Amendment to the Export Administration Regulations: List of Items Classified Under Export Control Classification 0Y521 Series-Biosensor Systems, 18814-18817 [2013-07132]
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18814
Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations
Country
License review
policy
Entity
License requirement
*
*
*
Liberty House Trading LLC, a.k.a.
the following two aliases: -Baet
Alhoreya Electronics Trading;
and -Baet Alhoreya, Apt #1811
Manchester Tower, Dubai Marina, Dubai, U.A.E.; and PO
Box 111831, Al Daghaya,
Dubai, U.A.E.; and Dubai
Shopping Center, Office 13,
Dubai, U.A.E.
*
For all items subject to the EAR.
(See § 744.11 of the EAR).
*
Presumption of
denial.
*
*
78 FR [INSERT FR PAGE NUMBER ] 3/28/13.
*
*
*
Moh Khoman, No. 405, Albakhit
Centre, Abu-Bakr, AE-Dubai,
U.A.E.; and P.O. Box 40150, Al
Bakhit
Centre,
Messanine
Floor, M–7, Deira, Dubai,
U.A.E.; and Mezzanine Fl, No.
M–7, Al Bakhit Centre, AbuBakr Rd, Deira, Dubai, U.A.E.
Mohamad Javad, No. 405,
Albakhit Centre, Abu-Bakr, AEDubai, U.A.E.; and P.O. Box
40150, Al Bakhit Centre,
Messanine Floor, M–7, Deira,
Dubai, U.A.E.; and Mezzanine
Fl, No. M–7, Al Bakhit Centre,
Abu-Bakr Rd, Deira, Dubai,
U.A.E.
*
For all items subject to the EAR.
(See § 744.11 of the EAR).
*
Presumption of
denial.
*
*
78 FR [INSERT FR PAGE NUMBER ] 3/28/13.
For all items subject to the EAR.
(See § 744.11 of the EAR).
Presumption of
denial.
78 FR [INSERT FR PAGE NUMBER ] 3/28/13.
*
*
Next Gulf Trading LLC, No. 75
Noor Mohammed Taleb Building, Opposite to Ascot Hotel,
Khaleed-bin-Valid
Rd,
Bur
Dubai, Dubai, U.A.E.; and No.
7 Noor Mohammad Taleb Bldg.
Opp. Ascot Hotel Khalid Bin
Rd, Dubai, U.A.E.; and No.
705, Noor Mohammad Taleb
Bldg, Bin Valid Road, Dubai,
U.A.E.; and P.O. Box 122114,
Dubai,
U.A.E.;
and
P.O.
111837, Dubai, U.A.E.
*
For all items subject to the EAR.
(See § 744.11 of the EAR).
*
Presumption of
denial.
*
*
78 FR [INSERT FR PAGE NUMBER ] 3/28/13.
*
*
*
*
Dated: March 21, 2013.
Kevin J. Wolf,
Assistant Secretary for Export
Administration.
*
*
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
[FR Doc. 2013–07135 Filed 3–27–13; 8:45 am]
15 CFR Part 774
[Docket No. 121025585–3248–01]
BILLING CODE 3510–33–P
RIN 0694–AF73
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Amendment to the Export
Administration Regulations: List of
Items Classified Under Export Control
Classification 0Y521 Series—
Biosensor Systems
Bureau of Industry and
Security, Commerce.
ACTION: Interim final rule with request
for comments.
AGENCY:
SUMMARY: In this interim final rule, the
Bureau of Industry and Security (BIS)
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amends the Export Administration
Regulations (EAR) to make certain items
subject to the EAR and to impose on
those items a license requirement for
export and reexport to all destinations,
except Canada. Specifically, this rule
classifies specified biosensor systems,
‘‘software’’ and ‘‘technology’’ under
Export Control Classification Numbers
(ECCNs) 0A521, 0D521 and 0E521,
respectively, on the Commerce Control
List (CCL). As described in the final rule
that established the 0Y521 series and
that was published in the Federal
Register on April 13, 2012 (77 FR
22191), items are added to the 0Y521
series upon a determination by the
Department of Commerce, with the
concurrence of the Departments of
Defense and State, that the items should
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be controlled for export because the
items provide at least a significant
military or intelligence advantage to the
United States or foreign policy reasons
justify control. The items identified in
this rule are controlled for regional
stability (RS) Column 1 reasons. The
only license exception available for
these items is for official use by
personnel and agencies of the U.S.
