[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Proposed Rules]
[Pages 56322-56331]
[FR Doc No: 2014-22403]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2014-0647, FRL-9916-85-Region 9]

Approval and Promulgation of Air Quality Implementation Plans;
Arizona; Regional Haze State and Federal Implementation Plans;
Reconsideration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a source-specific revision to the Arizona State Implementation
Plan (SIP) that establishes an alternative to best available retrofit
technology (BART) for Steam Units 2 and 3 (ST2 and ST3) at Arizona
Electric Power Cooperative's (AEPCO) Apache Generating Station
(Apache). The SIP revision also revises the emission limit for nitrogen
oxides (NOX) applicable to Steam Unit 1 (ST1), when it is
operated in combined-cycle mode with Gas Turbine 1 (GT1). EPA proposes
to find that the BART alternative for ST2 and ST3 would provide greater
reasonable progress

toward natural visibility conditions than BART, in accordance with the
requirements of the Clean Air Act (CAA) and EPA's Regional Haze Rule
(RHR). We also propose to approve the revision to the NOX
emission limit for ST1 and GT1. In conjunction with this proposed
approval, we propose to withdraw those portions of the federal
implementation plan (FIP) that address BART for Apache. We previously
partially granted AEPCO's petition for reconsideration of that FIP and
are now proposing to find that withdrawal of the FIP, as it applies to
Apache, constitutes our action on AEPCO's Petition for Reconsideration
of the FIP.

DATES: Written comments must be submitted on or before November 3,
2014. Requests for public hearing must be received on or before October
6, 2014.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for further
instructions on where and how to learn more about this proposal,
request a public hearing, or submit comments.

FOR FURTHER INFORMATION CONTACT: Thomas Webb, U.S. EPA, Region 9,
Planning Office, Air Division, Air-2, 75 Hawthorne Street, San
Francisco, CA 94105. Thomas Webb can be reached at telephone number
(415) 947-4139 and via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. General Information
II. Background
III. The Apache SIP Revision
IV. EPA's Proposed Action
V. Statutory and Executive Order Reviews

I. General Information

 A. Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
     The words or initials Act or CAA mean or refer to the
Clean Air Act, unless the context indicates otherwise.
     The initials ADEQ mean or refer to the Arizona Department
of Environmental Quality.
     The initials AEPCO mean or refer to Arizona Electric Power
Cooperative.
     The words Arizona and State mean the State of Arizona.
     The initials BART mean or refer to Best Available Retrofit
Technology.
     The term Class I area refers to a mandatory Class I
Federal area.\1\
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    \1\ Although states and tribes may designate as Class I
additional areas which they consider to have visibility as an
important value, the requirements of the visibility program set
forth in section 169A of the CAA apply only to ``mandatory Class I
Federal areas.''
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     The initials CBI mean or refer to Confidential Business
Information.
     The initials EGU mean or refer to Electric Generating
Unit.
     The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
     The initials FIP mean or refer to Federal Implementation
Plan.
     The initials GT1 mean or refer to Gas Turbine Unit 1.
     The initials LNB mean or refer to low-NOX
burners.
     The initials MMBtu mean or refer to million British
thermal units
     The initials NOX mean or refer to nitrogen
oxides.
     The initials OFA mean or refer to over fire air.
     The initials PM10 mean or refer to particulate
matter with an aerodynamic diameter of less than 10 micrometers.
     The initials RHR mean or refer to EPA's Regional Haze
Rule.
     The initials SCR mean or refer to Selective Catalytic
Reduction.
     The initials SIP mean or refer to State Implementation
Plan.
     The initials SO2 mean or refer to sulfur
dioxide.
     The initials ST1 mean or refer to Steam Unit 1.
     The initials ST2 mean or refer to Steam Unit 2.
     The initials ST3 mean or refer to Steam Unit 3.

B. Docket

    The proposed action relies on documents, information, and data that
are listed in the index on http://www.regulations.gov under docket
number EPA-R09-OAR-2014-0647. Although listed in the index, some
information is not publicly available (e.g., Confidential Business
Information (CBI)). Certain other material, such as copyrighted
material, is publicly available only in hard copy form. Publicly
available docket materials are available either electronically at
http://www.regulations.gov or in hard copy at the Planning Office of
the Air Division, AIR-2, EPA Region 9, 75 Hawthorne Street, San
Francisco, CA 94105. EPA requests that you contact the individual
listed in the FOR FURTHER INFORMATION CONTACT section to view the hard
copy of the docket. You may view the hard copy of the docket Monday
through Friday, 9-5:00 PDT, excluding Federal holidays.

C. Instructions for Submitting Comments to EPA

    Written comments must be submitted on or before November 3, 2014.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2014-
0647, by one of the following methods:
     Federal Rulemaking portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER> (Attention: Thomas Webb).
     Mail, Hand Delivery or Courier: Thomas Webb, EPA Region 9,
Air Division (AIR-2), 75 Hawthorne Street, San Francisco, California
94105. Hand and courier deliveries are only accepted Monday through
Friday, 8:30 a.m.-4:30 p.m., excluding Federal holidays. Special
arrangements should be made for deliveries of boxed information.
    EPA's policy is to include all comments received in the public
docket without change. We may make comments available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be CBI or other
information for which disclosure is restricted by statute. Do not
submit information that you consider to be CBI or that is otherwise
protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site is an ``anonymous access'' system, which
means 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 EPA, without going through http://www.regulations.gov, we
will include your email address as part of the comment that is placed
in the public docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, 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.

D. Submitting Confidential Business Information

    Do not submit CBI to EPA through http://www.regulations.gov or by
email. Clearly mark the part or all of the information that you claim
as CBI. For CBI information in a disk or CD-ROM that you mail to EPA,
mark the outside

of the disk or CD-ROM as CBI and identify electronically within the
disk or CD-ROM the specific information that is claimed as CBI. In
addition to one complete version of the comment that includes
information claimed as CBI, you must submit a copy of the comment that
does not contain the information claimed as CBI for inclusion in the
public docket. We will not disclose information so marked except in
accordance with procedures set forth in 40 CFR part 2.

E. Tips for Preparing Your Comments

    When submitting comments, remember to:
     Identify the rulemaking by docket number and other
identifying information (e.g., subject heading, Federal Register date
and page number).
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the identified
comment period deadline.

 F. Public Hearings

    If anyone contacts EPA by October 6, 2014 requesting to speak at a
public hearing, EPA will schedule a public hearing and announce the
hearing in the Federal Register. Contact Thomas Webb at<PHONE_NUMBER>
or at<EMAIL_ADDRESS>to request a hearing or to determine if a
hearing will be held.

