Rule2025-00723
Controls on Certain Laboratory Equipment and Related Technology To Address Dual Use Concerns About Biotechnology
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
January 16, 2025
Effective
January 16, 2025
Issuing agencies
Commerce DepartmentIndustry and Security Bureau
Abstract
With this interim final rule (IFR), the Bureau of Industry and Security (BIS) is revising the Export Administration Regulations (EAR) to address the accelerating development and deployment of advanced biotechnology tools contrary to U.S. national security and foreign policy interests. This rule institutes new controls on certain biotechnology equipment and related technology. It further solicits public comments on the changes it implements.
Full Text
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[Federal Register Volume 90, Number 10 (Thursday, January 16, 2025)]
[Rules and Regulations]
[Pages 4612-4617]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-00723]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 740, 742, 758, and 774
[Docket No. 250108-0012]
RIN 0694-AJ95
Controls on Certain Laboratory Equipment and Related Technology
To Address Dual Use Concerns About Biotechnology
AGENCY: Bureau of Industry and Security, Department of Commerce.
ACTION: Interim final rule.
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SUMMARY: With this interim final rule (IFR), the Bureau of Industry and
Security (BIS) is revising the Export Administration Regulations (EAR)
to address the accelerating development and deployment of advanced
biotechnology tools contrary to U.S. national security and foreign
policy interests. This rule institutes new controls on certain
biotechnology equipment and related technology. It further solicits
public comments on the changes it implements.
DATES: This rule is effective January 16, 2025.
Comments must be received by BIS no later than March 17, 2025.
ADDRESSES: Comments on this rule may be submitted to the Federal
rulemaking portal (<a href="http://www.regulations.gov">www.regulations.gov</a>). The <a href="http://regulations.gov">regulations.gov</a> ID for
this rule is: BIS-2024-0050. Please refer to RIN 0694-AJ95 in all
comments.
All filers using the portal 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
[[Page 4613]]
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 version of the 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.'' Any submissions with file names that do not
begin with either a ``BC'' or a ``P'' will be assumed to be public and
will be made publicly available through <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Commenters submitting business confidential information are encouraged
to scan a hard copy of the non-confidential version to create an image
of the file, rather than submitting a digital copy with redactions
applied, to avoid inadvertent redaction errors which could enable the
public to read business confidential information.
FOR FURTHER INFORMATION CONTACT: For all questions pertaining to this
rule, contact Theodore Curtin, Director of Chemical Biological Controls
Division; phone: 202-482-1979; <a href="/cdn-cgi/l/email-protection#3b6f535e545f54495e15784e494f52557b595248155f5458155c544d"><span class="__cf_email__" data-cfemail="b5e1ddd0dad1dac7d09bf6c0c7c1dcdbf5d7dcc69bd1dad69bd2dac3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
As noted in Executive Order (E.O.) 14081, ``Advancing Biotechnology
and Biomanufacturing Innovation for a Sustainable, Safe, and Secure
American Bioeconomy'' (87 FR 56849, September 15, 2022), advances in
biotechnology possess great promise but are inherently dual-use in
nature. Accordingly, the E.O. calls for safeguarding the United States
from foreign adversaries that could acquire technologies and data that
threaten our national security, while also promoting the ethical and
responsible development and deployment of biotechnology globally. The
E.O. provides a framework to ensure that biotechnologies do not
contribute to global instability through irresponsible or malicious
use.
The United States recognizes that ensuring the responsible use of
biotechnology, particularly when combined with advances in artificial
intelligence (AI) and data science, is essential to safeguard public
health, agriculture and food production, and the environment. At the
same time, the United States needs to address the benefits and risks of
dual-use biotechnology given the potential that its use, particularly
when coupled with AI and biological design tools, could strengthen the
military capabilities of countries of concern and lower barriers to the
design, deployment, and use of novel weapons. As described in the 2024
Annual Threat Assessment from the Office of the Director of National
Intelligence, ``new technologies--particularly in the fields of AI and
biotechnology--are being developed and are proliferating at a
[challenging] rate'' and that the consolidation of ``these emerging
technologies is likely to create breakthroughs, which could lead to the
rapid development of asymmetric threats . . . to U.S. interests.''
