
[Federal Register: July 8, 2008 (Volume 73, Number 131)]
[Rules and Regulations]               
[Page 38908-38910]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jy08-11]                         

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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: publiccomments@bis.doc.gov. 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 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, 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
