Implementation of the February 2017 Australia Group (AG) Intersessional Decisions and the June 2017 AG Plenary Understandings; Addition of India to the AG, 13849-13862 [2018-06581]
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Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations
(7) Consumer acknowledgment. You
must obtain from the consumer, at the
time a consumer receives the
disclosures required under paragraph (a)
or (b) of this section, or at the time of
the initial purchase by the consumer of
an insurance product or annuity, a
written acknowledgment by the
consumer that the consumer received
the disclosures. You may permit a
consumer to acknowledge receipt of the
disclosures electronically or in paper
form. If the disclosures required under
paragraph (a) or (b) of this section are
provided in connection with a
transaction that is conducted by
telephone, you must:
(i) Obtain an oral acknowledgment of
receipt of the disclosures and maintain
sufficient documentation to show that
the acknowledgment was given; and
(ii) Make reasonable efforts to obtain
a written acknowledgment from the
consumer.
(d) Advertisements and other
promotional material for insurance
products or annuities. The disclosures
described in paragraph (a) of this
section are required in advertisements
and promotional material for insurance
products or annuities unless the
advertisements and promotional
materials are of a general nature
describing or listing the services or
products offered by the institution.
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(a) General rule. An institution must,
to the extent practicable, keep the area
where the institution conducts
transactions involving insurance
products or annuities physically
segregated from areas where retail
deposits are routinely accepted from the
general public, identify the areas where
insurance product or annuity sales
activities occur, and clearly delineate
and distinguish those areas from the
areas where the institution’s retail
deposit-taking activities occur.
(b) Referrals. Any person who accepts
deposits from the public in an area
where such transactions are routinely
conducted in the institution may refer a
consumer who seeks to purchase an
insurance product or annuity to a
qualified person who sells that product
only if the person making the referral
receives no more than a one-time,
nominal fee of a fixed dollar amount for
each referral that does not depend on
whether the referral results in a
transaction.
An institution may not permit any
person to sell or offer for sale any
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Appendix A to Part 343—Consumer
Grievance Process
Any consumer who believes that any
institution or any other person selling,
soliciting, advertising, or offering
insurance products or annuities to the
consumer at an office of the institution
or on behalf of the institution has
violated the requirements of this part
should contact the Division of Depositor
and Consumer Protection, Consumer
Response Center, Federal Deposit
Insurance Corporation, at the following
address: 1100 Walnut Street, Box #11,
Kansas City, MO 64106, or telephone 1–
877–275–3342, or FDIC Electronic
Customer Assistance Form at https://
www5.fdic.gov/starsmail/index.asp.
PART 390—REGULATIONS
TRANSFERRED FROM THE OFFICE OF
THRIFT SUPERVISION
2. The authority citation for part 390
is revised to read as follows:
■
Authority: 12 U.S.C. 1831y.
Subpart I—[Removed and Reserved]
§ 343.50 Where insurance activities may
take place.
§ 343.60 Qualification and licensing
requirements for insurance sales
personnel.
insurance product or annuity in any
part of its office or on its behalf, unless
the person is at all times appropriately
qualified and licensed under applicable
State insurance licensing standards with
regard to the specific products being
sold or recommended.
3. Remove and reserve subpart I,
consisting of §§ 390.180 through
390.185, and appendix A.
■
Dated at Washington, DC, on March 20,
2018.
By order of the Board of Directors.
Federal Deposit Insurance Corporation.
Valerie J. Best,
Assistant Executive Secretary.
[FR Doc. 2018–06163 Filed 3–30–18; 8:45 am]
BILLING CODE 6714–01–P
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
Bureau of Industry and
Security, Commerce.
ACTION: Final rule.
AGENCY:
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13849
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-Diisopropylaminoethanethiol
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: Richard.Duncan@
bis.doc.gov.
SUMMARY:
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Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations
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.
SUPPLEMENTARY INFORMATION:
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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
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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/m3; 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
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‘‘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 dualuse 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-Diisopropylaminoethanethiol
hydrochloride. This rule also
alphabetically reorders the precursor
chemicals listed in ECCN 1C350.b, .c,
and .d to facilitate the identification of
these chemicals. The precursor
chemicals affected by these
amendments to ECCN 1C350 are
indicated in the following table.
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Previous CCL
designation
AG-Controlled precursor chemicals
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(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
(C.A.S.
#683–08–9) Diethyl methylphosphonate ...................................................................................
#15715–41–0) Diethyl methylphosphonite .................................................................................
