[Federal Register Volume 73, Number 131 (Tuesday, July 8, 2008)]
[Rules and Regulations]
[Pages 38908-38910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15386]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
15 CFR Parts 745 and 774
[Docket No. 080528717-8722-01]
RIN 0694-AE36
Implementation of the Understandings Reached at the April 2008
Australia Group (AG) Plenary Meeting; Additions 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 April 2008 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 avian influenza viruses to replace
the description of highly pathogenic avian influenza (HPAI) with new
HPAI language that is based on the definition currently used by the
World Organization for Animal Health (OIE).
This rule also amends the provisions in the EAR that describe the
advance notification and annual report requirements for exports of
Chemical Weapons Convention (CWC) Schedule 1 chemicals and the End-Use
Certificate requirement for certain exports of CWC Schedule 3 chemicals
by updating the fax number and address for submitting these documents
to BIS.
Finally, this rule amends the list of countries that currently are
States Parties to the CWC by adding ``Congo (Republic of the)'' and
``Guinea-Bissau,''which recently became States Parties. As a result of
this change, the CW (Chemical Weapons) license requirements and
policies in the EAR that apply to these two countries now conform with
those applicable to other CWC States Parties.
DATES: This rule is effective July 8, 2008. 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-AE36, by any
of the following methods:
E-mail: [email protected]. Include ``RIN 0694-
AE36'' 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 Street & Pennsylvania Avenue, NW., Room 2705,
Washington, DC 20230, ATTN: RIN 0694-AE36.
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 [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. Comments on
this collection of information should be submitted separately from
comments on the final rule (i.e., RIN 0694-AE36)--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:
[[Page 38909]]
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 April 14-18, 2008. 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 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 April 2008 annual plenary meeting
included a decision to update the AG ``Control List of Biological
Agents'' by revising the listing for avian influenza viruses to replace
the description of highly pathogenic avian influenza (HPAI), which was
based on a European Community (EC) directive (Directive 92/40/EC) that
was repealed, effective July 1, 2007. This decision allows AG
participating countries to adopt HPAI language that is based on the
definition currently used by the World Organization for Animal Health
(OIE). The latter is the standard definition used by international
reference laboratories for the identification and characterization of
HPAI. The OIE criteria for classifying an avian influenza (AI) virus as
a highly pathogenic avian influenza (HPAI) virus are described in the
``Manual of Diagnostic Tests and Vaccines for Terrestrial Animals''
(5th edition, 2004; see Chapter 2.7.12: Avian Influenza; last modified
May 2005).
This final rule amends the EAR to implement the AG decision
concerning the characterization of HPAI viruses by revising the listing
for avian influenza viruses in Export Control Classification Number
(ECCN) 1C352.a.2 on the Commerce Control List (CCL) (Supplement No. 1
to part 774 of the EAR) to conform with the OIE definition of HPAI. As
a result of the changes made by this rule, an avian influenza (AI)
virus will be considered to be highly pathogenic if the virus: (1) Has
an intravenous pathogenicity index (IVPI) in 6-week-old chickens
greater than 1.2; or (2) causes at least 75 percent mortality in 4- to
8-week-old chickens infected intravenously.
In addition, this rule adds a new Note to ECCN 1C352.a.2 that
identifies certain AI viruses of the H5 or H7 subtype that are
controlled under this ECCN even though they do not possess either of
the two HPAI characteristics described above. This new Note requires
that AI viruses of the H5 or H7 subtype that do not have either of
these characteristics be sequenced to determine whether multiple basic
amino acids are present at the cleavage site of the haemagglutinin
molecule (HA0). If the test indicates that the amino acid motif is
similar to that observed for other HPAI isolates, then the isolate
being tested should be considered as HPAI and the virus is controlled
under ECCN 1C352.a.2.
This rule also amends Section 745.1(a)(2) and (b)(3) of the EAR,
which describe the advance notification and annual report requirements
that apply to exports of Chemical Weapons Convention (CWC) Schedule 1
chemicals, by updating the fax number and address for submitting these
documents to BIS. In addition, this rule amends Section 745.2(a)(2) of
the EAR, which describes the End-Use Certificate requirement that
applies to certain exports of CWC Schedule 3 chemicals (i.e., exports
to States not Party to the CWC), by updating the fax number and address
for submitting this document to BIS.
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 ``Congo (Republic of the)'' and
``Guinea-Bissau,'' which became States Parties to the CWC on January 3,
2008, and June 19, 2008, respectively. As a result of this change, the
CW (Chemical Weapons) license requirements and policies that apply to
these two countries now conform with those applicable to other CWC
States Parties, as described in Section 742.18 of the EAR.
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 August 7, 2008, 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 August 22, 2008. Any such items not actually exported
or reexported before midnight, on August 22, 2008, 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 August 22, 2008. Beginning
at midnight on August 22, 2008, 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 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.