Government.
DATES: This rule is effective March 28,
2013. Comments must be received by
May 28, 2013.
ADDRESSES: You may submit comments
by any of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. The identification
number for this rulemaking is BIS–
2013–0007.
• By email directly to:
publiccomments@bis.doc.gov. Include
RIN 0694–AF73 in the subject line.
• By mail or delivery to Regulatory
Policy Division, Bureau of Industry and
Security, U.S. Department of Commerce,
Room 2099B, 14th Street and
Pennsylvania Avenue NW., Washington,
DC 20230. Refer to RIN 0694–AF73.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Sangine, Director, Chemical
and Biological Controls Division, Office
of Nonproliferation and Treaty
Compliance by phone at (202) 482–3343
or by email at
Elizabeth.Scottsangine@bis.doc.gov.
SUPPLEMENTARY INFORMATION:
Background
BIS established the ECCN 0Y521
series to identify items that warrant
control on the CCL but are not yet
identified in an existing ECCN. Items
are added to the ECCN 0Y521 series by
the Department of Commerce, with the
concurrence of the Departments of
Defense and State, upon a determination
that an item should be controlled
because it provides at least a significant
military or intelligence advantage to the
United States or because foreign policy
reasons justify such control. The ECCN
0Y521 series is a temporary holding
classification equivalent to United
States Munitions List (USML) Category
XXI (Miscellaneous Articles) in part 121
of the International Traffic in Arms
Regulations, but with a limitation that
while an item is temporarily classified
under ECCN 0Y521, the U.S.
Government works to adopt a control
through the relevant multilateral
regime(s), to determine an appropriate
longer-term control over the item, or
that the item does not warrant control
on the CCL.
Items classified under ECCN 0Y521,
including the items identified in this
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interim final rule as 0A521, 0D521 and
0E521 items, remain so-classified for
one year from the date a final rule
identifying the item is published in the
Federal Register amending the EAR,
unless the item is re-classified under a
different ECCN, under an EAR99
designation, or the 0Y521 classification
is extended. During this time, the U.S.
Government determines whether it is
appropriate to submit a proposed
control to the applicable export control
regime (e.g., the Australia Group) for
potential multilateral control, with the
understanding that multilateral controls
are preferable when practical. An item’s
ECCN 0Y521 classification may be
extended for two one-year periods to
provide time for the U.S. Government
and multilateral regime(s) to reach
agreement on controls for the item, and
provided that the U.S. Government has
submitted a proposal to obtain
multilateral controls over the item.
Further extension beyond three years
may occur only if the Under Secretary
for Industry and Security makes a
determination that such extension is in
the national security or foreign policy
interests of the United States. An
extension or re-extension, including a
determination by the Under Secretary
for Industry and Security, will be
published in the Federal Register.
License Requirements, Policies and
Exceptions
The license requirements and policies
for the ECCNs 0Y521 series appear in
§ 742.6(a)(7) of the EAR. ECCN 0Y521
items are subject to a nearly worldwide
license requirement (i.e., for every
country except Canada) with a case-bycase license review policy, through
regional stability (RS Column 1)
controls. The description and status of
ECCN 0Y521 items appear in
Supplement No. 5 to part 774 of the
EAR, along with any item-specific
license exceptions, where applicable.
Unless otherwise indicated, License
Exception GOV is applicable to all
ECCN 0Y521 series items, including
those items identified in this notice, if
the item is within the scope of
§ 740.11(b)(2)(ii) (Items for official use
by personnel and agencies of the U.S.
Government), as provided in
§ 740.2(a)(14). License Exception GOV is
the only license exception that can be
used for the items identified in this
interim final rule.
