Implementation of a Decision Adopted Under the Australia Group (AG) Intersessional Silent Approval Procedures in 2010 and Related Editorial Amendments, 56099-56103 [2011-22677]
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Federal Register / Vol. 76, No. 176 / Monday, September 12, 2011 / Rules and Regulations
(i) The applicant must validate the
adequacy of the maintenance actions
required under paragraph (b)(1) above.
(2) Include in the Airworthiness
Limitations section, any mandatory
inspections and serviceability limits
related to the use of the 30-minute AEO
rating.
(c) Section 33.87, Endurance Test. In
addition to the requirements of
§§ 33.87(a) and 33.87(d), the overall test
run must include a minimum of 25
hours of operation at 30 minute AEO
power and limits, divided into periods
of 30 minutes AEO power with alternate
periods at maximum continuous power
or less.
(1) Each § 33.87(d) continuous OEI
rating test period of 30 minutes or
longer, run at power and limits equal to
or higher then the 30 minute AEO
rating, may be credited toward this
requirement. Note that the test time
required for the takeoff or other OEI
ratings may not be counted toward the
25 hours of operation required at the 30minute AEO rating.
Issued in Burlington, Massachusetts, on
August 31, 2011.
Peter A. White,
Manager, Engine and Propeller Directorate,
Aircraft Certification Service.
[FR Doc. 2011–23189 Filed 9–9–11; 8:45 am]
BILLING CODE 4910–13–M
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
History
Federal Register Docket No. FAA–
2010–1325, Airspace Docket No. 10–
ASO–40, published in the Federal
Register of July 25, 2011 (76 FR 44257),
amends Class E airspace at Orangeburg
Municipal Airport, Orangeburg, SC. A
typographical error was made in the
state abbreviation and geographic
coordinates of the airport listed in the
airspace description. This action
corrects that error.
Class E airspace designations are
published in paragraph 6005 of FAA
Order 7400.9U, dated August 18, 2010
and effective September 15, 2010, which
is incorporated by reference in 14 CFR
part 71.1.
Correction to Final Rule
Accordingly, pursuant to the
authority delegated to me, in FR Doc.
2011–18173 published on July 25, 2011
(76 FR 44257) on page 44257, column 3,
line 26, correct the airspace descriptor
from ‘‘ASO GA E5 Orangeburg, SC
[Amended]’’ to ‘‘ASO SC E5
Orangeburg, SC [Amended]’’, and on
page 44257, column 3, line 28, in the
airspace description under Orangeburg
Municipal Airport, SC, remove ‘‘lat.
33°27′39″ N., long. 80°51′32″ W.’’ and
insert ‘‘lat. 33°27′25″ N., long. 80°51′34″
W.’’
Issued in College Park, Georgia, on August
19, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern
Service Center, Air Traffic Organization.
[FR Doc. 2011–23188 Filed 9–9–11; 8:45 am]
14 CFR Part 71
BILLING CODE 4910–13–P
[Docket No. FAA–2010–1325; Airspace
Docket No. 10–ASO–40]
DEPARTMENT OF COMMERCE
Amendment of Class E Airspace;
Orangeburg, SC
Bureau of Industry and Security
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule; correction.
AGENCY:
[Docket No. 110222155–1110–01]
This action corrects the
geographic coordinates and state
abbreviation of a final rule published in
the Federal Register of July 25, 2011,
that amends Class E airspace at
Orangeburg Municipal Airport,
Orangeburg, SC.
DATES: Effective Date 0901 UTC,
October 20, 2011.
FOR FURTHER INFORMATION CONTACT:
Richard Horrocks, Operations Support
Group, Eastern Service Center, Federal
Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320;
telephone (404) 305–5588.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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15 CFR Parts 740, 742 and 774
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RIN 0694–AF14
Implementation of a Decision Adopted
Under the Australia Group (AG)
Intersessional Silent Approval
Procedures in 2010 and Related
Editorial Amendments
Bureau of Industry and
Security, Commerce.
ACTION: Final rule.
AGENCY:
The Bureau of Industry and
Security (BIS) publishes this final rule
to amend the Export Administration
Regulations (EAR) to implement a
decision based on a proposal that was
discussed at the 2010 Australia Group
SUMMARY:
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56099
(AG) Plenary and adopted under the AG
intersessional silent approval
procedures in November 2010.
Specifically, this rule amends the
Commerce Control List (CCL) entry in
the EAR that controls human and
zoonotic pathogens and ‘‘toxins,’’
consistent with the intersessional
changes to the AG’s ‘‘List of Biological
Agents for Export Control.’’ First, this
rule clarifies the scope of the AG-related
controls in the EAR that apply to ‘‘South
American haemorrhagic fever (Sabia,
Flexal, Guanarito)’’ and ‘‘Pulmonary
and renal syndrome-haemorrhagic fever
viruses (Seoul, Dobrava, Puumala, Sin
Nombre)’’ by revising the list of viruses
in this CCL entry to remove these two
fevers and replace them with ten viral
causative agents for the fevers. These
changes are intended to more clearly
identify the causative agents that are of
concern for purposes of the controls
maintained by the AG. Second, this rule
alphabetizes and renumbers the list of
viruses in this CCL entry, consistent
with the 2010 intersessional changes to
the AG control list. Finally, this rule
makes an editorial change to the CCL
entry that controls human and zoonotic
pathogens and ‘‘toxins.’’ To assist
exporters to more easily identify the
bacteria and ‘‘toxins’’ that are controlled
under this CCL entry, this rule
alphabetizes and renumbers the lists of
bacteria and ‘‘toxins’’ in the entry.
DATES: This rule is effective September
12, 2011.
