[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Rules and Regulations]
[Pages 13849-13862]
[FR Doc No: 2018-06581]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 738, 740, 745 and 774

[Docket No. 170306234-7234-01]
RIN 0694-AH37

Implementation of the February 2017 Australia Group (AG)
Intersessional Decisions and the June 2017 AG Plenary Understandings;
Addition of India to the AG

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 recommendations presented at the February 2017 Australia Group (AG)
Intersessional Implementation Meeting, and later adopted pursuant to
the AG silent approval procedure, and the recommendations made at the
June 2017 AG Plenary Implementation Meeting and adopted by the AG
Plenary. This rule amends the following Export Control Classification
Numbers (ECCNs) on the Commerce Control List (CCL) to reflect the
February 2017 Intersessional Implementation Meeting recommendations
that were adopted by the AG: ECCN 2B350 (by adding certain
prefabricated repair assemblies, and specially designed components
therefor, that are designed for attachment to glass-lined reaction
vessels, reactors, storage tanks, containers or receivers controlled by
this entry); ECCN 2B351 (by clarifying that toxic gas monitoring
equipment includes toxic gas monitors and monitoring systems, as well
as their dedicated detecting components); and ECCN 2B352 (by adding
certain nucleic acid assemblers and synthesizers to this entry and
clarifying how the capacity of certain fermenters should be measured
for purposes of determining whether they are controlled under this
entry).
    Consistent with the June 2017 AG Plenary Implementation Meeting
recommendations that were adopted by the AG, this rule amends the
following ECCNs on the CCL: ECCN 1C353 (to clarify that genetically
modified organisms include organisms in which the nucleic acid
sequences have been created or altered by deliberate molecular
manipulation and that inactivated organisms containing recoverable
nucleic acids are considered to be genetic elements) and ECCN 1C350 (by
adding N,N-Diisopropylamino ethanethiol hydrochloride). This rule also
corrects several typographical errors in a note to ECCN 1C351 and
updates the advance notification requirements in the EAR that apply to
certain exports of saxitoxin. Finally, this rule amends the EAR to
reflect the addition of India as a participating country in the AG.

DATES: This rule is effective April 2, 2018.

FOR FURTHER INFORMATION CONTACT: Richard P. Duncan, Ph.D., Director,
Chemical and Biological Controls Division, Office of Nonproliferation
and Treaty Compliance, Bureau of Industry and Security, Telephone:
(202) 482-3343, Email: [email protected].

SUPPLEMENTARY INFORMATION: The Bureau of Industry and Security (BIS) is
amending the Export Administration Regulations (EAR) to implement the
recommendations presented at the Australia Group (AG) Intersessional
Implementation Meeting held in Buenos Aires, Argentina, on February 15,
2017, and adopted pursuant to the AG silent approval procedure in April
2017, and the recommendations presented at the Implementation Meeting
of the 2017 AG Plenary held in Paris, France, from June 26-30, 2017,
and adopted by the AG Plenary. This rule also amends the EAR to reflect
the addition of India as a participating country in the AG, as of
January 19, 2018. 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 2017 AG Intersessional
Recommendations

ECCN 2B350 (Chemical Manufacturing Facilities and Equipment)

    This final rule amends ECCN 2B350 on the CCL to reflect changes to
the AG ``Control List of Dual-Use Chemical Manufacturing Facilities and
Equipment and Related Technology and Software'' based on the February
2017 Intersessional Implementation Meeting recommendations that were
adopted by the AG pursuant to its silent approval procedure.
Specifically, this rule amends ECCN 2B350 to control prefabricated
repair assemblies, and their specially designed components, that: (1)
Are designed for mechanical attachment to glass-lined reaction vessels
and reactors controlled under 2B350.a or glass-lined storage tanks,
containers and receivers controlled under 2B350.c; and (2) have
metallic surfaces that are made from tantalum or tantalum alloys and
come in direct contact with the chemical(s) being processed. These
assemblies and components were added to the AG chemical manufacturing
facilities and equipment common control list, because they are capable
of being used to prolong the life, or even allow the recommissioning,
of glass-lined reactors and storage tanks that are suitable for use in
the production of chemical weapons (CW) agents or AG-listed precursor
chemicals.
    All items controlled under ECCN 2B350 continue to require a license
for chemical/biological (CB) reasons to destinations indicated in CB
Column 2 on the Commerce Country Chart (see Supplement No. 1 to part
738 of the EAR) and for anti-terrorism (AT) reasons to destinations
indicated in AT Column 1 on the Commerce Country Chart.

ECCN 2B351 (Toxic Gas Monitors and Monitoring Systems)

    This final rule amends ECCN 2B351 on the CCL to reflect changes to
the AG ``Control List of Dual-Use Chemical Manufacturing Facilities and
Equipment and Related Technology and Software'' based on the February
2017 Intersessional Implementation Meeting recommendations that were
adopted by the AG pursuant to its silent approval procedure.
Specifically, this rule amends ECCN 2B351 to clarify that this entry
controls toxic gas monitors and monitoring systems, and their dedicated
detecting components (i.e., detectors, sensor devices, and replaceable
sensor cartridges), having either of the following characteristics: (1)
Designed for continuous operation and usable for the detection of
chemical warfare agents or precursor chemicals controlled by ECCN 1C350
at concentrations of less than 0.3 mg/m\3\; or (2) designed for the
detection of cholinesterase-inhibiting activity. The decision to
specifically identify toxic gas monitors, in addition to toxic gas
monitoring systems, on the AG chemical manufacturing facilities and
equipment common control list is based on the fact that certain
portable toxic gas monitors (e.g., small handheld detectors) are
capable of satisfying the technical control criteria applicable to
toxic gas monitoring systems and, as such, may also be suitable for use
in a CW production or storage facility. This rule also amends related
``software'' controls in ECCN 2D351 to reflect the updates to ECCN
2B351 described above.
    All items controlled under ECCN 2B351 continue to require a license
for CB reasons to destinations indicated in CB Column 2 on the Commerce
Country Chart and for AT reasons to destinations indicated in AT Column
1 on the Commerce Country Chart.

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 2017 Intersessional
Implementation Meeting recommendations that were adopted by the AG
pursuant to its silent approval procedure. Specifically, this rule
amends ECCN 2B352 to indicate that the ``total internal volume'' of a
fermenter must be measured to determine whether its capacity meets the
control level of ``20 liters or greater'' specified in 2B352.b.1. This
clarification was made to ensure that all AG participating countries
apply the same criterion to measure capacity for purposes of
determining whether a fermenter is subject to control.
    This rule also amends ECCN 2B352 by adding a new paragraph .j to
control nucleic acid assemblers and synthesizers that are both: (1)
Partly or entirely automated; and (2) designed to generate continuous
nucleic acids greater than 1.5 kilobases in length with error rates
less than 5% in a single run. These items were added to the AG dual-use
biological equipment common control list because they are capable of
being used to generate pathogens and toxins without the need to acquire
controlled genetic elements and organisms.
    All items controlled under ECCN 2B352 continue to require a license
for CB reasons to destinations indicated in CB Column 2 on the Commerce
Country Chart and for AT reasons to destinations indicated in AT Column
1 on the Commerce Country Chart.

