Document ID: BIS-2013-0014-0001
Agency: bis
Document Type: Rule
Title: Implementation of the Understandings Reached at the 2012 Australia Group (AG) Plenary Meeting and the 2012 AG Intersessional Decisions: Changes to Select Agent Controls
Posted Date: 2013-06-05T04:00Z

[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Rules and Regulations]
[Pages 33692-33698]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13270]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 740, 742, and 774

[Docket No. 120806310-2310-01]
RIN 0694-AF76

Implementation of the Understandings Reached at the 2012 
Australia Group (AG) Plenary Meeting and the 2012 AG Intersessional 
Decisions; Changes to Select Agent Controls

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 2012 plenary meeting of the 
Australia Group (AG) and the 2012 AG intersessional decisions. 
Specifically, this rule amends the Commerce Control List (CCL) entry in 
the EAR that controls human and zoonotic pathogens and ``toxins'' to 
reflect changes to the AG ``List of Biological Agents for Export 
Control'' that were made based on the understandings adopted at the 
June 2012 AG plenary meeting. These changes included the addition of 
three pathogens and clarifications to two other items. This rule also 
amends the CCL entry in the EAR that controls plant pathogens to 
reflect: The 2012 AG Plenary agreement to add five pathogens to the AG 
``List of Plant Pathogens for Export Control;'' and the AG 
intersessional clarifications to six pathogens identified on this AG 
list. In addition, the CCL entry in the EAR that controls equipment 
capable of handling biological materials is amended to reflect the 2012 
AG intersessional decision to add certain spray-drying equipment to the 
AG ``Control List of Dual-Use Biological Equipment and Related 
Technology and Software.'' This rule also removes the CCL entry that 
controls select agents not identified on any of the AG common controls 
lists, but identified on the CCL because they are (or were, until 
recently) subject to controls maintained by the Centers for Disease 
Control and Prevention (CDC), U.S. Department of Health and Human 
Services, and the Animal and Plant Health Inspection Service (APHIS), 
U.S. Department of Agriculture, on their possession, use, and transfer 
within the United States. Rather than continuing to control these 
select agents in a separate CCL entry, this rule adds those select 
agents that remain subject to the CDC/APHIS controls (as well as a 
recent addition to the list of select agents) to the AG-related CCL 
entries that control human and zoonotic pathogens and ``toxins'' and 
plant pathogens, respectively.

DATES: This rule is effective June 5, 2013.

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 12-15, 2012. This rule also implements the 
recommendations presented at the AG intersessional implementation 
meeting held in Ottawa, Canada, on February 14-16, 2012, and adopted 
pursuant to the AG silent approval procedure, which closed on March 23, 
2012. The AG is a multilateral forum consisting of 40 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 2012 AG Plenary Changes

    The June 2012 AG plenary meeting adopted understandings that 
affected the AG ``List of Biological Agents for Export Control'' and 
the AG ``List of Plant Pathogens for Export Control.''
    This rule amends Export Control Classification Number (ECCN) 1C351 
to reflect the AG plenary changes to the ``List of Biological Agents 
for Export Control.'' Specifically, ECCN 1C351 (Human and zoonotic 
pathogens and ``toxins'') is amended by adding botulinum neurotoxin 
producing strains of the following bacteria to 1C351.c: Clostridium 
argentinense (formerly known as Clostridium botulinum Type G); 
Clostridium baratii; and Clostridium butyricum. ECCN 1C351.c is 
partially renumbered to control these bacteria under 1C351.c.8., .c.9, 
and .c.11, respectively, while the bacteria previously controlled under 
these subparagraphs (Clostridium botulinum; Clostridium perfringens, 
epsilon toxin producing types; and Coxiella burnetii) are now 
controlled under 1C351.c.10, .c.12. and .c.13, respectively. In 
addition, bacteria previously controlled under 1C351.c.12 through .c.17 
are now controlled under 1C351.c.14 through

[[Page 33693]]

