[Federal Register Volume 77, Number 67 (Friday, April 6, 2012)]
[Notices]
[Page 20828]
[FR Doc No: 2012-8354]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-E-0152]

Determination of Regulatory Review Period for Purposes of Patent
Extension; LATUDA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for LATUDA and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product LATUDA
(lurasidone hydrochloride). LATUDA is indicated as an atypical
antipsychotic agent for the treatment of patients with schizophrenia.
Subsequent to this approval, the Patent and Trademark Office received a
patent term restoration application for LATUDA (U.S. Patent No.
5,532,372) from Dainippon Sumitomo Pharma Co., Ltd., and the Patent and
Trademark Office requested FDA's assistance in determining this
patent's eligibility for patent term restoration. In a letter dated
April 26, 2011, FDA advised the Patent and Trademark Office that this
human drug product had undergone a regulatory review period and that
the approval of LATUDA represented the first permitted commercial
marketing or use of the product. Thereafter, the Patent and Trademark
Office requested that FDA determine the product's regulatory review
period.
    FDA has determined that the applicable regulatory review period for
LATUDA is 3,602 days. Of this time, 3,299 days occurred during the
testing phase of the regulatory review period, while 303 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: December 19, 2000. The applicant claims December 17, 2000,
as the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was December 19, 2000, when the project manager in the Division of
Neuropharmacological Drug Products, Center for Drug Evaluation and
Research, called the IND applicant on the behalf of the Division
Director, to notify the IND applicant that studies under the IND may
proceed. This date, December 19, 2000, rather than the claimed December
17, 2000, is also noted in Attachment F of the patent term extension
application.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
30, 2009. FDA has verified the applicant's claim that the new drug
application (NDA) for LATUDA (NDA 200-603) was submitted on December
30, 2009.
    3. The date the application was approved: October 28, 2010. FDA has
verified the applicant's claim that NDA 200-603 was approved on October
28, 2010.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,826 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by June 5, 2012. Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period
by October 3, 2012. To meet its burden, the petition must contain
sufficient facts to merit an FDA investigation. (See H. Rept. 857, part
1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the
format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
    Comments and petitions that have not been made publicly available
on regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 19, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-8354 Filed 4-5-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Notices]
[Pages 11498-11499]
[FR Doc No: 2023-03777]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34836; File No. 812-15356]

The RBB Fund, Inc., et al.

February 17, 2023.
AGENCY: Securities and Exchange Commission (``Commission'').

ACTION: Notice.

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    Notice of an application under section 6(c) of the Investment
Company Act of 1940 (the ``Act'') for an exemption from sections
2(a)(32), 5(a)(1), 22(d) and 22(e) of the Act and rule 22c-1 under the
Act and under sections 6(c) and 17(b) of the Act for an exemption from
sections 17(a)(1) and 17(a)(2) of the Act.

Summary of Application: Applicants request an order (``Order'') that
permits: (a) The Funds (as defined in the Applicants' application) to
issue shares (``Shares'') redeemable in large aggregations only
(``creation units''); (b) secondary market transactions in Shares to
occur at negotiated market prices rather than at net asset value; (c)
certain Funds to pay redemption proceeds, under certain circumstances,
more than seven days after the tender of Shares for redemption; and (d)
certain affiliated persons of a Fund to deposit securities into, and
receive securities from, the Fund in connection with the purchase and
redemption of creation units. The relief in the Order would incorporate
by reference terms and conditions of the same relief of a previous
order granting the same relief sought by applicants, as that order may
be amended from time to time (``Reference Order'').\1\
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    \1\ Blue Tractor ETF Trust and Blue Tractor Group, LLC,
Investment Company Act Rel. Nos. 33682 (Nov. 14, 2019) (notice) and
33710 (Dec. 10, 2019) (order).

Applicants: The RBB Fund, Inc.; Summit Global Investments, LLC; and
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Quasar Distributors, LLC.

Filing Dates: The application was filed on June 22, 2022, and amended
on September 26, 2022, November 1, 2022, and November 29, 2022.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing on any application by emailing
the Commission's Secretary at [email protected] and serving
applicants with a copy of the request by email, if an email address is
listed for the relevant applicant below, or personally or by mail, if a
physical address is listed for the relevant applicant below. Hearing
requests should be received by the Commission by 5:30 p.m. on March 14,
2023, and should be accompanied by proof of service on applicants, in
the form of an affidavit or, for lawyers, a certificate of service.
Pursuant to rule 0-5 under the Act, hearing requests should state the
nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by emailing the Commission's Secretary.

ADDRESSES: The Commission: [email protected]. Applicants:
Steven Plump, The RBB Fund, Inc., [email protected]; Jillian L.
Bosmann, Esq., Faegre Drinker Biddle & Reath LLP,
[email protected].

FOR FURTHER INFORMATION CONTACT: Stephan N. Packs, Senior Counsel, or
Terri G. Jordan, Branch Chief, at<PHONE_NUMBER> (Chief Counsel's
Office, Division of Investment Management).

SUPPLEMENTARY INFORMATION: For Applicants' representations, legal

analysis, and conditions, please refer to Applicants' third amended and
restated application, dated November 29, 2022, which may be obtained
via the Commission's website by searching for the file number at the
top of this document, or for an Applicant using the Company name search
field, on the SEC's EDGAR system. The SEC's EDGAR system may be
searched at https://www.sec.gov/edgar/searchedgar/legacy/companysearch.html. You may also call the SEC's Public Reference Room
at<PHONE_NUMBER>.

