Elon Musk’s brain-computer interface company, Neuralink, is being investigated by the US Department of Transportation for allegedly packaging and transporting contaminated hardware in an unsafe manner, a DOT spokesperson confirmed to CNBC.
In a letter to Transportation Secretary Pete Buttigieg on Thursday, the Animal Welfare Group’s Medical Committee for Responsible Medicine said it obtained public records indicating Neuralink may have mishandled a device carrying an infectious pathogen that posed a risk to human health in 2019.
The device was removed from the brain of a nonhuman primate and may have been contaminated with viruses like Herpes B and antibiotic-resistant bacteria like Staphylococcus and Klebsiella, according to the letter. PCRM claims the materials were not present or transported properly, possibly because Neuralink employees had not received proper safety training.
A DOT spokesperson told CNBC it is “standard practice” to investigate alleged violations of hazardous materials transportation regulations. The Pipeline and Hazardous Materials Safety Administration, part of the DOT, is conducting “standards investigations to ensure compliance and the general safety of workers and the public” based on information received from the PCRM, a spokeswoman said.
A representative from Neuralink did not respond to a request for comment.
Neuralink is one of the companies in the emerging brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technology, allowing patients to move the cursor, type and even access smart home devices using only their thoughts. Several companies have succeeded in creating devices with these capabilities.
Musk, who is also the CEO of Tesla, SpaceX and Twitter, founded Neuralink in 2016 with a group of scientists and engineers. The company is developing a BCI designed to be inserted directly into brain tissue, and while it has yet to test the device in humans, Musk said he expects to this year.
Public records obtained by PCRM, reviewed by CNBC, include emails exchanged between Neuralink and the University of California, Davis. The university partnered with Neuralink between 2017 and 2020 to help the company conduct experiments on primates.
In one exchange in March 2019, a UC Davis staff member, whose name has been redacted, wrote in an email that the hardware had been handled improperly, and that the transportation of hazardous materials should be performed by trained hazardous materials handlers.
The staffer wrote that if Neuralink employees have not completed the required training, UC Davis personnel are “always happy” to pack and deliver materials.
“Because the hardware components of the explanted neural devices are not sealed and not disinfected before leaving the Primate Center, it is dangerous for anyone has the potential to come into contact with the device,” said UC Davis staff in an email. “Only the labeling is ‘dangerous’ does not account for the potential risk of contracting Herpes B.”
In another case in April 2019, UC Davis staff, whose name has been redacted, wrote in an email that three explanted devices had arrived in “open boxes without secondary containers.” Staffer noted that uncontained, monkey-contaminated hardware puts members of the Primate Center at risk.
“This is an exposure for anyone who comes in contact with contaminated explant hardware and we make a big deal about it because we are concerned for human safety,” the staffer said in the email.
PCRM obtained the records from UC Davis through a public information request. Since Neuralink is a private company, it is not subject to public records laws. A representative from UC Davis did not respond to a request for comment.
PCRM opposes the use of animal testing in medical research, and the group has raised concerns about Neuralink before. In February 2022, the group filed a complaint with the US Department of Agriculture alleging that Neuralink had violated the Animal Welfare Act during its partnership with UC Davis. The complaint was referred to the USDA Inspector General, who allegedly launched a federal investigation into the company, according to a Reuters report.
Advocacy groups also asked the US Food and Drug Administration in December to investigate Neuralink for possible violations of good laboratory practices.
Representatives from the USDA and FDA did not respond to requests for comment.
Ryan Merkley, director of research advocacy at PCRM, said the latest investigation by the DOT shows Neuralink has been “reckless in a new way,” he told CNBC. He said there is no evidence that anyone has been infected by the hardware, but the tone of UC Davis personnel’s concern in the email “reflects the seriousness of this potential pathogen leak.”
“It’s another thing that obviously affects not only the animals, but the people who work at Neuralink, the people who work at UC Davis and everyone who interacts with it,” he said.