[Federal Register Volume 77, Number 127 (Monday, July 2, 2012)]
[Rules and Regulations]
[Pages 39162-39164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16001]


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

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 774

[Docket No. 120112039-2176-03]
RIN 0694-AF45


Implementation of the Understandings Reached at the 2011 
Australia Group (AG) Plenary Meeting and Other AG-Related 
Clarifications to the EAR

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 
the understandings reached at the June 2011 plenary meeting of the 
Australia Group (AG). This rule amends the Commerce Control List (CCL) 
entry in the EAR that controls human and zoonotic pathogens and 
``toxins'' and the entry that controls genetic elements and genetically 
modified organisms to reflect changes to the AG ``List of Biological 
Agents for Export Control'' that were made based on the understandings 
adopted at the June 2011 AG plenary meeting. In addition, this rule 
amends the CCL entries in the EAR that control chemical manufacturing 
facilities and equipment, and equipment capable of use in handling 
biological materials to reflect the June 2011 AG plenary changes to the 
``Control List of Dual-Use Chemical Manufacturing Facilities and 
Equipment and Related Technology and Software'' and the ``Control List 
of Dual-Use Biological Equipment and Related Technology and Software,'' 
respectively.

DATES: This rule is effective July 2, 2012.

ADDRESSES: Send comments regarding this collection of information, 
including suggestions for reducing the burden, to Jasmeet Seehra, 
Office of Management and Budget (OMB), by email to [email protected], 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 the understandings 
reached at the June 2011 plenary meeting of the Australia Group (AG). 
The AG is a multilateral forum consisting of 40 participating countries 
that maintain 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 June 2011 AG plenary meeting adopted understandings that 
affected the AG ``List of Biological Agents for Export Control,'' the 
AG ``Control List of Dual-Use Chemical Manufacturing Facilities and 
Equipment and Related Technology and Software'' and the AG ``Control 
List of Dual-Use Biological Equipment and Related Technology and 
Software.''
    This rule amends Export Control Classification Numbers (ECCNs) 
1C351 and 1C353 to reflect the AG changes to the ``List of Biological 
Agents for Export Control.'' Specifically, ECCN 1C351 (Human and 
zoonotic pathogens and ``toxins'') is amended by removing and reserving 
paragraph .b (Rickettsiae), since these organisms are more 
appropriately identified as bacteria. Coxiella burnetii and Rickettsia 
prowasecki (a.k.a. Rickettsia prowazekii), which were previously 
controlled under ECCN 1C351.b.2 and .b.3, respectively, are now 
controlled as bacteria under ECCN 1C351.c.10 and .c.13, respectively. 
Bartonella Quintana (Rochalimea Quintana, Rickettsia Quintana) and 
Rickettsia rickettsii, which were previously controlled under ECCN 
1C351.b.1 and .b.4, respectively, are removed from ECCN 1C351, since 
they are no longer included on the AG ``List of Biological Agents.''
    ECCN 1C353 (Genetic elements and genetically modified organisms) is 
amended by revising Technical Note 1 and adding a new Technical Note 4 
to clarify that this ECCN controls certain de novo chemically 
synthesized genetic material and artificially-produced organisms. 
Specifically, Technical Note 1 to ECCN 1C353 is revised to indicate 
that ``genetic elements'' also include chromosomes, genomes, plasmids, 
transposons, and vectors that have been ``chemically synthesized in 
whole or in part.'' New Technical Note 4 to ECCN 1C353 indicates that 
``genetically modified organisms'' include ``organisms in which the 
genetic material (nucleic acid sequences) has been altered in a way 
that does not occur naturally by mating and/or natural recombination, 
and encompasses those produced artificially in whole or in part.''
    This rule also amends ECCN 2B350 (Chemical manufacturing facilities 
and equipment) by adding a new Technical Note 3, at the end of the 
entry, to clarify that materials used for gaskets, packing, seals, 
screws or washers, or other materials performing a sealing function, do 
not determine the control status of the items listed in ECCN 2B350, 
provided that such components are designed to be interchangeable.
    In addition, this rule amends ECCN 2B352 (Equipment capable of use 
in handling biological materials) by revising the introductory text of 
paragraph .d.1 to remove the phrase ``without propagation of 
aerosols.'' Participating countries at the 2011 AG plenary agreed that 
this phrase was redundant, as it applied to cross (tangential) flow 
filtration equipment capable of separation of pathogenic 
microorganisms, viruses, toxins or cell cultures.
    Finally, this rule amends ECCNs 2B350 and 2B352 to clarify certain 
control parameters for pumps (i.e., multiple-seal and seal-less pumps 
and vacuum pumps) and steam sterilizable freeze-drying (lyophilization) 
equipment, respectively. Specifically, ECCN 2B350.i is amended by 
adding two parenthetical phrases in the introductory text to specify 
the maximum flow-rate of such pumps in liters of water per hour, as 
follows: ``multiple-seal and seal-less pumps with manufacturer's 
specified maximum flow-rate greater than 0.6 m\3\/hour (600 liters/
hour), or vacuum pumps with manufacturer's specified maximum flow-rate 
greater than 5 m\3\/hour (5,000 liters/hour).'' ECCN 2B352.e is amended