    For the Commission, by the Division of Investment Management,
under delegated authority.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-03777 Filed 2-22-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Proposed Rules]
[Pages 45320-45326]
[FR Doc No: 2012-18653]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2012-0238; FRL-9707-8]

Approval and Promulgation of Implementation Plans; Mississippi;
110(a)(2)(G) Infrastructure Requirement for the 1997 and 2006 Fine
Particulate Matter National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve, through parallel processing, a
draft revision to the Mississippi State Implementation Plan (SIP),
submitted by the Mississippi Department of Environmental Quality
(MDEQ), on July 13, 2012. The draft revisions pertain to Clean Air Act
(CAA) section 110(a)(2)(G) for the 1997 annual and 2006 24-hour fine
particulate matter (PM2.5) National Ambient Air Quality
Standards (NAAQS). Specifically, EPA is proposing to approve
Mississippi's December 7, 2007, October 6, 2009, and July 13, 2012,
submissions addressing section 110(a)(2)(G), of the CAA for both the
1997 and 2006 PM2.5 NAAQS. Section 110(a) of the CAA
requires that each state adopt and submit a SIP for the implementation,
maintenance, and enforcement of each NAAQS promulgated by EPA, which is
commonly referred to as an ``infrastructure'' SIP. MDEQ certified that
the Mississippi SIP contains provisions that ensure the 1997 and 2006
PM2.5 NAAQS are implemented, enforced, and maintained in
Mississippi (hereafter referred to as ``infrastructure submission'').
The subject of this notice is limited to infrastructure element
110(a)(2)(G). All other applicable Mississippi infrastructure elements
are being addressed in a separate rulemaking.

DATES: Written comments must be received on or before August 30, 2012.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2012-0238, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2012-0238,'' Regulatory Development Section,
Air Planning Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW., Atlanta, Georgia 30303-8960. Such deliveries are
only accepted during the Regional Office's normal hours of operation.
The Regional Office's official hours of business are Monday through
Friday, 8:30 to 4:30, excluding federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2012-0238. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
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 through www.regulations.gov or
email, information that you consider to be CBI or otherwise protected.
The 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 www.regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, 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, 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.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy at the Regulatory Development Section, Air Planning
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 to 4:30, excluding
federal holidays.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman, Regulatory Development
Section, Air Planning Branch, Air, Pesticides and Toxics Management
Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404)
562-9043. Mr. Lakeman can be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. What is parallel processing?
II. Background
III. What elements are required under Sections 110(a)(1) and (2)?
IV. Scope of Infrastructure SIPs
V. What is EPA's analysis of how Mississippi addressed element (G)
of Sections 110(a)(1) and (2) ``infrastructure'' provisions?
VI. Proposed Action
VII. Statutory and Executive Order Reviews

I. What is parallel processing?

    Consistent with EPA regulations found at 40 CFR part 51, Appendix
V, section 2.3.1, for purposes of expediting review of a SIP submittal,
parallel processing allows a state to submit a plan to EPA prior to
actual adoption by the state. Generally, the state submits a copy of
the proposed regulation or other revisions to EPA before conducting its
public hearing. EPA reviews this proposed state action, and prepares a
notice of proposed rulemaking. EPA's notice of proposed rulemaking is
published in the Federal Register during the same time frame that the
state is holding its public process. The state and EPA then provide for
concurrent public comment periods on both the state action and federal
action.
    If the revision that is finally adopted and submitted by the State
is changed in aspects other than those identified in the proposed
rulemaking on the parallel process submission, EPA will evaluate

those changes and if necessary and appropriate, issue another notice of
proposed rulemaking. The final rulemaking action by EPA will occur only
after the SIP revision has been adopted by the state and submitted
formally to EPA for incorporation into the SIP.
    On July 13, 2012, the State of Mississippi, through MDEQ, submitted
requests for parallel processing of draft SIP revision that the State
has taken through public comment. MDEQ requested parallel processing so
that EPA could begin to take action on its draft SIP revisions in
advance of the State's submission of the final SIP revisions. As stated
above, the final rulemaking action by EPA will occur only after the SIP
revision has been: (1) Adopted by Mississippi, (2) submitted formally
to EPA for incorporation into the SIP; and (3) evaluated by EPA,
including any changes made by the State after the July 13, 2012, draft
was submitted to EPA.

