[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Notices]
[Pages 11793-11796]
[FR Doc No: 2014-04560]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0053]

Revised Draft Guidance for Industry on Distributing Scientific
and Medical Publications on Unapproved New Uses--Recommended Practices;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised draft guidance for industry entitled
``Distributing Scientific and Medical Publications on Unapproved New
Uses--Recommended Practices.'' This draft guidance revises the final
guidance titled ``Good Reprint Practices for the Distribution of
Medical Journal Articles and Medical or Scientific Reference
Publications on Unapproved New Uses of Approved Drugs and Approved or
Cleared Medical Devices'' published in January 2009. The revised draft
guidance provides guidance on FDA's current thinking on recommended
practices for drug or medical device manufacturers and their
representatives to follow when distributing to health care
professionals or health care entities scientific or medical journal
articles, scientific or medical reference texts, or clinical practice
guidelines ((CPGs); all three collectively referred to as ``scientific
and medical publications'') that discuss unapproved new uses for
approved drugs or approved or cleared medical devices marketed in the
United States.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comments on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 2, 2014. Submit either electronic or written comments
on the proposed collection of information by May 2, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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; to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448; or to the
Division of Small Manufacturers, International and Consumer Assistance,
Office of Communication, Education and Radiation Programs, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist the office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance 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.

FOR FURTHER INFORMATION CONTACT:
    Regarding prescription drugs: Bryant Godfrey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave, Bldg. 51, Rm. 3258, Silver Spring, MD 20993-0002, 301-
796-1200.
    Regarding prescription biological products: Stephen Ripley, Center
for Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>.
    Regarding medical devices: Deborah Wolf, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3414, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Distributing Scientific and Medical Publications on
Unapproved New Uses--Recommended Practices.'' This draft guidance
describes recommended practices for drug or medical device
manufacturers or their representatives to follow when distributing to
health care professionals or health care entities scientific and
medical publications that discuss unapproved new uses of approved drugs
or approved or cleared medical devices.
    In January 2009, FDA published a final guidance titled ``Good
Reprint Practices for the Distribution of Medical Journal Articles and
Medical or Scientific Reference Publications on Unapproved New Uses of
Approved Drugs and Approved or Cleared Medical Devices,'' which set
forth the Agency's thinking as of that time regarding the dissemination
by manufacturers of medical journal articles and scientific or medical
reference publications that discuss unapproved or uncleared uses of
medical products.\1\ FDA received comments to the docket for the 2009
guidance, including submissions requesting clarification of how the
principles set forth in the 2009 guidance would apply to medical
textbooks and potential changes to those principles.
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    \1\ Please visit http://www.regulations.gov and enter docket
number FDA-2008-D-0053.
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    In July 2011 and September 2013, FDA received citizen petitions,
filed on behalf of multiple prescription drug and medical device
manufacturers, that include several requests related to FDA's approach
to the distribution of scientific and medical information reflecting
unapproved or uncleared uses, specifically including CPGs.\2\ FDA
continues to consider the specific requests made in the citizen
petitions, which include requests for issuance or revision of
regulations, and has not yet reached a final determination on those
petitions.
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    \2\ Please visit http://www.regulations.gov and enter docket
numbers FDA-2011-P-0512 and FDA-2013-P-1079.
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    At the same time, FDA continues actively to review, analyze, and
develop approaches to a variety of topics of interest to industry and
others, including issues raised in the petition. As part of this
process, FDA is soliciting public comment on the draft guidance made
available here. Similarly, as part of the Agency's ongoing efforts to
address industry questions, FDA continues to solicit public input and
consider approaches with respect to several related issues, including
the following:
    (1) Further explaining ``scientific exchange.'' On December 28,
2011, FDA issued a Federal Register notice (76 FR 81508) opening a
docket and requesting comments and information related to ``scientific
exchange.'' Comments were submitted to Docket No. FDA-2011-N-0912. FDA
is reviewing those comments and considering how that information may
inform future Agency action related to its policies on communications
and activities related to unapproved or uncleared uses of marketed
drugs and devices, as well as communications and activities related to
use of products that are not yet legally marketed for any use.

