Implementation of the February 2020 Australia Group Intersessional Decisions: Addition of Certain Rigid-Walled, Single-Use Cultivation Chambers and Precursor Chemicals to the Commerce Control List
| Published date | 17 June 2020 |
| Citation | 85 FR 36483 |
| Record Number | 2020-11625 |
| Section | Rules and Regulations |
| Court | Industry And Security Bureau |
Federal Register, Volume 85 Issue 117 (Wednesday, June 17, 2020)
[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Rules and Regulations]
[Pages 36483-36492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11625]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 748 and 774
[Docket No. 200521-0143]
RIN 0694-AH60
Implementation of the February 2020 Australia Group
Intersessional Decisions: Addition of Certain Rigid-Walled, Single-Use
Cultivation Chambers and Precursor Chemicals to the Commerce Control
List
AGENCY: Bureau of Industry and Security, Commerce.
ACTION: Final rule.
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SUMMARY: The Bureau of Industry and Security (BIS) publishes this final
rule to amend the Export Administration Regulations (EAR) to implement
the decisions made at the February 2020 Australia Group (AG)
Intersessional Implementation Meeting, and those later adopted pursuant
to the AG's silence procedure. Specifically, this rule amends Export
Control Classification Numbers (ECCNs) 1C350, 1C351 and 2B352 on the
Commerce Control List (CCL) to reflect these AG changes. ECCN 1C350 is
amended by adding twenty-four precursor chemicals, as well as mixtures
in which at least one of these chemicals constitutes 30 percent or more
of the weight of the mixture, to ECCN 1C350.d. ECCN 1C351 is amended to
add Middle East respiratory syndrome-related coronavirus (MERS-related
coronavirus). ECCN 2B352 is amended by adding a Technical Note to
indicate that cultivation chamber holding devices controlled in
2B352.b.2.b include single-use cultivation chambers with rigid walls.
The items addressed by this final rule were not previously listed on
the CCL or controlled multilaterally. BIS, consistent with the
interagency process described in the Export Control Reform Act of 2018
(ECRA), identified the precursor chemicals and single-use cultivation
chambers addressed by this final rule as emerging technologies that are
essential to U.S. national security and for which effective controls
can be implemented. The inclusion of such items in this final rule is
consistent with the requirements of ECRA and the decision of the AG to
add such items to its common control lists, thereby making exports of
such items subject to multilateral control (following the
implementation of these changes by individual AG participating
countries, including the United States).
DATES: This rule is effective June 17, 2020.
FOR FURTHER INFORMATION CONTACT: Dr. Wesley Johnson, Chemical and
Biological Controls Division, Office of Nonproliferation and Treaty
Compliance, Bureau of Industry and Security, Telephone: (202) 482-0091,
Email: [email protected].
SUPPLEMENTARY INFORMATION: The Bureau of Industry and Security (BIS)
is amending the Export Administration Regulations (EAR) to implement
the decisions made at the Australia Group (AG) Intersessional
Implementation Meeting held in Bratislava, Slovak Republic, on February
5 through 6, 2020, and those subsequently made pursuant to the AG
silence procedure which ended on February 28, 2020 (the AG silence
procedure provides for the adoption of a measure, subsequent to its
provisional acceptance at an AG plenary or intersessional meeting,
provided that no participating country submits an objection on or
before a specified date). The AG is a multilateral forum consisting of
42 participating countries and the European Union that 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.