#2404–03–7) Diethyl-N,N-dimethylphosphoroamidate ..............................................................
#41480–75–5) N,N-Diisopropylaminoethanethiol hydrochloride ................................................
#5842–07–9) N,N-Diisopropyl-beta-aminoethane thiol ..............................................................
#96–80–0) N,N-Diisopropyl-beta-aminoethanol .........................................................................
#96–79–7), N,N-Diisopropyl-beta-aminoethyl chloride ..............................................................
#4261–68–1) N,N-Diisopropyl-beta-aminoethyl chloride hydrochloride ....................................
#6163–75–3) Dimethyl ethylphosphonate .................................................................................
#756–79–6) Dimethyl methylphosphonate ................................................................................
#677–43–0) N,N-Dimethylamino-phosphoryl dichloride ............................................................
#1498–40–4) Ethyl phosphonous dichloride [Ethyl phosphinyl dichloride] ...............................
#430–78–4) Ethyl phosphonus difluoride [Ethyl phosphinyl difluoride] .....................................
#1066–50–8) Ethyl phosphonyl dichloride .................................................................................
#993–13–5) Methylphosphonic acid ..........................................................................................
#676–98–2) Methylphos-phonothioic dichloride ........................................................................
#464–07–3) Pinacolyl alcohol ....................................................................................................
#1619–34–7) 3-Quinuclidinol .....................................................................................................
#111–48–8) Thiodiglycol ............................................................................................................
#139–87–7) Ethyldiethanolamine ...............................................................................................
#10025–87–3) Phosphorus oxychloride ....................................................................................
#10026–13–8) Phosphorus pentachloride .................................................................................
#7719–12–2) Phosphorus trichloride .........................................................................................
#10025–67–9) Sulfur monochloride ...........................................................................................
#7719–09–7) Thionyl chloride ....................................................................................................
#102–71–6) Triethanolamine .....................................................................................................
#122–52–1) Triethyl phosphite ..................................................................................................
#121–45–9) Trimethyl phosphite ...............................................................................................
#109–89–7) Diethylamine ..........................................................................................................
#100–37–8) N,N-Diethylaminoethanol .......................................................................................
#298–06–6) O,O-Diethyl phosphorodithioate ............................................................................
#2465–65–8) O,O-Diethyl phosphorothioate .............................................................................
#108–18–9) Di-isopropylamine ..................................................................................................
#124–40–3) Dimethylamine .......................................................................................................
#506–59–2) Dimethylamine hydrochloride ................................................................................
#7664–39–3) Hydrogen fluoride ................................................................................................
#3554–74–3) 3-Hydroxyl-1-methylpiperidine .............................................................................
#76–89–1) Methyl benzilate .......................................................................................................
#1314–80–3) Phosphorus pentasulfide .....................................................................................
#75–97–8) Pinacolone ...............................................................................................................
#7789–29–9) Potassium bifluoride ............................................................................................
#151–50–8) Potassium cyanide .................................................................................................
#7789–23–3) Potassium fluoride ...............................................................................................
#3731–38–2) 3-Quinuclidone .....................................................................................................
#1333–83–1) Sodium bifluoride .................................................................................................
#143–33–9) Sodium cyanide .....................................................................................................
#7681–49–4) Sodium fluoride ....................................................................................................
#16893–85–9) Sodium hexafluorosilicate ..................................................................................
#1313–82–2) Sodium sulfide .....................................................................................................
#637–39–8) Triethanolamine hydrochloride ..............................................................................
#116–17–6) Tri-isopropyl 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.