II. Background

    On July 18, 1997 (62 FR 36852), EPA established an annual
PM2.5 NAAQS at 15.0 micrograms per cubic meter ([mu]g/m\3\)
based on a 3-year average of annual mean PM2.5
concentrations. At that time, EPA also established a 24-hour NAAQS of
65 [mu]g/m\3\. See 40 CFR 50.7. On October 17, 2006 (71 FR 61144), EPA
retained the 1997 annual PM2.5 NAAQS at 15.0 [mu]g/m\3\
based on a 3-year average of annual mean PM2.5
concentrations, and promulgated a new 24-hour NAAQS of 35 [mu]g/m\3\
based on a 3-year average of the 98th percentile of 24-hour
concentrations. By statute, SIPs meeting the requirements of sections
110(a)(1) and (2) are to be submitted by states within three years
after promulgation of a new or revised NAAQS. Sections 110(a)(1) and
(2) require states to address basic SIP requirements, including
emissions inventories, monitoring, and modeling to assure attainment
and maintenance of the NAAQS. States were required to submit such SIPs
to EPA no later than July 2000 for the 1997 annual PM2.5
NAAQS, and no later than October 2009 for the 2006 24-hour
PM2.5 NAAQS.
    On March 4, 2004, Earthjustice submitted a notice of intent to sue
related to EPA's failure to issue findings of failure to submit related
to the ``infrastructure'' requirements for the 1997 annual
PM2.5 NAAQS. On March 10, 2005, EPA entered into a consent
decree with Earthjustice which required EPA, among other things, to
complete a Federal Register notice announcing EPA's determinations
pursuant to section 110(k)(1)(B) as to whether each state had made
complete submissions to meet the requirements of section 110(a)(2) for
the 1997 PM2.5 NAAQS by October 5, 2008. In accordance with
the consent decree, EPA made completeness findings for each state based
upon what the Agency received from each state for the 1997
PM2.5 NAAQS as of October 3, 2008.
    On October 22, 2008, EPA published a final rulemaking entitled
``Completeness Findings for Section 110(a) State Implementation Plans
Pertaining to the Fine Particulate Matter (PM2.5) NAAQS''
making a finding that each state had submitted or failed to submit a
complete SIP that provided the basic program elements of section
110(a)(2) necessary to implement the 1997 PM2.5 NAAQS (See
73 FR 62902). For those states that did receive findings, the findings
of failure to submit for all or a portion of a state's implementation
plan established a 24-month deadline for EPA to promulgate a Federal
Implementation Plan (FIP) to address the outstanding SIP elements
unless, prior to that time, the affected states submitted, and EPA
approved, the required SIPs.
    The findings that all or portions of a state's submission are
complete established a 12-month deadline for EPA to take action upon
the complete SIP elements in accordance with section 110(k).
Mississippi's infrastructure submissions were received by EPA on
December 7, 2007, for the 1997 annual PM2.5 NAAQS and on
October 6, 2009, for the 2006 24-hour PM2.5 NAAQS. The
submissions were determined to be complete on June 7, 2008, and April
6, 2010, respectively. Mississippi was among other states that did not
receive findings of failure to submit because it had provided a
complete submission to EPA to address the infrastructure elements for
the 1997 PM2.5 NAAQS by October 3, 2008.
    On July 6, 2011, WildEarth Guardians and Sierra Club filed an
amended complaint related to EPA's failure to take action on the SIP
submittal related to the ``infrastructure'' requirements for the 2006
24-hour PM2.5 NAAQS. On October 20, 2011, EPA entered into a
consent decree with WildEarth Guardians and Sierra Club which required
EPA, among other things, to complete a Federal Register notice of the
Agency's final action either approving, disapproving, or approving in
part and disapproving in part the Mississippi 2006 24-hour
PM2.5 NAAQS Infrastructure SIP submittal addressing the
applicable requirements of sections 110(a)(2)(A)-(H), (J)-(M), except
for section 110(a)(2)(C) the nonattainment area requirements and
section 110(a)(2)(D)(i) interstate transport requirements, by September
30, 2012.
    Today's action is proposing to approve Mississippi's December 7,
2007, October 6, 2009, and July 13, 2012, infrastructure submissions
for the 1997 annual and 2006 24-hour PM2.5 NAAQS addressing
CAA section 110(a)(2)(G). EPA is taking action on Mississippi's
infrastructure submission for the 1997 and 2006 PM2.5 NAAQS
for sections 110(a)(2)(A)-(F), (H), (J)-(M), except for section
110(a)(2)(C) the nonattainment area requirements and section
110(a)(2)(D)(i) interstate transport and section 110(a)(2)(E)(ii)
requirements in a separate action.

III. What elements are required under Sections 110(a)(1) and (2)?

    Section 110(a) of the CAA requires states to submit SIPs to provide
for the implementation, maintenance, and enforcement of a new or
revised NAAQS within three years following the promulgation of such
NAAQS, or within such shorter period as EPA may prescribe. Section
110(a) imposes the obligation upon states to make a SIP submission to
EPA for a new or revised NAAQS, but the contents of that submission may
vary depending upon the facts and circumstances. In particular, the
data and analytical tools available at the time the state develops and
submits the SIP for a new or revised NAAQS affects the content of the
submission. The contents of such SIP submissions may also vary
depending upon what provisions the state's existing SIP already
contains. In the case of the 1997 and 2006 PM2.5 NAAQS,
states typically have met the basic program elements required in
section 110(a)(2) through earlier SIP submissions in connection with
previous PM NAAQS.
    More specifically, section 110(a)(1) provides the procedural and
timing requirements for SIPs. Section 110(a)(2) lists specific elements
that states must meet for ``infrastructure'' SIP requirements related
to a newly established or revised NAAQS. As mentioned above, these
requirements include SIP infrastructure elements such as modeling,
monitoring, and emissions inventories that are designed to assure
attainment and maintenance of the NAAQS. The requirements that are the
subject of the infrastructure rulemaking process are listed below \1\

