Implementation of the Understandings Reached at the 2012 Australia Group (AG) Plenary Meeting and the 2012 AG Intersessional Decisions; Changes to Select Agent Controls, 33692-33698 [2013-13270]
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interim staff guidance in the Federal
Register (76 FR 1100) for public
comment. Two comment letters were
received and considered during the
revision of the draft interim staff
guidance. The guidance was also
enhanced based on comments received
on the proposed rule.
The interim staff guidance document
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NRC staff for implementing the new
requirements in the Distribution of
Source Material Rule. The approaches
and methods described in the document
are provided for information only.
Methods and solutions different from
those described in the document are
acceptable if they meet the revised
requirements. The guidance is provided
in the form of questions and answers on
the primary provisions of the
Distribution of Source Material Rule.
Guidance consistent with the revised 10
CFR part 40 will be incorporated into
the next revision of relevant volumes of
NUREG–1556, ‘‘Consolidated Guidance
About Materials Licenses’’ (current
ADAMS Accession Nos. ML022830847
and ML003681951).
Congressional Review Act
This interim staff guidance is a rule as
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However, the Office of Management and
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Dated at Rockville, Maryland, this 30th day
of May, 2013.
For the Nuclear Regulatory Commission.
Brian J. McDermott,
Director, Division of Materials Safety and
State Agreements, Office of Federal and State
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[FR Doc. 2013–13344 Filed 6–4–13; 8:45 am]
BILLING CODE 7590–01–P
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 740, 742, and 774
[Docket No. 120806310–2310–01]
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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
Bureau of Industry and
Security, Commerce.
ACTION: Final rule.
AGENCY:
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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
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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
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.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
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(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 spraydryer 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
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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 AGrelated 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
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(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 tickborne 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
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1 controls, as well as AT Column 1
controls. Another tick-borne
encephalitis virus (Far Eastern subtype,
formerly known as Russian SpringSummer 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
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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
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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 tickborne 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
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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
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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]
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).
2. Section 740.20 is amended by
revising paragraph (b)(2)(v) to read as
follows:
■
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§ 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]
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).
§ 742.2
[Amended]
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]
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]
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
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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 § 742.18 of
the EAR). The U.S. Government must
provide advance notification and annual
reports to the OPCW of all exports of
Schedule 1 chemicals. See § 745.1 of the
EAR for notification procedures. See 22
CFR part 121, Category XIV and § 121.7 for
CWC Schedule 1 chemicals that are subject
to the 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
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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 (SARSCoV); 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);
*
*
*
*
*
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
■
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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:
*
*
*
*
*
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:
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■
1C353 Genetic elements and genetically
modified organisms, as follows (see List
of Items Controlled).
License Requirements
*
*
*
*
*
License Requirements Notes:
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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.
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.
*
License Requirements
*
*
*
*
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,
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*
*
*
*
*
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 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);
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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.
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.
■ 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).
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*
*
*
*
*
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.
*
*
*
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*
*
16:07 Jun 04, 2013
Jkt 229001
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
Country
chart
Control(s)
*
*
*
CB applies to ‘‘technology’’ for
items controlled by 1C351,
1C352, 1C353, or 1C354.
*
*
*
*
*
CB Column
1.
*
*
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.
License Requirements Note: * * *
[FR Doc. 2013–13270 Filed 6–4–13; 8:45 am]
*
BILLING CODE 3510–33–P
*
*
*
*
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.
Country
chart
Control(s)
CB applies to ‘‘technology’’ for
the disposal of items controlled by 1C351, 1C352,
1C353, or 1C354.
*
*
*
*
*
*
CB Column
1.
*
*
*
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.,
■
PO 00000
Frm 00010
Fmt 4700
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2013–N–0002]
New Animal Drugs; Dexmedetomidine;
Lasalocid; Melengestrol; Monensin;
and Tylosin; Correction
AGENCY:
Sfmt 4700
Food and Drug Administration,
HHS.
ACTION:
License Requirements
Reason for Control: CB, AT
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Correcting amendments.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
document amending the animal drug
regulations to reflect approval actions
for new animal drug applications and
abbreviated new animal drug
applications during March 2013 that
appeared in the Federal Register of
April 30, 2013. FDA is correcting the
approved strengths of dexmedetomidine
hydrochloride injectable solution. This
correction is being made to improve the
accuracy of the animal drug regulations.
DATES: This rule is effective June 5,
2013.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
E:\FR\FM\05JNR1.SGM
05JNR1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