Addition of ECCN 0A521, 0D521 and
0E521 Items
In this rule, BIS amends the EAR to
make specified biosensor systems, and
related ‘‘software,’’ and ‘‘technology’’
subject to the EAR and impose license
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18815
requirements on these items. These
items are being added to the 0Y521
series pursuant to a determination by
the Department of Commerce, with the
concurrence of the Departments of State
and Defense, that these items should be
controlled because they provide a
significant military or intelligence
advantage to the United States or
because foreign policy reasons justify
such controls. The specified biosensor
systems, ‘‘software,’’ and ‘‘technology’’
are classified under ECCNs 0A521,
0D521 and 0E521, respectively. A brief
description of each of these items and
ECCNs follows.
ECCN 0A521 covers biosensor
systems and dedicated detecting
components capable of detecting certain
aerosolized bioagents and having the
following characteristics: capable of
showing results in three minutes or less;
containing an integrated bioaerosol
collector and identifier; containing
antibodies to the bioagents listed in the
entry; and utilizing bioluminescence as
a process. This entry also includes a
Related Controls paragraph that
differentiates ECCNs 1A004.c detection
systems and 2B351 toxic gas monitoring
systems and their dedicated detecting
components controls on the CCL from
0A521 Biosensor Systems. That
paragraph also refers exporters to USML
Category XIV(f)(2) for equipment for the
detection, identification, warning or
monitoring of biological agents that is
subject to the licensing jurisdiction of
the Department of State, Directorate of
Defense Trade Controls. Finally, two
Technical Notes are provided for this
entry defining the term ‘dedicated’ and
clarifying that the entry does not control
biosensor systems that detect foodborne
pathogens.
0D521 is ‘‘Software’’ for the function
of biosensor systems controlled by
ECCN 0A521.
0E521 is ‘‘Technology’’ for the
‘‘development’’ or ‘‘production’’ of
biosensor systems controlled by ECCN
0A521.
The technical descriptions and the
status of the specified items appear in
the table found in Supplement No. 5 to
part 774 of the EAR.
License Applications for the New ECCN
0A521, 0D521 and 0E521 Items
License applications for these items
may be submitted through SNAP–R in
accordance with § 748.6 of the EAR.
Exporters are directed to include
detailed descriptions and technical
specifications with the license
application, and identify the hardware
as ECCN 0A521, the ‘‘software’’ as
ECCN 0D521, and the ‘‘technology’’ as
ECCN 0E521.
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Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Rules and Regulations
This rule is being issued in interim
final form because while the
Government believes that it is in the
national security interests of the United
States to immediately implement these
controls, it also wants to provide the
interested public with an opportunity to
comment to the Government on the
ultimate nature of export controls on
these items.
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 15, 2012, 77 FR 49699
(August 16, 2012), has continued the
Export Administration Regulations in
effect under the International
Emergency Economic Powers Act. BIS
continues to carry out the provisions of
the Export Administration Act, as
appropriate and to the extent permitted
by law, pursuant to Executive Order
13222.
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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, distribute 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 is 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
OMB control number. This rule affects
two approved collections: (1) The
Simplified Network Application
Processing + System (control number
0694–0088), which carries a burden
hour estimate of 43.8 minutes, including
the time necessary to submit license
applications, among other things, as
well as miscellaneous and other
recordkeeping activities that account for
12 minutes per submission; and (2)
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License Exceptions and Exclusions
(0694–0137). With these initial 0Y521
series items, BIS does not believe that
this rule will materially increase the
number of submissions under these
collections.
3. This rule does not contain policies
with Federalism implications as that
term is defined under E.O. 13132.
4. The provisions of the
Administrative Procedure Act (5 U.S.C.
553) requiring prior notice, the
opportunity for public comment and a
delay in effective date are inapplicable
because this regulation involves a
military or foreign affairs function of the
United States (See 5 U.S.C. 553(a)(1)).
BIS, with the concurrence of the U.S.
