[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Proposed Rules]
[Pages 59070-59073]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23256]


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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 774

[Docket No. 211019-0212]
RIN 0694-AI41


Request for Comments Concerning the Imposition of Export Controls 
on Certain Brain-Computer Interface (BCI) Emerging Technology

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Advance notice of proposed rulemaking (ANPRM).

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SUMMARY: The Bureau of Industry and Security (BIS) maintains controls 
on the export, reexport and transfer (in-country) of dual-use items and 
less sensitive military items pursuant to the Export Administration 
Regulations, including the Commerce Control List (CCL). Certain items 
that could be of potential concern for export control purposes are not 
yet listed on the CCL or controlled multilaterally, because they are 
emerging technologies. Among these items is Brain-Computer Interface 
(BCI) technology, which includes, inter alia, neural-controlled 
interfaces, mind-machine interfaces, direct neural interfaces, and 
brain-machine interfaces. BIS is seeking public comments on the 
potential uses of this technology, particularly with respect to its 
impact on U.S. national security (e.g., whether such technology could 
provide the United States, or any of its adversaries, with a 
qualitative military or intelligence advantage). This document also 
requests public comments on how to ensure that the scope of any 
controls that may be imposed on this technology would be effective (in 
terms of protecting U.S. national security interests) and appropriate 
(with respect to minimizing their potential impact on legitimate 
commercial or scientific applications).

DATES: Comments must be received by BIS no later than December 10, 
2021.

ADDRESSES: You may submit comments, identified by regulations.gov 
docket number BIS-2021-0032 or by RIN 0694-AI41, through any of the 
following:
     Federal eRulemaking Portal: https://www.regulations.gov. 
You can find this advance notice of proposed rulemaking by searching 
for its regulations.gov docket number, which is BIS-2021-0032.
     Email: [email protected]. Include RIN 0694-AI41 
in the subject line of the message.
    All filers using the portal or email should use the name of the 
person or entity submitting the comments as the name of their files, in 
accordance with the instructions below. Anyone submitting business 
confidential information should clearly identify the business 
confidential portion at the time of submission, file a statement 
justifying nondisclosure and referring to the specific legal authority 
claimed, and provide a non-confidential submission.
    For comments submitted electronically containing business 
confidential information, the file name of the business confidential 
version should begin with the characters ``BC.'' Any page containing 
business confidential information must be clearly marked ``BUSINESS 
CONFIDENTIAL'' on the top of that page. The corresponding non-
confidential version of those comments must be clearly marked 
``PUBLIC.'' The file name of the non-confidential version should begin 
with the character ``P.'' The ``BC'' and ``P'' should be followed by 
the name of the person or entity submitting the comments or rebuttal 
comments. Any submissions with file names that do not begin with a 
``P'' or ``BC'' will be assumed to be public and will be made publicly 
available through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For questions on Brain-Computer 
Interface technology, contact Dr. Betty Lee, Chemical and Biological 
Controls Division, Office of Nonproliferation and Treaty Compliance, 
Bureau of Industry and Security, U.S. Department of Commerce, (202) 
482-5817, Email:

[[Page 59071]]

[email protected]. For questions on the submission of comments, 
contact Willard Fisher, Regulatory Policy Division, Office of Exporter 
Services, Bureau of Industry and Security, U.S. Department of Commerce, 
(202) 482-6057, Email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    As part of the National Defense Authorization Act (NDAA) for Fiscal 
Year 2019, Public Law 115-232, Congress enacted the Export Control 
Reform Act of 2018 (ECRA), 50 U.S.C. 4801-4852. Section 1758 of ECRA 
(as codified under 50 U.S.C. 4817) authorizes the Bureau of Industry 
and Security (BIS) to establish appropriate controls on the export, 
reexport or transfer (in-country) of emerging and foundational 
technologies. Pursuant to ECRA, on November 19, 2018, BIS published an 
advance notice of proposed rulemaking (November 19 ANPRM) (83 FR 
58201). That ANPRM identified Brain-Computer Interface (BCI) technology 
as part of a representative list of technology categories concerning 
which BIS, through an interagency process, sought public comment to 
determine whether there are specific emerging technologies that are 
essential to U.S. national security and for which effective controls 
can be implemented.

