[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Rules and Regulations]
[Pages 16664-16668]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06406]
[[Page 16664]]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 710, 738, 740, 745, 772 and 774
[Docket No. 131211999-3999-01]
RIN 0694-AG04
Implementation of the Understandings Reached at the June 2013
Australia Group (AG) Plenary Meeting and the December 2012 AG
Intersessional Decisions
AGENCY: Bureau of Industry and Security, Commerce.
ACTION: Final rule.
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SUMMARY: The Bureau of Industry and Security (BIS) publishes this final
rule to amend the Export Administration Regulations (EAR) to implement
the understandings reached at the June 2013 plenary meeting of the
Australia Group (AG) and the December 2012 AG intersessional decisions.
Specifically, this rule amends the Commerce Control List (CCL) entry in
the EAR that controls equipment capable of handling biological
materials to reflect the 2013 AG Plenary understanding that clarifies
controls on fermenters, and certain components thereof, in the AG
``Control List of Dual-Use Biological Equipment and Related Technology
and Software.'' This rule also amends the CCL entry that controls
certain animal pathogens to reflect a recommendation made at the 2013
AG Plenary meeting, which was later adopted pursuant to the AG silent
approval procedure, to revise the AG ``List of Animal Pathogens for
Export Control'' to clarify the controls on the Lyssavirus genus. In
addition, this rule amends the EAR to reflect the addition of Mexico as
a participating country in the AG following the 2013 AG Plenary
meeting.
The recommendations agreed to through the silent approval procedure
included changes to the controls on Clostridium perfringens in the AG
``List of Biological Agents for Export Control'' and changes to the
description of ``genetic elements,'' which are included in three of the
AG common control lists. This rule also amends the CCL entry that
controls chemical manufacturing facilities and equipment to reflect the
AG intersessional decision to clarify the controls that apply to
certain agitators for use in reaction vessels or reactors described in
the CCL entry and to impellers, blades or shafts designed for such
agitators.
This rule also adds a License Exception STA paragraph to the CCL
entry that controls human and zoonotic pathogens and toxins to clarify
the scope of eligible items. Finally, this rule amends the EAR to
reflect the addition of Somalia and Syria as States Parties to the
Chemical Weapons Convention (CWC).
DATES: This rule is effective March 26, 2014. Comments on the
information collection may be submitted at any time.
ADDRESSES: Send comments regarding this collection of information,
including suggestions for reducing the burden, to Jasmeet Seehra,
Office of Management and Budget (OMB), 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.
FOR FURTHER INFORMATION CONTACT: Elizabeth Sangine, Director, Chemical
and Biological Controls Division, Office of Nonproliferation and Treaty
Compliance, Bureau of Industry and Security, Telephone: (202) 482-3343.
SUPPLEMENTARY INFORMATION:
Background
The Bureau of Industry and Security (BIS) is amending the Export
Administration Regulations (EAR) to implement the understandings
reached at the Australia Group (AG) plenary meeting held in Paris,
France, on June 3-7, 2013. This rule also implements the
recommendations presented at the AG intersessional implementation
meeting held in Bonn, Germany, on December 6-7, 2012, and adopted
pursuant to the AG silent approval procedure, which closed on March 11,
2013. The AG is a multilateral forum consisting of 41 participating
countries 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.
June 2013 AG Plenary Changes
The June 2013 AG plenary meeting adopted understandings that
affected the AG ``Control List of Dual-Use Biological Equipment and
Related Technology and Software.'' This rule amends Export Control
Classification Number (ECCN) 2B352 to reflect the AG plenary changes to
this AG common control list. Specifically, ECCN 2B352 (Equipment
capable of use in handling biological materials) is amended by revising
2B352.b to indicate that this ECCN controls fermenters with a capacity
of 20 liters or greater that are capable of the cultivation of
pathogenic micro-organisms, or of live cells, for the production of
pathogenic viruses or toxins without the propagation of aerosols. These
fermenters are described in new subparagraph b.1 of ECCN 2B352.b.
This rule also amends ECCN 2B352.b to indicate that this ECCN
controls the following components designed for the fermenters described
above: Cultivation chambers designed to be sterilized or disinfected in
situ; cultivation chamber holding devices; and 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). These components
are described in new subparagraph b.2 of ECCN 2B352.b. In addition,
this rule amends the Technical Note to ECCN 2B352.b to clarify that the
``fermenters'' controlled under this ECCN include all types of
bioreactors, including ``single-use (disposable) bioreactors,'' as well
as chemostats and continuous-flow systems.
