United States: Office for International Settlements announces review of potential controls on brain-computer interface technology and seeks public comment, expanding controls on certain biological equipment software and technologies

On October 26, 2021, the Department of Commerce’s Bureau of Industry and Security (“BIS”) posted an Advance Notice of Proposed Rule Development (“ANPRM”) for public comments regarding the definition of a “brain-computer interface” (BCI). Technology as an emerging technology and the potential for export controls on this technology. Comments are due no later than December 10, 2021.

BCI technology was identified by BIS in November 2018 ANPRM as part of a representative list of emerging technologies essential to the national security of the United States that are currently uncontrolled or subject to very limited controls under current US export control regimes. The most recent ANPRM summarizes comments received at the time regarding potential controls on BCI technology. For more details on ANPRM for 2018, please see our previous blog post.

BCI technology is defined in the latest ANPRM as including, Among other things, neural control interfaces, mind-machine interfaces, direct neural interfaces, and brain-machine interfaces that can be used in commercial, medical, and military applications. BCIs acquire, analyze and translate brain signals into commands that can be used to control external devices. BCI technology can be used in medical fields to replace or restore beneficial function in people with neuromuscular disorders, as an interaction tool for multimedia, entertainment and other fields, and it also has potential military use to enhance the capabilities of human soldiers.

BIS is seeking feedback on the potential uses of BCI technology, particularly its impact on the national security of the United States, and how to establish effective and appropriate export controls on BCI technology that balance the interest of protecting the national security of the United States while minimizing the impact on legitimate trade and scientific applications of this technology. The BIS is particularly interested in understanding the following issues:

  • International standards necessary for BCI technology;
  • The state of development of BCI technology in the United States compared to other countries;
  • The state of commercial application of BIC technology in foreign countries;
  • whether the current stage of development of BIC technology allows for commercial production and use;
  • Development status of non-invasive brain signal sensors and related software;
  • The potential impact of export controls on BCI technology on US technology leadership;
  • The potential interaction between the development of other emerging technologies (such as artificial intelligence technologies) and the development of BCI technology;
  • potential ethical or policy issues arising from the use of BCI technology;
  • potential benefits and risks arising from the application of BCI technology;
  • potential advantages and disadvantages of using BCI chips/sensors and related software for specific applications;
  • whether certain BIC technologies are more vulnerable to cybersecurity threats;
  • potential vulnerability of BCI data transmitted for hacking or tampering;
  • What aspects of BIS technology require monitoring by the US government;
  • What US government policies and regulations or industry standards should be in place before the broad commercial application of BCI technology; And
  • Whether export controls on BCI technology should be implemented multilaterally or unilaterally.

BIS also encourages comments addressing issues raised by comments in response to ANPRM 2018 and any other BCI technology topics relevant to this technology’s export controls.

BIS accepts comments to ANPRM via email ([email protected]) and through the Federal Electronic Systems Manufacturing Portal until December 10, 2021. Companies whose businesses include BIC technology are strongly encouraged to provide detailed feedback to BIS to help shape how this technology will be controlled going forward.

Baker McKenzie is pleased to assist interested companies in preparing and providing public comment in response to ANPRM.

Separately, on October 5, 2021, BIS published a final rule to amend the Export Administration Regulations to add new controls under ECCN 2D352 and 2E001 on certain emerging technology genetic sequencing programs, specifically the nucleic acid and synthesizer assembly program, and related technology capable of designing and constructing functional genetic elements. from numerical sequence data. These programs can be used to generate pathogens and toxins without the need to obtain controlled genetic elements and organisms, and thus can be used for biological weapons purposes. This final rule implements changes agreed at the plenary session of the Multilateral Group of Australia in May 2021. Such programs now require chemical and biological weapons (CB) and counter-terrorism (AT) licensing for some countries. These controls are already in effect as of October 5, 2021.

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