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 2019

Citation85 FR 8246
Record Number2020-02848
Published date13 February 2020
SectionNotices
CourtCommerce Department,Industry And Security Bureau
Federal Register, Volume 85 Issue 30 (Thursday, February 13, 2020)
[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
                [Notices]
                [Pages 8246-8247]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-02848]
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                DEPARTMENT OF COMMERCE
                Bureau of Industry and Security
                [Docket No. 200113-0009]
                RIN 0694-XC055
                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 2019
                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 that implementation of the Chemical Weapons
                Convention (CWC), through the Chemical Weapons Convention
                Implementation Act and the Chemical Weapons Convention Regulations
                (CWCR), has had on commercial activities involving ``Schedule 1''
                chemicals during calendar year 2019. 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 March 16, 2020.
                ADDRESSES: You may submit comments by any of the following methods
                (please refer to RIN 0694-XC055 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-2019-0028;
                 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
                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 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 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.
                 ``Schedule 1'' chemicals consist of those toxic chemicals and
                precursors set
                [[Page 8247]]
                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) 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
                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) 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) 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 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);
                 (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. The phrase ``production of a schedule
                1 chemical'' includes, in its meaning, 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 and the CWCR, has had on
                commercial activities involving ``Schedule 1'' chemicals during
                calendar year 2019. 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. The Department requires that all comments be submitted in
                written form. BIS will consider all comments received on or before
                March 16, 2020. All comments, including those comments containing any
                personally identifying information or information for which a claim of
                confidentially is asserted either in the 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.
                Richard E. Ashooh,
                Assistant Secretary for Export Administration.
                [FR Doc. 2020-02848 Filed 2-12-20; 8:45 am]
                 BILLING CODE 3510-33-P
                

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