Amendments to the CCL Based on the February 2020 AG Intersessional
Recommendations
ECCN 1C350 (Chemical Weapons Precursors)
This final rule amends Export Control Classification Number (ECCN)
1C350 on the Commerce Control List (CCL) (Supplement No. 1 to part 774
of the EAR) to reflect changes to the AG ``Chemical Weapons
Precursors'' common control list based on the February 2020
Intersessional Implementation Meeting recommendations that were
approved by the AG pursuant to a silence procedure which ended on
February 28, 2020. Specifically, this rule amends ECCN 1C350 by adding
the following twenty-four precursor chemicals under ECCN 1C350.d:
(C.A.S. #589-57-1) Diethyl chlorophosphite;
(C.A.S. #762-77-6) Ethyl chlorofluorophosphate;
(C.A.S. #1498-51-7) Ethyl dichlorophosphate;
(C.A.S. #460-52-6) Ethyl difluorophosphate;
(C.A.S. #754-01-8) Methyl chlorofluorophosphate;
(C.A.S. #677-24-7) Methyl dichlorophosphate;
(C.A.S. #22382-13-4) Methyl difluorophosphate;
(C.A.S. #14277-06-6) N,N-Diethylacetamidine;
(C.A.S. #53510-30-8) N,N-Diethylbutanamidine;
(C.A.S. #90324-67-7) N,N-Diethylformamidine;
(C.A.S. #1342789-47-2) N,N-Diethylisobutanamidine;
(C.A.S. #84764-73-8) N,N-Diethylpropanamidine;
(C.A.S. #1315467-17-4) N,N-Diisopropylbutanamidine;
(C.A.S. #857522-08-8) N,N-Diisopropylformamidine;
(C.A.S. #2909-14-0) N,N-Dimethylacetamidine;
(C.A.S. #1340437-35-5) N,N-Dimethylbutanamidine;
(C.A.S. #44205-42-7) N,N-Dimethylformamidine;
(C.A.S. #321881-25-8) N,N-Dimethylisobutanamidine;
(C.A.S. #56776-14-8) N,N-Dimethylpropanamidine;
(C.A.S. #1339586-99-0) N,N-Dipropylacetamidine;
[[Page 36484]]
(C.A.S. #1342422-35-8) N,N-Dipropylbutanamidine;
(C.A.S. #48044-20-8) N,N-Dipropylformamidine;
(C.A.S. #1342700-45-1) N,N-Dipropylisobutanamidine; and
(C.A.S. #1341496-89-6) N,N-Dipropylpropanamidine.
Note that mixtures in which at least one of the chemicals listed in
ECCN 1C350.d (which now includes the twenty-four precursor chemicals
listed above) constitutes 30 percent or more of the weight of the
mixture are also controlled under this ECCN.
In addition, although this rule does not amend ECCN 1D390
(``software'' for chemical production process control), ECCN 1E001
(``technology'' for the ``development'' or ``production'' of, inter
alia, precursor chemicals controlled by ECCN 1C350), ECCN 1E350
(``technology'' for chemical production facilities) or ECCN 1E351
(``technology'' for the disposal of, inter alia, precursor chemicals),
these ECCNs cross-reference items controlled by ECCN 1C350 and,
consequently, ``software'' or ``technology'' that is related to any of
the twenty-four precursor chemicals added by this rule to ECCN 1C350.d
is now subject to control under ECCN 1D390, 1E001, 1E350 or 1E351 if
such ``software'' or ``technology'' falls within the parameters of the
controls described therein.
Prior to the addition of these twenty-four precursor chemicals to
the AG chemical weapons precursors common control list, BIS, consistent
with the interagency process described in the Export Control Reform Act
of 2018 (ECRA) (50 U.S.C. 4801-4852) under Section 1758 (codified at 50
U.S.C. 4817), identified these items as emerging technologies that are
essential to U.S. national security and for which effective controls
can be implemented. This interagency process resulted in a finding that
the absence of export controls on these precursor chemicals could be
exploited for chemical weapons purposes. The inclusion of these
precursor chemicals in this final rule is consistent with the
requirements of ECRA and the decision of the AG to add these items to
their common control lists, thereby making exports of such items
subject to multilateral control.
This rule alphabetically reorders the precursor chemicals listed in
ECCN 1C350.d to reflect the addition of the twenty-four precursor
chemicals identified above. To assist in identifying the precursor
chemicals that are now controlled under ECCN 1C350.d, the following
table lists each chemical now found in ECCN 1C350.d, as well as the
previous ECCN 1C350.d listing (if any) for these chemicals.
------------------------------------------------------------------------
AG-controlled precursor Previous CCL Current CCL
chemicals designation designation
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(C.A.S. #1341-49-7) Ammonium ECCN 1C350.d.1.... ECCN 1C350.d.1.
hydrogen fluoride.