Departments of Defense and State, is
implementing this rule because the
items identified for the ECCN 0Y521
series in this rule provide a significant
military or intelligence advantage to the
United States. Immediate imposition of
a license requirement is necessary to
effect the national security and foreign
policy goals of this rule. Immediate
implementation will allow BIS to
prevent exports of these items to users
and for uses that pose a national
security threat to the United States or its
allies. If BIS delayed this rule to allow
for prior notice and opportunity for
public comment, the resulting delay in
implementation would afford an
opportunity for the export of these items
to users and uses that pose such a
national security threat, thereby
undermining the purpose of the rule. In
addition, if parties receive notice of the
U.S. Government’s intention to control
these items under 0Y521 once a final
rule was published, they might have an
incentive to either accelerate orders of
these items or attempt to have the items
exported prior to the imposition of the
control.
Further, BIS finds good cause to
waive the 30-day delay in effectiveness
under 5 USC 553(d)(3). Immediate
implementation will allow BIS to
prevent exports of these items to users
and for uses that pose a national
security threat to the United States or its
allies. If BIS delayed this rule to allow
for a 30-day delay in effectiveness, the
resulting delay in implementation
would afford an opportunity for the
export of these items to users and uses
that pose such a national security threat,
thereby undermining the purpose of the
rule.
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Because a notice of proposed
rulemaking and an opportunity for
public comment are not required to be
given for this rule by 5 U.S.C. 553, or
by any other law, the analytical
requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq., are
not applicable. Although notice and
opportunity for comment are not
required, BIS is issuing this rule as an
interim final rule with a request for
comments. All comments must be in
writing and submitted via one or more
of the methods listed under the
ADDRESSES caption to this notice. All
comments (including any personal
identifiable information) will be
available for public inspection and
copying. Those wishing to comment
anonymously may do so by submitting
their comment via regulations.gov and
leaving the fields for identifying
information blank.
List of Subjects in 15 CFR Part 774
Exports, Reporting and recordkeeping
requirements.
Accordingly, part 774 of the Export
Administration Regulations (15 CFR
parts 730–774) is amended as follows:
PART 774—[AMENDED]
1. The authority citation for 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).
2. Supplement No. 5 to Part 774 is
revised to read as follows:
■
Supplement No. 5 to Part 774—Items
Classified Under ECCNS 0A521, 0B521,
0C521, 0D521 and 0E521
The following table lists items subject to
the EAR that are not listed elsewhere in the
CCL, but which the Department of
Commerce, with the concurrence of the
Departments of Defense and State, has
identified warrant control for export or
reexport because the items provide at least a
significant military or intelligence advantage
to the United States or for foreign policy
reasons.
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Date of initial or
subsequent BIS classification.
(ID = initial date; SD =
subsequent date)
Item descriptor
Note: The description must match by model number or a
broader descriptor that does not necessarily need to be company specific
Date when the item will
be designated
EAR99, unless reclassified in another ECCN or
the 0Y521 classification
is reissued
18817
Item-specific license exception eligibility
0A521. Systems, Equipment and Components
No.1: Biosensor systems and dedicated detecting components,
i.e. cartridges and cells, capable of detecting all of the following aerosolized bioagents: anthrax, ricin,
Botulinum toxin, Francisella tularensis, orthopoxvirus and
Yersinia pestis, and having all of the following characteristics:
a. Capable of showing results in three minutes or less;
b. Has an integrated bioaerosol collector and identifier;
c. Contains antibodies for any of the bioagents listed
above; and
d. Utilizes bioluminescence as a process.
Related Controls. (1) See ECCN 1A004.c for detection systems
and ECCN 2B351 for toxic gas monitoring systems and their
dedicated detecting components, both of which are different
from ECCN 0A521.
Biosensor Systems. (2) See 22 CFR Part 121, Category XIV (f)
(2) for equipment for the detection, identification, warning or
monitoring of biological agents that is subject to the export licensing jurisdiction of the U.S. Department of State, Directorate of Defense Trade Controls.
Technical Notes:
1. For the purposes of this entry, the term dedicated
means committed entirely to a single purpose or device.
2. This entry does not control biosensor systems that detect food borne pathogens.
March 28, 2013 (ID) ......
March 28, 2014 .............
License Exception GOV
under
§ 740.11(b)(2)(ii) only.
