[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]



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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:

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[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