.c.16 (Francisella tularensis; Rickettsia prowazekii; and Salmonella 
typhi) and 1C351.c.18 through .c 20 (Shigella dysenteriae; Vibrio 
cholerae; and Yersinia pestis). Also note, with respect to ECCN 
1C351.c.15 as amended by this rule, that the listing for the bacterium 
``Rickettsia prowasecki (a.k.a. Rickettsia prowazekii)'' is amended to 
read ``Rickettsia prowazekii,'' consistent with the listing of this 
bacterium in the AG ``List of Biological Agents for Export Control'' 
and the commonly accepted spelling of this bacterium within the 
scientific community.
    This rule also amends ECCN 1C351.c to clarify that the controls on 
``Escherichia coli and other verotoxin producing serotypes'' apply to 
``Shiga toxin producing Escherichia coli (STEC) of serogroups O26, O45, 
O103, O104, O111, O121, O145, O157, and other shiga toxin producing 
serogroups.'' These bacteria are now controlled under 1C351.c.17. Prior 
to the publication of this rule and the partial renumbering of 1C351.c, 
these bacteria were controlled under 1C351.c.11. In addition, this rule 
amends 1C351.d.14 to clarify that the controls on ``Staphylococcus 
aureus toxins'' apply to ``Staphylococcus aureus enterotoxins, 
hemolysin alpha toxin, and toxic shock syndrome toxin (formerly known 
as Staphylococcus enterotoxin F).''
    This rule amends ECCN 1C354 (Plant pathogens) to reflect the AG 
plenary changes to the ``List of Plant Pathogens for Export Control.'' 
Specifically, ECCN 1C354 is amended by adding the following five fungi 
to 1C354.b: Peronosclerospora philippinensis (Peronosclerospora 
sacchari); Sclerophthora rayssiae var. zeae; Synchytrium endobioticum; 
Tilletia indica; and Thecaphora solani. These fungi are controlled 
under 1C354.b.7 through .b.11, respectively.

2012 AG Intersessional Changes

    This rule also implements the recommendations presented at the AG 
intersessional implementation meeting held in February 2012 and adopted 
pursuant to the AG silent approval procedure. These recommendations 
included changes to the AG ``List of Plant Pathogens for Export 
Control'' and the AG ``Control List of Dual-Use Biological Equipment 
and Related Technology and Software.'' This rule amends ECCN 1C354 
(Plant pathogens) to reflect the AG intersessional changes to the 
``List of Plant Pathogens for Export Control.'' Specifically, ECCN 
1C354.a (Bacteria) is amended to clarify that the controls for 
``Xanthomonas campestris pv. citri'' in 1C354.a.2 apply to 
``Xanthomonas axonopodis pv. citri (Xanthomonas campestris pv. citri A) 
(Xanthomonas campestris pv. citri)'' and that the controls for 
``Ralstonia solanacearum'' in 1C354.a.5 apply to ``Ralstonia 
solanacearum, race 3, biovar 2.'' This rule also amends ECCN 1C354.b 
(Fungi) to reorder the wording of the controls for ``Colletotrichum 
coffeanum var. virulans (Colletotrichum kahawae)'' in 1C354.b.1 to read 
``Colletotrichum kahawae (Colletotrichum coffeanum var. virulans).'' In 
addition, this rule amends the controls for ``Puccinia graminis'' in 
1C354.b.4 to clarify that they apply to ``Puccinnia graminis ssp. 
graminis var. graminis/Puccinia graminis ssp. graminis var. stakmanii 
(Puccinia graminis [syn. Puccinia graminis f. sp. tritici])'' and the 
controls for ``Magnaporthe grisea'' in 1C354.b.6 to clarify that they 
apply to ``Magnaporthe oryzae (Pyricularia oryzae).'' Furthermore, this 
rule amends 1C354.c to clarify the controls for ``Potato Andean latent 
tymovirus'' in 1C354.c.1 to read ``Andean potato latent virus (Potato 
Andean latent tymovirus).''
    In addition, this rule amends ECCN 2B352 (Equipment capable of use 
in handling biological materials) to reflect the AG intersessional 
changes to the ``Control List of Dual-Use Biological Equipment and 
Related Technology and Software.'' Specifically, this rule adds 
controls for certain spray-drying equipment under 2B352.f. Those items 
that were controlled under 2B352.f through .h, prior to the publication 
of this rule, are now controlled under 2B352.g through .i, 
respectively. ECCN 2B352.f, as revised by this rule, now controls 
spray-drying equipment capable of drying toxins or pathogenic 
microorganisms and having all of the following characteristics: (1) A 
water evaporation capacity of >= 0.4 kg/h and <= 400 kg/h; (2) the 
ability to generate a typical mean product particles 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 (3) capable of being sterilized or 
disinfected in situ.