(C.A.S. #107-07-3) 2- ECCN 1C350.d.2.... ECCN 1C350.d.2.
Chloroethanol.
(C.A.S. #109-89-7) Diethylamine. ECCN 1C350.d.3.... ECCN 1C350.d.3.
(C.A.S. #100-37-8) N,N- ECCN 1C350.d.4.... ECCN 1C350.d.4.
Diethylaminoethanol.
(C.A.S. #589-57-1) Diethyl Not listed........ ECCN 1C350.d.5.
chlorophosphite.
(C.A.S. #298-06-6) O,O-Diethyl ECCN 1C350.d.5.... ECCN 1C350.d.6.
phosphorodithioate.
(C.A.S. #2465-65-8) O,O-Diethyl ECCN 1C350.d.6.... ECCN 1C350.d.7.
phosphorothioate.
(C.A.S. #108-18-9) Di- ECCN 1C350.d.7.... ECCN 1C350.d.8.
isopropylamine.
(C.A.S. #124-40-3) Dimethylamine ECCN 1C350.d.8.... ECCN 1C350.d.9.
(C.A.S. #506-59-2) Dimethylamine ECCN 1C350.d.9.... ECCN 1C350.d.10.
hydrochloride.
(C.A.S. #762-77-6) Ethyl Not listed........ ECCN 1C350.d.11.
chlorofluorophosphate.
(C.A.S. #1498-51-7) Ethyl Not listed........ ECCN 1C350.d.12.
dichlorophosphate.
(C.A.S. #460-52-6) Ethyl Not listed........ ECCN 1C350.d.13.
difluorophosphate.
(C.A.S. #7664-39-3) Hydrogen ECCN 1C350.d.10... ECCN 1C350.d.14.
fluoride.
(C.A.S. #3554-74-3) 3-Hydroxyl-1- ECCN 1C350.d.11... ECCN 1C350.d.15.
methylpiperidine.
(C.A.S. #76-89-1) Methyl ECCN 1C350.d.12... ECCN 1C350.d.16.
benzilate.
(C.A.S. #754-01-8) Methyl Not listed........ ECCN 1C350.d.17.
chlorofluorophosphate.
(C.A.S. #677-24-7) Methyl Not listed........ ECCN 1C350.d.18.
dichlorophosphate.
(C.A.S. #22382-13-4) Methyl Not listed........ ECCN 1C350.d.19.
difluorophosphate.
(C.A.S. #14277-06-6) N,N Not listed........ ECCN 1C350.d.20.
Diethylacetamidine.
(C.A.S. #53510-30-8) N,N- Not listed........ ECCN 1C350.d.21.
Diethylbutanamidine.
(C.A.S. #90324-67-7) N,N- Not listed........ ECCN 1C350.d.22.
Diethylformamidine.
(C.A.S. #1342789-47-2) N,N Not listed........ ECCN 1C350.d.23.
Diethylisobutanamidine.
(C.A.S. #84764-73-8) N,N- Not listed........ ECCN 1C350.d.24.
Diethylpropanamidine.
(C.A.S. #1315467-17-4) N,N- Not listed........ ECCN 1C350.d.25.
Diisopropylbutanamidine.
(C.A.S. #857522-08-8) N,N- Not listed........ ECCN 1C350.d.26.
Diisopropylformamidine.
(C.A.S. #2909-14-0) N,N- Not listed........ ECCN 1C350.d.27.
Dimethylacetamidine.
(C.A.S. #1340437-35-5) N,N- Not listed........ ECCN 1C350.d.28.
Dimethylbutanamidine.
(C.A.S. #44205-42-7) N,N- Not listed........ ECCN 1C350.d.29.
Dimethylformamidine.
(C.A.S. #321881-25-8) N,N- Not listed........ ECCN 1C350.d.30.
Dimethylisobutanamidine.
(C.A.S. #56776-14-8) N,N- Not listed........ ECCN 1C350.d.31.
Dimethylpropanamidine.
(C.A.S. #1339586-99-0) N,N- Not listed........ ECCN 1C350.d.32.