0B521. Test, Inspection and Production Equipment
[RESERVED].
0C521. Materials
[RESERVED].
0D521. Software
No. 1 0D521 ‘‘Software’’ for the function of Biosensor Systems
controlled by ECCN 0A521.
March 28, 2013 (ID) ......
March 28, 2014 .............
License Exception GOV
under
§ 740.11(b)(2)(ii) only.
March 28, 2014 .............
License Exception GOV
under
§ 740.11(b)(2)(ii) only.
0E521. Technology
No. 1: 0E521 ‘‘Technology’’ for the ‘‘development’’ or ‘‘production’’ of Biosensor Systems controlled by ECCN 0A521.
Dated: March 21, 2013.
Kevin J. Wolf,
Assistant Secretary for Export
Administration.
March 28, 2013 (ID) ......
DEPARTMENT OF ENERGY
Federal Energy Regulatory
Commission
[FR Doc. 2013–07132 Filed 3–27–13; 8:45 am]
BILLING CODE 3510–33–P
18 CFR Part 40
[Docket No. RM12–4–000; Order No. 777]
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Revisions to Reliability Standard for
Transmission Vegetation Management
Federal Energy Regulatory
Commission.
ACTION: Final rule.
AGENCY:
SUMMARY: Under section 215 of the
Federal Power Act (FPA), the Federal
Energy Regulatory Commission
(Commission) approves Reliability
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Standard FAC–003–2 (Transmission
Vegetation Management), submitted to
the Commission for approval by the
North American Electric Reliability
Corporation (NERC), the Commissioncertified Electric Reliability
Organization. Reliability Standard FAC–
003–2 expands the applicability of the
standard to include overhead
transmission lines that are operated
below 200 kV, if they are either an
element of an Interconnection
Reliability Operating Limit or an
element of a Major WECC Transfer Path.
Reliability Standard FAC–003–2
incorporates a new minimum annual
inspection requirement, and
incorporates new minimum vegetation
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]]>Agencies
[Federal Register Volume 78, Number 60 (Thursday, March 28, 2013)]
[Rules and Regulations]
[Pages 18814-18817]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07132]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Part 774
[Docket No. 121025585-3248-01]
RIN 0694-AF73
Amendment to the Export Administration Regulations: List of Items
Classified Under Export Control Classification 0Y521 Series--Biosensor
Systems
AGENCY: Bureau of Industry and Security, Commerce.
ACTION: Interim final rule with request for comments.
-----------------------------------------------------------------------
SUMMARY: In this interim final rule, the Bureau of Industry and
Security (BIS) amends the Export Administration Regulations (EAR) to
make certain items subject to the EAR and to impose on those items a
license requirement for export and reexport to all destinations, except
Canada. Specifically, this rule classifies specified biosensor systems,
``software'' and ``technology'' under Export Control Classification
Numbers (ECCNs) 0A521, 0D521 and 0E521, respectively, on the Commerce
Control List (CCL). As described in the final rule that established the
0Y521 series and that was published in the Federal Register on April
13, 2012 (77 FR 22191), items are added to the 0Y521 series upon a
determination by the Department of Commerce, with the concurrence of
the Departments of Defense and State, that the items should
[[Page 18815]]
be controlled for export because the items provide at least a
significant military or intelligence advantage to the United States or
foreign policy reasons justify control. The items identified in this
rule are controlled for regional stability (RS) Column 1 reasons. The
only license exception available for these items is for official use by
personnel and agencies of the U.S. Government.
DATES: This rule is effective March 28, 2013. Comments must be received
by May 28, 2013.
ADDRESSES: You may submit comments by any of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
The identification number for this rulemaking is BIS-2013-0007.
By email directly to: publiccomments@bis.doc.gov. Include
RIN 0694-AF73 in the subject line.
By mail or delivery to Regulatory Policy Division, Bureau
of Industry and Security, U.S. Department of Commerce, Room 2099B, 14th
Street and Pennsylvania Avenue NW., Washington, DC 20230. Refer to RIN
0694-AF73.
