[Federal Register Volume 76, Number 237 (Friday, December 9, 2011)]
[Notices]
[Pages 76935-76937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31690]



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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

[Docket No. 111130706-1686-01]


Impact of Implementing the Chemical Weapons Convention (CWC) on 
Commercial Activities Involving ``Schedule 1'' Chemicals Through 
Calendar Year 2011; Impact of Adding Salts of CWC ``Schedule 1'' 
Chemicals to ``Schedule 1;'' Impact of Declaring Production of 
``Schedule 1'' Chemicals as Intermediates

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Notice of inquiry.

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SUMMARY: The Bureau of Industry and Security (BIS) is seeking public 
comments on the impact that implementation of the Chemical Weapons 
Convention (CWC), through the Chemical Weapons Convention 
Implementation Act (CWCIA), and the Chemical Weapons Convention 
Regulations (CWCR), has had on commercial activities involving 
``Schedule 1'' chemicals during calendar year 2011. Additionally, BIS 
seeks public comments on whether the addition of salts of certain CWC 
``Schedule 1'' chemicals (e.g., saxitoxin or nitrogen mustards) to the 
list of ``Schedule 1'' chemicals in the CWC Annex on Chemicals would 
impact any commercial activities. Finally, BIS is seeking public 
comments on whether any commercial chemical production activities in 
the U.S. could possibly involve the production of a ``Schedule 1'' 
chemical as an intermediate in the synthesis of other chemicals. In 
this regard, note that the CWC, CWCIA, and CWCR have the potential to 
impact commercial activities, not only when the ``Schedule 1'' 
chemicals are end products, but whenever ``Schedule 1'' chemicals 
(e.g., nitrogen mustards) are produced as intermediates in the 
synthesis of other chemicals.

DATES: Comments must be received by January 9, 2012.

ADDRESSES: You may submit comments by any of the following methods:
     Email: [email protected]. Include the phrase ``Schedule 
1 Notice of Inquiry'' in the subject line;
     Fax: (202) 482-3355 (Attn: Willard Fisher);
     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.

FOR FURTHER INFORMATION CONTACT: For questions on the Chemical Weapons 
Convention requirements for ``Schedule 1'' chemicals, contact Douglas 
Brown, Treaty Compliance Division, Office of Nonproliferation and 
Treaty Compliance, Bureau of Industry and Security, U.S. Department of 
Commerce, Phone: (202) 482-1001. For questions on the submission of 
comments, contact Willard Fisher, Regulatory Policy Division, Office of 
Exporter Services, Bureau of Industry and Security, U.S. Department of 
Commerce, Phone: (202) 482-2440.

SUPPLEMENTARY INFORMATION: 

Background

    The purpose of this notice of inquiry is threefold: (1) To collect 
information to assist BIS in its preparation of the annual 
certification to the Congress that is required under Condition 9 of 
Senate Resolution 75, April 24, 1997, in which the Senate gave its 
advice and consent to the ratification of the Chemical Weapons 
Convention; (2) to collect information that would assist BIS to 
evaluate whether salts of certain ``Schedule 1'' chemicals should be 
added to the list of ``Schedule 1'' chemicals; and (3) to collect 
information that would indicate to BIS whether any ``Schedule 1'' 
chemicals, or salts thereof, are produced as intermediates in the 
commercial production of some other chemical.

Request for Comments Concerning the Impact of Implementing the Chemical 
Weapons Convention (CWC) on Commercial Activities Involving ``Schedule 
1'' Chemicals Through Calendar Year 2011

