Document ID: BIS-2020-0020-0001
Agency: bis
Document Type: Rule
Title: 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
Posted Date: 2020-06-17T04:00Z

[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: Wesley.Johnson@bis.doc.gov.

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
------------------------------------------------------------------------
(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.
------------------------------------------------------------------------

    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 
Jasmeet_K._Seehra@omb.eop.gov 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 RPD2@bis.doc.gov.
    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 <=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 does not control 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.
* * * * *

Richard E. Ashooh,
Assistant Secretary for Export Administration.
[FR Doc. 2020-11625 Filed 6-16-20; 8:45 am]
BILLING CODE 3510-33-P