[Federal Register Volume 80, Number 141 (Thursday, July 23, 2015)]
[Notices]
[Pages 43779-43780]
[FR Doc No: 2015-18027]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2523]

Intent To Review a Study Data Reviewer's Guide Template

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

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SUMMARY: The Food and Drug Administration (FDA), Center for Drug
Evaluation and Research (CDER), is establishing a public docket to
collect comments related to a proposed Study Data Reviewer's Guide
(SDRG) template. As part of FDA's ongoing collaboration with the
Pharmaceutical Users Software Exchange (PhUSE), an independent, non-
profit consortium addressing computational science issues, a PhUSE
working group developed the PhUSE SRDG template. The purpose of this
review is to evaluate the template and determine whether FDA will
recommend its use either as is, or in a modified form, for regulatory
submissions of study data. FDA is seeking public comment on the use of
the PhUSE SDRG template for regulatory submissions.

DATES: Although you can comment on the PhUSE SRDG template at any time,
to ensure that the Agency considers your comments in this review,
please submit either electronic or written comments by September 21,
2015.

ADDRESSES: Submit written requests for single copies of the PhUSE SDRG
template to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests.
    Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Crystal Allard, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 1518, Silver Spring, MD 20993-0002, 301-
796-8856<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is a participating member of PhUSE, an independent, non-profit
consortium of academic, regulatory, non-profit, and private sector
entities. PhUSE provides a global platform for the discussion of topics
encompassing the work of biostatisticians, data managers, statistical
programmers, and e-clinical information technology professionals, with
the mission of providing an open, transparent, and collaborative forum
to address computational science issues. As part of this collaboration,
PhUSE working groups develop and periodically publish proposals for
enhancing the review and analysis of human and animal study data
submitted to regulatory agencies. You can learn more about PhUSE
working groups at http://www.phuse.eu/cs-working-groups.aspx.
    In December 2014, FDA published the Study Data Technical
Conformance Guide (the ``Guide,'' available at http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm), which
contains technical recommendations to sponsors for the submission of
animal and human study data and related information in a standardized
electronic format. In section 2.2 of the Guide, FDA recommends that
each submitted study contain a Study Data Reviewer's Guide containing
any special considerations or directions that may facilitate review of
the study data. FDA notes in the Guide that the PhUSE SDRG template is
an example of how to create an SDRG, but does not specifically
recommend its use.
    FDA now intends to review the PhUSE SDRG template, a deliverable of
the working group effort described above, with the potential result
that FDA could recommend the use of the template in its current form,
or in a modified form, for use in the regulatory submission of study
data in conformance with the Guide. FDA invites public comment on all
matters regarding the use of the PhUSE SDRG template. Interested
persons may submit either electronic comments to http://www.regulations.gov or written comments to the Division of Dockets
Management (see ADDRESSES). It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.

II. Electronic Access

    The PhUSE SDRG template is available online at http://www.phusewiki.org/wiki/index.php?title=Study_Data_Reviewer's_Guide.

    Dated: July 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18027 Filed 7-22-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: September 2, 2010 (Volume 75, Number 170)]
[Proposed Rules]
[Page 53883-53892]
[DOCID:fr02se10-22]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-HQ-OAR-2010-0107; FRL-9190-8]
RIN-2060-AQ45

Action To Ensure Authority To Issue Permits Under the Prevention
of Significant Deterioration Program to Sources of Greenhouse Gas
Emissions: Federal Implementation Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: In this rulemaking, EPA is proposing a Federal implementation
plan (FIP) to apply in any State that is unable to submit, by its
deadline, a corrective State implementation plan (SIP) revision to
ensure that the State has authority to issue permits under the Clean
Air Act's (CAA or Act) New Source Review Prevention of Significant
Deterioration (PSD) program for sources of greenhouse gases (GHGs).
This proposal is a companion rulemaking to ``Action to Ensure Authority
to Issue Permits Under the Prevention of Significant Deterioration
Program to Sources of Greenhouse Gas Emissions: Finding of Substantial
Inadequacy and SIP Call,'' which is being signed and published on the
same schedule. In that action, EPA is proposing to make a finding of
substantial inadequacy and proposing to issue a SIP call for 13 States
on grounds that their SIPs do not appear to apply the PSD program to
GHG-emitting sources.

DATES: Comments. Comments must be received on or before October 4,
2010.
    Public Hearing: One public hearing concerning the proposed
regulation will be held. The date, time and location will be announced
separately. Please refer to SUPPLEMENTARY INFORMATION for additional
information on the comment period and the public hearing.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2010-0107 by one of the following methods:
     www.regulations.gov: Follow the online instructions for
submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>
     Mail: Attention Docket ID No. EPA-HQ-OAR-2010-0107, U.S.
Environmental Protection Agency, EPA West (Air Docket), 1200
Pennsylvania Avenue, NW., Mail code: 6102T, Washington, DC 20460.
Please include a total of 2 copies.
     Hand Delivery: U.S. Environmental Protection Agency, EPA
West (Air Docket), 1301 Constitution Avenue, Northwest, Room 3334,
Washington, DC 20004, Attention Docket ID No. EPA-HQ-OAR-2010-0107.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2010-0107. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. 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 e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail 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, 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 avoid
the use of special characters, avoid any form of encryption, and be
free of any defects or viruses. For additional information about EPA's
public docket, visit the EPA Docket Center homepage at http://
www.epa.gov/epahome/dockets.htm. For additional instructions on
submitting comments, go to section I.C of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket. All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the U.S. Environmental
Protection Agency, Air Docket, EPA/DC, EPA West Building, Room 3334,
1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is
open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number for the Public Reading Room is
(202) 566-1744, and the telephone number for the Air Docket is (202)
566-1742.