Certain countries are actively pursuing a strategy to exploit the
combination of biotechnology with other enabling technologies for
asymmetric military advantage through applications such as human
performance enhancement and advanced biologically-derived materials for
military-industrial use. Given the dual-use nature and relevance of
specific biotechnology equipment to contribute to the research and
development of certain militarily relevant technologies, calibrated
export controls on these categories of equipment are necessary to limit
immediate risks and protect against long-term national security threats
in a field that could greatly impact security and defense capabilities.
This IFR identifies two categories of equipment for additional U.S.
export controls necessary to help protect U.S. national security. These
categories of equipment are: (1) high parameter flow cytometers, which
are used to simultaneously measure several characteristics of
individual cells or particles, and (2) liquid chromatography mass
spectrometers specially designed for top-down proteomics, which are
analytical instruments used to elucidate and quantify unknown
biomolecular structures, characterize molecules, and aid in the study
of molecular interactions. The field of proteomics generally aims to
identify and characterize proteins and study their structures,
functions, interactions, and post-translational modifications. All the
items described can be used towards innovative solutions in health,
climate change, energy, food, and agriculture. However, they can also
be used for research and development of concern to U.S. national
security, including through the generation of large amounts of high-
quality biological datasets that can be misused by countries of
concern. This misuse includes training artificial intelligence systems
for the development of certain militarily relevant applications,
including as well as but not limited to human performance enhancement,
brain-machine interfaces, biologically-inspired synthetic materials,
and possibly biological weapons.
To address the national security concerns described above, this IFR
establishes new controls narrowly focused on a subset of biotechnology
equipment. This IFR creates specific Export Control Classification
Numbers (ECCNs) for high-parameter flow cytometers and certain mass
spectrometry equipment. These items generate high-quality, high-content
biological data including that which is suitable for use to facilitate
the development of AI and biological design tools. The new ECCNs
facilitate identification of the items being controlled and will
provide more transparency in trade flows for this equipment. Moreover,
these controls will only apply to destinations that present a concern
of potential misuse or diversion to activities of national security
concern.
Regulatory Changes
New Export Control Classification Numbers and Corresponding Changes
Given the above-described national security concerns, BIS is moving
high-parameter flow cytometers and certain mass spectrometry equipment
from their current control under ECCN 3A999 into new ECCN 3A069. ECCN
3A069 contains two paragraphs as follows: paragraph .a identifies flow
cytometers and cell sorters that are ``specially designed'' for
spectral analysis or contain 26 or greater detectors or channels; and
paragraph .b identifies liquid chromatography mass spectrometry
instruments (LC/MS and LC-MS/MS) ``specially designed'' for top-down
proteomic analysis. Flow cytometers and mass spectrometers that are
devices, as defined in section 201(h) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act), 21 U.S.C. 321(h), that have been authorized
for marketing by the Food and Drug Administration under section 510(k),
section 513, or section 515 of the FD&C Act, 21 U.S.C. 360(k), 21
U.S.C. 360c, 21 U.S.C. 360e, or are exempt from the requirement of
premarket notification under section 510(k) of the FD&C Act, 21 U.S.C.
360(k), and that are included in a list
[[Page 4614]]
required by section 510(j) of the FD&C Act, 21 U.S.C. 360(j). are
excluded from the scope of ECCN 3A069; the exclusion appears as a
license requirement note to ECCN 3A069. This rule also makes two
conforming changes. First, ECCN 3A999 is updated to reference ECCN
3A069 as a related control. Second, the heading of ECCN 3E001 is
updated to reference ECCN 3A069 in the list of 3A items excepted.
Relatedly, BIS is creating ECCN 3E069 to describe ``technology''
for the ``development'' or ``production'' of ECCN 3A069 items. The list
of items controlled is contained in the ECCN heading. ECCNs 3A069 and
3E069 have the same reasons for control and licensing policies,
described below.
Reasons for Control, Authorizations, and EEI Filing Changes
ECCNs 3A069 and 3E069 are controlled for National Security,
Regional Stability, and Anti-Terrorism reasons. No licenses are
required for Country Group A:1 for these items. As described below,
certain license exceptions are also available for these items.