II. Background

A. Statutory and Regulatory Background

    This section provides a brief overview of the requirements of the
CAA and RHR, as they apply to this particular action. Please refer to
our previous rulemakings on the Arizona Regional Haze SIP for
additional background regarding the visibility protection provisions of
the CAA and the RHR.\2\
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    \2\ 77 FR 42834, 42837-42839 (July 20, 2012), (Arizona Regional
Haze ``Phase 1'' Rule) 77 FR 75704, 75709-75712 (December 21, 2012),
(Arizona Regional Haze ``Phase 2'' Rule).
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    In section 169A of the 1977 Amendments to the CAA, Congress created
a program for protecting visibility in the nation's national parks and
wilderness areas. This section of the CAA establishes as a national
goal the ``prevention of any future, and the remedying of any existing,
impairment of visibility in mandatory Class I Federal areas which
impairment results from manmade air pollution.'' \3\ It also directs
states to evaluate the use of retrofit controls at certain larger,
often uncontrolled, older stationary sources in order to address
visibility impacts from these sources. Specifically, section
169A(b)(2)(A) of the CAA requires states to revise their SIPs to
contain such measures as may be necessary to make reasonable progress
towards the natural visibility goal, including a requirement that
certain categories of existing major stationary sources built between
1962 and 1977 (known as ``BART-eligible'' sources) procure, install,
and operate BART. In the 1990 CAA Amendments, Congress amended the
visibility provisions in the CAA to focus attention on the problem of
regional haze, which is visibility impairment produced by a multitude
of sources and activities located across a broad geographic area.\4\
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    \3\ 42 U.S.C. 7491(a)(1).
    \4\ See CAA section 169B, 42 U.S.C. 7492.
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    In 1999, we promulgated the RHR, which requires states to develop
and implement SIPs to ensure reasonable progress toward improving
visibility in mandatory Class I Federal areas (Class I areas) \5\ by
reducing emissions that cause or contribute to regional haze.\6\ Under
the RHR, states are directed to conduct BART determinations for BART-
eligible sources that may be anticipated to cause or contribute to any
visibility impairment in a Class I area.\7\ In lieu of requiring
source-specific BART controls, states also have the flexibility to
adopt alternative measures, as long as the alternative provides greater
reasonable progress towards natural visibility conditions than BART
(i.e., the alternative must be ``better than BART'').\8\
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    \5\ Areas designated as mandatory Class I Federal areas consist
of national parks exceeding 6000 acres, wilderness areas and
national memorial parks exceeding 5000 acres, and all international
parks that were in existence on August 7, 1977. 42 U.S.C. 7472(a).
When we use the term ``Class I area'' in this action, we mean a
``mandatory Class I Federal area.''
    \6\ See generally 40 CFR 51.308.
    \7\ 40 CFR 51.308(e).
    \8\ 40 CFR 51.308(e)(2).
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B. Summary of State Submittals and EPA Actions

1. 2011 Arizona RH SIP
    On February 28, 2011, the Arizona Department of Environmental
Quality (ADEQ) submitted a Regional Haze SIP under Section 308 of the
RHR (``Arizona RH SIP'') to EPA. This submittal included BART
determinations for nitrogen oxides (NOX), particulate matter
with an aerodynamic diameter of less than 10 micrometers
(PM10), and sulfur dioxide (SO2) at Apache Units
ST1, ST2, and ST3. Unit ST1 is a wall-fired boiler with a net unit
output of 85 MW that burns pipeline-quality natural gas as its primary
fuel. Units ST2 and ST3 are both dry-bottom, Riley Stoker turbo-fired
boilers, operating on sub-bituminous coal, each with a gross unit
output of 204 MW.
2. 2012 EPA Action on Arizona RH SIP and FIP
    On December 5, 2012, we issued a final rule approving in part and
disapproving in part ADEQ's BART determinations for three sources,
including Apache.\9\ In particular, we approved ADEQ's BART
determinations for NOX, PM10, and SO2
at Apache ST1 and PM10 and SO2 at ST2 and ST3,
but disapproved ADEQ's BART determinations for NOX at ST2
and ST3. We also found that the SIP lacked enforceable emission limits
for all units and pollutants. In the same action, we promulgated a FIP
for the disapproved portions of the SIP, including NOX BART
determinations for ST2 and ST3. We determined that BART for
NOX at ST2 and ST3 was an emission limit of 0.070 pounds per
million British thermal units (lb/MMBtu) determined as an average
across the two units, based on a rolling 30-boiler-operating-day
average, which is achievable with the use of low-NOX burners
(LNB), overfire air (OFA) and selective catalytic reduction (SCR). We
also established compliance dates and requirements for equipment
maintenance, monitoring, recordkeeping, and reporting for all units and
all pollutants.
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    \9\ 77 FR 72512.
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3. 2013 AEPCO Petition for Reconsideration of RH FIP for Apache
Generating Station
    On February 4, 2013, AEPCO submitted a petition to EPA seeking
reconsideration of the final rule (``AEPCO Petition'').\10\ On May 29,
2013, AEPCO submitted a supplemental petition providing an alternative
to the BART determinations in that rule (``Apache BART
Alternative'').\11\ The Apache BART Alternative consisted of a
conversion to pipeline natural gas (PNG) combustion at ST2 and a
NOX emission

limit based upon selective non-catalytic reduction (SNCR) at ST3. On
June 6, 2013, we sent a letter to representatives of AEPCO granting
partial reconsideration of the final rule under CAA section
307(d)(7)(B).\12\ Specifically, we stated that we were granting
reconsideration of the emission limits for NOX,
PM10, and SO2 at ST2 and ST3, the compliance
methodology for NOX at ST2 and ST3, and the provisions of
the rule applicable to ST1 and GT1.
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    \10\ Letter from Eric Hiser, Jorden, Bischoff and Hiser, to Lisa
Jackson, EPA (February 2, 2013).
    \11\ Letter from Eric Hiser, Jorden, Bischoff and Hiser, to
Robert Perciasepe and Jared Blumenfeld, EPA (May 29, 2013).
    \12\ Letter from Jared Blumenfeld, EPA, to Eric Hiser, Jorden,
Bischoff and Hiser (June 6, 2013).
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4. 2013 Arizona RH SIP Revision and Clarification
    On May 3, 2013, ADEQ submitted a revision to the Arizona RH
SIP.\13\ Among other things, the SIP revision clarified that the BART
emission limits for ST1 apply when ST1 operates alone or if ST1 is
operated in combined-cycle mode with the adjacent GT1, but not to (a)
GT1 in stand-alone simple-cycle operation or (b) ST1/GT1 when ST1
burners are shut off and ST1 is not producing electricity.\14\ EPA
approved this clarification in our July 30, 2013 Phase 2 final rule on
the Arizona RH SIP.\15\
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    \13\ Letter from Eric Massey, ADEQ, to Jared Blumenfeld, EPA
(May 3, 2013), Enclosure 3, Arizona RH SIP Revision.
    \14\ Id. Appendix D, pages 5-6 (footnotes to tables 1.1, 1.2 and
1.3) and page 49. The reason for this distinction is that gas
turbines are not among the 26 industrial source categories included
in the definition of ``existing stationary facility'' in the
Regional Haze Rule, whereas combined cycle turbines are included in
this list. See 40 CFR 51.301; 40 CFR part 51 appendix Y, section
II.A.1.
    \15\ See Supplemental Proposal, 78 FR 46142, 46175 (codified at
40 CFR 52.120(c)(158)(ii)(A)(1)(iii)).
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5. 2014 Arizona RH SIP Revision for Apache Generating Station
    On May 13, 2014, ADEQ submitted a revision to the Arizona RH SIP
that incorporated the Apache BART Alternative (``Apache SIP
Revision'').\16\ The Apache SIP Revision also revised the
NOX emission limit for ST1 during combined-cycle operation.
The Apache SIP Revision is the subject of this proposal.
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    \16\ Letter from Eric Massey, ADEQ, to Jared Blumenfeld, EPA
(May 13, 2014), Enclosure 3, Revision to the Arizona RH Plan for
AEPCO Apache Generating Station.
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III. The Apache SIP Revision

 A. Summary of the Apache SIP Revision

    The Apache SIP Revision consists of two components: a BART
Alternative for ST2 and ST3, and a revised NOX emission
limit for ST1 and GT1 when operated in combined-cycle mode.
 1. Apache BART Alternative
    Under the Apache BART Alternative, ST2 would be converted from a
primarily coal-fired unit to a unit that combusts pipeline-quality
natural gas, while ST3 would remain as a coal-fired unit and would be
retrofitted with SNCR. The emission limits associated with the
Alternative are summarized in Table 1. The compliance date for all
limits is December 5, 2017, except that a more stringent limit for
PM10 at ST2 (0.008 lb/MMBtu) that will be effective on
December 5, 2018.

