Document ID: BIS-2014-0026-0001
Agency: bis
Document Type: Rule
Title: Export Administration Regulations: Update of Export Control Classification Number 0Y521 Series Supplement - Biosensor Systems and Related Software and Technology; Amendments
Posted Date: 2014-08-04T04:00Z

[Federal Register Volume 79, Number 149 (Monday, August 4, 2014)]
[Rules and Regulations]
[Pages 45088-45089]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17961]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 774

[Docket No. 140711578-4578-01]
RIN 0694--AG23

Technical Amendments to the Export Administration Regulations: 
Update of Export Control Classification Number 0Y521 Series 
Supplement--Biosensor Systems and Related Software and Technology

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: In this rule, the Bureau of Industry and Security (BIS) amends 
the Export Administration Regulations (EAR) by removing certain entries 
from the supplement that identifies those items subject to the EAR that 
are not listed elsewhere in the Commerce Control List (CCL), but which 
the Department of Commerce, with the concurrence of the Departments of 
Defense and State, has determined should be controlled for export for 
foreign policy reasons or because the items provide a significant 
military or intelligence advantage to the United States. Within one 
calendar year from the date that such items are listed in the 
supplement, BIS must publish a rule reclassifying the items under an 
entry on the CCL. Otherwise, such items automatically become designated 
as EAR99 items, unless BIS publishes a rule amending the supplement to 
extend the period in which the items will be listed therein. In 
accordance with this requirement, this rule removes references to 
biosensor systems and related ``software'' and ``technology'' from the 
supplement, because these items automatically became designated as 
EAR99 items on March 28, 2014, and the references to them in the 
supplement are now obsolete.

DATES: This rule is effective August 4, 2014.

FOR FURTHER INFORMATION CONTACT: Scott Hubinger, Senior Chemist and 
General Engineer, Chemical and Biological Controls Division, Office of 
Nonproliferation and Treaty Compliance by phone 202-482-5223 or by 
email at scott.hubinger@bis.doc.gov.

SUPPLEMENTARY INFORMATION:

Background

ECCN 0Y521 Series

    BIS established the ECCN 0Y521 series in a final rule published 
April 13, 2012 (72 FR 22191) (hereinafter ``April 13 rule'') to 
identify items that warrant control on the Commerce Control List (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 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.
    Under the procedures established in the April 13 rule and codified 
at Sec.  742.6(a)(7)(iii) of the EAR, items classified under ECCN 0Y521 
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 Wassenaar Arrangement) for potential multilateral control, 
with the understanding that multilateral controls are preferable when 
practical.

Technical Amendments Updating Supplement No. 5 to Part 774: Removal of 
References to Biosensor Systems and Related ``Software'' and 
``Technology''

    On March 28, 2013 (78 FR 18814), BIS imposed 0Y521 license 
requirements on biosensor systems and related ``software'' and 
``technology'' for export and reexport to all destinations, except 
Canada. Under the procedures established in the April 13 rule and as 
described in Supplement No. 5 to Part 774, the effective date of the 
initial classification was the date of that rule's publication, March 
28, 2013, and the date the items would be designated EAR99, unless 
reclassified in another ECCN or the 0Y521 classification was reissued, 
was one year later, March 28, 2014. In the interim, BIS, on behalf of 
the U.S. Government, submitted a proposal to the Australia Group (a 
multilateral regime of which the United States is a member) for control 
of the items for nonproliferation reasons. The Australia Group decided 
that it would not impose controls on the items, and the U.S. Government 
did not seek further consideration of multilateral controls, nor did 
BIS re-classify the items under a different ECCN or reissue the 0Y521 
classification. In accordance with Sec.  742.6(a)(7)(iii) of the EAR, 
as of March 28, 2014, the 0Y521 classification of the biosensor systems 
and related ``software'' and ``technology'' expired, meaning the items 
were no longer classified in the 0Y521 series and became designated 
EAR99. By removing the items from the list of items classified in the 
0Y521 series in Supplement No. 5 to Part, this rule removes text that