Select Agent Changes to the CCL

    This rule removes ECCN 1C360 (Select agents). This ECCN controlled 
select agents not included on any of the AG common controls lists that 
were identified on the CCL because they are (or were, until recently) 
subject to controls maintained by 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, on their possession, use, and transfer 
within the United States.
    As a result of amendments by CDC to the list of ``HHS select 
agents'' in 42 CFR 73.3 and the list of ``Overlap select agents and 
toxins'' in 42 CFR 73.4 and amendments by APHIS to the list of ``Plant 
Protection and Quarantine (PPQ) select agents and toxins'' in 7 CFR 
331.3 and the list of ``Veterinary Services (VS) select agents and 
toxins'' in 9 CFR 121.3, ten of the eighteen select agents that were 
listed in ECCN 1C360 are no longer included on the CDC/APHIS select 
agents lists. For this reason, as well as to assist exporters to more 
easily identify all of the select agents that are subject to the 
chemical/biological (CB) controls described in Section 742.2(a)(1) of 
the EAR (i.e., CB Column 1), BIS is removing ECCN 1C360 from the CCL 
and adding the select agents that were controlled by ECCN 1C360, and 
continue to be identified on the CDC/APHIS lists, to the appropriate 
AG-related ECCNs on the CCL (i.e., ECCNs 1C351 and 1C354). Prior to the 
publication of this rule, the CDC/APHIS select agents listed in these 
ECCNs included only those select agents that were also identified on 
one of the AG common control lists.
    As a result of the changes described above, the following select 
agents that were controlled by ECCN 1C360 are no longer listed on the 
CCL: Central European tick-borne encephalitis viruses (i.e., 
Absettarov, Hanzalova, Hypr, and Kumlinge); Cercopithecine herpesvirus 
1 (Herpes B virus); Flexal virus; Akabane virus; Bovine spongiform 
encephalopathy agent; Camel pox virus; Malignant catarrhal fever virus; 
Menangle virus; Erhlichia ruminantium (a.k.a. Cowdria ruminantium); and 
Xylella fastidiosa pv. citrus variegated chlorosis (CVC).
    Three select agents that were controlled under ECCN 1C360 and 
continue to be identified on the CDC/APHIS select agents lists are now 
controlled on the CCL, as follows: Reconstructed replication competent 
forms of the 1918 pandemic influenza virus containing any portion of 
the coding regions of all eight gene segments (now controlled under 
ECCN 1C351.b.1); Rathayibacter toxicus (now controlled under ECCN 
1C354.a.6); and Phoma glycinicola, formerly Pyrenochaeta glycines (now 
controlled under ECCN 1C354.b.12). None of these select agents are 
identified on any of the AG common control lists; however, they 
continue to be subject to CB controls (for those destinations indicated 
under CB Column 1 on the Commerce Country Chart in Supplement No. 1 to 
part 738 of the EAR), as well as anti-terrorism

[[Page 33694]]