ADDRESSES: Send comments regarding
this collection of information, including
suggestions for reducing the burden, to
Jasmeet Seehra, Office of Management
and Budget (OMB), by e-mail 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 a decision that was adopted
under the Australia Group (AG)
intersessional silent approval
procedures in November 2010. The AG
is a multilateral forum consisting of 40
participating countries that maintain
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Federal Register / Vol. 76, No. 176 / Monday, September 12, 2011 / Rules and Regulations
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.
The November 2010 intersessional
decision revised the AG ‘‘List of
Biological Agents for Export Control’’ to
clarify the scope of the AG controls that
apply to certain viruses connected with
the phenotypes or medical conditions
known as ‘‘South American
haemorrhagic fever’’ and ‘‘Pulmonary
and renal syndrome-haemorrhagic fever
viruses.’’ The purpose of these changes
was to address a concern by the AG that
the listings for ‘‘South American
haemorrhagic fever (Sabia, Flexal,
Guanarito)’’ and ‘‘Pulmonary and renal
syndrome-haemorrhagic fever viruses
(Seoul, Dobrova, Puumala, Sin
Nombre)’’ could be misinterpreted (e.g.,
by assuming that the causative agents
identified in the parentheses
represented an exhaustive listing of
such viruses). In addition, both of these
AG listings referred to phenotypes or
medical conditions known to be caused
by several distinct species of viruses,
some (but not all) of which were
identified in parentheses for each
listing.
To address this concern, the
November 2010 AG intersessional
decision removed ‘‘South American
haemorrhagic fever’’ and ‘‘Pulmonary
and renal syndrome-haemorrhagic fever
viruses’’ from the List of Biological
Agents and replaced them with ten viral
causative agents for the fevers. Five of
these causative agents (i.e., ‘‘DobravaBelgrade virus,’’ ‘‘Guanarito virus,’’
‘‘Sabia virus,’’ ‘‘Seoul virus,’’ and ‘‘Sin
nombre virus’’) were previously
identified in parentheses under the
listings for the two fevers, while the
other five causative agents (i.e., ‘‘Andes
virus,’’ ‘‘Chapare virus,’’ ‘‘Choclo
virus,’’ ‘‘Laguna Negra virus,’’ and ‘‘Lujo
virus’’) were not previously identified
on the AG List. Two other causative
agents (i.e., ‘‘Flexal virus’’ and
‘‘Puumala virus’’) that were previously
identified in parentheses under the
listings for the two fevers were removed
from the AG List. This rule amends
Export Control Classification Number
(ECCN) 1C351 on the Commerce Control
List (CCL) (Supplement No. 1 to part
774 of the EAR) by revising the list of
viruses contained in 1C351.a to reflect
these changes to the AG List of
Biological Agents.
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Consistent with the changes to ECCN
1C351 described above, this rule
alphabetizes and renumbers the list of
viruses in ECCN 1C351.a to conform
with the format in the AG List of
Biological Agents. In addition, for the
convenience of exporters attempting to
determine the control status of certain
pathogens and toxins, this rule
alphabetizes and renumbers the lists of
bacteria and toxins contained in ECCN
1C351.c and .d, respectively. Consistent
with this reordering, this rule revises
references to certain agents identified in
the ‘‘CW Controls’’ paragraph of this
ECCN, in the ‘‘License Requirements
Notes’’ under the License Requirements
section of this ECCN, and/or in the
‘‘Related Controls’’ paragraph under the
List of Items Controlled section of this
ECCN.
Although this rule removes ‘‘Flexal
virus’’ from ECCN 1C351, consistent
with the AG intersessional changes to
the AG List of Biological Agents as
described above, this virus continues to
be listed on the CCL. Specifically, this
rule adds ‘‘Flexal virus’’ to ECCN 1C360
(Select agents not controlled under
ECCN 1C351, 1C352, or 1C354), because
the virus is included in the list of select
agents and toxins maintained by the
Centers for Disease Control and
Prevention (CDC), U.S. Department of
Health and Human Services, in 42 CFR
73.3(b).
This rule also amends ECCNs 1C351
and 1C352 by revising the ‘‘Related
Controls’’ paragraph under the List of
Items Controlled for each ECCN to
correct the references to the regulations
maintained by CDC and the Animal and
Plant Health Inspection Service
(APHIS), U.S. Department of
Agriculture, that apply to certain select
agents and toxins.
Finally, this rule amends Section
740.20 (License Exception STA),
Section 742.18 (license requirements
and policies related to the Chemical
Weapons Convention), and the List of
Items Controlled section in ECCN 1C991
(Vaccines, immunotoxins, medical
products, and diagnostic and food
testing kits) to update the references to
certain items controlled under ECCN
1C351 that were alphabetized and
renumbered, as described above.
Section 740.20 also is amended to
include in paragraph (b)(2)(vi) certain
toxins controlled by ECCN 1C351.d that
were inadvertently omitted by the
License Exception STA rule that BIS
published on June 16, 2011 (76 FR
35276). The toxins identified in Section
740.20(b)(2)(vi) may be exported under
License Exception STA to countries
listed in Section 740.20(c)(1), provided
that such exports conform with the
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limits specified in Section
740.20(b)(2)(vi)(A) and (b)(2)(vi)(B).
None of the changes made by this rule
increase the scope of the controls in
ECCNs 1C351 and 1C991 (i.e., the items
that are controlled under these ECCNs
remain the same, although certain items
are now specifically identified under
separate listings in 1C351.a). As noted
above, ‘‘Flexal virus,’’ which was
previously controlled under ECCN
1C351.a, is now controlled as a ‘‘select
agent’’ under ECCN 1C360.a; however,
the license requirements for this virus
remain unchanged.
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 extended by the
Notice of August 12, 2010, 75 FR 50681
(August 16, 2010), has continued the
EAR in effect under the International
Emergency Economic Powers Act.