                              Table 1--Emission Limits for Apache BART Alternative
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                                           Emission limit (lb/MMbtu, averaged over 30 boiler-operating days)
                 Unit                 --------------------------------------------------------------------------
                                             NOX                          PM10                          SO2
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ST2..................................           0.085  0.01, then 0.008 (effective December 5,           0.00064
                                                        2018).
ST3..................................            0.23  0.03.....................................            0.15
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    ADEQ incorporated the revised emission limits, as well as
associated compliance deadlines and monitoring, recordkeeping, and
reporting requirements, as an addendum to Apache's Operating Permit,
which was submitted as part of the Apache SIP Revision.\17\ The SIP
revision also includes ADEQ's determination that the Apache BART
Alternative is ``better than BART,'' based on total estimated emissions
reductions, reductions in visibility impairing pollutants, IMPROVE
monitoring data, and improvements in modeled visibility impacts from
Apache.\18\ More information regarding ADEQ's analysis is set forth
below, along with EPA's evaluation of the analysis. On July 18, 2014,
EPA determined that the Apache SIP Revision was complete under CAA
section 110(k)(1)(B).\19\
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    \17\ Apache SIP Revision, Appendix B, Significant Revision No.
59195 to Air Quality Control Permit No. 55412 (``Apache Permit
Revision'')(issued May 13, 2014).
    \18\ Apache SIP Revision, sections 2.2 and 2.3.
    \19\ Letter from Deborah Jordan, EPA, to Eric Massey, ADEQ (July
18, 2014).
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2. Revised Emission Limit for ST1 and GT1
    The Apache SIP Revision revises the NOX emission limit
for the combined-cycle operation of ST1 with GT1 from 0.056 lb/MMBtu to
0.10 lb/MMBtu, based on a determination that the 0.056 lb/MMBtu limit
is not achievable during combined cycle operations and that inclusion
of emissions from GT1 would result in an emission rate of 0.10 lb/
MMbtu.\20\ In order to ensure that this revision does not result in an
overall increase in NOX emissions, the SIP Revision also
sets a 1205 lb/day limit, based on a 30-calendar-day average, for ST1
operating in standalone mode or in combined-cycle mode with GT1. ADEQ
derived this emission limit based on the existing emission limit of
0.056 lb/MMBtu (the original NOX emission limit required for
ST1 and GT1 in combined-cycle mode), and a conservative estimate of the
heat rate (10,985 Btu/kWhr) over the primary operating range of ST1 and
GT1 in combined-cycle operation.\21\
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    \20\ See letter from Eric Hiser, Jorden, Bischoff and Hiser, to
Eric Massey, ADEQ (November 25, 2013).
    \21\ Id. section 3.1, footnote 9.
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B. EPA's Evaluation of Apache BART Alternative

    The RHR requires that a SIP revision establishing a BART
alternative include three elements as listed below. We have evaluated
the Apache BART Alternative with respect to each of these elements.
     A demonstration that the emissions trading program or
other alternative measure will achieve greater reasonable progress than
would have resulted from the installation and operation of BART at all
sources subject to BART in the State and covered by the alternative
program.\22\
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    \22\ 40 CFR 51.308(e)(2)(i).
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     A requirement that all necessary emissions reductions take
place during

the period of the first long-term strategy for regional haze.\23\
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    \23\ 40 CFR 51.308(e)(2)(iii).
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     A demonstration that the emissions reductions resulting
from the alternative measure will be surplus to those reductions
resulting from measures adopted to meet requirements of the CAA as of
the baseline date of the SIP.\24\
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    \24\ 40 CFR 51.308(e)(2)(iv).
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1. Demonstration of the Alternative Measure Will Achieve Greater
Reasonable Progress
    Pursuant to 40 CFR 51.308(e)(2)(i), ADEQ must demonstrate that the
alternative measure will achieve greater reasonable progress than would
have resulted from the installation and operation of BART at all
sources subject to BART in the State and covered by the alternative
program. This demonstration must be based on five criteria, which are
addressed below.
a. A List of All BART-Eligible Sources Within the State
    Pursuant to 40 CFR 51.308(e)(2)(i)(A), the SIP must include a list
of all BART-eligible sources within the State. ADEQ included a list of
BART-eligible sources in the Arizona RH SIP.\25\ As part of the Phase 2
Arizona regional haze rulemaking, EPA approved the majority of ADEQ's
BART-eligibility determinations, but disapproved ADEQ's finding that
Tucson Electric Power (TEP) Sundt Unit 4 was not BART-eligible.\26\ In
the Phase 3 Arizona regional haze rulemaking, EPA determined that TEP
Sundt Unit 4 was BART-eligible and subject-to-BART and made final BART
determinations for this unit.\27\ Thus, all BART-eligible sources in
the State have been addressed either in a SIP or FIP. We propose to
find that the existing Arizona RH SIP and FIP fulfill the requirement
of 40 CFR 51.308(e)(2)(i)(A) for a list of all BART-eligible sources
within the State.
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    \25\ See 77 FR 75704, 75719-75720; 78 FR 46142, 46151-46152.
    \26\ Id.
    \27\ 79 FR 52420.
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b. A List of All BART-Eligible Sources and All Bart Source Categories
Covered by the Alternative Program
    Pursuant to 40 CFR 51.308(e)(2)(i)(B), each BART-eligible source in
the State must be subject to the requirements of the alternative
program or have a federally enforceable emission limitation determined
by the State and approved by EPA as meeting BART. In this instance, the
alternative program covers only Apache ST2 and ST3. All other BART-
eligible sources and units in the State have already been addressed in
the Arizona RH SIP and FIP.\28\ Therefore, we propose to find that the
Apache SIP Revision meets the requirement of 40 CFR 51.308(e)(2)(i)(B).
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    \28\ See generally 77 FR 72512, 78 FR 46142.
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c. Analysis of BART and Associated Emission Reductions
    Pursuant to 40 CFR 51.308(e)(2)(i)(C), the SIP must include an
analysis of BART and associated emission reductions at ST2 and ST3. As
noted above, ADEQ's BART analyses and determinations for ST2 and ST3
were included in the Arizona RH SIP. EPA approved ADEQ's BART
determinations for PM10 and SO2, but disapproved
ADEQ's BART determination for NOX at ST2 and ST3 and
conducted our own BART analysis and determination for NOX
BART for ST2 and ST3 in a FIP.
    In the Apache SIP Revision, ADEQ compared the BART Alternative both
to ADEQ's original BART determinations and to EPA's BART determinations
in the FIP. For purposes of our evaluation, we consider BART for ST2
and ST3 to consist of a combination of (1) ADEQ's BART determinations
for PM10 and SO2, which were approved into the
applicable SIP, and (2) EPA's BART determination for NOX in
the Arizona RH FIP. These BART determinations are summarized in Table
2.