(AT) controls (for those destinations indicated under AT Column 1 on 
the Commerce Country Chart--Country Group E:1, in Supplement No. 1 to 
part 740 of the EAR, lists those countries designated as ``terrorist-
supporting countries'' for purposes of the AT controls in the EAR).
    In addition, three select agents that were controlled under ECCN 
1C360, and continue to be identified on the APHIS select agents lists, 
have been added to the AG ``List of Plant Pathogens for Export 
Control,'' in accordance with the understandings reached at the 2012 AG 
Plenary (see the discussion of the 2012 AG Plenary changes, above). 
These select agents are now controlled on the CCL as follows: 
Peronosclerospora philippinensis (Peronosclerospora sacchari) (now 
controlled under ECCN 1C354.b.7); Sclerophthora rayssiae var. zeae (now 
controlled under ECCN 1C354.b.8); and Synchytrium endobioticum (now 
controlled under ECCN 1C354.b.9). This rule also amends ECCN 1C354.a.3 
to include the species of proteobacteria identified as Xanthomonas 
oryzae, which is identified on the APHIS list of PPQ select agents and 
toxins; however, only the pathovar Xanthomonas oryzae pv. oryzae (syn. 
Pseudomonas campestris pv. oryzae) is identified on the AG ``List of 
Plant Pathogens for Export Control.'' Like all other items controlled 
under ECCN 1C354, these select agents are subject to CB Column 1 
controls, as well as AT Column 1 controls.
    Furthermore, this rule eliminates redundant controls on two 
bacteria of the Mycoplasma mycoides cluster: Mycoplasma capricolum 
subspecies capripneumoniae and Mycoplasma mycoides subspecies mycoides 
small colony. These bacteria were identified under ECCN 1C360.b.2 and 
ECCN 1C352.b.1, prior to the publication of this rule, but are now 
controlled under ECCN 1C352.b.1, only. Both bacteria continue to be 
identified on the list of ``VS Select Agents and Toxins'' maintained by 
APHIS, as well as the AG ``List of Plant Pathogens for Export 
Control.'' Like all other items controlled under ECCN 1C352, these 
bacteria are subject to CB Column 1 controls, as well as AT Column 1 
controls.
    This rule also amends ECCN 1C351 by adding SARS-associated 
coronavirus (SARS-CoV) under 1C351.b.2 and tick-borne encephalitis 
virus (Siberian subtype) under 1C351.b.3. Both viruses were recently 
included in CDC's list of ``HHS select agents and toxins,'' but are not 
identified on any of the AG common control lists. However, like all 
other items controlled under ECCN 1C351, these viruses are subject to 
CB Column 1 controls, as well as AT Column 1 controls. Another tick-
borne encephalitis virus (Far Eastern subtype, formerly known as 
Russian Spring-Summer encephalitis virus) is controlled under ECCN 
1C351.a.35 and is currently included in both CDC's list of ``HHS select 
agents and toxins'' and the AG ``List of Biological Agents for Export 
Control.'' This rule amends ECCN 1C351.a.35 to reflect the current 
nomenclature (i.e., Far Eastern subtype) used by the International 
Committee on Taxonomy of Viruses.
    In addition to the select agents changes described above, this rule 
makes conforming changes to Sections 740.20 and 742.2 of the EAR and to 
ECCNs 1C353, 1C991, 1E001 and 1E351 to reflect the removal of ECCN 
1C360 from the CCL. Specifically, Section 740.20(b)(2)(v) is amended by 
removing two references to ECCN 1C360 from the description of 
biological items that are not eligible for License Exception Strategic 
Trade Authorization (STA). The items that were controlled under ECCN 
1C360 and that remain on the CCL are now controlled under ECCN 1C351.a 
or .b, ECCN 1C352 or ECCN 1C354, all of which are identified in 
paragraph (b)(2)(v). Section 742.2(a)(1)(i) of the EAR is amended by 
removing the reference to ECCN 1C360 from the description of the 
license requirements that apply to items controlled for CB reasons to 
destinations indicated under CB Column 1 on the Commerce Country Chart. 
ECCN 1C353 is amended by removing references to ECCN 1C360 from the 
following: The Related Controls paragraph; paragraphs a.1. and b.1. in 
the Items paragraph under the List of Items Controlled; and Technical 
Note 3. ECCN 1C991 is amended by removing references to ECCN 1C360 from 
the fourth sentence of the Related Definitions paragraph and from 
paragraph a. in the Items paragraph under the List of Items Controlled. 
ECCN 1E001 is amended by removing the reference to ECCN 1C360 from the 
control language for ``Country Chart--CB Column 1'' in the License 
Requirements section. ECCN 1E351 is amended by removing references to 
ECCN 1C360 from the ECCN heading and from the controls language for 
``Country Chart--CB Column 1'' in the License Requirements section.
    Finally, this rule amends ECCNs 1C351, 1C352, 1C353, and 1C354 by 
revising the License Requirements Note(s) in the License Requirements 
section of each ECCN to add a note indicating that ECCNs 1C351, 1C352, 
1C353, and 1C354 control all biological agents or ``toxins,'' 
regardless of quantity or attenuation, that are identified in the List 
of Items Controlled for each ECCN (or, in the case of ECCN 1C353, 
genetic elements or genetically modified organisms for such agents or 
``toxins''), 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 APHIS or CDC, in accordance 
with the APHIS regulations in 7 CFR part 331 or 9 CFR part 121 or the 
CDC regulations in 42 CFR part 73. These changes do not affect the 
scope of ECCNs 1C351, 1C352, 1C353, and 1C354 and conform with the 
controls described in the AG common control lists and in the AG 
``Guidelines for Transfers of Sensitive Chemical or Biological Items,'' 
neither of which provide an exemption from control for attenuated 
strains of biological agents or toxins. In conjunction with these 
changes, this rule amends the Related Controls paragraph in each of 
these four ECCNs to add a sentence referencing 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.