FOR FURTHER INFORMATION CONTACT: Elizabeth Sangine, Director, Chemical
and Biological Controls Division, Office of Nonproliferation and Treaty
Compliance by phone at (202) 482-3343 or by email at
Elizabeth.Scottsangine@bis.doc.gov.
SUPPLEMENTARY INFORMATION:
Background
BIS established the ECCN 0Y521 series to identify items that
warrant control on the CCL but are not yet identified in an existing
ECCN. Items are added to the ECCN 0Y521 series by the Department of
Commerce, with the concurrence of the Departments of Defense and State,
upon a determination that an item should be controlled because it
provides at least a significant military or intelligence advantage to
the United States or because foreign policy reasons justify such
control. The ECCN 0Y521 series is a temporary holding classification
equivalent to United States Munitions List (USML) Category XXI
(Miscellaneous Articles) in part 121 of the International Traffic in
Arms Regulations, but with a limitation that while an item is
temporarily classified under ECCN 0Y521, the U.S. Government works to
adopt a control through the relevant multilateral regime(s), to
determine an appropriate longer-term control over the item, or that the
item does not warrant control on the CCL.
Items classified under ECCN 0Y521, including the items identified
in this interim final rule as 0A521, 0D521 and 0E521 items, remain so-
classified for one year from the date a final rule identifying the item
is published in the Federal Register amending the EAR, unless the item
is re-classified under a different ECCN, under an EAR99 designation, or
the 0Y521 classification is extended. During this time, the U.S.
Government determines whether it is appropriate to submit a proposed
control to the applicable export control regime (e.g., the Australia
Group) for potential multilateral control, with the understanding that
multilateral controls are preferable when practical. An item's ECCN
0Y521 classification may be extended for two one-year periods to
provide time for the U.S. Government and multilateral regime(s) to
reach agreement on controls for the item, and provided that the U.S.
Government has submitted a proposal to obtain multilateral controls
over the item. Further extension beyond three years may occur only if
the Under Secretary for Industry and Security makes a determination
that such extension is in the national security or foreign policy
interests of the United States. An extension or re-extension, including
a determination by the Under Secretary for Industry and Security, will
be published in the Federal Register.
License Requirements, Policies and Exceptions
The license requirements and policies for the ECCNs 0Y521 series
appear in Sec. 742.6(a)(7) of the EAR. ECCN 0Y521 items are subject to
a nearly worldwide license requirement (i.e., for every country except
Canada) with a case-by-case license review policy, through regional
stability (RS Column 1) controls. The description and status of ECCN
0Y521 items appear in Supplement No. 5 to part 774 of the EAR, along
with any item-specific license exceptions, where applicable. Unless
otherwise indicated, License Exception GOV is applicable to all ECCN
0Y521 series items, including those items identified in this notice, if
the item is within the scope of Sec. 740.11(b)(2)(ii) (Items for
official use by personnel and agencies of the U.S. Government), as
provided in Sec. 740.2(a)(14). License Exception GOV is the only
license exception that can be used for the items identified in this
interim final rule.
Addition of ECCN 0A521, 0D521 and 0E521 Items
In this rule, BIS amends the EAR to make specified biosensor
systems, and related ``software,'' and ``technology'' subject to the
EAR and impose license requirements on these items. These items are
being added to the 0Y521 series pursuant to a determination by the
Department of Commerce, with the concurrence of the Departments of
State and Defense, that these items should be controlled because they
provide a significant military or intelligence advantage to the United
States or because foreign policy reasons justify such controls. The
specified biosensor systems, ``software,'' and ``technology'' are
classified under ECCNs 0A521, 0D521 and 0E521, respectively. A brief
description of each of these items and ECCNs follows.
