[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Rules and Regulations]
[Pages 13849-13862]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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].

[[Page 13850]]


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.

[[Page 13851]]



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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.
----------------------------------------------------------------------------------------------------------------

    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

[[Page 13852]]

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).

[[Page 13853]]

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

[[Page 13854]]

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 (202) 395-7285; and 
to the Regulatory Policy Division, Bureau of Industry and Security, 
Department of Commerce, 14th Street & Pennsylvania Avenue NW, Room 
2705, Washington, DC 20230 or by email to [email protected].
    3. This rule does not contain policies with Federalism implications 
as that term is defined in Executive Order 13132.
    4. 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.


[[Page 13855]]

* * * * *

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

[[Page 13856]]

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;

[[Page 13857]]

    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;

[[Page 13858]]

    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

[[Page 13859]]

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,

[[Page 13860]]

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

[[Page 13861]]



 
                                            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

[[Page 13862]]

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