FOR FURTHER INFORMATION CONTACT: Ms. Lisa Sutton, Air Quality Policy
Division, Office of Air Quality Planning and

Standards (C504-03), Environmental Protection Agency, Research Triangle
Park, NC 27711; telephone number:<PHONE_NUMBER>; fax number: (919)
541-5509; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: For questions related to a specific State,
local, or tribal permitting authority, or to submit information
requested in this action, please contact the appropriate EPA regional
office:

----------------------------------------------------------------------------------------------------------------
                                      Contact for regional office (person,
      EPA regional  office             mailing address, telephone number)             Permitting authority
----------------------------------------------------------------------------------------------------------------
I...............................  Dave Conroy, Chief, Air Programs Branch,     Connecticut, Massachusetts,
                                   EPA Region 1, 5 Post Office Square, Suite    Maine, New Hampshire, Rhode
                                   100, Boston, MA 02109-3912,<PHONE_NUMBER>.  Island, and Vermont.
II..............................  Raymond Werner, Chief, Air Programs Branch,  New Jersey, New York, Puerto
                                   EPA Region 2, 290 Broadway, 25th Floor,      Rico, and Virgin Islands.
                                   New York, NY 10007-1866,<PHONE_NUMBER>.
III.............................  Kathleen Anderson, Chief, Permits and        District of Columbia, Delaware,
                                   Technical Assessment Branch, EPA Region 3,   Maryland, Pennsylvania,
                                   1650 Arch Street, Philadelphia, PA 19103-    Virginia, and West Virginia.
                                   2029,<PHONE_NUMBER>.
IV..............................  Dick Schutt, Chief, Air Planning Branch,     Alabama, Florida, Georgia,
                                   EPA Region 4, Atlanta Federal Center, 61     Kentucky, Mississippi, North
                                   Forsyth Street, SW., Atlanta, GA 30303-      Carolina, South Carolina, and
                                   3104,<PHONE_NUMBER>.                        Tennessee.
V...............................  J. Elmer Bortzer, Chief, Air Programs        Illinois, Indiana, Michigan,
                                   Branch (AR-18J), EPA Region 5, 77 West       Minnesota, Ohio, and Wisconsin.
                                   Jackson Boulevard, Chicago, IL 60604-3507,
<PHONE_NUMBER>.
VI..............................  Jeff Robinson, Chief, Air Permits Section,   Arkansas, Louisiana, New Mexico,
                                   EPA Region 6, Fountain Place 12th Floor,     Oklahoma, and Texas.
                                   Suite 1200, 1445 Ross Avenue, Dallas, TX
                                   75202-2733,<PHONE_NUMBER>.
VII.............................  Mark Smith, Chief, Air Permitting and        Iowa, Kansas, Missouri, and
                                   Compliance Branch, EPA Region 7, 901 North   Nebraska.
                                   5th Street, Kansas City, KS 66101, (913)
                                   551-7876.
VIII............................  Carl Daly, Unit Leader, Air Permitting,      Colorado, Montana, North Dakota,
                                   Monitoring & Modeling Unit, EPA Region 8,    South Dakota, Utah, and Wyoming.
                                   1595 Wynkoop Street, Denver, CO 80202-
                                   1129,<PHONE_NUMBER>.
IX..............................  Gerardo Rios, Chief, Permits Office, EPA     Arizona; California; Hawaii and
                                   Region 9, 75 Hawthorne Street, San           the Pacific Islands; Indian
                                   Francisco, CA 94105,<PHONE_NUMBER>.         Country within Region 9 and
                                                                                Navajo Nation; and Nevada.
X...............................  Nancy Helm, Manager, Federal and Delegated   Alaska, Idaho, Oregon, and
                                   Air Programs Unit, EPA Region 10, 1200       Washington.
                                   Sixth Avenue, Suite 900, Seattle, WA
                                   98101,<PHONE_NUMBER>.
----------------------------------------------------------------------------------------------------------------

I. General Information

A. Does this action apply to me?

    Entities potentially affected by this rule include States, local
permitting authorities, and tribal authorities.\1\ Any SIP-approved PSD
air permitting regulation that is not structured such that it includes
GHGs among pollutants subject to regulation under the Act will
potentially be found substantially inadequate to meet CAA requirements,
under CAA section 110(k)(5), and the State will potentially be affected
by this rule. For example, if a State's PSD regulation identifies its
regulated NSR pollutants by specifically listing each individual
pollutant and the list omits GHGs, then the regulation is inadequate.
---------------------------------------------------------------------------

    \1\ EPA respects the unique relationship between the U.S.
government and tribal authorities and acknowledges that tribal
concerns are not interchangeable with State concerns. However, for
convenience, we refer to ``State'' in this rulemaking to
collectively mean State, local permitting authorities, and tribal
authorities.
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    Entities potentially affected by this rule also include sources in
all industry groups, which have a direct obligation under the CAA to
obtain a PSD permit for GHGs for projects that meet the applicability
thresholds set forth in the Tailoring Rule.\2\ This independent
obligation on sources is specific to PSD and derives from CAA section
165(a). Any source that is subject to a State PSD air permitting
regulation not structured to apply to GHG-emitting sources will
potentially rely on this rule to obtain a permit that contains emission
limitations that conform to requirements under CAA section 165(a). The
majority of entities potentially affected by this action are expected
to be in the following groups:
---------------------------------------------------------------------------

    \2\ Prevention of Significant Deterioration and Title V
Greenhouse Gas Tailoring Rule; Final Rule. 75 FR 31514 (June 3,
2010). The Tailoring Rule is described in more detail later in this
preamble.

------------------------------------------------------------------------
             Industry group                         NAICS \a\
------------------------------------------------------------------------
Utilities (electric, natural gas, other  2211, 2212, 2213.
 systems).
Manufacturing (food, beverages,          311, 312, 313, 314, 315, 316.
 tobacco, textiles, leather).
Wood product, paper manufacturing......  321, 322.
Petroleum and coal products              32411, 32412, 32419.
 manufacturing.
Chemical manufacturing.................  3251, 3252, 3253, 3254, 3255,
                                          3256, 3259.
Rubber product manufacturing...........  3261, 3262.
Miscellaneous chemical products........  32552, 32592, 32591, 325182,
                                          32551.
Nonmetallic mineral product              3271, 3272, 3273, 3274, 3279.
 manufacturing.
Primary and fabricated metal             3311, 3312, 3313, 3314, 3315,
 manufacturing.                           3321, 3322, 3323, 3324, 3325,
                                          3326, 3327, 3328, 3329.
Machinery manufacturing................  3331, 3332, 3333, 3334, 3335,
                                          3336, 3339.
Computer and electronic products         3341, 3342, 3343, 3344, 3345,
 manufacturing.                           4446.
Electrical equipment, appliance, and     3351, 3352, 3353, 3359.
 component manufacturing.
Transportation equipment manufacturing.  3361, 3362, 3363, 3364, 3365,
                                          3366, 3366, 3369.
Furniture and related product            3371, 3372, 3379.
 manufacturing.
Miscellaneous manufacturing............  3391, 3399.