Amendments to the CCL Based on the June 2017 AG Plenary Understandings

ECCN 1C350 (Precursor Chemicals)

    This final rule amends ECCN 1C350 to reflect updates to the AG
``Chemical Weapons Precursors'' control list adopted at the June 2017
AG Plenary meeting. Specifically, this rule amends ECCN 1C350.b by
adding the precursor chemical hydrochloride salt (C.A.S. #41480-75-5)
N,N-Diisopropylamino ethanethiol hydrochloride. This rule also
alphabetically reorders the precursor chemicals listed in ECCN 1C350.b,
.c, and .d to facilitate the identification of these chemicals. The
precursor chemicals affected by these amendments to ECCN 1C350 are
indicated in the following table.

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   AG-Controlled precursor chemicals           Previous CCL designation             Current CCL designation
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(C.A.S. #683-08-9) Diethyl               ECCN 1C350.b.22                      ECCN 1C350.b.4
 methylphosphonate.
(C.A.S. #15715-41-0) Diethyl             ECCN 1C350.b.4                       ECCN 1C350.b.5
 methylphosphonite.
(C.A.S. #2404-03-7) Diethyl-N,N-         ECCN 1C350.b.5                       ECCN 1C350.b.6
 dimethylphosphoroamidate.
(C.A.S. #41480-75-5) N,N-                None--EAR 99                         ECCN 1C350.b.7
 Diisopropylaminoethanethiol
 hydrochloride.
(C.A.S. #5842-07-9) N,N-Diisopropyl-     ECCN 1C350.b.6                       ECCN 1C350.b.8
 beta-aminoethane thiol.
(C.A.S. #96-80-0) N,N-Diisopropyl-beta-  ECCN 1C350.b.8                       ECCN 1C350.b.9
 aminoethanol.
(C.A.S. #96-79-7), N,N-Diisopropyl-beta- ECCN 1C350.b.9                       ECCN 1C350.b.10
 aminoethyl chloride.
(C.A.S. #4261-68-1) N,N-Diisopropyl-     ECCN 1C350.b.7                       ECCN 1C350.b.11
 beta-aminoethyl chloride hydrochloride.
(C.A.S. #6163-75-3) Dimethyl             ECCN 1C350.b.10                      ECCN 1C350.b.12
 ethylphosphonate.
(C.A.S. #756-79-6) Dimethyl              ECCN 1C350.b.11                      ECCN 1C350.b.13
 methylphosphonate.
(C.A.S. #677-43-0) N,N-Dimethylamino-    ECCN 1C350.b.23                      ECCN 1C350.b.14
 phosphoryl dichloride.
(C.A.S. #1498-40-4) Ethyl phosphonous    ECCN 1C350.b.12                      ECCN 1C350.b.15
 dichloride [Ethyl phosphinyl
 dichloride].
(C.A.S. #430-78-4) Ethyl phosphonus      ECCN 1C350.b.13                      ECCN 1C350.b.16
 difluoride [Ethyl phosphinyl
 difluoride].
(C.A.S. #1066-50-8) Ethyl phosphonyl     ECCN 1C350.b.14                      ECCN 1C350.b.17
 dichloride.
(C.A.S. #993-13-5) Methylphosphonic      ECCN 1C350.b.21                      ECCN 1C350.b.18
 acid.
(C.A.S. #676-98-2) Methylphos-           ECCN 1C350.b.24                      ECCN 1C350.b.19
 phonothioic dichloride.
(C.A.S. #464-07-3) Pinacolyl alcohol...  ECCN 1C350.b.18                      ECCN 1C350.b.20
(C.A.S. #1619-34-7) 3-Quinuclidinol....  ECCN 1C350.b.19                      ECCN 1C350.b.21
(C.A.S. #111-48-8) Thiodiglycol........  ECCN 1C350.b.20                      ECCN 1C350.b.22
(C.A.S. #139-87-7) Ethyldiethanolamine.  ECCN 1C350.c.12                      ECCN 1C350.c.3
(C.A.S. #10025-87-3) Phosphorus          ECCN 1C350.c.3                       ECCN 1C350.c.4
 oxychloride.
(C.A.S. #10026-13-8) Phosphorus          ECCN 1C350.c.4                       ECCN 1C350.c.5
 pentachloride.
(C.A.S. #7719-12-2) Phosphorus           ECCN 1C350.c.5                       ECCN 1C350.c.6
 trichloride.
(C.A.S. #10025-67-9) Sulfur              ECCN 1C350.c.6                       ECCN 1C350.c.8
 monochloride.
(C.A.S. #7719-09-7) Thionyl chloride...  ECCN 1C350.c.8                       ECCN 1C350.c.9
(C.A.S. #102-71-6) Triethanolamine.....  ECCN 1C350.c.9                       ECCN 1C350.c.10
(C.A.S. #122-52-1) Triethyl phosphite..  ECCN 1C350.c.10                      ECCN 1C350.c.11
(C.A.S. #121-45-9) Trimethyl phosphite.  ECCN 1C350.c.11                      ECCN 1C350.c.12
(C.A.S. #109-89-7) Diethylamine........  ECCN 1C350.d.25                      ECCN 1C350.d.3
(C.A.S. #100-37-8) N,N-                  ECCN 1C350.d.3                       ECCN 1C350.d.4
 Diethylaminoethanol.
(C.A.S. #298-06-6) O,O-Diethyl           ECCN 1C350.d.23                      ECCN 1C350.d.5
 phosphorodithioate.
(C.A.S. #2465-65-8) O,O-Diethyl          ECCN 1C350.d.22                      ECCN 1C350.d.6
 phosphorothioate.
(C.A.S. #108-18-9) Di-isopropylamine...  ECCN 1C350.d.4                       ECCN 1C350.d.7
(C.A.S. #124-40-3) Dimethylamine.......  ECCN 1C350.d.5                       ECCN 1C350.d.8
(C.A.S. #506-59-2) Dimethylamine         ECCN 1C350.d.6                       ECCN 1C350.d.9
 hydrochloride.
(C.A.S. #7664-39-3) Hydrogen fluoride..  ECCN 1C350.d.7                       ECCN 1C350.d.10
(C.A.S. #3554-74-3) 3-Hydroxyl-1-        ECCN 1C350.d.8                       ECCN 1C350.d.11
 methylpiperidine.
(C.A.S. #76-89-1) Methyl benzilate.....  ECCN 1C350.d.9                       ECCN 1C350.d.12
(C.A.S. #1314-80-3) Phosphorus           ECCN 1C350.d.10                      ECCN 1C350.d.13
 pentasulfide.
(C.A.S. #75-97-8) Pinacolone...........  ECCN 1C350.d.11                      ECCN 1C350.d.14
(C.A.S. #7789-29-9) Potassium            ECCN 1C350.d.14                      ECCN 1C350.d.15
 bifluoride.
(C.A.S. #151-50-8) Potassium cyanide...  ECCN 1C350.d.12                      ECCN 1C350.d.16
(C.A.S. #7789-23-3) Potassium fluoride.  ECCN 1C350.d.13                      ECCN 1C350.d.17
(C.A.S. #3731-38-2) 3-Quinuclidone.....  ECCN 1C350.d.15                      ECCN 1C350.d.18
(C.A.S. #1333-83-1) Sodium bifluoride..  ECCN 1C350.d.16                      ECCN 1C350.d.19
(C.A.S. #143-33-9) Sodium cyanide......  ECCN 1C350.d.17                      ECCN 1C350.d.20
(C.A.S. #7681-49-4) Sodium fluoride....  ECCN 1C350.d.18                      ECCN 1C350.d.21
(C.A.S. #16893-85-9) Sodium              ECCN 1C350.d.24                      ECCN 1C350.d.22
 hexafluorosilicate.
(C.A.S. #1313-82-2) Sodium sulfide.....  ECCN 1C350.d.19                      ECCN 1C350.d.23
(C.A.S. #637-39-8) Triethanolamine       ECCN 1C350.d.20                      ECCN 1C350.d.24
 hydrochloride.
(C.A.S. #116-17-6) Tri-isopropyl         ECCN 1C350.d.21                      ECCN 1C350.d.25
 phosphite.
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    All items controlled under ECCN 1C350 continue to require a license
for CB reasons to destinations indicated in CB Column 2 on the Commerce
Country Chart and for AT reasons to countries listed in Country Group
E:1 (see Supplement No. 1 to part 740 of the EAR). In addition, items
controlled under 1C350.b or .c require a license to certain
destinations for chemical weapons (CW) reasons, as described in the
License Requirements section of ECCN 1C350 and in Section 742.18 of the
EAR.

