Rule2023-00397
Implementation of Australia Group Decisions From 2021 and 2022 Virtual Meetings: Controls on Marine Toxins, Plant Pathogens and Biological Equipment
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Published
January 17, 2023
Effective
January 17, 2023
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 reflect decisions made at the November 2021 and March 2022 Australia Group (AG) Virtual Implementation Meetings and the AG Plenary Meeting held in July 2022. The amendments include revisions to certain Export Control Classification Numbers to clarify the controls on genetic elements and genetically modified organisms and the scope of the exclusion that applies to medical isolators "specially designed" for barrier nursing or transportation of infected patients; and makes clarifications by adding four naturally occurring, dual-use marine toxins (specifically, brevetoxins, gonyautoxins, nodularins and palytoxin) and removing cholera toxin. The addition of these four toxins is consistent with Section 1758 of the Export Control Reform Act of 2018 (ECRA) regarding emerging and foundational technologies. Finally, this rule also includes amendments to reflect the AG Plenary updates to the nomenclature of certain bacteria and fungi, and the clarification of the definition of "disinfected" as it applies to certain biological equipment.
Full Text
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<title>Federal Register, Volume 88 Issue 10 (Tuesday, January 17, 2023)</title>
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[Federal Register Volume 88, Number 10 (Tuesday, January 17, 2023)]
[Rules and Regulations]
[Pages 2507-2517]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00397]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 740, 742, and 774
[Docket No. 220909-0188]
RIN 0694-AI21
Implementation of Australia Group Decisions From 2021 and 2022
Virtual Meetings: Controls on Marine Toxins, Plant Pathogens and
Biological Equipment
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 reflect
decisions made at the November 2021 and March 2022 Australia Group (AG)
Virtual Implementation Meetings and the AG Plenary Meeting held in July
2022. The amendments include revisions to certain Export Control
Classification Numbers to clarify the controls on genetic elements and
genetically modified organisms and the scope of the exclusion that
applies to medical isolators ``specially designed'' for barrier nursing
or transportation of infected patients; and makes clarifications by
adding four naturally occurring, dual-use marine toxins (specifically,
brevetoxins, gonyautoxins, nodularins and palytoxin) and removing
cholera toxin. The addition of these four toxins is consistent with
Section 1758 of the Export Control Reform Act of 2018 (ECRA) regarding
emerging and foundational technologies. Finally, this rule also
includes amendments to reflect the AG Plenary updates to the
nomenclature of certain bacteria and fungi, and the clarification of
the definition of ``disinfected'' as it applies to certain biological
equipment.
DATES: This rule is effective January 17, 2023.
FOR FURTHER INFORMATION CONTACT: Dr. Tara Gonzalez, Chemical and
Biological Controls Division, Office of Nonproliferation and Treaty
Compliance, Bureau of Industry and Security, Telephone: (202) 482-3343,
Email: <a href="/cdn-cgi/l/email-protection#f0a4918291deb79f9e8a919c958ab0929983de949f93de979f86"><span class="__cf_email__" data-cfemail="b5e1d4c7d49bf2dadbcfd4d9d0cff5d7dcc69bd1dad69bd2dac3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
The Bureau of Industry and Security (BIS) is amending the Export
Administration Regulations (EAR) (15 CFR parts 730-774) to reflect the
decisions made at the November 2021 and March 2022 Australia Group (AG)
Virtual Implementation Meetings and the AG Plenary Meeting held in
Paris, France, from July 4 through July 8, 2022. 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.
At the November 2021 AG Virtual Implementation Meeting, the AG
revised its ``Control List of Dual-Use Biological Equipment and Related
Technology and Software'' to clarify the scope of the exclusion that
applies to
[[Page 2508]]
medical isolators ``specially designed'' for barrier nursing or
transportation of infected patients.
Consistent with decisions made at the AG's March 2022 Virtual
Implementation Meeting, two AG common control lists (i.e., the list of
``Human and Animal Pathogens and Toxins'' and the ``List of Plant
Pathogens for Export Control'') were updated to clarify that the
controls on genetic elements and genetically modified organisms
include, inter alia, any gene(s) or translated product(s) specific to
any controlled virus. Previously, the control text for viral genetic
elements referred only to the risk posed by the nucleic acid sequence
itself, and not to transcribed or translated products.
The AG also made changes to three of its common control lists to
reflect the decisions made at its July 2022 Plenary Meeting. The AG
revised its list of ``Human and Animal Pathogens and Toxins'' to add
four naturally occurring, dual-use marine toxins (specifically,
brevetoxins, gonyautoxins, nodularins and palytoxin) and remove cholera
toxin. The AG also revised its ``Control List of Dual-Use Biological
Equipment and Related Technology and Software'' by clarifying the
definition of ``disinfected'' to more closely reflect the use of this
term by the scientific and industrial communities. In addition, the AG
revised its ``List of Plant Pathogens for Export Control'' to update
the nomenclature for certain bacteria and fungi.
I. EAR Changes Reflecting the November 2021 AG Virtual Implementation
Meeting Decision
Amendments to ECCN 2B352
Consistent with the decision made at the November 2021 AG Virtual
Implementation Meeting, this rule amends ECCN 2B352 to reflect changes
in the Notes to the AG controls on biocontainment chamber, isolators
and biological safety cabinets described in the ``Control List of Dual-
Use Biological Equipment and Related Technology and Software.''
Specifically, Note 2 to 2B352.g.2 is revised to clarify that this ECCN
controls any isolator having all of the characteristics described in
2B352.g.2.a through g.2.d, regardless of its intended use and its
designation, except for medical isolators ``specially designed'' for
barrier nursing or transportation of infected patients. Additional
amendments to this ECCN, which reflect decisions made at the July 2022
AG Plenary Meeting, are described later in the preamble of this rule.
II. EAR Changes Reflecting the March 2022 AG Virtual Implementation
Meeting Decision
Amendments to Export Control Classification Number (ECCN) 1C353
Consistent with the decision made at the March 2022 AG Virtual
Implementation Meeting, this rule amends paragraph a.1 of ECCN 1C353 on
the Commerce Control List (CCL), in Supplement No. 1 to part 774 of the
EAR, to clarify that the controls on genetic elements and genetically
modified organisms include, inter alia, any gene(s) or translated
product(s) specific to any controlled virus. Prior to the publication
of this final rule, this ECCN did not explicitly state that its
controls on viral genetic elements also included translated product(s)
specific to any controlled virus. The control text in ECCN 1C353.a
previously referred to transcribed or translated product(s) only with
respect to bacterial and fungal genetic elements described in paragraph
a.2.a.
III. EAR Changes Reflecting the July 2022 AG Plenary Meeting Decisions
Amendments to ECCN 1C350
This final rule amends ECCN 1C350, consistent with the July 2022 AG
Plenary Meeting update to the ``Export Control List: Chemical Weapons
Precursors,'' by adding a clarification to Technical Note 3 in this
ECCN. This change is also consistent with a recommendation by the
Organization for the Prohibition of Chemical Weapons (OPCW) to control
all stereoisomers and isotopically-labeled forms of scheduled
chemicals, even if they have different CAS numbers. Specifically, this
rule revises the parenthetical ``(e.g., hydrates),'' in the second
sentence of Technical Note 3, to read ``(e.g., hydrates, isotopically-
labeled forms or all possible stereoisomers).''
Amendments to ECCN 1C351
This final rule reflects the recent updates to the AG ``Human and
Animal Pathogens and Toxins'' common control list, as described above,
by amending ECCN 1C351 to add four marine toxins (brevetoxins,
gonyautoxins, nodularins and palytoxin) and remove cholera toxin.
Specifically, the four marine toxins are added in alphabetical order to
ECCN 1C351.d, where they are controlled for chemical/biological (CB)
and anti-terrorism (AT) reasons. Certain other toxins in this ECCN are
renumbered, accordingly, to reflect the addition of the marine toxins
and the removal of cholera toxin.
This rule also makes conforming changes elsewhere in ECCN 1C351 to
update references to certain toxins (i.e., in the CW Reason for Control
paragraph, License Requirements Notes 1 and 2, the License Exception
STA eligibility paragraph and the Related Controls paragraph). Similar
conforming amendments to the Chemical Weapons Convention (CWC) and
License Exception Strategic Trade Authorization (STA) provisions in the
EAR are described below.
As described in more detail below, BIS identified the synthesis and
collection of the four marine toxins for evaluation according to the
criteria in Section 1758 of the Export Control Reform Act of 2018
(ECRA), 50 U.S.C. 4801-4852, pertaining to emerging and foundational
technologies. Other considerations prompted the decision to remove
cholera toxin from the list of ``Human and Animal Pathogens and
Toxins.'' At the time of its inclusion on this AG common control list,
cholera toxin did not have any significant commercial or medical uses.