National Security reasons for control are detailed under Sec.
742.4. Under paragraph (a)(2), 3A069 and 3E069 items will require a
license to all destinations, except those in Country Group A:1. This
IFR adds paragraph (b)(11) to Sec. 742.4, which identifies the license
review policy for license applications as follows: (a) presumption of
denial for destinations in both Country Group D:1 and D:5, Macau, or
destinations in Country Group E; and (b) for all other destinations for
which a license is required, case-by-case review based on a
determination of whether the items would make a significant
contribution to the military potential of any other destination or
combination of destinations that would prove detrimental to the
national security of the United States.
Regional Stability requirements for control are detailed under
Sec. 742.6. This IFR adds paragraph (a)(13) to Sec. 742.6, which
establishes a license requirement for the export, reexport, or transfer
(in-country) of any item controlled under ECCNs 3A069 and 3E069 when
destined to a Country Group D:5 destination or Macau. Consistent with
the license review policy for NS reasons of control, for destinations
that are in both Country Group D:1 and D:5, Macau, or destinations in
Country Group E, license applications for these items will be reviewed
under a presumption of denial. For all other destinations, applications
will be subject to case-by-case review. This case-by-case review policy
includes license applications for countries in Country Group D:5 that
are not also in Country Group D:1. This IFR adds the license review
policy for RS for these items to paragraph (b)(14).
Commodities controlled under ECCN 3A069 are generally eligible for
License Exception Shipments to Country Group B countries (GBS), set
forth in Sec. 740.4. However, License Exception GBS will not be
available for destinations subject to the RS control described in ECCN
3A999. Technology controlled under ECCN 3E069 is eligible for License
Exception Technology and software under restriction (TSR), detailed
under Sec. 740.6, except to destinations in Country Group D:5,
destinations subject to the RS control described in ECCN 3A999, or
Macau (in addition to existing destination-based restrictions on the
use of TSR). Under TSR, written assurances are required from the
importer that the technologies authorized under the License Exception
will not be reexported or released under certain conditions. Since TSR
eligibility will not apply to destinations in Country Group D:5,
destinations subject to the RS control in ECCN 3A999, and Macau, this
IFR adds paragraph (a)(1)(iv) to Sec. 740.6, which provides that a
written assurance is required for TSR authorization of ECCN 3E069
technology, assuring that the importer will not reexport or release the
technology to those destinations.
Finally, to better track the export of the items in ECCN 3A069,
this IFR revises the filing requirements for Electronic Export
Information (EEI) filings in the Automated Export System (AES). Under
new paragraph (b)(11) of Sec. 758.1, EEI filings are required for
exports of all items in ECCN 3A069 when destined for a Country Group D
destination.
Savings Clause
For the changes being made in this final rule, shipments of items
removed from eligibility for a License Exception or export, reexport,
or transfer (in-country) without a license (NLR) as a result of this
regulatory action that were en route aboard a carrier to a port of
export, reexport, or transfer (in-country), on January 16, 2025,
pursuant to actual orders for export, reexport, or transfer (in-
country) to or within a foreign destination, may proceed to that
destination under the previous eligibility for a License Exception or
export, reexport, or transfer (in-country) without a license (NLR)
before February 18, 2025. Any such items not actually exported,
reexported or transferred (in-country) before midnight, on February 18,
2025, require a license in accordance with this final rule.
Export Control Reform Act of 2018
On August 13, 2018, the President signed into law the John S.
McCain National Defense
Authorization Act for Fiscal Year 2019, which included the Export
Control Reform Act of 2018 (ECRA) (codified, as amended, at 50 U.S.C.
4801-4852). ECRA provides the legal basis for BIS's principal
authorities and serves as the authority under which BIS issues this
rule. In particular, and as noted elsewhere, Section 1753 of ECRA (50
U.S.C. 4812) authorizes the regulation of exports, reexports, and
transfers (in-country) of items subject to U.S. jurisdiction. Further,
Section 1754(a)(1)-(16) of ECRA (50 U.S.C. 4813(a)(1)-(16)) authorizes,
inter alia, the establishment of a list of controlled items; the
prohibition of unauthorized exports, reexports, and transfers (in-
country); the requirement of licenses or other authorizations for
exports, reexports, and transfers (in-country) of controlled items;
apprising the public of changes in policy, regulations, and procedures;
and any other action necessary to carry out ECRA that is not otherwise
prohibited by law. Pursuant to Section 1762(a) of ECRA (50 U.S.C.
