Document ID: BIS-2013-0016-0001
Agency: bis
Document Type: Rule
Title: Implementation of the Understandings Reached at the 2012 Australia Group (AG) Plenary Meeting and 2012 AG Intersessional Decisions: Changes to Select Agent Controls; Correction
Posted Date: 2013-07-03T04:00Z

[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Rules and Regulations]
[Pages 39971-39973]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15970]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 774

[Docket No. 120806310-3555-02]
RIN 0694-AF76

Implementation of the Understandings Reached at the 2012 
Australia Group (AG) Plenary Meeting and the 2012 AG Intersessional 
Decisions; Changes to Select Agent Controls--Correction

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule; correcting amendment.

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SUMMARY: The Bureau of Industry and Security (BIS) published a final 
rule in the Federal Register on Wednesday, June 5, 2013 (78 FR 33692), 
that amended the Export Administration Regulations (EAR) to implement 
the understandings reached at the June 2012 plenary meeting of the 
Australia Group (AG) and the 2012 AG intersessional decisions. That 
final rule also amended the EAR to reflect recent changes to the 
controls maintained by the Animal and Plant Health Inspection Service 
(APHIS), U.S. Department of Agriculture, and the Centers for Disease 
Control and Prevention (CDC), U.S. Department of Health and Human 
Services, on the possession, use, and transfer of select biological 
agents within the United States. The preamble of that final rule 
contained an error in its description of the amendments to Export 
Control Classification Number (ECCN) 1C351 that were based on the 
understandings reached at the 2012 AG Plenary. The preamble also 
contained an error in its description of the amendments to ECCN 2B352 
that were based on the 2012 AG intersessional decisions. In addition, 
that final rule contained errors affecting the control language in ECCN 
2B352, which controls specified equipment capable of use in handling 
biological materials. This document corrects these errors.

DATES: This rule is effective July 3, 2013.

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

    On June 5, 2013, the final rule ``Implementation of the 
Understandings Reached at the 2012 Australia Group (AG) Plenary Meeting 
and the 2012 AG Intersessional Decisions; Changes to Select Agent 
Controls'' was published in the Federal Register (78 FR 33692). In the 
preamble of that final rule, the discussion of the amendments to ECCN 
1C351 erroneously indicated that the bacterium ``Coxiella burnetii'' 
was previously controlled under ECCN 1C351.c.11 when, in fact, this 
bacterium was previously controlled under ECCN 1C351.c.10 and is now 
controlled under 1C351.c.13, based on the amendments contained that 
final rule. Instead, prior to the publication of that final rule, ECCN 
1C351.c.11 controlled ``Enterohaemorrhagic Escherichia coli, serotype 
O157 and other verotoxin producing serotypes.'' As a result of the

[[Page 39972]]

amendments made by that final rule, these bacteria are now controlled 
under ECCN 1C351.c.17, with the control language having been clarified 
to read ``Shiga toxin producing Escherichia coli (STEC) of serogroups 
O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin 
producing serogroups.''
    The preamble of that final rule also contained an error in its 
description of the amendments to ECCN 2B352. Specifically, in the 
description of the technical characteristics of the spray-drying 
equipment now controlled under ECCN 2B352.f, the preamble mistakenly 
referred to ``a typical mean product particles size'' when it should 
have said ``a typical mean product particle size,'' consistent with the 
control language in ECCN 2B352.f.2.
    In addition, that final rule amended ECCN 2B352, under the 
``Items'' paragraph in the List of Items Controlled, by redesignating 
paragraphs f. through h. as paragraphs g. through i., respectively, and 
adding a new paragraph f. to control specified spray drying equipment 
capable of drying toxins or pathogenic microorganisms. However, that 
final rule did not make the necessary conforming changes, in ECCN 
2B352.i.3 and Technical Note 2 to ECCN 2B352, to reflect the 
redesignation of 2B352.h (specified spraying or fogging systems and 
components therefor) as 2B352.i.
    This rule makes these conforming changes, as follows. First, in 
ECCN 2B352.i.3, the phrase ``as specified in paragraphs h.1 and h.2 of 
this ECCN'' is revised to read, ``as specified in paragraphs i.1 and 
i.2 of this ECCN.'' Second, in Technical Note 2 to ECCN 2B352, the 
phrase ``as specified in 2B352.h'' is revised to read, ``as specified 
in 2B352.i.'' These conforming changes do not affect either the scope 
of the EAR controls that apply to equipment controlled under ECCN 2B352 
or the specific equipment that is subject to these EAR controls.
    Although the Export Administration Act expired on August 20, 2001, 
the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 
2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 
8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of 
August 15, 2012, 77 FR 49699 (August 16, 2012), has continued the EAR 
in effect under the International Emergency Economic Powers Act. 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, 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 Office of Administration, Bureau of Industry and Security, 
Department of Commerce, 14th Street and Pennsylvania Avenue NW., Room 
6622, Washington, DC 20230.
    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 (5 U.S.C. 553(a)(1)). The changes 
contained in this rule are non-substantive technical corrections of a 
previously published rule that has already been exempted from notice 
and comment and delay in effective date provisions, because the content 
of the June 5, 2013, final rule involves a military and foreign affairs 
function of the United States (5 U.S.C. 553(a)(1)). The corrections 
contained in this final rule are essential to ensuring the accurate and 
complete implementation of the June 5, 2013, final rule.
    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 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 in 15 CFR Part 774

    Exports, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, 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 15 CFR Part 774 continues to read as 
follows:

    Authority:  50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.; 
10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C. 287c, 22 U.S.C. 3201 et 
seq., 22 U.S.C. 6004; 30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42 
U.S.C. 6212; 43 U.S.C. 1354; 15 U.S.C. 1824a; 50 U.S.C. app. 5; 22 
U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3 CFR, 
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 
783; Notice of August 15, 2012, 77 FR 49699 (August 16, 2012).

Supplement No. 1 to Part 774--[Amended]

0
2. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 2--Materials Processing, ECCN 2B352 is amended under the 
``Items'' paragraph in the List of Items Controlled section by revising 
paragraph i.3 and Technical Note 2 that follows paragraph i. to read as 
follows:

2B352 Equipment capable of use in handling biological materials, as 
follows (see List of Items Controlled).

* * * * *

List of Items Controlled

Unit: * * *
Related Controls: * * *
Related Definitions: * * *
Items:
* * * * *
    i. * * *
    i.3. Aerosol generating units specially designed for fitting to 
the systems as specified in paragraphs i.1 and i.2 of this ECCN.

Technical Notes:

[[Page 39973]]

    1. * * *
    2. This ECCN does not control spraying or fogging systems and 
components, as specified in 2B352.i., that are demonstrated not to 
be capable of delivering biological agents in the form of infectious 
aerosols.
* * * * *

    Dated: June 27, 2013.
Bernard Kritzer,
Director, Office of Exporter Services.
[FR Doc. 2013-15970 Filed 7-2-13; 8:45 am]
BILLING CODE 3510-33-P