and in EPA's October 2, 2007, memorandum entitled ``Guidance on SIP
Elements Required Under Section 110(a)(1) and (2) for the 1997 8-Hour
Ozone and PM2.5 National Ambient Air Quality Standards,''
and EPA's September 25, 2009, memorandum entitled ``Guidance on SIP
Elements Required Under Sections 110(a)(1) and (2) for the 2006 24-Hour
Fine Particle (PM2.5) National Ambient Air Quality Standards
(NAAQS) .''
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    \1\ Two elements identified in section 110(a)(2) are not
governed by the three year submission deadline of section 110(a)(1)
because SIPs incorporating necessary local nonattainment area
controls are not due within three years after promulgation of a new
or revised NAAQS, but rather due at the time the nonattainment area
plan requirements are due pursuant to section 172. These
requirements are: (1) Submissions required by section 110(a)(2)(C)
to the extent that subsection refers to a permit program as required
in part D Title I of the CAA; and (2) submissions required by
section 110(a)(2)(I) which pertain to the nonattainment planning
requirements of part D, Title I of the CAA. Today's proposed
rulemaking does not address infrastructure elements related to
section 110(a)(2)(I) or the nonattainment planning requirements of
110(a)(2)(C).
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     110(a)(2)(A): Emission limits and other control measures.
     110(a)(2)(B): Ambient air quality monitoring/data system.
     110(a)(2)(C): Program for enforcement of control
measures.\2\
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    \2\ This element is only addressed in the PM2.5
context as it relates to attainment areas.
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     110(a)(2)(D): Interstate transport.\3\
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    \3\ Today's proposed rule does not address element
110(a)(2)(D)(i) (Interstate Transport) for the 1997 and 2006
PM2.5 NAAQS. Interstate transport requirements were
formerly addressed by Mississippi consistent with the Clean Air
Interstate Rule (CAIR). On December 23, 2008, CAIR was remanded by
the DC Circuit Court of Appeals, without vacatur, back to EPA. See
North Carolina v. EPA, 531 F.3d 896 (D.C. Cir. 2008). Prior to this
remand, EPA took final action to approve Mississippi SIP revision,
which was submitted to comply with CAIR. See 72 FR 56268 (October 3,
2007). In so doing, Mississippi CAIR SIP revision addressed the
interstate transport provisions in section 110(a)(2)(D)(i) for the
1997 and 2006 PM2.5 NAAQS. In response to the remand of
CAIR, EPA has recently finalized a new rule to address the
interstate transport of nitrogen oxides and sulfur oxides in the
eastern United States. See 76 FR 48208 (August 8, 2011) (Transport
Rule). That rule was recently stayed by the DC Circuit Court of
Appeals. EPA's action on element 110(a)(2)(D)(i) will be addressed
in a separate action.
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     110(a)(2)(E): Adequate resources.
     110(a)(2)(F): Stationary source monitoring system.
     110(a)(2)(G): Emergency power.
     110(a)(2)(H): Future SIP revisions.
     110(a)(2)(I): Areas designated nonattainment and meet the
applicable requirements of part D.\4\
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    \4\ This requirement was inadvertently omitted from EPA's
October 2, 2007, memorandum entitled ``Guidance on SIP Elements
Required Under Section 110(a)(1) and (2) for the 1997 8-Hour Ozone
and PM2.5 National Ambient Air Quality Standards,'' but
as mentioned above is not relevant to today's proposed rulemaking.
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     110(a)(2)(J): Consultation with government officials;
public notification; and PSD and visibility protection.
     110(a)(2)(K): Air quality modeling/data.
     110(a)(2)(L): Permitting fees.
     110(a)(2)(M): Consultation/participation by affected local
entities.
    In today's action, EPA is only addressing section 110(a)(2)
requirements related to element 110(a)(2)(G) for Mississippi for both
the 1997 and 2006 PM2.5 NAAQS. EPA is addressing the other
1997 and 2006 PM2.5 NAAQS infrastructure requirements in a
separate rulemaking.

IV. Scope of Infrastructure SIPs

    EPA is currently acting upon SIPs that address the infrastructure
requirements of CAA section 110(a)(1) and (2) for ozone and
PM2.5 NAAQS for various states across the country.
Commenters on EPA's recent proposals for some states raised concerns
about EPA statements that it was not addressing certain substantive
issues in the context of acting on those infrastructure SIP
submissions.\5\ Those Commenters specifically raised concerns involving
provisions in existing SIPs and with EPA's statements in other
proposals that it would address two issues separately and not as part
of actions on the infrastructure SIP submissions: (i) Existing
provisions related to excess emissions during periods of start-up,
shutdown, or malfunction (SSM) at sources, that may be contrary to the
CAA and EPA's policies addressing such excess emission; and (ii)
existing provisions related to ``director's variance'' or ``director's
discretion'' that purport to permit revisions to SIP approved emissions
limits with limited public process or without requiring further
approval by EPA, that may be contrary to the CAA (director's
discretion). EPA notes that there are two other substantive issues for
which EPA likewise stated in other proposals that it would address
separately: (i) Existing provisions for minor source New Source Review
(NSR) programs that may be inconsistent with the requirements of the
CAA and EPA's regulations that pertain to such programs (minor source
NSR); and (ii) existing provisions for Prevention of Significant
Deterioration (PSD) programs that may be inconsistent with current
requirements of EPA's ``Final NSR Improvement Rule,'' 67 FR 80186
(December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (NSR
Reform). In light of the comments, EPA believes that its statements in
various proposed actions on infrastructure SIPs with respect to these
four individual issues should be explained in greater depth. It is
important to emphasize that EPA is taking the same position with
respect to these four substantive issues in this action on the
infrastructure SIPs for the 1997 and 2006 PM2.5 NAAQS from
Mississippi.
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    \5\ See Comments of Midwest Environmental Defense Center, dated
May 31, 2011. Docket  EPA-R05-OAR-2007-1179 (adverse
comments on proposals for three states in Region 5). EPA notes that
these public comments on another proposal are not relevant to this
rulemaking and do not have to be directly addressed in this
rulemaking. EPA will respond to these comments in the appropriate
rulemaking action to which they apply.
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    EPA intended the statements in the other proposals concerning these
four issues merely to be informational, and to provide general notice
of the potential existence of provisions within the existing SIPs of
some states that might require future corrective action. EPA did not
want states, regulated entities, or members of the public to be under
the misconception that the Agency's approval of the infrastructure SIP
submission of a given state should be interpreted as a re-approval of
certain types of provisions that might exist buried in the larger
existing SIP for such state. Thus, for example, EPA explicitly noted
that the Agency believes that some states may have existing SIP
approved SSM provisions that are contrary to the CAA and EPA policy,
but that ``in this rulemaking, EPA is not proposing to approve or
disapprove any existing state provisions with regard to excess
emissions during SSM of operations at facilities.'' EPA further
explained, for informational purposes, that ``EPA plans to address such
State regulations in the future.'' EPA made similar statements, for
similar reasons, with respect to the director's discretion, minor
source NSR, and NSR Reform issues. EPA's objective was to make clear
that approval of an infrastructure SIP for these ozone and
PM2.5 NAAQS should not be construed as explicit or implicit
re-approval of any existing provisions that relate to these four
substantive issues. EPA is reiterating that position in this action on
the infrastructure SIP for Mississippi.
    Unfortunately, the Commenters and others evidently interpreted
these statements to mean that EPA considered action upon the SSM
provisions and the other three substantive issues to be integral parts
of acting on an infrastructure SIP submission, and therefore that EPA
was merely postponing taking final action on the issues in the context
of the infrastructure SIPs. This was not EPA's intention. To the
contrary, EPA only meant to convey its awareness of the potential for
certain types of deficiencies in existing SIPs, and to prevent any
misunderstanding that it was reapproving any such existing provisions.
EPA's intention was to convey its position that the statute does