[[Page 38910]]
553) requiring notice of proposed rulemaking, the opportunity for
public participation, and a delay in effective date are inapplicable
for those changes to Export Control Classification Number (ECCN)
1C352.a.2 on the Commerce Control List (Supplement No. 1 to part 774)
and to Supplement No. 2 to part 745, because those revisions involve a
military and foreign affairs function of the United States (5 U.S.C.
553(a)(1)). The provisions of the Administrative Procedure Act
requiring notice of proposed rulemaking, the opportunity for public
participation, and a delay in effective date are inapplicable for those
changes to sections 745.1(a)(2) and (b)(3) and 745.2(a)(2), because
those revisions relate to rules of agency organization, procedure, or
practice. 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 745
Administrative practice and procedure, Chemicals, Exports, Foreign
trade, Reporting and recordkeeping requirements.
15 CFR Part 774
Exports, Foreign trade, Reporting and recordkeeping requirements.
0
Accordingly, parts 745 and 774 of the Export Administration Regulations
(15 CFR Parts 730-774) are amended as follows:
PART 745--[AMENDED]
0
1. The authority citation for 15 CFR part 745 continues 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 November 8, 2007, 72 FR 63963
(November 13, 2007).
0
2. Section 745.1 is amended by revising paragraphs (a)(2) and (b)(3) to
read as follows:
Sec. 745.1 Advance notification and annual report of all exports of
Schedule 1 chemicals to other States Parties.
* * * * *
(a) * * *
(2) Send the notification either by fax to (202) 482-1731 or by
mail or courier delivery to the following address: Information
Technology Team, Treaty Compliance Division, Bureau of Industry and
Security, U.S. Department of Commerce, Room 4515, 14th Street and
Pennsylvania Avenue, NW., Washington, DC 20230. Attn: ``Advance
Notification of Schedule 1 Chemical Export''.
* * * * *
(b) * * *
(3) Send the report either by fax to (202) 482-1731 or by mail or
courier delivery to the following address: Information Technology Team,
Treaty Compliance Division, Bureau of Industry and Security, U.S.
Department of Commerce, Room 4515, 14th Street and Pennsylvania Avenue,
NW., Washington, DC 20230. Attn: ``Annual Report of Schedule 1 Chemical
Export''.
0
3. Section 745.2(a)(2) is revised to read as follows:
Sec. 745.2 End-Use Certificate reporting requirements under the
Chemical Weapons Convention.
* * * * *
(a) * * *
(2) Submit a copy of the End-Use Certificate, no later than 7 days
after the date of export, either by fax to (202) 482-1731 or by mail or
courier delivery to the following address: Information Technology Team,
Treaty Compliance Division, Bureau of Industry and Security, U.S.
Department of Commerce, Room 4515, 14th Street and Pennsylvania Avenue,
NW., Washington, DC 20230. Attn: ``CWC End-Use Certificate Report''.
* * * * *
Supplement No. 2 to Part 745--[Amended]
0
4. Supplement No. 2 to Part 745 is amended:
0
a. By revising the undesignated center heading ``List of States Parties
as of August 1, 2007'' to read ``List of States Parties as of July 1,
2008''; and
0
b. By adding, in alphabetical order, the countries ``Congo (Republic of
the)'' and ``Guinea-Bissau''.
PART 774--[AMENDED]
0
5. 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; 46 U.S.C. app. 466c; 50 U.S.C. app. 5;
22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; E.O. 13026, 61 FR 58767, 3
CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp.,
p. 783; Notice of August 15, 2007, 72 FR 46137 (August 16, 2007).
Supplement No. 1 to Part 774--[Amended]
0
6. In Supplement No. 1 to Part 774 (the Commerce Control List),
Category 1--Materials, Chemicals, ``Microorganisms'' & ``Toxins,'' ECCN
1C352 is amended by revising paragraph (a)(2) 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:
a. * * *
a.2. Avian influenza (AI) viruses identified as having high
pathogenicity (HP), as follows:
a.2.a. AI viruses that have an intravenous pathogenicity index
(IVPI) in 6-week-old chickens greater than 1.2; or
a.2.b. AI viruses that cause at least 75% mortality in 4- to 8-
week-old chickens infected intravenously.
Note: Avian influenza (AI) viruses of the H5 or H7 subtype that
do not have either of the characteristics described in 1C352.a.2
(specifically, 1C352.a.2.a or a.2.b) should be sequenced to
determine whether multiple basic amino acids are present at the
cleavage site of the haemagglutinin molecule (HA0). If the amino
acid motif is similar to that observed for other HPAI isolates, then
the isolate being tested should be considered as HPAI and the virus
is controlled under 1C352.a.2.
* * * * *
Dated: July 1, 2008.
Eileen M. Albanese,
Acting Assistant Secretary for Export Administration.
[FR Doc. E8-15386 Filed 7-7-08; 8:45 am]
BILLING CODE 3510-33-P