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. With the removal of 
ECCN 1C360 from the CCL, ten select agents that were controlled under 
this ECCN prior to the publication of this rule are no longer 
identified on the CCL and are classified as EAR99, instead. All of 
these select agents were recently removed from the CDC/APHIS select 
agents lists. In addition, six other select agents that were controlled 
under ECCN 1C360 have been moved to ECCN 1C351 or ECCN 1C354 and 
continue to require a license for CB reasons to destinations indicated 
under CB Column 1 on the Commerce Country Chart and for AT reasons to 
destinations indicated under AT Column 1--all of these select agents 
continue to be identified on the CDC/APHIS select agents lists. Two 
additional select agents (Mycoplasma capricolum subspecies 
capripneumoniae and Mycoplasma mycoides subspecies mycoides small 
colony) also were controlled under ECCN 1C360 and continue to be 
identified on the CDC/APHIS select agents lists. As indicated above, 
this rule did not add these select agents to ECCN 1C352 because they 
were already described in ECCN 1C352.b.1 (i.e., the ECCN 1C360 controls 
on these select agents duplicated the controls in ECCN

[[Page 33695]]

1C352). This rule also adds two viruses that were recently included in 
CDC's list of ``HHS select agents and toxins'' (i.e., SARS-associated 
coronavirus and tick-borne encephalitis virus, Siberian subtype) to 
ECCN 1C351.b.
    Based on the understandings reached at the June 2012 AG Plenary 
meeting, this rule also adds three bacteria to ECCN 1C351 and two fungi 
to ECCN 1C354, none of which were identified on the CCL prior to the 
publication of this rule. The AG Plenary also added three additional 
fungi to the ``List of Plant Pathogens for Export Control,'' but these 
fungi were already controlled under ECCN 1C360, based on their 
inclusion by APHIS on the list of PPQ select agents and toxins (7 CFR 
part 331), and are now controlled under ECCN 1C354 (i.e., these fungi 
are among the six select agents that have been moved by this rule from 
ECCN 1C360 to ECCN 1C351 or ECCN 1C354, as indicated above).
    To summarize the biological agent and toxin changes described 
above, this rule removes ten CDC/APHIS select agents from the CCL, 
while adding three AG-listed bacteria and two fungi, as well as two 
viruses that were recently identified on CDC's list of ``HHS select 
agents and toxins.'' These changes are not expected to significantly 
affect the scope of the EAR controls on biological agents and toxins, 
because BIS estimates that there will be no increase in the number of 
license applications for these items.
    Finally, this rule expands the scope of the EAR controls that apply 
to dual-use equipment capable of handling biological materials by 
amending ECCN 2B352 to add certain spray-drying equipment. This change 
is not expected to significantly affect the scope of the EAR controls 
on such equipment, because BIS anticipates only a small increase in the 
number of license applications.
    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, 2012, 77 FR 49699 (August 16, 2012), has continued the EAR 
in effect under the International Emergency Economic Powers Act.

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 40 member countries that act 
on a consensus basis and the amendments set forth in this rule 
implement the understandings reached at the June 2012 AG plenary 
meeting, the 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 740

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

15 CFR Part 742

    Exports, Terrorism.

15 CFR Part 774

    Exports, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, parts 740, 742, and 774 of 
the Export Administration Regulations (15 CFR parts 730-774) are 
amended as follows:

PART 740--[AMENDED]

0
1. 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 15, 2012, 77 FR 49699 (August 16, 2012).

0
2. Section 740.20 is amended by revising paragraph (b)(2)(v) to read as 
follows:

[[Page 33696]]

Sec.  740.20  License Exception Strategic Trade Authorization (STA).