Dipropylacetamidine.
C.A.S. #1342422-35-8) N,N- Not listed........ ECCN 1C350.d.33.
Dipropylbutanamidine.
(C.A.S. #48044-20-8) N,N- Not listed........ ECCN 1C350.d.34.
Dipropylformamidine.
(C.A.S. #1342700-45-1) N,N- Not listed........ ECCN 1C350.d.35.
Dipropylisobutanamidine.
(C.A.S. #1341496-89-6) N,N- Not listed........ ECCN 1C350.d.36.
Dipropylpropanamidine.
(C.A.S. #1314-80-3) Phosphorus ECCN 1C350.d.13... ECCN 1C350.d.37.
pentasulfide.
(C.A.S. #75-97-8) Pinacolone.... ECCN 1C350.d.14... ECCN 1C350.d.38.
(C.A.S. #7789-29-9) Potassium ECCN 1C350.d.15... ECCN 1C350.d.39.
bifluoride.
(C.A.S. #151-50-8) Potassium ECCN 1C350.d.16... ECCN 1C350.d.40.
cyanide.
(C.A.S. #7789-23-3) Potassium ECCN 1C350.d.17... ECCN 1C350.d.41.
fluoride.
(C.A.S. #3731-38-2) 3- ECCN 1C350.d.18... ECCN 1C350.d.42.
Quinuclidone.
(C.A.S. #1333-83-1) Sodium ECCN 1C350.d.19... ECCN 1C350.d.43.
bifluoride.
(C.A.S. #143-33-9) Sodium ECCN 1C350.d.20... ECCN 1C350.d.44.
cyanide.
(C.A.S. #7681-49-4) Sodium ECCN 1C350.d.21... ECCN 1C350.d.45.
fluoride.
(C.A.S. #16893-85-9) Sodium ECCN 1C350.d.22... ECCN 1C350.d.46.
hexafluorosilicate.
[[Page 36485]]
(C.A.S. #1313-82-2) Sodium ECCN 1C350.d.23... ECCN 1C350.d.47.
sulfide.
(C.A.S. #637-39-8) ECCN 1C350.d.24... ECCN 1C350.d.48.
Triethanolamine hydrochloride.
(C.A.S. #116-17-6) Tri-isopropyl ECCN 1C350.d.25... ECCN 1C350.d.49.
phosphite.
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Note that all items controlled under ECCN 1C350.d, including the
newly added precursor chemicals described above, are controlled for
chemical/biological (CB) reasons and anti-terrorism (AT) reasons (see
CB Column 2 of the Commerce Country Chart in Supplement No. 1 to part
738 of the EAR and the AT license requirements described in part 742 of
the EAR that apply to Iran, North Korea, Sudan and Syria). A license
also is required to certain destinations in accordance with the
embargoes and other special controls described in part 746 of the EAR.
ECCN 1C351 (Human and Animal Pathogen and Toxins)
This final rule amends ECCN 1C351 on the CCL to reflect changes to
the AG ``Control List of Human and Animal Pathogens and Toxins'' based
on the February 2020 Intersessional Implementation Meeting
recommendations that were adopted by AG. Specifically, this rule adds
the Middle East respiratory syndrome-related coronavirus (MERS-related
coronavirus) to ECCN 1C351.a.30 due to its homology with severe acute
respiratory syndrome-related coronavirus (SARS-related coronavirus) and
its potential use in biological weapons activities. The viruses in ECCN
1C351.a that were previously numbered, in alphabetical order, as .a.30
through .a.57 have been renumbered as .a.31 through .a.58,
respectively, and relevant cross-references adjusted as necessary.
In addition, although this rule does not amend ECCN 1E001
(``technology'' for the ``development'' or ``production'' of, inter
alia, pathogens or ``toxins'' controlled by ECCN 1C351) or ECCN 1E351
(``technology'' for the disposal of, inter alia, microbiological
materials), these ECCNs cross-reference items controlled by ECCN 1C351
and, consequently, ``technology'' that is related to the MERS-related
coronavirus added by this rule to ECCN 1C351.a.30 is now subject to
control under ECCN 1E001 or 1E351 if such ``technology'' falls within
the parameters of the controls described therein.