Saving Clause
Shipments of items removed from
eligibility for export or reexport under a
license exception or without a license
(i.e., under the designator ‘‘NLR’’) as a
result of this regulatory action that were
on dock for loading, on lighter, laden
aboard an exporting carrier, or en route
aboard a carrier to a port of export, on
October 12, 2011, pursuant to actual
orders for export or reexport to a foreign
destination, may proceed to that
destination under the previously
applicable license exception or without
a license (NLR) so long as they are
exported or reexported before October
27, 2011. Any such items not actually
exported or reexported before midnight,
on October 27, 2011, require a license in
accordance with this regulation.
‘‘Deemed’’ exports of ‘‘technology’’
and ‘‘source code’’ removed from
eligibility for export under a license
exception or without a license (under
the designator ‘‘NLR’’) as a result of this
regulatory action may continue to be
made under the previously available
license exception or without a license
(NLR) before October 27, 2011.
Beginning at midnight on October 27,
2011, such ‘‘technology’’ and ‘‘source
code’’ may no longer be released,
without a license, to a foreign national
subject to the ‘‘deemed’’ export controls
in the EAR when a license would be
required to the home country of the
foreign national in accordance with this
regulation.
Rulemaking Requirements
1. Executive Orders 13563 and 12866
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
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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 determined to be not
significant for purposes of Executive
Order 12866.
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 a decision adopted under the
AG intersessional silent approval
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procedures in November 2010 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, Foreign trade.
15 CFR Part 774
Exports, Foreign trade, Reporting and
recordkeeping requirements.
Accordingly, 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 12, 2010, 75
FR 50681 (August 16, 2010).
2. Section 740.20 is amended by
revising paragraph (b)(2)(v) and
paragraph (b)(2)(vi) introductory text, as
follows:
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§ 740.20 License Exception Strategic
Trade Authorization (STA).
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(b) * * *
(2) * * *
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(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, 1C360, 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, 1C354 or
1C360) or ECCN 1E351.
(vi) Toxins controlled by ECCN
1C351.d.1 through 1C351.d.10 and
1C351.d.13 through 1C351.d.19 are
authorized under License Exception
STA to destinations indicated in
paragraph (c)(1) of this section, subject
to the following limits. For purposes of
this paragraph, all such toxins that are
sent from one exporter, reexporter or
transferor to a single end-user, on the
same day, constitute one shipment.
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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 12, 2010, 75 FR
50681 (August 16, 2010); Notice of November
4, 2010, 75 FR 68673 (November 8, 2010).
4. Section 742.18 is amended by
revising paragraph (a)(1), paragraph
(b)(1)(i) introductory text, and
paragraphs (b)(1)(ii) and (b)(1)(iii), as
follows:
■
§ 742.18 Chemical Weapons Convention
(CWC or Convention).
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■
56101
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(a) * * *
(1) Schedule 1 chemicals and
mixtures controlled under ECCN 1C351.
A license is required for CW reasons to
export or reexport Schedule 1 chemicals
controlled under ECCN 1C351.d.11 or
d.12 to all destinations including
Canada. CW applies to 1C351.d.11 for
ricin in the form of Ricinus Communis
AgglutininII (RCAII), which is also
known as ricin D or Ricinus Communis
LectinIII (RCLIII), and Ricinus Communis
LectinIV (RCLIV), which is also known as
ricin E. CW applies to 1C351.d.12 for
saxitoxin identified by C.A.S. #35523–
89–8. (Note that the advance
notification procedures and annual
reporting requirements described in
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§ 745.1 of the EAR also apply to exports
of Schedule 1 chemicals.)
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*
(b) * * *
(1) * * *
(i) Exports to States Parties to the
CWC. Applications to export Schedule 1
Chemicals controlled under ECCN
1C351.d.11 or .d.12 to States Parties to
the CWC (destinations listed in
Supplement No. 2 to part 745 of the
EAR) generally will be denied, unless
all of the following conditions are met:
*
*
*
*
*
(ii) Exports to States not party to the
CWC. Applications to export Schedule 1
chemicals controlled under ECCN
1C351.d.11 or .d.12 to States not Party
to the CWC (destinations not listed in
Supplement No. 2 to part 745 of the
EAR) generally will be denied,
consistent with U.S. obligations under
the CWC to prohibit exports of these
chemicals to States not Party to the
CWC.
(iii) Reexports. Applications to
reexport Schedule 1 chemicals
controlled under ECCN 1C351.d.11 or
.d.12 generally will be denied to all
destinations (including both States
Parties to the CWC and States not Party
to the CWC).
*
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*
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 12, 2010, 75
FR 50681 (August 16, 2010).
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 revising the
License Requirements section and the
‘‘Related Controls’’ and ‘‘Items’’
paragraphs in the List of Items
Controlled section, to read as follows:
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■
Supplement No. 1 to Part 774—The
Commerce Control List
*
*
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*
*
1C351 Human and zoonotic pathogens and
‘‘toxins’’, as follows (see List of Items
Controlled).
License Requirements
Reason for Control: CB, CW, AT
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Control(s)
Country chart
CB applies to entire entry ..
CB Column 1.
CW applies to 1C351.d.11 and d.12 and a
license is required for CW reasons for all
destinations, including Canada, as follows:
CW applies to 1C351.d.11 for ricin in the
form of (1) Ricinus Communis AgglutininII
(RCAII), also known as ricin D or Ricinus
Communis LectinIII (RCLIII) and (2) Ricinus
Communis LectinIV (RCLIV), also known as
ricin E. CW applies to 1C351.d.12 for
saxitoxin identified by C.A.S. #35523–89–8.
See § 742.18 of the EAR for licensing
information pertaining to chemicals subject
to restriction pursuant to the Chemical
Weapons Convention (CWC). The Commerce
Country Chart is not designed to determine
licensing requirements for items controlled
for CW reasons.
Control(s)
Country chart
AT applies to entire entry ..
AT Column 1.