not require that infrastructure SIPs address these specific substantive
issues in existing SIPs and that these issues may be dealt with
separately, outside the context of acting on the infrastructure SIP
submission of a state. To be clear, EPA did not mean to imply that it
was not taking a full final agency action on the infrastructure SIP
submission with respect to any substantive issue that EPA considers to
be a required part of acting on such submissions under section 110(k)
or under section 110(c). Given the confusion evidently resulting from
EPA's statements in those other proposals, however, we want to explain
more fully the Agency's reasons for concluding that these four
potential substantive issues in existing SIPs may be addressed
separately from actions on infrastructure SIP submissions.
    The requirement for the SIP submissions at issue arises out of CAA
section 110(a)(1). That provision requires that states must make a SIP
submission ``within 3 years (or such shorter period as the
Administrator may prescribe) after the promulgation of a national
primary ambient air quality standard (or any revision thereof)'' and
that these SIPs are to provide for the ``implementation, maintenance,
and enforcement'' of such NAAQS. Section 110(a)(2) includes a list of
specific elements that ``[e]ach such plan'' submission must meet. EPA
has historically referred to these particular submissions that states
must make after the promulgation of a new or revised NAAQS as
``infrastructure SIPs.'' This specific term does not appear in the
statute, but EPA uses the term to distinguish this particular type of
SIP submission designed to address basic structural requirements of a
SIP from other types of SIP submissions designed to address other
different requirements, such as ``nonattainment SIP'' submissions
required to address the nonattainment planning requirements of part D,
``regional haze SIP'' submissions required to address the visibility
protection requirements of CAA section 169A, NSR permitting program
submissions required to address the requirements of part D, and a host
of other specific types of SIP submissions that address other specific
matters.
    Although section 110(a)(1) addresses the timing and general
requirements for these infrastructure SIPs, and section 110(a)(2)
provides more details concerning the required contents of these
infrastructure SIPs, EPA believes that many of the specific statutory
provisions are facially ambiguous. In particular, the list of required
elements provided in section 110(a)(2) contains a wide variety of
disparate provisions, some of which pertain to required legal
authority, some of which pertain to required substantive provisions,
and some of which pertain to requirements for both authority and
substantive provisions.\6\ Some of the elements of section 110(a)(2)
are relatively straightforward, but others clearly require
interpretation by EPA through rulemaking, or recommendations through
guidance, in order to give specific meaning for a particular NAAQS.\7\
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    \6\ For example, section 110(a)(2)(E) provides that states must
provide assurances that they have adequate legal authority under
state and local law to carry out the SIP; section 110(a)(2)(C)
provides that states must have a substantive program to address
certain sources as required by part C of the CAA; section
110(a)(2)(G) provides that states must have both legal authority to
address emergencies and substantive contingency plans in the event
of such an emergency.
    \7\ For example, section 110(a)(2)(D)(i) requires EPA to be sure
that each state's SIP contains adequate provisions to prevent
significant contribution to nonattainment of the NAAQS in other
states. This provision contains numerous terms that require
substantial rulemaking by EPA in order to determine such basic
points as what constitutes significant contribution. See ``Rule To
Reduce Interstate Transport of Fine Particulate Matter and Ozone
(Clean Air Interstate Rule); Revisions to Acid Rain Program;
Revisions to the NOX SIP Call; Final Rule,'' 70 FR 25162
(May 12, 2005) (defining, among other things, the phrase
``contribute significantly to nonattainment'').
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    Notwithstanding that section 110(a)(2) provides that ``each'' SIP
submission must meet the list of requirements therein, EPA has long
noted that this literal reading of the statute is internally
inconsistent, insofar as section 110(a)(2)(I) pertains to nonattainment
SIP requirements that could not be met on the schedule provided for
these SIP submissions in section 110(a)(1).\8\ This illustrates that
EPA must determine which provisions of section 110(a)(2) may be
applicable for a given infrastructure SIP submission. Similarly, EPA
has previously decided that it could take action on different parts of
the larger, general ``infrastructure SIP'' for a given NAAQS without
concurrent action on all subsections, such as section 110(a)(2)(D)(i),
because the Agency bifurcated the action on these latter ``interstate
transport'' provisions within section 110(a)(2) and worked with states
to address each of the four prongs of section 110(a)(2)(D)(i) with
substantive administrative actions proceeding on different tracks with
different schedules.\9\ This illustrates that EPA may conclude that
subdividing the applicable requirements of section 110(a)(2) into
separate SIP actions may sometimes be appropriate for a given NAAQS
where a specific substantive action is necessitated, beyond a mere
submission addressing basic structural aspects of the state's
implementation plans. Finally, EPA notes that not every element of
section 110(a)(2) would be relevant, or as relevant, or relevant in the
same way, for each new or revised NAAQS and the attendant
infrastructure SIP submission for that NAAQS. For example, the
monitoring requirements that might be necessary for purposes of section
110(a)(2)(B) for one NAAQS could be very different than what might be
necessary for a different pollutant. Thus, the content of an
infrastructure SIP submission to meet this element from a state might
be very different for an entirely new NAAQS, versus a minor revision to
an existing NAAQS.\10\
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    \8\ See Id., 70 FR 25162, at 63-65 (May 12, 2005) (explaining
relationship between timing requirement of section 110(a)(2)(D)
versus section 110(a)(2)(I)).
    \9\ EPA issued separate guidance to states with respect to SIP
submissions to meet section 110(a)(2)(D)(i) for the 1997 ozone and
1997 PM2.5 NAAQS. See ``Guidance for State Implementation
Plan (SIP) Submissions to Meet Current Outstanding Obligations Under
Section 110(a)(2)(D)(i) for the 8-Hour Ozone and PM2.5
National Ambient Air Quality Standards,'' from William T. Harnett,
Director Air Quality Policy Division OAQPS, to Regional Air Division
Director, Regions I-X, dated August 15, 2006.
    \10\ For example, implementation of the 1997 PM2.5
NAAQS required the deployment of a system of new monitors to measure
ambient levels of that new indicator species for the new NAAQS.
---------------------------------------------------------------------------