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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,
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ECCN 1C350.b.22
ECCN 1C350.b.4
ECCN 1C350.b.5
None—EAR 99
ECCN 1C350.b.6
ECCN 1C350.b.8
ECCN 1C350.b.9
ECCN 1C350.b.7
ECCN 1C350.b.10
ECCN 1C350.b.11
ECCN 1C350.b.23
ECCN 1C350.b.12
ECCN 1C350.b.13
ECCN 1C350.b.14
ECCN 1C350.b.21
ECCN 1C350.b.24
ECCN 1C350.b.18
ECCN 1C350.b.19
ECCN 1C350.b.20
ECCN 1C350.c.12
ECCN 1C350.c.3
ECCN 1C350.c.4
ECCN 1C350.c.5
ECCN 1C350.c.6
ECCN 1C350.c.8
ECCN 1C350.c.9
ECCN 1C350.c.10
ECCN 1C350.c.11
ECCN 1C350.d.25
ECCN 1C350.d.3
ECCN 1C350.d.23
ECCN 1C350.d.22
ECCN 1C350.d.4
ECCN 1C350.d.5
ECCN 1C350.d.6
ECCN 1C350.d.7
ECCN 1C350.d.8
ECCN 1C350.d.9
ECCN 1C350.d.10
ECCN 1C350.d.11
ECCN 1C350.d.14
ECCN 1C350.d.12
ECCN 1C350.d.13
ECCN 1C350.d.15
ECCN 1C350.d.16
ECCN 1C350.d.17
ECCN 1C350.d.18
ECCN 1C350.d.24
ECCN 1C350.d.19
ECCN 1C350.d.20
ECCN 1C350.d.21
Current CCL
designation
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
ECCN
1C350.b.4
1C350.b.5
1C350.b.6
1C350.b.7
1C350.b.8
1C350.b.9
1C350.b.10
1C350.b.11
1C350.b.12
1C350.b.13
1C350.b.14
1C350.b.15
1C350.b.16
1C350.b.17
1C350.b.18
1C350.b.19
1C350.b.20
1C350.b.21
1C350.b.22
1C350.c.3
1C350.c.4
1C350.c.5
1C350.c.6
1C350.c.8
1C350.c.9
1C350.c.10
1C350.c.11
1C350.c.12
1C350.d.3
1C350.d.4
1C350.d.5
1C350.d.6
1C350.d.7
1C350.d.8
1C350.d.9
1C350.d.10
1C350.d.11
1C350.d.12
1C350.d.13
1C350.d.14
1C350.d.15
1C350.d.16
1C350.d.17
1C350.d.18
1C350.d.19
1C350.d.20
1C350.d.21
1C350.d.22
1C350.d.23
1C350.d.24
1C350.d.25
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
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Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Rules and Regulations
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.
items subject to control under this
ECCN or the license requirements
applicable to these items.
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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.
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.
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
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
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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 (incountry) 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).
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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.
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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
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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
PO 00000
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13853
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 × 29.6 minutes per
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response) for an estimated cost increase
of $222 (i.e., 7 hours and 24 minutes ×
$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 Jasmeet_K._
Seehra@omb.eop.gov or by fax to (202)
395–7285; and to the Regulatory Policy
Division, Bureau of Industry and
Security, Department of Commerce,
14th Street & Pennsylvania Avenue NW,
Room 2705, Washington, DC 20230 or
by email to RPD2@bis.doc.gov.
3. This rule does not contain policies
with Federalism implications as that
term is defined in Executive Order
13132.
4. 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]
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).
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
weapons
Nuclear
nonproliferation
National security
Missile
tech
Regional stability
Firearms
convention
Crime control
Anti-terrorism
Countries
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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
X
............
*
............
X
*
............
X
*
X
X
*
X
............
*
..................
............
*
............
............
............
............
*
India 7 .........................................
*
*
*
*
*
*
*
7 See
§ 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.
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*
*
*
*
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).
*
PART 740—[AMENDED]
3. The authority citation for part 740
continues to read as follows:
■
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]
Country
[A:1]
Wassenaar
participating
states 1
[A:2]
Missile
technology
control
regime
*
*
India ..........................................................
*
........................
X
*
1 Country
2 Country
*
*
*
*
X
*
........................
*
[A:5]
*
........................
*
[A:6]
*
X
*
Group A:1 is a list of the Wassenaar Arrangement Participating States, except for Malta, Russia and Ukraine.
Group A:4 is a list of the Nuclear Suppliers Group countries, except for the People’s Republic of China (PRC).
*
*
*
8. In Supplement No. 1 to Part 774
(the Commerce Control List), Category 1,
ECCN 1C350 is revised to read as
follows:
■
PART 745—[AMENDED]
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).
§ 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]
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).
16:23 Mar 30, 2018
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1C350 Chemicals that may be used as
precursors for toxic chemical agents (see
List of Items Controlled).
Control(s)
*
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Supplement No. 1 to Part 774—The
Commerce Control List
License Requirements
Reason for Control: CB, CW, AT
6. In § 745.1, the first sentence in
paragraph (a) is revised to read as
follows:
■
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*
*
[A:4]
Nuclear
suppliers
group 2
[A:3]
Australia
group
CB applies to entire
entry.
