[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)]
[Notices]
[Pages 2982-2983]
[FR Doc No: 2018-01014]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 96-045]

Pacific Gas and Electric Company; Notice of Intent To File
License Application, Filing of Pre-Application Document (Pad),
Commencement of Pre-Filing Process, and Joint Scoping With the
California State Water Resources Control Board; Request for Comments on
the Pad and Scoping Document, and Identification of Issues and
Associated Study Requests

    a. Type of Filing: Notice of Intent to File License Application for
a New License and Commencing Pre-filing Process
    b. Project No.: 96-045
    c. Dated Filed: November 16, 2017
    d. Submitted By: Pacific Gas & Electric Company (PG&E)
    e. Name of Project: Kerckhoff Hydroelectric Project
    f. Location: On the San Joaquin River, in Fresno and Madera
Counties, California, about 25 miles northeast of the city of Fresno,
California. The majority of the project is located on lands owned by
PG&E, National Forest System Lands administered by the U.S. Forest
Service, Sierra National Forest, and on lands managed by the U.S.
Bureau of Land Management.
    g. Filed Pursuant to: 18 CFR part 5 of the Commission's
Regulations.
    h. Applicant Contact: Debbie Powell, Senior Director, Power
Generation--Operations, Pacific Gas and Electric Company, P.O. Box
770000, MCN11D-1138, San Francisco, CA 94177-0001
    i. FERC Contact: Evan Williams at<PHONE_NUMBER> or
[email protected].
    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item o below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See 94 FERC 61,076
(2001).
    k. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, Part 402, (b) NOAA Fisheries under
section 305(b)(2) of the Magnuson-Stevens Fisheries Conservation and
Management Act; and (c) the State Historic Preservation Officer, as
required by section 106, National Historic Preservation Act, and the
implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    l. With this notice, we are designating PG&E as the Commission's
non-federal representatives for carrying out informal consultation,
pursuant to: Section 7 of the Endangered Species Act; section 305(b)(2)
of the Magnuson-Stevens Fisheries Conservation and Management Act; and
section 106 of the National Historic Preservation Act.
    m. On November 16, 2017, PG&E filed with the Commission a Pre-
Application Document (PAD; including a proposed process plan and
schedule), pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's website
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
[email protected],<PHONE_NUMBER> (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    o. With this notice, we are soliciting comments on the PAD and
Commission's staff Scoping Document 1 (SD1), as well as study requests.
All comments on the PAD and SD1, and study requests should be sent to
the address above in paragraph h. In addition, all comments on the PAD
and SD1, study requests, requests for cooperating agency status, and
all communications to and from Commission staff related to the merits
of the potential application must be filed with the Commission. Scoping
comments should be filed separately with the Commission and California
State Water Resources Control Board (State Water Board), as noted
below.
    Commission:
    The Commission strongly encourages electronic filing. Please file
all documents using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
[email protected] In lieu of electronic filing, please send a
paper copy to: Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. The first page of any filing
should include docket number P-96-045.
    All filings with the Commission must bear the appropriate heading:
Comments on Pre-Application Document, Study Requests, Comments on
Scoping Document 1, Request for Cooperating Agency Status, or
Communications to and from Commission Staff. Any individual or entity
interested in submitting study requests, commenting on the PAD or SD1,
and any agency requesting cooperating status must do so by March 17,
2018.
    State Water Board:
    Written comments should be provided as noted below. When submitting
your comments, provide the contact person's name and phone number. The
State Water Board is seeking information regarding what type of
environmental document should be prepared (i.e., negative declaration,
mitigated negative declaration, or environmental impact report), as
well as scoping comments.
    State Water Resources Control Board, Division of Water Rights--
Water Quality Certification Program, Attention: Philip Choy, P.O. Box
2000, Sacramento, CA 95812-2000, Phone:<PHONE_NUMBER>, Fax: (916) 341-
5400, Email: [email protected].

Scoping Meetings

    Commission staff will hold two scoping meetings in the vicinity of
the project at the times and places noted below. The daytime meeting
will focus on resource agency, Indian tribes, and non-governmental
organization concerns, while the evening meeting is primarily for
receiving input from the public. We invite all interested individuals,
organizations, and agencies to attend one or both of the meetings, and
to assist staff in identifying particular study needs, as well as the
scope of environmental issues to be addressed in the environmental
document.
    These scoping meetings are being coordinated with the State Water
Board and are considered joint scoping meetings for the purposes of
both the National Environmental Policy Act

(NEPA) and the California Environmental Quality Act (CEQA), should the
State Water Board prepare an environmental impact report (EIR). (See
Cal. Code Regs., tit. 14, 15083, 15223, 15226.) This notice is intended
to provide notice of the State Water Board's informal consultation with
responsible and trustee agencies pursuant to section 15063 of the CEQA
Guidelines as to the potential for the proposed action to cause a
significant impact to the environment. (Cal. Code Regs., tit. 14, Sec.
15063, subd. (g).) Recipients of this notice are invited to comment on
whether an EIR, negative declaration, or mitigated negative declaration
should be prepared. In addition, pursuant to CEQA Guidelines section
15083, subdivision (c), these meetings are intended to simultaneously
serve the purposes identified in California Code of Regulations, title
14, section 15082, subdivision (c). Any responsible or trustee agency
or other interested parties that believes an EIR should be prepared
should identify the scope and content of any environmental information
it believes should be required, should the State Water Board prepare an
EIR.
    The times and locations of these meetings are as follows:

Daytime Scoping Meeting

    Date: Tuesday, February 13, 2018.
    Time: 9:00 a.m.
    Location: Piccadilly Inn Airport, 5115 E McKinley Ave., Fresno, CA.
    Phone:<PHONE_NUMBER>.

Evening Scoping Meeting

    Date: Tuesday, February 13, 2018.
    Time: 6:00 p.m.
    Location: Piccadilly Inn Airport, 5115 E McKinley Ave., Fresno, CA.
    Phone:<PHONE_NUMBER>.
    SD1, which outlines the subject areas to be addressed in the
environmental document, was mailed to the individuals and entities on
the Commission's mailing list. Copies of SD1 will be available at the
scoping meetings, or may be viewed on the web at http://www.ferc.gov,
using the eLibrary link. Follow the directions for accessing
information in paragraph n. Based on all oral and written comments, a
Scoping Document 2 (SD2) may be issued. SD2 may include a revised
process plan and schedule, as well as a list of issues, identified
through the scoping process.

Environmental Site Review

    The potential applicant and Commission staff will conduct an
Environmental Site Review (site visit) of the project at 8:00 a.m.,
Wednesday, February 14, 2018. Participants are responsible for their
own transportation. Persons planning on participating in the site visit
must RSVP to Ms. Lisa Whitman of PG&E at [email protected] or (415)
973-7465, on or before February 1, 2018. Additional details concerning
the site visit are provided in SD1.

Meeting Objectives

    At the scoping meetings, staff will: (1) Initiate scoping of the
issues; (2) review and discuss existing conditions and resource
management objectives; (3) review and discuss existing information and
identify preliminary information and study needs; (4) review and
discuss the process plan and schedule for pre-filing activity that
incorporates the time frames provided for in Part 5 of the Commission's
regulations and, to the extent possible, maximizes coordination of
federal, state, and tribal permitting and certification processes; and
(5) discuss the appropriateness of any federal or state agency or
Indian tribe acting as a cooperating agency for development of an
environmental document.
    Meeting participants should come prepared to discuss their issues
and/or concerns. Please review the PAD in preparation for the scoping
meetings. Directions on how to obtain a copy of the PAD and SD1 are
provided in item n. of this document.

Meeting Procedures

    The meetings will be recorded by a stenographer and will be placed
in the public record of the Commission and State Water Board
proceedings for this project.