    Similarly, EPA notes that other types of SIP submissions required
under the statute also must meet the requirements of section 110(a)(2),
and this also demonstrates the need to identify the applicable elements
for other SIP submissions. For example, nonattainment SIPs required by
part D likewise have to meet the relevant subsections of section
110(a)(2) such as section 110(a)(2)(A) or (E). By contrast, it is clear
that nonattainment SIPs would not need to meet the portion of section
110(a)(2)(C) that pertains to part C, i.e., the PSD requirements
applicable in attainment areas. Nonattainment SIPs required by part D
also would not need to address the requirements of section 110(a)(2)(G)
with respect to emergency episodes, as such requirements would not be
limited to nonattainment areas. As this example illustrates, each type
of SIP submission may implicate some subsections of section 110(a)(2)
and not others.
    Given the potential for ambiguity of the statutory language of
section 110(a)(1) and (2), EPA believes that it is appropriate for EPA
to interpret that language in the context of acting on the
infrastructure SIPs for a given NAAQS. Because of the inherent
ambiguity of the list of requirements in section 110(a)(2),

EPA has adopted an approach in which it reviews infrastructure SIPs
against this list of elements ``as applicable.'' In other words, EPA
assumes that Congress could not have intended that each and every SIP
submission, regardless of the purpose of the submission or the NAAQS in
question, would meet each of the requirements, or meet each of them in
the same way. EPA elected to use guidance to make recommendations for
infrastructure SIPs for these ozone and PM2.5 NAAQS.
    On October 2, 2007, EPA issued guidance making recommendations for
the infrastructure SIP submissions for both the 1997 8-hour ozone NAAQS
and the 1997 PM2.5 NAAQS.\11\ Within this guidance document,
EPA described the duty of states to make these submissions to meet what
the Agency characterized as the ``infrastructure'' elements for SIPs,
which it further described as the ``basic SIP requirements, including
emissions inventories, monitoring, and modeling to assure attainment
and maintenance of the standards.'' \12\ As further identification of
these basic structural SIP requirements, ``attachment A'' to the
guidance document included a short description of the various elements
of section 110(a)(2) and additional information about the types of
issues that EPA considered germane in the context of such
infrastructure SIPs. EPA emphasized that the description of the basic
requirements listed on attachment A was not intended ``to constitute an
interpretation of'' the requirements, and was merely a ``brief
description of the required elements.'' \13\ EPA also stated its belief
that with one exception, these requirements were ``relatively self
explanatory, and past experience with SIPs for other NAAQS should
enable States to meet these requirements with assistance from EPA
Regions.'' \14\ However, for the one exception to that general
assumption (i.e., how states should proceed with respect to the
requirements of section 110(a)(2)(G) for the 1997 PM2.5
NAAQS), EPA gave much more specific recommendations. But for other
infrastructure SIP submittals, and for certain elements of the
submittals for the 1997 PM2.5 NAAQS, EPA assumed that each
State would work with its corresponding EPA regional office to refine
the scope of a State's submittal based on an assessment of how the
requirements of section 110(a)(2) should reasonably apply to the basic
structure of the State's implementation plans for the NAAQS in
question.
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    \11\ See ``Guidance on SIP Elements Required Under Section
110(a)(1) and (2) for the 1997 8-hour Ozone and PM2.5
National Ambient Air Quality Standards,'' from William T. Harnett,
Director Air Quality Policy Division, to Air Division Directors,
Regions I-X, dated October 2, 2007 (the ``2007 Guidance'').
    \12\ Id., at page 2.
    \13\ Id., at attachment A, page 1.
    \14\ Id., at page 4. In retrospect, the concerns raised by
commenters with respect to EPA's approach to some substantive issues
indicate that the statute is not so ``self explanatory,'' and indeed
is sufficiently ambiguous that EPA needs to interpret it in order to
explain why these substantive issues do not need to be addressed in
the context of infrastructure SIPs and may be addressed at other
times and by other means.
---------------------------------------------------------------------------

