Document ID: BIS-2020-0024-0002
Agency: bis
Document Type: Rule
Title: Commerce Control List: Expansion of Controls on Certain Biological Equipment Software
Posted Date: 2021-10-05T04:00Z

[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 [www.gpo.gov]
[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: Wesley.Johnson@bis.doc.gov.

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 glassdoor.com (glassdoor.com 
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: www.reginfo.gov/public/do/PRAMain. 
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