However, in recent years, there has been a significant increase in
biomedical research involving cholera toxins and in the use of cholera
toxin in biomedical applications. Furthermore, cholera toxin, by itself
(i.e., in the absence of live bacteria), is known to have limited
cytotoxicity (e.g., compared to other toxins such as botulinum,
saxitoxin, or ricin), and cannot be transmitted from person to person.
Cholera toxin has not been the major focus of a biological weapons
research program, although it may have been evaluated for such
purposes. Consequently, the removal of chemical/biological (CB)
controls on cholera toxins is not expected to have a significant impact
on the proliferation, development, production or use of biological
weapons, nor would the relative costs of such controls (e.g., in terms
of their impact on public health and on biomedical and related
research) be justified going forward.
Expansion of ECCN 1E001 Controls
Although this rule does not amend ECCN 1E001 (which controls, inter
alia, ``technology'' for the ``development'' or ``production'' of the
human and animal pathogens and ``toxins'' described in ECCN 1C351), the
heading of ECCN 1E001 indicates that, with limited exceptions, ECCN
1E001 controls ``technology for the ``development'' or ``production''
of items listed under Category 1C of the CCL. Consequently, ECCN 1E001
now controls ``technology'' for the ``development'' or ``production''
of the four marine toxins that are being added to ECCN 1C351 by this
rule.
[[Page 2509]]
Other Conforming Amendments To Reflect the Reordering of Toxins in ECCN
1C351.d
This rule amends Sec. 740.20--License Exception Strategic Trade
Authorization (STA) to make conforming changes to the ECCN 1C351.d
references in paragraph (b)(2)(v) and paragraph (b)(2)(vi).
Specifically, Sec. 740.20(b)(2)(v) is amended to reference the
exclusion of ECCN 1C351.d.14 and d.15 items from License Exception STA
eligibility, consistent with the proposed renumbering of ricin and
saxitoxin (which were previously controlled under ECCN 1C351.d.11 and
d.12, respectively). Similarly, Sec. 740.20(b)(2)(vi) is amended,
consistent with the renumbering of the toxins in ECCN 1C351.d, by
revising the references to the ECCN 1C351.d toxins that are authorized
(with certain limitations) under License Exception STA to destinations
indicated in Country Group A:5 (see Supplement No. 1 to part 740 of the
EAR).
This rule also makes conforming changes to Sec. 742.18--Chemical
Weapons Convention (CWC) and ECCN 1C991 (Vaccines, immunotoxins,
medical products, diagnostic and food testing kits) to reflect the
renumbering of the toxins in ECCN 1C351.d. Specifically, Sec.
742.18(a)(1), (b)(1)(i), and (b)(1)(ii) and (iii) are amended to
reference ECCN 1C351.d.14 and d.15, consistent with the renumbering of
ricin and saxitoxin described above. In ECCN 1C991, 1C991.c.1 and .e
are amended to make conforming changes to the references therein to
ECCN 1C351 that are affected by the renumbering of the toxins in ECCN
1C351.d.
None of the conforming amendments described above changes the scope
of the controls in the affected EAR provisions.
Amendments to ECCN 1C354
This final rule reflects the AG Plenary changes to the ``List of
Plant Pathogens for Export Control,'' which updated the nomenclature
for certain bacteria and fungi. Specifically, this rule amends ECCN
1C354.a by updating the nomenclature of the bacteria ``Xanthomonas
axonopodis pv. citri (Xanthomonas campestris pv. citri A) (Xanthomonas
campestris pv. citri)'' and ``Clavibacter michiganensis subspecies
sepedonicus (syn. Corynebacterium michiganensis subspecies sepedonicum
or Corynebacterium sepedonicum)'' to read ``Xanthomonas citri pv. citri
(Xanthomonas axonopodis pv. citri, Xanthomonas campestris pv. citri)''
and ``Clavibacter michiganensis subsp. sepedonicus, (Clavibacter
sepedonicus, Clavibacter michiganense subsp. sepedonicus,
Corynebacterium michiganensis subsp. sepedonicum, Corynebacterium
sepedonicum),'' respectively. In addition, ECCN 1C354.b is amended to
update the nomenclature of the fungi ``Cochliobolus miyabeanus
(Helminthosporium oryzae)'' and ``Microcyclus ulei (syn. Dothidella
ulei)'' to read ``Bipolaris oryzae (Cochliobolus miyabeanus,
Helminthosporium oryzae)'' and ``Pseudocercospora ulei (Microcyclus
ulei, Dothidella ulei),'' respectively. To maintain the listing of
these fungi in alphabetical order, ``Bipolaris oryzae (Cochliobolus
miyabeanus, Helminthosporium oryzae),'' which was previously controlled
under ECCN 1C354.b.2, is now controlled under ECCN 1C354.b.1 and
``Colletotrichum kahawae (Colletotrichum coffeanum var. virulans),''
which was previously controlled under ECCN 1C354.b.1, is now controlled
under ECCN 1C354.b.2.
Amendments to ECCN 2B352
In addition to the ECCN 2B352 amendments described above (see
discussion of amendments per the November 2021 AG Virtual
Implementation Meeting decision), this final rule amends ECCN 2B352 to
reflect the recent updates to the AG ``Control List of Dual-Use
Biological Equipment and Related Technology and Software,'' by revising
the definition of ``disinfected'' to more closely reflect the use of
this term by the scientific and industrial communities. Specifically,
this rule amends the Technical Note following ECCN 2B352.d.2 by
revising the definition of ``disinfected'' to indicate that this term
``denotes a process to reduce the number of microorganisms, but not
usually of bacterial spores, through the use of chemical agents,
without necessarily killing or removing all organisms.'' This change
eliminates what appeared to be a disparity between the commonly
accepted use of this term in scientific and industrial circles and the
previous AG definition, wherein the latter described both
``disinfection'' and ``sterilization'' as being distinct from
``sanitization'' (with ``sanitization'' referring to cleaning
procedures designed to lower the microbial content of equipment without
necessarily achieving elimination of all microbial infectivity or
viability).
Marine Toxins Identified for Evaluation Under Section 1758 of ECRA
In advance of the 2022 AG Plenary meeting, BIS identified the
synthesis and collection of the four marine toxins addressed in this
final rule for evaluation according to the criteria in Section 1758 of
ECRA, pertaining to emerging and foundational technologies. These
marine toxins have the potential (through either accidental or
deliberate release) to cause casualties in humans or animals, degrade
equipment, or damage crops or the environment. Because these toxins are
now capable of being more easily isolated and purified due to novel
synthesis methods and equipment, BIS determined that the absence of
export controls on the toxins 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 May 23, 2022 (87 FR
31195), to provide the public with notice and the opportunity to
comment on its proposal to amend ECCN 1C351 on the CCL to add these
marine toxins to ECCN 1C351.
Comments Submitted in Response to BIS's May 23 Proposed Rule
BIS received comments from two respondents in response to the
publication of its May 23 proposed rule. The comments from these
respondents, together with BIS's responses, are described below.
Comment: One respondent indicated that clarification was needed
concerning whether any of the four marine toxins proposed for control
have an identified and specific biological synthesis pathway. In the
respondent's opinion, if this were the case, then certain genes or gene
clusters may become subject to control as a result of imposing controls
on the toxin. If not, then the respondent thought it unlikely that any
genes or gene clusters would become subject to control as a consequence
of controlling the toxin.
BIS response: ECCN 1C353.a.3 controls any genetically modified
organism that contains, or any genetic element that codes for, any
toxins (or their subunits) controlled by 1C351.d. Genetically modified
organisms and genetic elements are defined in Technical Notes 1 and 2,
respectively, in ECCN 1C353. To the extent that any genes and gene
clusters became subject to control under ECCN 1C353, as a result of the
imposition of controls on the four marine toxins and their subunits
under ECCN 1C351.d, they would be among the genetically modified
organisms and genetic elements described in ECCN 1C353.a.3. BIS
believes that the controls described in ECCN 1C353.a.3 are sufficiently
clear
[[Page 2510]]
in this respect and, consequently, that no further clarification is
necessary.
Comment: Another respondent submitted comments that addressed COVID
vaccines and treatments within the context of the World Trade
Organization's Trade-Related Aspects of Intellectual Property Rights
(TRIPS).
BIS response: These TRIPS-based comments were not responsive to the
request for comments in BIS's May 23 proposed rule, as they were
focused almost exclusively on the potential relationship between
intellectual property rights and the availability of COVID vaccines
within various countries. Furthermore, the comments did not
specifically address whether and, if so, how export controls would
impact the availability of such vaccines in those countries.
Consequently, these comments are not addressed in this final rule.
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
January 17, 2023, 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 March 20, 2023. Any such items not
actually exported, reexported or transferred (in-country) before
midnight, on March 20, 2023, 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 March 20, 2023. Beginning at
midnight on March 20, 2023, 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 final 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 final rule has been designated a ``significant
regulatory action,'' although not economically significant, under
section 3(f) of Executive Order 12866. Accordingly, this final rule has
been reviewed by the Office of Management and Budget (OMB).