                                    Table 2--BART Emission Limits for Apache
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                                           Emission limit (lb/MMbtu, averaged over 30 boiler-operating days)
                 Unit                 --------------------------------------------------------------------------
                                                          NOX                          PM10             SO2
----------------------------------------------------------------------------------------------------------------
ST2..................................  0.070 (across two units).................            0.03            0.15
ST3..................................  .........................................            0.03            0.15
----------------------------------------------------------------------------------------------------------------

    In the Technical Support Document (TSD) included with the Apache
SIP Revision, ADEQ calculated estimated annual emission reductions
achievable with BART by comparing projected emissions from ST2 and ST3
with BART \29\ to baseline emissions.\30\ The results of these
calculations are shown in Table 3. Because BART for PM10 and
SO2 was determined to be consistent with existing controls,
no emission reductions are expected to result from BART. However,
significant NOX emission reductions (4,502 tpy) are expected
to result from implementation of BART.
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    \29\ ADEQ refers to the BART control scenario as ``2013 SCR.''
See TSD page 4 (``This scenario assumes SCR, LNB, and OFA
implementation as well as ESP and wet scrubber upgrades.'').
    \30\ ADEQ considered two different baseline scenarios--2007
(assuming use of Electrostatic Precipitation (ESP) and wet scrubber
upgrades) and 2013 (assuming use of OFA, ESP, and wet scrubber
upgrades). See SIP TSD at 3. We have chosen to employ the 2013
Baseline, consistent with our original BART analysis, which used a
baseline with OFA. See 78 FR 42856, Table 16.

                     Table 3--Summary of Emission Reductions Achievable With BART at Apache
----------------------------------------------------------------------------------------------------------------
                                                                        ST2 and ST3 Total emissions  (tpy)
                                                                 -----------------------------------------------
                                                                        NOX            PM10             SO2
----------------------------------------------------------------------------------------------------------------
Baseline (``2013 Baseline'') \a\................................           5,441             403           2,013
BART (``2013 SCR'') \b\.........................................             939             403           2,013
Emission Reduction (``2013 SCR'' minus ``2013 Baseline'') \c\...           4,502               0               0
----------------------------------------------------------------------------------------------------------------
\a\ Apache SIP Revision TSD Table 6.

\b\ Id.
\c\ Id. Table 7.

We propose to find that ADEQ has met the requirement for an analysis of
BART and associated emission reductions achievable at Apache ST2 and
ST3 under 40 CFR 51.308(e)(2)(i)(C).
d. Analysis of Projected Emissions Reductions Achievable Through the
BART Alternative
    In the Apache SIP Revision TSD, ADEQ calculated emissions
reductions achievable through the BART Alternative by comparing
estimated annual emissions from ST2 and ST3 under the BART Alternative
\31\ with baseline emissions. The results of these calculations are
shown in Table 4.
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    \31\ ADEQ refers to the BART Alternative as ``2013 9bv2 PNGt.''
See TSD page 4 (``The 2013 9bv2 PNGt scenario reflects the
implementation of the AEPCO alternative controls . . .'').

                 Table 4--Summary of Emission Reductions Achievable With Apache BART Alternative
----------------------------------------------------------------------------------------------------------------
                                                                        ST2 and ST3 Total emissions  (tpy)
                                                                 -----------------------------------------------
                                                                        NOX            PM10             SO2
----------------------------------------------------------------------------------------------------------------
Baseline (``2013 Baseline'') \a\................................           5,441             403           2,013
BART Alternative (``2013 9bv2 PNGt'') \b\.......................           2,122             262           1,056
Emission Reduction (``2013 9bv2 PNGt'' minus ``2013 Baseline'')            3,318             141             957
 \ c\...........................................................
----------------------------------------------------------------------------------------------------------------
\a\ Apache SIP Revision TSD Table 6.
\b\ Id.
\c\ Id. Table 7.

We propose to find that ADEQ has met the requirement for an analysis of
the projected emissions reductions achievable through the alternative
measure under 40 CFR 51.308(e)(2)(i)(D).
e. A Determination That the Alternative Achieves Greater Reasonable
Progress Than Would Be Achieved Through the Installation and Operation
of BART
    Pursuant to 40 CFR 51.308(e)(2)(i)(E), the State must provide a
determination that the alternative achieves greater reasonable progress
than BART under 40 CFR 51.308(e)(3) or otherwise based on the clear
weight of evidence. 40 CFR 51.308(e)(3), in turn, provides two
different tests for determining whether the alternative achieves
greater reasonable progress than BART. If the distribution of emissions
is not substantially different than under BART, and the alternative
measure results in greater emission reductions, then the alternative
measure may be deemed to achieve greater reasonable progress. If the
distribution of emissions is significantly different, however, then the
State must conduct dispersion modeling to determine differences in
visibility between BART and the trading program for each impacted Class
I area, for the worst and best 20 percent of days. The modeling would
demonstrate ``greater reasonable progress'' if both of the following
two criteria are met: (1) Visibility does not decline in any Class I
area, and; (2) there is an overall improvement in visibility,
determined by comparing the average differences between BART and the
alternative over all affected Class I areas.
    In the Apache SIP Revision, ADEQ determined that neither of the two
tests under 51.308(e)(3) was appropriate for evaluating the Apache BART
Alternative. Therefore, ADEQ conducted a weight-of-evidence analysis
based on reductions in visibility-impairing pollutants, IMPROVE
monitoring data, and improvements in modeled visibility impacts from
Apache.
    The reductions in visibility-impairing pollutants from the Apache
BART Alternative, as estimated by ADEQ, are summarized in Table 4
above. As noted above, compared with BART, ADEQ projects that the
Apache BART Alternative will result in 1183 tpy more NOX
emissions, 957 tpy fewer SO2 emissions, and 141 tpy fewer
PM10 emissions than BART.
    ADEQ next considered historical emission inventory and ambient
monitoring data. In particular, ADEQ noted that, in 2008, state-wide
emissions of SO2 (84,784 tons) were less than a third of
state-wide NOX emissions (290,344 tons). ADEQ also reviewed
ambient monitoring data from Class I areas impacted by emissions from
Apache and found that visibility impairment due to SO2 was
more than three times greater than impairment from NOX.\32\
Based on the monitoring and emission inventory data, ADEQ concluded
that, ``for the State of Arizona, it is likely more beneficial to
reduce SO2 emissions as compared to NOX emissions
when applying pollution controls to point sources to improve class I
area visibility. Therefore, ADEQ believes AEPCO's proposed alternative
control methodology would realize higher real-world visibility benefits
than the other control methods tested.'' \33\
---------------------------------------------------------------------------

    \32\ Apache SIP Revision page 5.
    \33\ Id. TSD page 13.
---------------------------------------------------------------------------

    Finally, ADEQ considered the results of air quality modeling (using
the CALPUFF model) performed by AEPCO to assess the visibility impacts
of Apache under various control scenarios.\34\ These results,
summarized in Table 5, show that, compared with BART, the Apache BART
Alternative would result in greater visibility improvement at all but
two areas (Gila Wilderness Area and Mount Baldy Wilderness Area), and
would result in greater improvement on average across all areas. In
addition, implementation of the Apache BART Alternative would result in
improvement at all affected Class I areas, in comparison to the base
case.
---------------------------------------------------------------------------

    \34\ Id. See also TSD pages 15-22.

                                                      Table 5--Modeled Visibility Impacts of Apache
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Baseline (2013 baseline)             BART (2013 SCR)           BART alternative (2013 9bv2
                                                         ----------------------------------------------------------------              PNGt)
                                                             Visibility impacts  (dv)        Visibility impacts  (dv)    -------------------------------
                      Class I area                       ----------------------------------------------------------------    Visibility impacts  (dv)
                                                                                -------------------------------
                                                             Avg 98th        22nd high       Avg 98th        22nd high       Avg 98th        22nd high
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chiricahua National Monument............................           3.328           3.409           1.978           1.996           1.882           1.909
Chiricahua Wilderness Area..............................           3.418           3.464           1.886           1.979           1.851           1.852
Galiuro Wilderness Area.................................           2.178           2.219           1.208           1.205           1.111           1.135
Gila Wilderness Area....................................           0.642           0.629           0.262           0.279           0.287           0.295
Mazatzal Wilderness Area................................           0.266           0.277           0.156           0.147           0.126           0.124
Mt. Baldy Wilderness Area...............................           0.269           0.282           0.109           0.114           0.112           0.116
Saguaro National Park...................................           2.502           2.493           1.421           1.463           1.346           1.317
Sierra Ancha Wilderness Area............................           0.289           0.287           0.153           0.158           0.130           0.128
Superstition Wilderness Area............................           0.596           0.612           0.313           0.315           0.275           0.283
Average.................................................           1.499           1.519           0.832           0.851           0.791           0.795
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: ``Avg 98th'' refers to the average of the annual 98th percentile visibility impacts in deciviews (dv) from 2001-2003. ``22nd high'' refers to the
  22nd highest visibility impact in deciviews for combined 2001-2003 data. In all modeling scenarios, background ammonia concentrations are 1 ppb for
  Method 8 estimations using best 20-percent days visibility.

