Document ID: BIS-2014-0008-0001
Agency: bis
Document Type: Rule
Title: Implementation of Understandings Reached at June 2013 Australia Group Plenary Meeting and December 2012 AG Intersessional Decisions
Posted Date: 2014-03-26T04:00Z

[Federal Register Volume 79, Number 58 (Wednesday, March 26, 2014)]
[Rules and Regulations]
[Pages 16664-16668]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 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.

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]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                   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   ........  ........
 
                                                                                          * * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
Mexico............................................  ...............  ...............               X   ...............  ...............  ...............
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

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