Rule2021-21493
Commerce Control List: Expansion of Controls on Certain Biological Equipment “Software”
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 5, 2021
Effective
October 5, 2021
Issuing agencies
Commerce DepartmentIndustry and Security Bureau
Abstract
The Bureau of Industry and Security (BIS) publishes this final rule to amend the Export Administration Regulations (EAR) to implement the decision made at the Australia Group (AG) Virtual Implementation Meeting session held in May 2021, and later adopted pursuant to the AG's silence procedure. This decision updated the AG Common Control List for dual-use biological equipment by adding controls on nucleic acid assembler and synthesizer "software" that is capable of designing and building functional genetic elements from digital sequence data. Prior to this AG decision, BIS, consistent with the interagency process described in the Export Control Reform Act of 2018 (ECRA), identified this "software" as a technology to be evaluated as an emerging technology. The decision by BIS to amend the CCL to include this "software" complies with the requirements of ECRA and also reflects the decision of the AG to add it to the regime's Common Control List, thereby making exports of this "software" subject to multilateral control through the implementation of these changes by individual AG participating countries (including the United States).
Full Text
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<title>Federal Register, Volume 86 Issue 190 (Tuesday, October 5, 2021)</title>
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[Federal Register Volume 86, Number 190 (Tuesday, October 5, 2021)]
[Rules and Regulations]
[Pages 54814-54819]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21493]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 742 and 774
[Docket No. 210928-0198]
RIN 0694-AI08
Commerce Control List: Expansion of Controls on Certain
Biological Equipment ``Software''
AGENCY: Bureau of Industry and Security, Commerce.
ACTION: Final rule.
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SUMMARY: The Bureau of Industry and Security (BIS) publishes this final
rule to amend the Export Administration Regulations (EAR) to implement
the decision made at the Australia Group (AG) Virtual Implementation
Meeting session held in May 2021, and later adopted pursuant to the
AG's silence procedure. This decision updated the AG Common Control
List for dual-use biological equipment by adding controls on nucleic
acid assembler and synthesizer ``software'' that is capable of
designing and building functional genetic elements from digital
sequence data. Prior to this AG decision, BIS, consistent with the
interagency process described in the Export Control Reform Act of 2018
(ECRA), identified this ``software'' as a technology to be evaluated as
an emerging technology. The decision by BIS to amend the CCL to include
this ``software'' complies with the requirements of ECRA and also
reflects the decision of the AG to add it to the regime's Common
Control List, thereby making exports of this ``software'' subject to
multilateral control through the implementation of these changes by
individual AG participating countries (including the United States).
DATES: This rule is effective October 5, 2021.
FOR FURTHER INFORMATION CONTACT: Dr. Wesley Johnson, Chemical and
Biological Controls Division, Office of Nonproliferation and Treaty
Compliance, Bureau of Industry and Security, Telephone: (202) 482-0091,
Email: <a href="/cdn-cgi/l/email-protection#94c3f1e7f8f1edbadefbfcfae7fbfad4f6fde7baf0fbf7baf3fbe2"><span class="__cf_email__" data-cfemail="1443716778716d3a5e7b7c7a677b7a54767d673a707b773a737b62">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Bureau of Industry and Security (BIS) is
amending the Export Administration Regulations (EAR) to implement the
decision made at the Australia Group (AG) Virtual Implementation
Meeting session held in May 2021, and subsequently adopted pursuant to
the AG silence procedure (the AG silence procedure provides for the
adoption of a measure, subsequent to its provisional acceptance at an
AG plenary or intersessional meeting, provided that no participating
country submits an objection on or before a specified date). The AG is
a multilateral forum consisting of 42 participating countries and the
European Union. These participants maintain export controls on a list
of chemicals, biological agents, and related equipment and technology
that could be used in a chemical or biological weapons program. The AG
periodically reviews items on its control list to enhance the
effectiveness of participating governments' national controls and to
achieve greater harmonization among these controls.
Addition of New Export Control Classification Number (ECCN) 2D352--
``Software'' for Nucleic Acid Assemblers/Synthesizers
This final rule amends the Commerce Control List (CCL), in
Supplement No. 1 to part 774 of the EAR, to add a new ECCN 2D352 to
reflect a decision made at the May 2021 Virtual Implementation Meeting
session to modify the AG biological equipment list to add controls on
``software'' that is: (1) Designed for nucleic acid assemblers and
synthesizers described on this AG Common Control List; and (2) capable
of designing and building functional genetic elements from digital
sequence data. Specifically, new ECCN 2D352 controls ``software''
designed for nucleic acid assemblers and synthesizers controlled by
ECCN 2B352.j that is capable of designing and building functional
genetic elements from digital sequence data.