    Dated: January 16, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-01014 Filed 1-19-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 24 (Friday, February 4, 2022)]
[Proposed Rules]
[Pages 6466-6473]
[FR Doc No: 2022-01923]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2018-0746; FRL-6494.1-01-OAR]
RIN 2060-AV54

Reconsideration of the 2020 National Emission Standards for
Hazardous Air Pollutants: Miscellaneous Organic Chemical Manufacturing
Residual Risk and Technology Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; reconsideration of final rule.

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SUMMARY: On August 12, 2020, the U.S. Environmental Protection Agency
(EPA) published the final National Emission Standards for Hazardous Air
Pollutants (NESHAP): Miscellaneous Organic Chemical Manufacturing
Residual Risk and Technology Review. Subsequently, the Agency received
and granted petitions for reconsideration on two issues, specifically,
the use of the EPA's 2016 Integrated Risk Information System (IRIS)
value for ethylene oxide in assessing cancer risk for the source
category and the use of the Texas Commission on Environmental Quality
(TCEQ) risk value for ethylene oxide as an alternative risk value to
the EPA's IRIS value. Here, the EPA is addressing these two issues and
is also requesting public comment. The EPA is seeking comment only on
the two identified petition issues. The EPA will not respond to
comments addressing any other issues or any other provisions of the
final rule.

DATES:
    Comments. Comments must be received on or before March 24, 2022.
    Public hearing: If anyone contacts us requesting a public hearing
on or before February 9, 2022, we will hold a virtual public hearing.
See SUPPLEMENTARY INFORMATION for information on requesting and
registering for a public hearing.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OAR-2018-0746, by any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov/
(our preferred method). Follow the online instructions for submitting
comments.
     Email: [email protected]. Include Docket ID No. EPA-
HQ-OAR-2018-0746 in the subject line of the message.
     Fax:<PHONE_NUMBER>. Attention Docket ID No. EPA-HQ-OAR-
2018-0746.
     Mail: U.S. Environmental Protection Agency, EPA Docket
Center, Docket ID No. EPA-HQ-OAR-2018-0746, Mail Code 28221T, 1200
Pennsylvania Avenue NW, Washington, DC 20460.
     Hand/Courier Delivery: EPA Docket Center, WJC West
Building, Room 3334, 1301 Constitution Avenue NW, Washington, DC 20004.
The Docket Center's hours of operation are 8:30 a.m.-4:30 p.m., Monday-
Friday (except Federal holidays).
    Instructions: All submissions received must include the Docket ID
No. for this rulemaking. Comments received may be posted without change
to https://www.regulations.gov/, including any personal information
provided. For detailed instructions on sending comments and additional
information on the rulemaking process, see the SUPPLEMENTARY
INFORMATION section of this document. Out of an abundance of caution
for members of the public and our staff, the EPA Docket Center and
Reading Room are open to the public by appointment only to reduce the
risk of transmitting COVID-19. Our Docket Center staff also continues
to provide remote customer service via email, phone, and webform. Hand
deliveries and couriers may be received by scheduled appointment only.
For further information on EPA Docket Center services and the current
status, please visit us online at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For questions about this proposed
action, contact Ms. Tegan Lavoie, Sector Policies and Programs Division
(E-143-01), Office of Air Quality Planning and Standards, U.S.
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number:<PHONE_NUMBER>; and email address:
[email protected].

SUPPLEMENTARY INFORMATION:
    Participation in virtual public hearing. Please note that because
of the current Centers for Disease Control and Prevention (CDC)
recommendations, as well as state and local orders for social
distancing to limit the spread of COVID-19, the EPA cannot hold in-
person public meetings at this time.
    If requested, the virtual hearing will be held on February 22,
2022. The hearing will convene at 11:00 a.m. Eastern Time (ET) and will
conclude at 7:00 p.m. ET. The EPA may close a session 15 minutes after
the last pre-registered speaker has testified if there are no
additional speakers. The EPA will announce further details at https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission.
    The EPA will begin pre-registering speakers for the hearing upon
publication of this document in the Federal Register. To register to
speak at the virtual hearing, please use the online registration form
available at https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission or
contact the public hearing team at<PHONE_NUMBER> or by email at
[email protected]. The last day to pre-register to speak at the
hearing will be February 16, 2022. Prior to the hearing, the EPA will
post a general agenda that will list pre-registered speakers in
approximate order at: https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission.
    The EPA will make every effort to follow the schedule as closely as
possible on the day of the hearing, if requested, however, please plan
for the hearings to run either ahead of schedule or behind schedule.
    If a hearing is requested, each commenter will have 5 minutes to
provide oral testimony. The EPA encourages commenters to provide the
EPA with a copy of their oral testimony electronically (via email) by
emailing it to [email protected]. The EPA also recommends submitting
the text of your oral testimony as written comments to the rulemaking
docket.
    The EPA may ask clarifying questions during the oral presentations
but will not respond to the presentations at that time. Written
statements and supporting information submitted during the comment
period will be considered with the same weight as oral testimony and
supporting information presented at the public hearing.
    Please note that any updates made to any aspect of the hearing, if
requested, will be posted online at https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission. While the EPA expects the hearing, if requested, to
go forward as set forth above, please monitor our website to determine
if there are any updates. The EPA does not intend to publish a document
in the Federal Register announcing updates.
    If you require the services of a translator or special
accommodation such as audio description, please pre-register for the
hearing with the public hearing team and describe your needs by
February 11, 2022. The EPA may not be able to arrange accommodations
without advanced notice.
    Docket. The EPA has established a docket for this rulemaking under
Docket ID No. EPA-HQ-OAR-2018-0746. All documents in the docket are
listed in https://www.regulations.gov/. Although listed, some
information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy. With the exception of such material, publicly available docket
materials are available electronically in Regulations.gov.
    Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2018-

0746. The EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
https://www.regulations.gov/, including any personal information
provided, unless the comment includes information claimed to be CBI or
other information whose disclosure is restricted by statute. Do not
submit electronically any information that you consider to be CBI or
other information whose disclosure is restricted by statute. This type
of information should be submitted by mail as discussed below.
    The EPA may publish any comment received to its public docket.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e., on the Web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.
    The https://www.regulations.gov/ website allows you to submit your
comment anonymously, which means the EPA will not know your identity or
contact information unless you provide it in the body of your comment.
If you send an email comment directly to the EPA without going through
https://www.regulations.gov/, your email address will be automatically
captured and included as part of the comment that is placed in the
public docket and made available on the internet. If you submit an
electronic comment, the EPA recommends that you include your name and
other contact information in the body of your comment and with any
digital storage media you submit. If the EPA cannot read your comment
due to technical difficulties and cannot contact you for clarification,
the EPA may not be able to consider your comment. Electronic files
should not include special characters or any form of encryption and be
free of any defects or viruses. For additional information about the
EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets.
    Due to public health concerns related to COVID-19, the Docket
Center and Reading Room are open to the public by appointment only. Our
Docket Center staff also continues to provide remote customer service
via email, phone, and webform. Hand deliveries or couriers will be
received by scheduled appointment only. For further information and
updates on EPA Docket Center services, please visit us online at
https://www.epa.gov/dockets.
    The EPA continues to carefully and continuously monitor information
from the CDC, local area health departments, and our Federal partners
so that we can respond rapidly as conditions change regarding COVID-19.
    Submitting CBI. Do not submit information containing CBI to the EPA
through https://www.regulations.gov/ or email. Clearly mark the part or
all of the information that you claim to be CBI. For CBI information on
any digital storage media that you mail to the EPA, mark the outside of
the digital storage media as CBI and then identify electronically
within the digital storage media the specific information that is
claimed as CBI. In addition to one complete version of the comments
that includes information claimed as CBI, you must submit a copy of the
comments that does not contain the information claimed as CBI directly
to the public docket through the procedures outlined in Instructions
above. If you submit any digital storage media that does not contain
CBI, mark the outside of the digital storage media clearly that it does
not contain CBI. Information not marked as CBI will be included in the
public docket and the EPA's electronic public docket without prior
notice. Information marked as CBI will not be disclosed except in
accordance with procedures set forth in 40 Code of Federal Regulations
(CFR) part 2. Send or deliver information identified as CBI only to the
following address: OAQPS Document Control Officer (C404-02), OAQPS,
U.S. Environmental Protection Agency, Research Triangle Park, North
Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2018-0746. Note that
written comments containing CBI and submitted by mail may be delayed
and no hand deliveries will be accepted.
    Preamble acronyms and abbreviations. Throughout this document
wherever ``we,'' ``us,'' or ``our'' is used, it is intended to refer to
the EPA. We use multiple acronyms and terms in this preamble. While
this list may not be exhaustive, to ease the reading of this preamble
and for reference purposes, the EPA defines the following terms and
acronyms here:

ACC American Chemistry Council
AIC Akaike Information Criterion
ATSDR Agency for Toxic Substances and Disease Registry
CAA Clean Air Act
CBI Confidential Business Information
CFR Code of Federal Regulations
DSD Development Support Document
EPA Environmental Protection Agency
HAP hazardous air pollutant(s)
IRIS Integrated Risk Information System
MACT maximum achievable control technology
MON Miscellaneous Organic Chemical Manufacturing NESHAP
NAICS North American Industry Classification System
NESHAP national emission standards for hazardous air pollutants
NIOSH National Institute for Occupational Safety and Health
NTTAA National Technology Transfer and Advancement Act
OAQPS Office of Air Quality Planning and Standards
OAR Office of Air and Radiation
OMB Office of Management and Budget
PRA Paperwork Reduction Act
RFA Regulatory Flexibility Act
RFC request for correction
RTR residual risk and technology review
SAB Science Advisory Board
SSM startup, shutdown, and malfunction
TCEQ Texas Commission on Environmental Quality
UMRA Unfunded Mandates Reform Act
URE unit risk estimate

    Organization of this document. The information in this preamble is
organized as follows:

I. General Information
    A. What is the statutory authority for the reconsideration
action?
    B. Does this action apply to me?
    C. Where can I get a copy of this document and other related
information?
II. Background
III. Reconsideration Issues and Request for Public Comments
    A. Use of the EPA's IRIS Value for Ethylene Oxide in Assessing
Cancer Risk for the Source Category
    B. Use of the TCEQ Risk Value for Ethylene Oxide in Assessing
Cancer Risk for the Source Category
IV. Summary of Cost, Environmental, and Economic Impacts
    A. What are the affected sources?
    B. What are the air quality impacts?
    C. What are the cost impacts?
    D. What are the economic impacts?
    E. What are the benefits?
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    I. National Technology Transfer and Advancement Act (NTTAA) and
1 CFR Part 51
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. General Information

A. What is the statutory authority for the reconsideration action?

    The statutory authority for this action is provided by sections 112
and 307(d)(7)(B) of the Clean Air Act (CAA) (42 U.S.C. 7412 and
7607(d)(7)(B)).

B. Does this action apply to me?

    Regulated entities. Categories and entities potentially regulated
by this action are shown in Table 1 of this preamble.

    Table 1--NESHAP and Industrial Source Categories Affected by This
                             Proposed Action
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         Source category                NESHAP          NAICS Code \1\
------------------------------------------------------------------------
Miscellaneous Organic Chemical    40 CFR part 63,     3251, 3252, 3253,
 Manufacturing.                    subpart FFFF.       3254, 3255, 3256,
                                                       and 3259, with
                                                       several
                                                       exceptions.
------------------------------------------------------------------------
\1\ North American Industry Classification System.

    Table 1 of this preamble is not intended to be exhaustive, but
rather provides a guide for readers regarding the entities that this
proposed action is likely to affect. To determine whether your facility
is affected, you should examine the applicability criteria in the
appropriate NESHAP. If you have any questions regarding the
applicability of any aspect of these NESHAP, please contact the person
listed in the preceding FOR FURTHER INFORMATION CONTACT section of this
preamble.

C. Where can I get a copy of this document and other related
information?

    In addition to being available in the docket, an electronic copy of
this action is available on the internet. Following signature by the
EPA Administrator, the EPA will post a copy of this proposed action at
https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission. Following publication
in the Federal Register, the EPA will post the Federal Register version
of the proposal at this same website.

II. Background

    On December 17, 2019, the EPA published a proposed rule in the
Federal Register addressing the risk and technology review (RTR) for
the Miscellaneous Organic Chemical Manufacturing NESHAP (MON), 40 CFR
part 63, subpart FFFF (84 FR 69182). On August 12, 2020, after
receiving and addressing public comments, the EPA finalized
determinations pursuant to CAA sections 112(d)(6) and (f)(2) for the
Miscellaneous Organic Chemical Manufacturing source category and
amended the rule based on those determinations (85 FR 49084). The
August 2020 final action, herein referred to as the ``2020 MON final
rule,'' included amendments pursuant to the technology review for
equipment leaks and heat exchange systems, and also amendments pursuant
to the risk review to specifically address ethylene oxide emissions
from storage tanks, process vents, and equipment leaks. In addition,
the 2020 MON final rule corrected and clarified regulatory provisions
related to emissions during periods of startup, shutdown, and
malfunction (SSM), including removing general exemptions for periods of
SSM, adding work practice standards for periods of SSM where
appropriate, and clarifying regulatory provisions for certain vent
control bypasses. The final action also added monitoring and
operational requirements for flares that control ethylene oxide
emissions and flares used to control emissions from processes that
produce olefins and polyolefins, added provisions for electronic
reporting of performance test results and other reports, and included
other technical corrections to improve consistency and clarity.
    In the 2020 MON final rule's risk assessment,\1\ we calculated
cancer risks using the EPA's IRIS inhalation unit risk estimate (URE)
for ethylene oxide,\2\ and the risk review included a determination
that the risks for this source category under the current Maximum
Achievable Control Technology (MACT) provisions were unacceptable due
to ethylene oxide emissions. When risks are unacceptable, the EPA must
determine the emissions standards necessary to reduce risk to an
acceptable level. As such, the EPA promulgated final amendments to the
MON pursuant to CAA section 112(f)(2) that require control of ethylene
oxide emissions for process vents, storage tanks, and equipment in
ethylene oxide service. The 2020 MON final rule reduced risks to an
acceptable level that also provides an ample margin of safety to
protect public health. The final rule preamble stated that ``the EPA
remains open to new and updated scientific information,'' and new dose-
response values, such as those then being developed by the TCEQ (85 FR
49098). However, by the close of the public comment period for the
proposed rulemaking (March 19, 2020), the TCEQ dose-response value had
not yet been finalized and could not be considered in the final action.
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    \1\ Residual Risk Assessment for the Miscellaneous Organic
Chemical Manufacturing Source Category in Support of the 2020 Risk
and Technology Review: Final Rule, August 2020. Available at:
https://www.regulations.gov/document/EPA-HQ-OAR-2018-0746-0189.
    \2\ U.S. EPA. Evaluation of the Inhalation Carcinogenicity of
Ethylene Oxide (CASRN 75-21-8) In Support of Summary Information on
the Integrated Risk Information System (IRIS). December 2016. EPA/
635/R-16/350Fa. Available at: https://cfpub.epa.gov/ncea/iris/iris_documents/documents/toxreviews/1025tr.pdf and in the docket for
this rulemaking (see Docket ID No. EPA-HQ-OAR-2018-0746).
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    Following promulgation of the 2020 MON final rule, the EPA received
five separate petitions for reconsideration from four petitioners. The
EPA received two petitions from the American Chemistry Council (ACC)
(one petition dated October 2020, one dated December 2020), one from
the TCEQ (dated October 2020), one from Squire Patton Boggs (US) LLP
(submitted on behalf of Huntsman Petrochemical, LLC) (dated October
2020), and one from Earthjustice (submitted on behalf of RISE St.
James, Louisiana Bucket Brigade, Louisiana Environmental Action
Network, Texas Environmental Justice Advocacy Services (t.e.j.a.s.),
Air Alliance Houston, Ohio Valley Environmental Coalition, Blue Ridge
Environmental Defense League, Inc., Environmental Justice Health
Alliance for Chemical Policy Reform, Sierra Club, Environmental
Integrity Project, and Union of Concerned Scientists) (dated October
2020). Copies of the petitions are available in the docket for this
rulemaking (see Docket ID No. EPA-HQ-OAR-2018-0746).
    Three petitioners (ACC, TCEQ, Huntsman Petrochemical, LLC)