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. Although
this rule makes important changes to the EAR for items controlled for
chemical/biological reasons, BIS believes that the overall increases in
burdens and costs associated with the following information collections
due to this rule will be minimal:
<bullet> OMB control number 0694-0088 (Simplified Network
Application Processing System)--this collection includes license
applications and carries a burden estimate of 29.4 minutes per manual
or electronic submission;
<bullet> OMB Control Number 0694-0096 (Five Year Records Retention
Period)--this collection includes recordkeeping requirements and
carries a burden estimate of less than 1 minute per response;
<bullet> OMB Control Number 0607-0152 (Automated Export System
(AES) Program)--this collection carries a burden hour estimate of 3
minutes per electronic submission and contains the Electronic Export
Information (EEI) filing requirements under the Automated Export System
(AES).
Additional information regarding these collections of information,
including all background materials, can be found at <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a> and using the search function to
enter either the title of the collection or the OMB Control Number.
3. This final 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 decisions made at the Australia Group
(AG) Plenary Meeting held in Paris, France, from July 4 through July 8,
2022. 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 May 23, 2022 (87 FR
31195), to provide the public with notice and the opportunity to
comment on its proposal to amend ECCN 1C351 on the Commerce Control
List (CCL) to add four marine toxins (i.e., brevetoxins, gonyautoxins,
nodularins and palytoxin) to ECCN 1C351, the synthesis and collection
of which BIS had identified for evaluation according to the criteria in
Section 1758 of the Export Control Reform Act of 2018 (ECRA) pertaining
to emerging and foundational technologies. 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 May 23
proposed rule would not have a significant economic impact on a
substantial number of small entities.
BIS received comments from two respondents on its May 23 proposed
rule--these comments and BIS's responses are summarized in the preamble
of this final rule. BIS did not
[[Page 2511]]
receive any comments in response to the analyses and conclusions
contained in the IRFA for its May 23 proposed rule. Accordingly, no
regulatory flexibility analysis is required for this final rule, and
none has been prepared.
List of Subjects
15 CFR Part 740
Administrative practice and procedure, Exports Reporting and
recordkeeping requirements, Terrorism.
15 CFR Part 742
Exports, Terrorism.
15 CFR Part 774
Exports, Reporting and recordkeeping requirements, Terrorism.
For the reasons stated in the preamble, parts 740, 742, 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 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 740.20 is amended by revising paragraph (b)(2)(v) and
paragraph (b)(2)(vi) introductory text to read as follows:
Sec. 740.20 License Exception Strategic Trade Authorization (STA).
* * * * *
(b) * * *
(2) * * *
(v) License Exception STA may not be used for any item controlled
by ECCN 1C351.a, .b, .c, .d.14, .d.15 or .e, ECCNs 1C353, 1C354, 1E001
(i.e., for technology, as specified in ECCN 1E001, for items controlled
by ECCN 1C351.a, .b, .c, .d.14, .d.15 or .e or ECCNs 1C353 or 1C354) or
ECCN 1E351.
(vi) Toxins controlled by ECCN 1C351.d.1 through 1C351.d.13 and
1C351.d.16 through 1C351.d.21 are authorized under License Exception
STA to destinations indicated in Country Group A:5 (See supplement no.
1 to this part 740), subject to the following limits. For purposes of
this paragraph (b)(2)(vi), all such toxins that are sent from one
exporter, reexporter or transferor to a single end-user, on the same
day, constitute one shipment.
* * * * *
PART 742--CONTROL POLICY--CCL BASED CONTROLS
0
3. The authority citation for part 742 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 10, 2021, 86 FR 62891 (November
12, 2021).
0
4. Section 742.18 is amended by revising paragraph (a)(1), paragraph
(b)(1)(i) introductory text, and paragraphs (b)(1)(ii) and (iii) to
read as follows:
Sec. 742.18 Chemical Weapons Convention (CWC or Convention).
* * * * *
(a) * * *
(1) Schedule 1 chemicals and mixtures controlled under ECCN 1C351.
A license is required for CW reasons to export or reexport Schedule 1
chemicals controlled under ECCN 1C351.d.14 or .d.15 to all destinations
including Canada. CW applies to 1C351.d.14 for ricin in the form of
Ricinus Communis AgglutininII (RCA<INF>II</INF>), which is also known
as ricin D or Ricinus Communis LectinIII (RCL<INF>III</INF>), and
Ricinus Communis LectinIV (RCL<INF>IV</INF>), which is also known as
ricin E. CW applies to 1C351.d.15 for saxitoxin identified by C.A.S.
#35523-89-8. (Note that the advance notification procedures and annual
reporting requirements described in Sec. 745.1 of the EAR also apply
to exports of Schedule 1 chemicals.)
* * * * *
(b) * * *
(1) * * *
(i) Exports to States Parties to the CWC. Applications to export
Schedule 1 Chemicals controlled under ECCN 1C351.d.14 or .d.15 to
States Parties to the CWC (destinations listed in supplement no. 2 to
part 745 of the EAR) generally will be denied, unless all of the
following conditions are met:
* * * * *
(ii) Exports to States not party to the CWC. Applications to export
Schedule 1 chemicals controlled under ECCN 1C351.d.14 or .d.15 to
States not Party to the CWC (destinations not listed in supplement no.
2 to part 745 of the EAR) generally will be denied, consistent with
U.S. obligations under the CWC to prohibit exports of these chemicals
to States not Party to the CWC.
(iii) Reexports. Applications to reexport Schedule 1 chemicals
controlled under ECCN 1C351.d.14 or .d.15 generally will be denied to
all destinations (including both States Parties to the CWC and States
not Party to the CWC).
* * * * *
PART 774--THE COMMERCE CONTROL LIST
0
5. 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.
0
6. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 1, revise ECCNs 1C350, 1C351, 1C353, 1C354, 1C991, and 2B352
to read as follows:
Supplement No. 1 to Part 774--The Commerce Control List
* * * * *
1C350 Chemicals that may be used as precursors for toxic chemical
agents (see List of Items Controlled).
License Requirements
Reason for Control: CB, CW, AT
Country chart (See Supp. No.
Control(s) 1 to part 738)
CB applies to entire entry................ CB Column 2.
CW applies to 1C350.b and .c. The Commerce Country Chart is not
designed to determine licensing requirements for items controlled
for CW reasons. A license is required, for CW reasons, to export or
reexport Schedule 2 chemicals and mixtures identified in 1C350.b to
States not Party to the CWC (destinations not listed in Supplement
No. 2 to part 745 of the EAR). A license is required, for CW
reasons, to export Schedule 3 chemicals and mixtures identified in
1C350.c to States not Party to the CWC, unless an End-Use
Certificate issued by the government of the importing country has
been obtained by the exporter prior to export. A license is
required, for CW reasons, to reexport Schedule 3 chemicals and
mixtures identified in 1C350.c from a State not Party to the CWC to
any other State not Party to the CWC. (See Sec. 742.18 of the EAR
for license requirements and policies for toxic and precursor
chemicals controlled for CW reasons. See Sec. 745.2 of the EAR for
End-Use Certificate requirements that apply to
[[Page 2512]]
exports of Schedule 3 chemicals to countries not listed in
Supplement No. 2 to part 745 of the EAR.)
AT applies to entire entry. The Commerce Country Chart is not
designed to determine licensing requirements for items controlled
for AT reasons in 1C350. A license is required, for AT reasons, to
export or reexport items controlled by 1C350 to a country in Country
Group E:1 of Supplement No. 1 to part 740 of the EAR. (See part 742
of the EAR for additional information on the AT controls that apply
to Iran, North Korea, and Syria. See part 746 of the EAR for
additional information on sanctions that apply to Iran, North Korea,
and Syria.)
License Requirement Notes
1. SAMPLE SHIPMENTS: Subject to the following requirements and
restrictions, a license is not required for sample shipments when
the cumulative total of these shipments does not exceed a 55-gallon
container or 200 kg of a single chemical to any one consignee during
a calendar year. A consignee that receives a sample shipment under
this exclusion may not resell, transfer, or reexport the sample
shipment, but may use the sample shipment for any other legal
purpose unrelated to chemical weapons.
a. Chemicals Not Eligible
A. [Reserved]
B. CWC Schedule 2 chemicals (States not Party to the CWC). No
CWC Schedule 2 chemical or mixture identified in 1C350.b is eligible
for sample shipment to States not Party to the CWC (destinations not
listed in Supplement No. 2 to part 745 of the EAR) without a
license.
b. Countries Not Eligible: Countries in Country Group E:1 of
Supplement No. 1 to part 740 of the EAR are not eligible to receive
sample shipments of any chemicals controlled by this ECCN without a
license.
c. Sample shipments that require an End-Use Certificate for CW
reasons: No CWC Schedule 3 chemical or mixture identified in 1C350.c
is eligible for sample shipment to States not Party to the CWC
(destinations not listed in Supplement No. 2 to part 745 of the EAR)
without a license, unless an End-Use Certificate issued by the
government of the importing country is obtained by the exporter
prior to export (see Sec. 745.2 of the EAR for End-Use Certificate
requirements).
d. Sample shipments that require a license for reasons set forth
elsewhere in the EAR: Sample shipments, as described in this Note 1,
may require a license for reasons set forth elsewhere in the EAR.