    In providing its advice and consent to the ratification of the 
Convention on the Prohibition of the Development, Production, 
Stockpiling, and Use of Chemical Weapons and Their Destruction, 
commonly called the Chemical Weapons Convention (CWC) (the Convention), 
the Senate included, in Senate Resolution 75 (S. Res. 75, April 24, 
1997), several conditions to its ratification. Condition 9, titled 
``Protection of Advanced Biotechnology,'' calls for the President to 
certify to Congress on an annual basis that ``the legitimate commercial 
activities and interests of chemical, biotechnology, and pharmaceutical 
firms in the United States are not being significantly harmed by the 
limitations of the Convention on access to, and production of, those 
chemicals and toxins listed in Schedule 1.'' On July 8, 2004, President 
Bush, by Executive Order 13346, delegated his authority to make the 
annual certification to the Secretary of Commerce.
    The CWC is an international arms control treaty that contains 
certain verification provisions. In order to implement these 
verification provisions, the CWC established the Organization for the 
Prohibition of Chemical Weapons (OPCW). The CWC imposes certain 
obligations on countries that have ratified the Convention (i.e., 
States Parties), among which are the enactment of legislation to 
prohibit the production, storage, and use of chemical weapons, and the 
establishment of a National Authority to serve as the national focal 
point for effective liaison with the OPCW and other States Parties for 
the purpose of achieving the object and purpose of the Convention and 
the implementation of its provisions. The CWC also requires each State 
Party to implement a comprehensive data declaration and inspection 
regime to provide transparency and to verify that both the public and 
private sectors of the State Party are not engaged in activities 
prohibited under the CWC.
    ``Schedule 1'' chemicals consist of those toxic chemicals and 
precursors set forth in the CWC ``Annex on Chemicals'' and in 
Supplement No. 1 to part 712 of the Chemical Weapons Convention 
Regulations (CWCR) (15 CFR parts 710-722). The CWC identified these 
toxic chemicals and precursors as posing a high risk to the object and 
purpose of the Convention.
    The CWC restricts the production of ``Schedule 1'' chemicals for 
protective purposes to two facilities per State Party. The CWC Article-
by-Article Analysis submitted to the Senate in Treaty Doc. 103-21 
defined the term ``protective purposes'' to mean ``used for determining 
the adequacy of defense equipment and measures.'' Consistent with this 
definition, U.S. implementation, as authorized via Presidential 
Decision Directive (PDD) 70, December 17, 1999, assigned the 
responsibility to operate these two facilities to the Department of 
Defense (DOD), thereby precluding commercial production of ``Schedule 
1'' chemicals for protective purposes in the United States. The 
Department of Defense maintains strict controls on ``Schedule 1'' 
chemicals produced at its facilities in order to ensure the 
accountability and proper use of such chemicals, consistent with the 
object and purpose of the Convention. These actions did not establish 
any limitations on ``Schedule 1'' chemical activities that are not 
prohibited by the CWC. However, the CWC stipulates a one metric ton 
limit for ``Schedule 1'' chemicals in a State Party.

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    The provisions of the CWC that affect commercial activities 
involving ``Schedule 1'' chemicals are implemented in the CWCR (see 15 
CFR 712) and in the Export Administration Regulations (EAR) (see 15 CFR 
742.18 and 15 CFR 745), both of which are administered by the Bureau of 
Industry and Security (BIS). Pursuant to CWC requirements, the CWCR 
restrict commercial production of ``Schedule 1'' chemicals to research, 
medical, or pharmaceutical purposes. Other industrial uses are 
prohibited. The CWCR also contain other requirements and prohibitions 
that apply to ``Schedule 1'' chemicals and/or ``Schedule 1'' 
facilities. Specifically, the CWCR:
    (1) Prohibit the import of ``Schedule 1'' chemicals from States not 
Party to the Convention (15 CFR 712.2(b));
    (2) Require annual declarations by certain facilities engaged in 
the production of ``Schedule 1'' chemicals in excess of 100 grams 
aggregate per calendar year (i.e., declared ``Schedule 1'' facilities) 
for purposes not prohibited by the Convention (15 CFR 712.5(a)(1) and 
(a)(2));
    (3) Require government approval of ``declared Schedule 1'' 
facilities (15 CFR 712.5(f));
    (4) Provide that ``declared Schedule 1'' facilities are subject to 
initial and routine inspection by the Organization for the Prohibition 
of Chemical Weapons (15 CFR 712.5(e) and 716.1(b)(1));
    (5) Require 200 days advance notification of establishment of new 
``Schedule 1'' production facilities producing greater than 100 grams 
aggregate of ``Schedule 1'' chemicals per calendar year (15 CFR 712.4);
    (6) Require advance notification and annual reporting of all 
imports and exports of ``Schedule 1'' chemicals to, or from, other 
States Parties to the Convention (15 CFR 712.6, 742.18(a)(1) and 
745.1); and
    (7) Prohibit the export of ``Schedule 1'' chemicals to States not 
Party to the Convention (15 CFR 742.18(a)(1) and (b)(1)(ii)).
    In order to assist in determining whether the legitimate commercial 
activities and interests of chemical, biotechnology, and pharmaceutical 
firms in the United States are significantly harmed by the limitations 
of the Convention on access to, and production of, ``Schedule 1'' 
chemicals as described in this notice, BIS is seeking public comments 
on any effects that implementation of the Chemical Weapons Convention, 
through the Chemical Weapons Convention Implementation Act and the 
Chemical Weapons Convention Regulations, has had on commercial 
activities involving ``Schedule 1'' chemicals during calendar year 
2011. To allow BIS to properly evaluate the significance of any harm to 
commercial activities involving ``Schedule 1'' chemicals, public 
comments submitted in response to this notice of inquiry should include 
both a quantitative and qualitative assessment of the impact of the CWC 
on such activities.