4821(a)), these changes can be imposed in a final rule without prior
notice and comment.
Rulemaking Requirements
1. This rule has been determined to be a significant regulatory
action for purposes of Executive Order 12866.
2. Notwithstanding any other provision of law, no person is
required to respond to or 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 regulation involves
collections previously approved by OMB under control number 0694-0088,
Simplified Network Application Processing System, which includes, among
other things, license applications and commodity classifications, and
carries a burden estimate of 29.7 minutes for a manual or electronic
submission for a total burden estimate of 38,826 hours. Total burden
hours associated with the PRA and OMB control number 0694-0088 are
expected to increase as a result of this rule. This rule is expected to
increase the licensing burden by approximately 1170 licenses per year;
this will result
[[Page 4615]]
in an overall increase in burden hours by around 580 hours per year for
licensing, for a new total burden estimate of 39,406 hours.
3. This rule does not contain policies with federalism implications
as that term is defined in Executive Order 13132.
4. Pursuant to section 1762 of the Export Control Reform Act of
2018, this action is exempt from the Administrative Procedure Act (5
U.S.C. 553) requirements for notice of proposed rulemaking, opportunity
for public participation, and delay in effective date. While Section
1762 of ECRA on its own provides sufficient authority for such an
exemption, this action is also independently exempt from the same APA
requirements because it involves a military or foreign affairs function
of the United States (5 U.S.C. 553(a)(1)). Nonetheless, BIS is
accepting comments on this IFR.
5. Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule by 5 U.S.C.
553, or by any other law, the analytical requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq., are not applicable.
Accordingly, no regulatory flexibility analysis is required, and none
has been prepared.
List of Subjects
15 CFR Parts 740 and 758
Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.
15 CFR Part 742
Exports, Terrorism.
15 CFR Part 742
Exports, Terrorism.
15 CFR Part 774
Exports, Reporting and recordkeeping requirements, Terrorism.
Accordingly, parts 740, 742, 758, and 774 of the Export
Administration Regulations (15 CFR parts 730-774) are amended as
follows:
PART 740--LICENSE EXCEPTIONS
0
1. The authority citation for 15 CFR part 740 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. 7201 et seq.; 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
2. Section 740.6 is amended by adding paragraph (a)(1)(iv) to read as
follows:
Sec. 740.6 Technology and software under restriction (TSR).
(a) * * *
(1) * * *
(iv) Reexport to a destination in Country Group D:5, a destination
subject to the Regional Stability control under ECCN 3A999, or Macau or
release the technology to a national of such destinations, if the
technology is controlled under ECCN 3E069.
* * * * *
PART 742--CONTROL POLICY--CCL BASED CONTROLS
0
3. The authority citation for 15 CFR part 742 is revised 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 7, 2024, 89 FR 88867 (November 8,
2024).
0
4. Section 742.4 is amended by revising (b)(11) to read as follows:
PART 742--CONTROL POLICY--CCL BASED CONTROLS
Sec. 742.4 National security.
* * * * *
(b) * * *
(11) License review policy for items specified in ECCNs 3A069 and
3E069. License applications to export, reexport, or transfer (in-
country) items specified in ECCNs 3A069 and 3E069 will be reviewed
under a presumption of denial when destined for a country that is in
both Country Groups D:1 and D:5, Macau, or a country in Country Group
E. All other license applications for these items will be reviewed on a
case-by-case basis to determine if the items would make a significant
contribution to the military potential of any other destination or
combination of destinations that would prove detrimental to the
national security of the United States.
* * * * *
0
5. Section 742.6 is amended by adding paragraphs (a)(13) and (b)(14) to
read as follows:
Sec. 742.6 Regional stability.
