Elon Musk’s brain-computer interface company Neuralink is under investigation by the US Department of Transportation for allegedly unsafely packaging and transporting contaminated hardware, a DOT spokesman confirmed to CNBC.
In a letter to Transport Secretary Pete Buttigieg on Thursday, the medical committee of the animal welfare group for responsible medicine said it had received public records that suggest Neuralink may have mishandled devices carrying infectious disease agents that posed a risk to human health in 2019.
According to the letter, the devices were removed from the brains of non-human primates and could have been contaminated with viruses such as herpes B and antibiotic-resistant bacteria such as Staphylococcus and Klebsiella. PCRM claimed the materials were not properly contained or transported, possibly because Neuralink employees had not received adequate safety training.
A DOT spokesman told CNBC it was “standard practice” to investigate alleged violations of hazardous materials transportation regulations. The Pipeline and Hazardous Materials Safety Administration, part of the DOT, is conducting a “standard investigation to ensure compliance and the public safety of workers and the public,” based on information received from PCRM, the spokesman said.
Neuralink representatives did not respond to requests for comment.
Neuralink is one of many companies in the emerging brain-computer interface, or BCI, industry. A BCI is a system that decodes brain signals and translates them into commands for external technologies, allowing patients to move cursors, type, and even access smart home devices using just their minds. Several companies have successfully developed devices with these capabilities.
Musk, who is also the CEO of Tesla, SpaceX and Twitter co-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’s not yet testing its device in humans, Musk hopes to do so later this year.
The public records obtained by PCRM, which have been 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 a March 2019 exchange, a UC Davis employee, whose name has been redacted, wrote in an email that hardware had been mishandled and the transport of hazardous materials must be performed by a trained hazardous materials handler.
The employee wrote that when Neuralink employees had not completed the required training, UC Davis employees were “always happy” to pack and ship materials.
“Because the hardware components of the explanted neural device are not sealed and it was not disinfected prior to leaving the primate center, this poses a hazard to anyone who may come into contact with the device,” the UC Davis staffer said in the E- Mail. “The mere labeling as ‘dangerous’ does not take into account the risk of potential infection with herpes B.”
In another case, in April 2019, a UC Davis employee, whose name has been redacted, emailed that three explanted devices arrived in an “open box with no secondary container.” The worker noted that the unprotected monkey-contaminated hardware put members of the primate center at risk.
“This is an exposure for anyone coming into contact with the contaminated explanted hardware, and we’re making a big deal out of it because we care about people’s safety,” the employee said in the email.
PCRM obtained these records from UC Davis through a public information request. Because Neuralink is a private company, it is not subject to public records laws. UC Davis officials did not respond to requests for comment.
PCRM opposes the use of animal testing in medical research, and the group has previously raised concerns about Neuralink. In February 2022, the group filed a complaint with the US Department of Agriculture alleging that Neuralink violated animal welfare laws during its partnership with UC Davis. The complaint was escalated to the USDA Inspector General, who allegedly launched a federal investigation into the company, according to a Reuters report.
The advocacy group also asked the U.S. Food and Drug Administration in December to investigate Neuralink for possible violations of good laboratory practices.
USDA and FDA officials did not respond to requests for comment.
Ryan Merkley, director of research advocacy at PCRM, said the DOT’s recent investigation suggested that Neuralink had been “sloppy in a whole new way,” he told CNBC. He said there was no evidence anyone was infected because of exposure to the hardware, but that the concerned tone of UC Davis staff in the emails “reflects the seriousness of this potential pathogen leak.”
“This is a very different matter that obviously affects not only the affected animals, but also the Neuralink staff, the UC Davis staff, and everyone they came into contact with,” he said.