Note that all items controlled under ECCN 1C351.d, including the
newly added MERS-related coronavirus, require a license for CB reasons
and AT reasons to the destinations indicated under CB Column 1 and AT
Column 1, respectively, on the Commerce Country Chart in Supplement No.
1 to part 738 of the EAR (also see the AT license requirements
described in part 742 of the EAR that apply to Iran, North Korea, Sudan
and Syria). In addition, a license is required to certain destinations
in accordance with the embargoes and other special controls described
in part 746 of the EAR. Also note that, in addition to the license
requirements described above, items controlled under ECCN 1C351.d.11 or
.d.12 require a license to certain destinations for chemical weapons
(CW) reasons, as described in the License Requirements section of ECCN
1C351 and in Section 742.18 of the EAR.
ECCN 2B352 (Equipment Capable of Use in Handling Biological Materials)
This final rule amends ECCN 2B352 on the CCL to reflect changes to
the AG ``Control List of Dual-Use Biological Equipment and Related
Technology and Software'' based on the February 2020 Intersessional
Implementation Meeting recommendations that were adopted by the AG.
Specifically, this rule adds a Technical Note to ECCN 2B352.b to
indicate that cultivation chamber holding devices controlled in
2B352.b.2.b include single-use cultivation chambers with rigid walls.
Consequently, such single-use cultivation chambers require a license
for CB reasons and AT reasons to the destinations indicated under CB
Column 2 and AT Column 1, respectively, on the Commerce Country Chart
in Supplement No. 1 to part 738 of the EAR (also see the AT license
requirements described in part 742 that apply to Iran, North Korea,
Sudan and Syria). A license also is required to certain destinations in
accordance with the embargoes and other special controls described in
part 746 of the EAR.
In addition, although this rule does not amend ECCNs 2E001, 2E002
and 2E301 (which control, respectively, ``technology'' for the
``development,'' ``production'' or ``use'' of, inter alia, ECCN 2B352
equipment), these ECCNs cross-reference items controlled by ECCN 2B352
and, consequently, ``technology'' that is related to rigid-walled,
single-use cultivation chambers added by this rule to ECCN 2B352.b.2.b
is now subject to control under ECCN 2E001, 2E002 or 2E301 if such
``technology'' falls within the parameters of the controls described
therein.
Prior to the addition of these cultivation chambers to the AG
biological equipment common control list, BIS, consistent with the
interagency process described in Section 1758 of ECRA, identified these
items as emerging technologies that are essential to U.S. national
security and for which effective controls can be implemented. This
interagency process resulted in a finding that disposable cultivation
chambers that do not require the use of a holding device have recently
gained significant market share in the single-use biological equipment
market (both within and outside the United States) and, furthermore,
that they are capable of functioning as cultivation chamber holding
devices controlled under ECCN 2B352.b.2.b. Consequently, the absence of
export controls on these single-use cultivation chambers could be
exploited for chemical and biological weapons (CBW) purposes. Among the
items of concern, in this regard, are impeller-mixed liquid culture
chambers, as well as novel packed-bed and hollow-fiber models. The
inclusion of these cultivation chambers in this final rule is
consistent with the requirements of ECRA and the decision of the AG to
add these items to their common control lists, thereby making exports
of such items subject to multilateral control.
Conforming Changes to Supplement No. 7 to Part 748
This final rule also amends Supplement No. 7 to part 748 to update
the ECCN reference to hydrogen fluoride (C.A.S. #7664-39-3) in the
eligible item descriptions for the following validated end-users: (1)
``Samsung China Semiconductor Co. Ltd.'' and (2) ``Shanghai Huahong
Grace Semiconductor Manufacturing Corporation.'' As described above,
hydrogen fluoride was previously classified under ECCN 1C350.d.10, but
is now classified under ECCN 1C350.d.14 with the publication of this
rule. These conforming amendments do not change the scope of eligible
items for either of the two validated end-users indicated above--they
merely update the ECCN references in Supplement No.