There was also a recommendation made at the 2013 AG Plenary meeting
to revise the AG ``List of Animal Pathogens for Export Control'' to
clarify the controls on Lyssavirus (a.k.a. Rabies). This recommendation
was adopted pursuant to the AG silent approval procedure, which closed
on July 14, 2013. Consistent with this AG change, this rule amends ECCN
1C352a.8 to clarify that it controls the Rabies virus and all other
members of the Lyssavirus genus.
December 2012 AG Intersessional Changes
This rule also implements the recommendations presented at the AG
intersessional implementation meeting held in December 2012 and adopted
pursuant to the AG silent approval procedure in March 2013. These
recommendations included changes to the AG ``List of Biological Agents
for Export Control'' and to the description of ``genetic elements,'' as
the term is used in this AG list, as well as in the AG ``List of Animal
Pathogens for Export Control'' and the AG ``List of Plant Pathogens for
Export Control.''
This rule amends ECCN 1C351 (Human and zoonotic pathogens and
toxins) to reflect the AG intersessional changes to the AG ``List of
Biological Agents for Export Control.'' Specifically, ECCN 1C351.d.5 is
revised to clarify
[[Page 16665]]
that the export controls on Clostridium perfringens apply only to the
following exotoxins: Clostridium perfringens alpha, beta 1, beta 2,
epsilon and iota toxins. Prior to this change, ECCN 1C351.d.5 referred
to Clostridium perfringens toxins, generally.
In addition, this rule amends ECCN 1C353 to reflect the AG
intersessional changes to the description of ``genetic elements'' in
the AG common control lists for biological agents, animal pathogens,
and plant pathogens. Specifically, this rule revises the Technical Note
1 to ECCN 1C353 to clarify that ``genetic elements'' include, inter
alia, not only chromosomes, genomes, plasmids, transposons, and
vectors, whether genetically modified or unmodified, but also those
chromosomes, genomes, plasmids, transposons, and vectors that have been
``chemically synthesized in whole or in part.''
This rule also amends the introductory text of ECCN 2B350.b, which
controls agitators for use in reaction vessels or reactors described in
2B350.a and impellers, blades or shafts designed for such agitators.
Specifically, the introductory text of ECCN 2B350.b is revised to read
as follows: ``Agitators designed for use in reaction vessels or
reactors described in 2B350.a, 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.'' This change is intended to clarify that ECCN
2B350.b controls only agitators (and impellers, blades or shafts for
such agitators) where: (1) The agitators are for use in reaction
vessels or reactors described in 2B350.a; and (2) all surfaces of the
agitators (and of the impellers, blades or shafts for such agitators)
that come in direct contact with the chemical(s) being processed or
contained are made from any of the materials identified in ECCN
2B350.b.1 through .b.8.
Change in Frequency of ``Sample Shipment'' Reports Required Under ECCN
1C350
This rule amends the ``sample shipments'' provisions in License
Requirement Note 1 of ECCN 1C350 to change the reporting requirement
from quarterly to annual, consistent with the frequency of the reports
required for imports and exports of CWC Schedule 2 and 3 chemicals
under Sections 713.3 and 714.2, respectively, of the Chemical Weapons
Convention Regulations (CWCR) (15 CFR parts 710-721). Consistent with
the CWCR timetable, annual reports of ``sample shipments'' under ECCN
1C350 must be submitted to BIS no later than February 28 of the year
following the calendar year in which the ``sample shipments'' were
made.
Addition of Mexico as a Participating Country in the AG
This final rule amends the EAR to reflect the addition, on August
12, 2013, of Mexico as a participating country in the Australia Group
(AG). Specifically, this rule amends Supplement No. 1 to part 738 of
the EAR (Commerce Country Chart) by revising the entry for Mexico to
remove the license requirements indicated under CB Column 2. This rule
also amends Supplement No. 1 to part 740 of the EAR (Country Groups) by
adding Mexico to Country Group A:3 (Australia Group). In addition, this
rule revises the definition of ``Australia Group'' in Section 772.1 of
the EAR (Definitions of Terms used in the EAR) by adding Mexico.