ECCN 1C353 (Genetic Elements and Genetically Modified Organisms)

    This final rule amends ECCN 1C353 on the CCL to reflect updates to
the AG controls on certain genetic elements and genetically modified
organisms adopted at the June 2017 AG Plenary meeting. Specifically,
this rule amends ECCN 1C353 to control any genetically modified
organism that contains, or any genetic element that codes for: (1) Any
gene or genes specific to any virus controlled by ECCN 1C351.a or .b or
1C354.c; (2) any gene or genes specific to any bacterium controlled by
ECCN 1C351.c or 1C354.a, or any fungus controlled by ECCN 1C351.e or
1C354.b, and which in itself or through its transcribed or translated
products represents a significant hazard to human, animal or plant
health or could endow or enhance pathogenicity; or (3) any toxins, or
their subunits, controlled by ECCN 1C351.d.
    In addition, this rule amends the Technical Notes to ECCN 1C353 to
clarify that ``genetically modified organisms include organisms in
which the nucleic acid sequences have been created or altered by
deliberate molecular manipulation'' (see Technical Note 1 to ECCN
1C353, as amended by this rule) and that inactivated organisms
containing recoverable nucleic acids are

considered to be genetic elements, whether genetically modified or
unmodified, or chemically synthesized in whole or in part (see
Technical Note 2 to ECCN 1C353, as amended by this rule). Technical
Note 3 to ECCN 1C353, as amended by this rule, states that this ECCN
does not control nucleic acid sequences of shiga toxin producing
Escherichia coli of serogroups O26, O45, O103, O104, O111, O121, O145,
O157, and other shiga toxin producing serogroups, other than those
genetic elements coding for shiga toxin, or for its subunits.
    This rule also defines the term ``endow or enhance pathogenicity,''
for purposes of the controls in ECCN 1C353 (see Technical Note 4 to
ECCN 1C353, as amended by this rule), as when the insertion or
integration of the nucleic acid sequence or sequences is/are likely to
enable or increase a recipient organism's ability to be used to
deliberately cause disease or death. This might include alterations to,
inter alia: virulence, transmissibility, stability, route of infection,
host range, reproducibility, ability to evade or suppress host
immunity, resistance to medical countermeasures, or detectability.
    All items controlled under ECCN 1C353 continue to require a license
for CB reasons to destinations indicated in CB Column 1 on the Commerce
Country Chart and for AT reasons to destinations indicated in AT Column
1 on the Commerce Country Chart.

Amendments to the EAR To Reflect the Addition of India to the AG

    This rule makes conforming amendments to the EAR to reflect the
addition of India to the AG, as of January 19, 2018. Specifically, this
rule amends the entry for India in the Commerce Country Chart
(Supplement No. 1 to part 738 of the EAR) by removing the ``X'' from
this entry under the column CB 2. In addition, this rule amends the
Country Groups chart (Supplement No. 1 to part 740 of the EAR) by
adding an ``X'' to the entry for India under column A:3, Australia
Group.

Corrections to ECCN 1C351 (Human and Animal Pathogens and ``Toxins'')

    This final rule amends ECCN 1C351 on the CCL by removing several
outdated references to former ECCN 1C352 in the Note that follows
1C351.a.4, which describes avian influenza (AI) viruses subject to
control under this ECCN, and adding in their place references to the
relevant AI controls described in 1C351.a.4. These corrections do not
affect the scope of the items subject to control under this ECCN or the
license requirements applicable to these items.

Correction To Advance Notification Requirements for Certain Exports of
Saxitoxin

    This final rule also corrects the Chemical Weapons Convention (CWC)
Schedule 1 chemical advance notification requirements in Section 745.1
of the EAR to reflect the April 27, 2006 (71 FR 24918), amendments to
the Chemical Weapons Convention Regulations (CWCR) (15 CFR parts 710-
722) that, inter alia, amended the definition of advance notification
in Section 710.1 of the CWCR, as well as the advance notification
requirements in Section 712.6(a) of the CWCR, to indicate that the 45-
day advance notification requirement for exports or imports of Schedule
1 chemicals does not apply to the export or import of 5 milligrams or
less of saxitoxin (see ECCN 1C351.d.12) for medical or diagnostic
purposes only--the latter requires only a 3-day advance notification.
Specifically, this final rule amends the first sentence in Section
745.1(a) of the EAR to read as follows: ``You must notify BIS at least
45 calendar days prior to exporting any quantity of a Schedule 1
chemical listed in Supplement No. 1 to this part to another State
Party, except that notifications for exports of 5 milligrams or less of
saxitoxin (for medical or diagnostic purposes only) must be submitted
to BIS at least 3 calendar days prior to the date of export (see 15 CFR
712.6(a)).'' The advance notification requirements in Section 745.1 of
the EAR refer only to exports, because imports are outside the scope of
these EAR requirements. However, as indicated above, the advance
notification requirements described in Section 712.6(a) of the CWCR
apply to imports, as well as exports. The exemption from the 45-day
advance notification requirement, for certain exports and imports of
saxitoxin (as described above), was approved and entered into force for
all CWC States Parties on October 31, 1999.