[[Page 36486]]
7 to part 748 to correctly identify which ECCN 1C350.d items are
eligible for each of these validated end-users. Because this rule does
not add or remove any validated end-users or revise the scope of
eligible items, the citation for this rule is not indicated in the
``Federal Register Citation'' column of Supplement No. 7.
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
June 17, 2020, 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 August 17, 2020. Any such items not
actually exported, reexported or transferred (in-country) before
midnight, on August 17, 2020, 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 August 17, 2020. Beginning
at midnight on August 17, 2020, 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
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), 50 U.S.C.
Sections 4801-4852. ECRA provides the legal basis for BIS's principal
authorities and serves as the authority under which BIS issues this
rule. As set forth in section 1768 of ECRA, all delegations, rules,
regulations, orders, determinations, licenses, or other forms of
administrative action that were made, issued, conducted, or allowed to
become effective under the Export Administration Act of 1979
(previously, 50 U.S.C. 4601 et seq.) (as in effect prior to August 13,
2018, and as continued in effect pursuant to the International
Emergency Economic Powers Act (50 U.S.C. 1701 et seq.)) or the Export
Administration Regulations, and were in effect as of August 13, 2018,
shall continue in effect according to their terms until modified,
superseded, set aside, or revoked under the authority of ECRA.
Rulemaking Requirements
1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including: Potential economic, environmental, public
health and safety effects; distributive impacts; and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits and of reducing costs, harmonizing rules, and promoting
flexibility. This rule has been designated a ``significant regulatory
action,'' although not economically significant, under section 3(f) of
Executive Order 12866. Accordingly, the rule has been reviewed by the
Office of Management and Budget.
The cost-benefit analysis required pursuant to Executive Orders
13563 and 12866 indicates that this rule is intended to improve
national security as its primary direct benefit. Specifically,
implementation, in a timely manner, of the Australia Group (AG)
agreements described herein will enhance the national security of the
United States by reducing the risk that global international trade
involving dual-use chemical and biological items would contribute to
the proliferation of chemical and biological weapons of mass
destruction. The principal objective of AG participating countries is
to use licensing measures to ensure that exports of certain chemicals,
biological agents, and dual-use chemical and biological manufacturing
facilities and equipment, do not contribute to the proliferation of
chemical and biological weapons of mass destruction, which has been
identified as a threat to domestic and international peace and
security. The AG achieves this objective by harmonizing participating
countries' national export licensing measures. These controls are
essential given that the international chemical and biotechnology
industries are a target for proliferators as a source of materials for
chemical and biological weapons programs.
In calculating the costs that will be imposed by this rule, BIS
estimates that no more than 25 additional license applications will
have to be submitted to BIS, annually, as a result of the
implementation of the amendments described in this rule (see Rulemaking
Requirements #2, below). Application of the cost-benefit analysis
required under Executive Orders 13563 and 12866 to this rule, as
described above, indicates that this rule is intended to improve the
national security of the United States as its primary direct benefit.
Accordingly, consistent with the stated purpose of the proposed
amendments to ECCNs 1C350, 1C351 and 2B352, this rule meets the
requirements set forth in the April 5, 2017, OMB guidance implementing
Executive Order 13771 (82 FR 9339, February 3, 2017), regarding what
constitutes a regulation issued ``with respect to a national security
function of the United States,'' and it is, therefore, exempt from the
requirements of E.O. 13771.
2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with, a collection of information subject to the
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.) (PRA), unless that collection of information displays a currently
valid Office of Management and Budget (OMB) Control Number. This rule
contains the following collections of information subject to the
requirements of the PRA. These collections have been approved by OMB
under control numbers 0694-0088 (Simplified Network Application
Processing System) and 0694-0096 (Five Year Records Retention Period).
The approved information collection under OMB control number 0694-0088
includes license applications, among other things, and carries a burden
estimate of 29.6 minutes per manual or electronic submission for a
total burden estimate of 31,833 hours. The approved information
collection under OMB control number 0694-0096 includes recordkeeping
requirements and carries a burden estimate of less than 1 minute per
response for a total burden estimate of 248 hours.