Waste management and remediation.......  5622, 5629.
Hospitals/nursing and residential care   6221, 6231, 6232, 6233, 6239.
 facilities.
Personal and laundry services..........  8122, 8123.
Residential/private households.........  8141.
Non-residential (commercial)...........  Not available. Codes only exist
                                          for private households,
                                          construction and leasing/sales
                                          industries.
------------------------------------------------------------------------
\a\ North American Industry Classification System.

B. 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 proposal will also be available on the World Wide Web. Following
signature by the EPA Administrator, a copy of this notice will be
posted on the EPA's NSR Web site, under Regulations & Standards, at
http://www.epa.gov/nsr.

C. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of
the information that you claim to be 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 then 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, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2. Send or deliver information
identified as CBI only to the following address: Roberto Morales, OAQPS
Document Control Officer (C404-02), U.S. EPA, Research Triangle Park,
NC 27711, Attention Docket ID No. EPA-HQ-OAR-2010-0107.
    2. Tips for preparing your comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section 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 comment period
deadline identified.

D. How can I find information about the public hearing?

    The EPA will hold one public hearing on this proposal. The date,
time, and location of the public hearing will be announced separately.
The EPA encourages commenters to provide written versions of their oral
testimonies either electronically or in paper copy. If you would like
to present oral testimony at the public hearing, please notify Ms.
Pamela S. Long, New Source Review Group, Air Quality Policy Division
(C504-03), U.S. EPA, Research Triangle Park, NC 27711, telephone number
(919) 541-0641, or e-mail<EMAIL_ADDRESS>Persons interested in
presenting oral testimony should notify Ms. Long at least 2 days in
advance of the public hearing. Persons interested in attending the
public hearing should also contact Ms. Long to verify the time, date,
and location of the hearing. The public hearing will provide interested
parties the opportunity to present data, views, or arguments concerning
the proposed rule.

E. How is the preamble organized?

    The information presented in this preamble is organized as follows:

I. General Information
    A. Does this action apply to me?
    B. Where can I get a copy of this document and other related
information?
    C. What should I consider as I prepare my comments for EPA?
    D. How can I find information about the public hearing?
    E. How is the preamble organized?
II. Background and Context of Proposed Rule
    A. Introduction
    B. CAA and Regulatory Context
    C. SIP Inadequacy and Corrective Action; Federal Implementation
Plans
    D. States That Do Not Appear To Apply the PSD Program to GHG
Sources; PSD GHG SIP Call
III. Proposed Federal Implementation Plan
    A. Timing for FIP
    B. Substance of FIP
    C. Primacy of the SIP Process
IV. Statutory and Executive Order Reviews
    A. Executive Order 12866--Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform
    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
    J. Executive Order 12898--Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Determination Under Section 307(d)
V. Statutory Authority

II. Background and Context of Proposed Rule

A. Introduction

    In this rulemaking under the CAA, EPA is proposing a FIP for 13
States for which, in a companion action, EPA is proposing a finding of
SIP substantial inadequacy and is proposing to issue a SIP Call because
the States' PSD SIP programs do not appear to apply to sources of GHGs.
``Action to Ensure Authority to Issue Permits Under the Prevention of
Significant Deterioration Program to Sources of Greenhouse Gas
Emissions: Finding of Substantial Inadequacy and SIP Call'' (the ``PSD
GHG SIP Call'' or ``SIP Call''). These two rulemakings address States
whose permitting regulations and SIPs appear to fail to apply the PSD
program to sources of GHGs in those States. As discussed further in
this preamble, certain larger GHG-emitting sources will be subject to
PSD permitting requirements on and after January 2, 2011. Thus, in
States whose PSD programs do not apply to sources of GHGs, sources will
be unable to obtain

a PSD permit that covers GHG emissions and therefore potentially unable
to undertake construction or modification projects on and after January
2, 2011.
    The States for which we are proposing a FIP are listed in table II-
1, ``States with SIPs That Do Not Appear To Apply PSD to GHG Sources
(Presumptive SIP Call List).'' If any of these States are not in a
position to submit to EPA a corrective SIP revision by its deadline,
EPA will promulgate a FIP that will provide authority to issue PSD
permits for construction or modification of appropriate GHG sources in
the State.

   Table II-1--States With SIPs That Do Not Appear To Apply PSD to GHG
                   Sources (Presumptive SIP Call List)
------------------------------------------------------------------------
                State (or area)                        EPA  region
------------------------------------------------------------------------
Alaska........................................  X
Arizona: Pinal County; Rest of State (Excludes  IX
 Maricopa County, Pima County, and Indian
 Country).
Arkansas......................................  VI
California: Sacramento Metropolitan AQMD......  IX
Connecticut...................................  I
Florida.......................................  IV
Idaho.........................................  X
Kansas........................................  VII
Kentucky: Jefferson County; Rest of State.....  IV
Nebraska......................................  VII
Nevada: Clark County..........................  IX
Oregon........................................  X
Texas.........................................  VI
------------------------------------------------------------------------

    The rest of the States with approved SIP PSD programs (meaning each
of those not listed in table II-1) are listed in table II-2, ``States
with SIPs that Appear to Apply PSD to GHG Sources (Presumptive Adequacy
List).'' For each of the States listed in table II-2 (as well as for
any States with approved SIP PSD programs that we may have
inadvertently omitted from table II-2), EPA is soliciting comment in
the SIP Call companion notice on whether their SIPs do or do not apply
the PSD program to GHG-emitting sources. We are not at this time
proposing a FIP for the States listed in table II-2. However, if EPA
concludes, on the basis of information EPA receives, that such a
State's SIP does not apply the PSD program to GHG-emitting sources,
then EPA will proceed to issue for that State a finding of substantial
inadequacy and a SIP Call on the same schedule as for the States listed
in table II-1 (the presumptive SIP Call list). If a SIP-called State is
not able to submit to EPA a SIP revision that applies the PSD program
to GHG sources by the deadline required in the SIP Call, then EPA
proposes to promulgate a FIP without further notice and comment. The
promulgated FIP will apply the PSD program to GHG sources in the State
and provide PSD permitting authority for construction and modification
of affected sources. Accordingly, interested parties in a State for
which we, in the companion SIP Call rulemaking, solicit comment on the
adequacy of its SIP to apply PSD to GHG-emitting sources should
consider the comment period for the present notice to be their
opportunity to comment on the FIP that EPA would implement in their
State (should EPA ultimately determine to issue a SIP Call for their
State in EPA's final action on the companion SIP Call rulemaking).

