[Federal Register: September 12, 2007 (Volume 72, Number 176)]
[Rules and Regulations]
[Page 52000-52003]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se07-8]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 738, 740, 745, 772, and 774
[Docket No. 070705267-7492-01]
RIN 0694-AE08
Implementation of the Understandings Reached at the June 2007
Australia Group (AG) Plenary Meeting; Addition to the List of States
Parties to the Chemical Weapons Convention (CWC)
AGENCY: Bureau of Industry and Security, Commerce.
ACTION: Final rule.
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SUMMARY: The Bureau of Industry and Security (BIS) is publishing this
final rule to amend the Export Administration Regulations (EAR) to
implement the understandings reached at the June 2007 plenary meeting
of the Australia Group (AG). This final rule amends the EAR to reflect
changes to the AG ``Control List of Biological Agents'' that the
countries participating in the AG adopted at the plenary meeting.
Specifically, this rule revises the Commerce Control List (CCL) entry
that controls animal pathogens on the AG ``Control List of Biological
Agents'' by revising the listing for mycoplasma mycoides to include
only the specific subspecies and strains of mycoplasma mycoides that
are of most concern as the causative agents of disease in animals,
i.e., Mycoplasma mycoides subspecies mycoides SC (small colony) and
Mycoplasma capricolum subspecies capripneumoniae (``strain F38''). In
addition, this rule makes conforming changes to the CCL entry that
controls certain select agents not included on any of the AG Common
Control Lists.
This rule also amends the EAR to reflect the admission of Croatia
to the Australia Group and updates the definition of ``Australia
Group'' in the EAR by adding Croatia to the list of participating
countries.
In addition to the AG plenary meeting changes described above, this
rule amends the EAR by revising the CCL entry that controls certain
equipment capable of being used in handling biological materials. This
rule revises a Technical Note in the CCL entry by updating the edition
of the World Health Organization (WHO) ``Laboratory Biosafety Manual''
referenced therein to to identify the current edition of the manual.
This WHO manual contains safety requirements for P3 or P4 (BL3, BL4,
L3, L4) complete containment facilities.
Finally, this rule amends the list of countries that currently are
States Parties to the Chemical Weapons Convention (CWC) by adding
``Barbados,'' which recently became a State Party. As a result of this
change, the CW (Chemical Weapons) license requirements and policies in
the EAR that apply to Barbados now conform with those applicable to
other CWC States Parties. This rule also clarifies the scope of the
entry for ``China'' on the list of CWC States Parties by revising the
footnote to this entry to indicate that, for CWC purposes only, China
includes ``Macau,'' as well as ``Hong Kong.''
DATES: This rule is effective September 12, 2007. Although there is no
formal comment period, public comments on this regulation are welcome
on a continuing basis.
ADDRESSES: You may submit comments, identified by RIN 0694-AE08, by any
of the following methods:
E-mail: publiccomments@bis.doc.gov. Include ``RIN 0694-
AE08'' in the subject line of the message.
Fax: (202) 482-3355. Please alert the Regulatory Policy
Division, by calling (202) 482-2440, if you are faxing comments.
Mail or Hand Delivery/Courier: Willard Fisher, U.S.
Department of Commerce, Bureau of Industry and Security, Regulatory
Policy Division, 14th St. & Pennsylvania Avenue, NW., Room 2705,
Washington, DC 20230, ATTN: RIN 0694-AE08.
Send comments regarding this collection of information, including
suggestions for reducing the burden, to David Rostker, Office of
Management and Budget (OMB), by e-mail to David_Rostker@omb.eop.gov,
or by fax to (202) 395-7285; and to the Regulatory Policy Division,
Bureau of Industry and Security, Department of Commerce, P.O. Box 273,
Washington, DC 20044. Comments on this collection of information should
be submitted separately from comments on the final rule (i.e., RIN
0694-AE08)--all comments on the latter should be submitted by one of
the three methods outlined above.
FOR FURTHER INFORMATION CONTACT: Elizabeth Scott, 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 annual plenary meeting of the Australia Group (AG) that
was held in Paris on June 4-7, 2007. The Australia Group is a
multilateral forum, consisting of 40 participating countries, that
maintains 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
[[Page 52001]]
reviews items on its control list to enhance the effectiveness of
participating governments' national controls and to achieve greater
harmonization among these controls.