Although this rule contains important changes to the EAR for items
controlled for chemical/biological (CB) reasons, BIS believes the
overall increase in costs and burdens due to the implementation of
these changes will be minimal. Specifically, BIS expects the burden
hours associated with these collections will increase, slightly, by 12
hours and 45 minutes (i.e., 25 applications x 30.6 minutes per
response) for a total
[[Page 36487]]
estimated cost increase of $382.50 (i.e., 12 hours and 45 minutes x $30
per hour). The $30 per hour cost estimate for OMB control numbers 0694-
0088 and 0694-0096 is consistent with the salary data for export
compliance specialists currently available through glassdoor.com
(glassdoor.com estimates that an export compliance specialist makes
$55,280 annually, which computes to roughly $26.58 per hour). This
increase is not expected to exceed the existing estimates currently
associated with OMB control numbers 0694-0088 and 0694-0096. Send
comments regarding this burden estimate or any other aspect of this
collection of information, including suggestions for reducing the
burden, to Jasmeet Seehra, Office of Management and Budget, by email to
[email protected] or by fax to (202) 395-7285; and to the
Regulatory Policy Division, Bureau of Industry and Security, Department
of Commerce, 14th Street & Pennsylvania Avenue NW, Room 2705,
Washington, DC 20230 or by email to [email protected].
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 (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 rule by the APA or
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 Part 748
Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.
15 CFR Part 774
Exports, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, parts 748 and 774 of the
Export Administration Regulations (15 CFR parts 730-774) are amended as
follows:
PART 748--[AMENDED]
0
1. The authority citation for 15 CFR part 748 continues to read as
follows:
Authority: 50 U.S.C. 4801-4582; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 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; Notice of
August 14, 2019, 84 FR 41881 (August 15, 2019).
0
2. Supplement 7 to part 748 is amended by revising the validated end-
user entries for ``Samsung China Semiconductor Co. Ltd.'' and
``Shanghai Huahong Grace Semiconductor Manufacturing Corporation,''
listed under the country ``China (People's Republic of)'' to read as
follows:
Supplement No. 7 to Part 748--Authorization Validated End-User (VEU): List of Validated End-Users, Respective
Items Eligible for Export, Reexport and Transfer, and Eligible Destinations
----------------------------------------------------------------------------------------------------------------
Eligible items (by Federal Register
Country Validated end-user ECCN) Eligible destination citation
----------------------------------------------------------------------------------------------------------------
Nothing in this Supplement shall be deemed to supersede other provisions in the EAR, including but not limited
to Sec. 748.15(c).
----------------------------------------------------------------------------------------------------------------
China (People's Republic * * * * * *
of)
Samsung China 1C350.c.4, Samsung China 78 FR 41291, 7/10/
Semiconductor Co. 1C350.d.14, Semiconductor Co., 13. 78 FR 69535,
Ltd. 2B006.a, Ltd., No. 1999, 11/20/13. 79 FR
2B006.b.1.d, 2B230, North Xiaohe Road, 30713, 5/29/14. 80
2B350.d.2, Xi'an, China 710119. FR 11863, 3/5/15.
2B350.g.3,
2B350.i.3, 3A233,
3B001.a.1, 3B001.b,
3B001.e, 3B001.f,
3B001.h, 3C002,
3C004, 3D002, and
3E001 (limited to
``technology'' for
items classified
under 3C002 and
3C004 and
``technology'' for
use consistent with
the International
Technology Roadmap
for Semiconductors
process for items
classified under
ECCNs 3B001 and
3B002).
[[Page 36488]]
Shanghai Huahong 1C350.c.4, Shanghai Huahong 78 FR 32981, 6/3/
Grace Semiconductor 1C350.d.14, 2B230, Grace Semiconductor 13.
Manufacturing 2B350.d.2, Manufacturing
Corporation. 2B350.g.3, Corporation--HFab
2B350.i.4, 2, 668 Guoshoujing
3B001.a.1, 3B001.b, Road, Zhangjiang Hi-
3B001.e, 3B001.f, Tech Park, Shanghai
3B001.h, 3C002, 201203 China.