License Requirement Notes
1. All vaccines and ‘‘immunotoxins’’ are
excluded from the scope of this entry. Certain
medical products and diagnostic and food
testing kits that contain biological toxins
controlled under paragraph (d) of this entry,
with the exception of toxins controlled for
CW reasons under d.11 and d.12, are
excluded from the scope of this entry.
Vaccines, ‘‘immunotoxins’’, certain medical
products, and diagnostic and food testing kits
excluded from the scope of this entry are
controlled under ECCN 1C991.
2. For the purposes of this entry, only
saxitoxin is controlled under paragraph d.12;
other members of the paralytic shellfish
poison family (e.g. neosaxitoxin) are
designated EAR99.
3. Clostridium perfringens strains, other
than the epsilon toxin-producing strains of
Clostridium perfringens described in c.9, are
excluded from the scope of this entry, since
they may be used as positive control cultures
for food testing and quality control.
License Exceptions
*
*
*
*
*
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
additional CWC Schedule 1 chemicals
controlled by the Department of State. (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)).
PO 00000
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Fmt 4700
Sfmt 4700
Related Definitions: * * *
Items:
a. Viruses, as follows:
a.1. Andes virus;
a.2. Chapare virus;
a.3. Chikungunya virus;
a.4. Choclo virus;
a.5. Congo-Crimean haemorrhagic fever
virus (a.k.a. Crimean-Congo haemorrhagic
fever virus);
a.6. Dengue fever virus;
a.7. Dobrava-Belgrade virus;
a.8. Eastern equine encephalitis virus;
a.9. Ebola virus;
a.10. Guanarito virus;
a.11. Hantaan virus;
a.12. Hendra virus (Equine morbillivirus);
a.13. Japanese encephalitis virus;
a.14. Junin virus;
a.15. Kyasanur Forest virus;
a.16. Laguna Negra virus;
a.17. Lassa fever virus;
a.18. Louping ill virus;
a.19. Lujo virus;
a.20. Lymphocytic choriomeningitis virus;
a.21. Machupo virus;
a.22. Marburg virus;
a.23. Monkey pox virus;
a.24. Murray Valley encephalitis virus;
a.25. Nipah virus;
a.26. Omsk haemorrhagic fever virus;
a.27. Oropouche virus;
a.28. Powassan virus;
a.29. Rift Valley fever virus;
a.30. Rocio virus;
a.31. Sabia virus;
a.32. Seoul virus;
a.33. Sin nombre virus;
a.34. St. Louis encephalitis virus;
a.35. Tick-borne encephalitis virus
(Russian Spring-Summer encephalitis virus);
a.36. Variola virus;
a.37. Venezuelan equine encephalitis virus;
a.38. Western equine encephalitis virus; or
a.39. Yellow fever virus.
b. Rickettsiae, as follows:
b.1. Bartonella quintana (Rochalimea
quintana, Rickettsia quintana);
b.2. Coxiella burnetii;
b.3. Rickettsia prowasecki (a.k.a. Rickettsia
prowazekii); or
b.4. Rickettsia rickettsii.
c. Bacteria, 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. Clostridium botulinum;
c.9. Clostridium perfringens, epsilon toxin
producing types;
c.10. Enterohaemorrhagic Escherichia coli,
serotype O157 and other verotoxin producing
serotypes;
c.11. Francisella tularensis;
c.12. Salmonella typhi;
c.13. Shigella dysenteriae;
c.14. Vibrio cholerae; or
c.15. Yersinia pestis.
d. ‘‘Toxins’’, as follows, and ‘‘subunits’’
thereof:
E:\FR\FM\12SER1.SGM
12SER1
Federal Register / Vol. 76, No. 176 / Monday, September 12, 2011 / Rules and Regulations
d.1. Abrin;
d.2. Aflatoxins;
d.3. Botulinum toxins;
d.4. Cholera toxin;
d.5. Clostridium perfringens toxins;
d.6. Conotoxin;
d.7. Diacetoxyscirpenol toxin;
d.8. HT–2 toxin;
d.9. Microcystin (Cyanginosin);
d.10. Modeccin toxin;
d.11. Ricin;
d.12. Saxitoxin;
d.13. Shiga toxin;
d.14. Staphylococcus aureus toxins;
d.15. T–2 toxin;
d.16. Tetrodotoxin;
d.17. Verotoxin and other Shiga-like
ribosome inactivating proteins;
d.18. Viscum Album Lectin 1 (Viscumin);
or
d.19. Volkensin toxin.
e. ‘‘Fungi’’, as follows:
e.1. Coccidioides immitis; or
e.2. Coccidioides posadasii.
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
‘‘Related Controls’’ paragraph in the List
of Items Controlled section, to read as
follows:
■
1C352 Animal pathogens, as follows (see
List of Items Controlled).
*
*
*
*
emcdonald on DSK5VPTVN1PROD with RULES
*
*
*
*
■ 8. 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 amended by revising paragraph
(a) in the ‘‘Items’’ paragraph in the List
of Items Controlled to read as follows:
1C360 Select agents not controlled under
ECCN 1C351, 1C352, or 1C354.
*
*
*
*
*
*
*
9. 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 by revising the
‘‘Items’’ paragraph in the List of Items
Controlled to read as follows:
■
1C991 Vaccines, immunotoxins, medical
products, diagnostic and food testing
kits, as follows (see List of Items
controlled).
*
*
*
*
16:09 Sep 09, 2011
Retail Foreign Exchange Transactions;
Conforming Changes to Existing
Regulations in Response to the DoddFrank Wall Street Reform and
Consumer Protection Act
Commodity Futures Trading
Commission.
ACTION: Final rules; interpretation.
AGENCY:
The Commodity Futures
Trading Commission (Commission or
CFTC) is amending its regulations
governing off-exchange foreign currency
transactions with members of the retail
public (i.e., retail forex transactions).