Request for Comments Concerning the Impact of Adding Salts of Certain 
CWC ``Schedule 1'' Chemicals to the List of ``Schedule 1'' Chemicals in 
the CWC Annex on Chemicals

    The OPCW has recently been considering whether to add salts of 
certain ``Schedule 1'' chemicals, specifically of saxitoxin and 
nitrogen mustards, to the list of ``Schedule 1'' chemicals in the CWC 
Annex on Chemicals. This would mean that the salts of these ``Schedule 
1'' chemicals would likely be identified as ``Schedule 1'' chemicals, 
themselves. As a result, they too would become subject to any impact 
that implementation of the CWC, through the CWCIA and the CWCR, has on 
commercial activities involving ``Schedule 1'' chemicals.
    BIS seeks comments as to whether salts of any ``Schedule 1'' 
chemical, which are not currently listed as ``Schedule 1'' chemicals in 
the CWC Annex on Chemicals, are produced (as an end product or in a 
captive use situation), consumed, transferred, or stored in the United 
States. Note that, if the CWC were to add any of these salts to the 
list of ``Schedule 1'' chemicals in the CWC Annex on Chemicals, this 
could impact commercial activities in the event that these new 
``Schedule 1'' chemicals were produced as intermediates in the 
synthesis of other chemicals. For example, such production or captive 
use by a facility, following a decision by the OPCW to add any of these 
salts to the list of ``Schedule 1'' chemicals in the CWC Annex on 
Chemicals, could subject that facility to the CWC requirements for 
destruction of ``chemical weapons production facilities.''

Request for Comments on Whether Any ``Schedule 1'' Chemicals, or Salts 
Thereof, Are Produced as Intermediates in the Commercial Production of 
Some Other Chemical

    As defined in 15 CFR 710.1, production of a ``Schedule 1'' chemical 
means formation through chemical synthesis as well as processing to 
extract and isolate ``Schedule 1'' chemicals. On November 10, 2005, the 
Organization for the Prohibition of Chemical Weapons (OPCW) decided, 
``that the production of a ``Schedule 1'' chemical is understood, for 
declaration purposes, to include intermediates, by-products, or waste 
products that are produced and consumed within a defined chemical 
manufacturing sequence, where such intermediates, by-products, or waste 
products are chemically stable and therefore exist for a sufficient 
time to make isolation from the manufacturing stream possible, but 
where, under normal or design operating conditions, isolation does not 
occur'' (C-10/DEC.12). At the time of this decision, there were no 
known examples of so-called captive use of ``Schedule 1'' chemicals. 
This is no longer the case. Based on new information provided by 
Denmark to the Executive Council of the OPCW, the United States is 
aware that a commercial pharmaceutical facility in Denmark produced a 
``Schedule 1'' chemical (a nitrogen mustard), as an intermediate in the 
production of another chemical, which, arguably, would cause the 
facility to meet the definition of a Chemical Weapons Production 
Facility.
    While it appears unlikely that the pharmaceutical facility will be 
determined to be a Chemical Weapons Production Facility, Denmark has 
ordered the facility to halt future production of the pharmaceutical 
product and sought resolution through the OPCW Executive Council.
    In view of this development, BIS is seeking public comments as to 
whether any similar situations of so-called captive use of a ``Schedule 
1'' chemical may exist in the United States.

Submission of Comments

    All comments must be submitted to one of the addresses indicated in 
this notice. The Department requires that all comments be submitted in 
written form.
    The Department encourages interested persons who wish to comment to 
do so at the earliest possible time. The period for submission of 
comments will close on January 9, 2012. The Department will consider 
all comments received before the close of the comment period. Comments 
received after the end of the comment period will be considered if 
possible, but their consideration cannot be assured. The Department 
will not accept comments accompanied by a request that a part or all of 
the material be treated confidentially because of its business 
proprietary nature or for any other reason. The Department will return 
such comments and materials to the persons submitting the comments and 
will not consider them. All

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comments submitted in response to this notice will be a matter of 
public record and will be available for public inspection and copying.
    The Office of Administration, Bureau of Industry and Security, U.S. 
Department of Commerce, displays public comments on the BIS Freedom of 
Information Act (FOIA) Web site at http://www.bis.doc.gov/foia. This 
office does not maintain a separate public inspection facility. If you 
have technical difficulties accessing this Web site, please call BIS's 
Office of Administration, at (202) 482-1093, for assistance.

    Dated: December 5, 2011.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2011-31690 Filed 12-8-11; 8:45 am]
BILLING CODE 3510-33-P