  Table II-2--States With SIPs That Appear To Apply PSD to GHG Sources
                       (Presumptive Adequacy List)
------------------------------------------------------------------------
                State (or area)                        EPA  region
------------------------------------------------------------------------
Alabama: Jefferson County; Huntsville; Rest of  IV
 State.
California: Mendocino County AQMD; Monterey     IX
 Bay Unified APCD; North Coast Unified AQMD;
 Northern Sonoma County APCD.
Colorado......................................  VIII
Delaware......................................  III
Georgia.......................................  IV
Indiana.......................................  V
Iowa..........................................  VII
Louisiana.....................................  VI
Maine.........................................  I
Maryland......................................  III
Michigan......................................  V
Mississippi...................................  IV
Missouri......................................  VII
Montana.......................................  VIII
New Hampshire.................................  I
New Mexico: Albuquerque; Rest of State........  VI
North Carolina: Forsythe County; Mecklenburg;   IV
 Western NC; Rest of State.
North Dakota..................................  VIII
Ohio..........................................  V
Oklahoma......................................  VI
Pennsylvania: All except Allegheny County.....  III
Rhode Island..................................  I
South Carolina................................  IV

South Dakota..................................  VIII
Tennessee: Chattanooga; Nashville; Knoxville;   IV
 Memphis; Rest of State.
Vermont.......................................  I
Virginia......................................  III
West Virginia.................................  III
Wisconsin.....................................  V
Wyoming.......................................  VIII
Utah..........................................  VIII
------------------------------------------------------------------------

    The background and context for this proposed rule is the same as
for the proposed PSD GHG SIP Call and other actions cross-referenced in
that action. Familiarity with the proposed PSD GHG SIP Call is
presumed. As a result, the background and context for this rule will be
only briefly summarized here.

B. CAA and Regulatory Context

1. SIP PSD Requirements
    Under the CAA PSD requirements, a new or existing source that emits
or has the potential to emit ``any air pollutant'' in specified
quantities cannot construct or modify unless it first obtains a PSD
permit that, among other things, imposes emission limitations that
qualify as best available control technology (BACT). CAA sections
165(a)(1), 165(a)(4), 169(1). Longstanding EPA regulations have
interpreted the term ``any air pollutant'' narrowly so that only
emissions of any ``regulated NSR pollutant'' trigger PSD. 40 CFR
52.21(j)(2), (b)(50)(iv). The term ``regulated NSR pollutant'' is
defined to include the following four classes of air pollutants:
    (i) any pollutant for which a NAAQS has been promulgated;
    (ii) any pollutant subject to an NSPS promulgated under CAA 111;
    (iii) any pollutant subject to a standard promulgated under CAA
title VI; and
    (iv) ``any pollutant that otherwise is subject to regulation under
the Act'' (excluding HAPs listed under CAA section 112).
    The CAA contemplates that the PSD program be implemented in the
first instance by the States. States are required to include PSD
requirements in their SIPs. CAA section 110(a)(2)(C). Most States have
PSD programs that have been approved into their SIPs, and these States
implement their PSD program and act as the permitting authority. For
the most part, these approved SIPs mirror EPA regulatory requirements,
as found in 40 CFR 51.166 (except for the recently added revisions from
the Tailoring Rule). As a result, most SIPs include the applicability
requirement that PSD apply to sources that construct or modify and
thereby increase their emissions of any ``regulated NSR pollutant.'' A
number of States do not have PSD programs approved into their SIPs; in
those States, EPA's regulations at 40 CFR 52.21 govern, and either EPA
or the State as EPA's delegatee acts as the permitting authority.
2. Recent EPA Regulatory Actions Concerning PSD Requirements for GHG-
emitting Sources
    Beginning on January 2, 2011, certain stationary sources that
construct or undertake modifications will become subject to the CAA
requirement to obtain a PSD permit for their GHG emissions. This is
because of the following EPA regulatory actions.
    By notice dated December 15, 2009, pursuant to CAA section 202(a),
EPA issued, in a single final action, two findings \3\ regarding GHGs
that are commonly referred to as the ``Endangerment Finding'' and the
``Cause or Contribute Finding.'' In the Endangerment Finding, EPA found
that six long-lived and directly emitted GHGs--carbon dioxide
(CO2), methane (CH4), nitrous oxide
(N2O), hydrofluorocarbons (HFCs), perfluorocarbons (PFCs),
and sulfur hexafluoride (SF6)--may reasonably be anticipated
to endanger public health and welfare. In the Cause or Contribute
Finding, the Administrator ``define[d] the air pollutant as the
aggregate group of the same six * * * greenhouse gases,'' 74 FR 66536,
and found that the combined emissions of this air pollutant from new
motor vehicles and new motor vehicle engines contribute to the GHG air
pollution that endangers public health and welfare.
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    \3\ ``Endangerment and Cause or Contribute Findings for
Greenhouse Gases Under Section 202(a) of the Clean Air Act.'' 74 FR
66496.
---------------------------------------------------------------------------

    By notice dated May 7, 2010, EPA published what is commonly known
as the ``Light-Duty Vehicle Rule'' (LDVR),\4\ which for the first time
established Federal controls on GHGs, those emitted from light-duty
vehicles. This rule specifies, in its applicability provisions, the air
pollutant subject to control as the aggregate group of the six GHGs,
including CO2, CH4, N2O, HFCs, PFCs,
and SF6. 75 FR 25686 (40 CFR 86.1818-12(a)).
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    \4\ ``Light-Duty Vehicle Greenhouse Gas Emission Standards and
Corporate Average Fuel Economy Standards; Final Rule,'' 75 FR 25324
(May 7, 2010).
---------------------------------------------------------------------------

    By notice dated April 2, 2010, EPA promulgated what is commonly
known as the Johnson Memo Reconsideration.\5\ The Johnson Memo
Reconsideration interpreted one of the regulatory triggers for PSD
applicability--the term ``subject to regulation''--and concluded that
promulgation of the LDVR would render GHGs ``subject to regulation''
and thereby trigger PSD applicability for GHG-emitting sources on
January 2, 2011, which according to EPA is the date upon which the LDVR
takes effect.
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    \5\ ``Interpretation of Regulations that Determine Pollutants
Covered by Clean Air Act Permitting Programs'' (75 FR 17004; April
2, 2010) (finalizing EPA response to petition for reconsideration of
``EPA's Interpretation of Regulations that Determine Pollutants
Covered by Federal Prevention of Significant Deterioration (PSD)
Permit Program'' (commonly known as the ``Johnson Memo''), December
18, 2008).
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    By notice dated June 3, 2010, EPA published what is commonly known
as the ``Tailoring Rule,''\6\ which limits the applicability of PSD to
certain GHG-emitting sources through a multi-step phase-in approach. In
the Tailoring Rule, EPA established the first two steps of the phase-in
approach as follows:
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    \6\ ``Prevention of Significant Deterioration and Title V
Greenhouse Gas Tailoring Rule; Final Rule,'' 75 FR 31514.