ECCN 0A521 covers biosensor systems and dedicated detecting
components capable of detecting certain aerosolized bioagents and
having the following characteristics: capable of showing results in
three minutes or less; containing an integrated bioaerosol collector
and identifier; containing antibodies to the bioagents listed in the
entry; and utilizing bioluminescence as a process. This entry also
includes a Related Controls paragraph that differentiates ECCNs 1A004.c
detection systems and 2B351 toxic gas monitoring systems and their
dedicated detecting components controls on the CCL from 0A521 Biosensor
Systems. That paragraph also refers exporters to USML Category
XIV(f)(2) for equipment for the detection, identification, warning or
monitoring of biological agents that is subject to the licensing
jurisdiction of the Department of State, Directorate of Defense Trade
Controls. Finally, two Technical Notes are provided for this entry
defining the term `dedicated' and clarifying that the entry does not
control biosensor systems that detect foodborne pathogens.
0D521 is ``Software'' for the function of biosensor systems
controlled by ECCN 0A521.
0E521 is ``Technology'' for the ``development'' or ``production''
of biosensor systems controlled by ECCN 0A521.
The technical descriptions and the status of the specified items
appear in the table found in Supplement No. 5 to part 774 of the EAR.
License Applications for the New ECCN 0A521, 0D521 and 0E521 Items
License applications for these items may be submitted through SNAP-
R in accordance with Sec. 748.6 of the EAR. Exporters are directed to
include detailed descriptions and technical specifications with the
license application, and identify the hardware as ECCN 0A521, the
``software'' as ECCN 0D521, and the ``technology'' as ECCN 0E521.
[[Page 18816]]
This rule is being issued in interim final form because while the
Government believes that it is in the national security interests of
the United States to immediately implement these controls, it also
wants to provide the interested public with an opportunity to comment
to the Government on the ultimate nature of export controls on these
items.
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 15,
2012, 77 FR 49699 (August 16, 2012), has continued the Export
Administration Regulations in effect under the International Emergency
Economic Powers Act. BIS continues to carry out the provisions of the
Export Administration Act, as appropriate and to the extent permitted
by law, pursuant to Executive Order 13222.
Rulemaking Requirements
1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distribute 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 is 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 OMB
control number. This rule affects two approved collections: (1) The
Simplified Network Application Processing + System (control number
0694-0088), which carries a burden hour estimate of 43.8 minutes,
including the time necessary to submit license applications, among
other things, as well as miscellaneous and other recordkeeping
activities that account for 12 minutes per submission; and (2) License
Exceptions and Exclusions (0694-0137). With these initial 0Y521 series
items, BIS does not believe that this rule will materially increase the
number of submissions under these collections.
3. This rule does not contain policies with Federalism implications
as that term is defined under E.O. 13132.
4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring prior notice, the opportunity for public comment and a
delay in effective date are inapplicable because this regulation
involves a military or foreign affairs function of the United States
(See 5 U.S.C. 553(a)(1)). BIS, with the concurrence of the U.S.
Departments of Defense and State, is implementing this rule because the
items identified for the ECCN 0Y521 series in this rule provide a
significant military or intelligence advantage to the United States.
Immediate imposition of a license requirement is necessary to effect
the national security and foreign policy goals of this rule. Immediate
implementation will allow BIS to prevent exports of these items to
users and for uses that pose a national security threat to the United
States or its allies. If BIS delayed this rule to allow for prior
notice and opportunity for public comment, the resulting delay in
implementation would afford an opportunity for the export of these
items to users and uses that pose such a national security threat,
thereby undermining the purpose of the rule. In addition, if parties
receive notice of the U.S. Government's intention to control these
items under 0Y521 once a final rule was published, they might have an
incentive to either accelerate orders of these items or attempt to have
the items exported prior to the imposition of the control.
Further, BIS finds good cause to waive the 30-day delay in
effectiveness under 5 USC 553(d)(3). Immediate implementation will
allow BIS to prevent exports of these items to users and for uses that
pose a national security threat to the United States or its allies. If
BIS delayed this rule to allow for a 30-day delay in effectiveness, the
resulting delay in implementation would afford an opportunity for the
export of these items to users and uses that pose such a national
security threat, thereby undermining the purpose of the rule.
Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule by 5 U.S.C.
