[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]
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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.
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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