Comments to the November 19 ANPRM on Brain-Computer Interface 
Technology

    In response to its November 19 ANPRM, BIS received approximately 13 
comments related to the potential designation of BCI technology as an 
emerging technology. The substance of these comments is summarized in 
the following paragraphs.
    One respondent noted that BCI technology, although still in the 
early stages of development, is currently available in Wassenaar 
Arrangement participating countries (including the United States), as 
well as in other countries.
    Similarly, another respondent indicated that emerging BCI 
technology has important applications in human health care and 
assistive technologies and that, consequently, overly broad export 
controls on such technology could hinder research in these areas. In 
addition, a respondent in the aerospace sector stated that overly broad 
export controls would discourage information sharing and thereby hinder 
BCI research and development projects in the aerospace industry. This 
respondent also urged that license exceptions should apply to those 
situations involving technological collaboration with our allies.
    Another respondent noted that the imposition of export controls on 
the representative general categories of technology (including BCI 
technology) identified in BIS's November 19 ANPRM would impact the 
fields of automotive development (e.g., autonomous driving and 
automotive safety), artificial intelligence, advanced materials 
development, human-machine interfaces and robotics. This respondent 
expressed the concern that the imposition of overly strict export 
controls on such technology by the United States could drive future 
research and development programs to other technologically 
sophisticated countries in Europe, Asia and the Americas that would not 
impose unilateral export controls on such technology. As examples of 
the possible adverse effect of export controls on such technology, this 
respondent cited the impact that the tightening of export controls had 
on the U.S. commercial satellite sector and on LiDAR controlled under 
ECCN 6A001 or ECCN 6A008.j.2.
    One respondent urged that U.S. export controls on BCI technology be 
addressed through the establishment of harmonized multilateral 
controls. Otherwise, the imposition of export controls on such 
technology by the United States could adversely impact future 
collaboration with our allies (e.g., foreign companies might become 
reluctant to utilize U.S.-origin BCI products or technology if they 
were subject to unilateral export controls). This respondent also 
recommended that the United States view its national security interests 
more narrowly, observing that the United States likely would lose 
credibility in multilateral export control forums if it tried to tie 
its national security and economic security interests too closely 
together. This respondent also asked whether these controls would be 
applied, across-the-board, to all countries or if they would vary 
depending upon the country of destination. In addition, the respondent 
inquired as to whether the de minimis provisions in the Export 
Administration Regulations (EAR) would apply, how often the United 
States would evaluate and update the scope of these emerging technology 
controls, and what additional measures (i.e., other than obtaining 
export or reexport licenses) U.S. companies and non-US entities would 
be expected to take in order to protect such technology.
    Another respondent also warned about the potential harm to U.S. 
technological leadership and competitiveness if the United States were 
to impose broad unilateral controls on emerging technologies (including 
BCI technologies), instead of working with our allies to develop and 
implement multilateral controls. This respondent stressed that any 
export controls that are imposed on emerging technologies must apply 
only to those emerging technologies that are determined to be essential 
to U.S. national security (e.g., export controls on such technologies 
should address specific U.S. national security concerns, rather than 
trade policy issues). In addition, this respondent urged that emerging 
technologies should not be controlled unless they are exclusive to the 
United States and encompass only core technologies. This respondent 
also recommended that U.S. controls should focus primarily on 
technology required for ``development,'' rather than technology for 
``production'' or ``use.'' This respondent further urged that, to the 
extent possible, any future EAR controls on emerging technologies 
should be designed to complement the existing controls on the Commerce 
Control List and the EAR definitions that apply to similar items, and 
not be described in vague terms (e.g., as capable for use with one or 
more specified items).
    One respondent observed that the digital information field of BCI 
technology is quite mature and that, consequently, digital information 
technologies should remain unencumbered for the free exchange and 
cross-pollination of advancements across borders. In a similar vein, 
another respondent stated that, if export controls on quantum computing 
and BCI technologies were not properly crafted, these controls could 
damage U.S. competitiveness and undermine U.S. technological leadership 
by slowing development, limiting resources, reducing market 
participation and limiting collaborative opportunities. This respondent 
emphasized that, in developing and implementing export controls on such 
technologies, an effective partnership among government, industry and 
academia would be essential.