    For the first step of this Tailoring Rule, which will begin on
January 2, 2011, PSD * * * requirements will apply to sources' GHG
emission only if the sources are subject to PSD * * * anyway due to
their non-GHG pollutants. [We call these sources ``anyway
sources.''] Therefore, EPA will not require sources or modifications
to evaluate whether they are subject to PSD * * * requirements
solely on account of their GHG emissions.

Specifically, for PSD, Step 1 requires that as of January 2, 2011,
the applicable requirements of PSD, most notably, the best available
control technology (BACT) requirement, will apply to projects that
increase net GHG emissions by at least 75,000 tpy carbon dioxide
equivalent (CO2e) but only if the project also
significantly increase emissions of at least one non-GHG pollutant.
    The second step * * * beginning on July 1, 2011, will phase in
additional large sources of GHG emissions. New sources * * * that
emit, or have the potential to emit, at least 100,000 tpy
CO2e will become subject to the PSD * * * requirements.
In addition, sources that emit or have the potential to emit at
least 100,000 tpy CO2e and that undertake a modification
that increases net emissions of GHGs by at least 75,000 tpy
CO2e will also be subject to PSD requirements. [We call
this the 100,000/75,000 threshold.] For both steps, we note that if
sources or modifications exceed these CO2e-adjusted GHG
triggers, they are not covered by permitting requirements unless
their GHG emissions also exceed the corresponding mass-based
triggers (i.e., unadjusted for CO2e.)

    75 FR 31516. In the Tailoring Rule, EPA codified the Johnson Memo
Reconsideration interpretation of the term ``subject to regulation''
and added a further interpretation of that term designed to expedite
the adoption of the phase-in approach by the States into their SIPs. In
addition, in the Tailoring Rule, EPA identified the air pollutant as
the aggregate of the six GHGs, again, CO2, CH4,
N2O, HFCs, PFCs, and SF6. The Tailoring Rule
further provided that for purposes of determining whether the amount of
GHG emissions exceeds specified thresholds and therefore triggers the
application of PSD, the amount of emissions must be calculated on both
a mass basis and, as alluded to above, a carbon dioxide equivalent
(CO2e) basis. With respect to the latter, according to the
rule, ``PSD * * * applicability is based on the quantity that results
when the mass emissions of each of these gases is multiplied by the
Global Warming Potential (GWP) of that gas, and then summed for all six
gases.'' 75 FR 31518.
    Further information on the applicable CAA provisions, the
Endangerment and Cause or Contribute Findings, the LDRV, the Johnson
Memo Reconsideration, and the Tailoring Rule is contained in the
Tailoring Rule and the proposed PSD GHG SIP Call.
    We note that in this rulemaking we are not addressing the issue of
accounting for emissions of GHGs from bioenergy and other biogenic
sources (which are generated during the combustion or decomposition of
biologically based material such as forest or agriculture products).
When we finalized the Tailoring Rule, we noted that EPA planned to seek
comment on how to address emissions of biogenic CO2 under
the PSD and title V programs through future action, such as a separate
Advance Notice of Proposed Rulemaking (ANPR) (75 FR at 31591). As a
first step, we recently issued a Call for Information (CFI) to solicit
public comment and data on technical issues that might be used to
consider biomass fuels and the emissions resulting from their
combustion differently with regard to applicability under PSD and with
regard to the BACT review process under PSD. See ``Call for
Information: Information on Greenhouse Gas Emissions Associated with
Bioenergy and Other Biogenic Sources,'' 75 FR 41173 (July 15, 2010).
    Additional information on this CFI is available at http://
www.epa.gov/climatechange/emissions/biogenic_emissions.html. In the
CFI we stated: ``In response to this Call for Information, interested
parties are invited to assist EPA in the following: (1) Surveying and
assessing the science by submitting research studies or other relevant
information, and (2) evaluating different accounting approaches and
options by providing policy analyses, proposed or published
methodologies, or other relevant information. Interested parties are
also invited to submit data or other relevant information about the
current and projected scope of GHG emissions from bioenergy and other
biogenic sources.'' 75 FR at 41174.
    Without prejudging the outcome of the CFI process, EPA anticipates
that the comments we receive in response to the CFI, with regard to
applicability under PSD and with regard to the BACT review process
under PSD, will inform any subsequent actions to address applicability
of emissions of GHGs from bioenergy and other biogenic sources under
the PSD program.

C. SIP Inadequacy and Corrective Action; Federal Implementation Plans

    The CAA provides a mechanism for the correction of SIPs that are
inadequate, under CAA section 110(k)(5), which provides:

    (5) Calls for plan revisions
    Whenever the Administrator finds that the applicable
implementation plan for any area is substantially inadequate to * *
* comply with any requirement of this Act, the Administrator shall
require the State to revise the plan as necessary to correct such
inadequacies. The Administrator shall notify the State of the
inadequacies and may establish reasonable deadlines (not to exceed
18 months after the date of such notice) for the submission of such
plan revisions.

    This provision by its terms authorizes the Administrator to
``find[] that [a SIP] * * * is substantially inadequate to * * * comply
with any requirement of this Act,'' and, based on that finding,
``require the State to revise the [SIP] * * * to correct such
inadequacies.'' This latter action is commonly known as a ``SIP call.''
In addition, this provision provides that EPA must notify the State of
the inadequacies and authorizes EPA to establish a ``reasonable
deadline[] (not to exceed 18 months after the date of such notice)''
for the submission of the corrective SIP revision.
    If the State fails to submit the corrective SIP revision by the
deadline, CAA section 110(c) authorizes EPA to ``find[] that [the]
State has failed to make a required submission.'' CAA section
110(c)(1)(A). Once EPA makes that finding, CAA section 110(c)(1)
requires EPA to ``promulgate a Federal implementation plan at any time
with 2 years after the [finding] * * * unless the State corrects the
deficiency, and [EPA] approves the plan or plan revision, before [EPA]
promulgates such [FIP].''