See, in particular, the end-use/end-user restrictions in part 744 of
the EAR, and the restrictions that apply to embargoed countries in
part 746 of the EAR.
e. Annual report requirement. The exporter is required to submit
an annual written report for shipments of samples made under this
Note 1. The report must be on company letterhead stationery (titled
``Report of Sample Shipments of Chemical Precursors'' at the top of
the first page) and identify the chemical(s), Chemical Abstract
Service Registry (C.A.S.) number(s), quantity(ies), the ultimate
consignee's name and address, and the date of export for all sample
shipments that were made during the previous calendar year. The
report must be submitted no later than February 28 of the year
following the calendar year in which the sample shipments were made,
to: U.S. Department of Commerce, Bureau of Industry and Security,
14th Street and Pennsylvania Ave. NW, Room 2099B, Washington, DC
20230, Attn: ``Report of Sample Shipments of Chemical Precursors.''
2. MIXTURES:
a. Mixtures that contain precursor chemicals identified in ECCN
1C350, in concentrations that are below the levels indicated in
1C350.b through .d, are controlled by ECCN 1C395 or 1C995 and are
subject to the licensing requirements specified in those ECCNs.
b. A license is not required under this ECCN for a mixture, when
the controlled chemical in the mixture is a normal ingredient in
consumer goods packaged for retail sale for personal use. Such
consumer goods are designated EAR99. However, a license may be
required for reasons set forth elsewhere in the EAR.
Note to Mixtures: Calculation of concentrations of AG-controlled
chemicals:
a. Exclusion. No chemical may be added to the mixture (solution)
for the sole purpose of circumventing the Export Administration
Regulations;
b. Percent Weight Calculation. When calculating the percentage,
by weight, of ingredients in a chemical mixture, include all
ingredients of the mixture, including those that act as solvents.
3. COMPOUNDS. Compounds created with any chemicals identified in
this ECCN 1C350 may be shipped NLR (No License Required), without
obtaining an End-Use Certificate, unless those compounds are also
identified in this entry or require a license for reasons set forth
elsewhere in the EAR.
4. TESTING KITS: Certain medical, analytical, diagnostic, and
food testing kits containing small quantities of chemicals
identified in this ECCN 1C350, are excluded from the scope of this
ECCN and are controlled under ECCN 1C395 or 1C995. (Note that
replacement reagents for such kits are controlled by this ECCN 1C350
if the reagents contain one or more of the precursor chemicals
identified in 1C350 in concentrations equal to or greater than the
control levels for mixtures indicated in 1C350.)
Technical Notes:
1. For purposes of this entry, a ``mixture'' is defined as a
solid, liquid or gaseous product made up of two or more ingredients
that do not react together under normal storage conditions.
2. The scope of this control applicable to Hydrogen Fluoride
(see 1C350.d.14 in the List of Items Controlled) includes its
liquid, gaseous, and aqueous phases, and hydrates.
3. Precursor chemicals in ECCN 1C350 are listed by name,
Chemical Abstract Service (CAS) number and CWC Schedule (where
applicable). Precursor chemicals of the same structural formula
(e.g., hydrates, isotopically-labeled forms or all possible
stereoisomers) are controlled by ECCN 1C350, regardless of name or
CAS number. CAS numbers are shown to assist in identifying whether a
particular precursor chemical or mixture is controlled under ECCN
1C350, irrespective of nomenclature. However, CAS numbers cannot be
used as unique identifiers in all situations because some forms of
the listed precursor chemical have different CAS numbers, and
mixtures containing a precursor chemical listed in ECCN 1C350 may
also have different CAS numbers.
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: See USML Category XIV(c) for related chemicals
``subject to the ITAR'' (see 22 CFR parts 120 through 130).
Related Definitions: See Sec. 770.2(k) of the EAR for synonyms for
the chemicals listed in this entry.
Items:
a. [Reserved]
b. Australia Group-controlled precursor chemicals also
identified as Schedule 2 chemicals under the CWC, as follows, and
mixtures in which at least one of the following chemicals
constitutes 30 percent or more of the weight of the mixture:
b.1. (C.A.S. #7784-34-1) Arsenic trichloride;
b.2. (C.A.S. #76-93-7) Benzilic acid;
b.3. (C.A.S. #78-38-6) Diethyl ethylphosphonate;
b.4. (C.A.S. #683-08-9) Diethyl methylphosphonate;
b.5. (C.A.S. #15715-41-0) Diethyl methylphosphonite;
b.6. (C.A.S. #2404-03-7) Diethyl-N,N-dimethylphosphoroamidate;
b.7. (C.A.S. #41480-75-5) N,N-Diisopropylaminoethanethiol
hydrochloride;
b.8. (C.A.S. #5842-07-9) N,N-Diisopropyl-beta-aminoethane thiol;
b.9. (C.A.S. #96-80-0) N,N-Diisopropyl-beta-aminoethanol;
b.10. (C.A.S. #96-79-7), N,N-Diisopropyl-beta-aminoethyl
chloride;
b.11. (C.A.S. #4261-68-1) N,N-Diisopropyl-beta-aminoethyl
chloride hydrochloride;
b.12. (C.A.S. #6163-75-3) Dimethyl ethylphosphonate;
b.13. (C.A.S. #756-79-6) Dimethyl methylphosphonate;
b.14. (C.A.S. #677-43-0) N,N-dimethylamino-phosphoryl
dichloride;
b.15. (C.A.S. #1498-40-4) Ethyl phosphonous dichloride [Ethyl
phosphinyl dichloride];
b.16. (C.A.S. #430-78-4) Ethyl phosphonus difluoride [Ethyl
phosphinyl difluoride];
b.17. (C.A.S. #1066-50-8) Ethyl phosphonyl dichloride;
b.18. (C.A.S. #993-13-5) Methylphosphonic acid;
b.19. (C.A.S. #676-98-2) Methylphosphonothioic dichloride.
b.20. (C.A.S. #464-07-3) Pinacolyl alcohol;
b.21. (C.A.S. #1619-34-7) 3-Quinuclidinol;
b.22. (C.A.S. #111-48-8) Thiodiglycol.
c. Australia Group-controlled precursor chemicals also
identified as Schedule 3 chemicals under the CWC, as follows, and
mixtures in which at least one of the following chemicals
constitutes 30 percent or more of the weight of the mixture:
[[Page 2513]]
c.1. (C.A.S. #762-04-9) Diethyl phosphite;
c.2. (C.A.S. #868-85-9) Dimethyl phosphite (dimethyl hydrogen
phosphite);
c.3. (C.A.S. #139-87-7) Ethyldiethanolamine;
c.4. (C.A.S. #10025-87-3) Phosphorus oxychloride;
c.5. (C.A.S. #10026-13-8) Phosphorus pentachloride;
c.6. (C.A.S. #7719-12-2) Phosphorus trichloride;
c.7. (C.A.S. #10545-99-0) Sulfur dichloride;
c.8. (C.A.S. #10025-67-9) Sulfur monochloride;
c.9. (C.A.S. #7719-09-7) Thionyl chloride;
c.10. (C.A.S. #102-71-6) Triethanolamine;
c.11. (C.A.S. #122-52-1) Triethyl phosphite;
c.12. (C.A.S. #121-45-9) Trimethyl phosphite.