Addition of Somalia and Syria as States Parties to the Chemical Weapons
Convention (CWC)
This rule also amends the EAR to reflect the addition of Somalia
and Syria as States Parties to the CWC on June 28, 2013, and October
14, 2013, respectively. Specifically, this rule amends Supplement No. 2
to part 745 of the EAR (States Parties to the CWC) to add Somalia and
Syria in alphabetical order. Because Somalia is not an AG participating
country, its addition to the list of CWC States Parties in Supplement
No. 2 to part 745 does not affect the CB Column 1 and CB Column 2
license requirements for Somalia that are indicated in Supplement No. 1
to part 738 of the EAR (Commerce Country Chart). However, a license is
no longer required for CB or CW (chemical weapons) reasons for exports
to Somalia of mixtures and test kits controlled under ECCN 1C395.a and
.b, respectively, although a license would be required if any of the
end-user or end-use requirements in part 744 of the EAR apply. The
addition of Syria to the list of CWC States Parties in Supplement No. 2
to part 745 does not affect any CB or CW license requirements for
exports to Syria, because Section 746.9(a) of the EAR requires a
license for exports and reexports to Syria of all items subject to the
EAR (including, but not limited to, all items identified on the CCL),
except for food and medicine classified as EAR99.
In order to maintain consistency between the EAR and the Chemical
Weapons Convention Regulations (CWCR) (15 CFR parts 710-721), with
respect to those countries that are identified as States Parties to the
CWC, this rule also amends Supplement No. 1 to part 710 of the CWCR
(States Parties to the CWC) to add the following countries in
alphabetical order: Bahamas, Barbados, Congo (Democratic Republic of
the), Dominican Republic, Iraq, Somalia, and Syria.
License Exception STA Paragraph Added to ECCN 1C351
In addition to the changes related to the AG or the CWC described
above, this final rule also adds a License Exception STA paragraph to
the license exceptions section of ECCN 1C351 in order to clarify the
existing eligibility requirements for certain items controlled under
this ECCN. Specifically, the new License Exception STA paragraph in
ECCN 1C351 indicates that paragraph (c)(1) of License Exception STA
(see Section 740.20(c)(1) of the EAR) may be used for items in
1C351.d.1 through 1C351.d.10 and 1C351.d.13 through 1C351.d.19.
Exporters are referred to Section 740.20(b)(2)(vi) of the EAR for
restrictions on the quantity of any one toxin that may be exported in a
single STA shipment and the number of STA shipments that may be made to
any one end user in a single calendar year. This STA paragraph also
reminds exporters about the Automated Export System (AES) requirements
in Section 758.1(b)(4) of the EAR, which apply to all STA shipments.
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 biological agents and toxins, chemical
manufacturing facilities/equipment, and equipment capable of use in
handling biological materials. Specifically, the amendments to the List
of Items Controlled in ECCNs 1C351 (human and zoonotic pathogens) and
2B352 (biological equipment) and to Technical Note 1 to ECCN 1C353
(genetic elements) do not affect the scope of the controls in these
ECCNs to a degree that would significantly impact the number of license
applications that would have to be submitted for the affected items
controlled therein.
As indicated above, the addition of Somalia and Syria to the list
of CWC States Parties in Supplement No. 2 to part 745 of the EAR is
expected to have very little impact on the number of license
applications that will have to be submitted for these destinations.
Similarly, the addition of a License Exception STA paragraph to ECCN
1C351 and the clarifications to the
[[Page 16666]]
controls on agitators in ECCN 2B350.b do not alter the scope of the
controls that apply to any of the affected items in these ECCNs.
However, the amendments to the EAR to reflect the addition of
Mexico as a participating member of the AG are expected to result in a
modest reduction in the number of license applications that will have
to be submitted for exports of precursor chemicals (ECCN 1C350) and
chemical/biological production and processing equipment (ECCNs 2B350,
2B351, and 2B352). These items generally will no longer require a
license to Mexico because, in response to the addition of Mexico as a
participating member of the AG, this rule removes the license
requirements indicated for Mexico under CB Column 2 of the Commerce
Country Chart.
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 8, 2013, 78 FR 49107 (August 12, 2013), has continued the Export
Administration Regulations in effect under the International Emergency
Economic Powers Act. 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.
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.