D. States That Do Not Appear To Apply the PSD Program to GHG Sources;
PSD GHG SIP Call

    A number of States do not have an approved PSD SIP; as a result, in
these States \7\ the applicable regulatory authority is EPA's
regulations, found in 40 CFR 52.21, which constitute a FIP. For sources
in these States, either the EPA Regional Office or the State acting as
EPA's delegatee is the permitting authority. In these States, EPA's
regulations apply directly. As a result, the regulations apply the PSD
program to any constructing or modifying source that emits the
requisite quantity of any ``regulated NSR pollutant,'' 40 CFR
52.21(b)(50), which includes any ``pollutant subject to regulation,''
which, in turn, as discussed earlier in this preamble, will cover GHG
emissions on January 2, 2011.
---------------------------------------------------------------------------

    \7\ In the following listed State or local jurisdictions, as
well as in all Indian country, EPA is the PSD permitting authority,
implementing the Federal PSD regulation at 40 CFR 52.21: American
Samoa; Arizona (some areas); California (most areas); District of
Columbia; Guam; Massachusetts; New Jersey; New York; Northern
Mariana Islands; Puerto Rico; Trust Territories; and the Virgin
Islands. In a smaller number of areas, listed as follows, the State
or local permitting authority is delegated at least partial
authority by EPA to implement the Federal PSD regulation: Arizona
(some areas); California (some areas); Hawaii; Illinois; Minnesota;
Nevada (most areas); Pennsylvania (some areas); and Washington.
---------------------------------------------------------------------------

    All of the other States administer their PSD programs through an
approved SIP and, as a result, they or their local

entities are the PSD permitting authority. Of these States, most appear
to have SIP PSD applicability provisions that parallel EPA's regulatory
PSD applicability provisions and therefore apply PSD to any stationary
source that emits the requisite amount of any air pollutant ``subject
to regulation.'' As a result, and absent any other provision under
State law that limits the applicability of these provisions, these PSD
SIPs will cover GHG sources, just as the current FIPs do, in these
States, on and after January 2, 2011. Therefore, these States or local
authorities will be able to act as the permitting authority for GHG
sources in their States.
    As discussed in the PSD GHG SIP Call, it appears, on the basis of
preliminary research and information received that for 13 of the States
with approved PSD SIPs, the PSD programs do not apply to GHG-emitting
sources. In many of these SIPs, the PSD applicability provisions do not
mirror EPA's regulatory provisions by applying PSD requirements to
sources of any air pollutant ``subject to regulation.'' Instead, the
applicability provisions specifically list the air pollutants to which
the PSD program applies and do not include GHGs on that list. Although,
as discussed in the proposed PSD GHG SIP Call, these SIPs may have
other provisions that provide the State with general authority to issue
permits that meet CAA requirements, until EPA receives more
information, we will proceed on the basis that these SIPs do not apply
their PSD programs to GHG sources. Also as discussed in the proposed
SIP Call, the State of Connecticut explicitly excludes GHGs from the
State PSD program. In addition, as discussed in the proposed SIP Call,
some States with SIP PSD applicability provisions that do mirror EPA's
regulatory provisions by applying PSD requirements to sources of any
air pollutant ``subject to regulation'' nevertheless do not appear to
apply PSD to GHG-emitting sources because these States have other State
law constraints against applying State law or SIP requirements without
specific State action authorizing such application of law.
    In the SIP Call, EPA proposed to find the SIPs for these 13 States
to be substantially inadequate, and EPA proposed a SIP Call under CAA
section 110(k)(5). EPA stated that it intends to finalize the finding
of substantial inadequacy and the SIP Call by December 1, 2010. EPA
further stated that it would allow States 12 months from the date of
signing the finding and the SIP Call for States to submit their
corrective SIP revisions, but that States could indicate to EPA that
they do not object to a shorter deadline, and in that event EPA would
impose that shorter deadline.
    In the proposed SIP Call, EPA also solicited comment on whether the
approved SIPs for those other States (listed in table II-2 of this
preamble, for which EPA was not proposing a SIP Call) do or do not
apply their PSD programs to GHG-emitting sources. EPA asked the other
States to review their SIPs and, if their SIPs fail to apply PSD to
GHG-emitting sources, advise EPA by the end of the comment period of
the State's inadequacy and also inform EPA if they do not object to a
shorter deadline for submittal of the required corrective SIP revision.
    In the proposed SIP Call, we stated that the required corrective
SIP revision could constitute a simple addition of GHGs to the list of
pollutants subject to PSD applicability, with GHGs defined as the
aggregate of six pollutants--CO2, CH4,
N2O, HFCs, PFCs, and SF6.

III. Proposed Federal Implementation Plan

    In this rulemaking, we propose a FIP, under CAA section
110(c)(1)(A), for any State--if ultimately there is any--for which we
issue a finding of failure to submit a SIP submission required under
the PSD GHG SIP Call.

A. Timing for FIP

    If any of the States for which we issue the SIP Call does not meet
its SIP submittal deadline, we will immediately issue a finding of
failure to submit a required SIP submission, under CAA section
110(c)(1)(A), and immediately thereafter promulgate a FIP for the
State. This timing for FIP promulgation is authorized under CAA section
110(c)(1), which authorizes us to promulgate a FIP ``at any time within
2 years after'' finding a failure to submit a required SIP submission.
We intend to take these actions immediately in order to minimize any
period of time during which larger-emitting sources may be under an
obligation to obtain PSD permits for their GHGs when they construct or
modify, but no permitting authority is authorized to issue those
permits.
    After we have promulgated a FIP, it must remain in place until the
State submits a SIP revision and we approve that SIP revision. CAA
section 110(c)(1). Under the present circumstances, we will act on a
SIP revision to apply the PSD program to GHG sources as quickly as
possible. Upon request of the State, we will parallel-process the SIP
submittal. That is, if the State submits to us the draft SIP submittal
for which the State intends to hold a hearing, we will propose the
draft SIP submittal for approval and open a comment period during the
same time as the State hearing. If the SIP submittal that the State
ultimately submits to us is substantially similar to the draft SIP
submittal, we will proceed to take final action without a further
proposal or comment period. If we approve such a SIP revision, we will
at the same time rescind the FIP.

