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 2024, 97583-97584 [2024-28755]

Agencies

• DEPARTMENT OF COMMERCE
• Bureau of Industry and Security

[Federal Register Volume 89, Number 236 (Monday, December 9, 2024)]
[Notices]
[Pages 97583-97584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-28755]


-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

[Docket No. 241127-0304]
RIN 0694-XC110


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 2024

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Notice of inquiry.

-----------------------------------------------------------------------

SUMMARY: The Bureau of Industry and Security (BIS) is seeking public 
comments on the impact that implementation of the Chemical Weapons 
Convention (CWC or ``the Convention''), through the Chemical Weapons 
Convention Implementation Act of 1998 and the Chemical Weapons 
Convention Regulations (CWCR), has had on commercial activities 
involving ``Schedule 1'' chemicals during calendar year 2024. 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 CWC.

DATES: Comments must be received by January 8, 2025.

ADDRESSES: Comments on this rule may be submitted to the Federal 
rulemaking portal at: www.regulations.gov. The regulations.gov ID for 
this rule is: BIS-2024-0054. Please refer to RIN 0694-XC110 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 at: 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 David Johnston, Treaty Compliance 
Division, (202) 482-2450, Email: David [email protected].
    For questions on the submission of comments, contact Logan Norton, 
Regulatory Policy Division, (202) 482-2440; Email: [email protected].

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 (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 George W. 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

[[Page 97584]]

for the Prohibition of Chemical Weapons (OPCW). In order to achieve the 
object and purpose of the Convention and the implementation of its 
provisions, 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. 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. 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.
    ``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 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 and a 
facility for production in quantities not exceeding 10 kilograms (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 object and purpose of the Convention. 
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 
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) Require 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) Provide 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) 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 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 2024. 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 8, 2025.

Matthew S. Borman,
Principal Deputy Assistant Secretary for Strategic Trade and Technology 
Security.
[FR Doc. 2024-28755 Filed 12-6-24; 8:45 am]
BILLING CODE 3510-33-P