requested the EPA reconsider the rule to reassess the risk assessment
for the 2020 MON final rule using the TCEQ's alternative risk value for
ethylene oxide instead of the EPA's 2016 IRIS value for ethylene oxide.
These three petitioners further argued that the EPA's 2016 IRIS value
for ethylene oxide is flawed, citing disagreement with the 2016 IRIS
assessment's model selection and inclusion of breast cancer data. In
their October 2020 petition, ACC argued that ``CAA Section 307(d)(7)(B)
requires EPA to convene a reconsideration proceeding where (1) it was
either impractical to raise an objection during the comment period or
new information becomes available after the close of the comment
period; and (2) such information is of central relevance to the outcome
of the rule.'' Earthjustice did not raise a similar issue in their
petition. Two petitioners (ACC and Earthjustice) raised other issues
unrelated to the use of the IRIS value or TCEQ value for assessing risk
from ethylene oxide emissions (see Docket ID No. EPA-HQ-OAR-2018-0746).
    On June 22, 2021, the EPA sent letters to all the petitioners
informing them that: (1) The EPA was granting reconsideration requests
on two specific issues (described later in this section), (2) the EPA
intended to issue a Federal Register document initiating a notice and
comment rulemaking on the issues for which the Agency granted
reconsideration, and (3) the EPA was continuing to review the other
issues in the petitions for reconsideration and may choose to initiate
reconsideration of additional issues in the future. Copies of the
letters to petitioners are available in the docket for this rulemaking
(see Docket ID No. EPA-HQ-OAR-2018-0746).
    Pursuant to CAA section 307(d)(7)(B), the Agency granted
reconsideration of the following aspects of the 2020 MON final rule:
(1) The use of the EPA's IRIS value for ethylene oxide in assessing
cancer risk for the source category, and (2) the use of the TCEQ risk
value for ethylene oxide as an alternative risk value to the EPA's IRIS
value for purposes of evaluating risk under CAA section 112(f)(2).
Reconsideration was granted on these two topics on the following bases:
The TCEQ risk value for ethylene oxide was finalized after the comment
period for the proposed MON rulemaking closed, and the 2020 MON final
rule preamble stated that the EPA remains open to new and updated
scientific information, such as the TCEQ value; and because the risk
posed by ethylene oxide is of central relevance to the EPA's
determination that the risks from sources in the Miscellaneous Organic
Chemical Manufacturing source category remaining after imposition of
the then-current CAA section 112(d)(2) MACT standards were unacceptable
and that more stringent standards are required. Because the criteria
for mandatory reconsideration under CAA section 307(d)(7)(B) have been
satisfied, the Agency is publishing this proposed reconsideration
action in the Federal Register and requesting public comment on the
issues discussed in this action. The EPA is seeking comment only on the
issues subject to mandatory reconsideration and discussed in this
proposed rule. The Agency will not respond to any comments addressing
other issues raised by petitioners related to the 2020 MON final rule,
or the EPA's December 13, 2021 response \3\ to the Request for
Correction (RFC) \4\ of the IRIS value for ethylene oxide that was
submitted to the EPA by petitioner ACC under the Information Quality
Act, Public Law 106-554 (IQA). As discussed in section III.B of this
preamble, the ACC requested correction of the ethylene oxide
information in the EPA's most recent update to the National Air Toxics
Assessment (NATA) released on August 22, 2018. In the EPA's response to
the RFC, the EPA found that the RFC did not identify a need for
correction in the 2016 ethylene oxide IRIS Assessment and determined
that the inhalation URE derived in the 2016 ethylene oxide IRIS
Assessment was the appropriate human health value to use for ethylene
oxide in the 2014 NATA. The EPA's response to the RFC noted that the
EPA's use of the IRIS value in CAA rulemakings would be addressed in
the reconsideration of the 2020 MON final rule, and that the review
would include consideration of additional information presented in
comments on the 2020 MON rule that were not included in the 2018 RFC
and addressed in the EPA's response to the RFC. As such, we are not
reconsidering comments on the EPA's reliance upon the National
Institute for Occupational Safety and Health (NIOSH) worker exposure
studies, selection of dose-response models, and consideration of
endogenous sources (i.e., what the body produces) of ethylene oxide
that were previously addressed in the response to ACC's RFC.
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    \3\ U.S. EPA. EPA's Response to American Chemistry Council
(ACC)'s Request for Correction to the IRIS Value for Ethylene Oxide
(EtO) used in the National Air Toxics Assessment (NATA) in 2018.
December 13, 2021. Available at: https://www.epa.gov/quality/epa-information-quality-guidelines-requests-correction-and-requests-reconsideration#18003 and in the docket for this rulemaking (see
Docket ID No. EPA-HQ-OAR-2018-0746).
    \4\ American Chemistry Council. Request for Correction under the
Information Quality Act: 2014 National Air Toxics Assessment (NATA).
September 20, 2018. Available at: https://www.epa.gov/quality/epa-information-quality-guidelines-requests-correction-and-requests-reconsideration#18003 and in the docket for this rulemaking (see
Docket ID No. EPA-HQ-OAR-2018-0746).
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III. Reconsideration Issues and Request for Public Comments

    The EPA is proposing to take comment on the two selected issues
raised in the petitions for reconsideration as described in sections
III.A. and III.B. below.

A. Use of the EPA's IRIS Value for Ethylene Oxide in Assessing Cancer
Risk for the Source Category

    The EPA's IRIS program was created to provide an internal Agency
database of human health effects that may result from chronic exposure
to chemicals found in the environment to which the public might be
exposed. The IRIS database is intended to be used by the EPA's program
and regional offices in risk assessments to inform decision making.\5\
The development of IRIS values includes a robust peer-review, beginning
with internal reviews to reach consensus within the Agency on the
scientific positions, followed by external federal agency review, an
opportunity for public review and comment, and an independent, external
peer-review by the EPA's Science Advisory Board (SAB).\6\ During this
process, the EPA considers and responds to comments received from the
public and the SAB, and revises the assessment to ensure that the best
available science is represented.
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    \5\ U.S. EPA. Framework for Human Health Risk Assessment to
Inform Decision Making. EPA/100/R-14/001. April 2014. Available at
https://www.epa.gov/sites/default/files/2014-12/documents/hhra-framework-final-2014.pdf and in the docket for this rulemaking (see
Docket ID No. EPA-HQ-OAR-2018-0746).
    \6\ U.S. EPA. Process for Developing IRIS Health Assessments.
Integrated Risk Information System (IRIS). https://www.epa.gov/iris/basic-information-about-integrated-risk-information-system#process.
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    During development of the 2020 MON final rule, the EPA used the
2016 IRIS cancer risk value for ethylene oxide \7\ in the risk review.
The EPA received and responded to numerous public comments on the use
of the IRIS value in the 2020 MON final rule. A summary of these
comments and responses is available in the preamble of the 2020