B. Substance of FIP

    The proposed FIP constitutes the EPA regulations found in 40 CFR
52.21, including the PSD applicability provisions, with a limitation to
assure that, strictly for purposes of this rulemaking, the FIP applies
only to GHGs. Under the PSD applicability provisions in 40 CFR
52.21(b)(50), the PSD program applies to sources that emit the
requisite amounts of any ``regulated NSR pollutant[s],'' including any
air pollutant ``subject to regulation.'' However, in States for which
EPA would promulgate a FIP to apply PSD to GHG-emitting pollutants, the
approved SIP already applies PSD to other air pollutants. To
appropriately limit the scope of the FIP, EPA proposes in this action
to amend 40 CFR 52.21(b)(50) to limit the applicability provision to
GHGs.
    We propose this FIP because it would, to the greatest extent
possible, mirror EPA regulations (as well as those of most of the
States). In addition, this FIP would readily incorporate the phase-in
approach for PSD applicability to GHG sources that EPA has developed in
the Tailoring Rule and expects to develop further through additional
rulemaking. As explained in the Tailoring Rule, incorporating this
phase-in approach--including Steps 1 and 2 of the phase-in as
promulgated in the Tailoring Rule--can be most readily accomplished
through interpretation of the terms in the definition ``regulated NSR
pollutant,'' including the term ``subject to regulation.''
    In accordance with the Tailoring Rule, as described earlier in this
preamble, the FIP would apply in Step 1 of the phase-in approach only
to ``anyway sources'' (that is, sources undertaking construction or
modification projects that are required to apply for PSD permits anyway
due to their non-GHG emissions and that emit GHGs in the amount of at
least 75,000 tpy on a CO2e basis) and would apply in Step 2
of the phase-in approach to both ``anyway sources'' and sources that
meet the 100,000/75,000-tpy threshold (that is, (i) sources that newly
construct and would not be subject to PSD on account

of their non-GHG emissions, but that emit GHGs in the amount of at
least 100,000 tpy CO2e, and (ii) existing sources that emit
GHGs in the amount of at least 100,000 tpy CO2e, that
undertake modifications that would not trigger PSD on the basis of
their non-GHG emissions, but that increase GHGs by at least 75,000 tpy
CO2e).
    Under the FIP, with respect to permits for ``anyway sources,'' EPA
will be responsible for acting on permit applications for only the GHG
portion of the permit, and the State will retain responsibility for the
rest of the permit. Likewise, with respect to permits for sources that
meet the 100,000/75,000-tpy threshold, our preferred approach--for
reasons of consistency--is that EPA will be responsible for acting on
permit applications for only the GHG portion of the permit, that the
State permitting authorities will be responsible for the non-GHG
portion of the permit, and EPA will coordinate with the State
permitting authority as needed in order to fully cover any non-GHG
emissions that, for example, are subject to BACT because they exceed
the significance levels. We recognize that questions may arise as to
whether the State permitting authorities have authority to permit non-
GHG emissions; as a result, we solicit comment on whether EPA should
also be the permitting authority for the non-GHG portion of the permit
for these latter sources.
    We propose that the FIP consist of the regulatory provisions
included in 40 CFR 52.21, except that the applicability provision would
include a limitation so that it applies for purposes of this rulemaking
only to GHGs.

C. Primacy of the SIP Process

    This proposal is secondary to our overarching goal, which is to
assure that in every instance, it will be the State that will be that
permitting authority. EPA continues to recognize that the States are
best suited to the task of permitting because they and their sources
have experience working together in the State PSD program to process
permit applications. EPA seeks to remain solely in its primary role of
providing guidance and acting as a resource for the States as they make
the various required permitting decisions for GHG emissions.
    Accordingly, beginning immediately we intend to work closely with
the States--as we have already begun to do since earlier in the year--
to help them promptly develop and submit to us their corrective SIP
revisions that extend their PSD program to GHG-emitting sources.
Moreover, we intend to promptly act on their SIP submittals. Again,
EPA's goal is to have each and every affected State have in place the
necessary permitting authorities by the time businesses seeking
construction permits need to have their applications processed and the
permits issued--and to achieve that outcome by means of engaging with
the States directly through a concerted process of consultation and
support.
    EPA is taking up the additional task of proposing this FIP and the
companion SIP Call action only because the Agency believes it is
compelled to do so by the need to assure businesses, to the maximum
extent possible and as promptly as possible, that a permitting
authority is available to process PSD permit applications for GHG-
emitting sources once they become subject to PSD requirements on
January 2, 2011.
    In order to provide that assurance, we are obligated to recognize,
as both States and the regulated community already do, that there may
be circumstances in which States are simply unable to develop and
submit those SIP revisions by January 2, 2011, or for some period of
time beyond that date. As a result, absent further action by EPA, those
States' affected sources confront the risk that they may have to put on
hold their plans to construct or modify, a risk that may have adverse
consequences for the economy.
    Given these exigent circumstances, EPA proposes this plan, within
the limits of our power, with the intent to make a back-up permitting
authority available--and to send a signal of assurance expeditiously in
order to reduce uncertainty and thus facilitate businesses' planning.
Within the design of the CAA, it is EPA that must fill that role of
back-up permitting authority. This FIP and the companion SIP Call
action fulfill the CAA requirements to establish EPA in that role.
    At the same time, we propose these actions with the intent that
States retain as much discretion as possible in the hand of the States.
In the SIP Call rulemaking, EPA proposes that States may choose the
deadline they consider reasonable for submission of their corrective
SIP revision. If, under CAA requirements, we are compelled to
promulgate a FIP, we invite the affected State to accept a delegation
of authority to implement that FIP, so that it will still be the State
that processes the permit applications, albeit operating under Federal
law. In addition, if we are compelled to issue a FIP, we intend to
continue to work closely with the State to assist in developing and
submitting for approval its corrective SIP revision, so as to minimize
the amount of time that the FIP must remain in place.
    Finally, we can report that in informal conversations, officials of
various States have acknowledged the need for our SIP Call and FIP
actions. That is, they have acknowledged that a short-term FIP may be
necessary in their States to establish permitting authority to
construct and modify in accordance with environmental safeguards for
these sources. In addition, some States have indicated that they will
closely consider their opportunities to accept delegation of the
permitting responsibilities.

IV. Statutory and Executive Order Reviews

A. Executive Order 12866--Regulatory Planning and Review

    Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993),
this action is a ``significant regulatory action'' because it raises
novel legal or policy issues. Accordingly, EPA submitted this action to
the Office of Management and Budget (OMB) for review under EO 12866 and
any changes made in response to OMB recommendations have been
documented in the docket for this action.