This ``software,'' as controlled under new ECCN 2D352, requires a
license for chemical and biological weapons (CB) reasons and anti-
terrorism (AT) reasons to the destinations indicated under CB Column 2
and AT Column 1, respectively, on the Commerce Country Chart in
Supplement No. 1 to part 738 of the EAR (also see the AT license
requirements described in part 742 that apply to Iran, North Korea and
Syria). A license also is required to certain
[[Page 54815]]
destinations in accordance with the embargoes and other special
controls described in part 746 of the EAR.
ECCN 2E001 Amended To Include ``technology'' for New ECCN 2D352
In addition, this rule amends ECCN 2E001 (which controls, inter
alia, ``technology'' for the ``development'' of the nucleic acid
assemblers and synthesizers described in ECCN 2B352.j) to indicate that
``technology'' for the ``development'' of ``software'' controlled by
new ECCN 2D352 is controlled by ECCN 2E001 for CB reasons and AT
reasons to the destinations indicated under CB Column 2 and AT Column
1, respectively, on the Commerce Country Chart in Supplement No. 1 to
part 738 of the EAR. The CB control entry in the License Requirements
table for ECCN 2E001 is amended to reflect this change. The heading of
ECCN 2E001 does not need to be amended to reflect this change because
the ECCN heading indicates that, with limited specified exceptions,
this ECCN controls ``technology'' for the ``development'' of
``software'' listed under Category 2D of the CCL, which now includes
new ECCN 2D352.
Conforming Amendments to Sec. 742.2 (Proliferation of Chemical and
Biological Weapons)
Consistent with the May 2021 AG decision described above, this
final rule amends Section 742.2 of the EAR by revising paragraphs
(a)(2)(viii) and (a)(2)(ix) to reflect the addition of ECCN 2D352 to
the CCL and to indicate that ``technology'' for the ``development'' of
``software'' controlled by new ECCN 2D352 is controlled by ECCN 2E001.
These changes were not included in a proposed rule that BIS published
on November 6, 2020 (85 FR 71012), which is described in more detail,
below. However, because they are merely conforming changes that cross
reference the aforementioned amendments to the CCL, BIS is making the
changes in this final rule.
Evaluation of Nucleic Acid Assembler/Synthesizer ``Software'' as an
Emerging Technology
Prior to the addition of nucleic acid assembler/synthesizer
``software'' to the AG biological equipment list, BIS identified this
``software'' as a technology to be evaluated as an emerging technology,
consistent with the interagency process described in Section 1758 of
the Export Control Reform Act of 2018 (ECRA) (codified at 50 U.S.C.
4817). This identification was based on a finding that this
``software'' is capable of being used to operate nucleic acid
assemblers and synthesizers controlled under ECCN 2B352 for the purpose
of generating pathogens and toxins without the need to acquire
controlled genetic elements and organisms. Consequently, the absence of
export controls on this ``software'' could be exploited for biological
weapons purposes.
Consistent with the emerging and foundational technologies notice
and comment requirements in Section 1758(a)(2)(C) of ECRA (50 U.S.C.
4817(a)(2)(C)), BIS published a proposed rule on November 6, 2020 (85
FR 71012) (hereinafter, ``November 6 proposed rule''), to provide the
public with notice and the opportunity to comment on adding new ECCN
2D352 to control ``software'' for the operation of nucleic acid
assemblers and synthesizers described in ECCN 2B352.j that is capable
of designing and building functional genetic elements from digital
sequence data. The November 6 proposed rule also indicated that
``technology'' for the ``development'' of such ``software'' would be
controlled under ECCN 2E001.
As stated above, the imposition of controls on this ``software'' by
this final rule (under new ECCN 2D352) reflects a decision by the AG to
add this ``software'' to its biological equipment control list.
Consequently, this action by BIS also conforms with Section 1758(c) of
ECRA, which specifies 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 Section 1758(a) of ECRA be added to
the list of technologies controlled by the relevant multilateral export
control regimes.''
Comments Submitted in Response to BIS's November 6 Proposed Rule
BIS received comments from four respondents in response to the
publication of its November 6 proposed rule. The comments from these
respondents, together with BIS's responses, are described below.
