Proposed Rule2022-19430
Request for Comments Concerning the Imposition of Section 1758 Technology Export Controls on Instruments for the Automated Chemical Synthesis of Peptides
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Published
September 13, 2022
Issuing agencies
Commerce DepartmentIndustry and Security Bureau
Abstract
The Bureau of Industry and Security (BIS), Department of Commerce, 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 (EAR), including the Commerce Control List (CCL). Certain instruments for the automated synthesis of peptides (automated peptide synthesizers) have been identified by BIS for evaluation according to the criteria in section 1758 of the Export Control Reform Act of 2018 (ECRA) pertaining to emerging and foundational technologies. 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 advance notice of proposed rulemaking 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).
Full Text
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<title>Federal Register, Volume 87 Issue 176 (Tuesday, September 13, 2022)</title>
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[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Proposed Rules]
[Pages 55930-55932]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-19430]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Part 774
[Docket No. 220826-0174]
RIN 0694-AI84
Request for Comments Concerning the Imposition of Section 1758
Technology Export Controls on Instruments for the Automated Chemical
Synthesis of Peptides
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), Department of
Commerce, 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 (EAR), including the Commerce
Control List (CCL). Certain instruments for the automated synthesis of
peptides (automated peptide synthesizers) have been identified by BIS
for evaluation according to the criteria in section 1758 of the Export
Control Reform Act of 2018 (ECRA) pertaining to emerging and
foundational technologies. 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 advance notice of
proposed rulemaking 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 October 28, 2022.
ADDRESSES: You may submit comments, identified by <a href="http://regulations.gov">regulations.gov</a>
docket number BIS-2022-0023 or by RIN 0694-AI84, through any of the
following:
<bullet> Federal eRulemaking Portal: <a href="http://www.regulations.gov">http://www.regulations.gov</a>.
You can find this advance notice of proposed rulemaking by searching
for its <a href="http://regulations.gov">regulations.gov</a> docket number, which is BIS-2022-0023.
<bullet> Email: <a href="/cdn-cgi/l/email-protection#2b7b5e49474248684446464e455f586b494258054f4448054c445d"><span class="__cf_email__" data-cfemail="85d5f0e7e9ece6c6eae8e8e0ebf1f6c5e7ecf6abe1eae6abe2eaf3">[email protected]</span></a>. Include RIN 0694-AI84
in the subject line of the message.
All filers using the portal or email should include the name of the
person or entity submitting the comments in the name of their file(s),
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 to be made publicly
available.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
FOR FURTHER INFORMATION CONTACT: For questions on automated peptide
synthesizers, contact Dr. Tara Gonzalez, Chemical and Biological
Controls Division, Office of Nonproliferation and Treaty Compliance,
Bureau of Industry and Security, Telephone: (202) 482-3343, Email:
<a href="/cdn-cgi/l/email-protection#194d786b78375e76776378757c63597b706a377d767a377e766f"><span class="__cf_email__" data-cfemail="baeedbc8db94fdd5d4c0dbd6dfc0fad8d3c994ded5d994ddd5cc">[email protected]</span></a>. 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: <a href="/cdn-cgi/l/email-protection#2d7f7d691f6d4f445e0349424e034a425b"><span class="__cf_email__" data-cfemail="95c7c5d1a7d5f7fce6bbf1faf6bbf2fae3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
Identification of Section 1758 Technologies
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 essential to the national security of the United States.
Due to the absence of specific definitions or other guidance in ECRA
differentiating the terms ``emerging technology'' or ``foundational
technology,'' and in order to ensure greater efficiency in implementing
controls for such items, BIS has chosen to characterize such
technologies as ``Section 1758 technologies'' for purposes of section
1758 of ECRA, rather than characterizing a specific technology as
either ``emerging'' or ``foundational.''
As described in section 1758(a)(2)(B) of ECRA, the identification
of Section 1758 technologies takes into account: (i) the development of
these technologies in foreign countries; (ii) the effect export
controls imposed pursuant to this section may have on the development
of such technologies in the United States; and (iii) the effectiveness
of export controls imposed pursuant to this section on limiting the
proliferation of the emerging and foundational technologies in foreign
countries.
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
[[Page 55931]]
end-uses and end-users of Section 1758 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.
In addition, section 1758(a)(2)(C) of ECRA (50 U.S.C.
4817(a)(2)(C)) requires the interagency process for identifying Section
1758 technologies to include a notice and comment period.
November 19 Advance Notice of Proposed Rulemaking
On November 19, 2018, BIS published an advance notice of proposed
rulemaking, ``Review of Controls for Certain Emerging Technologies''
(83 FR 58201) (November 19 ANPRM). The November 19 ANPRM identified
biotechnology in a representative list of fourteen technology
categories concerning which BIS 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. The biotechnology-related comments submitted to BIS in
response to its November 19 ANPRM are not addressed in this ANPRM,
because none of the comments specifically addressed the question of
export controls on automated peptide synthesizers.
Evaluation of Automated Peptide Synthesizers Pursuant to Section 1758
of ECRA
Instruments for the automated synthesis of peptides (automated
peptide synthesizers) have been identified by BIS for evaluation
according to the criteria in section 1758 of ECRA pertaining to
emerging and foundational technologies.
