[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40389-40392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17256]
[[Page 40389]]
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DEPARTMENT OF COMMERCE
Bureau of Industry and Security
[Docket No. 190215128-9128-01]
RIN 0694-XC053
Impact of Proposed Additions to the ``Annex on Chemicals'' to the
Chemical Weapons Convention (CWC) on Legitimate Commercial Chemical,
Biotechnology, and Pharmaceutical Activities Involving ``Schedule 1''
Chemicals (Including Schedule 1 Chemicals Produced 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 on commercial activities of proposed additions
to ``Schedule 1'' in the ``Annex on Chemicals'' to the Chemical Weapons
Convention (CWC), as implemented through the Chemical Weapons
Convention Implementation Act (CWCIA) and the Chemical Weapons
Convention Regulations (CWCR). The purpose of this notice of inquiry is
to collect information to assist BIS in assessing the likely impact on
United States industry of the proposed addition of five chemical
families to ``Schedule 1'' in the ``Annex on Chemicals.''
DATES: Comments must be received by September 13, 2019.
ADDRESSES: You may submit comments by any of the following methods
(please refer to RIN 0694-XC053 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-2019-0002;
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 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) 482-2163. 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
23, titled ``Additions to the Annex on Chemicals,'' calls for the
President to submit a report to the Committee on Foreign Relations of
the Senate, detailing the likely impact of the proposed addition of a
chemical or biological substance to a schedule in the ``Annex on
Chemicals.'' This report shall include, inter alia, an assessment of
the likely impact on United States industry of the proposed addition.
President Trump, in his Memorandum of November 5, 2018 (83 FR 62679,
December 4, 2018), delegated the authority to carry out this function
to the Secretary of State, in coordination with other U.S. Government
departments and agencies (including the Department of Commerce),
consistent with the process described in National Security Presidential
Memorandum-4 of April 4, 2017 (82 FR 16881, April 6, 2017).
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--Schedule 1 Chemicals 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)/NSC-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 per PDD/NSC-70 effectively
precluded the commercial production of ``Schedule 1'' chemicals for
protective purposes in the United States, it did not otherwise
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 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 only. The CWCR prohibit commercial
production of ``Schedule 1'' chemicals for ``protective purposes''
because such production is effectively precluded per PDD/NSC-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));
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(2) Require annual declarations by 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 OPCW (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 by a biochemical or
biologically mediated reaction. 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.
Proposed Addition of Five Families of Chemicals to ``Schedule 1'' in
the CWC ``Annex on Chemicals''
On October 16, 2018 the United States, Canada, and the Netherlands
submitted a proposal to the OPCW Director General to add two families
of chemicals to ``Schedule 1'' in the CWC ``Annex on Chemicals.'' On
December 7, 2018, Russia submitted additional proposals to the Director
General, which included adding three additional families to ``Schedule
1.'' However, the CWC States Parties have yet to reach agreement on
adding the five chemical families to ``Schedule 1'' in the CWC ``Annex
on Chemicals.''
The following five ``Schedule 1'' chemical families are under
consideration for being listed as toxic chemicals in ``Schedule 1''
(the addition of the first two chemical families to ``Schedule 1'' was
proposed by the United States, Canada, and the Netherlands; the
addition of the other three chemical families was proposed by Russia):
(1) P-alkyl-N-fluorophosphonyl amidines Generic name: P-Alkyl (H or <=
C10, incl. cycloalkyl) N-(1-(dialkyl(<= C10, incl.
cycloalkyl)amino))alkylidene(H or <= C10, incl. cycloalkyl)
phosphoramidic flourides and corresponding alkylated or protonated
salts
Generic structure:
[GRAPHIC] [TIFF OMITTED] TN14AU19.489
Example: N-(1-(di-n-decylamino)-n-decylidene)-P-
decylphosphonamidic fluoride (No CAS Number)
(2) [Ocy]-Alkyl-N-fluorophosphorylamidines
Generic name: O-alkyl (H or <= C10, incl. cycloalkyl) N-(1-
(dialkyl(<= C10, incl. cycloalkyl)amino))alkylidene(H or <= C10,
incl. cycloalkyl) phosphoramidofluoridates and corresponding
alkylated or protonated salts
Generic structure:
[GRAPHIC] [TIFF OMITTED] TN14AU19.490
Example: O-n-decyl N-(1-(di-n-decylamino)-n-decylidene)
phosphoramidofluoridate (No CAS Number)
(3) [Rcy]-alkyl-N-fluorophosphonyl guanidines
Generic name: P-Alkyl (H or <= C10, incl. cycloalkyl)-
(bis((alkyl (H or <= C10, incl. cycloalkyl)alkyl(H or <= C10, incl.