These amendments (Amendments) are
necessary to incorporate into Part 5 of
the Commission’s regulations changes
made to the Commodity Exchange Act
(CEA) by the Dodd-Frank Wall Street
Reform and Consumer Protection Act
(Dodd-Frank Act). The Commission is
also issuing certain related technical
interpretations of various provisions of
the CEA as amended by the Dodd-Frank
Act with respect to retail forex
transactions.
SUMMARY:
Effective September 12, 2011.
DATES:
FOR FURTHER INFORMATION CONTACT:
Dated: August 26, 2011.
Kevin J. Wolf,
Assistant Secretary for Export
Administration.
[FR Doc. 2011–22677 Filed 9–9–11; 8:45 am]
BILLING CODE 3510–33–P
Jkt 223001
17 CFR Part 5
Unit: * * *
Related Controls: * * *
Related Definitions: * * *
Items:
a. Vaccines against items controlled by
ECCN 1C351, 1C352, 1C353, 1C354, or
1C360;
b. Immunotoxins containing items
controlled by 1C351.d;
c. Medical products containing botulinum
toxins controlled by ECCN 1C351.d.3 or
conotoxins controlled by ECCN 1C351.d.6;
d. Medical products containing items
controlled by ECCN 1C351.d (except
botulinum toxins controlled by ECCN
1C351.d.3, conotoxins controlled by ECCN
1C351.d.6, and items controlled for CW
reasons under 1C351.d.11 or .d.12);
e. Diagnostic and food testing kits
containing items controlled by ECCN
1C351.d (except items controlled for CW
reasons under ECCN 1C351.d.11 or .d.12).
List of Items Controlled
Unit: * * *
Related Controls: * * *
Related Definitions: * * *
Items:
Note: * * *
VerDate Mar<15>2010
COMMODITY FUTURES TRADING
COMMISSION
List of Items Controlled
*
*
*
*
*
List of Items Controlled
Unit: * * *
Related Controls: 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)).
Related Definitions: * * *
Items:
*
a. Human and zoonotic pathogens, as
follows:
a.1. Viruses, as follows:
a.1.a. Central European tick-borne
encephalitis viruses, as follows:
a.1.a.1. Absettarov;
a.1.a.2. Hanzalova;
a.1.a.3. Hypr;
a.1.a.4. Kumlinge;
a.1.b. Cercopithecine herpesvirus 1 (Herpes
B virus);
a.1.c. Flexal virus;
a.1.d. Reconstructed replication competent
forms of the 1918 pandemic influenza virus
containing any portion of the coding regions
of all eight gene segments;
a.2. [RESERVED];
56103
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Fmt 4700
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Christopher W. Cummings, Special
Counsel, Division of Clearing and
Intermediary Oversight, or Barbara S.
Gold, Associate Director, Division of
Clearing and Intermediary Oversight,
Commodity Futures Trading
Commission, 1155 21st Street, NW.,
Washington, DC 20581; telephone
number: (202) 418–5450; facsimile
number: (202) 418–5528; and electronic
mail: ccummings@cftc.gov or
bgold@cftc.gov, respectively.
SUPPLEMENTARY INFORMATION:
I. Background
On July 21, 2010, President Obama
signed the Dodd-Frank Act.1 Title VII of
the Dodd-Frank Act 2 amended the
CEA 3 to establish a comprehensive new
regulatory framework for swaps and
security-based swaps. The goal of this
legislation was to reduce risk, increase
transparency, and promote market
integrity within the financial system by,
1 See Dodd-Frank Wall Street Reform and
Consumer Protection Act, Pub. L. No. 111–203, 124
Stat. 1376 (2010). The text of the Dodd-Frank Act
may be accessed through the Commission’s Web
site at https://www.cftc.gov/.
2 Pursuant to Section 701 of the Dodd-Frank Act,
Title VII may be cited as the ‘‘Wall Street
Transparency and Accountability Act of 2010.’’
3 7 U.S.C. 1 et seq. (2006). The CEA also can be
accessed through the Commission’s Web site.
E:\FR\FM\12SER1.SGM
12SER1
]]>Agencies
[Federal Register Volume 76, Number 176 (Monday, September 12, 2011)]
[Rules and Regulations]
[Pages 56099-56103]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22677]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 740, 742 and 774
[Docket No. 110222155-1110-01]
RIN 0694-AF14
Implementation of a Decision Adopted Under the Australia Group
(AG) Intersessional Silent Approval Procedures in 2010 and Related
Editorial Amendments
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
a decision based on a proposal that was discussed at the 2010 Australia
Group (AG) Plenary and adopted under the AG intersessional silent
approval procedures in November 2010. Specifically, this rule amends
the Commerce Control List (CCL) entry in the EAR that controls human
and zoonotic pathogens and ``toxins,'' consistent with the
intersessional changes to the AG's ``List of Biological Agents for
Export Control.'' First, this rule clarifies the scope of the AG-
related controls in the EAR that apply to ``South American haemorrhagic
fever (Sabia, Flexal, Guanarito)'' and ``Pulmonary and renal syndrome-
haemorrhagic fever viruses (Seoul, Dobrava, Puumala, Sin Nombre)'' by
revising the list of viruses in this CCL entry to remove these two
fevers and replace them with ten viral causative agents for the fevers.
These changes are intended to more clearly identify the causative
agents that are of concern for purposes of the controls maintained by
the AG. Second, this rule alphabetizes and renumbers the list of
viruses in this CCL entry, consistent with the 2010 intersessional
changes to the AG control list. Finally, this rule makes an editorial
change to the CCL entry that controls human and zoonotic pathogens and
``toxins.'' To assist exporters to more easily identify the bacteria
and ``toxins'' that are controlled under this CCL entry, this rule
alphabetizes and renumbers the lists of bacteria and ``toxins'' in the
entry.