Process To Identify and Control Emerging Technology

    Under ECRA, emerging and foundational technologies are those 
essential to the national security of the United States, but not 
described in Section 721(a)(6)(A)(i)-(v) of the Defense Production Act 
of 1950 (50 U.S.C. 4565(a)), as amended. Section 1758(a) of ECRA (50 
U.S.C. 4817(a)) outlines an interagency process for identifying 
emerging and foundational

[[Page 59072]]

technologies. This process considers both public and classified 
information, as well as information from the Emerging Technology 
Technical Advisory Committee and the Committee on Foreign Investment in 
the United States. In identifying specific emerging technologies, this 
process also takes into account all of the following:
     The development of the emerging technologies in foreign 
countries;
     The effect export controls might have on the development 
of the emerging technologies in the United States; and
     The effectiveness of export controls on limiting the 
proliferation of the emerging technologies in foreign countries.
    In addition, Section 1758(a)(2)(C) of ECRA (50 U.S.C. 
4817(a)(2)(C)) requires that the interagency process for identifying 
emerging technologies include a notice and comment period.
    The Secretary of Commerce must establish appropriate controls on 
the export, reexport or transfer (in-country) of technology identified 
pursuant to the Section 1758 process. In so doing, the Secretary must 
consider the potential end-uses and end-users of emerging and 
foundational technologies, and the countries to which exports from the 
United States are restricted (e.g., embargoed countries). While the 
Secretary has discretion to set the level of export controls, at a 
minimum a license must be required for the export of such technologies 
to countries subject to a U.S. embargo, including those countries 
subject to an arms embargo.
    BCI technology has been identified as a technology for evaluation 
as a potential emerging technology, consistent with the interagency 
process described in Section 1758 of ECRA. Consequently, BIS is 
publishing this ANPRM to obtain feedback from the public and U.S. 
industry concerning whether such technology could provide the United 
States, or any of its adversaries, with a qualitative military or 
intelligence advantage.
    Fundamentally, BCIs provide a direct communication pathway between 
an enhanced or wired brain and an external device, with bidirectional 
information flow.\1\ BCIs frequently involve a process in which brain 
signals are acquired, analyzed and then translated into commands that 
are: (1) Used to control machines; (2) potentially transferred to other 
humans; or (3) used for human assessment or enhancement. Medical uses 
of BCI technology include replacing or restoring useful function to 
people disabled by neuromuscular disorders such as amyotrophic lateral 
sclerosis, cerebral palsy, stroke, or spinal cord injury.
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    \1\ Krucoff, M.O., Rahimpour, S., Slutzky, M.W., Edgerton, V.R., 
Turner, D.A. (2016), ``Enhancing Nervous System Recovery through 
Neurobiologics, Neural Interface Training, and 
Neurorehabilitation,'' Neuroprosthetics, 10 (584).
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    BCI technology can also be a promising interaction tool for the 
public, with many potential applications in multimedia, entertainment 
and other fields. This technology will also have potential for military 
use in enhancing the capabilities of human soldiers, including 
collaboration for improved decision making, assisted-human operations, 
and advanced manned and unmanned military operations.\2\
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    \2\ Binnendijk, A., Marler, T., Bartels, E.M. (2019), ``Brain-
Computer Interfaces: U.S. Tactical Military Applications and 
Implications,'' RAND Report RR-2996-CGRS.
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    Although the ability to apply BCI technology remains subject to 
certain limitations (e.g., approximately 15-30% of individuals 
currently are thought to be unable to produce brain signals robust 
enough to operate a BCI), the scientific community is addressing these 
limitations through strategies such as: (1) An adaptive machine 
learning approach that incorporates neurophysiological and 
psychological traits; and (2) the development of more advanced sensors 
(e.g., a coordinated network of independent, wireless microscale neural 
sensors that are able to gather data from much larger groups of brain 
cells than most current BCI systems).