Comment: One respondent stated that BIS should not treat
commodities and ``software'' as potential emerging technologies,
because Section 1758 of ECRA, which provides the statutory standard for
establishing new controls on emerging and foundational technologies,
refers only to ``technology,'' as defined in Section 1742 of ECRA
(codified at 50 U.S.C. 4801). The respondent noted that Section 1758 of
ECRA makes no mention of commodities or ``software,'' which, together
with ``technology,'' are included in the statutory definition of
``item.'' The respondent further observed that the term ``item'' is
included in other sections of ECRA and that its absence from Section
1758 is given meaning by considering only ``technology'' as defined in
Section 1742 of ECRA. The respondent also noted that this
interpretation would be consistent with the EAR definition of
``technology,'' which does not include commodities or ``software.''
Consequently, the respondent recommended that BIS should follow this
interpretation of the statute, as well as its own regulations regarding
the definition of ``technology,'' by identifying only emerging
``technology'' and not related emerging commodities and ``software.''
BIS response: The terms ``technologies,'' ``emerging technologies''
and ``critical technologies'' are used in Section 1758 of ECRA (50
U.S.C. 4817) and Section 721(a)(6) of the Defense Production Act of
1950 (DPA), as amended (50 U.S.C. 4565(a)(6)), with the latter defining
``critical technologies'' to mean those described in 50 U.S.C.
4565(a)(6)(A)(i) through (vi). The DPA indicates that the term
``critical technologies'' includes by definition emerging and
foundational technologies controlled pursuant to Section 1758 of ECRA,
as well as ``items included on the Commerce Control List'' for
multilateral reasons or for surreptitious listening or regional
stability reasons. As the respondent noted, the term ``items'' includes
``commodities,'' ``software'' and ``technology.'' Consequently, the
term ``technologies,'' as used within the context of these ECRA and DPA
provisions, encompasses ``commodities,'' ``software'' and
``technology,'' and not ``technology'' only (e.g., as that term is more
narrowly defined in Section 1742 of ECRA). Furthermore, note that BIS's
August 27, 2020 (85 FR 52934), advance notice of proposed rulemaking on
the identification and review of controls for certain foundational
technologies stated that the term ``technologies,'' as used in Section
1758 of ECRA, includes not only ``technology,'' but also
``commodities'' and ``software'' as those terms are used in the EAR.
Comment: One respondent observed that the ``capable of'' standard
does not place sufficient emphasis upon the purpose for which an item
is designed. Consequently, this standard might inadvertently control
technology that is not designed to produce a controlled item, even when
the ability of the technology to produce the controlled item is wholly
unrelated to the primary
[[Page 54816]]
purpose of the technology. Furthermore, the respondent noted that an
exporter could be unaware that a given technology is ``capable of''
performing a function for which the technology was not designed and for
which it is not commonly used.
BIS response: The consensus of the interagency process followed in
accordance with Section 4817 of ECRA was that emerging technology
controls should apply to ``software'' designed for nucleic acid
assemblers and synthesizers controlled by 2B352.j that is ``capable
of'' designing and building functional genetic elements from digital
sequence data. The scope of this control is also consistent with the
decision made at the AG's May 2021 Virtual Implementation Meeting
session to add this ``software'' to its ``Control List of Dual-Use
Biological Equipment and Related Technology and Software.'' If the
controls on this ``software'' applied only to ``software'' ``designed''
or ``specially designed'' for the purpose of generating pathogens and
toxins without the need to acquire controlled genetic elements and
organisms, the scope of the controls would have been far too narrow.
Consequently, there would have been a significantly increased risk that
certain ``software'' not captured by narrower controls could have been
exploited for biological weapons purposes.
Comment: One respondent stated that the ``software'' controls
proposed to be implemented in new ECCN 2D352, and all future emerging
and foundational technology controls, should be implemented
multilaterally, rather than unilaterally. The respondent noted that a
multilateral approach to export controls would increase their
effectiveness and minimize their impact on U.S. industry. Specifically,
multilateral export controls are preferable to unilateral controls,
because the former typically place U.S. industry on a more level
playing field versus producers/suppliers in other countries.