The understandings reached at the June 2007 annual plenary meeting
included a decision to revise the AG ``Control List of Biological
Agents'' by narrowing the scope of the listing for mycoplasma mycoides
to include only the specific subspecies and strains of mycoplasma
mycoides that are of most concern as the causative agents of disease in
animals. This rule amends the EAR to reflect that decision by revising
Export Control Classification Number (ECCN) 1C352, which controls
certain animal pathogens, to narrow the scope of the listing for
mycoplasma mycoides in this ECCN to include only the following
subspecies and strains: Mycoplasma mycoides subspecies mycoides SC
(small colony) and Mycoplasma capricolum subspecies capripneumoniae
(``strain F38''). Mycoplasma mycoides subspecies mycoides SC (small
colony) causes severe respiratory disease primarily in cattle (i.e.,
contagious bovine pleuropneumonia (CBPP)), while Mycoplasma capricolum
subspecies capripneumoniae (``strain F38'') causes severe respiratory
disease primarily in goats (i.e., contagious caprine pleuropneumonia
(CCPP)).
Prior to the publication of this rule, ECCN 1C352 controlled all
subspecies and strains of mycoplasma mycoides. Mycoplasma capricolum
and F38-type caprine mycoplasma (i.e., mycoplasma F38), however, were
listed separately under ECCN 1C360, which contains unilaterally
controlled select agents not included on any of the AG Common Control
Lists. The Centers for Disease Control and Prevention (CDC), U.S.
Department of Health and Human Services, and the Animal and Plant
Health Inspection Service (APHIS), U.S. Department of Agriculture,
maintain controls on the possession, use, and transfer within the
United States of the unilaterally controlled select agents listed in
ECCN 1C360, as well as certain AG agents and toxins listed in ECCN
1C352. Since mycoplasma F38 (i.e., Mycoplasma capricolum subspecies
capripneumoniae (``strain F38'')) is now specifically identified and
controlled under ECCN 1C352 and the select agent mycoplasma mycoides
capri is no longer controlled under this ECCN, this rule makes
conforming changes to the list of unilaterally controlled select agents
in ECCN 1C360 by removing mycoplasma F38 from the listing of mycoplasma
controlled under this ECCN and adding mycoplasma mycoides capri. All
Mycoplasma capricolum, except subspecies capripneumoniae, continues to
be controlled under ECCN 1C360.
The EAR license requirements that apply to the specific items
affected by the amendments to ECCN 1C352 and 1C360 (described above)
remain unchanged. The affected items in these ECCNs continue to require
a license for export or reexport to all countries or destinations
indicated under CB Column 1 or AT Column 1 on the Commerce Country
Chart (Supplement No. 1 to Part 738 of the EAR).
This rule also amends the EAR to reflect the addition of Croatia as
the newest participating country in the Australia Group (which now
includes a total of 40 countries). Supplement No. 1 to Part 738
(Commerce Country Chart) is revised by removing the license
requirements indicated for Croatia, under CB Column 2, to conform with
the country scope of the CB license requirements that apply to other AG
participating countries (see Section 742.2 of the EAR). Supplement No.
1 to Part 740 (Country Groups) is revised to add Croatia to Country
Group A:3 (Australia Group). The definition of ``Australia Group'' in
Section 772.1 of the EAR is updated by adding Croatia to the list of
participating countries.
In addition to the AG plenary meeting changes described above, this
rule amends the EAR by revising the Technical Note to ECCN 2B352.a to
update a reference therein to the World Health Organization (WHO)
``Laboratory Biosafety Manual'' to identify the current edition of the
manual (i.e., 3rd edition, Geneva, 2004). This WHO manual contains
safety requirements for P3 or P4 (BL3, BL4, L3, L4) complete
containment facilities.
Finally, this rule amends Supplement No. 2 to Part 745 of the EAR
(titled ``States Parties to the Convention on the Prohibition of the
Development, Production, Stockpiling, and Use of Chemical Weapons and
on Their Destruction'') by adding ``Barbados,'' which became a State
Party to the CWC on April 6, 2007. As a result of this change, the CW
(Chemical Weapons) license requirements and policies that apply to
Barbados now conform with those applicable to other CWC States Parties,
as described in Section 742.18 of the EAR. This rule also clarifies the
scope of the entry for ``China'' in the list of CWC States Parties by
revising the footnote to this entry to indicate that, for CWC purposes
only, China includes ``Macau,'' as well as ``Hong Kong.''