Effect of This Rule on the Scope of the CB Controls in the EAR

    The changes made by this rule only marginally affect the scope of
the EAR controls on chemical weapons precursors, human and animal
pathogens/toxins, chemical manufacturing equipment, and equipment
capable of use in handling biological materials.
    The scope of the CCL-based CB controls on human and animal
pathogens and toxins was not affected by the correction to ECCN 1C351
in which outdated references to former ECCN 1C352 were removed from the
Note that follows 1C351.a.4 and references to the relevant avian
influenza (AI) controls described in 1C351.a.4 were added in their
place. In addition, the updates to the controls on genetic elements and
genetically modified organisms described in ECCN 1C353 clarified the
scope of these controls, but did not actually expand them. In short,
neither of these changes is expected to result in an increase in the
number of license applications that will have to be submitted to BIS
for exports, reexports, or transfers (in-country) of these items.
    However, the changes made by this final rule to the CCL entries
controlling chemical weapons precursors, chemical manufacturing
equipment, and equipment capable of use in handling biological
materials are expected to result in a slight increase in the number of
license applications that will have to be submitted for these items.
Specifically, the addition of the precursor chemical hydrochloride salt
N,N-Diisopropylaminoethanethiol hydrochloride (C.A.S. #41480-75-5) to
ECCN 1C350.b is expected to result in the submission of one or two
additional license applications per year. The addition of controls on
certain prefabricated repair assemblies, and their specially designed
components, to ECCN 2B350 is expected to result in the submission of
four or five additional license applications per year. Specifically
listing toxic gas monitors in ECCN 2B351 (to clarify that this entry
controls, inter alia, certain portable gas monitors as well as toxic
gas monitoring systems) is expected to result in the submission of two
or three additional license applications per year. The addition of
controls on nucleic acid assemblers and synthesizers to ECCN 2B352 is
expected to result in the submission of four or five additional license
applications per year.
    Therefore, the number of additional license applications that would
have to be submitted per year, as a result of the amendments to ECCNs
1C350, 2B350, 2B351 and 2B352 described above, is not expected to
exceed fifteen license applications. This total represents a relatively
insignificant portion of the overall trade in such items and is well
within the scope of the information collection approved by the Office
of Management and Budget (OMB) under control number 0694-0088 (see
Rulemaking Requirements #2, below).

Saving Clause

    Shipments of items removed from eligibility for export or reexport
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 May 2, 2018, pursuant to
actual orders for export or reexport 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 or
reexported before May 17, 2018. Any such items not actually exported or
reexported before midnight, on May 17, 2018, 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 orwithout a license (NLR) before May 17, 2018. Beginning at
midnight on May 17, 2018, 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 Administration Act

    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March
8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of
August 15, 2017 (82 FR 39005 (August 16, 2017)), has continued the
Export Administration Regulations in effect under the International
Emergency Economic Powers Act (50 U.S.C. 1701 et seq.). BIS continues
to carry out the provisions of the Export Administration Act, as
appropriate and to the extent permitted by law, pursuant to Executive
Order 13222 as amended by Executive Order 13637.

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, of reducing costs, of harmonizing rules, and of 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 AG agreements described
herein would enhance the national security of the United States by
reducing the risk that global international trade involving dual-use
chemical/biological items would contribute to the proliferation of
chemical and biological weapons of mass destruction. The first meeting
of what subsequently became known as the Australia Group (AG) took
place in Brussels in June 1985. At that meeting, the 15 participating
countries and the European Commission agreed to explore how existing
export controls might be made more effective to prevent the spread of
chemical weapons. The AG has met regularly since then, and annual
meetings are now held in Paris. The scope of the export controls
addressed by the AG has evolved to address emerging threats and
challenges. Evidence of the diversion of dual-use materials to
biological weapons programs in the early 1990s led to participants'
adoption of export controls on specific biological agents. The common
control lists developed by the AG have also expanded to include
technology and equipment that can be used in the manufacturing or
disposal of chemical and biological weapons. The number of countries
participating in the AG has grown from 15 in 1985 to 42, plus the
European Union. 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 (CBW) 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. The AG's activities are especially important given that the
international chemical and biotechnology industries are a target for
proliferators as a source of materials for CBW programs. In calculating
the costs that would be imposed by this rule, Commerce estimates that
no more than 15 additional license applications would have to be
submitted to BIS, annually, as a result of the implementation of the
AG-related 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.
Furthermore, this rule qualifies for a good cause exception under 5
U.S.C. 553(b)(B) of the Administrative Procedure Act (5 U.S.C. 553)
requiring notice of proposed rulemaking, the opportunity for public
participation, and a delay in effective date--this finding, and a brief
statement of the reasons therefor, are described under Rulemaking
Requirements #4, below. Accordingly, this rule meets the requirements
set forth in the April 5, 2017, OMB guidance implementing E.O. 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 a collection of information subject to the requirements of the
PRA. This collection has been approved by OMB under control number
0694-0088, Simplified Network Application Processing System. This
collection 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. Although this
final rule makes important changes to the EAR for items controlled for
chemical/biological (CB) reasons, Commerce believes the overall
increase in costs and burdens due to this rule will be minimal.
Specifically, BIS expects the burden hours associated with this
collection to increase, slightly, by 7 hours and 24 minutes (i.e., 15
applications x 29.6 minutes per

response) for an estimated cost increase of $222 (i.e., 7 hours and 24
minutes x $30 per hour). This increase is not expected to exceed the
existing estimates currently associated with OMB control number 0694-
0088. 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<PHONE_NUMBER>; 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. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking, the opportunity for
public participation, and a delay in effective date, are inapplicable
because this regulation involves a military and foreign affairs
function of the United States (see 5 U.S.C. 553(a)(1)). Immediate
implementation of these amendments is non-discretionary and fulfills
the United States' international obligation to the Australia Group
(AG). The AG contributes to international security and regional
stability through the harmonization of export controls and seeks to
ensure that exports do not contribute to the development of chemical
and biological weapons. The AG consists of 42 member countries that act
on a consensus basis and the amendments set forth in this rule
implement changes made to the AG common control lists (as a result of
the adoption of the recommendations made at the February 2017 AG
Intersessional Implementation Meeting and the understandings reached at
the June 2017 AG Plenary Implementation Meeting) and other changes that
are necessary to ensure consistency with the controls maintained by the
AG. Because the United States is a significant exporter of the items in
this rule, immediate implementation of this provision is necessary for
the AG to achieve its purpose.
    Although the APA requirements in section 553 are not applicable to
this action under the provisions of paragraph (a)(1), this action also
falls within two other exceptions in the section. The subsection (b)
requirement that agencies publish a notice of proposed rulemaking,
which includes information on the public proceedings, does not apply
when an agency for good cause finds that the notice and public
procedures are impracticable, unnecessary, or contrary to the public
interest, and the agency incorporates the finding (and the reasons
therefor) in the rule that is issued (5 U.S.C. 553(b)(B)). In addition,
the section 553(d) requirement that publication of a rule shall be made
not less than 30 days before its effective date can be waived if an
agency findsthere is good cause to do so.
    The section 553 requirements for notice and public procedures and
for a delay in the date of effectiveness do not apply to this rule, as
there is good cause to waive such practices. Any delay in
implementation will create a disruption in the movement of affected
items globally because of disharmony between export control measures
implemented by AG members, resulting in tension between member
countries. Export controls work best when all countries implement the
same export controls in a timely manner. Delaying this rulemaking would
prevent the United States from fulfilling its commitment to the AG in a
timely manner, would injure the credibility of the United States in
this and other multilateral regimes, and may impair the international
community's ability to effectively control the export of certain
potentially national- and international security-threatening items.
Therefore, this regulation is issued in final form, and is effective
April 2, 2018.
    Further, no other law requires that a notice of proposed rulemaking
and an opportunity for public comment be given for this final rule.
Because a notice of proposed rulemaking and an opportunity for public
comment are not required to be given for this rule under the
Administrative Procedure Act or by any other law, the analytical
requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.)
are not applicable. Accordingly, no regulatory flexibility analysis is
required and none has been prepared.