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 (Multi-Purpose Application), which carries a burden hour
estimate of 58 minutes to prepare and submit form BIS-748. 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 (OMB), and
to the Regulatory Policy Division, Bureau of Industry and Security,
Department of Commerce, as indicated in the ADDRESSES section of this
rule.
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 41 member countries that act
on a consensus basis and the amendments set forth in this rule
implement the understandings reached at the June 2013 AG plenary
meeting, the December 2012 AG intersessional changes, and other changes
that are necessary to ensure consistency with the controls maintained
by the AG. Since 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. 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 and coordinated manner.
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. Therefore, this regulation is issued in final form.
List of Subjects
15 CFR Part 710
Chemicals, Exports, Foreign trade, Imports, Treaties.
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 772
Exports.
15 CFR Part 774
Exports, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, part 710 of the Chemical
Weapons Convention Regulations (15 CFR parts 710-721) and parts 738,
740, 745, 772 and 774 of the Export Administration Regulations (15 CFR
parts 730-774) are amended as follows:
PART 710--[AMENDED]
0
1. The authority citation for 15 CFR Part 710 continues to read as
follows:
Authority: 22 U.S.C. 6701 et seq.; E.O. 13128, 64 FR 36703, 3
CFR 1999 Comp., p. 199.
0
2. Supplement No. 1 to Part 710 is amended by revising the undesignated
center heading ``List of States Parties as of December 20, 2008'' to
read ``List of States Parties as of November 1, 2013'' and by adding,
in alphabetical order, the countries ``Bahamas'', ``Barbados'', ``Congo
(Democratic Republic of the)'', ``Dominican Republic'', ``Iraq'',
``Somalia'', and ``Syria''.
PART 738--[AMENDED]
0
3. The authority citation for 15 CFR Part 738 continues to read as
follows:
Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
10 U.S.C. 7420; 10 U.S.C.
[[Page 16667]]
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; 42 U.S.C. 6212; 43 U.S.C.
1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 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
8, 2013, 78 FR 49107 (August 12, 2013).
0
4. Supplement No. 1 to Part 738 is amended by revising the entry for
``Mexico'' to read as follows:
Supplement No. 1 to Part 738--Commerce Country Chart
[Reason for control]
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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
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
Mexico........................ X ........ ........ X ........ X X X X X X X ........ X ........ ........
* * * * * * *
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PART 740--[AMENDED]
0
5. The authority citation for 15 CFR Part 740 continues to read as
follows:
Authority: 50 U.S.C. app. 2401 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 8, 2013, 78 FR 49107 (August 12, 2013).
0
6. In Supplement No. 1 to Part 740, Country Groups, Country Group A is
amended by adding, in alphabetical order, a new entry for ``Mexico'' to
read as follows:
Supplement No. 1 to Part 740--Country Groups
[Country Group A]
--------------------------------------------------------------------------------------------------------------------------------------------------------
[A:2] Missile
Country [A:1] technology [A:3] [A:4] Nuclear [A:5] [A:6]
control regime Australia group suppliers group
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* * * * * * *
Mexico............................................ ............... ............... X ............... ............... ...............
* * * * * * *
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PART 745--[AMENDED]
0
7. The authority citation for 15 CFR 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 7, 2013, 78 FR 67289
(November 12, 2013).
0
8. Supplement No. 2 to Part 745 is amended by revising the undesignated
center heading ``List of States Parties as of May 21, 2009'' to read
``List of States Parties as of November 1, 2013'' and by adding, in
alphabetical order, the countries ``Somalia'' and ``Syria''.
PART 772--[AMENDED]
0
9. The authority citation for 15 CFR Part 772 continues to read as
follows:
Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
8, 2013, 78 FR 49107 (August 12, 2013).
0
10. In Sec. 772.1, the definition of ``Australia Group'' is revised to
read as follows:
Sec. 772.1 Definitions of terms as used in the Export Administration
Regulations (EAR).
* * * * *
Australia Group. The countries participating in the Australia Group
have agreed to adopt harmonized controls on certain dual-use chemicals
(i.e., precursor chemicals), biological agents, related manufacturing
facilities and equipment, and related technology in order to ensure
that exports of these items do not contribute to the proliferation of
chemical or biological weapons. Countries participating in the
Australia Group as of November 1, 2013, include: Argentina, Australia,
Austria, Belgium, Bulgaria, Canada, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Japan, Korea (South), Latvia, Lithuania, Luxembourg,
Malta, Mexico, the Netherlands, New Zealand, Norway, Poland, Portugal,
Romania, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey,
Ukraine, the United Kingdom, and the United States. See also Sec.
