Notice2023-27951
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) During Calendar Year 2023
Primary source
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Published
December 20, 2023
Issuing agencies
Commerce DepartmentIndustry and Security Bureau
Abstract
The Bureau of Industry and Security is seeking public comments on the impact that the implementation of the Chemical Weapons Convention, through the Chemical Weapons Convention Implementation Act of 1998 and the Chemical Weapons Convention Regulations, has had on commercial activities involving "Schedule 1" chemicals during calendar year 2023. 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 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 Chemical Weapons Convention.
Full Text
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<title>Federal Register, Volume 88 Issue 243 (Wednesday, December 20, 2023)</title>
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[Federal Register Volume 88, Number 243 (Wednesday, December 20, 2023)]
[Notices]
[Pages 88049-88050]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-27951]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
[Docket No. 231208-0291]
RIN 0694-XC103
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) During Calendar
Year 2023
AGENCY: Bureau of Industry and Security, Commerce.
ACTION: Notice of inquiry.
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SUMMARY: The Bureau of Industry and Security is seeking public comments
on the impact that the implementation of the Chemical Weapons
Convention, through the Chemical Weapons Convention Implementation Act
of 1998 and the Chemical Weapons Convention Regulations, has had on
commercial activities involving ``Schedule 1'' chemicals during
calendar year 2023. 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 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
Chemical Weapons Convention.
DATES: Comments must be received by January 19, 2024.
ADDRESSES: Comments on this rule may be submitted to the Federal
rulemaking portal <a href="https://www.regulations.gov">https://www.regulations.gov</a>. The <a href="http://regulations.gov">regulations.gov</a> ID
for this rule is: BIS-2023-0039. Please refer to RIN 0694-XC103 in all
comments.
All filers using the portal should use the name of the person or
entity submitting the comments as the name of their files, in
accordance with the instructions below. Anyone submitting business
confidential information should clearly identify the business
confidential portion at the time of submission, file a statement
justifying nondisclosure and referring to the specific legal authority
claimed, and provide a non-confidential version of the submission.
For comments submitted electronically containing business
confidential information, the file name of the business confidential
version should begin with the characters ``BC.'' Any page containing
business confidential information must be clearly marked ``BUSINESS
CONFIDENTIAL'' on the top of that page. The corresponding non-
confidential version of those comments must be clearly marked
``PUBLIC.'' The file name of the non-confidential version should begin
with the character ``P.'' Any submissions with file names that do not
begin with either a ``BC'' or a ``P'' will be assumed to be public and
will be made publicly available through <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Commenters submitting business confidential information are
encouraged to scan a hard copy of the non-confidential version to
create an image of the file, rather than submitting a digital copy with
redactions applied, to avoid inadvertent redaction errors which could
enable the public to read business confidential information.
FOR FURTHER INFORMATION CONTACT: For questions on the Chemical Weapons
Convention requirements for ``Schedule 1'' chemicals, contact James
Truske, Treaty Compliance Division, (202) 482-2509, Email:
<a href="/cdn-cgi/l/email-protection#aac0cbc7cfd984ded8dfd9c1cfeac8c3d984cec5c984cdc5dc"><span class="__cf_email__" data-cfemail="7d171c10180e53090f080e16183d1f140e5319121e531a120b">[email protected]</span></a>. For questions on the submission of comments,
contact Logan Norton, Regulatory Policy Division, Email:
<a href="/cdn-cgi/l/email-protection#0153514533416368722f656e622f666e77"><span class="__cf_email__" data-cfemail="742624304634161d075a101b175a131b02">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
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'') is an international arms control treaty that seeks to
eliminate chemical weapons through requiring ratifying countries
(States Parties) to prohibit the development, production, acquisition,
stockpiling, retention, and transfer of chemical weapons. The CWC
imposes certain obligations on States Parties, among which are the
enactment of legislation to implement the treaty's prohibitions. In the
United States, the Chemical Weapons Convention Implementation Act of
1998, 22 U.S.C. 6701 et seq., implements the provisions of the CWC. In
providing its advice and consent to the ratification of the CWC, 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
George W. Bush, by Executive Order 13346, delegated his authority to
make the annual certification to the Secretary of Commerce.
``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--SCHEDULE 1 CHEMICALS'' of the Chemical
Weapons Convention Regulations (CWCR) (15 CFR parts 710-722). The CWC
identified these toxic chemicals and
[[Page 88050]]
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 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. DOD maintains 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 Convention's objectives. 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.
The provisions of the CWC that affect commercial activities
involving ``Schedule 1'' chemicals are implemented in the CWCR (see 15
CFR part 712) and in the Export Administration Regulations (EAR) (see
15 CFR 742.18 and 15 CFR part 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) Prohibits the import of ``Schedule 1'' chemicals from States
not Party to the Convention (15 CFR 712.2(b));
(2) Requires 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) Provides for government approval of ``declared Schedule 1''
facilities (15 CFR 712.5(f));
(4) Requires 200 days advance notification of the establishment of
new ``Schedule 1'' production facilities producing greater than 100
grams aggregate of ``Schedule 1'' chemicals per calendar year (15 CFR
712.4);
(5) Provides that ``declared Schedule 1'' facilities are subject to
initial and routine inspection by the OPCW (15 CFR 712.5(e) and
716.1(b)(1));
(6) Requires 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) Prohibits 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 the definition of ``production'' in
15 CFR 710.1), the phrase ``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. The
phrase also encompasses the formation of a chemical through chemical
reaction, including by a biochemical or biologically mediated reaction.
``Production of a Schedule 1 chemical'' 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
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 CWC, through the Chemical
Weapons Convention Implementation Act of 1998 and the CWCR, has had on
commercial activities involving ``Schedule 1'' chemicals during
calendar year 2023. 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 and in accordance with the instructions provided herein.
BIS will consider all comments received on or before January 19, 2024.
Matthew S. Borman,
Deputy Assistant Secretary for Export Administration.
[FR Doc. 2023-27951 Filed 12-19-23; 8:45 am]
BILLING CODE 3510-33-P
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