[[Page 39163]]

by adding two parenthetical phrases that specify the condenser capacity 
of such equipment in liters of water per 24 hours, as follows: ``10 kgs 
of ice or greater in 24 hours (10 liters of water or greater in 24 
hours), but less than 1,000 kgs of ice in 24 hours (less than 1,000 
liters of water in 24 hours).'' These changes are being made by BIS in 
order to indicate these AG control parameters in units of measure that 
are more commonly used in the United States.
    None of the changes made by this rule increase the scope of the 
controls in ECCNs 1C351, 1C353, 2B350 and 2B352. Except for the removal 
of Bartonella Quintana and Rickettsia rickettsii from ECCN 1C351, the 
items that are controlled under these ECCNs remain the same.
    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, 
2011, 76 FR 50661 (August 16, 2011), has continued the EAR in effect 
under the International Emergency Economic Powers Act.

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 designated a ``significant regulatory 
action'' although not economically significant, under section 3(f) of 
Executive Order 12866. Accordingly, the rule has been reviewed by the 
Office of Management and Budget.
    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 the understandings reached at the June 2011 AG plenary 
meeting 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 in 15 CFR Part 774

    Exports, Foreign trade, 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 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, 2011, 76 FR 50661 (August 16, 2011).

0
2. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 1, ECCN 1C351 is amended under the ``Items'' paragraph in the 
List of Items Controlled section by removing and reserving paragraph b. 
and by revising paragraph c. 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).
* * * * *

List of Items Controlled

* * * * *
    Items:
* * * * *
    b. [Reserved]
    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. Coxiella burnetii;
    c.11. Enterohaemorrhagic Escherichia coli, serotype O157 and 
other verotoxin producing serotypes;
    c.12. Francisella tularensis;
    c.13. Rickettsia prowasecki (a.k.a. Rickettsia prowazekii);
    c.14. Salmonella typhi;
    c.15. Shigella dysenteriae;
    c.16. Vibrio cholerae; or
    c.17. Yersinia pestis.
* * * * *


0
3. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 1,

[[Page 39164]]

ECCN 1C353 is amended under the ``Items'' paragraph in the List of 
Items Controlled section by revising Technical Note 1 and by adding a 
new Technical Note 4 in numerical order, to read as follows:

    1C353 Genetic elements and genetically modified organisms, as 
follows (see List of Items Controlled).
* * * * *

List of Items Controlled

* * * * *
    Items:
* * * * *
    Technical Notes: 1. ``Genetic elements'' include, inter alia, 
chromosomes, genomes, plasmids, transposons, and vectors, whether 
genetically modified or unmodified, or chemically synthesized in 
whole or in part.
* * * * *
    4. ``Genetically modified organisms'' include organisms in which 
the genetic material (nucleic acid sequences) has been altered in a 
way that does not occur naturally by mating and/or natural 
recombination, and encompasses those produced artificially in whole 
or in part.



0
4. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 2, ECCN 2B350 is amended under the ``Items'' paragraph in the 
List of Items Controlled section by revising the introductory text of 
paragraph i. and by adding a new ``Technical Note 3,'' in numerical 
order, to read as follows:

    2B350 Chemical manufacturing facilities and equipment, except 
valves controlled by 2A226 or 2A292, as follows (see List of Items 
Controlled).
* * * * *
    List of Items Controlled
* * * * *
    Items:
* * * * *
    i. Multiple-seal and seal-less pumps with manufacturer's 
specified maximum flow-rate greater than 0.6 m\3\/hour (600 liters/
hour), or vacuum pumps with manufacturer's specified maximum flow-
rate greater than 5 m\3\/hour (5,000 liters/hour) (under standard 
temperature (273 K (0 [deg]C)) and pressure (101.3 kPa) conditions), 
and casings (pump bodies), preformed casing liners, impellers, 
rotors or jet pump nozzles designed for such pumps, in which all 
surfaces that come into direct contact with the chemical(s) being 
processed are made from any of the following materials:
* * * * *

    Technical Note 3:
     The materials used for gaskets, packing, seals, screws or 
washers, or other materials performing a sealing function, do not 
determine the control status of the items in this ECCN, provided 
that such components are designed to be interchangeable.



0
5. In Supplement No. 1 to Part 774 (the Commerce Control List), 
Category 2, ECCN 2B352 is amended under the ``Items'' paragraph in the 
List of Items Controlled section by revising the introductory text of 
paragraph d.1 and by revising paragraph e to read as follows:

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

List of Items Controlled

* * * * *
    Items:
* * * * *
    d. * * *
    d.1. Cross (tangential) flow filtration equipment capable of 
separation of pathogenic microorganisms, viruses, toxins or cell 
cultures having all of the following characteristics:
* * * * *
    e. Steam sterilizable freeze-drying (lyophilization) equipment 
with a condenser capacity of 10 kgs of ice or greater in 24 hours 
(10 liters of water or greater in 24 hours), but less than 1,000 kgs 
of ice in 24 hours (less than 1,000 liters of water in 24 hours).
* * * * *


    Dated: June 22, 2012.
Kevin J. Wolf
Assistant Secretary for Export Administration.
[FR Doc. 2012-16001 Filed 6-29-12; 8:45 am]
BILLING CODE 3510-33-P