    On September 25, 2009, EPA issued guidance to make recommendations
to states with respect to the infrastructure SIPs for the 2006
PM2.5 NAAQS.\15\ In the 2009 Guidance, EPA addressed a
number of additional issues that were not germane to the infrastructure
SIPs for the 1997 8-hour ozone and 1997 PM2.5 NAAQS, but
were germane to these SIP submissions for the 2006 PM2.5
NAAQS (e.g., the requirements of section 110(a)(2)(D)(i) that EPA had
bifurcated from the other infrastructure elements for those specific
1997 ozone and PM2.5 NAAQS). Significantly, neither the 2007
Guidance nor the 2009 Guidance explicitly referred to the SSM,
director's discretion, minor source NSR, or NSR Reform issues as among
specific substantive issues EPA expected states to address in the
context of the infrastructure SIPs, nor did EPA give any more specific
recommendations with respect to how states might address such issues
even if they elected to do so. The SSM and director's discretion issues
implicate section 110(a)(2)(A), and the minor source NSR and NSR Reform
issues implicate section 110(a)(2)(C). In the 2007 Guidance and the
2009 Guidance, however, EPA did not indicate to states that it intended
to interpret these provisions as requiring a substantive submission to
address these specific issues in existing SIP provisions in the context
of the infrastructure SIPs for these NAAQS. Instead, EPA's 2007
Guidance merely indicated its belief that the states should make
submissions in which they established that they have the basic SIP
structure necessary to implement, maintain, and enforce the NAAQS. EPA
believes that states can establish that they have the basic SIP
structure, notwithstanding that there may be potential deficiencies
within the existing SIP. Thus, EPA's proposals for other states
mentioned these issues not because the Agency considers them issues
that must be addressed in the context of an infrastructure SIP as
required by section 110(a)(1) and (2), but rather because EPA wanted to
be clear that it considers these potential existing SIP problems as
separate from the pending infrastructure SIP actions. The same holds
true for this action on the infrastructure SIPs for Mississippi.
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    \15\ See ``Guidance on SIP Elements Required Under Sections
110(a)(1) and (2) for the 2006 24-Hour Fine Particle
(PM2.5) National Ambient Air Quality Standards (NAAQS),''
from William T, Harnett, Director Air Quality Policy Division, to
Regional Air Division Directors, Regions I-X, dated September 25,
2009 (the ``2009 Guidance'').
---------------------------------------------------------------------------

    EPA believes that this approach to the infrastructure SIP
requirement is reasonable because it would not be feasible to read
section 110(a)(1) and (2) to require a top to bottom, stem to stern,
review of each and every provision of an existing SIP merely for
purposes of assuring that the state in question has the basic
structural elements for a functioning SIP for a new or revised NAAQS.
Because SIPs have grown by accretion over the decades as statutory and
regulatory requirements under the CAA have evolved, they may include
some outmoded provisions and historical artifacts that, while not fully
up to date, nevertheless may not pose a significant problem for the
purposes of ``implementation, maintenance, and enforcement'' of a new
or revised NAAQS when EPA considers the overall effectiveness of the
SIP. To the contrary, EPA believes that a better approach is for EPA to
determine which specific SIP elements from section 110(a)(2) are
applicable to an infrastructure SIP for a given NAAQS, and to focus
attention on those elements that are most likely to need a specific SIP
revision in light of the new or revised NAAQS. Thus, for example, EPA's
2007 Guidance specifically directed states to focus on the requirements
of section 110(a)(2)(G) for the 1997 PM2.5 NAAQS because of
the absence of underlying EPA regulations for emergency episodes for
this NAAQS and an anticipated absence of relevant provisions in
existing SIPs.
    Finally, EPA believes that its approach is a reasonable reading of
section 110(a)(1) and (2) because the statute provides other avenues
and mechanisms to address specific substantive deficiencies in existing
SIPs. These other statutory tools allow the Agency to take appropriate
tailored action, depending upon the nature and severity of the alleged
SIP deficiency. Section 110(k)(5) authorizes EPA to issue a ``SIP
call'' whenever the Agency determines that a state's SIP is
substantially inadequate to attain or maintain the NAAQS, to mitigate
interstate transport, or otherwise to comply with the CAA.\16\ Section