553, or by any other law, the analytical requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Although
notice and opportunity for comment are not required, BIS is issuing
this rule as an interim final rule with a request for comments. All
comments must be in writing and submitted via one or more of the
methods listed under the ADDRESSES caption to this notice. All comments
(including any personal identifiable information) will be available for
public inspection and copying. Those wishing to comment anonymously may
do so by submitting their comment via regulations.gov and leaving the
fields for identifying information blank.
List of Subjects in 15 CFR Part 774
Exports, Reporting and recordkeeping requirements.
Accordingly, part 774 of the Export Administration Regulations (15
CFR parts 730-774) is amended as follows:
PART 774--[AMENDED]
0
1. The authority citation for 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).
0
2. Supplement No. 5 to Part 774 is revised to read as follows:
Supplement No. 5 to Part 774--Items Classified Under ECCNS 0A521,
0B521, 0C521, 0D521 and 0E521
The following table lists items subject to the EAR that are not
listed elsewhere in the CCL, but which the Department of Commerce,
with the concurrence of the Departments of Defense and State, has
identified warrant control for export or reexport because the items
provide at least a significant military or intelligence advantage to
the United States or for foreign policy reasons.
[[Page 18817]]
----------------------------------------------------------------------------------------------------------------
Date when the item will
Item descriptor Note: The description Date of initial or be designated EAR99,
must match by model number or a subsequent BIS unless reclassified in
broader descriptor that does not classification. (ID = another ECCN or the Item-specific license
necessarily need to be company initial date; SD = 0Y521 classification is exception eligibility
specific subsequent date) reissued
----------------------------------------------------------------------------------------------------------------
0A521. Systems, Equipment and Components
----------------------------------------------------------------------------------------------------------------
No.1: Biosensor systems and dedicated March 28, 2013 (ID).... March 28, 2014......... License Exception GOV
detecting components, i.e. cartridges under Sec.
and cells, capable of detecting all 740.11(b)(2)(ii)
of the following aerosolized only.
bioagents: anthrax, ricin,
Botulinum toxin, Francisella
tularensis, orthopoxvirus and
Yersinia pestis, and having all of
the following characteristics:.
a. Capable of showing results in
three minutes or less;
b. Has an integrated bioaerosol
collector and identifier;
c. Contains antibodies for any of
the bioagents listed above; and
d. Utilizes bioluminescence as a
process.
Related Controls. (1) See ECCN 1A004.c
for detection systems and ECCN 2B351
for toxic gas monitoring systems and
their dedicated detecting components,
both of which are different from ECCN
0A521.
Biosensor Systems. (2) See 22 CFR Part
121, Category XIV (f) (2) for
equipment for the detection,
identification, warning or monitoring
of biological agents that is subject
to the export licensing jurisdiction
of the U.S. Department of State,
Directorate of Defense Trade
Controls.
Technical Notes:
1. For the purposes of this entry,
the term dedicated means
committed entirely to a single
purpose or device.
2. This entry does not control
biosensor systems that detect
food borne pathogens.
----------------------------------------------------------------------------------------------------------------
0B521. Test, Inspection and Production Equipment
----------------------------------------------------------------------------------------------------------------
[RESERVED]............................
----------------------------------------------------------------------------------------------------------------
0C521. Materials
----------------------------------------------------------------------------------------------------------------
[RESERVED]............................
----------------------------------------------------------------------------------------------------------------
0D521. Software
----------------------------------------------------------------------------------------------------------------
No. 1 0D521 ``Software'' for the March 28, 2013 (ID).... March 28, 2014......... License Exception GOV
function of Biosensor Systems under Sec.
controlled by ECCN 0A521. 740.11(b)(2)(ii)
only.
----------------------------------------------------------------------------------------------------------------
0E521. Technology
----------------------------------------------------------------------------------------------------------------
No. 1: 0E521 ``Technology'' for the March 28, 2013 (ID).... March 28, 2014......... License Exception GOV
``development'' or ``production'' of under Sec.
Biosensor Systems controlled by ECCN 740.11(b)(2)(ii)
0A521. only.
----------------------------------------------------------------------------------------------------------------
Dated: March 21, 2013.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2013-07132 Filed 3-27-13; 8:45 am]
BILLING CODE 3510-33-P