MON final rule (85 FR 49084; August 12, 2020) and also in the ``Summary
of Public Comments and Responses for the Risk and Technology Review for
Miscellaneous Organic Chemical Manufacturing'' document in the docket
for this rulemaking.\8\
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    \7\ The age-adjusted inhalation URE for ethylene oxide is 0.005
per [micro]g/m\3\. The URE is the upper-bound additional lifetime
cancer risk estimated to result from continuous (24 hours/day)
lifetime (70 years) exposure to ethylene oxide at a concentration of
1 [micro]g/m\3\ in air. Because ethylene oxide is mutagenic (i.e.,
damages DNA), an age-dependent adjustment factor was applied to
account for childhood exposures.
    \8\ Summary of Public Comments and Responses for the Risk and
Technology Review for Miscellaneous Organic Chemical Manufacturing,
August 2020. Available at: https://www.regulations.gov/document/EPA-HQ-OAR-2018-0746-0200.
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    For CAA section 112(f)(2) risk reviews, the EPA performs health
risk assessments for the hazardous air pollutants (HAP) that are
emitted from the source category after imposition of MACT standards
under CAA section 112(d)(2). Consistent with the purpose of the IRIS
database for use by the EPA's program and regional offices in risk
assessments and the advice from the SAB, the ``Residual Risk Assessment
for the Miscellaneous Organic Chemical Manufacturing Source Category in
Support of the 2020 Risk and Technology Review: Final Rule'' in the
docket for this rulemaking \9\ described that the preferred source of
chronic dose-response data is the IRIS database. If the EPA's IRIS
program does not have an up-to-date hazard and/or dose-response
assessment for a HAP, the EPA considers publicly available assessments
that have been developed by other government agencies in a manner that
is conceptually similar to the EPA's approach. This includes
consistency with the EPA's risk assessment guidelines, incorporation of
an independent external peer review, inclusion of a public review
period, and use of the best available science with respect to dose-
response information.
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    \9\ Residual Risk Assessment for the Miscellaneous Organic
Chemical Manufacturing Source Category in Support of the 2020 Risk
and Technology Review: Final Rule, August 2020. Available at:
https://www.regulations.gov/document/EPA-HQ-OAR-2018-0746-0189.
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    Application of this approach generally results in the following
priority order for sources of risk values such as an inhalation URE:
(1) U.S. EPA IRIS, (2) Agency for Toxic Substances and Disease Registry
(ATSDR), (3) California EPA, and (4) other sources. Documentation of
this approach, as applied in the CAA section 112(f)(2) reviews, is in
the EPA report titled ``Risk and Technology (RTR) Risk Assessment
Methodologies: For Review by the EPA's Science Advisory Board: Case
Studies--MACT I Petroleum Refining Sources and Portland Cement
Manufacturing''.\10\ This approach is also documented in the risk
assessment technical support document for each RTR NESHAP rulemaking
and is included in the rulemaking docket for this
action.11 12
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    \10\ U.S. EPA. Risk and Technology Review (RTR) Risk Assessment
Methodologies: For Review by the EPA's Science Advisory Board with
Case Studies--MACT I Petroleum Refining Sources and Portland Cement
Manufacturing, June 2009. EPA-452/R-09-006. Available at https://www3.epa.gov/airtoxics/rrisk/rtrpg.html and in the docket for this
rulemaking (see Docket ID No. EPA-HQ-OAR-2018-0746).
    \11\ Summary of Public Comments and Responses for the Risk and
Technology Review for Miscellaneous Organic Chemical Manufacturing,
August 2020. Available at: https://www.regulations.gov/document/EPA-HQ-OAR-2018-0746-0200.
    \12\ Residual Risk Assessment for the Miscellaneous Organic
Chemical Manufacturing Source Category in Support of the 2020 Risk
and Technology Review: Final Rule, August 2020. Available at:
https://www.regulations.gov/document/EPA-HQ-OAR-2018-0746-0189.
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    This approach was presented to the SAB in 2009. In a May 7, 2010,
memo \13\ to the EPA Administrator regarding review of the EPA's RTR
assessment methodologies, the SAB panel supported the EPA's approach to
selecting dose-response chronic toxicity values. In the same memo, they
also noted that: ``The preferred database for chronic dose-response
data is and should be the IRIS database. However, some chemicals of
interest do not have IRIS values, and values for other chemicals have
not been reviewed recently. The Panel urges the Agency to address these
gaps and provide the resources necessary to maintain the updating
process. Additional sources of data may also be considered if they have
undergone adequate and rigorous scientific peer review.'' Id. at 5.
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    \13\ SAB. Recommendations of the SAB Risk and Technology Review
Methods Panel are provided in their report, Review of EPA's draft
entitled, ``Risk and Technology Review (RTR) Risk Assessment
Methodologies: For Review by the EPA's Science Advisory Board with
Case Studies--MACT I Petroleum Refining Sources and Portland Cement
Manufacturing. Available at: https://yosemite.epa.gov/sab/
sabproduct.nsf/4AB3966E263D943A8525771F00668381/$File/EPA-SAB-10-
007-unsigned.pdf and in the docket for this rulemaking (see Docket
ID No. EPA-HQ-OAR-2018-0746).
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    In the 2020 MON final rule, the EPA followed this documented
approach in selecting the 2016 EPA IRIS value for ethylene oxide for
use in the risk review. We have carefully reviewed the three
petitioners' comments that the 2016 IRIS value for ethylene oxide
should not have been used, but after careful consideration of the
issues raised, we have determined that these petitioners have not
identified a basis for changing our approach to the risk assessment in
the 2020 MON final rule. The substantive arguments raised by these
petitioners regarding the 2016 IRIS value have been addressed in the
EPA's response to the RFC, in the 2020 MON final rule's preamble (85 FR
49084; August 12, 2020), and in the response to comment document \14\
for the 2020 MON final rule; beyond these alleged flaws in the 2016
IRIS value, these petitioners have presented no new arguments for why
the EPA should not follow the documented approach for selecting risk
values. The EPA proposes to not change its decision to use the IRIS
inhalation URE for ethylene oxide in the 2020 MON final rule.
Consequently, the EPA is proposing no changes to our risk assessment
for the 2020 MON final rule.
---------------------------------------------------------------------------

    \14\ Summary of Public Comments and Responses for the Risk and
Technology Review for Miscellaneous Organic Chemical Manufacturing,
August 2020. Available at: https://www.regulations.gov/document/EPA-HQ-OAR-2018-0746-0200.
---------------------------------------------------------------------------

B. Use of the TCEQ Risk Value for Ethylene Oxide in Assessing Cancer
Risk for the Source Category

    During development of the 2020 MON final rule, the EPA received and
responded to numerous public comments related to the use of the TCEQ's
risk value for ethylene oxide as an alternative to the EPA's IRIS value
in the 2020 MON risk assessment. TCEQ submitted its draft Development
Support Document (DSD), which included the dose-response analysis
underlying TCEQ's draft cancer risk value, as a comment during the 2020
MON rulemaking's comment period. Because the TCEQ risk value was not
final until after the close of the comment period, the EPA did not
directly assess the draft DSD from TCEQ in our final rule; however, the
EPA received and addressed public comments from other groups (e.g.,
ACC) that included the same analytical approaches utilized by TCEQ. A
summary of these comments and responses is available in the 2020 MON
final rule's preamble (85 FR 49084; August 12, 2020) and in the
response to comment document \15\ for the 2020 MON final rule. In this
action, the EPA reaffirms those responses in support of its decision to
use the IRIS inhalation URE in the 2020 MON final rule.
---------------------------------------------------------------------------

    \15\ Summary of Public Comments and Responses for the Risk and
Technology Review for Miscellaneous Organic Chemical Manufacturing,
August 2020. Available at: https://www.regulations.gov/document/EPA-HQ-OAR-2018-0746-0200.
---------------------------------------------------------------------------