    In evaluating ADEQ's weight-of-evidence demonstration, we have
considered all elements of ADEQ's analysis, but we have given the most
weight to the visibility impacts based on air quality modeling. In
order to evaluate whether the Apache BART Alternative is indeed better
than BART, we have applied a modified version of the two-prong modeling
test set forth in 40 CFR 51.308(e)(3), using the air quality modeling
results. In particular, rather than considering the best twenty-percent
days and worst twenty-percent days, as provided for under 40 CFR
51.308(e)(3), we have considered the 98th percentile impacts (averaged
across three years), consistent with the approach recommended by the
BART Guidelines for comparing control alternatives at a single
source.\35\ Under the first prong of the test (the ``no-degradation
prong''), we compared the Apache BART Alternative to baseline
conditions to ensure that the alternative will not result in worsened
conditions anywhere than would otherwise exist.\36\ The Apache BART
Alternative clearly meets this prong, as the visibility modeling
results indicated that the Alternative will result in improved
visibility at all affected Class I areas compared with baseline
conditions, as shown in Table 5. Under the second prong, we compared
the average differences between BART and the Apache BART Alternative
over all affected Class I areas to ensure that there is an overall
improvement in visibility.\37\ The Apache BART Alternative also meets
this prong, as the modeling results indicated that the Alternative
would result in improved visibility, on average, across all Class I
Areas, compared with BART.
---------------------------------------------------------------------------

    \35\ 70 FR 39170. CALPUFF is the single source air quality model
that is recommended in the BART Guidelines. Since CALPUFF was used
for this analysis, the modeling results were post-processed in a
manner consistent with the BART Guidelines.
    \36\ See 70 FR 39137.
    \37\ 40 CFR 51.308(e)(3)(ii).
---------------------------------------------------------------------------

    Based on the weight-of-evidence presented, we propose to approve
ADEQ's determination that the Apache BART Alternative would achieve
greater reasonable progress than BART under 40 CFR 51.308(e)(2)(i)(E).
In particular, the BART Alternative will result in 957 tpy fewer
SO2 emissions compared to BART. In spite of more
NOX emissions (1183 tpy) compared to BART, modeling
submitted by ADEQ shows that the BART Alternative will result in
improved visibility at all affected Class I areas compared with
baseline conditions and will result in improved visibility, on average,
across all Class I Areas, compared with BART. This conclusion is
further supported by the IMPROVE visibility monitoring data, which
indicates that all of the affected Class I areas have more than three
times the visibility impairment due to SO2 compared to
NOX.
2. Requirement That Emission Reductions Take Place During Period of
First Long-Term Strategy
    Pursuant to 40 CFR 51.308(e)(2)(iii), the State must ensure that
all necessary emission reductions take place during the period of the
first long-term strategy for regional haze, i.e. by December 31, 2018.
The RHR further provides that, to meet this requirement, the State must
provide a detailed description of the alternative measure, including
schedules for implementation, the emission reductions required by the
program, all necessary administrative and technical procedures for
implementing the program, rules for accounting and monitoring
emissions, and procedures for enforcement.\38\
---------------------------------------------------------------------------

    \38\ 40 CFR 51.308(e)(2)(iii).
---------------------------------------------------------------------------

    As noted above, the Apache SIP Revision incorporates the Apache
Permit Revision, which includes conditions implementing the Apache BART
Alternative. In addition to the emission limitations for
NOX, PM10, and SO2 listed in Table 1
above, the Apache Permit Revision includes compliance dates, operation
and maintenance requirements, and monitoring, recordkeeping, and
reporting requirements. We propose to find that these provisions meet
the requirements of 40 CFR 51.308(e)(2)(iii).
3. Demonstration That Emissions Reductions From Alternative Measure
Will Be Surplus
    Pursuant to 40 CFR 51.308(e)(2)(iv), the SIP must demonstrate that
the emissions reductions resulting from the alternative measure will be
surplus to those reductions resulting from measures adopted to meet
requirements of the CAA as of the baseline date of the SIP. The
baseline date for regional haze SIPs is 2002.\39\ All of the emission
reductions required by the Apache BART Alternative are surplus to
reductions resulting from measures applicable to Apache as of 2002.
Therefore, we propose to find that the Apache BART Alternative complies
with 40 CFR 51.308(e)(2)(iv).
---------------------------------------------------------------------------

    \39\ See Memorandum from Lydia Wegman and Peter Tsirigotis, 2002
Base Year Emission Inventory SIP Planning: 8-hr Ozone,
PM2.5, and Regional Haze Programs, November 8, 2002.
http://www.epa.gov/ttn/oarpg/t1/memoranda/2002bye-gm.pdf.

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

    In sum, we propose to find that the Apache BART Alternative meets
all of the applicable requirements of 40 CFR 51.308(e)(2).

C. EPA's Evaluation of the ST1 Emission Limit Revision

    In addition to the Apache BART Alternative, which applies to ST2
and ST3, the Apache SIP Revision includes a revision in the
NOX limit for ST1 when operating in combined-cycle mode with
GT1. The SIP Revision would raise this limit from 0.056 lb/MMbtu to
0.10 lb/MMbtu based on a determination that the 0.056 lb/MMbtu limit is
unachievable when ST1 is operated in combined cycle with GT1.\40\ The
revised limit of 0.10 is lb/MMbtu achievable when ST1 is operated in
combined cycle with GT1 and is consistent with the use of natural gas,
which ADEQ previously determined to constitute BART for this unit.
Therefore, we propose to find that this revision to the emission limit
for ST1, when operated in combined cycle mode with GT1, is consistent
with the provisions of 40 CFR 51.308(e) requiring SIPs to contain
emission limits representing BART.
---------------------------------------------------------------------------

    \40\ See letter from Eric Hiser, Jorden, Bischoff and Hiser, to
Eric Massey, ADEQ (November 25, 2013).
---------------------------------------------------------------------------

D. EPA's Evaluation of Other Applicable Requirements

1. Enforceable Emission Limits
    CAA section 110(a)(2)(A) requires SIPs to include enforceable
emissions limitations necessary or appropriate to meet the applicable
requirements of the Act. In addition, SIPs must contain regulatory
requirements related to monitoring, recordkeeping, and reporting for
applicable emissions limitations.\41\ The Apache Permit Revision
includes such enforceable emission limits, as well as associated
monitoring, recordkeeping, and reporting requirements, for all units
and pollutants. Therefore, we propose to find that the Apache SIP
Revision meets the requirements of the CAA and EPA's implementing
regulations for enforceable emission limitations.
---------------------------------------------------------------------------

    \41\ See, e.g. CAA section 110(a)(2)(F) and 40 CFR 51.212(c).
---------------------------------------------------------------------------