BIS response: This final rule imposes controls on ``software''
designed for nucleic acid assemblers and synthesizers controlled by
2B352.j to reflect the decision made at the AG's May 2021 Virtual
Implementation Meeting session to add such ``software'' to its
``Control List of Dual-Use Biological Equipment and Related Technology
and Software.'' This action by BIS is in accordance with Section
4817(c) of ECRA, which specifies 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 Section 4817(a) of
ECRA be added to the list of technologies controlled by the relevant
multilateral export control regimes.''
Comment: One respondent recommended that BIS issue emerging and
foundational technology controls as proposed rules and closely follow
ECRA's statutory requirements and guidance. This would provide industry
with the opportunity to provide formal comments to government officials
so that the latter could address industry's questions and concerns. The
respondent further noted that such consultations are critical to the
effectiveness of regulations in achieving national security goals,
without placing undue or unintended burdens on U.S. exports.
BIS response: Consistent with the emerging and foundational
technologies notice and comment requirements in Section 4817(a)(2)(C)
of ECRA, BIS published a proposed rule on November 6, 2020 (85 FR
71012), to provide the public with notice and the opportunity to
comment on adding a new ECCN 2D352 to control ``software'' for the
operation of nucleic acid assemblers and synthesizers described in ECCN
2B352.j that is capable of designing and building functional genetic
elements from digital sequence data. As indicated above, BIS received
comments from four respondents in response to the publication of its
November 6 proposed rule. These comments are addressed by BIS in the
preamble of this final rule.
Comment: One respondent expressed concern that the acquisition of
the nucleic acid assembler and synthesizer ``software'' proposed for
control under new ECCN 2D352 by BIS's November 6 proposed rule could be
used to generate pathogens and toxins without the need to directly
acquire controlled genetic elements and organisms. This respondent
indicated that ``the capabilities of this ``software'' lower the bar
for acquisition of controlled genetic elements and so represent an
increase in the risk of proliferation of biological weapons-related
technology.'' According to this respondent, automated benchtop
synthesis devices could allow unskilled individuals to create DNA
sequences that might be used to produce a biological weapon. This
respondent also expressed a growing concern about the potential for
active circumvention of ``software'' for the operation of nucleic acid
assemblers and synthesizers. For example, ``software'' for operating
benchtop nucleic acid synthesis devices could be written to incorporate
biosecurity screening onboard the device. Consequently, if such
``software'' were easily acquired (e.g., in the absence of export
controls), these devices could be hacked to circumvent biosecurity
screening, thereby enabling covert synthesis of otherwise controlled
genetic elements. For this reason, these devices (and, in certain
instances, their components and operating ``software'') should be
subject to export controls. In this regard, the respondent indicated a
preference for multilateral export controls (e.g., the adoption of
export controls by the Australia Group).
BIS Response: The views expressed by this respondent support, and
expand upon, the rationale provided by BIS (both in its November 6
proposed rule and in this final rule) for the imposition of controls on
this nucleic acid assembler/synthesizer ``software'' under new ECCN
2D352. In addition, as noted in response to other comments described in
this final rule, the controls on this ``software'' reflect the decision
made at the AG's May 2021 Virtual Implementation Meeting session and,
consequently, are being imposed multilaterally by all AG participating
countries (including the United States).
Comment: One respondent expressed concern that the establishment by
BIS of more restrictive controls on ``software'' for the operation of
certain automated nucleic acid assemblers and synthesizers could damage
trade and collaboration in this field with certain U.S. allies and
thereby decrease the United States' global competitiveness in this
field. Consequently, this respondent stated that any controls that are
placed on such ``software'' should not impair the ability of the United
States and its allies to trade in intermediate goods or to collaborate
on R&D, both of which are crucial to maintaining their shared
advantages vis-[agrave]-vis other foreign competitors. In this regard,
the respondent noted that the methods for manipulating, growing,
recovering, concentrating, stabilizing, and testing biological
materials for use in weapons employ many of the same materials and
equipment used to produce vaccines, pharmaceuticals, and a wide variety
of food products.
BIS response: As indicated above, new ECCN 2D352 controls
``software'' designed for nucleic acid assemblers and synthesizers
controlled by 2B352.j, consistent with the decision made at the AG's
May 2021 Virtual Implementation Meeting session to add such
``software'' to its ``Control List of Dual-Use Biological Equipment and
Related Technology and Software.'' This ``software,'' as controlled
under new ECCN 2D352, requires a license for CB reasons and AT reasons
to the destinations indicated under CB
[[Page 54817]]
Column 2 and AT Column 1, respectively, on the Commerce Country Chart
in Supplement No. 1 to part 738 of the EAR. Consequently, this
``software'' generally does not require a license for export, reexport
or transfer (in-country) to destinations located in AG-participating
countries. That being the case, the controls that apply to this
``software'' under new ECCN 2D352 should not impair the ability of the
United States to trade in intermediate goods with most of its allies or
to collaborate on R&D with such countries.