    As part of this proposed reconsideration of the 2020 MON final
rule, the EPA reviewed the final TCEQ ethylene oxide DSD, which TCEQ
referenced in its petition for reconsideration, including the assertion
that the final DSD contained ``additional scientific analyses''. Based
on this review, we have determined that TCEQ

did not submit new data for the EPA's consideration that would cause us
to use the final TCEQ cancer risk value instead of the IRIS cancer risk
value for the MON risk review. Rather, TCEQ has pursued a different
approach to analyzing the same NIOSH occupational exposure dataset that
is the basis of the 2016 IRIS cancer risk value.
    By using this approach, TCEQ estimated a risk value for ethylene
oxide that is 2000-fold lower than that of the IRIS risk value.\16\
TCEQ's analytical approach (i.e., modeling mortality using a Cox
proportional hazards model) closely mirrors the approach by Valdez-
Flores (2010) \17\ previously presented by other public commenters in
the 2020 MON final rule, and which the EPA addressed in both its
response to comments document \18\ and its December 13, 2021 response
\19\ to the ACC's 2018 RFC regarding the EPA's use of the IRIS value
for ethylene oxide. In addition to pursuing an analytical approach
similar to that used by Valdez-Flores (2010), TCEQ went a step further
and excluded women from their analysis. This exclusion included all
lymphoid cancers in women, as well as the exclusion of breast cancer as
an endpoint. Although modeling cancer mortality (instead of cancer
incidence, which the EPA modeled) and excluding women from the lymphoid
cancer analysis impacted the final URE value, the 2000-fold difference
in the IRIS versus TCEQ risk values is driven primarily by two major
differences: (1) TCEQ selected a different statistical model to
represent the occupational exposure data; and (2) TCEQ excluded breast
cancer from the derivation of a cancer risk value based on the claim
that there is insufficient weight of evidence that ethylene oxide
exposure causes breast cancer.
---------------------------------------------------------------------------

    \16\ TCEQ's age-adjusted URE is 2.3 x 10-6 per
[micro]g/m\3\.
    \17\ Valdez-Flores C, Sielken RL Jr, Teta MJ. 2010. Quantitative
cancer risk assessment based on NIOSH and UCC epidemiological data
for workers exposed to ethylene oxide. Regul Toxicol Pharmacol,
56(3): 312-20.
    \18\ Summary of Public Comments and Responses for the Risk and
Technology Review for Miscellaneous Organic Chemical Manufacturing,
August 2020. Available at: https://www.regulations.gov/document/EPA-HQ-OAR-2018-0746-0200.
    \19\ U.S. EPA. EPA's Response to American Chemistry Council
(ACC)'s Request for Correction to the IRIS Value for Ethylene Oxide
(EtO) used in the National Air Toxics Assessment (NATA) in 2018.
December 13, 2021. Available at: https://www.epa.gov/quality/epa-information-quality-guidelines-requests-correction-and-requests-reconsideration#18003 and in the docket for this rulemaking (see
Docket ID No. EPA-HQ-OAR-2018-0746).
---------------------------------------------------------------------------

    The questions of the appropriate dose-response model to use to
evaluate the risk of ethylene oxide and the strength of the evidence
linking ethylene oxide exposure to breast cancer were addressed in the
2016 ethylene oxide IRIS assessment. These questions were raised again
in comments on the 2020 MON final rule and responded to in both the
preamble (85 FR 49084; August 12, 2020) and associated response to
comments document 18 for the 2020 MON final rule. Briefly,
these responses note that the EPA's 2016 IRIS risk value for ethylene
oxide is based on a statistical model selected to best represent the
available data on cancers in workers exposed to ethylene oxide. This
model, a two-piece linear spline model, was selected after extensive
review by the EPA and the SAB. The Agency and the SAB 20 21
carefully considered and evaluated multiple alternative models,
including a Cox proportional hazards regression model similar to that
used by TCEQ. In its response to the SAB's recommendations, the EPA
noted: ``The EPA has followed the SAB's recommendations for model
selection. Model selection for both the breast cancer incidence (see
section <IP_ADDRESS>) and lymphoid cancer (see section <IP_ADDRESS>) data
prioritizes functional forms that allow more local fits in the low-
exposure range (e.g., spline models), relies less on AIC,\22\ and
includes consideration of biological plausibility . . .'' (IRIS, 2016,
Appendix I, p. I-3). As such, in the 2016 ethylene oxide IRIS
assessment, the EPA selected a model that best represented potential
general population exposures, making it align well with the purpose of
the risk assessment in the 2020 MON final rule, which sought to assess
general risk exposure to the public.
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    \20\ SAB. (2007). Science Advisory Board Review of Office of
Research and Development (ORD) draft assessment entitled,
``Evaluation of the Carcinogenicity of Ethylene Oxide'' [EPA
Report]. (EPA-SAB-08-004). Washington, DC: U.S. EPA, SAB. Available
at: http://yosemite.epa.gov/sab/sabproduct.nsf/
368203f97a15308a852574ba005bbd01/5D661BC118B527A3852573B80068C97B/
$File/EPA-SAB-08-004-unsigned.pdf and in the docket for this
rulemaking (see Docket ID No. EPA-HQ-OAR-2018-0746).
    \21\ SAB. (2015). Science Advisory Board Review of the EPA's
Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide:
Revised external review draft--August 2014 [EPA Report]. (EPA-SAB-
15-012). Washington, DC: U.S. EPA, SAB. Available at: https://
yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/
BD2B2DB4F84146A585257E9A0070E655/$File/EPA-SAB-15-012+unsigned.pdf
and in the docket for this rulemaking (see Docket ID No. EPA-HQ-OAR-
2018-0746).
    \22\ The Akaike information criterion (AIC) is a mathematical
model for evaluating how well a model fits the underlying dataset
from which it was generated.
---------------------------------------------------------------------------

    Additionally, the EPA considered the weight of evidence regarding
the risk of breast cancer from exposure to ethylene oxide in the IRIS
process. In the 2016 IRIS ethylene oxide assessment, the EPA determined
that the available epidemiological evidence for a causal relationship
between ethylene oxide exposure and breast cancer was strong, and there
were sufficient data to include breast cancer in the derivation of the
URE. The SAB supported this determination. Comments on the evidence for
breast cancer as an endpoint following ethylene oxide exposure were
also addressed during the review process for the IRIS ethylene oxide
assessment. For example, in response to a public comment on the IRIS
2013 draft claiming that the evidence for breast cancer is too weak to
rely on in setting the URE, the EPA responded:
    ``Although the epidemiological database for breast cancer is more
limited (i.e., few studies with sufficient numbers of female breast
cancer cases) than that for lymphohematopoietic cancers, the EPA
determined that the available evidence is sufficient to consider breast
cancer a potential hazard from ethylene oxide exposure . . .The 2007
SAB panel did not object to the derivation of unit risk estimates based
on the available breast cancer evidence.'' (IRIS, 2016, Appendix K, p.
K-3).\23\ The IRIS cancer risk value is representative of potential
health risks to the general population because it reflects the combined
cancer risk of developing lymphoid cancers in all people, and breast
cancer in women.
---------------------------------------------------------------------------

    \23\ U.S. EPA. Evaluation of the Inhalation Carcinogenicity of
Ethylene Oxide (CASRN 75-21-8) In Support of Summary Information on
the Integrated Risk Information System (IRIS). December 2016. EPA/
635/R-16/350Fa. Available at: https://cfpub.epa.gov/ncea/iris/iris_documents/documents/toxreviews/1025tr.pdf and in the docket for
this rulemaking (see Docket ID No. EPA-HQ-OAR-2018-0746).
---------------------------------------------------------------------------

    After careful consideration of the TCEQ DSD and material provided
in the petitions for reconsideration that requested the EPA use TCEQ's
final cancer risk value, the EPA is proposing to determine that the
TCEQ assessment and the petitions for reconsideration do not provide a
scientifically supportable basis for relying on the URE developed by
TCEQ to assess the residual risk for sources in the 2020 MON final
rule. No new studies or other information have been identified by TCEQ
or the petitioners requesting reconsideration that would call into
question the conclusions in the 2016 IRIS ethylene oxide assessment or
suggest that TCEQ's URE provides a better estimate of the risk of
exposure from ethylene oxide. The 2016 ethylene oxide IRIS

assessment remains the best available science, and the EPA proposes to
reaffirm its decision to use the IRIS inhalation URE in the 2020 MON
final rule.