DATES: This rule is effective September 12, 2011.
ADDRESSES: Send comments regarding this collection of information,
including suggestions for reducing the burden, to Jasmeet Seehra,
Office of Management and Budget (OMB), by e-mail 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 a decision that was
adopted under the Australia Group (AG) intersessional silent approval
procedures in November 2010. The AG is a multilateral forum consisting
of 40 participating countries that maintain
[[Page 56100]]
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.
The November 2010 intersessional decision revised the AG ``List of
Biological Agents for Export Control'' to clarify the scope of the AG
controls that apply to certain viruses connected with the phenotypes or
medical conditions known as ``South American haemorrhagic fever'' and
``Pulmonary and renal syndrome-haemorrhagic fever viruses.'' The
purpose of these changes was to address a concern by the AG that the
listings for ``South American haemorrhagic fever (Sabia, Flexal,
Guanarito)'' and ``Pulmonary and renal syndrome-haemorrhagic fever
viruses (Seoul, Dobrova, Puumala, Sin Nombre)'' could be misinterpreted
(e.g., by assuming that the causative agents identified in the
parentheses represented an exhaustive listing of such viruses). In
addition, both of these AG listings referred to phenotypes or medical
conditions known to be caused by several distinct species of viruses,
some (but not all) of which were identified in parentheses for each
listing.
To address this concern, the November 2010 AG intersessional
decision removed ``South American haemorrhagic fever'' and ``Pulmonary
and renal syndrome-haemorrhagic fever viruses'' from the List of
Biological Agents and replaced them with ten viral causative agents for
the fevers. Five of these causative agents (i.e., ``Dobrava-Belgrade
virus,'' ``Guanarito virus,'' ``Sabia virus,'' ``Seoul virus,'' and
``Sin nombre virus'') were previously identified in parentheses under
the listings for the two fevers, while the other five causative agents
(i.e., ``Andes virus,'' ``Chapare virus,'' ``Choclo virus,'' ``Laguna
Negra virus,'' and ``Lujo virus'') were not previously identified on
the AG List. Two other causative agents (i.e., ``Flexal virus'' and
``Puumala virus'') that were previously identified in parentheses under
the listings for the two fevers were removed from the AG List. This
rule amends Export Control Classification Number (ECCN) 1C351 on the
Commerce Control List (CCL) (Supplement No. 1 to part 774 of the EAR)
by revising the list of viruses contained in 1C351.a to reflect these
changes to the AG List of Biological Agents.
Consistent with the changes to ECCN 1C351 described above, this
rule alphabetizes and renumbers the list of viruses in ECCN 1C351.a to
conform with the format in the AG List of Biological Agents. In
addition, for the convenience of exporters attempting to determine the
control status of certain pathogens and toxins, this rule alphabetizes
and renumbers the lists of bacteria and toxins contained in ECCN
1C351.c and .d, respectively. Consistent with this reordering, this
rule revises references to certain agents identified in the ``CW
Controls'' paragraph of this ECCN, in the ``License Requirements
Notes'' under the License Requirements section of this ECCN, and/or in
the ``Related Controls'' paragraph under the List of Items Controlled
section of this ECCN.
Although this rule removes ``Flexal virus'' from ECCN 1C351,
consistent with the AG intersessional changes to the AG List of
Biological Agents as described above, this virus continues to be listed
on the CCL. Specifically, this rule adds ``Flexal virus'' to ECCN 1C360
(Select agents not controlled under ECCN 1C351, 1C352, or 1C354),
because the virus is included in the list of select agents and toxins
maintained by the Centers for Disease Control and Prevention (CDC),
U.S. Department of Health and Human Services, in 42 CFR 73.3(b).
This rule also amends ECCNs 1C351 and 1C352 by revising the
``Related Controls'' paragraph under the List of Items Controlled for
each ECCN to correct the references to the regulations maintained by
CDC and the Animal and Plant Health Inspection Service (APHIS), U.S.
Department of Agriculture, that apply to certain select agents and
toxins.
Finally, this rule amends Section 740.20 (License Exception STA),
Section 742.18 (license requirements and policies related to the
Chemical Weapons Convention), and the List of Items Controlled section
in ECCN 1C991 (Vaccines, immunotoxins, medical products, and diagnostic
and food testing kits) to update the references to certain items
controlled under ECCN 1C351 that were alphabetized and renumbered, as
described above. Section 740.20 also is amended to include in paragraph
(b)(2)(vi) certain toxins controlled by ECCN 1C351.d that were
inadvertently omitted by the License Exception STA rule that BIS
published on June 16, 2011 (76 FR 35276). The toxins identified in
Section 740.20(b)(2)(vi) may be exported under License Exception STA to
countries listed in Section 740.20(c)(1), provided that such exports
conform with the limits specified in Section 740.20(b)(2)(vi)(A) and
(b)(2)(vi)(B).
None of the changes made by this rule increase the scope of the
controls in ECCNs 1C351 and 1C991 (i.e., the items that are controlled
under these ECCNs remain the same, although certain items are now
specifically identified under separate listings in 1C351.a). As noted
above, ``Flexal virus,'' which was previously controlled under ECCN
1C351.a, is now controlled as a ``select agent'' under ECCN 1C360.a;
however, the license requirements for this virus remain unchanged.
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 extended by the Notice of August 12,
2010, 75 FR 50681 (August 16, 2010), has continued the EAR in effect
under the International Emergency Economic Powers Act.
Saving Clause
Shipments of items removed from eligibility for export or reexport
under a license exception or without a license (i.e., under the
designator ``NLR'') as a result of this regulatory action that were on
dock for loading, on lighter, laden aboard an exporting carrier, or en
route aboard a carrier to a port of export, on October 12, 2011,
pursuant to actual orders for export or reexport to a foreign
destination, may proceed to that destination under the previously
applicable license exception or without a license (NLR) so long as they
are exported or reexported before October 27, 2011. Any such items not
actually exported or reexported before midnight, on October 27, 2011,
require a license in accordance with this regulation.