Comment: One respondent asserted that the nucleic acid assembler
and synthesizer ``software'' proposed for control under new ECCN 2D352
by BIS's November 6 proposed rule is currently subject to the controls
described in Category XIV (m) of the United States Munitions List
(USML) (22 CFR 121.1), as well as the controls described in USML
Category XIV(f)(8). Specifically, this respondent stated that such
``software'' involves technical data directly related to the defense
articles enumerated in paragraphs (a) through (l) and (n) of USML
Category XIV and that, as such, it is subject to the export licensing
jurisdiction of the Directorate of Defense Trade Controls, U.S.
Department of State, under the International Traffic in Arms
Regulations (ITAR) (22 CFR parts 120-130). Furthermore, the respondent
asserted that such ``software'' is also restricted per USML Category
XIV(f)(8)(ii) and (f)(8)(iii), which apply to any part, component,
accessory, attachment, equipment, or system that is either manufactured
using classified production data or being developed using classified
information.
BIS Response: The ``software'' that this final rule controls under
new ECCN 2D352 on the CCL is dual-use ``software'' that, as noted
above, was added to the AG ``Control List of Dual-Use Biological
Equipment and Related Technology and Software'' following a decision
made at the AG's May 2021 Virtual Implementation Meeting session. As
indicated in its title, all of the items included on this AG common
control list are dual-use items--not military items. Consequently, the
respondent is mistaken in claiming that such ``software'' is restricted
per USML Category XIV(f)(8)(ii) and (f)(8)(iii), which apply to any
part, component, accessory, attachment, equipment, or system that is
either manufactured using classified production data or being developed
using classified information. New ECCN 2D352 does not control
``software'' that was manufactured, or is in the process of being
developed, using classified information subject to control under the
ITAR or the regulations of any other U.S. Government agency.
Saving Clause
Shipments of items removed from eligibility for export, reexport or
transfer (in-country) under a license exception or without a license
(i.e., under the designator ``NLR'') as a result of this regulatory
action that were on dock for loading, on lighter, laden aboard an
exporting carrier, or en route aboard a carrier to a port of export, on
October 5, 2021, pursuant to actual orders for export, reexport or
transfer (in-country) to a foreign destination, may proceed to that
destination under the previously applicable license exception or
without a license (NLR) so long as they are exported, reexported or
transferred (in-country) before December 6, 2021. Any such items not
actually exported, reexported or transferred (in-country) before
midnight, on December 6, 2021, require a license in accordance with
this regulation.
``Deemed'' exports of ``technology'' and ``source code'' removed
from eligibility for export under a license exception or without a
license (under the designator ``NLR'') as a result of this regulatory
action may continue to be made under the previously available license
exception or without a license (NLR) before December 6, 2021. Beginning
at midnight on December 6, 2021, such ``technology'' and ``source
code'' may no longer be released, without a license, to a foreign
national subject to the ``deemed'' export controls in the EAR when a
license would be required to the home country of the foreign national
in accordance with this regulation.
Export Control Reform Act of 2018
The Export Control Reform Act of 2018 (ECRA), as amended, codified
at 50 U.S.C. 4801-4852, serves as the authority under which BIS issues
this rule.
Rulemaking Requirements
1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including: Potential economic, environmental, public
health and safety effects; distributive impacts; and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits and of reducing costs, harmonizing rules, and promoting
flexibility. This rule has been designated a ``significant regulatory
action,'' although not economically significant, under section 3(f) of
Executive Order 12866. Accordingly, this rule has been reviewed by the
Office of Management and Budget.
2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with, a collection of information subject to the
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.) (PRA), unless that collection of information displays a currently
valid Office of Management and Budget (OMB) Control Number. This rule
contains the following collections of information subject to the
requirements of the PRA. These collections have been approved by OMB
under control numbers 0694-0088 (Simplified Network Application
Processing System) and 0694-0096 (Five Year Records Retention Period).