d. Other Australia Group-controlled precursor chemicals not also
identified as Schedule 1, 2, or 3 chemicals under the CWC, as
follows, and mixtures in which at least one of the following
chemicals constitutes 30 percent or more of the weight of the
mixture:
d.1. (C.A.S. #1341-49-7) Ammonium hydrogen fluoride;
d.2. (C.A.S. #107-07-3) 2-Chloroethanol;
d.3. (C.A.S. #109-89-7) Diethylamine;
d.4. (C.A.S. #100-37-8) N,N-Diethylaminoethanol;
d.5. (C.A.S. #589-57-1) Diethyl chlorophosphite;
d.6. (C.A.S. #298-06-6) O,O-Diethyl phosphorodithioate;
d.7. (C.A.S. #2465-65-8) O,O-Diethyl phosphorothioate;
d.8. (C.A.S. #108-18-9) Di-isopropylamine;
d.9. (C.A.S. #124-40-3) Dimethylamine;
d.10. (C.A.S. #506-59-2) Dimethylamine hydrochloride;
d.11. (C.A.S. #762-77-6) Ethyl chlorofluorophosphate;
d.12. (C.A.S. #1498-51-7) Ethyl dichlorophosphate;
d.13. (C.A.S. #460-52-6) Ethyl difluorophosphate;
d.14. (C.A.S. #7664-39-3) Hydrogen fluoride;
d.15. (C.A.S. #3554-74-3) 3-Hydroxyl-1-methylpiperidine;
d.16. (C.A.S. #76-89-1) Methyl benzilate;
d.17. (C.A.S. #754-01-8) Methyl chlorofluorophosphate;
d.18. (C.A.S. #677-24-7) Methyl dichlorophosphate;
d.19. (C.A.S. #22382-13-4) Methyl difluorophosphate;
d.20. (C.A.S. #14277-06-6) N,N Diethylacetamidine;
d.21. (C.A.S. #53510-30-8) N,N-Diethylbutanamidine;
d.22. (C.A.S. #90324-67-7) N,N-Diethylformamidine;
d.23. (C.A.S. #1342789-47-2) N,N Diethylisobutanamidine;
d.24. (C.A.S. #84764-73-8) N,N-Diethylpropanamidine;
d.25. (C.A.S. #1315467-17-4) N,N-Diisopropylbutanamidine;
d.26. (C.A.S. #857522-08-8) N,N-Diisopropylformamidine;
d.27. (C.A.S. #2909-14-0) N,N-Dimethylacetamidine;
d.28. (C.A.S. #1340437-35-5) N,N-Dimethylbutanamidine;
d.29. (C.A.S. #44205-42-7) N,N-Dimethylformamidine;
d.30. (C.A.S. #321881-25-8) N,N-Dimethylisobutanamidine;
d.31. (C.A.S. #56776-14-8) N,N-Dimethylpropanamidine;
d.32. (C.A.S. #1339586-99-0) N,N-Dipropylacetamidine;
d.33. C.A.S. #1342422-35-8) N,N-Dipropylbutanamidine;
d.34. (C.A.S. #48044-20-8) N,N-Dipropylformamidine;
d.35. (C.A.S. #1342700-45-1) N,N-Dipropylisobutanamidine;
d.36. (C.A.S. #1341496-89-6) N,N-Dipropylpropanamidine;
d.37. (C.A.S. #1314-80-3) Phosphorus pentasulfide;
d.38. (C.A.S. #75-97-8) Pinacolone;
d.39. (C.A.S. #7789-29-9) Potassium bifluoride;
d.40. (C.A.S. #151-50-8) Potassium cyanide;
d.41. (C.A.S. #7789-23-3) Potassium fluoride;
d.42. (C.A.S. #3731-38-2) 3-Quinuclidone;
d.43. (C.A.S. #1333-83-1) Sodium bifluoride;
d.44. (C.A.S. #143-33-9) Sodium cyanide;
d.45. (C.A.S. #7681-49-4) Sodium fluoride;
d.46. (C.A.S. #16893-85-9) Sodium hexafluorosilicate;
d.47. (C.A.S. #1313-82-2) Sodium sulfide;
d.48. (C.A.S. #637-39-8) Triethanolamine hydrochloride;
d.49. (C.A.S. #116-17-6) Tri-isopropyl phosphite.
1C351 Human and animal pathogens and ``toxins,'' as follows (see
List of Items Controlled).
License Requirements
Reason for Control: CB, CW, AT
Country chart (See Supp. No.
Control(s) 1 to part 738)
CB applies to entire entry................ CB Column 1.
CW applies to 1C351.d.14 and .d.15 and a license is required for
CW reasons for all destinations, including Canada, as follows: CW
applies to 1C351.d.14 for ricin in the form of (1) Ricinus communis
AgglutininII (RCA<INF>II</INF>), also known as ricin D or Ricinus
Communis LectinIII (RCL<INF>III</INF>) and (2) Ricinus communis
LectinIV (RCL<INF>IV</INF>), also known as ricin E. CW applies to
1C351.d.15 for saxitoxin identified by C.A.S. #35523-89-8. See Sec.
742.18 of the EAR for licensing information pertaining to chemicals
subject to restriction pursuant to the Chemical Weapons Convention
(CWC). The Commerce Country Chart is not designed to determine
licensing requirements for items controlled for CW reasons.
Country chart (See Supp. No.
Control(s) 1 to part 738)
AT applies to entire entry................ AT Column 1.
License Requirement Notes: 1. All vaccines and `immunotoxins'
are excluded from the scope of this entry. Certain medical products
and diagnostic and food testing kits that contain biological toxins
controlled under 1C351.d, with the exception of toxins controlled
for CW reasons under 1C351.d.14 or .d.15, are excluded from the
scope of this entry. Vaccines, `immunotoxins,' certain medical
products, and diagnostic and food testing kits excluded from the
scope of this entry are controlled under ECCN 1C991.
2. For the purposes of this entry, only saxitoxin is controlled
under 1C351.d.15; other members of the paralytic shellfish poison
family (e.g., neosaxitoxin) are designated EAR99.
3. Clostridium perfringens strains, other than the epsilon
toxin-producing strains of Clostridium perfringens described in
1C351.c.12, are excluded from the scope of this entry, since they
may be used as positive control cultures for food testing and
quality control.
4. Unless specified elsewhere in this ECCN 1C351 (e.g., in
License Requirement Notes 1-3), this ECCN controls all biological
agents and ``toxins,'' regardless of quantity or attenuation, that
are identified in the List of Items Controlled for this ECCN,
including small quantities or attenuated strains of select
biological agents or ``toxins'' that are excluded from the lists of
select biological agents or ``toxins'' by the Animal and Plant
Health Inspection Service (APHIS), U.S. Department of Agriculture
(USDA), or the Centers for Disease Control and Prevention (CDC),
U.S. Department of Health and Human Services (HHS), in accordance
with their regulations in 9 CFR part 121 and 42 CFR part 73,
respectively.
5. Biological agents and pathogens are controlled under this
ECCN 1C351 when they are an isolated live culture of a pathogen
agent, or a preparation of a toxin agent that has been isolated or
extracted from any source or material, including living material
that has been deliberately inoculated or contaminated with the
agent. Isolated live cultures of a pathogen agent include live
cultures in dormant form or in dried preparations, whether the agent
is natural, enhanced or modified.
List Based License Exceptions (See Part 740 for a Description of All
License Exceptions)
LVS: N/A
GBS: N/A
Special Conditions for STA
STA: (1) Paragraph (c)(1) of License Exception STA (Sec.
740.20(c)(1)) may be used for items in 1C351.d.1 through 1C351.d.13
and 1C351.d.16 through 1C351.d.21. See Sec. 740.20(b)(2)(vi) for
restrictions on the quantity of any one toxin that may be exported
in a single shipment and the number of shipments that may be made to
any one end user in a single calendar year. Also see the Automated
Export System (AES) requirements in Sec. 758.1(b)(4) of the EAR.
(2) Paragraph (c)(2) of License Exception STA (Sec. 740.20(c)(2) of
the EAR) may not be used for any items in 1C351.
[[Page 2514]]
List of Items Controlled
Related Controls: (1) Certain forms of ricin and saxitoxin in
1C351.d.14 and .d.15 are CWC Schedule 1 chemicals (see Sec. 742.18
of the EAR). The U.S. Government must provide advance notification
and annual reports to the OPCW of all exports of Schedule 1
chemicals. See Sec. 745.1 of the EAR for notification procedures.
See 22 CFR part 121, Category XIV and Sec. 121.7 for CWC Schedule 1
chemicals that are ``subject to the ITAR.'' (2) The Animal and Plant
Health Inspection Service (APHIS), U.S. Department of Agriculture,
and the Centers for Disease Control and Prevention (CDC), U.S.
Department of Health and Human Services, maintain controls on the
possession, use, and transfer within the United States of certain
items controlled by this ECCN (for APHIS, see 7 CFR 331.3(b), 9 CFR
121.3(b), and 9 CFR 121.4(b); for CDC, see 42 CFR 73.3(b) and 42 CFR
73.4(b)). (3) See 22 CFR part 121, Category XIV(b), for modified
biological agents and biologically derived substances that are
``subject to the ITAR.''
Related Definitions: For the purposes of this entry, `immunotoxins'
are monoclonal antibodies linked to a toxin with the intention of
destroying a specific target cell while leaving adjacent cells
intact.
Items:
a. Viruses identified on the Australia Group (AG) ``List of
Human and Animal Pathogens and Toxins for Export Control,'' as
follows:
a.1. African horse sickness virus;
a.2. African swine fever virus;
a.3. Andes virus;
a.4. Avian influenza (AI) viruses identified as having high
pathogenicity (HP), as follows:
a.4.a. AI viruses that have an intravenous pathogenicity index
(IVPI) in 6-week-old chickens greater than 1.2; or
a.4.b. AI viruses that cause at least 75% mortality in 4- to 8-
week-old chickens infected intravenously.