742.2 of the EAR.
* * * * *
PART 774--[AMENDED]
0
11. The authority citation for 15 CFR Part 774 continues to read as
follows:
Authority: 50 U.S.C. app. 2401 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; 42
U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 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 8, 2013, 78 FR 49107 (August 12, 2013).
0
12. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 1--Special Materials and Related Equipment, Chemicals,
``Microorganisms'' and ``Toxins,'' ECCN 1C350 is amended, under the
License Requirements section, by revising paragraph .e of License
Requirement Note 1 (``Sample Shipments'') to read as follows:
Supplement No. 1 to Part 774--The Commerce Control List
* * * * *
[[Page 16668]]
1C350 Chemicals that may be used as precursors for toxic chemical
agents.
License Requirements
* * * * *
License Requirement Notes
1. Sample Shipments: * * *
* * * * *
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.''
* * * * *
0
13. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 1--Special Materials and Related Equipment, Chemicals,
``Microorganisms'' and ``Toxins,'' ECCN 1C351 is amended, under the
List Based License Exceptions section, by adding an ``STA'' paragraph
following the ``CIV'' paragraph and, under the List of Items Controlled
section, by revising paragraph d.5 in the ``Items'' paragraph to read
as follows:
1C351 Human and zoonotic pathogens and ``toxins'', as follows (see
List of Items Controlled).
* * * * *
List Based License Exceptions (See Part 740 for a Description of All
License Exceptions)
LVS: * * *
GBS: * * *
CIV: * * *
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: * * *
Related Definitions: * * *
Items:
* * * * *
d. * * *
d.5. Clostridium perfringens alpha, beta 1, beta 2, epsilon and
iota toxins;
* * * * *
0
14. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 1--Special Materials and Related Equipment, Chemicals,
``Microorganisms'' and ``Toxins,'' ECCN 1C352 is amended by revising
paragraph a.8. in the ``Items'' paragraph under the List of Items
Controlled section to read as follows:
1C352 Animal pathogens, as follows (see List of Items Controlled).
* * * * *
List of Items Controlled
Related Controls: * * *
Related Definitions: * * *
Items:
a. * * *
a.8. Rabies virus and all other members of the Lyssavirus genus;
* * * * *
0
15. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 1--Special Materials and Related Equipment, Chemicals,
``Microorganisms'' and ``Toxins,'' ECCN 1C353 is amended by revising
Technical Note 1, following the ``Items'' paragraph under the List of
Items Controlled section, to read as follows:
1C353 Genetic elements and genetically modified organisms, as
follows (see List of Items Controlled).
* * * * *
List of Items Controlled
Related Controls: * * *
Related Definition: * * *
Items:
* * * * *
Technical Notes:
1. ``Genetic elements'' include, inter alia, chromosomes,
genomes, plasmids, transposons, and vectors, whether genetically
modified or unmodified, or chemically synthesized in whole or in
part.
* * * * *
0
16. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 2--Materials Processing, ECCN 2B350 is amended by revising the
introductory text of paragraph b. in the ``Items'' paragraph under the
List of Items Controlled section to read as follows:
2B350 Chemical manufacturing facilities and equipment, except valves
controlled by 2A226 or 2A292, as follows (see List of Items
Controlled).
* * * * *
List of Items Controlled
Related Controls: * * *
Related Definition: * * *
Items:
a. * * *
b. Agitators designed for use in reaction vessels or reactors
described in 2B350.a, 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:
* * * * *
0
17. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 2--Materials Processing, ECCN 2B352 is amended under the
``Items'' paragraph in the List of Items Controlled section by revising
paragraph b. and the Technical Note thereto to read as follows:
2B352 Equipment capable of use in handling biological materials, as
follows (see List of Items Controlled).
* * * * *
List of Items Controlled
Related Controls: * * *
Related Definitions: * * *
Items:
a. * * *
b. Fermenters and components as follows:
b.1. Fermenters capable of cultivation of pathogenic micro-
organisms or of live cells for the production of pathogenic viruses
or toxins, without the propagation of aerosols, having a capacity 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.
* * * * *
Dated: March 18, 2014.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2014-06406 Filed 3-25-14; 8:45 am]
BILLING CODE 3510-33-P