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 15,
2007, 72 FR 46137 (August 16, 2007), has continued the Export
Administration Regulations in effect under the International Emergency
Economic Powers Act.
Saving Clause
Shipments of items removed from eligibility for export or reexport
under a license exception or without a license (i.e., under the
designator ``NLR'') as a result of this regulatory action that were on
dock for loading, on lighter, laden aboard an exporting carrier, or en
route aboard a carrier to a port of export, on October 12, 2007,
pursuant to actual orders for export or reexport to a foreign
destination, may proceed to that destination under the previously
applicable license exception or without a license (NLR) so long as they
are exported or reexported before October 29, 2007. Any such items not
actually exported or reexported before midnight, on October 29, 2007,
require a license in accordance with this regulation.
``Deemed'' exports of ``technology'' and ``source code'' removed
from eligibility for export under a license exception or without a
license (under the designator ``NLR'') as a result of this regulatory
action may continue to be made under the previously available license
exception or without a license (NLR) before October 29, 2007. Beginning
at midnight on October 29, 2007, such ``technology'' and ``source
code'' may no longer be released, without a license, to a foreign
national subject to the ``deemed'' export controls in the EAR when a
license would be required to the home country of the foreign national
in accordance with this regulation.
Rulemaking Requirements
1. 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
[[Page 52002]]
BIS-748. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for
reducing the burden, to David Rostker, 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 (Sec. 5 U.S.C. 553(a)(1)). 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 5 U.S.C. 553 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. Although there
is no formal comment period, public comments on this regulation are
welcome on a continuing basis.
List of Subjects
15 CFR Part 738
Administrative practice and procedure, Exports, Foreign trade.
15 CFR Part 740
Administrative practice and procedure, Exports, Foreign trade,
Reporting and recordkeeping requirements.
15 CFR Part 745
Administrative practice and procedure, Chemicals, Exports, Foreign
trade, Reporting and recordkeeping requirements.
15 CFR Part 772
Exports.
15 CFR Part 774
Exports, Foreign trade, Reporting and recordkeeping requirements.
0
Accordingly, parts 738, 740, 745, 772, and 774 of the Export
Administration Regulations (15 CFR parts 730-799) are amended as
follows:
PART 738--[AMENDED]
0
1. The authority citation for 15 CFR part 738 is revised 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; 46 U.S.C. app. 466c; 50 U.S.C. app. 5;
Sec. 901-911, Pub. L. 106-387; Sec. 221, Pub. L. 107-56; 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, 2007, 72 FR 46137
(August 16, 2007).
0
2. Supplement No. 1 to part 738 is amended by revising the entry for
``Croatia'' to read as follows:
Supplement No. 1 to Part 738--Commerce Country Chart
[Reason for control]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Chemical & biological Nuclear National security Missile Regional stability Firearms Crime control Anti-terrorism
weapons nonproliferation -------------------- tech convention -------------------------------------------------
Countries -------------------------------------------------- --------------------------------------------
CB 1 CB 2 CB 3 NP 1 NP 2 NS 1 NS 2 MT 1 RS 1 RS 2 FC 1 CC 1 CC 2 CC 3 AT 1 AT 2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
Croatia..................... X ........ ........ X ........ X X X X X ............ X ........ X ........ ........
* * * * * * *
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PART 740--[AMENDED]
0
3. The authority citation for 15 CFR part 740 is revised to read as
follows:
Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
Sec. 901-911, Pub. L. 106-387; 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, 2007, 72 FR 46137 (August 16, 2007).
0
4. In Supplement No. 1 to part 740, Country Groups, Country Group A is
amended by adding, in alphabetical order, a new entry for ``Croatia''
to read as follows:
Supplement No. 1 to Part 740--Country Groups
Country Group A
----------------------------------------------------------------------------------------------------------------
Missile Australia group Nuclear
----------------- technology suppliers group
Country control regime ---------------------------------
[A:1] -----------------
[A:2] [A:3] [A:4]
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Croatia..................................... ............... ............... X
* * * * * * *
----------------------------------------------------------------------------------------------------------------
PART 745--[AMENDED]
0
5. The authority citation for 15 CFR part 745 is revised to read as
follows:
Authority: 50 U.S.C. 1701 et seq.; E.O. 12938, 59 FR 59099, 3
CFR, 1994 Comp., p. 950; Notice of October 27, 2006, 71 FR 64109
(October 31, 2006).