(a) * * *
(13) RS requirement that applies for items specified in ECCNs 3A069
and 3E069. A license is required for the export, reexport, or transfer
(in-country) of any item specified in ECCNs 3A069 and 3E069 when
destined to a Country Group D:5 destination or Macau. See supplement
no. 1 to part 740 of the EAR for Country Groups.
(b) * * *
(14) License review policy for items specified in paragraph
(a)(13). License applications to export, reexport, or transfer (in-
country) items described in paragraph (a)(13) of this section will be
reviewed under a presumption of denial when destined for a country that
is in both Country Groups D:1 andD:5, Macau, or a country in Country
Group E. All other license applications for these items will be
reviewed on a case-by-case basis.
PART 758--EXPORT CLEARANCE REQUIREMENTS AND AUTHORITIES
0
6. The authority citation for part 758 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.; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783.
0
7. Section 758.1 is amended by adding paragraph (b)(11) to read as
follows:
Sec. 758.1 The Electronic Export Information (EEI) filing to the
Automated Export System (AES).
* * * * *
(b) * * *
(11) For all exports of items in ECCN 3A069 when destined to a
destination in Country Group D.
PART 774--THE COMMERCE CONTROL LIST
0
8. The authority citation for 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.
Supplement No. 1 to Part 774--The Commerce Control List
0
9. Supplement no.1 to part 774 is revised by adding ECCN 3A069,
modifying ECCNs 3A999 and 3E001, and adding ECCN 3E069.
The addition and revision read as follows:
* * * * *
[[Page 4616]]
Category 3--Electronics
A. ``End Items,'' ``Equipment,'' ``Accessories,'' ``Attachments,''
``Parts,'' ``Components,'' and ``Systems''
* * * * *
ECCN 3A069 Specific Laboratory Equipment as Follows (See List of
Items Controlled)
License Requirements
Reason for Control: NS, RS, AT
Country chart (see Supp. No.
Control(s) 1 to part 738)
NS applies to entire entry................ NS Column 2.
RS applies to entire entry................ To or within Macau or a
destination specified in
Country Group D:5 of
supplement no. 1 to part
740 of the EAR. See Sec.
742.6(a)(12) of the EAR.
AT applies to entire entry................ AT Column 1.
List Based License Exceptions (See Part 740 for a Description of All
License Exceptions)
LVS: N/A
GBS: Yes, except N/A for destinations subject to the RS control in
3A999.
List of Items Controlled
Related Controls: See also 3A999 for specific processing equipment,
n.e.s.. See also 3E069 for technology for the ``development'' and
``production'' of items detailed in 3A069.
License Requirement Note: Excluded from the scope of this entry
are flow cytometers and mass spectrometers that are devices, as
defined in section 201(h) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act), 21 U.S.C. 321(h), that have been authorized for
marketing by the Food and Drug Administration under section 510(k),
section 513, or section 515 of the FD&C Act, 21 U.S.C. 360(k), 21
U.S.C. 360c, 21 U.S.C. 360e, or are exempt from the requirement of
premarket notification under section 510(k) of the FD&C Act, 21
U.S.C. 360(k), and that are included in a list required by section
510(j) of the FD&C Act, 21 U.S.C. 360(j).
Related Definitions: N/A
Items:
a. Flow cytometers and cell sorters that are ``specially
designed'' for spectral analysis or contain 26 or greater detectors
or channels.
b. Liquid chromatography mass spectrometry instruments (LC/MS
and LC-MS/MS) ``specially designed'' for top-down proteomic
analysis.
* * * * *
3A999 Specific Processing Equipment, n.e.s., as Follows (See List of
Items Controlled).
License Requirements
Reason for Control: RS, AT
Country chart (see Supp. No.
Control(s) 1 to part 738)
RS applies to entire entry................ A license is required for
items controlled by this
entry for export or
reexport to Iraq or
Pakistan or transfer within
Iraq or Pakistan for
regional stability reasons.
The Commerce Country Chart
is not designed to
determine RS license
requirements for this
entry. See Sec. Sec.
742.6 and 746.3 of the EAR
for additional information.