* * * * *
    (b) * * *
    (2) * * *
    (v) License Exception STA may not be used for any item controlled 
by ECCN 1C351.a, .b, .c, d.11, .d.12 or .e, ECCNs 1C352, 1C353, 1C354, 
1E001 (i.e., for technology, as specified in ECCN 1E001, for items 
controlled by ECCN 1C351.a, .b, .c, .d.11, .d.12 or .e or ECCNs 1C352, 
1C353, or 1C354) or ECCN 1E351.
* * * * *

PART 742--[AMENDED]

0
3. The authority citation for 15 CFR Part 742 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. 3201 et seq.; 42 U.S.C. 2139a; 22 U.S.C. 7201 et seq.; 22 
U.S.C. 7210; Sec 1503, Pub. L. 108-11, 117 Stat. 559; E.O. 12058, 43 
FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR 33181, 3 CFR, 
1993 Comp., p. 608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 Comp., p. 
950; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 
66 FR 44025, 3 CFR, 2001 Comp., p. 783; Presidential Determination 
2003-23 of May 7, 2003, 68 FR 26459, May 16, 2003; Notice of August 
15, 2012, 77 FR 49699 (August 16, 2012); Notice of November 9, 2011, 
76 FR 70319 (November 10, 2011).

Sec.  742.2  [Amended]

0
4. Section 742.2 is amended by removing the phrase ``ECCNs 1C351, 
1C352, 1C353, 1C354, and 1C360'' in paragraph (a)(1)(i) and adding in 
its place the phrase ``ECCNs 1C351, 1C352, 1C353, and 1C354''.

PART 774--[AMENDED]

0
5. 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 15, 2012, 77 FR 49699 (August 16, 2012).

Supplement No. 1 to Part 774--[Amended]

0
6. 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 by adding a 
new Note 4 in the ``License Requirements Notes'' under the License 
Requirements section, by revising the ``Related Controls'' paragraph 
under the List of Items Controlled section, and, in the ``Items'' 
paragraph under the List of Items Controlled section, by revising the 
heading of paragraph a., by revising paragraph a.35, by adding a new 
paragraph b., by revising paragraph c., by revising the heading of 
paragraph d., and by revising paragraph d.14 to read as follows:

1C351 Human and zoonotic pathogens and ``toxins'', as follows (see 
List of Items Controlled).

License Requirements

* * * * *
License Requirement Notes: * * *

    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.
* * * * *

List of Items Controlled

Unit: * * *
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 export licensing jurisdiction of 
the U.S. Department of State, Directorate of Defense Trade Controls. 
(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 export licensing 
jurisdiction of the U.S. Department of State, Directorate of Defense 
Trade Controls.
Related Definitions: * * *
Items:

    a. Viruses identified on the Australia Group (AG) ``List of 
Biological Agents for Export Control,'' as follows:
* * * * *
    a.35. Tick-borne encephalitis virus (Far Eastern subtype, 
formerly known as Russian Spring-Summer encephalitis virus--see 
1C351.b.3 for Siberian subtype);
* * * * *
    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 Biological Agents 
for Export Control,'' as follows:
    b.1. Reconstructed replication competent forms of the 1918 
pandemic influenza virus containing any portion of the coding 
regions of all eight gene segments;
    b.2. SARS-associated coronavirus (SARS-CoV); or
    b.3. Tick-borne encephalitis virus (Siberian subtype, formerly 
West Siberian virus--see 1C351.a.35 for Far Eastern subtype).
    c. Bacteria identified on the Australia Group (AG) ``List of 
Biological Agents 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. Chlamydophila psittaci (formerly known as Chlamydia 
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. Rickettsia prowazekii;
    c.16. Salmonella typhi;
    c.17. Shiga toxin producing Escherichia coli (STEC) of 
serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other 
shiga toxin producing serogroups;
    Note: Shiga toxin producing Escherichia coli (STEC) is also 
known as enterohaemorrhagic E. coli (EHEC) or verocytotoxin 
producing E. coli (VTEC).
    c.18. Shigella dysenteriae;
    c.19. Vibrio cholerae; or
    c.20. Yersinia pestis.
    d. ``Toxins'' identified on the Australia Group (AG) ``List of 
Biological Agents for Export Control,'' as follows, and ``subunits'' 
thereof:
* * * * *
    d.14. Staphylococcus aureus enterotoxins, hemolysin alpha toxin, 
and toxic shock syndrome toxin (formerly known as Staphylococcus 
enterotoxin F);
* * * * *

0
7. 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 
the ``License Requirement Note'' under the License Requirements section 
and by

[[Page 33697]]

revising the ``Related Controls'' paragraph under the List of Items 
Controlled section to read as follows:

1C352 Animal pathogens, as follows (see List of Items Controlled).