Peptides and polypeptides are polymeric chains of amino acids,
linked together by peptide bonds. Proteins are three-dimensional (3D)
macromolecules composed of one or more folded large chains of
polypeptides. Proteins must fold into the correct 3D shape to be
functionally active. The first peptide bond was synthesized over 100
years ago. However, in the last few decades, advances in chemical
synthesis methods have established automated peptide synthesis as a
common laboratory technique.\1\ Long-established synthesis methods
using fluorenylmethyloxycarbonyl (Fmoc) chemistry can reliably and
routinely produce high quality polypeptides around 50 amino acids in
length.\2\
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\1\ R.B. Merrifield, Solid Phase Peptide Synthesis. I. The
Synthesis of a Tetrapeptide, 85 J. Am. Chemistry Soc'y 2149 (1963).
\2\ Da'san M.M. Jaradat, Thirteen Decades of Peptide Synthesis:
Key Developments in Solid Phase Peptide Synthesis and Amide Bond
Formation Utilized in Peptide Ligation, 50 Amino Acids 39 (2017).
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Recent advances in peptide synthesis technology and instrumentation
have increased both the speed of peptide synthesis and the length of
peptide products, including peptides and proteins greater than 100
amino acids in length.\3\ Most protein toxins that are controlled under
Export Control Classification Number (ECCN) 1C351 on the Commerce
Control List (CCL) (see Supplement No. 1 to part 774 of the EAR) are
over 100 amino acids in length and have an average length of 300 amino
acids (with the notable exception of conotoxins, which range between
10-100 amino acids in length). Consequently, absent the imposition of
additional controls on the export, reexport or transfer (in-country) of
certain peptide synthesis technology and instrumentation (e.g.,
automated peptide synthesizers), there would be an increased risk that
such technology and instrumentation could be used to produce controlled
toxins for biological weapons purposes.
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\3\ Sameer S. Kulkarni et al., Rapid and Efficient Protein
Synthesis Through Expansion of the Native Chemical Ligation Concept,
Nature Revs. Chemistry, Mar. 29, 2018, at 1.
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Request for Comments
Consistent with section 1758(a)(2)(C) of ECRA (50 U.S.C.
4817(a)(2)(C)), BIS welcomes comments on the following questions. If
specific automated peptide synthesizer instruments are described by
respondents, BIS requests that this should be done, to the extent
practicable, within the context of the following questions.
(1) What is the current state of development of automated peptide
synthesizers in the United States, including those having primarily
academic or commercial applications, and how does this compare with
that of other countries (e.g., is the United States at the forefront of
such development in the academic and commercial fields)? Where
possible, please identify any publicly available studies that support
your position.
(2) What is the current availability and predominate application(s)
of automated peptide synthesizers in the United States and how does
this compare with that of other countries (e.g., how common is the use
of these instruments in life sciences laboratories/institutions and
other academic or commercial settings)?
(3) To what extent are custom peptide synthesis services available
in the United States and other countries, and would the availability of
such services (particularly for academic or commercial applications) be
likely to impact domestic or foreign demand for automated peptide
synthesizers?
(4) To what extent are current or near-term developments in peptide
synthesis technology expected to address the challenges of peptide
length, sequence fidelity, and protein folding (e.g., are efforts
currently underway to integrate protein folding into the automation
process)?
(5) To what extent would the establishment of Section 1758
technology export controls on automated peptide synthesizer
instruments, and related ``software'' and ``technology,'' impact U.S.
technological leadership in this field (e.g., within the academic or
commercial spheres) and would this impact be distinctly different if
controls were placed primarily on ``software'' as opposed to hardware,
or vice versa?
(6) To what extent would the imposition of Section 1758 technology
export controls on automated peptide synthesizer instruments, and
related ``software'' and ``technology,'' likely be effective in terms
of limiting the proliferation of these items abroad (including the
potential use of such items to produce controlled toxins for biological
weapons purposes)?
(7) To what extent has the increased availability of lower cost
coupling reagents, together with recent advances in automated peptide
synthesizers and related technology, overcome economic or technological
factors that previously might have limited the availability and use of
this technology, abroad?
(8) To what extent should Section 1758 technology export controls
on peptide synthesizer technology be implemented multilaterally (rather
than unilaterally), in the interest of increasing their effectiveness
and minimizing their impact on U.S. industry?
Several 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 with respect to 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
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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] [which
addresses the interagency process for identifying Section 1758
technologies] be added to the list of technologies controlled by the
relevant multilateral export control regimes.''
Finally, BIS encourages comments addressing any other automated
peptide synthesizer technology topics deemed to be relevant to this
inquiry.
Comments should be submitted as described in the ADDRESSES section
of this ANPRM and must be received no later than October 28, 2022.
This ANPRM has been designated a ``significant regulatory action,''
although not economically significant, under Executive Order 12866.
Accordingly, this ANPRM has been reviewed by the Office of Management
and Budget (OMB).
Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2022-19430 Filed 9-12-22; 8:45 am]
BILLING CODE 3510-33-P
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