B. Paperwork Reduction Act

    This action imposes new information collection burden. The action
is based on information concerning whether the States have authority to
regulate GHGs under their SIP PSD provisions, which information is
already requested of the States in the Tailoring Rule. The OMB has
previously approved the information collection requirements contained
in the existing regulations for PSD (see, e.g., 40 CFR 52.21) and title
V (see 40 CFR parts 70 and 71) under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control
number 2060-0003 and OMB control number 2060-0336 respectively. The OMB
control numbers for EPA's regulations in 40 CFR are listed in 40 CFR
part 9.
    The Tailoring Rule does not establish any new requirements (either
control or reporting) for any sources. It merely establishes the
thresholds that trigger NSR and title V for GHG sources. The trigger
for GHG and title V is not due to the Tailoring Rule but the result of
the endangerment finding and the LDVR. The NSR and title V ICRs will
need to be modified to include the new sources that will be triggered
due to the GHG requirements (in July 2011). The Agency anticipates
making such modifications upon renewal of the NSR and title V ICRs at
the end of the year.

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 this notice on small
entities, small entity is defined as: (1) A small business that is a
small industrial entity as defined in the U.S. Small Business
Administration (SBA) size standards (see 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; or (3) a small organization that is any not-for-profit
enterprise that is independently owned and operated and is not dominant
in its field.
    After considering the economic impacts of this proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. Although
this rule would lead to Federal permitting requirements for certain
sources, those sources are large emitters of GHGs and tend to be large
sources. We continue to be interested in the potential impacts of the
proposed rule on small entities and welcome comments on issues related
to such impacts.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA, 2 U.S.C.
1531-1538) for State, local or tribal governments or the private
section. The action imposes no enforceable duty on any State, local or
tribal governments or the private sector. This action merely prescribes
EPA's action for States that do not meet their existing obligation for
PSD SIP submittal. Thus, this proposed rule is not subject to the
requirements of sections 202 or 205 of UMRA.
    This action 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 action merely
prescribes EPA's action for States that do not meet their existing
obligation for PSD SIP submittal.

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, as
specified in Executive Order 13132. This action merely prescribes EPA's
action for States that do not meet their existing obligation for PSD
SIP submittal. Thus, Executive Order 13132 does not apply to this
action.
    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 rule
from State and local officials.

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

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This action does
not impose a FIP in any tribal area. Thus, Executive Order 13175 does
not apply to this action.
    Although Executive Order 13175 does not apply to this proposed
rule, EPA specifically solicits additional comment on this proposed
action 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 merely prescribes EPA's action for States that do not
meet their existing obligation for PSD SIP submittal.

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

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy. This action merely prescribes EPA's
action for States that do not meet their existing obligation for PSD
SIP submittal.

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(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the Agency decides not to use
available and applicable voluntary consensus standards.
    This proposed rulemaking does not involve technical standards.
Therefore, EPA is not considering the use of any voluntary consensus
standards.

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 U.S.
    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 does not
affect the level of protection provided to human health or the
environment. This proposed rule merely prescribes EPA's action for
States that do not meet their existing obligation for PSD SIP
submittal.

K. Determination Under Section 307(d)

    Pursuant to sections 307(d)(1)(B) of the CAA, this action is
subject to the provisions of section 307(d). Section 307(d)(1)(B)
provides that the provisions of section 307(d) apply to ``the
promulgation or revision of an implementation plan by the Administrator
under section 110(c) of this Act.''

V. Statutory Authority

    The statutory authority for this action is provided by sections
110, 165, 301, and 307(d)(1)(B) of the CAA as amended (42 U.S.C. 7410,
7475, 7601, and 7407(d)(1)(B)). This action is subject to section
307(d) of the CAA (42 U.S.C. 7407(d)).

Page 46 of 49--Action To Ensure Authority To Issue Permits Under the
Prevention of Significant Deterioration Program to Sources of
Greenhouse Gas Emissions: Federal Implementation Plan

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon dioxide,
Carbon dioxide equivalents, Carbon monoxide, Greenhouse gases,
Hydrofluorocarbons, Intergovernmental relations, Lead, Methane,
Nitrogen dioxide, Nitrous oxide, Ozone, Particulate matter,
Perfluorocarbons, Reporting and recordkeeping requirements, Sulfur
hexafluoride, Sulfur oxides, Volatile organic compounds.

    Dated: August 12, 2010.
Lisa P. Jackson,
Administrator.
    For the reasons set out in the preamble, title 40, chapter I of the
Code of Federal Regulations is proposed to be amended as follows:

PART 52--[AMENDED]

    1. The authority citation for part 52 continues to read as follows:

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

    2. Section 52.37 is added to read as follows:

Sec.  52.37  What are the requirements of the Federal Implementation
Plans (FIPs) to issue permits under the Prevention of Significant
Deterioration requirements to sources that emit greenhouse gases?

    (a) The requirements of sections 160 through 165 of the Clean Air
Act are not met to the extent the plan, as approved, of the States
listed in paragraph (b) of this section does not apply with respect to
emissions of the pollutant GHGs from certain stationary sources.
Therefore, the provisions of Sec.  52.21 except paragraph (a)(1) are
hereby made a part of the plan for each State listed in paragraph (b)
of this section for: (1) Beginning January 2, 2011, the pollutant GHGs
from stationary sources described in Sec.  52.21(b)(49)(iv), and
[Alternative 1 for paragraph (a)(2)]
    (2) Beginning July 1, 2011, in addition to the pollutant GHGs from
sources described under paragraph (a)(1) of this section, the pollutant
GHGs from stationary sources described in Sec.  52.21(b)(49)(v).
[Alternative 2 for paragraph (a)(2)]
    (2) Beginning July 1, 2011, in addition to the pollutant GHGs from
sources described under paragraph (a)(1) of this section, stationary
sources described in Sec.  52.21(b)(49)(v).
    (b) Paragraph (a) of this section applies to:
    (1) Alaska;
    (2) Arizona, Pinal County; Rest of State (Excludes Maricopa County,
Pima County, and Indian Country);
    (3) Arkansas;
    (4) California, Sacramento Metropolitan AQMD;
    (5) Connecticut;
    (6) Florida;
    (7) Idaho;
    (8) Kansas;
    (9) Kentucky, Jefferson County and Rest of State;
    (10) Nebraska;
    (11) Nevada, Clark County;
    (12) Oregon;
    (13) Texas.
    (c) For purposes of this section, references to the ``pollutant
GHGs'' refers to the pollutant GHGs, as described in Sec.
52.21(b)(49)(i).

[FR Doc. 2010-21706 Filed 9-1-10; 8:45 am]
BILLING CODE 6560-50-P