``Deemed'' exports of ``technology'' and ``source code'' removed
from eligibility for export under a license exception or without a
license (under the designator ``NLR'') as a result of this regulatory
action may continue to be made under the previously available license
exception or without a license (NLR) before October 27, 2011. Beginning
at midnight on October 27, 2011, such ``technology'' and ``source
code'' may no longer be released, without a license, to a foreign
national subject to the ``deemed'' export controls in the EAR when a
license would be required to the home country of the foreign national
in accordance with this regulation.
Rulemaking Requirements
1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is
[[Page 56101]]
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 determined to be not significant for purposes of
Executive Order 12866.
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 a decision adopted under the AG intersessional silent
approval procedures in November 2010 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, Foreign trade.
15 CFR Part 774
Exports, Foreign trade, Reporting and recordkeeping requirements.
Accordingly, 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 12, 2010, 75 FR 50681 (August 16, 2010).
0
2. Section 740.20 is amended by revising paragraph (b)(2)(v) and
paragraph (b)(2)(vi) introductory text, as follows:
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,
1C360, 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, 1C354 or 1C360) or ECCN 1E351.
(vi) Toxins controlled by ECCN 1C351.d.1 through 1C351.d.10 and
1C351.d.13 through 1C351.d.19 are authorized under License Exception
STA to destinations indicated in paragraph (c)(1) of this section,
subject to the following limits. For purposes of this paragraph, all
such toxins that are sent from one exporter, reexporter or transferor
to a single end-user, on the same day, constitute one shipment.
* * * * *
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
12, 2010, 75 FR 50681 (August 16, 2010); Notice of November 4, 2010,
75 FR 68673 (November 8, 2010).
0
4. Section 742.18 is amended by revising paragraph (a)(1), paragraph
(b)(1)(i) introductory text, and paragraphs (b)(1)(ii) and (b)(1)(iii),
as follows:
Sec. 742.18 Chemical Weapons Convention (CWC or Convention).
* * * * *
(a) * * *
(1) Schedule 1 chemicals and mixtures controlled under ECCN 1C351.
A license is required for CW reasons to export or reexport Schedule 1
chemicals controlled under ECCN 1C351.d.11 or d.12 to all destinations
including Canada. CW applies to 1C351.d.11 for ricin in the form of
Ricinus Communis AgglutininII (RCAII), which is
also known as ricin D or Ricinus Communis LectinIII
(RCLIII), and Ricinus Communis LectinIV
(RCLIV), which is also known as ricin E. CW applies to
1C351.d.12 for saxitoxin identified by C.A.S. 35523-89-8.
(Note that the advance notification procedures and annual reporting
requirements described in
[[Page 56102]]
Sec. 745.1 of the EAR also apply to exports of Schedule 1 chemicals.)
* * * * *
(b) * * *
(1) * * *
(i) Exports to States Parties to the CWC. Applications to export
Schedule 1 Chemicals controlled under ECCN 1C351.d.11 or .d.12 to
States Parties to the CWC (destinations listed in Supplement No. 2 to
part 745 of the EAR) generally will be denied, unless all of the
following conditions are met:
* * * * *
(ii) Exports to States not party to the CWC. Applications to export
Schedule 1 chemicals controlled under ECCN 1C351.d.11 or .d.12 to
States not Party to the CWC (destinations not listed in Supplement No.
2 to part 745 of the EAR) generally will be denied, consistent with
U.S. obligations under the CWC to prohibit exports of these chemicals
to States not Party to the CWC.
(iii) Reexports. Applications to reexport Schedule 1 chemicals
controlled under ECCN 1C351.d.11 or .d.12 generally will be denied to
all destinations (including both States Parties to the CWC and States
not Party to the CWC).
* * * * *
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 12, 2010, 75 FR 50681 (August 16, 2010).
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 revising
the License Requirements section and the ``Related Controls'' and
``Items'' paragraphs in the List of Items Controlled section, to read
as follows:
Supplement No. 1 to Part 774--The Commerce Control List
* * * * *
1C351 Human and zoonotic pathogens and ``toxins'', as follows (see
List of Items Controlled).
License Requirements
Reason for Control: CB, CW, AT
Control(s) Country chart
CB applies to entire entry............. CB Column 1.
CW applies to 1C351.d.11 and d.12 and a license is required for CW
reasons for all destinations, including Canada, as follows: CW
applies to 1C351.d.11 for ricin in the form of (1) Ricinus Communis
AgglutininII (RCAII), also known as ricin D or
Ricinus Communis LectinIII (RCLIII) and (2)
Ricinus Communis LectinIV (RCLIV), also known
as ricin E. CW applies to 1C351.d.12 for saxitoxin identified by
C.A.S. 35523-89-8. See Sec. 742.18 of the EAR for
licensing information pertaining to chemicals subject to restriction
pursuant to the Chemical Weapons Convention (CWC). The Commerce
Country Chart is not designed to determine licensing requirements
for items controlled for CW reasons.
Control(s) Country chart
AT applies to entire entry............. AT Column 1.
License Requirement Notes
1. All vaccines and ``immunotoxins'' are excluded from the scope
of this entry. Certain medical products and diagnostic and food
testing kits that contain biological toxins controlled under
paragraph (d) of this entry, with the exception of toxins controlled
for CW reasons under d.11 and d.12, are excluded from the scope of
this entry. Vaccines, ``immunotoxins'', certain medical products,
and diagnostic and food testing kits excluded from the scope of this
entry are controlled under ECCN 1C991.
2. For the purposes of this entry, only saxitoxin is controlled
under paragraph d.12; other members of the paralytic shellfish
poison family (e.g. neosaxitoxin) are designated EAR99.
