Implementation of the Understandings Reached at the 2011 Australia Group (AG) Plenary Meeting and Other AG-Related Clarifications to the EAR, 39162-39164 [2012-16001]
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39162
Federal Register / Vol. 77, No. 127 / Monday, July 2, 2012 / Rules and Regulations
availability of this material at the FAA, call
(816) 329–4148.
(4) You may also review copies of the
service information that is incorporated by
reference at the National Archives and
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information on the availability of this
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Issued in Kansas City, Missouri, on June
21, 2012.
James E. Jackson,
Acting Manager, Small Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 2012–15752 Filed 6–29–12; 8:45 am]
BILLING CODE 4910–13–P
suggestions for reducing the burden, to
Jasmeet Seehra, Office of Management
and Budget (OMB), by email to
Jasmeet_K._Seehra@omb.eop.gov, 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
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 AGRelated Clarifications to the EAR
Bureau of Industry and
Security, Commerce.
ACTION: Final rule.
AGENCY:
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
pmangrum on DSK3VPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
15:02 Jun 29, 2012
Jkt 226001
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,
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Fmt 4700
Sfmt 4700
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 m3/hour (600
liters/hour), or vacuum pumps with
manufacturer’s specified maximum
flow-rate greater than 5 m3/hour (5,000
liters/hour).’’ ECCN 2B352.e is amended
E:\FR\FM\02JYR1.SGM
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Federal Register / Vol. 77, No. 127 / Monday, July 2, 2012 / Rules and Regulations
pmangrum on DSK3VPTVN1PROD with RULES
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
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15:02 Jun 29, 2012
Jkt 226001
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.
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39163
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]
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).
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.
*
*
*
*
*
3. In Supplement No. 1 to Part 774
(the Commerce Control List), Category 1,
■
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39164
Federal Register / Vol. 77, No. 127 / Monday, July 2, 2012 / Rules and Regulations
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:
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:
1C353 Genetic elements and genetically
modified organisms, as follows (see List of
Items Controlled).
2B352 Equipment capable of use in
handling biological materials, as follows (see
List of Items Controlled).
*
*
*
*
*
*
List of Items Controlled
*
*
*
*
*
*
Items:
*
*
*
*
*
*
*
*
*
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).
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
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.
5. In Supplement No. 1 to Part 774
(the Commerce Control List), Category 2,
■
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*
*
*
*
*
*
*
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
DEPARTMENT OF HOMELAND
SECURITY
33 CFR Part 147
i. Multiple-seal and seal-less pumps with
manufacturer’s specified maximum flow-rate
greater than 0.6 m3/hour (600 liters/hour), or
vacuum pumps with manufacturer’s
specified maximum flow-rate greater than 5
m3/hour (5,000 liters/hour) (under standard
temperature (273 K (0 °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:
*
*
Coast Guard
*
Items:
*
*
*
List of Items Controlled
*
*
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:
*
■
pmangrum on DSK3VPTVN1PROD with RULES
*
*
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.
*
*
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.
*
*
List of Items Controlled
15:02 Jun 29, 2012
Jkt 226001
[Docket No. USCG–2011–1143]
RIN 1625–AA00
Safety Zone; KULLUK, Outer
Continental Shelf Mobile Offshore
Drilling Unit (MODU), Beaufort Sea, AK
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a 500-meter safety zone in
the navigable waters, from the surface to
seabed, around the MODU KULLUK
while anchored or deploying and
recovering moorings on location in
order to drill exploratory wells at
various prospects located in the
Beaufort Sea Outer Continental Shelf,
Alaska, on or about July 1, 2012,
through November 30, 2012. See TABLE
1. The purpose of the temporary safety
zone is to protect the MODU from
surface and subsurface vessels that are
SUMMARY:
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
operating outside the normal shipping
channels and fairways. Placing a safety
zone around the MODU will
significantly reduce the threat of
allisions that could result in oil spills,
and releases of natural gas, and thereby
protect the safety of life, property, and
the environment. Lawful
demonstrations may be conducted
outside of the safety zone.
DATES: The temporary safety zone
becomes effective on July 1, 2012, and
terminates on December 1, 2012, unless
sooner terminated by the Commander,
Seventeenth Coast Guard District.
ADDRESSES: Comments and material
received from the public, as well as
documents mentioned in this preamble
as being available in the docket, are part
of docket USCG–2011–1143 and are
available online by going to https://
www.regulations.gov, inserting USCG–
2011–1143 in the ‘‘Keyword’’ box, and
then clicking ‘‘Search.’’ This material is
also available for inspection or copying
at the Docket Management Facility (M–
30), U.S. Department of Transportation,
West Building Ground Floor, Room
W12–140, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email LT Jason Smilie, Seventeenth
Coast Guard District (dpi); telephone
907–463–2809,
Jason.A.Smilie@uscg.mil. If you have
questions on viewing or submitting
material to the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
Regulatory Information
On February 23, 2012, the Coast
Guard published a notice of proposed
rulemaking (NPRM) entitled ‘‘Safety
Zone; KULLUK, Outer Continental Shelf
Mobile Offshore Drilling Unit (MODU),
Beaufort Sea, Alaska’’ in the Federal
Register (77 FR 10711). The NPRM
included a 30-day comment period. We
received 2 (two) submissions with
comments on the proposed rule. No
public meeting was requested, and none
was held.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. The Coast Guard finds that
good cause exists for making this rule
effective less than 30 days after
publication because to do otherwise
would be contrary to the public interest
since immediate action is required to
protect mariners, vessels, and the
E:\FR\FM\02JYR1.SGM
02JYR1
]]>Agencies
[Federal Register Volume 77, Number 127 (Monday, July 2, 2012)]
[Rules and Regulations]
[Pages 39162-39164]
From the Federal Register Online via the Government Printing 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 Jasmeet_K._Seehra@omb.eop.gov, 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