    (2) Developing guidance on the issue of manufacturer responses to
unsolicited requests for information relating to unapproved or
uncleared uses. In December 2011, FDA issued a draft guidance entitled
``Responding to Unsolicited Requests for Off-Label Information About
Prescription Drugs and Medical Devices.'' FDA is currently considering
comments on that draft guidance to inform its further action on this
topic.
    (3) Considering draft guidance on industry interactions with
formulary committees, payors, and similar entities. This includes
clarifying the Agency's interpretation of several terms included in
section 114 of the Food and Drug Administration Modernization Act of
1997 (Pub. L. 105-115) and the Agency's recommendations for evidentiary
support for health care economic information included in promotional
materials disseminated to formulary committees and similar entities.
    Among the other issues under evaluation, FDA is considering a range
of options for responding to questions about industry participation in
scientific discussions and for addressing industry dissemination of new
scientific information related to approved or cleared uses of marketed
drugs and devices.
    FDA is soliciting public comment on the revised draft guidance made
available here, which presents recommended practices for drug or
medical device manufacturers and their representatives to follow if
they choose to distribute to health care professionals or health care
entities scientific or medical journal articles, scientific or medical
reference texts, or CPGs that discuss unapproved or uncleared uses of
legally marketed drugs and devices. If the recommended practices are
followed, FDA does not intend to use distribution of these publications
as evidence of the manufacturer's intent that the product be used for
an unapproved new use. FDA is issuing the revised guidance in draft
form to enable the public to provide comments on the proposed
recommendations.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115) and, when finalized, will
represent the Agency's current thinking on the topic. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

II. The Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following topics: (1)
Whether the proposed information collected is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimated burden of
the proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Distributing Scientific and Medical Publications on
Unapproved New Uses--Recommended Practices.
    Description of Respondents: Respondents to this collection of
information are manufacturers and distributors (firms) of approved drug
products or approved/cleared medical devices.
    Burden Estimate: The draft guidance pertains to the distribution of
scientific and medical publications by FDA-regulated industry that
discuss unapproved new uses for approved or cleared products. The draft
guidance explains that FDA's current position is that if a manufacturer
follows the recommendations as described in the draft guidance, FDA
does not intend to use the distribution of the scientific and medical
publications as evidence of intent that the product be used for an
unapproved new use. Because the draft guidance recommends that
scientific and medical publications reflecting unapproved or uncleared
uses that are distributed have certain characteristics, and that
certain other information be distributed with them, the guidance
recommends a ``third-party disclosure'' that constitutes a ``collection
of information'' under the PRA.
    The draft guidance provides recommendations regarding the
characteristics of scientific and medical publications that companies
may choose to distribute. Elaborated in more detail in the draft
guidance, these characteristics in general include that these
publications be from journals, scientific or medical reference texts,
and CPGs that are produced by independent sources and meet criteria for
professional/peer review; be based on specified types of scientific
evidence; and be complete, unabridged, and without highlighting or
characterization by the manufacturer. In addition, the draft guidance
provides recommendations for additional information to be supplied with
the publications.
    Specifically, the draft guidance recommends the following:
    Scientific or medical journal articles should:
     Be disseminated with the approved labeling or, in the case
of a medical device reviewed under section 510(k) of the FD&C Act (21
U.S.C. 360(k)), labeling for the indications in the product's cleared
indications for use statement, for each of the manufacturer's products
that is included in the distributed article.
     Be disseminated with a comprehensive bibliography, when
such information exists, of publications discussing adequate and well-
controlled clinical studies published in scientific journals, medical
journals, or scientific texts about the use of the drug or medical
device covered by the information disseminated (unless the information
already includes such a bibliography).
     Be disseminated with a representative publication, when
such information exists, that reaches contrary or different conclusions
regarding the unapproved use--especially when the conclusions of
articles to be disseminated have been specifically called into question
by another publication.
     Be accompanied by a prominently displayed and permanently
affixed statement disclosing:
    [cir] The drug(s) or device(s) included in the journal reprint in
which the manufacturer has an interest;
    [cir] That some or all uses of the manufacturer's drugs or devices
described in the information have not

