81 FR 86322 - 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) Through Calendar Year 2016
DEPARTMENT OF COMMERCE
Bureau of Industry and Security Federal Register Volume 81, Issue 230 (November 30, 2016)
Bureau of Industry and Security
Federal Register Volume 81, Issue 230 (November 30, 2016)
| Page Range | 86322-86323 | |
| FR Document | 2016-28799 |
[Federal Register Volume 81, Number 230 (Wednesday, November 30, 2016)] [Notices] [Pages 86322-86323] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28799] [[Page 86322]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF COMMERCE Bureau of Industry and Security [Docket No. 161024999-6999-01] 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) Through Calendar Year 2016 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), through the Chemical Weapons Convention Implementation Act (CWCIA) and the Chemical Weapons Convention Regulations (CWCR), has had on commercial activities involving ``Schedule 1'' chemicals during calendar year 2016. The purpose of this notice of inquiry is to collect information to assist BIS in its preparation of the annual certification to Congress on whether the legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms are being 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 December 30, 2016. ADDRESSES: You may submit comments by any of the following methods (please refer to RIN 0694-XC034 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-2016-0038; 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) 482-1001. 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). 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 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. 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. However, DOD does maintain 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. 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 (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: [[Page 86323]] (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 Organization for the Prohibition of Chemical Weapons (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 biologically. 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. 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 Chemical Weapons Convention, through the Chemical Weapons Convention Implementation Act and the Chemical Weapons Convention Regulations, has had on commercial activities involving ``Schedule 1'' chemicals during calendar year 2016. 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. The Department encourages interested persons who wish to comment to do so at the earliest possible time. The period for submission of comments will close on December 30, 2016. The Department will consider all comments received before the close of the comment period. Comments received after the end of the comment period may not be considered. The Department will not accept comments accompanied by a request that a part or all of the material be treated confidentially because of its business proprietary nature or for any other reason. The Department will return such comments and materials to the persons submitting the comments and will not consider them. All comments submitted in response to this notice will be a matter of public record and will be available for public inspection and copying. The Office of Administration, Bureau of Industry and Security, U.S. Department of Commerce, displays public comments on the BIS Freedom of Information Act (FOIA) Web site at http://www.bis.doc.gov/foia. This office does not maintain a separate public inspection facility. If you have technical difficulties accessing this Web site, please call BIS's Office of Administration, at (202) 482-1093, for assistance. Dated: November 23, 2016. Kevin J. Wolf, Assistant Secretary for Export Administration. [FR Doc. 2016-28799 Filed 11-29-16; 8:45 am] BILLING CODE 3510-33-P
![86322 Federal Register / Vol. 81, No. 230 / Wednesday, November 30, 2016 / Notices
DEPARTMENT OF COMMERCE 1’’ chemicals, contact Douglas Brown, forth in the CWC ‘‘Annex on
Treaty Compliance Division, Office of Chemicals’’ and in Supplement No. 1 to
Bureau of Industry and Security Nonproliferation and Treaty part 712 of the Chemical Weapons
[Docket No. 161024999–6999–01] Compliance, Bureau of Industry and Convention Regulations (CWCR) (15
Security, U.S. Department of Commerce, CFR parts 710–722). The CWC
Impact of the Implementation of the Phone: (202) 482–1001. For questions identified these toxic chemicals and
Chemical Weapons Convention (CWC) on the submission of comments, contact precursors as posing a high risk to the
on Legitimate Commercial Chemical, Willard Fisher, Regulatory Policy object and purpose of the Convention.
Biotechnology, and Pharmaceutical Division, Office of Exporter Services,
The CWC (Part VI of the ‘‘Verification
Activities Involving ‘‘Schedule 1’’ Bureau of Industry and Security, U.S.