License Requirements

* * * * *
    License Requirements Notes:

    1. All vaccines are excluded from the scope of this ECCN. See 
ECCN 1C991 for vaccines.
    2. Unless specified elsewhere in this ECCN 1C352 (e.g., in 
License Requirement Note 1), this ECCN controls all biological 
agents, 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 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.
* * * * *

List of Items Controlled

Unit: * * *
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 
(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)). (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 Definitions: * * *
Items:
* * * * *

0
8. 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, under the 
License Requirements section, by revising the ``License Requirements 
Note'' and, under the List of Items Controlled section, by revising the 
``Related Controls'' paragraph, by revising paragraphs a.1. and b.1. in 
the ``Items'' paragraph, and by revising Technical Note 3, to read as 
follows:

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

License Requirements

* * * * *
License Requirements Notes:

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

List of Items Controlled

Unit: * * *
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, 1C352, 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: * * *
Items:

    a. * * *
    a.1. Genetic elements that contain nucleic acid sequences 
associated with the pathogenicity of microorganisms controlled by 
1C351.a to .c, 1C352, or 1C354;
    a.2. * * *
    b. * * *
    b.1. Genetically modified organisms that contain nucleic acid 
sequences associated with the pathogenicity of microorganisms 
controlled by 1C351.a to .c, 1C352, or 1C354;
    b.2. * * *

Technical Notes:

* * * * *
    3. ``Nucleic acid sequences associated with the pathogenicity of 
any of the microorganisms controlled by 1C351.a to .c, 1C352, or 
1C354'' means any sequence specific to the relevant controlled 
microorganism that:
    a. In itself or through its transcribed or translated products 
represents a significant hazard to human, animal or plant health; or
    b. Is known to enhance the ability of a microorganism controlled 
by 1C351.a to .c, 1C352, or 1C354, or any other organism into which 
it may be inserted or otherwise integrated, to cause serious harm to 
human, animal or plant health.
* * * * *

0
9. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 1--Special Materials and Related Equipment, Chemicals, 
``Microorganisms'' and ``Toxins,'' ECCN 1C354 is amended by revising 
the ``License Requirements Note'' under the License Requirements 
section and by revising the ``Related Controls'' paragraph and the 
``Items'' paragraph under the List of Items Controlled section to read 
as follows:

1C354 Plant pathogens, as follows (see List of Items Controlled).

License Requirements

* * * * *
License Requirements Notes:

    1. All vaccines are excluded from the scope of this ECCN. See 
ECCN 1C991 for vaccines.
    2. Unless specified elsewhere in this ECCN 1C354 (e.g., in 
License Requirement Note 1), this ECCN controls all biological 
agents, 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 that 
are excluded from the list of PPQ select agents and ``toxins'' by 
the Animal and Plant Health Inspection Service (APHIS), U.S. 
Department of Agriculture, in accordance with their regulations in 7 
CFR part 331.
* * * * *

List of Items Controlled

Unit: * * *
Related Controls: (1) The Animal and Plant Health Inspection Service 
(APHIS), U.S. Department of Agriculture, maintains controls on the 
possession, use, and transfer within the United States of certain 
items controlled by this ECCN (see 7 CFR 331.3(c), 9 CFR 121.3(c), 
and 9 CFR 121.4(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: * * *
Items:

    a. Bacteria, as follows:
    a.1. Xanthomonas albilineans;
    a.2. Xanthomonas axonopodis pv. citri (Xanthomonas campestris 
pv. citri A) (Xanthomonas campestris pv. citri);
    a.3. Xanthomonas oryzae [this species of proteobacteria is 
identified on the APHIS ``select agents'' list (see Related Controls 
paragraph for this ECCN), but only the pathovar Xanthomonas oryzae 
pv. oryzae (syn. Pseudomonas campestris pv. oryzae) is identified on 
the Australia Group (AG) ``List of Plant Pathogens for Export 
Control''];
    a.4. Clavibacter michiganensis subspecies sepedonicus (syn. 
Corynebacterium michiganensis subspecies sepedonicum or 
Corynebacterium sepedonicum);