Request for Comments

    Consistent with Section 1758(a)(2)(C) of ECRA (50 U.S.C. 
4817(a)(2)(C)), this ANPRM provides the public with notice and the 
opportunity to comment for the purpose of evaluating BCI technology as 
an emerging technology. Consequently, BIS welcomes comments on this 
ANPRM that would address, but not necessarily be limited to, the 
following questions. If specific BCI systems are discussed as part of 
any response to these questions, the public is requested to address the 
effectiveness of such systems (e.g., with respect to validation, 
assessment, detection of errors and ability to operate, as intended, 
for all types of individuals).
    (1) What specific uniform standards for BCI technology would need 
to be adopted to ensure their application on a global basis (i.e., as 
international standards for BCI technology)?
    (2) Where does the development of BCI in the United States stand 
with respect to other countries (e.g., is the United States on the 
forefront of BCI technology development)?
    (3) Is BCI technology currently available for commercial use in 
certain foreign countries and, if so, where and for what specific 
purposes (e.g., have foreign companies already developed devices or 
chips for specific commercial applications)?
    (4) Has the current stage of development with respect to invasive 
and/or non-invasive BCI technology reached the point at which such 
technology is ready for commercial production and use?
    (5) Is the main progress with respect to non-invasive brain signal 
sensors being made in terms of real-time algorithms designed to 
transform neural signals into commands (i.e., what is developing 
faster: ``software'' (algorithms) or hardware (sensors))?
    (6) What impact would the establishment of export controls on BCI 
technology have on U.S. technological leadership (i.e., not only in the 
field of BCI technology, but overall) and would this impact be 
distinctly different if controls were placed primarily on ``software'' 
as opposed to hardware, or vice versa?
    (7) How is the future development of artificial intelligence (AI) 
technology or other emerging technologies likely to impact the 
development of BCI technology, or vice versa?
    (8) What types of ethical or policy issues are likely to arise from 
the use of BCI technology (e.g., for medical or military purposes)?
    (9) What kinds of risks and benefits currently exist, or are likely 
to arise, as a result of the application of BCI technology?
    (10) What are the potential advantages or disadvantages of using 
invasive and non-invasive BCI chips/sensors and related ``software'' 
(e.g., algorithms for signal processing) for specific applications? To 
what extent would these advantages or disadvantages correspond (or 
differ) based upon whether invasive or non-invasive BCI chips/sensors 
and related ``software'' were being used?
    (11) Are there any BCI technologies that are significantly more 
vulnerable than others to cybersecurity threats (e.g., military systems 
employing BCI technologies that could adversely impact U.S. 
biodefense)?
    (12) What is the potential for transmitted BCI data to be hacked or 
manipulated to influence the user or machine? Is such data inherently 
more vulnerable to hacking or manipulation than other forms of data? 
Would the invasive or non-invasive characteristics of BCI data have any 
impact on the potential vulnerability of such data?

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    In addition to public comments that would assist BIS in evaluating 
the status of BCI technology as an emerging technology, BIS encourages 
comments that would help it to determine:
    (1) Which aspects of BCI technology would be more likely to require 
monitoring by the U.S. Government (USG); and
    (2) Whether specific USG policies and regulations, as well as 
industry standards, need to be established before this technology 
becomes widely available for use in commercial applications.
    BIS also welcomes comments concerning whether export controls on 
BCI technology should be implemented multilaterally (rather than 
unilaterally), in the interest of increasing their effectiveness and 
minimizing their impact on U.S. industry. As noted above, a number of 
respondents who commented on BIS's November 19 ANPRM indicated their 
preference for multilateral export controls over unilateral export 
controls, because the former typically place U.S. industry on a more 
level playing field versus producers/suppliers in other countries. In 
this regard, note that Section 1758(c) of ECRA (as codified under 50 
U.S.C. 4817(c)) provides that ``the Secretary of State, in consultation 
with the Secretary [of Commerce] and the Secretary of Defense, and the 
heads of other Federal agencies, as appropriate, shall propose that any 
technology identified pursuant to subsection (a) [of ECRA] be added to 
the list of technologies controlled by the relevant multilateral export 
control regimes.'' Subsection (a) of section 1758 (as codified under 50 
U.S.C. 4817(a)) addresses the interagency process for identifying 
emerging technologies.
    BIS also encourages comments that address issues raised in the 
November 19 emerging technology ANPRM public comments (as summarized 
above) and any other BCI technology topics that they consider to be 
relevant to this inquiry. The information provided by the respondents 
in response to this ANPRM will assist BIS in evaluating BCI as a 
potential emerging technology for the purpose of formulating export 
control policies that will be both effective and appropriate, with 
respect to their objective and scope.
    Comments should be submitted to BIS as described in the ADDRESSES 
section of this ANPRM and must be received by BIS no later than 
December 10, 2021.
    This rule has been designated a ``significant regulatory action,'' 
although not economically significant, under Executive Order 12866. 
Accordingly, this rule has been reviewed by the Office of Management 
and Budget (OMB).

Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2021-23256 Filed 10-25-21; 8:45 am]
BILLING CODE 3510-33-P