3. Clostridium perfringens strains, other than the epsilon
toxin-producing strains of Clostridium perfringens described in c.9,
are excluded from the scope of this entry, since they may be used as
positive control cultures for food testing and quality control.
License Exceptions
* * * * *
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 additional CWC
Schedule 1 chemicals controlled by the Department of State. (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)).
Related Definitions: * * *
Items:
a. Viruses, as follows:
a.1. Andes virus;
a.2. Chapare virus;
a.3. Chikungunya virus;
a.4. Choclo virus;
a.5. Congo-Crimean haemorrhagic fever virus (a.k.a. Crimean-
Congo haemorrhagic fever virus);
a.6. Dengue fever virus;
a.7. Dobrava-Belgrade virus;
a.8. Eastern equine encephalitis virus;
a.9. Ebola virus;
a.10. Guanarito virus;
a.11. Hantaan virus;
a.12. Hendra virus (Equine morbillivirus);
a.13. Japanese encephalitis virus;
a.14. Junin virus;
a.15. Kyasanur Forest virus;
a.16. Laguna Negra virus;
a.17. Lassa fever virus;
a.18. Louping ill virus;
a.19. Lujo virus;
a.20. Lymphocytic choriomeningitis virus;
a.21. Machupo virus;
a.22. Marburg virus;
a.23. Monkey pox virus;
a.24. Murray Valley encephalitis virus;
a.25. Nipah virus;
a.26. Omsk haemorrhagic fever virus;
a.27. Oropouche virus;
a.28. Powassan virus;
a.29. Rift Valley fever virus;
a.30. Rocio virus;
a.31. Sabia virus;
a.32. Seoul virus;
a.33. Sin nombre virus;
a.34. St. Louis encephalitis virus;
a.35. Tick-borne encephalitis virus (Russian Spring-Summer
encephalitis virus);
a.36. Variola virus;
a.37. Venezuelan equine encephalitis virus;
a.38. Western equine encephalitis virus; or
a.39. Yellow fever virus.
b. Rickettsiae, as follows:
b.1. Bartonella quintana (Rochalimea quintana, Rickettsia
quintana);
b.2. Coxiella burnetii;
b.3. Rickettsia prowasecki (a.k.a. Rickettsia prowazekii); or
b.4. Rickettsia rickettsii.
c. Bacteria, 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. Clostridium botulinum;
c.9. Clostridium perfringens, epsilon toxin producing types;
c.10. Enterohaemorrhagic Escherichia coli, serotype O157 and
other verotoxin producing serotypes;
c.11. Francisella tularensis;
c.12. Salmonella typhi;
c.13. Shigella dysenteriae;
c.14. Vibrio cholerae; or
c.15. Yersinia pestis.
d. ``Toxins'', as follows, and ``subunits'' thereof:
[[Page 56103]]
d.1. Abrin;
d.2. Aflatoxins;
d.3. Botulinum toxins;
d.4. Cholera toxin;
d.5. Clostridium perfringens toxins;
d.6. Conotoxin;
d.7. Diacetoxyscirpenol toxin;
d.8. HT-2 toxin;
d.9. Microcystin (Cyanginosin);
d.10. Modeccin toxin;
d.11. Ricin;
d.12. Saxitoxin;
d.13. Shiga toxin;
d.14. Staphylococcus aureus toxins;
d.15. T-2 toxin;
d.16. Tetrodotoxin;
d.17. Verotoxin and other Shiga-like ribosome inactivating
proteins;
d.18. Viscum Album Lectin 1 (Viscumin); or
d.19. Volkensin toxin.
e. ``Fungi'', as follows:
e.1. Coccidioides immitis; or
e.2. Coccidioides posadasii.
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 ``Related Controls'' paragraph in the List of Items Controlled
section, to read as follows:
1C352 Animal pathogens, as follows (see List of Items Controlled).
* * * * *
List of Items Controlled
Unit: * * *
Related Controls: 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)).
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 1C360 is amended by revising
paragraph (a) in the ``Items'' paragraph in the List of Items
Controlled to read as follows:
1C360 Select agents not controlled under ECCN 1C351, 1C352, or
1C354.
* * * * *
List of Items Controlled
Unit: * * *
Related Controls: * * *
Related Definitions: * * *
Items:
Note: * * *
a. Human and zoonotic pathogens, as follows:
a.1. Viruses, as follows:
a.1.a. Central European tick-borne encephalitis viruses, as
follows:
a.1.a.1. Absettarov;
a.1.a.2. Hanzalova;
a.1.a.3. Hypr;
a.1.a.4. Kumlinge;
a.1.b. Cercopithecine herpesvirus 1 (Herpes B virus);
a.1.c. Flexal virus;
a.1.d. Reconstructed replication competent forms of the 1918
pandemic influenza virus containing any portion of the coding
regions of all eight gene segments;
a.2. [RESERVED];
* * * * *
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 1C991 is amended by revising
the ``Items'' paragraph in the List of Items Controlled 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: * * *
Items:
a. Vaccines against items controlled by ECCN 1C351, 1C352,
1C353, 1C354, or 1C360;
b. Immunotoxins containing items controlled by 1C351.d;
c. Medical products containing botulinum toxins controlled by
ECCN 1C351.d.3 or conotoxins controlled by ECCN 1C351.d.6;
d. Medical products containing items controlled by ECCN 1C351.d
(except botulinum toxins controlled by ECCN 1C351.d.3, conotoxins
controlled by ECCN 1C351.d.6, and items controlled for CW reasons
under 1C351.d.11 or .d.12);
e. Diagnostic and food testing kits containing items controlled
by ECCN 1C351.d (except items controlled for CW reasons under ECCN
1C351.d.11 or .d.12).
Dated: August 26, 2011.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2011-22677 Filed 9-9-11; 8:45 am]
BILLING CODE 3510-33-P