The approved information collection under OMB control number 0694-0088
includes license applications, among other things, and carries a burden
estimate of 29.6 minutes per manual or electronic submission for a
total burden estimate of 31,833 hours. The approved information
collection under OMB control number 0694-0096 includes recordkeeping
requirements and carries a burden estimate of less than 1 minute per
response for a total burden estimate of 248 hours.
Although this final rule makes important changes to the EAR for
items controlled for chemical/biological (CB) reasons, BIS has
determined that the overall increase in costs and burdens due to this
rule will be minimal. Specifically, BIS expects the burden hours
associated with these collections will increase, slightly, by 7 hours
and 39 minutes (i.e., 15 applications x 30.6 minutes per response) for
a total estimated cost increase of $230 (i.e., 7 hours and 39 minutes x
$30 per hour). The $30 per hour cost estimate for OMB control number
0694-0088 is consistent with the salary data for export compliance
specialists currently available through <a href="http://glassdoor.com">glassdoor.com</a> (<a href="http://glassdoor.com">glassdoor.com</a>
estimates that an export compliance specialist makes $55,280 annually,
which computes to roughly $26.58 per hour). This increase is not
expected to exceed the existing estimates currently associated with OMB
control numbers 0694-0088 and 0694-0096.
Written comments and recommendations for the information
collections referenced above should be sent within 30 days of the
publication of this final rule to: <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>.
Find these
[[Page 54818]]
particular information collections by selecting ``Currently under 30-
day Review--Open for Public Comments'' or by using the search function.
3. This rule does not contain policies with Federalism implications
as that term is defined in Executive Order 13132.
4. As stated in the preamble of this final rule, the amendments
contained in this rule reflect a decision made at the Australia Group
(AG) Virtual Implementation Meeting session held in May 2021, and later
adopted pursuant to the AG's silence procedure. Therefore, pursuant to
Section 1762 of the Export Control Reform Act of 2018 (ECRA) (50 U.S.C.
Sec. 4821), this action is exempt from the Administrative Procedure Act
(APA) (5 U.S.C. 553) requirements for notice of proposed rulemaking,
opportunity for public participation and delay in effective date.
Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this final rule by the
APA or any other law, the analytical requirements of the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.), as amended by the Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C.
601 et seq.), are not applicable.
Consistent with the emerging and foundational technologies notice
and comment requirements in Section 1758(a)(2)(C) of ECRA (50 U.S.C.
4817(a)(2)(C)), BIS published a proposed rule on November 6, 2020 (85
FR 71012), to provide the public with notice and the opportunity to
comment on its proposal to add a new ECCN 2D352 to the Commerce Control
List (CCL), for the purpose of controlling ``software'' for certain
nucleic acid synthesizers and assemblers for chemical/biological (CB)
reasons. In addition, consistent with the Regulatory Flexibility Act,
BIS prepared an initial regulatory flexibility analysis (IRFA) of the
impact that the proposed rule, if adopted, would have on small
businesses. The IRFA prepared by BIS requested comments on the analyses
and conclusions contained therein, including the overall conclusion
that the amendments in BIS's November 6 proposed rule would not have a
significant economic impact on a substantial number of small entities.
BIS received comments from four respondents on its November 6
proposed rule--these comments and BIS's responses are summarized in the
preamble of this final rule. BIS did not receive any comments in
response to the analyses and conclusions contained in the IRFA for its
November 6 proposed rule. Accordingly, no regulatory flexibility
analysis is required for this final rule, and none has been prepared.
List of Subjects
15 CFR Part 742
Exports, Terrorism.
15 CFR Part 774
Exports, Reporting and recordkeeping requirements, Terrorism.
For the reasons stated in the preamble, parts 742 and 774 of the
Export Administration Regulations (15 CFR parts 730-774) are amended as
follows:
PART 742--CONTROL POLICY--CCL BASED CONTROLS
0
1. The authority citation for 15 CFR part 774 continues to read as
follows:
Authority: 50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117
Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O.
12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR
59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004
Comp., p. 320; Notice of November 12, 2020, 85 FR 72897 (November
13, 2020).
0
2. Section 742.2 is amended by revising paragraphs (a)(2)(viii) and
(ix) to read as follows:
Sec. 742.2 Proliferation of chemical and biological weapons.
(a) * * *
(2) * * *
(viii) Software identified in ECCN 2D351 or 2D352, as follows:
(A) Dedicated software identified in ECCN 2D351 for the ``use'' of
toxic gas monitoring systems and their dedicated detecting components
controlled by ECCN 2B351;
(B) Software designed for nucleic acid assemblers and synthesizers
controlled by 2B352.j that is capable of designing and building
functional genetic elements from digital sequence data.