IV. Summary of Cost, Environmental, and Economic Impacts

A. What are the affected sources?

    We estimate that, as of November 6, 2018, there were 201 MON
facilities, nine of which reported ethylene oxide emissions to the 2014
National Emissions Inventory. However, as the EPA is not proposing any
changes to the regulatory text or regulatory requirements in this
action, we do not anticipate that any sources will be affected by this
reconsideration. A complete list of known MON facilities is available
in Appendix 1 of the document, Residual Risk Assessment for the
Miscellaneous Organic Chemical Manufacturing Source Category in Support
of the 2019 Risk and Technology Review Proposed Rule, which is
available in the docket for this rulemaking (see Docket Item No. EPA-
HQ-OAR-2018-0746-0011).

B. What are the air quality impacts?

    The EPA does not project any air quality impacts associated with
this action because this action does not propose any changes to the
standards or other requirements on affected sources.

C. What are the cost impacts?

    The EPA does not project any incremental costs associated with this
action because it does not propose any changes to the standards or
other requirements on affected sources.

D. What are the economic impacts?

    The EPA does not project any economic impacts because there are no
incremental costs associated with this action.

E. What are the benefits?

    The EPA does not project any incremental benefits associated with
this action because it does not propose any changes to the standards or
other requirements on affected sources.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the EPA concludes that the impact of concern
for this rule is any significant adverse economic impact on small
entities and that the Agency is certifying that this rule will not have
a significant economic impact on a substantial number of small entities
if the rule has no net burden on the small entities subject to the
rule. As we are not proposing any changes to the regulatory text or
regulatory requirements, we do not anticipate any economic impacts
resulting from this action. We have therefore concluded that this
action will have no net regulatory burden for all directly regulated
small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action proposes no enforceable duty on any
state, local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. None of the MON facilities that have been
identified as being affected by this action are owned or operated by
tribal governments or located within tribal lands within a 10 mile
radius. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because this action does not present any changes to the rule that would
affect environmental health or safety risks, including those that would
present a disproportionate risk to children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA) and 1 CFR
Part 51

    This rulemaking does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because it does not establish an
environmental health or safety standard. This regulatory action acts to
clarify the language in the preamble of a previously promulgated
regulatory action and does not have any impact on human health or the
environment.

Michael S. Regan,
Administrator.
[FR Doc. 2022-01923 Filed 2-3-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 156 (Thursday, August 13, 2015)]
[Rules and Regulations]
[Pages 48431-48433]
[FR Doc No: 2015-19138]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-0671; Airspace Docket No. 15-ANM-5]

Establishment of Class E Airspace, and Amendment of Class D and E
Airspace; Ogden-Hinckley Airport, UT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace as an extension to
the Class D surface area, modifies Class D airspace, and Class E
airspace extending from 700 feet above the surface at Ogden-Hinckley
Airport, Ogden, UT. The FAA's review of the airspace area revealed that
modification of controlled airspace enhances the safety and management
of Standard Instrument Approach Procedures for Instrument Flight Rules
(IFR) operations at the airport. This action updates the geographic
coordinates of Ogden-Hinckley Airport and Hill AFB, Ogden, UT, and
corrects an error in the regulatory text of the Class E airspace
designated as an extension.

DATES: Effective 0901 UTC, October 15, 2015. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Y, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. The Order is also available for

inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15. For further
information, you can contact the Airspace Policy and ATC Regulations
Group, Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 29591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Steve Haga, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes controlled airspace at Ogden-Hinckley Airport, Ogden,
UT.

History

    On May 1, 2015, the FAA published in the Federal Register a notice
of proposed rulemaking (NPRM) to establish Class E airspace as an
extension to the Class D surface area, modify Class D airspace, and
Class E airspace extending from 700 feet above the surface, at Ogden-
Hinckley Airport, Ogden, UT (80 FR 24861). Interested parties were
invited to participate in this rulemaking effort by submitting written
comments on the proposal to the FAA. No comments were received.
Subsequent to publication, the FAA identified an error in the
geographic coordinates in the legal description of the airspace
designated as an extension to Class D airspace. This action corrects
the error.
    Class D and Class E airspace designations are published in
paragraph 5000, 6004, and 6005, respectively, of FAA Order 7400.9Y,
dated August 6, 2014, and effective September 15, 2014, which is
incorporated by reference in 14 CFR 71.1. The Class D and Class E
airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Y, airspace Designations and
Reporting Points, dated August 6, 2014, and effective September 15,
2014. FAA Order 7400.9Y is publicly available as listed in the
ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes Class E airspace as an extension to the Class D
surface area, modifies Class D airspace, and Class E airspace extending
upward from 700 feet above the surface at Ogden-Hinckley Airport,
Ogden, UT. Class E airspace as an extension to the Class D surface area
is established with a segment extending from the 4.3-mile radius of the
airport to 16 miles southwest of the airport. The Class D airspace
common boundary between Ogden-Hinckley Airport and Hill AFB, Ogden, UT,
is moved 1 mile northwest. Class E airspace extending upward from 700
feet above the surface is modified to within a 5.3-mile radius of the
airport, with segments extending from the 5.3-mile radius to 11 miles
northwest, and 13 miles southwest of the airport. This action updates
the geographic coordinates for Ogden-Hinckley Airport and Hill AFB, as
well as corrects coordinates in the legal description for the Class E
airspace area designated as an extension. This action enhances the
safety and management of controlled airspace within the NAS.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

     Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y,
Airspace Designations and Reporting Points, dated August 6, 2014, and
effective September 15, 2014, is amended as follows:

Paragraph 5000 Class D Airspace

* * * * *

ANM UT D Ogden-Hinckley Airport, UT [Modified]

Ogden-Hinckley Airport, UT
    (Lat. 41[deg]11'44'' N., long. 112[deg]00'47'' W.)
Hill AFB, UT
    (Lat. 41[deg]07'26'' N., long. 111[deg]58'23'' W.)

    That airspace extending upward from the surface up to, but not
including, 7,800 feet within a 4.3-mile radius of the Ogden-Hinckley
Airport, and that airspace beginning at a point where the Ogden-
Hinckley 216[deg] radial intersects the Hill AFB 4.6-mile radius to
the point where the Ogden-Hinckley 231[deg] radial intersects the
4.3-mile radius, thence clockwise along the 4.3-mile

radius to where the Ogden-Hinckley 84[deg] radial intersects the
4.3-mile radius to the point where the Ogden-Hinckley 99[deg] radial
intersects the Hill AFB 4.6-mile radius, excluding the portion
southeast of a line beginning where the 216[deg] radial intersects
the Hill AFB 4.6-mile radius; thence northeast to lat.
41[deg]10'21'' N., long. 112[deg]00'55 W.; to lat. 41[deg]10'56''
N., long. 111[deg]59'19'' W.; to a point where the Ogden-Hinckley
99[deg] radial intersects the Hill AFB 4.6-nm radius. This airspace
is effective during the specific dates and times established in
advance by a Notice to Airmen. The effective date and time will
thereafter be published in the Airport/Facility Directory.