2. Non-Interference With Applicable Requirements
    The CAA requires that any revision to an implementation plan shall
not be approved by the Administrator if the revision would interfere
with any applicable requirement concerning attainment and reasonable
further progress or any other applicable requirement of the Act.\42\
EPA has promulgated health-based standards, known as the national
ambient air quality standards (NAAQS), for seven pollutants, including
SO2, PM10, NO2 (a component of
NOX), and pollutants such as ozone and PM2.5 that
are formed in the atmosphere from reactions between NOX and
other pollutants. Using a process that considers air quality data and
other factors, EPA designates areas as ``nonattainment'' if those areas
cause or contribute to violations of a NAAQS. Reasonable further
progress, as defined in section 171 of the CAA, is related to
attainment and means annual incremental reductions in emissions of the
relevant air pollutant for the purpose of ensuring attainment of the
applicable NAAQS. Apache is located in north central Cochise County,
Arizona, which is designated as Unclassifiable/Attainment for all of
the NAAQS.\43\ Therefore, we propose to find that a revision to the
BART emission limits for NOX will not interfere with
attainment or reasonable further progress for any air quality standard.
---------------------------------------------------------------------------

    \42\ CAA Section 110(l), 42 U.S.C. 7410(l).
    \43\ Apache SIP Revision, pages 9-10, Table 1.5.
---------------------------------------------------------------------------

    The other requirements of the CAA that are applicable to Apache
are:
     Standards of Performance for New Stationary Sources
(NSPS), 40 CFR part 60, subpart D;
     National Emission Standards for Hazardous Air Pollutants
(NESHAP), 40 CFR part 63, subpart UUUUU;
     Compliance Assurance Monitoring (CAM), 40 CFR part 64; and
     BART and other visibility protection requirements under
CAA section 169A and 40 CFR Part 52, subpart P.

Today's proposed revisions would not affect the applicable requirements
of the NESHAP, NSPS or CAM. Furthermore, as noted by ADEQ, a switch
from coal to gas at ST2 will result in significant reductions in
hazardous air pollutants.\44\ Therefore, we propose to find that these
revisions would not interfere with these requirements.
---------------------------------------------------------------------------

    \44\ Id. page 12.
---------------------------------------------------------------------------

    The proposed revisions would alter the applicable emission limits
for NOX, SO2 and PM10 at Apache under
CAA section 169A and 40 CFR 51.308(e). However, as explained above, the
visibility improvement expected to result from the Apache BART
Alternative for ST2 and ST3 is expected to result in greater visibility
improvement on average across all affected Class I areas compared with
BART. In addition, while there will be an increase in the
NOX limit for ST1 when operating in combined-cycle mode with
GT1, from 0.056 lb/MMbtu to 0.10 lb/MMbtu, the addition of a lb/day
limit will ensure that there will not be an increase in overall
emissions from this unit.\45\ Therefore, we propose to find that the
Apache SIP Revision would not interfere with any applicable requirement
of the CAA.
---------------------------------------------------------------------------

    \45\ Id. page 11, footnote 9.
---------------------------------------------------------------------------

IV. EPA's Proposed Action

    For the reasons described above, EPA proposes to approve the Apache
SIP Revision and withdraw the provisions of the Arizona Regional Haze
FIP that apply to Apache. We also propose to find that withdrawal of
the FIP would constitute our action on AEPCO's Petition for
Reconsideration of the FIP.

V. Statutory and Executive Order Reviews

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

    This proposed action is not a ``significant regulatory action''
under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993)
and is therefore not subject to review under Executive Orders 12866 and
13563 (76 FR 3821, January 21, 2011). This proposed rule applies to
only one facility and is therefore not a rule of general applicability.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b).

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's proposed rule on
small entities, small entity is defined as: (1) A small business as
defined by the Small Business Administration's (SBA) regulations at 13
CFR 121.201; (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a

population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field. Firms primarily engaged in the
generation, transmission, and/or distribution of electric energy for
sale are small if, including affiliates, the total electric output for
the preceding fiscal year did not exceed 4 million megawatt hours.
AEPCO sold under 3 million megawatt hours in 2013 and is therefore a
small entity.\46\
---------------------------------------------------------------------------

    \46\ Arizona's G&T Cooperatives Annual Report (2013), page 17.
---------------------------------------------------------------------------

    After considering the economic impacts of this proposed action on
small entities, I certify that this proposed action will not have a
significant economic impact on a substantial number of small entities.
The proposed approval of the SIP, if finalized, merely approves state
law as meeting Federal requirements and imposes no additional
requirements beyond those imposed by state law. See Mid-Tex Electric
Cooperative, Inc. v. FERC, 773 F.2d 327 (D.C. Cir. 1985). The proposed
FIP withdrawal would alleviate economic impacts on AEPCO and therefore
would not have a significant adverse impact on any small entity.

D. Unfunded Mandates Reform Act (UMRA)

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2
U.S.C. 1531-1538, requires Federal agencies, unless otherwise
prohibited by law, to assess the effects of their regulatory actions on
State, local, and tribal governments and the private sector. Federal
agencies must also develop a plan to provide notice to small
governments that might be significantly or uniquely affected by any
regulatory requirements. The plan must enable officials of affected
small governments to have meaningful and timely input in the
development of EPA regulatory proposals with significant Federal
intergovernmental mandates and must inform, educate, and advise small
governments on compliance with the regulatory requirements.
    This proposed rule does not contain a Federal mandate that may
result in expenditures of $100 million or more for state, local, and
tribal governments, in the aggregate, or the private sector in any one
year. Thus, this rule is not subject to the requirements of sections
202 or 205 of UMRA.
    This proposed rule is also not subject to the requirements of
section 203 of UMRA because it contains no regulatory requirements that
might significantly or uniquely affect small governments. This proposed
rule does not impose regulatory requirements on any government entity.

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 in the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132.
    In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicits comment on this proposed action
from State and local officials.

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

    Under Executive Order 13175 (65 FR 67249, November 9, 2000), EPA
may not issue a regulation that has tribal implications, that imposes
substantial direct compliance costs, and that is not required by
statute, unless the federal government provides the funds necessary to
pay the direct compliance costs incurred by tribal governments, or EPA
consults with tribal officials early in the process of developing the
proposed regulation and develops a tribal summary impact statement.
    This proposed rule does not have tribal implications, as specified
in Executive Order 13175. It will not have substantial direct effects
on tribal governments. Thus, Executive Order 13175 does not apply to
this rule. EPA specifically solicits additional comment on this
proposed rule from tribal officials.

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

    EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying
only to those regulatory actions that concern health or safety risks,
such that the analysis required under section 5-501 of the EO has the
potential to influence the regulation. This action is not subject to EO
13045 because it does not establish an environmental standard intended
to mitigate health or safety risks. This proposed action addresses
regional haze and visibility protection.

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

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is exempt under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, 12(10)(15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards (VCS) in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. VCS are technical standards
(e.g., materials specifications, test methods, sampling procedures and
business practices) that are developed or adopted by the VCS bodies.
The NTTAA directs EPA to provide Congress, through annual reports to
OMB, with explanations when the Agency decides not to use available and
applicable VCS.
    EPA believes that VCS are inapplicable to this action. Today's
action does not require the public to perform activities conducive to
the use of VCS.