List of Subjects

15 CFR Part 738

    Administrative practice and procedure, Exports, Foreign trade.

15 CFR Part 740

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

15 CFR Part 745

    Administrative practice and procedure, Chemicals, Exports, Foreign
trade, Reporting and recordkeeping requirements.

15 CFR Part 774

    Exports, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, parts 738, 740, 745 and 774
of the Export Administration Regulations (15 CFR parts 730-774) are
amended as follows:

PART 738--[AMENDED]

0
1. The authority citation for part 738 continues to read as follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10
U.S.C. 7420; 10 U.S.C. 7430(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. 1824a; 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; Notice of August 15, 2017, 82 FR 39005 (August
16, 2017).

0
2. Supplement No. 1 to Part 738 is amended by revising the entry for
``India'' to read as follows:

                                                                      Supplement No. 1 to Part 738--Commerce Country Chart
                                                                                [Reason for control]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                  Chemical and biological          Nuclear        National security   Missile  Regional stability    Firearms           Crime control           Anti-terrorism
                                          weapons             nonproliferation  --------------------   tech                         convention -------------------------------------------------
          Countries           --------------------------------------------------                    -------------------------------------------
                                 CB 1      CB 2      CB 3      NP 1      NP 2      NS 1      NS 2      MT 1      RS 1      RS 2        FC 1       CC 1      CC 2      CC 3      AT 1      AT 2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                                * * * * * * *
India 7......................        X   ........  ........        X   ........        X         X         X         X   ........  ...........  ........  ........  ........  ........  ........

                                                                                * * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\7\ See Sec.   758.1(b)(9) for an AES filing requirement for exports of CC column 1 or 3, or RS column 2 items to India. Also note that a license is still required for items controlled under
  ECCNs 6A003.b.4.b and 9A515.e for RS column 2 reasons when destined to India.

* * * * *

PART 740--[AMENDED]

0
3. The authority citation for part 740 continues to read as follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 22
U.S.C. 7201 et seq.; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p.
228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of
August 15, 2017, 82 FR 39005 (August 16, 2017).

0
4. In Supplement No. 1 to Part 740, Country Groups, Country Group A is
amended by revising the entry for ``India'' to read as follows:

                                                      Supplement No. 1 to Part 740--Country Groups
                                                                    [Country Group A]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    [A:1] Wassenaar   [A:2] Missile                     [A:4] Nuclear
                      Country                        participating      technology    [A:3] Australia  suppliers group       [A:5]            [A:6]
                                                        states 1      control regime       group              2
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
India.............................................  ...............               X                X   ...............  ...............               X

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Country Group A:1 is a list of the Wassenaar Arrangement Participating States, except for Malta, Russia and Ukraine.
2 Country Group A:4 is a list of the Nuclear Suppliers Group countries, except for the People's Republic of China (PRC).

* * * * *

PART 745--[AMENDED]

0
5. The authority citation for part 745 continues to read as follows:

    Authority: 50 U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3
CFR, 1994 Comp., p. 950; Notice of November 8, 2016, 81 FR 79379
(November 10, 2016).

0
6. In Sec.  745.1, the first sentence in paragraph (a) is revised to
read as follows:

Sec.  745.1  Advance notification and annual report of all exports of
Schedule 1 chemicals to other States Parties.

* * * * *
    (a) Advance notification of exports. You must notify BIS at least
45 calendar days prior to exporting any quantity of a Schedule 1
chemical listed in Supplement No. 1 to this part to another State
Party, except that notifications for exports of 5 milligrams or less of
saxitoxin (for medical or diagnostic purposes only) must be submitted
to BIS at least 3 calendar days prior to the date of export (see 15 CFR
712.6(a)). * * *
* * * * *

PART 774--[AMENDED]

0
7. The authority citation for part 774 continues to read as follows:

    Authority: 50 U.S.C. 4601 et seq.; 50 U.S.C. 1701 et seq.; 10
U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et
seq.; 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 43
U.S.C. 1354; 15 U.S.C. 1824a; 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; Notice of
August 15, 2017, 82 FR 39005 (August 16, 2017).

0
8. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 1, ECCN 1C350 is revised to read as follows:

Supplement No. 1 to Part 774--The Commerce Control List

1C350 Chemicals that may be used as precursors for toxic chemical
agents (see List of Items Controlled).

License Requirements

Reason for Control: CB, CW, AT

                                            Country chart (See Supp. No.
                Control(s)                         1 to part 738)

CB applies to entire entry................  CB Column 2

    CW applies to 1C350 .b, and .c. The Commerce Country Chart is
not designed to determine licensing requirements for items
controlled for CW reasons. A license is required, for CW reasons, to
export or reexport Schedule 2 chemicals and mixtures identified in
1C350.b to States not Party to the CWC (destinations not listed in
Supplement No. 2 to part 745 of the EAR). A license is required, for
CW reasons, to export Schedule 3 chemicals and mixtures identified
in 1C350.c to States not Party to the CWC, unless an End-Use
Certificate issued by the government of the importing country has
been obtained by the exporter prior to export. A license is
required, for CW reasons, to reexport Schedule 3 chemicals and
mixtures identified in 1C350.c from a State not Party to the CWC to
any other State not Party to the CWC. (See Sec.  742.18 of the EAR
for license requirements and policies for toxic and precursor
chemicals controlled for CW reasons. See Sec.  745.2 of the EAR for
End-Use Certificate requirements that apply to 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.
    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.7 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. #298-06-6) O,O-Diethyl phosphorodithioate;
    d.6. (C.A.S. #2465-65-8) O,O-Diethyl phosphorothioate;
    d.7. (C.A.S. #108-18-9) Di-isopropylamine;
    d.8. (C.A.S. #124-40-3) Dimethylamine;
    d.9. (C.A.S. #506-59-2) Dimethylamine hydrochloride;
    d.10. (C.A.S. #7664-39-3) Hydrogen fluoride;
    d.11. (C.A.S. #3554-74-3) 3-Hydroxyl-1-methylpiperidine;
    d.12. (C.A.S. #76-89-1) Methyl benzilate;
    d.13. (C.A.S. #1314-80-3) Phosphorus pentasulfide;
    d.14. (C.A.S. #75-97-8) Pinacolone;
    d.15. (C.A.S. #7789-29-9) Potassium bifluoride;
    d.16. (C.A.S. #151-50-8) Potassium cyanide;
    d.17. (C.A.S. #7789-23-3) Potassium fluoride;
    d.18. (C.A.S. #3731-38-2) 3-Quinuclidone;
    d.19. (C.A.S. #1333-83-1) Sodium bifluoride;

    d.20. (C.A.S. #143-33-9) Sodium cyanide;
    d.21. (C.A.S. #7681-49-4) Sodium fluoride;
    d.22. (C.A.S. #16893-85-9) Sodium hexafluorosilicate;
    d.23. (C.A.S. #1313-82-2) Sodium sulfide;
    d.24. (C.A.S. #637-39-8) Triethanolamine hydrochloride;
    d.25. (C.A.S. #116-17-6) Tri-isopropyl phosphite.

0
9. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 1, ECCN 1C351 is revised to read as follows:

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.

