[Federal Register Volume 80, Number 220 (Monday, November 16, 2015)]
[Notices]
[Pages 70752-70754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29182]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
[Docket No. 151022984-5984-01]
Impact of the Implementation of the Chemical Weapons Convention
(CWC) on Legitimate Commercial Chemical, Biotechnology, and
Pharmaceutical Activities Involving ``Schedule 1'' Chemicals (Including
Schedule 1 Chemicals Produced as Intermediates) Through Calendar Year
2015
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 2015. The purpose of this
notice of inquiry is to collect information to assist BIS in its
preparation of the annual certification to the Congress on whether the
legitimate commercial activities and interests of chemical,
biotechnology, and pharmaceutical firms are being harmed by such
implementation. This certification 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 CWC.
DATES: Comments must be received by December 16, 2015.
ADDRESSES: You may submit comments by any of the following methods
(please refer to RIN 0694-XC028 in all comments and in the subject line
of email comments):
Federal rulemaking portal (http://www.regulations.gov)--
you can find this notice by searching on its regulations.gov docket
number, which is BIS-2015-0039;
Email: [email protected]--include the phrase
``Schedule 1 Notice of Inquiry'' in the subject line;
Fax: (202) 482-3355 (Attn: Willard Fisher);
By mail or delivery to Regulatory Policy Division, Bureau
of Industry and
[[Page 70753]]
Security, U.S. Department of Commerce, Room 2099B, 14th Street and
Pennsylvania Avenue NW., 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
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 or ``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 in
order to achieve 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 (Part VI of the ``Verification Annex'') restricts the
production of ``Schedule 1'' chemicals for protective purposes to two
facilities per State Party: A single small-scale facility (SSSF) and a
facility for production in quantities not exceeding 10 kg per year. 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 and as authorized by Presidential
Decision Directive (PDD) 70 (December 17, 1999), which specifies agency
and departmental responsibilities as part of the U.S. implementation of
the CWC, the Department of Defense (DOD) was assigned the
responsibility to operate these two facilities. Although this
assignment of responsibility to DOD under PDD-70 effectively precluded
commercial production of ``Schedule 1'' chemicals for protective
purposes in the United States, it did not establish any limitations on
``Schedule 1'' chemical activities that are not prohibited by the CWC.
However, DOD does maintain strict controls on ``Schedule 1'' chemicals
produced at its facilities in order to ensure accountability for such
chemicals, as well as their proper use, consistent with the object and
purpose of the Convention.
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 (the CWCR prohibit commercial
production of ``Schedule 1'' chemicals for ``protective purposes''
because such production is effectively precluded per PDD-70, as
described above--see 15 CFR 712.2(a)). 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) Provide for 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)).
For purposes of the CWCR (see 15 CFR 710.1), ``production of a
Schedule 1 chemical'' means the formation of ``Schedule 1'' chemicals
through chemical synthesis, as well as processing to extract and
isolate ``Schedule 1'' chemicals produced biologically. Such production
is understood, for CWCR 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.
Request for Comments
In order to assist in determining whether the legitimate commercial
activities and interests of chemical, biotechnology, and pharmaceutical
[[Page 70754]]
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
2015. 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.
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 December 16, 2015. 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 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: November 6, 2015.
Kevin J. Wolf,
Assistant Secretary for Export Administration.
[FR Doc. 2015-29182 Filed 11-13-15; 8:45 am]
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