[[Page 33698]]

    a.5. Ralstonia solanacearum, race 3, biovar 2;
    a.6. Raythayibactor toxicus [this bacterium is identified on the 
APHIS ``select agents'' list (see the Related Controls paragraph for 
this ECCN), but is not identified on the Australia Group (AG) ``List 
of Plant Pathogens for Export Control''].
    b. Fungi, as follows:
    b.1. Colletotrichum kahawae (Colletotrichum coffeanum var. 
virulans);
    b.2. Cochliobolus miyabeanus (Helminthosporium oryzae);
    b.3. Microcyclus ulei (syn. Dothidella ulei);
    b.4. Puccinnia graminis ssp. graminis var. graminis/Puccinia 
graminis ssp. graminis var. stakmanii (Puccinia graminis [syn. 
Puccinia graminis f. sp. tritici]);
    b.5. Puccinia striiformis (syn. Puccinia glumarum);
    b.6. Magnaporthe oryzae (Pyricularia oryzae);
    b.7. Peronosclerospora philippinensis (Peronosclerospora 
sacchari);
    b.8. Sclerophthora rayssiae var. zeae;
    b.9. Synchytrium endobioticum;
    b.10. Tilletia indica;
    b.11. Thecaphora solani;
    b.12. Phoma glycinicola (formerly Pyrenochaeta glycines) [this 
fungus is identified on the APHIS ``select agents'' list (see the 
Related Controls paragraph for this ECCN), but is not identified on 
the Australia Group (AG) ``List of Plant Pathogens for Export 
Control''].
    c. Viruses, as follows:
    c.1. Andean potato latent virus (Potato Andean latent 
tymovirus);
    c.2. Potato spindle tuber viroid.

0
10. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 1--Special Materials and Related Equipment, Chemicals, 
``Microorganisms'' and ``Toxins,'' ECCN 1C360 is removed.

0
11. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 1--Special Materials and Related Equipment, Chemicals, 
``Microorganisms'' and ``Toxins,'' ECCN 1C991 is amended under the List 
of Items Controlled section by revising the fourth sentence in the 
``Related Definitions'' paragraph and by revising paragraph a. in the 
``Items'' paragraph to read as follows:

1C991 Vaccines, immunotoxins, medical products, diagnostic and food 
testing kits, as follows (see List of Items Controlled).
* * * * *

List of Items Controlled

Unit: * * *
Related Controls: * * *
Related Definitions: * * * Biological toxins in any other 
configuration, including bulk shipments, or for any other end-uses 
are controlled by ECCN 1C351. * * *
Items:

    a. Vaccines against items controlled by ECCN 1C351, 1C352, 1C353 
or 1C354.
* * * * *

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 1E001 is amended by revising 
the ECCN heading and by revising the ``Control(s)'' language for 
``Country Chart--CB Column 1'' in the License Requirements section to 
read as follows:

1E001 ``Technology'' according to the General Technology Note for 
the ``Development'' or ``Production'' of items controlled by 
1A001.b, 1A001.c, 1A002, 1A003, 1A004, 1A005, 1A006.b, 1A007, 1A008, 
1A101, 1B (except 1B999), or 1C (except 1C355, 1C980 to 1C984, 
1C988, 1C990, 1C991, 1C995 to 1C999).

License Requirements

Reason for Control: NS, MT, NP, CB, RS, AT

 
                Control(s)                         Country chart
 
 
                                * * * * *
CB applies to ``technology'' for items     CB Column 1.
 controlled by 1C351, 1C352, 1C353, or
 1C354.
 
                                * * * * *
 

License Requirements Note: * * *
* * * * *

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 1E351 is amended by revising 
the ECCN heading and by revising the ``Control(s)'' language for 
``Country Chart--CB Column 1'' in the License Requirements section to 
read as follows:

1E351 ``Technology'' according to the ``General Technology Note'' for 
the disposal of chemicals or microbiological materials controlled by 
1C350, 1C351, 1C352, 1C353, or 1C354.

License Requirements

Reason for Control: CB, AT

 
                Control(s)                         Country chart
 
CB applies to ``technology'' for the       CB Column 1.
 disposal of items controlled by 1C351,
 1C352, 1C353, or 1C354.
 
                                * * * * *
 

* * * * *

0
14. 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 
redesignating paragraphs f. through h. as paragraphs g. through i., 
respectively, and adding a new paragraph f. to read as follows:

2B352 Equipment capable of use in handling biological materials, as 
follows (see List of Items Controlled).
* * * * *

List of Items Controlled

Unit: * * *
Related Controls: * * *
Related Definitions: * * *
Items:
* * * * *
    f. Spray-drying equipment capable of drying toxins or pathogenic 
microorganisms having all of the flowing 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.
* * * * *

    Dated: May 29, 2013.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2013-13270 Filed 6-4-13; 8:45 am]
BILLING CODE 3510-33-P