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19 September 2008

[Federal Register: September 19, 2008 (Volume 73, Number 183)]
[Rules and Regulations]               
[Page 54314-54315]
From the Federal Register Online via GPO Access []



22 CFR Part 121

[Public Notice: 6364]

Amendment to the International Traffic in Arms Regulations: U.S. 
Munitions List Interpretation

AGENCY: Department of State.

ACTION: Final rule.


SUMMARY: The Department of State is amending the International Traffic 
in Arms Regulations (ITAR) to clarify that certain anti-tumor drugs are 
not within the definition of ``chemical agents.''

DATES: Effective Date: This rule is effective September 19, 2008.

ADDRESSES: Interested parties may submit comments at any time by any of 
the following methods:
     E-mail: with an appropriate 
subject line.
     Mail: Department of State, Directorate of Defense Trade 
Controls, Office of Defense Trade Controls Policy, ATTN: Regulatory 
Change, 12th Floor, SA-1, Washington, DC 20522-0112.
     Fax: 202-261-8199.
    Persons with access to the Internet may also view this notice by 
going to the Web site at:

FOR FURTHER INFORMATION CONTACT: Lisa Wenger, Office of Defense Trade 
Controls Policy, Department of State; Telephone 202-663-2171 or FAX 
202-261-8199; e-mail: ATTN: Regulatory 

SUPPLEMENTARY INFORMATION: In this regulatory change, we clarify that 
certain anti-tumor drugs are not considered defense articles under this 
subchapter; however, the know-how for production of nitrogen mustards 
or their salts is specifically retained on the U.S. Munitions List.

Regulatory Analysis and Notices

Administrative Procedure Act

    This amendment involves a foreign affairs function of the United 
States and, therefore, is not subject to the procedures contained in 5 
U.S.C. 553 and 554.

Regulatory Flexibility Act

    Because this final rule is exempt from notice and comment 
rulemaking under 5 U.S.C. 553, it is exempt from the provisions of 
section 603 and 604 of the Regulatory Flexibility Act (5 U.S.C. 603 and 

Unfunded Mandates Act of 1995

    This amendment does not involve a mandate that will result in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100 million or more in any year and it 
will not significantly or uniquely affect small governments. Therefore, 
no actions were deemed necessary under the provisions of the Unfunded 
Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This amendment has been found not to be a major rule within the 
meaning of the Small Business Regulatory Enforcement Fairness Act of 

Executive Orders 12372 and 13132

    This amendment will not have substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Therefore, in accordance with Executive 
Order 13132, it is determined that this amendment does not have 
sufficient federalism implications to require consultations or warrant 
the preparation of a federalism summary impact statement. Executive 
Order 12372, regarding intergovernmental consultation on Federal 
programs and activities, does not apply to this amendment.

Executive Order 12866

    This amendment is exempt from review under Executive Order 12866, 
but has been reviewed internally by the Department of State to ensure 
consistency with the purposes thereof.

Paperwork Reduction Act

    This rule does not impose any new reporting or recordkeeping 
requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 

List of Subjects in 22 CFR Part 121

    Arms and munitions, Exports, U.S. Munitions List.

Accordingly, for the reasons set forth above, Title 22, Chapter I, 
Subchapter M, part 121 is amended as follows:


1. The authority citation for part 121 continues to read as follows:

    Authority: Secs. 2, 38, and 71, Pub.L. 90-629, 90 Stat. 744 (22 
U.S.C. 2752, 2778, 2797); E.O. 11958, 42 FR 4311; 3 CFR, 1977 Comp. 
p. 79; 22 U.S.C. 2658; Pub.L. 105-261, 112 Stat. 1920.

2. In Sec.  121.1, paragraph (c) Category XIV is amended by adding NOTE 
5 to read as follows:

Sec.  121.1  General. The United States Munitions List.

* * * * *
    (c) * * *
* * * * *

Category XIV--Toxicological Agents, Including Chemical Agents, 
Biological Agents, and Associated Equipment

* * * * *

[[Page 54315]]

    Note 5: Pharmacological formulations containing nitrogen 
mustards and certain reference standards for these drugs are not 
considered to be chemical agents and are licensed by the Department 
of Commerce when:
    (1) The drug is in the form of a final medical product; or
    (2) The reference standard contains salts of HN2 [bis(2-
chloroethyl) methylamine], the quantity to be shipped is 150 
milligrams or less, and individual shipments do not exceed twelve 
per calendar year per end user.
    Technical data for the production of HN1 [bis(2-
chloroethyl)ethylamine]; HN2 [bis(2-chloroethyl)methylamine], HN3 
[tris(2-chloroethyl)amine]; or salts of these, such as tris (2-
chloroethyl)amine hydrochloride, remains controlled under this 

* * * * *

    Dated: September 3, 2008.
Frank J. Ruggiero,
Acting Assistant Secretary for Political-Military Affairs, Department 
of State.
[FR Doc. E8-21832 Filed 9-18-08; 8:45 am]