Note: Avian influenza (AI) viruses of the H5 or H7 subtype that
do not have either of the characteristics described in 1C351.a.4
(specifically, 1C351.a.4.a or .a.4.b) should be sequenced to
determine whether multiple basic amino acids are present at the
cleavage site of the haemagglutinin molecule (HA0). If the amino
acid motif is similar to that observed for other HPAI isolates, then
the isolate being tested should be considered as HPAI and the virus
is controlled under 1C351.a.4.
a.5. Bluetongue virus;
a.6. Chapare virus;
a.7. Chikungunya virus;
a.8. Choclo virus;
a.9. Classical swine fever virus (Hog cholera virus);
a.10. Crimean-Congo hemorrhagic fever virus;
a.11. Dobrava-Belgrade virus;
a.12. Eastern equine encephalitis virus;
a.13. Ebolavirus (includes all members of the Ebolavirus genus);
a.14. Foot-and-mouth disease virus;
a.15. Goatpox virus;
a.16. Guanarito virus;
a.17. Hantaan virus;
a.18. Hendra virus (Equine morbillivirus);
a.19. Japanese encephalitis virus;
a.20. Junin virus;
a.21. Kyasanur Forest disease virus;
a.22. Laguna Negra virus;
a.23. Lassa virus;
a.24. Louping ill virus;
a.25. Lujo virus;
a.26. Lumpy skin disease virus;
a.27. Lymphocytic choriomeningitis virus;
a.28. Machupo virus;
a.29. Marburgvirus (includes all members of the Marburgvirus
genus);
a.30. Middle East respiratory syndrome-related coronavirus
(MERS-related coronavirus);
a.31. Monkeypox virus;
a.32. Murray Valley encephalitis virus;
a.33. Newcastle disease virus;
a.34. Nipah virus;
a.35. Omsk hemorrhagic fever virus;
a.36. Oropouche virus;
a.37. Peste-des-petits ruminants virus;
a.38. Porcine Teschovirus;
a.39. Powassan virus;
a.40. Rabies virus and all other members of the Lyssavirus
genus;
a.41. Reconstructed 1918 influenza virus;
Technical Note: 1C351.a.41 includes reconstructed replication
competent forms of the 1918 pandemic influenza virus containing any
portion of the coding regions of all eight gene segments.
a.42. Rift Valley fever virus;
a.43. Rinderpest virus;
a.44. Rocio virus;
a.45. Sabia virus;
a.46. Seoul virus;
a.47. Severe acute respiratory syndrome-related coronavirus
(SARS-related coronavirus);
a.48. Sheeppox virus;
a.49. Sin Nombre virus;
a.50. St. Louis encephalitis virus;
a.51. Suid herpesvirus 1 (Pseudorabies virus; Aujeszky's
disease);
a.52. Swine vesicular disease virus;
a.53. Tick-borne encephalitis virus (Far Eastern subtype,
formerly known as Russian Spring-Summer encephalitis virus--see
1C351.b.3 for Siberian subtype);
a.54. Variola virus;
a.55. Venezuelan equine encephalitis virus;
a.56. Vesicular stomatitis virus;
a.57. Western equine encephalitis virus; or
a.58. Yellow fever virus.
b. Viruses identified on the APHIS/CDC ``select agents'' lists
(see Related Controls paragraph #2 for this ECCN), but not
identified on the Australia Group (AG) ``List of Human and Animal
Pathogens and Toxins for Export Control,'' as follows:
b.1. [Reserved];
b.2. [Reserved]; or
b.3. Tick-borne encephalitis virus (Siberian subtype, formerly
West Siberian virus--see 1C351.a.53 for Far Eastern subtype).
c. Bacteria identified on the Australia Group (AG) ``List of
Human and Animal Pathogens and Toxins for Export Control,'' as
follows:
c.1. Bacillus anthracis;
c.2. Brucella abortus;
c.3. Brucella melitensis;
c.4. Brucella suis;
c.5. Burkholderia mallei (Pseudomonas mallei);
c.6. Burkholderia pseudomallei (Pseudomonas pseudomallei);
c.7. Chlamydia psittaci (Chlamydophila psittaci);
c.8. Clostriduim argentinense (formerly known as Clostridium
botulinum Type G), botulinum neurotoxin producing strains;
c.9. Clostridium baratii, botulinum neurotoxin producing
strains;
c.10. Clostridium botulinum;
c.11. Clostridium butyricum, botulinum neurotoxin producing
strains;
c.12. Clostridium perfringens, epsilon toxin producing types;
c.13. Coxiella burnetii;
c.14. Francisella tularensis;
c.15. Mycoplasma capricolum subspecies capripneumoniae (``strain
F38'');
c.16. Mycoplasma mycoides subspecies mycoides SC (small colony)
(a.k.a. contagious bovine pleuropneumonia);
c.17. Rickettsia prowazekii;
c.18. Salmonella enterica subspecies enterica serovar Typhi
(Salmonella typhi);
c.19. Shiga toxin producing Escherichia coli (STEC) of
serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other
shiga toxin producing serogroups;
Note: Shiga toxin producing Escherichia coli (STEC) includes,
inter alia, enterohaemorrhagic E. coli (EHEC), verotoxin producing
E. coli (VTEC) or verocytotoxin producing E. coli (VTEC).
c.20. Shigella dysenteriae;
c.21. Vibrio cholerae; or
c.22. Yersinia pestis.
d. ``Toxins'' identified on the Australia Group (AG) ``List of
Human and Animal Pathogens and Toxins for Export Control,'' as
follows, or their subunits:
d.1. Abrin;
d.2. Aflatoxins;
d.3. Botulinum toxins;
d.4. Brevetoxins;
d.5. Clostridium perfringens alpha, beta 1, beta 2, epsilon and
iota toxins;
d.6. Conotoxins;
d.7. Diacetoxyscirpenol;
d.8. Gonyautoxins;
d.9. HT-2 toxin;
d.10. Microcystins (Cyanginosins);
d.11. Modeccin;
d.12. Nodularins;
d.13. Palytoxin;
d.14. Ricin;
d.15. Saxitoxin;
d.16. Shiga toxins (shiga-like toxins, verotoxins, and
verocytotoxins);
d.17. Staphylococcus aureus enterotoxins, hemolysin alpha toxin,
and toxic shock syndrome toxin (formerly known as Staphylococcus
enterotoxin F);
d.18. T-2 toxin;
d.19. Tetrodotoxin;
d.20. Viscumin (Viscum album lectin 1); or
d.21. Volkensin.
e. ``Fungi'', as follows:
e.1. Coccidioides immitis; or
e.2. Coccidioides posadasii.
* * * * *
1C353 Genetic elements and genetically modified organisms, as
follows (see List of Items Controlled).
License Requirements
Reason for Control: CB, AT
[[Page 2515]]
Country chart (See Supp. No.
Control(s) 1 to part 738)
CB applies to entire entry................ CB Column 1.
AT applies to entire entry................ AT Column 1.
License Requirements Notes:
1. Vaccines that contain genetic elements or genetically
modified organisms identified in this ECCN are controlled by ECCN
1C991.
2. Unless specified elsewhere in this ECCN 1C353 (e.g., in
License Requirement Note 1), this ECCN controls genetic elements or
genetically modified organisms for all biological agents and
``toxins,'' regardless of quantity or attenuation, that are
identified in the List of Items Controlled for this ECCN, including
genetic elements or genetically modified organisms for attenuated
strains of select biological agents or ``toxins'' that are excluded
from the lists of select biological agents or ``toxins'' by the
Animal and Plant Health Inspection Service (APHIS), U.S. Department
of Agriculture, or the Centers for Disease Control and Prevention
(CDC), U.S. Department of Health and Human Services, in accordance
with the APHIS regulations in 7 CFR part 331 and 9 CFR part 121 and
the CDC regulations in 42 CFR part 73.
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) The Animal and Plant Health Inspection Service
(APHIS), U.S. Department of Agriculture, and the Centers for Disease
Control and Prevention (CDC), U.S. Department of Health and Human
Services, maintain controls on the possession, use, and transfer
within the United States of certain items controlled by this ECCN,
including (but not limited to) certain genetic elements, recombinant
nucleic acids, and recombinant organisms associated with the agents
or toxins in ECCN 1C351 or 1C354 (for APHIS, see 7 CFR 331.3(c), 9
CFR 121.3(c), and 9 CFR 121.4(c); for CDC, see 42 CFR 73.3(c) and 42
CFR 73.4(c)). (2) See 22 CFR part 121, Category XIV(b), for modified
biological agents and biologically derived substances that are
subject to the export licensing jurisdiction of the U.S. Department
of State, Directorate of Defense Trade Controls.
