[Federal Register Volume 88, Number 243 (Wednesday, December 20, 2023)]
[Notices]
[Pages 88049-88050]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov. The regulations.gov 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 https://www.regulations.gov.
    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: 
[email protected]. For questions on the submission of comments, 
contact Logan Norton, Regulatory Policy Division, Email: 
[email protected].

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