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, 86322-86323 [2016-28799]
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Federal Register / Vol. 81, No. 230 / Wednesday, November 30, 2016 / Notices
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
Bureau of Industry and
Security, Commerce.
ACTION: Notice of inquiry.
AGENCY:
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 (https://
www.regulations.gov)—you can find this
notice by searching on its
regulations.gov docket number, which is
BIS–2016–0038;
• Email: willard.fisher@bis.doc.gov—
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
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SUMMARY:
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16:51 Nov 29, 2016
Jkt 241001
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
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Fmt 4703
Sfmt 4703
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:
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Federal Register / Vol. 81, No. 230 / Wednesday, November 30, 2016 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
(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, byproducts, or waste products that are
produced and consumed within a
defined chemical manufacturing
sequence, where such intermediates, byproducts, 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
VerDate Sep<11>2014
16:51 Nov 29, 2016
Jkt 241001
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
https://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]
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86323
DEPARTMENT OF COMMERCE
United States Patent and Trademark
Office
[Docket No. PTO–P–2016–0051]
Notice of Roundtables and Extension
of the Period for Comments on
Examination Time Goals
United States Patent and
Trademark Office, Commerce.
ACTION: Notice of public roundtables
and extension of the comment period.
AGENCY:
The United States Patent and
Trademark Office (Office or USPTO)
previously announced information for
roundtables in Alexandria, Virginia, and
Dallas, Texas, to solicit public feedback
as part of an effort to reevaluate its
examination time goals. Examination
time goals vary by technology and
represent the average amount of time
that a patent examiner is expected to
spend examining a patent application in
a particular technology. The Office now
is providing information on the
additional three roundtables that the
Office will be conducting in Detroit,
Michigan; Denver, Colorado; and San
Jose, California. In addition, the Office
is extending the written comment
period to ensure that all stakeholders
have sufficient opportunity to submit
comments on the reevaluation of the
Office’s examination time goals.
DATES: Written Comments Deadline: To
be ensured of consideration, written
comments must be received on or before
January 30, 2017.
ADDRESSES: Written comments should
be sent by electronic mail addressed to
ExternalExaminationTimeStudy@
USPTO.gov. Comments also may be
submitted by postal mail addressed to:
Mail Stop Comments—Patents,
Commissioner for Patents, P.O. Box
1450, Alexandria, VA 22313–1450,
marked to the attention of Raul Tamayo,
Senior Legal Advisor, Office of Patent
Legal Administration, Office of the
Deputy Commissioner for Patent
Examination Policy.
Although comments may be
submitted by postal mail, the Office
prefers to receive comments by
electronic mail in order to facilitate
posting on the USPTO’s Internet Web
site (https://www.uspto.gov). Electronic
comments may be submitted in plain
text, ADOBE® portable document
format, or MICROSOFT WORD® format.
Comments not submitted electronically
should be submitted on paper in a
format that facilitates digital scanning
into ADOBE® portable document
format.
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 230 (Wednesday, November 30, 2016)]
[Notices]
[Pages 86322-86323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28799]
[[Page 86322]]
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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 (https://www.regulations.gov)--
you can find this notice by searching on its regulations.gov docket
number, which is BIS-2016-0038;
Email: willard.fisher@bis.doc.gov--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 https://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