Annex’’) restricts the production of
Chemicals (Including Schedule 1 Department of Commerce, Phone: (202)
‘‘Schedule 1’’ chemicals for protective
Chemicals Produced as Intermediates) 482–2440.
purposes to two facilities per State
Through Calendar Year 2016 SUPPLEMENTARY INFORMATION:
Party: a single small-scale facility
AGENCY: Bureau of Industry and Background (SSSF) and a facility for production in
Security, Commerce. In providing its advice and consent to quantities not exceeding 10 kg per year.
the ratification of the Convention on the The CWC Article-by-Article Analysis
ACTION: Notice of inquiry.
Prohibition of the Development, submitted to the Senate in Treaty Doc.
SUMMARY: The Bureau of Industry and Production, Stockpiling, and Use of 103–21 defined the term ‘‘protective
Security (BIS) is seeking public Chemical Weapons and Their purposes’’ to mean ‘‘used for
comments on the impact that Destruction, commonly called the determining the adequacy of defense
implementation of the Chemical Chemical Weapons Convention (CWC or equipment and measures.’’ Consistent
Weapons Convention (CWC), through ‘‘the Convention’’), the Senate included, with this definition and as authorized
the Chemical Weapons Convention in Senate Resolution 75 (S. Res. 75, by Presidential Decision Directive (PDD)
Implementation Act (CWCIA) and the April 24, 1997), several conditions to its 70 (December 17, 1999), which specifies
Chemical Weapons Convention ratification. Condition 9, titled agency and departmental
Regulations (CWCR), has had on ‘‘Protection of Advanced responsibilities as part of the U.S.
commercial activities involving Biotechnology,’’ calls for the President implementation of the CWC, the
‘‘Schedule 1’’ chemicals during calendar to certify to Congress on an annual basis Department of Defense (DOD) was
year 2016. The purpose of this notice of that ‘‘the legitimate commercial assigned the responsibility to operate
inquiry is to collect information to assist activities and interests of chemical, these two facilities. Although this
BIS in its preparation of the annual biotechnology, and pharmaceutical assignment of responsibility to DOD
certification to Congress on whether the firms in the United States are not being under PDD–70 effectively precluded
legitimate commercial activities and significantly harmed by the limitations commercial production of ‘‘Schedule 1’’
interests of chemical, biotechnology, of the Convention on access to, and chemicals for protective purposes in the
and pharmaceutical firms are being production of, those chemicals and United States, it did not establish any
harmed by such implementation. This toxins listed in Schedule 1.’’ On July 8, limitations on ‘‘Schedule 1’’ chemical
certification is required under Condition 2004, President Bush, by Executive activities that are not prohibited by the
9 of Senate Resolution 75, April 24, Order 13346, delegated his authority to CWC. However, DOD does maintain
1997, in which the Senate gave its make the annual certification to the strict controls on ‘‘Schedule 1’’
advice and consent to the ratification of Secretary of Commerce. chemicals produced at its facilities in
the CWC. The CWC is an international arms order to ensure accountability for such
DATES: Comments must be received by control treaty that contains certain chemicals, as well as their proper use,
December 30, 2016. verification provisions. In order to consistent with the object and purpose
implement these verification provisions, of the Convention.