AT applies to entire entry................ A license is required for
items controlled by this
entry to North Korea for
anti-terrorism reasons. The
Commerce Country Chart is
not designed to determine
AT licensing requirements
for this entry. See Sec.
742.19 of the EAR for
additional information.
List Based License Exceptions (See Part 740 for a Description of All
License Exceptions)
LVS: N/A
GBS: N/A
List of Items Controlled
Related Controls: (1) See also 3A225 (for frequency changers capable
of operating in the frequency range of 600 Hz and above) and 3A233.
(2) Certain auxiliary systems, equipment, ``parts'' and
``components'' for isotope separation plants made of or protected by
UF<INF>6</INF> resistant materials are subject to the export
licensing authority of the Nuclear Regulatory Commission (see 10 CFR
part 110). (3) See also 3A069 for flow cytometers and cell sorters
that are ``specially designed'' for spectral analysis or contain 26
or greater detectors or channels as well as liquid chromatography
mass spectrometry instruments (LC/MS and LC-MS/MS) ``specially
designed'' for top-down proteomic analysis.
Related Definitions: N/A
Items:
a. Frequency changers capable of operating in the frequency
range from 300 up to 600 Hz, n.e.s;
b. Mass spectrometers n.e.s;
c. All flash x-ray machines, and ``parts'' or ``components'' of
pulsed power systems designed thereof, including Marx generators,
high power pulse shaping networks, high voltage capacitors, and
triggers;
d. Pulse amplifiers, n.e.s.;
e. Electronic equipment for time delay generation or time
interval measurement, as follows:
e.1. Digital time delay generators with a resolution of 50
nanoseconds or less over time intervals of 1 microsecond or greater;
or
e.2. Multi-channel (three or more) or modular time interval
meter and chronometry equipment with resolution of 50 nanoseconds or
less over time intervals of 1 microsecond or greater;
f. Chromatography and spectrometry analytical instruments,
n.e.s.
* * * * *
E. ``Technology''
* * * * *
3E001 ``Technology'' according to the General Technology Note for
the ``development'' or ``production'' of commodities controlled by
3A (except 3A069, 3A901, 3A904, 3A980, 3A981, 3A991, 3A992, or
3A999), 3B (except 3B001.a.4, c, d, f.1, f.5, k to n, p.2, p.4, r,
3B002.c, 3B903, 3B904, 3B991, 3B992, 3B993, or 3B994) or 3C (except
3C907, 3C908, 3C909, or 3C992).
License Requirements
Reason for Control: NS, MT, NP, RS, AT
Country chart (see Supp. No.
Control(s) 1 to part 738)
NS applies to ``technology'' for NS Column 1.
commodities controlled by 3A001, 3A002,
3A003, 3B001 (except as noted in the
heading), 3B002 (except 3B002.c), or
3C001 to 3C006.
MT applies to ``technology'' for MT Column 1.
commodities controlled by 3A001 or 3A101
for MT Reasons.
NP applies to ``technology'' for NP Column 1.
commodities controlled by 3A001, 3A201,
or 3A225 to 3A234 for NP reasons.
RS applies to ``technology'' for Worldwide (see Sec.
commodities controlled in 3A090, when 742.6(a)(6)(ii)).
exported from Macau or a destination
specified in Country Group D:5.
RS applies to ``technology'' for To or within destinations
commodities controlled by 3A001.z, 3A090 specified in Country Groups
(except for 3A090.c). D:1, D:4, and D:5 of
supplement no. 1 to part
740 of the EAR, excluding
any destination also
specified in Country Groups
A:5 or A:6. See Sec.
742.6(a)(6)(iii) of the
EAR.
RS applies to ``technology'' for To or within Macau or a
commodities controlled by 3A090.c. destination specified in
Country Group D:5 of
supplement no. 1 to part
740 of the EAR. See Sec.
742.6(a)(6)(i)(B) of the
EAR.
RS applies to ``technology'' for RS Column 2.
commodities controlled by 3A001.a.15 or
b.13, 3A004, 3B003, 3C007, 3C008, or
3C009.
AT applies to entire entry................ AT Column 1.