Country chart (See
Supp. No. 1 to part
738)
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 § 742.18 of the
EAR for license requirements and policies for
toxic and precursor chemicals controlled for
CW reasons. See § 745.2 of the EAR for EndUse 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
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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 EndUse 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 § 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
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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
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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 § 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,Ndimethylphosphoroamidate;
b.7. (C.A.S. #41480–75–5) N,NDiisopropylaminoethanethiol hydrochloride;
b.8. (C.A.S. #5842–07–9) N,N-Diisopropylbeta-aminoethane thiol;
b.9. (C.A.S. #96–80–0) N,N-Diisopropylbeta-aminoethanol;
b.10. (C.A.S. #96–79–7), N,N-Diisopropylbeta-aminoethyl chloride;
b.11. (C.A.S. #4261–68–1) N,NDiisopropyl-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,NDimethylamino-phosphoryl dichloride;
b.15. (C.A.S. #1498–40–4) Ethyl
phosphonous dichloride [Ethyl phosphinyl
dichloride];
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b.16. (C.A.S. #430–78–4) Ethyl phosphonus
difluoride [Ethyl phosphinyl difluoride];
b.17. (C.A.S. #1066–50–8) Ethyl
phosphonyl dichloride;
b.18. (C.A.S. #993–13–5)
Methylphosphonic acid;
b.19. (C.A.S. #676–98–2) Methylphosphonothioic dichloride;
b.20. (C.A.S. #464–07–3) Pinacolyl alcohol;
b.21. (C.A.S. #1619–34–7) 3-Quinuclidinol;
b.22. (C.A.S. #111–48–8) Thiodiglycol.
c. Australia Group-controlled precursor
chemicals also identified as Schedule 3
chemicals under the CWC, as follows, and
mixtures in which at least one of the
following chemicals constitutes 30 percent or
more of the weight of the mixture:
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,NDiethylaminoethanol;
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-1methylpiperidine;
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;
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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.
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
Control(s)
CB applies to entire
entry.
Country chart (See
Supp. No. 1 to part
738)
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 § 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.
Control(s)
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AT applies to entire
entry.
Country chart (See
Supp. No. 1 to part
738)
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.
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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 (§ 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
§ 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 § 758.1(b)(4) of the EAR. (2)
Paragraph (c)(2) of License Exception STA
(§ 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 § 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 § 745.1 of the EAR for
notification procedures. See 22 CFR part 121,
Category XIV and § 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.’’
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13857
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;
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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 syndromerelated 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,
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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.
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
(See Supp.
No. 1 to part
738)
Control(s)
CB applies to entire entry .....
AT applies to entire entry .....
CB Column 1
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.
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Sfmt 4700
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
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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.
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. 1 to part
738)
Control(s)
CB applies to entire
entry.
AT applies to entire
entry.
CB Column 2
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.
daltland on DSKBBV9HB2PROD with RULES
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 m3 (100
liters) and less than 20 m3 (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:
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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 m3 (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.
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d. Heat exchangers or condensers with a
heat transfer surface area of less than 20 m2,
but greater than 0.15 m2, 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,
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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 m3/hour (600 liters/hour), or
vacuum pumps with manufacturer’s
specified maximum flow-rate greater than 5
m3/hour (5,000 liters/hour) (under standard
temperature (273 K (0 °C)) and pressure
(101.3 kPa) conditions), and casings (pump
bodies), preformed casing liners, impellers,
rotors or jet pump nozzles designed for such
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16:23 Mar 30, 2018
Jkt 244001
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 °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).
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.,
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Sfmt 4700
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. 1 to part
738)
Control(s)
CB applies to entire
entry.
AT applies to entire
entry.
CB Column 2
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/
m3; or
b. Designed for the detection of
cholinesterase-inhibiting activity.
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
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Country Chart (See
Supp. No. 1 to part
738)
Control(s)
CB applies to entire
entry.
AT applies to entire
entry.
CB Column 2
AT Column 1
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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
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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 m2); 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 m2) 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 freezedrying 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
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13861
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
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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.
14. In Supplement No. 1 to Part 774
(the Commerce Control List), Category 2,
ECCN 2D351 is revised to read as
follows:
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
License Requirements
CB applies to entire
entry.
AT applies to entire
entry.
20 CFR Part 404
[Docket No. SSA–2018–0007]
RIN 0960–AI18
Extension of Expiration Dates for Two
Body System Listings
ACTION:
Country Chart (See
Supp. No. 1 to part
738)
Control(s)
SOCIAL SECURITY ADMINISTRATION
Social Security Administration.
Final rule.