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

    Executive Order 12898 (59 FR 7629, February 16, 1994), establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it increases the
level of environmental protection for all affected populations without
having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population, at a lower cost than the FIP.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Particulate
matter, Reporting and recordkeeping requirements, Sulfur dioxide,
Visibility.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: September 5, 2014.
Jared Blumenfeld,
Regional Administrator, EPA Region IX.
[FR Doc. 2014-22403 Filed 9-18-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 148 (Thursday, August 1, 2019)]
[Notices]
[Pages 37649-37651]
[FR Doc No: 2019-16384]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3049]

E8(R1) General Considerations for Clinical Studies; International
Council for Harmonisation; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``E8(R1)
General Considerations for Clinical Studies.'' The draft guidance was
prepared under the auspices of the International Council for
Harmonisation (ICH), formerly the International Conference on
Harmonisation. The draft guidance describes internationally accepted
principles and practices for the design and conduct of clinical studies
of drug and biologic products. In addition, the draft guidance provides
an overview of the types of clinical studies that may be performed and
data sources during the product's life cycle. The draft guidance is
intended to promote the quality of the studies submitted to regulatory
authorities, while allowing for flexibility.

DATES: Submit either electronic or written comments on the draft
guidance by September 30, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:

     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-3049 for ``E8(R1) General Considerations for Clinical
Studies.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Bldg., 4th Floor, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Mark Levenson,
Center for Drug Evaluation and Research, Food and Drug Administration,
Bldg. 21, Rm. 4626, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Amanda Roache, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6364, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, regulatory authorities and industry associations
from around the world have participated in many important initiatives
to promote international harmonization of regulatory requirements under
the ICH. FDA has participated in several ICH meetings designed to
enhance harmonization, and FDA is committed to seeking scientifically
based harmonized technical procedures for pharmaceutical development.
One of the goals of harmonization is to identify and reduce differences
in technical requirements for drug development among regulatory
Agencies.
    ICH was established to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; FDA; the Japanese Ministry
of Health, Labour, and Welfare; the Japanese Pharmaceutical
Manufacturers Association; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
    The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers.
The Assembly is responsible for the endorsement of draft guidelines and
adoption of final guidelines. FDA publishes ICH guidelines as FDA
guidance.
    In May 2019, the ICH Assembly endorsed the draft guideline entitled
``E8(R1) General Considerations for Clinical Studies'' and agreed that
the guideline should be made available for public comment. The draft
guideline is the product of the E8(R1) Expert Working Group of the ICH.
Comments about this draft will be considered by FDA and the E8(R1)
Expert Working Group.
    The draft revised guidance describes internationally accepted
principles and practices in the design and conduct of clinical studies
of drug and biologic products. The original ICH guidance ``E8 General
Considerations for Clinical Trials'' (available at<EMAIL_ADDRESS>was adopted in 1997 and has not undergone revision.
Since its adoption, clinical trial design and conduct have become more
complex, impacting the time and feasibility of developing drugs. In
response, the draft revised guidance directly addresses study quality
to ensure the protection of study subjects and the generation of
reliable and meaningful results, while promoting study efficiency.
E8(R1) focuses on the identification of factors that are critical to
the study quality and the

management of risks to those factors. Additionally, a wider range of
study designs and data sources play an increasingly important role in
drug development and are not adequately addressed in the original ICH
E8 guidance. Hence, the draft revised guidance addresses a broad range
of study designs and data sources. The revised guidance also provides
an updated cross-referencing to other relevant ICH guidelines that
inform the design, planning and conduct of clinical research, without
reproducing the detailed material found in those guidelines.
    This draft guidance has been left in the original ICH format. The
final guidance will be reformatted and edited to conform with FDA's
good guidance practices regulation (21 CFR 10.115) and style before
publication. The draft guidance, when finalized, will represent the
current thinking of FDA on ``E8(R1) General Considerations for Clinical
Studies.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: July 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16384 Filed 7-31-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 122 (Tuesday, June 27, 2017)]
[Notices]
[Pages 29077-29079]
[FR Doc No: 2017-13332]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9961-83-OA]

Request for Nominations of Candidates to the EPA's Clean Air
Scientific Advisory Committee (CASAC) and the EPA Science Advisory
Board (SAB)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) invites
nominations of scientific experts from a diverse range of disciplines
to be considered for appointment to the Clean Air Scientific Advisory
Committee (CASAC), the EPA Science Advisory Board (SAB), and six SAB
committees described in this notice. Appointments will be announced by
the EPA Administrator.

DATES: Nominations should be submitted in time to arrive no later than
July 27, 2017.

FOR FURTHER INFORMATION CONTACT: For information about the CASAC
membership appointment process and schedule, please contact Mr. Aaron
Yeow, DFO, by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>For information about the chartered SAB membership
appointment process and schedule, please contact Mr. Thomas Carpenter,
DFO, by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>For all other inquiries, nominators should
contact the appropriate Designated Federal Officers (DFO) for the
committees, as identified below. Anyone unable to submit electronic
nominations may send a paper copy to the appropriate DFO.

SUPPLEMENTARY INFORMATION:
    Background: The CASAC is a chartered Federal Advisory Committee,
established pursuant to the Clean Air Act (CAA) Amendments of 1977,
codified at 42 U.S.C. 7409(d)(2), to provide advice, information and
recommendations to the EPA Administrator on the scientific and
technical aspects of air quality criteria and National Ambient Air
Quality Standards (NAAQS). The SAB is a chartered Federal Advisory
Committee, established in 1978, under the authority of the
Environmental Research, Development and Demonstration Authorization Act
(ERDDAA), codified at 42 U.S.C. 4365, to provide independent scientific
and technical peer review, consultation, advice and recommendations to
the EPA Administrator on the scientific bases for EPA's actions and
programs. Members of the CASAC and the SAB constitute distinguished
bodies of non-EPA scientists, engineers, economists, and behavioral and
social scientists who are nationally and internationally recognized
experts in their respective fields. Members are appointed by the EPA
Administrator for a three-year term and serve as Special Government
Employees who provide independent expert advice to the agency.
    Additional information about the CASAC is available at http://www.epa.gov/casac and information about the SAB is available at http://www.epa.gov/sab.
    Expertise Sought for CASAC: The CASAC was established pursuant to
the Clean Air Act (CAA) Amendments of 1977, codified at 42 U.S.C.
7409(d)(2), to review air quality criteria and NAAQS and recommend to
the EPA Administrator any new NAAQS and revisions of existing criteria
and NAAQS as may be appropriate. The CASAC shall also: Advise the EPA
Administrator of areas in which additional knowledge is required to
appraise the adequacy and basis of existing, new, or revised NAAQS;
describe the research efforts necessary to provide the required
information; advise the EPA Administrator on the relative contribution
to air pollution concentrations of natural as well as anthropogenic
activity; and advise the EPA Administrator of any adverse public
health, welfare, social, economic, or energy effects which may result
from various strategies for attainment and maintenance of such NAAQS.
As required under the CAA section 109(d), the CASAC is composed of
seven members, with at least one member of the National Academy of
Sciences, one physician, and one person representing state air
pollution control agencies. Accordingly, the SAB Staff Office is
seeking nominations of experts to serve on the CASAC who are physicians
and members of the National Academy of Sciences with expertise in the
health effects of air pollution. The SAB Staff Office is especially
interested in scientists with expertise described above who have
knowledge and experience in air quality relating to criteria pollutants
(ozone, particulate matter, carbon monoxide, nitrogen oxides, sulfur
oxides, and lead). For further information about the CASAC membership
appointment process and schedule, please contact Mr. Aaron Yeow, DFO,
by telephone at<PHONE_NUMBER> or by email at<EMAIL_ADDRESS>

