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 2021

CourtCommerce Department,Industry And Security Bureau
Citation86 FR 68213
Record Number2021-26101
Publication Date01 December 2021
Federal Register, Volume 86 Issue 228 (Wednesday, December 1, 2021)
[Federal Register Volume 86, Number 228 (Wednesday, December 1, 2021)]
                [Notices]
                [Pages 68213-68215]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2021-26101]
                =======================================================================
                -----------------------------------------------------------------------
                DEPARTMENT OF COMMERCE
                Bureau of Industry and Security
                [Docket No. 211124-0245]
                RIN 0694-XC087
                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 2021
                AGENCY: Bureau of Industry and Security, Commerce.
                ACTION: Notice of inquiry.
                -----------------------------------------------------------------------
                SUMMARY: The Bureau of Industry and Security is seeking public comments
                on the impact that 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
                2021. 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
                [[Page 68214]]
                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 3, 2022.
                ADDRESSES: You may submit comments, identified by regulations.gov
                docket number BIS-2021-0043 or by RIN 0694-XC087, using any of the
                following methods:
                 Federal rulemaking portal (http://www.regulations.gov).
                You can find this notice by searching under its regulations.gov docket
                number, which is BIS-2021-0043;
                 Email: [email protected]. Include RIN 0694-XC087
                in the subject line of the message.
                 All filers using the portal or email should use the name of the
                person or entity submitting the comments as the name of their files, in
                accordance with the instructions below. Parties 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 also provide a non-confidential version of the submission.
                 For comments (including rebuttal 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.'' The ``BC'' or ``P'' (as
                appropriate) in the file name should be followed by the name of the
                person or entity submitting the comments. Any submissions with file
                names that do not begin with a ``P'' or ``BC'' will be assumed to be
                public and will be made publicly available through http://www.regulations.gov.
                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, (202) 482-5808, Email: [email protected]. 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, (202) 482-6057,
                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,
                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 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 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 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 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
                [[Page 68215]]
                ``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 2021. 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 3, 2022.
                Matthew S. Borman,
                Deputy Assistant Secretary for Export Administration.
                [FR Doc. 2021-26101 Filed 11-30-21; 8:45 am]
                BILLING CODE 3510-33-P
                

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT