the agency has fined just two research facilities — for less than $6,000 each — and issued warnings to five labs, according to public documents.
The USDA Inspection Service said in 2021 it opened just 118 cases after 7,670 site inspections, issued 58 official warnings, obtained eight administrative orders and suspended one establishment’s license for five. year.
Some animal welfare advocates interviewed by Reuters point to these statistics, arguing that greater enforcement is needed.
“There’s been this culture of non-enforcement that pervades the agency,” said Ingrid Seggerman, senior director of federal affairs for the American Society for the Prevention of Cruelty to Animals.
The agency’s handling of Envigo is a good example, these advocates say. As of 2021, USDA inspectors discovered multiple violations at Envigo facilities during routine inspections, including maggot-infested dog food and more than 300 dead puppies, but only took no measurement.
Reuters could not determine why the agency did not intervene to address what U.S. prosecutors later called violations of animal welfare laws.
Envigo was forced to sign the consent decree renouncing the beagles only after the USDA Inspector General and the Department of Justice investigated and found evidence of inhumane treatment.
USDA inspectors cannot examine every facility every year, despite their mandate to do so, due to their limited resources, and inspect about 65% of them instead, the Research Service reported this year. of Congress.
According to Eric Kleiman, a researcher at the Animal Welfare Institute, an advocacy group, only about 0.008% of the agency’s latest $430 billion budget is spent on animal welfare law enforcement. The figures were confirmed by Reuters.
“This funding is a pittance, as you can see, compared to the wealth and size and power of, say, many research facilities, let alone Elon Musk,” Kleiman said.
(Reporting by Rachael Levy, Sarah N. Lynch and Marisa Taylor in Washington, DC; Editing by Greg Roumeliotis and Ross Colvin)
By Rachael Levy, Sarah N. Lynch and Marisa Taylor
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