[[Page 45089]]

imposes no license requirement but has potential to confuse readers 
about the items' EAR99 status.
    Further, BIS received two comments in response to the March 28, 
2013 interim final rule. One commenter stated that designating the 
Biosensor System No. 1 0A521 without license exception options other 
than License Exception GOV section 740.11(b)(2)(ii) may result in 
regulating the item more restrictively than it would under the ITAR and 
may result in ``chilling effects toward academic research and thereby 
diminish innovation.'' Another commenter raised concerns that the scope 
of what is covered by the No.1 0E521 ``Technology'' might be overly 
broad without a reference to the General Technology Note and that BIS 
should provide guidance on how to interpret the scope. The change of 
status of the biosensor systems and related ``software'' and 
``technology'' to EAR99 renders the comments moot.
    Therefore, in this rule, BIS amends the EAR to update certain 
entries in Supplement No. 5 to Part 774-- Items Classified Under Export 
Control Classification Numbers (ECCNs) 0A521, 0B521, 0C521, 0D521 and 
0E521--according to the procedure set forth in the April 13 rule that 
established the 0Y521 series. Specifically, in this rule, BIS removes 
references to biosensor systems and related ``software'' and 
``technology'' under ECCNs 0A521 No. 1, 0D521 No. 1 and 0E521 No. 1, 
respectively, from Supplement No. 5 to Part 774 of the EAR to conform 
with the current legal status of those items under the EAR and rid the 
Supplement of obsolete references. The items are EAR99 and the 0Y521 
series license requirements do not apply. This is a technical amendment 
that only updates Supplement No. 5 to Part 774 of the EAR. It does not 
alter any right, obligation or prohibition under the EAR.

Export Administration Act

    Since August 21, 2001, the Export Administration Act has been in 
lapse and the President, through Executive Order 13222 of August 17, 
2001 (3 CFR, 2001 Comp., 783 (2002)), as amended by Executive Order 
13637 of March 8, 2013, 78 FR 16129 (March 13, 2013), and extended most 
recently by the Notice of August 8, 2013, 78 FR 49107 (August 12, 
2013), has continued the EAR 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 as amended 
by Executive Order 13637.

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 final 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 
does not involve any collection of information.
    3. This rule does not contain policies with Federalism implications 
as that term is defined under E.O. 13132.
    4. The Department finds that there is good cause under 5 U.S.C. 
553(b)(3)(B) to waive the provisions of the Administrative Procedure 
Act requiring prior notice and the opportunity for public comment 
because they are unnecessary. This rule only updates Supplement No. 5 
to Part 774 to the EAR by removing references to certain items to make 
the Supplement conform to the current legal status of those items under 
the EAR. These revisions are merely technical and reflect what already 
is in effect under the EAR in accordance with established procedure, 
and the procedure itself was proposed to the public and the subject of 
public comment. This rule clarifies information, which serves to avoid 
confusing readers about the items' EAR99 status. It does not alter any 
right, obligation or prohibition that applies to any person under the 
EAR. Because these revisions are not substantive changes, it is 
unnecessary to provide notice and opportunity for public comment. In 
addition, the 30-day delay in effectiveness required by 5 U.S.C. 553(d) 
is not applicable because this rule is not a substantive rule. Because 
neither the Administrative Procedure Act nor any other law requires 
that notice of proposed rulemaking and an opportunity for public 
comment be given for this rule, the analytical requirements of the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are not applicable.

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 8, 2013, 78 FR 49107 (August 12, 2013).

0
2. Supplement No. 5 to Part 774--Items Classified Under ECCNs Items 
Classified Under Export Control Classification Numbers (ECCNs) 0A521, 
0B521, 0C521, 0D521 and 0E521--is amended by:
0
a. Removing and reserving the entire entry for item ``No. 1 Biosensor 
systems and dedicated detecting components'' under the section ``0A521. 
Systems, Equipment and Components'';
0
b. Removing and reserving the entire entry for item ``No. 1 0D521 
``Software'' for the function of Biosensor Systems controlled by ECCN 
0A521.'' under section ``0D521. Software''; and
0
c. Removing and reserving the entire entry for item ``No. 1 0E521 
``Technology for the ``development'' or ``production'' of Biosensor 
Systems controlled by ECCN 0A521.'' under section ``0E521. 
Technology''.

    Dated: July 25, 2014.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2014-17961 Filed 8-1-14; 8:45 am]
BILLING CODE 3510-33-P