AGENCY:
Reason for Control: CB, AT
CB Column 2
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
Cheryl A. Williams, Director, Office of
Medical Policy, 6401 Security
Boulevard, Baltimore, MD 21235–6401,
(410) 965–1020. For information on
eligibility or filing for benefits, call our
national toll-free number, 1–800–772–
1213, or TTY 1–800–325–0778, or visit
our internet site, Social Security Online,
at https://www.socialsecurity.gov.
SUPPLEMENTARY INFORMATION:
Background
■
2D351 Dedicated ‘‘software’’ for toxic gas
monitors and monitoring systems, and
their dedicated detecting ‘‘parts’’ and
‘‘components,’’ controlled by ECCN
2B351.
FOR FURTHER INFORMATION CONTACT:
We are extending the
expiration dates of the following body
systems in the Listing of Impairments
(listings) in our regulations: Special
Senses and Speech and Congenital
Disorders That Affect Multiple Body
Systems. We are making no other
revisions to these body systems in this
final rule. This extension ensures that
we will continue to have the criteria we
need to evaluate impairments in the
affected body systems at step three of
the sequential evaluation processes for
initial claims and continuing disability
reviews.
DATES: This final rule is effective on
April 2, 2018.
SUMMARY:
We use the listings in appendix 1 to
subpart P of part 404 of 20 CFR at the
third step of the sequential evaluation
process to evaluate claims filed by
adults and children for benefits based
on disability under the title II and title
XVI programs.1 20 CFR 404.1520(d),
416.920(d), 416.924(d). The listings are
in two parts: Part A has listings criteria
for adults and Part B has listings criteria
for children. If you are age 18 or over,
we apply the listings criteria in Part A
when we assess your impairment or
combination of impairments. If you are
under age 18, we first use the criteria in
Part B of the listings when we assess
your impairment(s). If the criteria in
Part B do not apply, we may use the
criteria in Part A when those criteria
consider the effects of your
impairment(s). 20 CFR 404.1525(b),
416.925(b).
Explanation of Changes
In this final rule, we are extending the
dates on which the listings for the
following two body systems will no
longer be effective as set out in the
following chart:
Listing
Current expiration date
Extended expiration date
Special Senses and Speech (2.00 and 102.00) .....................................
Congenital Disorders That Affect Multiple Body Systems (10.00 and
110.00).
April 29, 2018 ................................
April 5, 2018 ..................................
April 24, 2020.
April 3, 2020.
daltland on DSKBBV9HB2PROD with RULES
We continue to revise and update the
listings on a regular basis, including
those body systems not affected by this
final rule.2 We intend to update the two
listings affected by this final rule as
quickly as possible, but may not be able
to publish final rules revising these
listings by the current expiration dates.
Therefore, we are extending the
expiration dates listed above.
Regulatory Procedures
We follow the Administrative
Procedure Act (APA) rulemaking
procedures specified in 5 U.S.C. 553 in
promulgating regulations. Section
702(a)(5) of the Social Security Act, 42
U.S.C. 902(a)(5). Generally, the APA
requires that an agency provide prior
notice and opportunity for public
comment before issuing a final
regulation. The APA provides
exceptions to the notice-and-comment
requirements when an agency finds
there is good cause for dispensing with
such procedures because they are
impracticable, unnecessary, or contrary
to the public interest.
We have determined that good cause
exists for dispensing with the notice and
public comment procedures. 5 U.S.C.
553(b)(B). This final rule only extends
the date on which two body system
listings will no longer be effective. It
makes no substantive changes to our
rules. Our current regulations 3 provide
that we may extend, revise, or
1 We also use the listings in the sequential
evaluation processes we use to determine whether
a beneficiary’s disability continues. See 20 CFR
404.1594, 416.994, and 416.994a.
2 Since we last extended the expiration dates of
the listings affected by this rule in August 2016 (81
FR 51100), we have published final rules revising
the medical criteria for evaluating mental disorders
(81 FR 66137 (2016)) and human immunodeficiency
virus (HIV infection (81 FR 86915 (2016)).
3 See the first sentence of appendix 1 to subpart
P of part 404 of 20 CFR.
VerDate Sep<11>2014
16:23 Mar 30, 2018
Jkt 244001
Justification for Final Rule
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
E:\FR\FM\02APR1.SGM
02APR1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]]
----------------------------------------------------------------------------------------------------------------
AG-Controlled precursor chemicals Previous CCL designation Current CCL designation
----------------------------------------------------------------------------------------------------------------
(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 form