110(k)(6) authorizes EPA to correct errors in past actions, such as
past approvals of SIP submissions.\17\ Significantly, EPA's
determination that an action on the infrastructure SIP is not the
appropriate time and place to address all potential existing SIP
problems does not preclude the Agency's subsequent reliance on
provisions in section 110(a)(2) as part of the basis for action at a
later time. For example, although it may not be appropriate to require
a state to eliminate all existing inappropriate director's discretion
provisions in the course of acting on the infrastructure SIP, EPA
believes that section 110(a)(2)(A) may be among the statutory bases
that the Agency cites in the course of addressing the issue in a
subsequent action.\18\
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    \16\ EPA has recently issued a SIP call to rectify a specific
SIP deficiency related to the SSM issue. See, ``Finding of
Substantial Inadequacy of Implementation Plan; Call for Utah State
Implementation Plan Revision,'' 76 FR 21639 (April 18, 2011).
    \17\ EPA has recently utilized this authority to correct errors
in past actions on SIP submissions related to PSD programs. See
``Limitation of Approval of Prevention of Significant Deterioration
Provisions Concerning Greenhouse Gas Emitting-Sources in State
Implementation Plans; Final Rule,'' 75 FR 82536 (December 30, 2010).
EPA has previously used its authority under CAA 110(k)(6) to remove
numerous other SIP provisions that the Agency determined it had
approved in error. See 61 FR 38664 (July 25, 1996) and 62 FR 34641
(June 27, 1997) (corrections to American Samoa, Arizona, California,
Hawaii, and Nevada SIPs); 69 FR 67062 (November 16, 2004)
(corrections to California SIP); and 74 FR 57051 (November 3, 2009)
(corrections to Arizona and Nevada SIPs).
    \18\ EPA has recently disapproved a SIP submission from Colorado
on the grounds that it would have included a director's discretion
provision inconsistent with CAA requirements, including section
110(a)(2)(A). See 75 FR 42342, 42344 (July 21, 2010) (proposed
disapproval of director's discretion provisions); 76 FR 4540
(January 26, 2011) (final disapproval of such provisions).
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V. What is EPA's analysis of how Mississippi addressed element (G) of
Section 110(a)(1) and (2) ``infrastructure'' provisions?

    The Mississippi infrastructure submission address the provision of
section 110(a)(2) with respect to element (G), as described below.
    110(a)(2)(G) Emergency episodes: Section 110(a)(2)(G) requires
states to provide for authority to address activities causing imminent
and substantial endangerment to public health, including contingency
plans to implement the emergency episode provisions in their SIPs. On
September 25, 2009, EPA released the guidance entitled ``Guidance on
SIP Elements Required Under Sections 110(a)(1) and (2) for the 2006 24-
Hour Fine Particulate (PM2.5) National Ambient Air Quality
Standards (NAAQS).'' This guidance clarified that ``to address the
section 110(a)(2)(G) element, states with air quality control regions
identified as either Priority I, IA, or Priority II by the `Prevention
of Air Pollution Emergency Episodes' rule at 40 CFR 51.150, must
develop emergency episode contingency plans.'' EPA's September 25,
2009, guidance also states that ``until the Agency finalized changes to
the emergency episode regulation to establish for PM2.5
specific levels for classifying areas as Priority I, IA, or II for
PM2.5, and to establish a significant harm level (SHL) * *
*,'' it recommends that states with a 24-Hour PM2.5
concentration above 140 [micro]g/m\3\ (using the most recent three
years of data) develop an emergency episode plan. For states where this
level has not been exceeded, the state can certify that it has
appropriate general emergency powers to address PM2.5
related episodes, and that no specific emergency episode plans are
needed at this time.
    On December 7, 2007, and October 6, 2009, MDEQ made submissions to
EPA certifying that its SIP adequately addressed the section
110(a)(2)(G) requirements for the 1997 and 2006 PM2.5 NAAQS,
because it is a Class III Priority Area and is exempt from adopting
emergency episode plan for the PM2.5 NAAQS. However,
Mississippi had not previously public noticed its submissions with
regard to 110(a)(2)(G) for the PM2.5 NAAQS, so on June 16,
2012, Mississippi provided public notice for this element.
    EPA has reviewed Mississippi's July 13, 2012, draft SIP revision
(requesting parallel processing) and has made the preliminary
determination, that this draft SIP revision, and in combination with
Mississippi's December 7, 2007, and October 6, 2009, submissions meet
the requirements of 110(a)(2)(G). Given the State's monitored
PM2.5 levels, EPA is proposing that Mississippi is not
required to submit an emergency episode plan and contingency measures
at this time, for the 1997 and 2006 PM2.5 standards. As a
result, EPA is proposing to approve Mississippi's infrastructure
submissions for the 1997 and 2006 PM2.5 NAAQS as these
submissions related to the section 110(a)(2)(G) requirement. EPA has
made the preliminary determination that Mississippi's SIP and practices
are adequate for emergency powers related to the 1997 and 2006
PM2.5 NAAQS.

VI. Proposed Action

    As described above, EPA is proposing to approve Mississippi's July
13, 2012, draft SIP revision to incorporate provisions into the
Mississippi SIP to address section 110(a)(2)(G) of the CAA.
Specifically, EPA is proposing to approve Mississippi's December 7,
2007, October 6, 2009, and July 13, 2012, submissions addressing
section 110(a)(2)(G), of the CAA for both the 1997 and 2006
PM2.5 NAAQS because they are consistent with section 110 of
the CAA.

VII. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule does not have tribal implications
as specified by Executive Order 13175 (65 FR 67249,

November 9, 2000), because the SIP is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen dioxide, Particulate Matter, Reporting and
recordkeeping requirements, Volatile organic compounds.

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

    Dated: July 20, 2012.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 2012-18653 Filed 7-30-12; 8:45 am]
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