(ix) Technology identified in ECCN 2E001 for the ``development'' of
software controlled by ECCN 2D351 or 2D352.
* * * * *
PART 774--THE COMMERCE CONTROL LIST
0
3. The authority citation for 15 CFR part 774 continues to read as
follows:
Authority: 50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 10 U.S.C. 8720; 10 U.S.C. 8730(e); 22 U.S.C.
287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15
U.S.C. 1824; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210;
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783.
0
4. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 2, add an entry for ECCN 2D352 immediately following ECCN
2D351, and revise ECCN 2E001 to read as follows:
Supplement No. 1 to Part 774--The Commerce Control List
* * * * *
2D352 ``Software'' designed for nucleic acid assemblers and
synthesizers controlled by 2B352.j that is capable of designing and
building functional genetic elements from digital sequence data.
License Requirements
Reason for Control: CB, AT
Country chart (see Supp. No.
Control(s) 1 to part 738)
CB applies to entire entry................ CB Column 2.
AT applies to entire entry................ AT Column 1.
List Based License Exceptions (See Part 740 for a Description of All
License Exceptions)
TSR: N/A
List of Items Controlled
Related Controls: See ECCN 1E001 for ``development'' or ``production
``technology'' for genetic elements controlled by ECCN 1C353.
Related Definitions: See Section 772.1 of the EAR for the
definitions of ``software,'' ``program,'' and ``microprogram.''
Items: The list of items controlled is contained in the ECCN
heading.
* * * * *
2E001 ``Technology'' according to the General Technology Note for
the ``development'' of equipment or ``software'' controlled by 2A
(except 2A983, 2A984, 2A991, or 2A994), 2B (except 2B991, 2B993,
2B996, 2B997, 2B998, or 2B999), or 2D (except 2D983, 2D984, 2D991,
2D992, or 2D994).
License Requirements
Reason for Control: NS, MT, NP, CB, AT
Country chart (see Supp. No.
Control(s) 1 to part 738)
NS applies to ``technology'' for items NS Column 1.
controlled by 2A001, 2B001 to 2B009,
2D001 or 2D002.
[[Page 54819]]
MT applies to ``technology'' for items MT Column 1.
controlled by 2B004, 2B009, 2B104, 2B105,
2B109, 2B116, 2B117, 2B119 to 2B122,
2D001, or 2D101 for MT reasons.
NP applies to ``technology'' for items NP Column 1.
controlled by 2A225, 2A226, 2B001, 2B004,
2B006, 2B007, 2B009, 2B104, 2B109, 2B116,
2B201, 2B204, 2B206, 2B207, 2B209, 2B225
to 2B233, 2D001, 2D002, 2D101, 2D201, or
2D202 for NP reasons.
NP applies to ``technology'' for items NP Column 2.
controlled by 2A290, 2A291, or 2D290 for
NP reasons.
CB applies to ``technology'' for equipment CB Column 2.
controlled by 2B350 to 2B352, valves
controlled by 2A226 having the
characteristics of those controlled by
2B350.g, and software controlled by 2D351
or 2D352.
AT applies to entire entry................ AT Column 1.
Reporting Requirements
See Sec. 743.1 of the EAR for reporting requirements for
exports under License Exceptions, and Validated End-User
authorizations.
List Based License Exceptions (See Part 740 for a Description of All
License Exceptions)
TSR: Yes, except N/A for MT
Special Conditions for STA
STA: License Exception STA may not be used to ship or transmit
``technology'' according to the General Technology Note for the
``development'' of ``software'' specified in the License Exception
STA paragraph in the License Exception section of ECCN 2D001 or for
the ``development'' of equipment as follows: ECCN 2B001 entire
entry; or ``Numerically controlled'' or manual machine tools as
specified in 2B003 to any of the destinations listed in Country
Group A:6 (See Supplement No. 1 to part 740 of the EAR).
List of Items Controlled
Related Controls: See also 2E101, 2E201, and 2E301
Related Definitions: N/A
Items:
The list of items controlled is contained in the ECCN heading.
Note 1 to 2E001: ECCN 2E001 includes ``technology'' for the
integration of probe systems into coordinate measurement machines
specified by 2B006.a.
Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2021-21493 Filed 10-4-21; 8:45 am]
BILLING CODE 3510-33-P
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