Document ID: BIS-2013-0008-0001
Agency: bis
Document Type: Rule
Title: Export Administration Regulations: List of Items Classified Under Export Control Classification 0Y521 Series - Biosensor Systems
Posted Date: 2013-03-28T04:00Z

[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]

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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.

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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: http://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]]

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                                                                 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
 
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                                    0A521. Systems, Equipment and Components
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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.
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                                0B521. Test, Inspection and Production Equipment
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[RESERVED]............................
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                                                0C521. Materials
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[RESERVED]............................
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                                                 0D521. Software
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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.
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                                                0E521. Technology
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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.
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    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