cycloalkyl)amino))methylene) phosphonamidofluoridates and
corresponding alkylated or protonated salts
Generic structure:
[[Page 40391]]
[GRAPHIC] [TIFF OMITTED] TN14AU19.491
Example: Methyl-
(bis(diethylamino)methylene)phosphonamidofluoridate (No CAS Number)
(4) Carbamates (quaternaries and bisquaternaries of
dimethylcarbamoyloxypyridines)
Generic names: N-(n-Bromo (Alkyl)-N-(3-dimethylcarbamoxy-
[alpha]-picolinyl)-N,N- (CnH2n-1, n=1,2,3) ammonium bromide (n=1-
10); 1-[N,N-Dialkyl(C<=10)-N-(n-(hydroxyl, cyano,
acetoxy)alkyl(C<=10)ammonio]-n-[N-(3-methyl-carbamoxy-[alpha]-
picolinyl)-N,N-dialkyl(C<=10)ammonio]decane dibromide (n=1-8); 1,n-
Bis[N-(3-dimethylcarbamoxy-[alpha]-picolyl)-N,N-
dialkyl(C<=10)ammonio]-alkane-(2,(n-l)-dione) dibromide (n=2-12)
Generic structures:
[GRAPHIC] [TIFF OMITTED] TN14AU19.492
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Examples: N-(10-Bromodecyl)-N-(3-dimethylcarbamoxy-[alpha]-
picolinyl)-N,N-dimethylammonium bromide; 1-[N,N-Dimethyl-N-(2-
hydroxy)ethylammonio]-10-[N-(3-dimethyl-carbamoxy-[alpha]-
picolinyl)-N,N-dimethylammonio]decane dibromide (CAS number: 77104-
62-2); 1,10-Bis[N-(3-dimethylcarbamoxy-a-picolyl)-N-ethyl-N-
methylammonio]-decane-2,9-dione dibromide (CAS number: 77104-00-8)
(5) Fluorophosphoryl dihaloformaldoximes (also referred to as
substituted ((alkyliden)amino)oxy-phosphates and phosphonates)
Generic name: O-(1-Alkyl(H, Me)-2-alkyl(H, Me)-2-chloroethyl)-
(((dihalo(F, Cl)methylene)amino)-oxy)phosphorofluoridates
Generic structure:
[GRAPHIC] [TIFF OMITTED] TN14AU19.493
Examples: 2-Chloroethyl(((chlorofluoro-
methylene)amino)oxy)phosphoro-fluoridate (CAS number: 26102-97-6);
1-Chloropropan-2-yl(((chlorofluoro-methylene)amino)oxy)phosphoro-
fluoridate (CAS number: 26102-98-7); 3-Chlorobutan-2-
yl(((chlorofluoro-methylene)amino)oxy)phosphoro-fluoridate (CAS
number: 26102-99-8)
Request for Comments
BIS is seeking public comments to assist in determining whether the
legitimate commercial activities and interests of chemical,
biotechnology, and pharmaceutical firms in the United States would be
significantly harmed by the limitations that would be imposed on access
to, and production of, the compounds included in the five chemical
families identified above, if the CWC States Parties were to agree to
add these chemical families to ``Schedule 1'' in the CWC ``Annex on
Chemicals.'' To allow BIS to properly evaluate the significance of any
harm to commercial activities involving the proposed ``Schedule 1''
chemical families, 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. BIS will consider all comments received on or before
September 13, 2019. All comments (including any personally identifying
information or information for which a claim of confidentially is
asserted either in those comments or their transmittal emails) will be
made available for public inspection and copying. Parties who wish to
comment anonymously may do so by submitting their comments via
Regulations.gov, leaving the fields that would identify the commenter
blank and including no identifying information in the comment itself.
Dated: August 6, 2019.
Richard E. Ashooh,
Assistant Secretary for Export Administration.
[FR Doc. 2019-17256 Filed 8-13-19; 8:45 am]
BILLING CODE 3510-33-P