License Requirements Note: See Sec. 744.17 of the EAR for
additional license requirements for microprocessors having a
processing speed of 5 GFLOPS or more and an arithmetic logic unit
with an access width of 32 bit or more, including those
[[Page 4617]]
incorporating ``information security'' functionality, and associated
``software'' and ``technology'' for the ``production'' or
``development'' of such microprocessors.
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, and ``technology'' for the
``development'' or ``production'' of: (a) vacuum electronic device
amplifiers described in 3A001.b.8, having operating frequencies
exceeding 19 GHz; (b) solar cells, coverglass-interconnect-cells or
covered-interconnect-cells (CIC) ``assemblies,'' solar arrays and/or
solar panels described in 3A001.e.4; (c) ``Monolithic Microwave
Integrated Circuit'' (``MMIC'') amplifiers in 3A001.b.2; (d)
discrete microwave transistors in 3A001.b.3; and (e) commodities
described in 3A090.
Note: See Sec. 740.2(a)(9)(ii) of the EAR for license exception
restrictions for ECCN 3E001 ``technology'' for commodities
controlled by 3A001.z, 3A090.
IEC: Yes, for ``technology'' for equipment controlled by 3B001.q,
see Sec. 740.2(a)(22) and Sec. 740.24 of the EAR.
Special Conditions for Strategic Trade Authorization (STA)
STA: License Exception STA may not be used to ship or transmit
``technology'' according to the General Technology Note for the
``development'' or ``production'' of equipment specified by ECCNs
3A002.g.1 or 3B001.a.2 to any of the destinations listed in Country
Group A:6 (see supplement no.1 to part 740 of the EAR). License
Exception STA may not be used to ship or transmit ``technology''
according to the General Technology Note for the ``development'' or
``production'' of components specified by ECCN 3A001.b.2, b.3,
commodities specified in 3A090, to any of the destinations listed in
Country Group A:5 or A:6 (see supplement no. 1 to part 740 of the
EAR).
List of Items Controlled
Related Controls: (1) ``Technology'' according to the General
Technology Note for the ``development'' or ``production'' of certain
``space-qualified'' atomic frequency standards described in Category
XV(e)(9), MMICs described in Category XV(e)(14), and oscillators
described in Category XV(e)(15) of the USML are ``subject to the
ITAR'' (see 22 CFR parts 120 through 130). See also ECCNs 3E101,
3E201 and 9E515. (2) ``Technology'' for ``development'' or
``production'' of ``Microwave Monolithic Integrated Circuits''
(``MMIC'') amplifiers in 3A001.b.2 is controlled in this ECCN 3E001;
5E001.d refers only to that additional ``technology'' ``required''
for telecommunications.
Related Definition: N/A.
Items: The list of items controlled is contained in the ECCN
heading.
Note 1: 3E001 does not control ``technology'' for equipment or
``components'' controlled by 3A003.
Note 2: 3E001 does not control ``technology'' for integrated
circuits controlled by 3A001.a.3 to a.14 or z, having all of the
following:
(a) Using ``technology'' at or above 0.130 [mu]m; and
(b) Incorporating multi-layer structures with three or fewer
metal layers.
* * * * *
3E069 ``Technology'' according to the General Technology Note for
the ``development'' or ``production'' of items controlled by 3A069.
License Requirements
Reason for Control: NS, RS, AT
Country chart (see Supp. No.
Control(s) 1 to part 738)
NS applies to entire entry................ NS Column 2.
RS applies to entire entry................ To or within Macau or a
destination specified in
Country Group D:5 of
supplement no. 1 to part
740 of the EAR. See Sec.
742.6(a)(13) of the EAR.
AT applies to entire entry................ AT Column 1.
List Based License Exceptions (See Part 740 for a Description of All
License Exceptions)
TSR: Yes, except N/A for Macau, destinations in Country Group D:5,
or destinations subject to the RS control in 3A999.
List of Items Controlled
Related Controls: N/A
Related Definitions: N/A
Items: The list of items controlled is contained in the ECCN
heading.
* * * * *
Thea D. Rozman Kendler,
Assistant Secretary for Export Administration.
[FR Doc. 2025-00723 Filed 1-15-25; 8:45 am]
BILLING CODE 3510-33-P
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