    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. Monkeypox virus;
    a.31. Murray Valley encephalitis virus;
    a.32. Newcastle disease virus;
    a.33. Nipah virus;
    a.34. Omsk hemorrhagic fever virus;
    a.35. Oropouche virus;
    a.36. Peste-des-petits ruminants virus;
    a.37. Porcine Teschovirus;
    a.38. Powassan virus;
    a.39. Rabies virus and all other members of the Lyssavirus
genus;

    a.40. Reconstructed 1918 influenza virus;

    Technical Note: 1C351.a.40 includes reconstructed replication
competent forms of the 1918 pandemic influenza virus containing any
portion of the coding regions of all eight gene segments.

    a.41. Rift Valley fever virus;
    a.42. Rinderpest virus;
    a.43. Rocio virus;
    a.44. Sabia virus;
    a.45. Seoul virus;
    a.46. Severe acute respiratory syndrome-related coronavirus
(SARS-related coronavirus);
    a.47. Sheeppox virus;
    a.48. Sin Nombre virus;
    a.49. St. Louis encephalitis virus;
    a.50. Suid herpesvirus 1 (Pseudorabies virus; Aujeszky's
disease);
    a.51. Swine vesicular disease virus;
    a.52. Tick-borne encephalitis virus (Far Eastern subtype,
formerly known as Russian Spring-Summer encephalitis virus--see
1C351.b.3 for Siberian subtype);
    a.53. Variola virus;
    a.54. Venezuelan equine encephalitis virus;
    a.55. Vesicular stomatitis virus;
    a.56. Western equine encephalitis virus; or
    a.57. 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.52 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.

0
10. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 1, ECCN 1C353 is revised to read as follows:

1C353 Genetic elements and genetically modified organisms, as
follows (see List of Items Controlled).

License Requirements

Reason for Control: CB, AT

                                                           Country Chart
                       Control(s)                         (See Supp. No.
                                                          1 to part 738)

CB applies to entire entry..............................     CB Column 1
AT applies to entire entry..............................     AT Column 1

    License Requirements Notes: 1. Vaccines that contain genetic
elements or genetically modified organisms identified in this ECCN
are controlled by ECCN 1C991.
    2. Unless specified elsewhere in this ECCN 1C353 (e.g., in
License Requirement Note 1), this ECCN controls genetic elements or
genetically modified organisms for all biological agents and
``toxins,'' regardless of quantity or attenuation, that are
identified in the List of Items Controlled for this ECCN, including
genetic elements or genetically modified organisms for attenuated
strains of select biological agents or ``toxins'' that are excluded
from the lists of select biological agents or ``toxins'' by the
Animal and Plant Health Inspection Service (APHIS), U.S. Department
of Agriculture, or the Centers for Disease Control and Prevention
(CDC), U.S. Department of Health and Human Services, in accordance
with the APHIS regulations in 7 CFR part 331 and 9 CFR part 121 and
the CDC regulations in 42 CFR part 73.

List Based License Exceptions (See Part 740 for a Description of All
License Exceptions)

LVS: N/A
GBS: N/A
CIV: N/A

List of Items Controlled

Related Controls: (1) The Animal and Plant Health Inspection Service
(APHIS), U.S. Department of Agriculture, and the Centers for Disease
Control and Prevention (CDC), U.S. Department of Health and Human
Services, maintain controls on the possession, use, and transfer
within the United States of certain items controlled by this ECCN,
including (but not limited to) certain genetic elements, recombinant
nucleic acids, and recombinant organisms associated with the agents
or toxins in ECCN 1C351 or 1C354 (for APHIS, see 7 CFR 331.3(c), 9
CFR 121.3(c), and 9 CFR 121.4(c); for CDC, see 42 CFR 73.3(c) and 42
CFR 73.4(c)). (2) See 22 CFR part 121, Category XIV(b), for modified
biological agents and biologically derived substances that are
subject to the export licensing jurisdiction of the U.S. Department
of State, Directorate of Defense Trade Controls.

Related Definition: N/A
Items:

    a. Any genetically modified organism that contains, or any
genetic element that codes for, any of the following:
    a.1. Any gene or genes specific to any virus controlled by
1C351.a or .b or 1C354.c;
    a.2. Any gene or genes specific to any bacterium controlled by
1C351.c or 1C354.a, or any fungus controlled by 1C351.e or 1C354.b,
and which;
    a.2.a. In itself or through its transcribed or translated
products represents a significant hazard to human, animal or plant
health; or
    a.2.b. Could endow or enhance pathogenicity; or
    a.3. Any toxins, or their subunits, controlled by 1C351.d.
    b. [Reserved].

    Technical Notes: 1. Genetically modified organisms include
organisms in which the nucleic acid sequences have been created or
altered by deliberate molecular manipulation.

    2. ``Genetic elements'' include, inter alia, chromosomes,
genomes, plasmids, transposons, vectors, and inactivated organisms
containing recoverable nucleic acid fragments, whether genetically
modified or unmodified, or chemically synthesized in whole or in
part. For the purposes of this ECCN 1C353, nucleic acids from an
inactivated organism, virus, or sample are considered to be
`recoverable' if the inactivation and preparation of the material is
intended or known to facilitate isolation, purification,
amplification, detection, or identification of nucleic acids.
    3. This ECCN does not control nucleic acid sequences of shiga
toxin producing

Escherichia coli of serogroups O26, O45, O103, O104, O111, O121,
O145, O157, and other shiga toxin producing serogroups, other than
those genetic elements coding for shiga toxin, or for its subunits.
    4. `Endow or enhance pathogenicity' is defined as when the
insertion or integration of the nucleic acid sequence or sequences
is/are likely to enable or increase a recipient organism's ability
to be used to deliberately cause disease or death. This might
include alterations to, inter alia: virulence, transmissibility,
stability, route of infection, host range, reproducibility, ability
to evade or suppress host immunity, resistance to medical
countermeasures, or detectability.

0
11. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 2, ECCN 2B350 is revised to read as follows:

2B350 Chemical manufacturing facilities and equipment, except valves
controlled by 2A226, 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

    License Requirement Note: This ECCN does not control equipment
that is both: (1) ``Specially Designed'' for use in civil
applications e.g., food processing, pulp and paper processing, or
water purification) and (2) inappropriate, by the nature of its
design, for use in storing, processing, producing or conducting and
controlling the flow of the chemical weapons precursors controlled
by 1C350.

