On October 26, 2021, the Department of Commerce’s Bureau of Industry and Security (“BIS”) published an advance notice of proposed rulemaking (“ANPRM”) seeking public comments concerning the identification of certain neuro “brain-computer interface” (BCI) technology as an emerging technology and the potential imposition of export controls on such technology. Comments are due no later than December 10, 2021.
BCI technology was identified by BIS back in a November 2018 ANPRM as part of a representative list of emerging technologies that are essential to US national security and that are currently subject to no or very limited controls under existing US export control regimes. The latest ANPRM summarises comments received at that time regarding potential controls on BCI Technology. For more details about the 2018 ANPRM, please see our prior blog post.
BCI technology is defined in the latest ANPRM as including, inter alia, neural-controlled interfaces, mind-machine interfaces, direct neural interfaces, and brain-machine interfaces that could be used in commercial, medical, and military applications. BCIs acquire brain signals, analyze them, and translate them into commands that can be used to control external devices. BCI technology can be used in medical fields to replace or restore useful function in persons affected by neuromuscular disorders, as an interaction tool for multimedia, entertainment and other fields, and also has potential military use to enhance capabilities of human soldiers.
BIS is seeking comments on the potential uses of BCI technology, especially its impact on US national security, and on how to establish effective and appropriate export controls on BCI technology that balance the interest of protecting US national security while minimizing the impact on legitimate commercial and scientific applications of this technology. BIS is particularly interested in understanding the following issues:
- The necessary international standards for BCI technology;
- The development status of BCI technology in the United States compared to other countries;
- The status of BIC technology’s commercial application in foreign countries;
- Whether the current development stage of BIC technology allows for commercial production and use;
- The development status of non-invasive brain signal sensors and related software;
- The potential impact of export controls on BCI technology on US technological leadership;
- The potential interaction between the development of other emerging technologies (e.g., AI technologies) and the development of BCI technology;
- The potential ethical or policy issues resulting from the use of BCI technology;
- The potential benefits and risks resulting from the application of BCI technology;
- The potential advantages and disadvantages of using BCI chips/sensors and related software for specific applications;
- Whether certain BIC technologies are significantly more vulnerable to cybersecurity threats;
- The potential vulnerability of transmitted BCI data to hacking or manipulation;
- Which aspects of BIS technology would require monitoring by the US Government;
- What USG policies and regulations or industry standards need to be established before the broad commercial application of the BCI technology; and
- Whether export controls on BCI technology should be implemented multilaterally or unilaterally.
BIS also encourages comments that address issues raised by comments in response to the 2018 ANPRM and any other BCI technology topics that are relevant to the export controls of such technology.
BIS is accepting comments to the ANPRM by email ([email protected]) and via the Federal eRulemaking Portal until December 10, 2021. Companies whose business involves BIC technology are strongly encouraged to submit detailed comments to BIS to help shape how this technology may be controlled going forward.
Baker McKenzie would be happy to assist interested companies in preparing and submitting public comments in response to the ANPRM.
Separately, on October 5, 2021, BIS published a Final Rule amending the Export Administration Regulations to add new controls under ECCN 2D352 and 2E001 on certain emerging technology genetic sequencing software, specifically nucleic acid assembler and synthesizer software, and related technology capable of designing and building functional genetic elements from digital sequence data. Such software can be used to generate pathogens and toxins without the need to acquire controlled genetic elements and organisms and thus has potential use for biological weapons purposes. This Final Rule implements changes agreed at the May 2021 multilateral Australia Group plenary. Such software now requires a license for chemical and biological weapons (CB) and anti-terrorism (AT) reasons to certain countries. These controls are already in effect as of October 5, 2021.