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area

* * * * *

ANM UT E4 Ogden-Hinckley Airport, UT [New]

Ogden-Hinckley Airport, UT
    (Lat. 41[deg]11'44'' N., long. 112[deg]00'47'' W.)
Hill AFB, UT
    (Lat. 41[deg]07'26'' N., long. 111[deg]58'23'' W.)

    That airspace extending upward from the surface 4 miles north
and parallel to the 225[deg] radial of the Ogden-Hinckley Airport,
extending from the 4.3-mile radius to 16 miles southwest of the
airport, thence southeast to lat. 40[deg]57'3'' N., long.
112[deg]12'44'' W., thence northeast to the point where the Ogden-
Hinckley 99[deg] radial intersects the Hill AFB 4.6-mile radius,
thence to the point of beginning.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth

* * * * *

ANM UT E5 Ogden-Hinckley Airport, UT [Modified]

Ogden-Hinckley Airport, UT
    (Lat. 41[deg]11'44'' N., long. 112[deg]00'47'' W.)

    That airspace extending upward from 700 feet above the surface
within a 5.3-mile radius of Ogden-Hinckley Airport, and that
airspace 3 miles either side of the 294[deg] radial from the airport
extending from the 5.3-mile radius to 11 miles northwest of the
airport, and that airspace 4 miles either side of the Ogden-Hinckley
226[deg] radial from the 5.3-mile radius to 13 miles southwest of
the airport.

    Issued in Seattle, Washington, on July 27, 2015.
Johanna Forkner,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2015-19138 Filed 8-12-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)]
[Notices]
[Pages 88311-88312]
[FR Doc No: 2016-29292]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79447; File No. SR-NASDAQ-2016-163]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Change the Titles of Equities Rule 7015 and Options Chapter XV, Section
3, and To Make Related Changes

December 1, 2016.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 28, 2016, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to rename the title of rules that assess fees
for connectivity to systems operated by the Exchange or FINRA under
Equities Rule 7015 and Options Chapter XV, Section 3, and to make
related changes to other rules that reference the renamed rules.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaq.cchwallstreet.com, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to rename related text
in Rule 7015 and Chapter XV, Section 3, to more accurately reflect the
services being provided and eliminate an outdated term. Both Rule 7015
and Chapter XV, Section 3, include connectivity to services that are
not related to connecting to the Exchange trading system, such as
TradeInfo,\3\ Specialized Services Related to FINRA/NASDAQ Trade
Reporting Facility,\4\ and the NASDAQ IPO Workstation.\5\ As a
consequence, the Exchange believes that it is appropriate to rename the
title of Rule 7015 as ``Ports and other Services'' and rename the title
of Chapter XV, Section 3, as ``NASDAQ Options Market--Ports and other
Services,'' which the Exchange believes more accurately describe the
depth and breadth of services provided to members under those rules.
---------------------------------------------------------------------------

    \3\ TradeInfo is an Internet-based tool that, among other
things, allows users to view all of the NASDAQ order and execution
information for their entire firm for both equities and options
through a single interface. TradeInfo may be subscribed to under
both Rule 7015 and Chapter XV Section 3.
    \4\ Specialized Services Related to FINRA/NASDAQ Trade Reporting
Facility includes WebLink ACT or Nasdaq Workstation Post Trade, and
ACT Workstation. See Rule 7015(e).
    \5\ The NASDAQ IPO Workstation provides subscribing member firms
with the IPO Indicator service, which provides information on order
execution that would be received in an IPO during the launch
process.
---------------------------------------------------------------------------

    The Exchange is also proposing to amend reference to the title of
Rule 7015 in Rule 7007(a), which is titled ``Collection of Exchange
Fees and Other Claims and Billing Policy,'' and is also amending
reference to the title of Chapter XV, Section 3, found under Section
7(c)(2) of Chapter XV to reflect the amended titles of Rule 7015 and
Chapter XV, Section 3.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\6\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\7\

in particular, in that it is designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in general
to protect investors and the public interest, by clarifying
applicability of rules whose current titles could confuse market
participants. Specifically, the Exchange is eliminating the term
``Access'' and replacing it with the phrase ``Ports and other'' because
the new titles will more accurately describe the depth and breadth of
services provided to members under Rule 7015 and Chapter XV, Section 3.
As explained above, the various connectivity and services offered under
Rule 7015 and Chapter XV, Section 3, include services listed that are
not related to connecting to the Exchange such as TradeInfo,
Specialized Services Related to FINRA/NASDAQ Trade Reporting Facility,
or the NASDAQ IPO Workstation. These services allow members to view
information and are not related to connecting to the Exchange. Thus,
the changes proposed herein do not impact the fees, connectivity or
services described under Rule 7015 and Chapter XV, Section 3, but
rather merely clarify and harmonize the terminology used to better
align it with what is provided under the rules.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act. The Exchange believes that, to
the extent it has any impact on competition, the proposed change will
promote competition by making it clear to all market participants and
exchange competitors what is provided under Rule 7015 and Chapter XV,
Section 3.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not (i)
significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \8\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\9\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \9\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative for 30 days after the date of its filing. However,
Rule 19b-4(f)(6)(iii) \10\ permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has requested that the
Commission waive the 30-day operative delay so that the proposed rule
change will become operative on filing. The Exchange stated that the
proposed rule change promotes the protection of investors and the
public interest by clarifying and harmonizing the terminology used in
the Exchange's rules. Waiver of the operative delay would allow the
Exchange, without delay, to rename the rules to make clear what the
rules cover, therefore, the Commission believes that waiver of the 30-
day operative delay is consistent with the protection of investors and
the public interest. Therefore, the Commission designates the proposed
rule change to be operative upon filing.\11\
---------------------------------------------------------------------------

    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NASDAQ-2016-163 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2016-163. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NASDAQ-2016-163, and should
be submitted on or before December 28, 2016.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2016-29292 Filed 12-6-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Page 15576]
[FR Doc No: 2018-07437]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4561]

Advisory Committee; Bone, Reproductive and Urologic Drugs
Advisory Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Bone, Reproductive and Urologic Drugs Advisory Committee
by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Bone, Reproductive and Urologic Drugs Advisory Committee for an
additional 2 years beyond the charter expiration date. The new charter
will be in effect until March 23, 2020.

DATES: Authority for the Bone, Reproductive and Urologic Drugs Advisory
Committee will expire on March 23, 2020, unless the Commissioner
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Kalyani Bhatt, Division of Advisory
Committee and Consultant Management, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Bone, Reproductive and Urologic Drugs Advisory Committee
(the Committee). The Committee is a discretionary Federal advisory
committee established to provide advice to the Commissioner.
    The Committee advises the Commissioner or designee in discharging
responsibilities as they relate to helping to ensure safe and effective
drugs for human use and, as required, any other product for which FDA
has regulatory responsibility.
    The Committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational human drug products for
use in the practice of osteoporosis and metabolic bone disease,
obstetrics, gynecology, urology, and related specialties, and makes
appropriate recommendations to the Commissioner.
    The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of osteoporosis and metabolic bone disease, obstetrics,
gynecology, urology, pediatrics, epidemiology, or statistics and
related specialties. Members will be invited to serve for overlapping
terms of up to 4 years. Almost all non-Federal members of this
committee serve as Special Government Employees. The core of voting
members may include one technically qualified member, selected by the
Commissioner or designee, who is identified with consumer interests and
is recommended by either a consortium of consumer-oriented
organizations or other interested persons. In addition to the voting
members, the Committee may include one non-voting member who is
identified with industry interests.
    Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/ucm107572.htm or by contacting
the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT).
In light of the fact that no change has been made to the committee name
or description of duties, no amendment will be made to 21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07437 Filed 4-10-18; 8:45 am]
 BILLING CODE 4164-01-P