List Based License Exceptions (See Part 740 for a Description of All
License Exceptions)

LVS: $2,000 for all Country Group B destinations, except those also
listed under Country Group D:3 (see Supplement No. 1 to part 740 of
the EAR).
GBS: N/A
CIV: N/A

List of Items Controlled

Related Controls: See also ECCNs 2A226, 2A992, 2A993, 2B231, and
2B999.
Related Definitions: For purposes of this entry the term `chemical
warfare agents' includes those agents ``subject to the ITAR'' (see
22 CFR parts 120 through 130).
Items:

    a. Reaction vessels, reactors and prefabricated repair
assemblies therefor, as follows:
    a.1. Reaction vessels or reactors, with or without agitators,
with total internal (geometric) volume greater than 0.1 m\3\ (100
liters) and less than 20 m\3\ (20,000 liters), where all surfaces
that come in direct contact with the chemical(s) being processed or
contained are made from any of the following materials:
    a.1.a Alloys with more than 25% nickel and 20% chromium by
weight;
    a.1.b. Nickel or alloys with more than 40% nickel by weight;
    a.1.c. Fluoropolymers (polymeric or elastomeric materials with
more than 35% fluorine by weight);
    a.1.d. Glass (including vitrified or enameled coating or glass
lining);
    a.1.e. Tantalum or tantalum alloys;
    a.1.f. Titanium or titanium alloys;
    a.1.g. Zirconium or zirconium alloys; or
    a.1.h. Niobium (columbium) or niobium alloys;
    a.2. Prefabricated repair assemblies, and their specially
designed components, that:
    a.2.a. Are designed for mechanical attachment to glass-lined
reaction vessels or reactors described in 2B350.a.1; and
    a.2.b. Have metallic surfaces that are made from tantalum or
tantalum alloys and come in direct contact with the chemical(s)
being processed.
    b. Agitators designed for use in reaction vessels or reactors
described in 2B350.a.1, and impellers, blades or shafts designed for
such agitators, where all surfaces that come in direct contact with
the chemical(s) being processed or contained are made from any of
the following materials:
    b.1. Alloys with more than 25% nickel and 20% chromium by
weight;
    b.2. Nickel or alloys with more than 40% nickel by weight;
    b.3. Fluoropolymers (polymeric or elastomeric materials with
more than 35% fluorine by weight);
    b.4. Glass (including vitrified or enameled coatings or glass
lining);
    b.5. Tantalum or tantalum alloys;
    b.6. Titanium or titanium alloys;
    b.7. Zirconium or zirconium alloys; or
    b.8. Niobium (columbium) or niobium alloys.
    c. Storage tanks, containers, receivers and prefabricated repair
assemblies therefor, as follows:
    c.1. Storage tanks, containers or receivers with a total
internal (geometric) volume greater than 0.1 m\3\ (100 liters) where
all surfaces that come in direct contact with the chemical(s) being
processed or contained are made from any of the following materials:
    c.1.a. Alloys with more than 25% nickel and 20% chromium by
weight;
    c.1.b. Nickel or alloys with more than 40% nickel by weight;
    c.1.c. Fluoropolymers (polymeric or elastomeric materials with
more than 35% fluorine by weight);
    c.1.d. Glass (including vitrified or enameled coatings or glass
lining);
    c.1.e. Tantalum or tantalum alloys;
    c.1.f. Titanium or titanium alloys;
    c.1.g. Zirconium or zirconium alloys; or
    c.1.h. Niobium (columbium) or niobium alloys;
    c.2. Prefabricated repair assemblies, and their specially
designed components, that:
    c.2.a. Are designed for mechanical attachment to glass-lined
storage tanks, containers or receivers described in 2B350.c.1; and
    c.2.b. Have metallic surfaces that are made from tantalum or
tantalum alloys and come in direct contact with the chemical(s)
being processed.
    d. Heat exchangers or condensers with a heat transfer surface
area of less than 20 m\2\, but greater than 0.15 m\2\, and tubes,
plates, coils or blocks (cores) designed for such heat exchangers or
condensers, where all surfaces that come in direct contact with the
chemical(s) being processed are made from any of the following
materials:
    d.1. Alloys with more than 25% nickel and 20% chromium by
weight;
    d.2. Nickel or alloys with more than 40% nickel by weight;
    d.3. Fluoropolymers (polymeric or elastomeric materials with
more than 35% fluorine by weight);
    d.4. Glass (including vitrified or enameled coatings or glass
lining);
    d.5. Tantalum or tantalum alloys;
    d.6. Titanium or titanium alloys;
    d.7. Zirconium or zirconium alloys;
    d.8. Niobium (columbium) or niobium alloys;
    d.9. Graphite or carbon-graphite;
    d.10. Silicon carbide; or
    d.11. Titanium carbide.
    e. Distillation or absorption columns of internal diameter
greater than 0.1 m, and liquid distributors, vapor distributors or
liquid collectors designed for such distillation or absorption
columns, where all surfaces that come in direct contact with the
chemical(s) being processed are made from any of the following
materials:
    e.1. Alloys with more than 25% nickel and 20% chromium by
weight;
    e.2. Nickel or alloys with more than 40% nickel by weight;
    e.3. Fluoropolymers (polymeric or elastomeric materials with
more than 35% fluorine by weight);
    e.4. Glass (including vitrified or enameled coatings or glass
lining);
    e.5. Tantalum or tantalum alloys;
    e.6. Titanium or titanium alloys;
    e.7. Zirconium or zirconium alloys;
    e.8. Niobium (columbium) or niobium alloys; or
    e.9. Graphite or carbon-graphite.
    f. Remotely operated filling equipment in which all surfaces
that come in direct contact with the chemical(s) being processed are
made from any of the following materials:
    f.1. Alloys with more than 25% nickel and 20% chromium by
weight; or
    f.2. Nickel or alloys with more than 40% nickel by weight.
    g. Valves, as follows:
    g.1. Valves having both of the following characteristics:
    g.1.a. A nominal size greater than 1.0 cm (\3/8\ in.); and
    g.1.b. All surfaces that come in direct contact with the
chemical(s) being produced, processed, or contained are made from
materials identified in Technical Note 1 to 2B350.g.
    g.2. Valves, except for valves controlled by 2B350.g.1, having
all of the following characteristics:
    g.2.a. A nominal size equal to or greater than 2.54 cm (1 inch)
and equal to or less than 10.16 cm (4 inches);
    g.2.b. Casings (valve bodies) or preformed casing liners
controlled by 2B350.g.3, in which all surfaces that come in direct
contact with the chemical(s) being produced,

processed, or contained are made from materials identified in
Technical Note 1 to 2B350.g; and
    g.2.c. A closure element designed to be interchangeable.
    g.3. Casings (valve bodies) and preformed casing liners having
both of the following characteristics:
    g.3.a. Designed for valves in 2B350.g.1 or .g.2; and
    g.3.b. All surfaces that come in direct contact with the
chemical(s) being produced, processed, or contained are made from
materials identified in Technical Note 1 to 2B350.g.

    Technical Note 1 to 2B350.g: All surfaces of the valves
controlled by 2B350.g.1, and the casings (valve bodies) and
preformed casing liners controlled by 2B350.g.3, that come in direct
contact with the chemical(s) being produced, processed, or contained
are made from the following materials:

    a. Alloys with more than 25% nickel and 20% chromium by weight;
    b. Nickel or alloys with more than 40% nickel by weight;
    c. Fluoropolymers (polymeric or elastomeric materials with more
than 35% fluorine by weight);
    d. Glass (including vitrified or enameled coating or glass
lining);
    e. Tantalum or tantalum alloys;
    f. Titanium or titanium alloys;
    g. Zirconium or zirconium alloys;
    h. Niobium (columbium) or niobium alloys; or
    i. Ceramic materials, as follows:
    i.1. Silicon carbide with a purity of 80% or more by weight;
    i.2. Aluminum oxide (alumina) with a purity of 99.9% or more by
weight; or
    i.3. Zirconium oxide (zirconia).