Related Definition: N/A
Items:
a. Any genetically modified organism that contains, or any
genetic element that codes for, any of the following:
a.1. Any gene, genes, translated product or translated products
specific to any virus controlled by 1C351.a or .b or 1C354.c;
a.2. Any gene or genes specific to any bacterium controlled by
1C351.c or 1C354.a, or any fungus controlled by 1C351.e or 1C354.b,
and which;
a.2.a. In itself or through its transcribed or translated
products represents a significant hazard to human, animal or plant
health; or
a.2.b. Could endow or enhance pathogenicity; or
a.3. Any toxins, or their subunits, controlled by 1C351.d.
b. [Reserved].
Technical Notes:
1. Genetically modified organisms include organisms in which the
nucleic acid sequences have been created or altered by deliberate
molecular manipulation.
2. ``Genetic elements'' include, inter alia, chromosomes,
genomes, plasmids, transposons, vectors, and inactivated organisms
containing recoverable nucleic acid fragments, whether genetically
modified or unmodified, or chemically synthesized in whole or in
part. For the purposes of this ECCN 1C353, nucleic acids from an
inactivated organism, virus, or sample are considered to be
`recoverable' if the inactivation and preparation of the material is
intended or known to facilitate isolation, purification,
amplification, detection, or identification of nucleic acids.
3. This ECCN does not control nucleic acid sequences of shiga
toxin producing Escherichia coli of serogroups O26, O45, O103, O104,
O111, O121, O145, O157, and other shiga toxin producing serogroups,
other than those genetic elements coding for shiga toxin, or for its
subunits.
4. `Endow or enhance pathogenicity' is defined as when the
insertion or integration of the nucleic acid sequence or sequences
is/are likely to enable or increase a recipient organism's ability
to be used to deliberately cause disease or death. This might
include alterations to, inter alia: virulence, transmissibility,
stability, route of infection, host range, reproducibility, ability
to evade or suppress host immunity, resistance to medical
countermeasures, or detectability.
1C354 Plant pathogens, as follows (see List of Items Controlled).
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 1.
AT applies to entire entry................ AT Column 1.
License Requirements Notes
1. All vaccines are excluded from the scope of this ECCN. See
ECCN 1C991 for vaccines.
2. Unless specified elsewhere in this ECCN 1C354 (e.g., in
License Requirement Note 1), this ECCN controls all biological
agents, regardless of quantity or attenuation, that are identified
in the List of Items Controlled for this ECCN, including small
quantities or attenuated strains of select biological agents that
are excluded from the list of PPQ select agents and ``toxins'' by
the Animal and Plant Health Inspection Service (APHIS), U.S.
Department of Agriculture, in accordance with their regulations in 7
CFR part 331.
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) The Animal and Plant Health Inspection Service
(APHIS), U.S. Department of Agriculture, maintains controls on the
possession, use, and transfer within the United States of certain
items controlled by this ECCN (see 7 CFR 331.3(c), 9 CFR 121.3(c),
and 9 CFR 121.4(c)). (2) See 22 CFR part 121, Category XIV(b), for
modified biological agents and biologically derived substances that
are subject to the export licensing jurisdiction of the U.S.
Department of State, Directorate of Defense Trade Controls.
Related Definitions: N/A
Items:
a. Bacteria, as follows:
a.1. Xanthomonas albilineans;
a.2. Xanthomonas citri pv. citri (Xanthomonas axonopodis pv.
citri, Xanthomonas campestris pv. citri);
a.3. Xanthomonas oryzae [this species of proteobacteria is
identified on the APHIS ``select agents'' list (see Related Controls
paragraph for this ECCN), but only the pathovar Xanthomonas oryzae
pv. oryzae (syn. Pseudomonas campestris pv. oryzae) is identified on
the Australia Group (AG) ``List of Plant Pathogens for Export
Control''];
a.4. Clavibacter michiganensis subsp. sepedonicus (Clavibacter
sepedonicus, Clavibacter michiganense subsp. sepedonicus,
Corynebacterium michiganensis subsp. sepedonicum, Corynebacterium
sepedonicum);
a.5. Ralstonia solanacearum, race 3, biovar 2;
a.6. Raythayibactor toxicus [this bacterium is identified on the
APHIS ``select agents'' list (see the Related Controls paragraph for
this ECCN), but is not identified on the Australia Group (AG) ``List
of Plant Pathogens for Export Control''].
b. Fungi, as follows:
b.1. Bipolaris oryzae (Cochliobolus miyabeanus, Helminthosporium
oryzae);
b.2. Colletotrichum kahawae (Colletotrichum coffeanum var.
virulans);
b.3. Pseudocercospora ulei (Microcyclus ulei, Dothidella ulei);
b.4. Puccinnia graminis ssp. graminis var. graminis/Puccinia
graminis ssp. graminis var. stakmanii (Puccinia graminis [syn.
Puccinia graminis f. sp. tritici]);
b.5. Puccinia striiformis (syn. Puccinia glumarum);
b.6. Magnaporthe oryzae (Pyricularia oryzae);
b.7. Peronosclerospora philippinensis (Peronosclerospora
sacchari);
b.8. Sclerophthora rayssiae var. zeae;
b.9. Synchytrium endobioticum;
b.10. Tilletia indica;
b.11. Thecaphora solani;
b.12. Phoma glycinicola (formerly Pyrenochaeta glycines) [this
fungus is identified on the APHIS ``select agents'' list (see the
Related Controls paragraph for this ECCN), but is not identified on
the Australia Group (AG) ``List of Plant Pathogens for Export
Control''].
c. Viruses, as follows:
c.1. Andean potato latent virus (Potato Andean latent
tymovirus);
c.2. Potato spindle tuber viroid.
* * * * *
[[Page 2516]]
1C991 Vaccines, immunotoxins, medical products, diagnostic and food
testing kits, as follows (see List of Items Controlled).
License Requirements
Reason for Control: CB, AT
Country chart (See Supp. No.
Control(s) 1 to part 738)
CB applies to 1C991.c..................... CB Column 3.
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: N/A
List of Items Controlled
Related Controls: (1) Medical products containing ricin or
saxitoxin, as follows, are controlled for CW reasons under ECCN
1C351:
(a) Ricinus communis AgglutininII (RCA<INF>II</INF>), also known
as ricin D, or Ricinus Communis LectinIII (RCL<INF>III</INF>);
(b) Ricinus communis LectinIV (RCL<INF>IV</INF>), also known as
ricin E; or
(c) Saxitoxin identified by C.A.S. #35523-89-8.
(2) The export of a ``medical product'' that is an
``Investigational New Drug'' (IND), as defined in 21 CFR 312.3, is
subject to certain U.S. Food and Drug Administration (FDA)
requirements that are independent of the export requirements
specified in this ECCN or elsewhere in the EAR. These FDA
requirements are described in 21 CFR 312.110 and must be satisfied
in addition to any requirements specified in the EAR.
(3) Also see 21 CFR 314.410 for FDA requirements concerning
exports of new drugs and new drug substances.
Related Definitions: For the purpose of this entry, `immunotoxins'
are monoclonal antibodies linked to a toxin with the intention of
destroying a specific target cell while leaving adjacent cells
intact. For the purpose of this entry, `medical products' are: (1)
Pharmaceutical formulations designed for testing and human (or
veterinary) administration in the treatment of medical conditions;
(2) prepackaged for distribution as clinical or medical products;
and (3) approved by the U.S. Food and Drug Administration either to
be marketed as clinical or medical products or for use as an
``Investigational New Drug'' (IND) (see 21 CFR part 312). For the
purpose of this entry, `diagnostic and food testing kits' are
specifically developed, packaged and marketed for diagnostic or
public health purposes. Biological toxins in any other
configuration, including bulk shipments, or for any other end-uses
are controlled by ECCN 1C351. For the purpose of this entry,
`vaccine' is defined as a medicinal (or veterinary) product in a
pharmaceutical formulation, approved by the U.S. Food and Drug
Administration or the U.S. Department of Agriculture to be marketed
as a medical (or veterinary) product or for use in clinical trials,
that is intended to stimulate a protective immunological response in
humans or animals in order to prevent disease in those to whom or to
which it is administered.
Items:
Technical Note: For purposes of the controls described in this
ECCN, `toxins' refers to those toxins, or their subunits, controlled
under ECCN 1C351.d.
a. Vaccines containing, or designed for use against, items
controlled by ECCN 1C351, 1C353 or 1C354.
b. Immunotoxins containing toxins controlled by 1C351.d;
c. Medical products that contain any of the following:
c.1. Toxins controlled by ECCN 1C351.d (except for botulinum
toxins controlled by ECCN 1C351.d.3, conotoxins controlled by ECCN
1C351.d.6, or items controlled for CW reasons under ECCN 1C351.d.14
or .d.15); or
c.2. Genetically modified organisms or genetic elements
controlled by ECCN 1C353.a.3 (except for those that contain, or code
for, botulinum toxins controlled by ECCN 1C351.d.3 or conotoxins
controlled by ECCN 1C351.d.6);
d. Medical products not controlled by 1C991.c that contain any
of the following:
d.1. Botulinum toxins controlled by ECCN 1C351.d.3;
d.2. Conotoxins controlled by ECCN 1C351.d.6; or
d.3. Genetically modified organisms or genetic elements
controlled by ECCN 1C353.a.3 that contain, or code for, botulinum
toxins controlled by ECCN 1C351.d.3 or conotoxins controlled by ECCN
1C351.d.6;
e. Diagnostic and food testing kits containing toxins controlled
by ECCN 1C351.d (except for items controlled for CW reasons under
ECCN 1C351.d.14 or .d.15).