ADDRESSES: You may submit comments
the CWC established the Organization
by any of the following methods (please for the Prohibition of Chemical The provisions of the CWC that affect
refer to RIN 0694–XC034 in all Weapons (OPCW). The CWC imposes commercial activities involving
comments and in the subject line of certain obligations on countries that ‘‘Schedule 1’’ chemicals are
email comments): have ratified the Convention (i.e., States implemented in the CWCR (see 15 CFR
• Federal rulemaking portal (http:// Parties), among which are the enactment 712) and in the Export Administration
www.regulations.gov)—you can find this of legislation to prohibit the production, Regulations (EAR) (see 15 CFR 742.18
notice by searching on its storage, and use of chemical weapons, and 15 CFR 745), both of which are
regulations.gov docket number, which is and the establishment of a National administered by the Bureau of Industry
BIS–2016–0038; Authority to serve as the national focal and Security (BIS). Pursuant to CWC
• Email: willard.fisher@bis.doc.gov— point for effective liaison with the requirements, the CWCR restrict
include the phrase ‘‘Schedule 1 Notice OPCW and other States Parties in order commercial production of ‘‘Schedule 1’’
of Inquiry’’ in the subject line; to achieve the object and purpose of the chemicals to research, medical, or
• Fax: (202) 482–3355 (Attn: Willard Convention and the implementation of pharmaceutical purposes (the CWCR
Fisher); its provisions. The CWC also requires prohibit commercial production of
• By mail or delivery to Regulatory each State Party to implement a ‘‘Schedule 1’’ chemicals for ‘‘protective
Policy Division, Bureau of Industry and purposes’’ because such production is
sradovich on DSK3GMQ082PROD with NOTICES
comprehensive data declaration and
Security, U.S. Department of Commerce, inspection regime to provide effectively precluded per PDD–70, as
Room 2099B, 14th Street and transparency and to verify that both the described above—see 15 CFR 712.2(a)).
Pennsylvania Avenue NW., Washington, public and private sectors of the State The CWCR also contain other
DC 20230. Party are not engaged in activities requirements and prohibitions that
FOR FURTHER INFORMATION CONTACT: For prohibited under the CWC. apply to ‘‘Schedule 1’’ chemicals and/or
questions on the Chemical Weapons ‘‘Schedule 1’’ chemicals consist of ‘‘Schedule 1’’ facilities. Specifically, the
Convention requirements for ‘‘Schedule those toxic chemicals and precursors set CWCR:
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![Federal Register / Vol. 81, No. 230 / Wednesday, November 30, 2016 / Notices 86323
(1) Prohibit the import of ‘‘Schedule that implementation of the Chemical DEPARTMENT OF COMMERCE
1’’ chemicals from States not Party to Weapons Convention, through the
the Convention (15 CFR 712.2(b)); Chemical Weapons Convention United States Patent and Trademark
(2) Require annual declarations by Implementation Act and the Chemical Office
certain facilities engaged in the Weapons Convention Regulations, has [Docket No. PTO–P–2016–0051]
production of ‘‘Schedule 1’’ chemicals had on commercial activities involving
in excess of 100 grams aggregate per ‘‘Schedule 1’’ chemicals during calendar Notice of Roundtables and Extension
calendar year (i.e., declared ‘‘Schedule year 2016. To allow BIS to properly of the Period for Comments on
1’’ facilities) for purposes not prohibited evaluate the significance of any harm to Examination Time Goals
by the Convention (15 CFR 712.5(a)(1)
commercial activities involving
and (a)(2)); AGENCY: United States Patent and
(3) Provide for government approval ‘‘Schedule 1’’ chemicals, public
Trademark Office, Commerce.
of ‘‘declared Schedule 1’’ facilities (15 comments submitted in response to this
ACTION: Notice of public roundtables
CFR 712.5(f)); notice of inquiry should include both a
quantitative and qualitative assessment and extension of the comment period.
(4) Provide that ‘‘declared Schedule
1’’ facilities are subject to initial and of the impact of the CWC on such SUMMARY: The United States Patent and
routine inspection by the Organization activities. Trademark Office (Office or USPTO)
for the Prohibition of Chemical previously announced information for
Submission of Comments
Weapons (15 CFR 712.5(e) and roundtables in Alexandria, Virginia, and
716.1(b)(1)); All comments must be submitted to Dallas, Texas, to solicit public feedback
(5) Require 200 days advance one of the addresses indicated in this as part of an effort to reevaluate its
notification of establishment of new notice. The Department requires that all examination time goals. Examination
‘‘Schedule 1’’ production facilities comments be submitted in written form. time goals vary by technology and
producing greater than 100 grams represent the average amount of time
aggregate of ‘‘Schedule 1’’ chemicals per The Department encourages interested
that a patent examiner is expected to
calendar year (15 CFR 712.4); persons who wish to comment to do so spend examining a patent application in
(6) Require advance notification and at the earliest possible time. The period a particular technology. The Office now
annual reporting of all imports and for submission of comments will close is providing information on the
exports of ‘‘Schedule 1’’ chemicals to, or on December 30, 2016. The Department additional three roundtables that the
from, other States Parties to the will consider all comments received Office will be conducting in Detroit,
Convention (15 CFR 712.6, 742.18(a)(1) before the close of the comment period. Michigan; Denver, Colorado; and San
and 745.1); and Comments received after the end of the Jose, California. In addition, the Office
(7) Prohibit the export of ‘‘Schedule comment period may not be considered. is extending the written comment
1’’ chemicals to States not Party to the The Department will not accept period to ensure that all stakeholders
Convention (15 CFR 742.18(a)(1) and comments accompanied by a request have sufficient opportunity to submit
(b)(1)(ii)). that a part or all of the material be comments on the reevaluation of the
For purposes of the CWCR (see 15 treated confidentially because of its Office’s examination time goals.