    Technical Note 2 to 2B350.g: The `nominal size' is defined as
the smaller of the inlet and outlet port diameters.

    h. Multi-walled piping incorporating a leak detection port, in
which all surfaces that come in direct contact with the chemical(s)
being processed or contained are made from any of the following
materials:
    h.1. Alloys with more than 25% nickel and 20% chromium by
weight;
    h.2. Nickel or alloys with more than 40% nickel by weight;
    h.3. Fluoropolymers (polymeric or elastomeric materials with
more than 35% fluorine by weight);
    h.4. Glass (including vitrified or enameled coatings or glass
lining);
    h.5. Tantalum or tantalum alloys;
    h.6. Titanium or titanium alloys;
    h.7. Zirconium or zirconium alloys;
    h.8. Niobium (columbium) or niobium alloys; or
    h.9. Graphite or carbon-graphite.
    i. Multiple-seal and seal-less pumps with manufacturer's
specified maximum flow-rate greater than 0.6 m\3\/hour (600 liters/
hour), or vacuum pumps with manufacturer's specified maximum flow-
rate greater than 5 m\3\/hour (5,000 liters/hour) (under standard
temperature (273 K (0 [deg]C)) and pressure (101.3 kPa) conditions),
and casings (pump bodies), preformed casing liners, impellers,
rotors or jet pump nozzles designed for such pumps, in which all
surfaces that come into direct contact with the chemical(s) being
processed are made from any of the following materials:
    i.1. Alloys with more than 25% nickel and 20% chromium by
weight;
    i.2. Nickel or alloys with more than 40% nickel by weight;
    i.3. Fluoropolymers (polymeric or elastomeric materials with
more than 35% fluorine by weight);
    i.4. Glass (including vitrified or enameled coatings or glass
lining);
    i.5. Tantalum or tantalum alloys;
    i.6. Titanium or titanium alloys;
    i.7. Zirconium or zirconium alloys;
    i.8. Niobium (columbium) or niobium alloys.
    i.9. Graphite or carbon-graphite;
    i.10. Ceramics; or
    i.11. Ferrosilicon (high silicon iron alloys).

    Technical Note to 2B350.i: The seals referred to in 2B350.i come
into direct contact with the chemical(s) being processed (or are
designed to do so), and provide a sealing function where a rotary or
reciprocating drive shaft passes through a pump body.

    j. Incinerators designed to destroy chemical warfare agents,
chemical weapons precursors controlled by 1C350, or chemical
munitions having ``specially designed'' waste supply systems,
special handling facilities and an average combustion chamber
temperature greater than 1000 [deg]C in which all surfaces in the
waste supply system that come into direct contact with the waste
products are made from or lined with any of the following materials:
    j.1. Alloys with more than 25% nickel and 20% chromium by
weight;
    j.2. Nickel or alloys with more than 40% nickel by weight; or
    j.3. Ceramics.

    Technical Note 1: Carbon-graphite is a composition consisting
primarily of graphite and amorphous carbon, in which the graphite is
8 percent or more by weight of the composition.

    Technical Note 2: For the items listed in 2B350, the term
`alloy,' when not accompanied by a specific elemental concentration,
is understood as identifying those alloys where the identified metal
is present in a higher percentage by weight than any other element.

    Technical Note 3: The materials used for gaskets, packing,
seals, screws or washers, or other materials performing a sealing
function, do not determine the control status of the items in this
ECCN, provided that such components are designed to be
interchangeable.

    Note:  See Categories V and XIV of the United States Munitions
List for all chemicals that are ``subject to the ITAR'' (see 22 CFR
parts 120 through 130).

0
12. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 2, ECCN 2B351 is revised to read as follows:

2B351 Toxic gas monitors and monitoring systems, and their dedicated
detecting ``parts'' and ``components'' (i.e., detectors, sensor
devices, and replaceable sensor cartridges), as follows, except
those systems and detectors controlled by ECCN 1A004.c (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 ECCN 2D351 for ``software'' for toxic gas
monitors and monitoring systems, and their dedicated detecting
``parts'' and ``components,'' controlled by this ECCN. Also see ECCN
1A004, which controls chemical detection systems and ``specially
designed'' ``parts'' and ``components'' therefor that are
``specially designed'' or modified for detection or identification
of chemical warfare agents, but not ``specially designed'' for
military use, and ECCN 1A995, which controls certain detection
equipment, ``parts'' and ``components'' not controlled by ECCN 1A004
or by this ECCN.
Related Definitions: (1) For the purposes of this entry, the term
``dedicated'' means committed entirely to a single purpose or
device. (2) For the purposes of this entry, the term ``continuous
operation'' describes the capability of the equipment to operate on
line without human intervention. The intent of this entry is to
control toxic gas monitors and monitoring systems capable of
collection and detection of samples in environments such as chemical
plants, rather than those used for batch-mode operation in
laboratories.
Items:
    a. Designed for continuous operation and usable for the
detection of chemical warfare agents or precursor chemicals
controlled by 1C350 at concentrations of less than 0.3 mg/m\3\; or
    b. Designed for the detection of cholinesterase-inhibiting
activity.

0
13. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 2--Materials Processing, ECCN 2B352 is revised to read as
follows:

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: P3 or P4 (BL3, BL4, L3, L4) containment levels
are as specified in the WHO Laboratory Biosafety Manual (3rd
edition, Geneva, 2004).

    a.2. Equipment designed for fixed installation in containment
facilities specified in paragraph a.1 of this ECCN, as follows:
    a.2.a. Double-door pass-through decontamination autoclaves;
    a.2.b. Breathing air suit decontamination showers;
    a.2.c. Mechanical-seal or inflatable-seal walkthrough doors.
    b. Fermenters and components as follows:
    b.1. Fermenters capable of cultivation of micro-organisms or of
live cells for the production of viruses or toxins, without the
propagation of aerosols, having a total internal volume of 20 liters
or greater.
    b.2. Components designed for such fermenters, as follows:
    b.2.a. Cultivation chambers designed to be sterilized or
disinfected in situ;
    b.2.b. Cultivation chamber holding devices; or
    b.2.c. Process control units capable of simultaneously
monitoring and controlling two or more fermentation system
parameters (e.g., temperature, pH, nutrients, agitation, dissolved
oxygen, air flow, foam control).

    Technical Note: Fermenters include bioreactors (including
single-use (disposable) bioreactors), chemostats and continuous-flow
systems.

    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: 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 dependant upon a
tethered external air supply and operating under positive pressure.

    Technical Note: This entry 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: 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.

0
14. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 2, ECCN 2D351 is revised to read as follows:

2D351 Dedicated ``software'' for toxic gas monitors and monitoring
systems, and their dedicated detecting ``parts'' and ``components,''
controlled by ECCN 2B351.

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)

CIV: N/A
TSR: N/A

List of Items Controlled

Related Controls: N/A
Related Definitions: (1) For the purposes of this entry, the term
``dedicated'' means committed entirely to a single purpose or
device. (2) See Section 772.1 of the EAR for the definitions of
``software,'' ``program,'' and ``microprogram.''
Items: The list of items controlled is contained in the ECCN
heading.

    Dated: March 27, 2018.
Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2018-06581 Filed 3-30-18; 8:45 am]
 BILLING CODE 3510-33-P