    Expertise Sought for the SAB: The chartered SAB provides strategic
advice to the EPA Administrator on a variety of EPA science and
research programs. All the work of SAB committees and panels is under
the direction of the chartered SAB. The chartered SAB reviews all SAB
committee and panel draft reports and determines whether they are
appropriate to send to the EPA Administrator. The SAB Staff Office is
seeking nominations of experts to serve on the chartered SAB in the
following disciplines as they relate to human health and the
environment: analytical chemistry; benefit-cost analysis; causal
inference; complex systems; ecological sciences and ecological
assessment; economics; engineering; geochemistry; health sciences;
hydrology; hydrogeology; medicine; microbiology; modeling; pediatrics;
public health; risk assessment; social, behavioral and decision
sciences; statistics; toxicology, and uncertainty analysis.
    The SAB Staff Office is especially interested in scientists in the
disciplines described above who have knowledge and experience in air
quality; agricultural sciences; atmospheric sciences; benefit-cost
analysis; complex systems; drinking water; energy and the environment;
epidemiological risk analyses; water quality; water quantity and reuse;
ecosystem services; community environmental health; sustainability;
chemical safety; green chemistry; homeland security; uncertainty
analysis; and waste management.
    For further information about the chartered SAB membership
appointment process and schedule, please contact Mr. Thomas Carpenter,
DFO, by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>    The SAB Staff Office is also seeking nominations of experts for six
SAB committees: The Chemical Assessment Advisory Committee; the
Drinking Water Committee; the Ecological Processes and Effects
Committee; the Environmental Economics Advisory Committee; the
Environmental Engineering Committee; and the Radiation Advisory
Committee.
    (1) The SAB Chemical Assessment Advisory Committee (CAAC) provides
advice through the chartered SAB regarding selected toxicological
reviews of environmental chemicals available on EPA's Integrated Risk
Information System (IRIS). The SAB Staff Office is seeking nominations
of experts with experience in chemical assessments. Members should have
expertise in one or more of the following disciplines: toxicology,
including, developmental/reproductive toxicology, and inhalation
toxicology; carcinogenesis; biostatistics; uncertainty analysis; and
risk assessment. For further information about the CAAC membership
appointment process and schedule, please contact Dr. Suhair Shallal,
DFO, by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>    (2) The SAB Drinking Water Committee (DWC) provides advice on the
scientific and technical aspects of EPA's national drinking water
program. The SAB Staff Office is seeking nominations of experts with
experience on drinking water issues. Members should have expertise in
one or more of the following disciplines: environmental engineering;
epidemiology; microbiology; public health; uncertainty analysis; and
risk assessment. For further information about the DWC membership
appointment process and schedule, please contact Mr. Thomas Carpenter,
DFO, by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>    (3) The SAB Environmental Economics Advisory Committee (EEAC)
provides advice on methods and analyses related to economics, costs,
and benefits of EPA environmental programs. The SAB Staff Office is
seeking nominations of experts in benefit-cost analysis and
environmental economics to serve on the EEAC. For further information
about the EEAC membership appointment process and schedule, please
contact Dr. Holly Stallworth, DFO, by telephone at<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>    (4) The SAB Environmental Engineering Committee (EEC) provides
advice on risk management technologies to control and prevent
pollution. The SAB Staff Office is seeking nominations of experts to
serve on the EEC with demonstrated expertise in the following
disciplines: environmental and water quality engineering; and
remediation and technology. For further information about the EEC
membership appointment process and schedule, please contact Mr. Edward
Hanlon, DFO, by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>    (5) The Radiation Advisory Committee (RAC) provides advice on
radiation protection, radiation science, and radiation risk assessment.
The SAB Staff Office is seeking nominations of experts to serve on the
RAC with demonstrated expertise in the following disciplines: radiation
carcinogenesis; radiation epidemiology; radiation exposure; radiation
health and safety; radiological risk assessment; uncertainty analysis;
and radionuclide fate and transport. For further information about the
RAC membership appointment process and schedule, please contact Mr.
Edward Hanlon, DFO, by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>    (6) The SAB Ecological Processes and Effects Committee (EPEC)
provides advice through the chartered SAB on the science and research
to assess, protect and restore the health of ecosystems. The SAB Staff
Office is seeking nominations of experts to serve on the EPEC with
demonstrated expertise in the following disciplines: aquatic ecology;
marine and estuarine ecology; ecological risk assessment; complex
systems; uncertainty analysis; ecotoxicology; and systems ecology. For
further information about the EPEC membership appointment process and
schedule, please contact Dr. Thomas Armitage, DFO, by telephone at
(202) 564-2155 or by email at<EMAIL_ADDRESS>
Selection Criteria for the CASAC, SAB and the SAB Committees

    Nominees are selected based on their individual qualifications.
Curriculum vitae should reflect the following:

--Demonstrated scientific credentials and disciplinary expertise in
relevant fields;
--Willingness to commit time to the committee and demonstrated ability
to work constructively and effectively on committees; and
--Background and experiences that would help members contribute to the
diversity of perspectives on the committee, e.g., geographical,
economic, social, cultural, educational backgrounds, professional
affiliations; and other considerations.

    For the committee as a whole, consideration of the collective
breadth and depth of scientific expertise; and a balance of scientific
perspectives is important. As these committees undertake specific
advisory activities, the SAB Staff Office will consider two additional
criteria for each new activity: Absence of financial conflicts of
interest and absence of an appearance of a loss of impartiality.
    How to Submit Nominations: Any interested person or organization
may nominate qualified persons to be considered for appointment to
these advisory committees. Individuals may self-nominate. Nominations
should be submitted in electronic format (preferred) using the online
nomination form under the ``Nomination of Experts'' category at the
bottom of the SAB home page at http://www.epa.gov/sab. To be
considered, all nominations should include the information requested

below. EPA values and welcomes diversity. All qualified candidates are
encouraged to apply regardless of sex, race, disability or ethnicity.
    Nominators are asked to identify the specific committee for which
nominees are to be considered. The following information should be
provided on the nomination form: Contact information for the person
making the nomination; contact information for the nominee; the
disciplinary and specific areas of expertise of the nominee; the
nominee's curriculum vitae; and a biographical sketch of the nominee
indicating current position, educational background; research
activities; sources of research funding for the last two years; and
recent service on other national advisory committees or national
professional organizations. To help the agency evaluate the
effectiveness of its outreach efforts, please indicate how you learned
of this nomination opportunity. Persons having questions about the
nomination process or the public comment process described below, or
who are unable to submit nominations through the SAB Web site, should
contact the DFO for the committee, as identified above. The DFO will
acknowledge receipt of nominations and in that acknowledgement will
invite the nominee to provide any additional information that the
nominee feels would be useful in considering the nomination, such as
availability to participate as a member of the committee; how the
nominee's background, skills and experience would contribute to the
diversity of the committee; and any questions the nominee has regarding
membership. The names and biosketches of qualified nominees identified
by respondents to this Federal Register notice, and additional experts
identified by the SAB Staff Office, will be posted in a List of
Candidates on the SAB Web site at http://www.epa.gov/sab. Public
comments on each List of Candidates will be accepted for 21 days from
the date the list is posted. The public will be requested to provide
relevant information or other documentation on nominees that the SAB
Staff Office should consider in evaluating candidates.
    Candidates invited to serve will be asked to submit the
``Confidential Financial Disclosure Form for Special Government
Employees Serving on Federal Advisory Committees at the U.S.
Environmental Protection Agency'' (EPA Form 3110-48). This confidential
form allows EPA to determine whether there is a statutory conflict
between that person's public responsibilities as a Special Government
Employee and private interests and activities, or the appearance of a
loss of impartiality, as defined by Federal regulation. The form may be
viewed and downloaded through the ``Ethics Requirements for Advisors''
link on the SAB home page at http://www.epa.gov/sab. This form should
not be submitted as part of a nomination.

    Dated: June 20, 2017.
Christopher S. Zarba,
Director, EPA Science Advisory Staff Office.
[FR Doc. 2017-13332 Filed 6-26-17; 8:45 am]
 BILLING CODE 6560-50-P