CFR 710.1), ‘‘production of a Schedule
business proprietary nature or for any DATES: Written Comments Deadline: To
1 chemical’’ means the formation of
other reason. The Department will be ensured of consideration, written
‘‘Schedule 1’’ chemicals through
chemical synthesis, as well as return such comments and materials to comments must be received on or before
processing to extract and isolate the persons submitting the comments January 30, 2017.
‘‘Schedule 1’’ chemicals produced and will not consider them. All ADDRESSES: Written comments should
biologically. Such production is comments submitted in response to this be sent by electronic mail addressed to
understood, for CWCR declaration notice will be a matter of public record ExternalExaminationTimeStudy@
purposes, to include intermediates, by- and will be available for public USPTO.gov. Comments also may be
products, or waste products that are inspection and copying. submitted by postal mail addressed to:
produced and consumed within a The Office of Administration, Bureau Mail Stop Comments—Patents,
defined chemical manufacturing of Industry and Security, U.S. Commissioner for Patents, P.O. Box
sequence, where such intermediates, by- Department of Commerce, displays 1450, Alexandria, VA 22313–1450,
products, or waste products are public comments on the BIS Freedom of marked to the attention of Raul Tamayo,
chemically stable and therefore exist for Senior Legal Advisor, Office of Patent
Information Act (FOIA) Web site at
a sufficient time to make isolation from Legal Administration, Office of the
http://www.bis.doc.gov/foia. This office
the manufacturing stream possible, but Deputy Commissioner for Patent
does not maintain a separate public Examination Policy.
where, under normal or design inspection facility. If you have technical
operating conditions, isolation does not Although comments may be
difficulties accessing this Web site, submitted by postal mail, the Office
occur.
please call BIS’s Office of prefers to receive comments by
Request for Comments Administration, at (202) 482–1093, for electronic mail in order to facilitate
In order to assist in determining assistance. posting on the USPTO’s Internet Web
whether the legitimate commercial Dated: November 23, 2016. site (http://www.uspto.gov). Electronic
activities and interests of chemical, comments may be submitted in plain
sradovich on DSK3GMQ082PROD with NOTICES
Kevin J. Wolf,
biotechnology, and pharmaceutical text, ADOBE® portable document
Assistant Secretary for Export
firms in the United States are Administration.
format, or MICROSOFT WORD® format.
significantly harmed by the limitations Comments not submitted electronically
[FR Doc. 2016–28799 Filed 11–29–16; 8:45 am]
of the Convention on access to, and should be submitted on paper in a
production of, ‘‘Schedule 1’’ chemicals BILLING CODE 3510–33–P format that facilitates digital scanning
as described in this notice, BIS is into ADOBE® portable document
seeking public comments on any effects format.
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Document Created: 2016-11-30 02:18:03
Document Modified: 2016-11-30 02:18:03
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of inquiry. | |
| Dates | Comments must be received by December 30, 2016. | |
| 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) 482-1001. 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. | |
| FR Citation | 81 FR 86322 |
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