* * * * *
2B352 Equipment Capable of Use in Handling Biological Materials, as
Follows (See List of Items Controlled).
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)
LVS: N/A
GBS: N/A
List of Items Controlled
Related Controls: See ECCNs 1A004 and 1A995 for protective equipment
that is not covered by this entry. Also see ECCN 9A120 for controls
on certain ``UAV'' systems designed or modified to dispense an
aerosol and capable of carrying elements of a payload in the form of
a particulate or liquid, other than fuel ``parts'' or ``components''
of such vehicles, of a volume greater than 20 liters.
Related Definitions: (1) ``Lighter than air vehicles''--balloons and
airships that rely on hot air or on lighter-than-air gases, such as
helium or hydrogen, for their lift. (2) ``UAVs''--Unmanned Aerial
Vehicles. (3) ``VMD''--Volume Median Diameter.
Items:
a. Containment facilities and related equipment, as follows:
a.1. Complete containment facilities at P3 or P4 containment
level.
Technical Note to 2B352.a.1: P3 or P4 (BL3, BL4, L3, L4)
containment levels are as specified in the WHO Laboratory Biosafety
Manual (3rd edition, Geneva, 2004).
a.2. Equipment designed for fixed installation in containment
facilities specified in paragraph a.1 of this ECCN, as follows:
a.2.a. Double-door pass-through decontamination autoclaves;
a.2.b. Breathing air suit decontamination showers;
a.2.c. Mechanical-seal or inflatable-seal walkthrough doors.
b. Fermenters and components as follows:
b.1. Fermenters capable of cultivation of micro-organisms or of
live cells for the production of viruses or toxins, without the
propagation of aerosols, having a total internal volume of 20 liters
or greater.
b.2. Components designed for such fermenters, as follows:
b.2.a. Cultivation chambers designed to be sterilized or
disinfected in situ;
b.2.b. Cultivation chamber holding devices; or
b.2.c. Process control units capable of simultaneously
monitoring and controlling two or more fermentation system
parameters (e.g., temperature, pH, nutrients, agitation, dissolved
oxygen, air flow, foam control).
Technical Notes to 2B352.b:
1. Fermenters include bioreactors (including single-use
(disposable) bioreactors), chemostats and continuous-flow systems.
2. Cultivation chamber holding devices controlled by 2B352.b.2.b
include single-use cultivation chambers with rigid walls.
c. Centrifugal separators capable of the continuous separation
of pathogenic microorganisms, without the propagation of aerosols,
and having all of the following characteristics:
c.1. One or more sealing joints within the steam containment
area;
c.2. A flow rate greater than 100 liters per hour;
c.3. ``Parts'' or ``components'' of polished stainless steel or
titanium; and
c.4. Capable of in-situ steam sterilization in a closed state.
Technical Note to 2B352.c: Centrifugal separators include
decanters.
d. Cross (tangential) flow filtration equipment and
``accessories'', as follows:
d.1. Cross (tangential) flow filtration equipment capable of
separation of microorganisms, viruses, toxins or cell cultures
having all of the following characteristics:
d.1.a. A total filtration area equal to or greater than 1 square
meter (1 m\2\); and
d.1.b. Having any of the following characteristics:
[[Page 2517]]
d.1.b.1. Capable of being sterilized or disinfected in-situ; or
d.1.b.2. Using disposable or single-use filtration ``parts'' or
``components''.
N.B.: 2B352.d.1 does not control reverse osmosis and
hemodialysis equipment, as specified by the manufacturer.
d.2. Cross (tangential) flow filtration ``parts'' or
``components'' (e.g., modules, elements, cassettes, cartridges,
units or plates) with filtration area equal to or greater than 0.2
square meters (0.2 m\2\) for each ``part'' or ``component'' and
designed for use in cross (tangential) flow filtration equipment
controlled by 2B352.d.1.
Technical Note: In this ECCN, ``sterilized'' denotes the
elimination of all viable microbes from the equipment through the
use of either physical (e.g., steam) or chemical agents.
``Disinfected'' denotes a process to reduce the number of
microorganisms, but not usually of bacterial spores, through the use
of chemical agents, without necessarily killing or removing all
organisms.
e. Steam, gas or vapor sterilizable freeze-drying equipment with
a condenser capacity of 10 kg of ice or greater in 24 hours (10
liters of water or greater in 24 hours) and less than 1000 kg of ice
in 24 hours (less than 1,000 liters of water in 24 hours).
f. Spray-drying equipment capable of drying toxins or pathogenic
microorganisms having all of the following characteristics:
f.1. A water evaporation capacity of >=0.4 kg/h and <=400 kg/h;
f.2. The ability to generate a typical mean product particle
size of <=10 micrometers with existing fittings or by minimal
modification of the spray-dryer with atomization nozzles enabling
generation of the required particle size; and
f.3. Capable of being sterilized or disinfected in situ.
g. Protective and containment equipment, as follows:
g.1. Protective full or half suits, or hoods dependent upon a
tethered external air supply and operating under positive pressure.
Technical Note to 2B352.g.1: 2B352.g.1 does not control suits
designed to be worn with self-contained breathing apparatus.
g.2. Biocontainment chambers, isolators, or biological safety
cabinets having all of the following characteristics, for normal
operation:
g.2.a. Fully enclosed workspace where the operator is separated
from the work by a physical barrier;
g.2.b. Able to operate at negative pressure;
g.2.c. Means to safely manipulate items in the workspace; and
g.2.d. Supply and exhaust air to and from the workspace is high-
efficiency particulate air (HEPA) filtered.
Note 1 to 2B352.g.2: 2B352.g.2 controls class III biosafety
cabinets, as specified in the WHO Laboratory Biosafety Manual (3rd
edition, Geneva, 2004) or constructed in accordance with national
standards, regulations or guidance.
Note 2 to 2B352.g.2: 2B352.g.2 controls any isolator having all
of the characteristics described in 2B352.g.2.a through g.2.d,
regardless of its intended use and its designation, except for
medical isolators ``specially designed'' for barrier nursing or
transportation of infected patients.
h. Aerosol inhalation equipment designed for aerosol challenge
testing with microorganisms, viruses or toxins, as follows:
h.1. Whole-body exposure chambers having a capacity of 1 cubic
meter or greater;
h.2. Nose-only exposure apparatus utilizing directed aerosol
flow and having a capacity for the exposure of 12 or more rodents,
or two or more animals other than rodents, and closed animal
restraint tubes designed for use with such apparatus.
i. Spraying or fogging systems and ``parts'' and ``components''
therefor, as follows:
i.1. Complete spraying or fogging systems, ``specially
designed'' or modified for fitting to aircraft, ``lighter than air
vehicles,'' or ``UAVs,'' capable of delivering, from a liquid
suspension, an initial droplet ``VMD'' of less than 50 microns at a
flow rate of greater than 2 liters per minute;
i.2. Spray booms or arrays of aerosol generating units,
``specially designed'' or modified for fitting to aircraft,
``lighter than air vehicles,'' or ``UAVs,'' capable of delivering,
from a liquid suspension, an initial droplet ``VMD'' of less than 50
microns at a flow rate of greater than 2 liters per minute;
i.3. Aerosol generating units ``specially designed'' for fitting
to the systems as specified in paragraphs i.1 and i.2 of this ECCN.
Technical Notes to 2B352.i:
1. Aerosol generating units are devices ``specially designed''
or modified for fitting to aircraft and include nozzles, rotary drum
atomizers and similar devices.
2. This ECCN does not control spraying or fogging systems,
``parts'' and ``components,'' as specified in 2B352.i, that are
demonstrated not to be capable of delivering biological agents in
the form of infectious aerosols.
3. Droplet size for spray equipment or nozzles ``specially
designed'' for use on aircraft or ``UAVs'' should be measured using
either of the following methods (pending the adoption of
internationally accepted standards):
a. Doppler laser method,
b. Forward laser diffraction method.
j. Nucleic acid assemblers and synthesizers that are both:
j.1 Partly or entirely automated; and
j.2. Designed to generate continuous nucleic acids greater than
1.5 kilobases in length with error rates less than 5% in a single
run.
* * * * *
Thea D. Rozman Kendler,
Assistant Secretary, for Export Administration.
[FR Doc. 2023-00397 Filed 1-13-23; 8:45 am]
BILLING CODE 3510-33-P
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</html>Indexed from Federal Register on January 17, 2023.
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