3C004, 5B002, and Shanghai Huahong
5E002 (controlled Grace Semiconductor
by ECCNs 5A002, Manufacturing
5A004, or 5A992 Corporation--HFab
that have been 1, 1188 Chuanqiao
successfully Road, Pudong,
reviewed under the Shanghai 201206
encryption review China.
process specified Shanghai Huahong
in Sections Grace Semiconductor
740.17(b)(2) or Manufacturing
740.17(b)(3) of the Corporation--GFab1,
EAR). 1399 Zuchongzhi
Road, Zhangjiang Hi-
Tech Park, Shanghai
201203 China.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
PART 774--[AMENDED]
0
3. The authority citation for 15 CFR part 774 continues to read as
follows:
Authority: 50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 10 U.S.C. 8720; 10 U.S.C. 8730(e); 22 U.S.C.
287c, 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15
U.S.C. 1824; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210;
E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783.
0
4. Supplement 1 to part 774 is amended in category 1 by revising ECCN
1C350 and ECCN 1C351 and in category 2 by revising ECCN 2B352 to read
as follows:
Supplement No. 1 to Part 774--The Commerce Control List
* * * * *
Category 1--Special Materials and Related Equipment, Chemicals,
``Microorganisms,'' and ``Toxins''
* * * * *
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 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, Sudan, 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.
[[Page 36489]]
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) 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
CIV: 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) Methylphos-phonothioic 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:
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;
[[Page 36490]]
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.11 and d.12 and a license is required for
CW reasons for all destinations, including Canada, as follows: CW
applies to 1C351.d.11 for ricin in the form of (1) Ricinus Communis
AgglutininII (RCAII), also known as ricin D or Ricinus Communis
LectinIII (RCLIII) and (2) Ricinus Communis LectinIV (RCLIV), also
known as ricin E. CW applies to 1C351.d.12 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 paragraph (d) of this entry, with the exception of
toxins controlled for CW reasons under d.11 and d.12, 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 paragraph d.12; 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
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,
or the Centers for Disease Control and Prevention (CDC), U.S.
Department of Health and Human Services, 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
CIV: 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.10
and 1C351.d.13 through 1C351.d.19. 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.
List of Items Controlled
Related Controls: (1) Certain forms of ricin and saxitoxin in
1C351.d.11. and d.12 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: (1) For the purposes of this entry
``immunotoxin'' is defined as an antibody-toxin conjugate intended
to destroy specific target cells (e.g., tumor cells) that bear
antigens homologous to the antibody. (2) For the purposes of this
entry ``subunit'' is defined as a portion of the ``toxin''.
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.
[[Page 36491]]
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, and ``subunits'' thereof:
d.1. Abrin;
d.2. Aflatoxins;
d.3. Botulinum toxins;
d.4. Cholera toxin;
d.5. Clostridium perfringens alpha, beta 1, beta 2, epsilon and
iota toxins;
d.6. Conotoxins;
d.7. Diacetoxyscirpenol;
d.8. HT-2 toxin;
d.9. Microcystins (Cyanginosins);
d.10. Modeccin;
d.11. Ricin;
d.12. Saxitoxin;
d.13. Shiga toxins (shiga-like toxins, verotoxins, and
verocytotoxins);
d.14. Staphylococcus aureus enterotoxins, hemolysin alpha toxin,
and toxic shock syndrome toxin (formerly known as Staphylococcus
enterotoxin F);
d.15. T-2 toxin;
d.16. Tetrodotoxin;
d.17. Viscumin (Viscum album lectin 1); or
d.18. Volkensin.
e. ``Fungi'', as follows:
e.1. Coccidioides immitis; or
e.2. Coccidioides posadasii.
* * * * *
Category 2--Materials Processing
* * * * *
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
CIV: 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:
[[Page 36492]]
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:
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 the destruction of potential microbial
infectivity in the equipment through the use of chemical agents with
a germicidal effect. ``Disinfection'' and ``sterilization'' are
distinct from ``sanitization'', the latter referring to cleaning
procedures designed to lower the microbial content of equipment
without necessarily achieving elimination of all microbial
infectivity or viability.
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