Supplement No. 2 to Part 745 [Amended]
0
6. Supplement No. 2 to part 745 is amended:
[[Page 52003]]
0
a. By revising the undesignated center heading ``List of States Parties
as of November 1, 2006'' to read ``List of States Parties as of August
1, 2007'';
0
b. By adding, in alphabetical order, the country ``Barbados''; and
0
c. By revising the footnote for China to read ``* For CWC purposes
only, China includes Hong Kong and Macau.''
PART 772--[AMENDED]
0
7. The authority citation for 15 CFR part 772 is revised to read as
follows:
Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
15, 2007, 72 FR 46137 (August 16, 2007).
0
8. In Sec. 772.1, the definition of ``Australia Group'' is revised to
read as follows:
Sec. 772.1 Definitions of terms as used in the Export Administration
Regulations (EAR).
* * * * *
Australia Group. The countries participating in the Australia Group
have agreed to adopt harmonized controls on certain dual-use chemicals
(i.e., precursor chemicals), biological agents, related manufacturing
facilities and equipment, and related technology in order to ensure
that exports of these items do not contribute to the proliferation of
chemical or biological weapons. Countries participating in the
Australia Group as of July 1, 2007, include: Argentina, Australia,
Austria, Belgium, Bulgaria, Canada, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Japan, Korea (South), Latvia, Lithuania, Luxembourg,
Malta, the Netherlands, New Zealand, Norway, Poland, Portugal, Romania,
Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine,
the United Kingdom, and the United States. See also Sec. 742.2 of the
EAR.
* * * * *
PART 774--[AMENDED]
0
9. The authority citation for 15 CFR part 774 is revised 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; 46 U.S.C. app. 466c; 50 U.S.C. app. 5;
Sec. 901-911, Pub. L. 106-387; Sec. 221, Pub. L. 107-56; 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, 2007, 72 FR 46137
(August 16, 2007).
Supplement No. 1 to Part 774--[Amended]
0
10. In Supplement No. 1 to part 774 (the Commerce Control List),
Category 1--Materials, Chemicals, ``Microorganisms'' & ``Toxins,'' ECCN
1C352 is amended by revising paragraph (b) under ``Items'' in the List
of Items Controlled to read as follows:
1C352 Animal pathogens, as follows (see List of Items
Controlled).
* * * * *
List of Items Controlled
Unit: * * *
Related Controls: * * *
Related Definitions: * * *
Items:
* * * * *
b. Bacteria, as follows:
b.1. Mycoplasma mycoides, as follows:
b.1.a. Mycoplasma mycoides subspecies mycoides SC (small colony)
(a.k.a. contagious bovine pleuropneumonia);
b.1.b. Mycoplasma capricolum subspecies capripneumoniae
(``strain F38'').
b.2. [RESERVED.]
Supplement No. 1 to Part 774--[Amended]
0
11. In Supplement No. 1 to part 774 (the Commerce Control List),
Category 1--Materials, Chemicals, ``Microorganisms'' & ``Toxins,'' ECCN
1C360 is amended by revising paragraph (b)(2) under ``Items'' in the
List of Items Controlled to read as follows:
1C360 Select agents not controlled under ECCN 1C351, 1C352, or
1C354.
* * * * *
List of Items Controlled
Unit: * * *
Related Controls: * * *
Related Definitions: * * *
Items:
* * * * *
b. * * *
b.2. Mycoplasma, as follows:
b.2.a. Mycoplasma capricolum, except subspecies capripneumoniae
(see ECCN 1C352.b.1.b);
b.2.b. Mycoplasma mycoides capri;
* * * * *
Supplement No. 1 to Part 774--[Amended]
0
12. In Supplement No. 1 to part 774 (the Commerce Control List),
Category 2--Materials Processing, ECCN 2B352 is amended by revising
parenthetical phrase ``(Geneva, 1983)'' to read ``(3rd edition, Geneva,
2004)'' in the Technical Note immediately following paragraph (a) in
the List of Items Controlled.
Dated: September 6, 2007.
Christopher A. Padilla,
Assistant Secretary for Export Administration.
[FR Doc. E7-18018 Filed 9-11-07; 8:45 am]
BILLING CODE 3510-33-P