been approved or cleared by FDA, as applicable to the described drug(s)
or device(s);
    [cir] Any author known to the manufacturer as having a financial
interest in the manufacturer or in a product of the manufacturer that
is included in the journal article, or who is receiving compensation
from the manufacturer, along with the affiliation of the author, to the
extent known by the manufacturer, and the nature and amount of any such
financial interest of the author or compensation received by the author
from the manufacturer;
    [cir] Any person known to the manufacturer who has provided funding
for the study;
    [cir] All significant risks or safety concerns associated with the
unapproved use(s) of the manufacturer's product(s) discussed in the
journal article that are known to the manufacturer but not discussed in
the journal article.
    Scientific or medical reference texts should:
     When distributed in their entirety by a manufacturer:
    [cir] Contain a prominently displayed and permanently affixed
statement identifying the distributing manufacturer and disclosing that
some of the uses for drugs and/or devices described in the reference
text might not be approved or cleared by FDA. The statement should also
disclose that the author(s) of some chapters also might have a
financial interest in the manufacturer or its products, unless the
manufacturer has verified that none of the authors for the reference
text has a financial interest in the manufacturer or a product being
written about.\3\ This statement should be placed by sticker, stamp, or
other similar means on the front cover of the textbook;
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    \3\ If a reference text is distributed in its entirety with this
statement affixed, manufacturers are not expected to have reviewed
every element of the reference text to identify discussions of off-
label uses of their products. However, even where an entire
reference text is being distributed, manufacturers should determine
whether one or more individual chapters of that reference text
devote primary substantive discussion to an individual product or
products of the manufacturer distributing it, in order to determine
whether dissemination of product labeling is recommended.
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    [cir] In situations where a reference text is distributed in its
entirety but one or more individual chapters of that reference text
devote primary substantive discussion to an individual product or
products of the manufacturer distributing it, be disseminated with the
approved product labeling for each such product or, in the case of a
medical device reviewed under section 510(k) of the FD&C Act, labeling
for the indications in the product's cleared indications for use
statement.
     If, in lieu of an entire scientific or medical reference
text, a manufacturer distributes an individual chapter(s) that includes
information on unapproved/uncleared uses of the manufacturer's
product(s), the chapter(s) should:
    [cir] When necessary to provide context, be disseminated with other
unaltered/unabridged chapters extracted directly from the same
scientific or medical reference text, such as chapters which provide
related or supportive information;
    [cir] Contain a prominently displayed and permanently affixed
statement identifying the distributing manufacturer and disclosing: (1)
The drug(s) or device(s) addressed in the individual chapter(s) in
which the manufacturer has an interest; (2) that some or all uses of
the manufacturer's drugs and/or devices described in the ensuing
information have not been approved or cleared by FDA, as applicable to
the described drug(s) or medical device(s); (3) any author known to the
manufacturer as having a financial interest in the manufacturer or in a
product of the manufacturer that is included in the individual
chapter(s), or who is receiving compensation from the manufacturer,
along with the affiliation of the author, to the extent known by the
manufacturer, and the nature and amount of any such financial interest
of the author or compensation received by the author from the
manufacturer; and (4) all significant risks or safety concerns
associated with the unapproved use(s) of the manufacturer's products
discussed in the individual chapter(s) that are known to the
manufacturer but not discussed in the chapter(s);
    [cir] Be disseminated with the approved labeling, or, in the case
of a medical device reviewed under section 510(k) of the FD&C Act,
labeling for the indications in the cleared indications for use
statement, for each of the manufacturer's products that are included in
the distributed chapter(s).
    CPGs should:
     When distributed by a manufacturer in their entirety:
    [cir] Contain a prominently displayed and permanently affixed
statement identifying the distributing manufacturer and disclosing that
some of the uses of drugs and/or devices described in the CPG might not
be approved or cleared by FDA. The statement should also disclose that
the author(s) of some sections might have a financial interest in the
manufacturer or its products, unless the manufacturer has verified that
none of the authors for the CPG has a financial interest in the
manufacturer or a product being written about. This statement should be
placed by sticker, stamp, or other similar means on the front page of
the CPG.
    [cir] In situations where a CPG is distributed in its entirety but
one or more individual sections of that CPG devotes primary substantive
discussion to an individual product or products of the manufacturer
distributing it, be disseminated with the approved product labeling for
each such product or, in the case of a medical device reviewed under
section 510(k) of the FD&C Act, labeling for the indications in the
product's cleared indications for use statement.
     If, in lieu of an entire CPG, a manufacturer distributes
an individual section(s) that includes information on unapproved/
uncleared uses of the manufacturer's product(s), the section(s) should:
    [cir] When necessary to provide context, be disseminated with other
unaltered/unabridged sections extracted directly from the same CPG,
such as sections which provide related or supportive information;
    [cir] Contain a prominently displayed and permanently affixed
statement identifying the distributing manufacturer and disclosing: (1)
The drug(s) or device(s) addressed in the individual section(s) in
which the manufacturer has an interest; (2) that some or all uses of
the manufacturer's drugs and/or devices described in the attached
information have not been approved or cleared by FDA, as applicable to
the described drug(s) or medical device(s); (3) any author known to the
manufacturer as having a financial interest in the manufacturer or in a
product of the manufacturer that is included in the individual
section(s), or who is receiving compensation from the manufacturer,
along with the affiliation of the author, to the extent known by the
manufacturer, and the nature and amount of any such financial interest
of the author or compensation received by the author from the
manufacturer; and (4) all significant risks or safety concerns
associated with the unapproved use(s) of the manufacturer's products
discussed in the individual section(s) that are known to the
manufacturer but not discussed in the section(s).
    [cir] Be disseminated with the approved labeling, or, in the case
of a medical device reviewed under section 510(k) of the FD&C Act,
labeling for the indications in the cleared indications for use
statement, for each of the manufacturer's products that is included in
the distributed section(s).

    FDA estimates that approximately 400 firms (``number of
respondents'' in table 1) distribute scientific and medical
publications that discuss unapproved new uses for FDA-approved or -
cleared products. FDA also estimates that each firm would include some
or all of the additional information described previously when
distributing annually a total of approximately 40,000 scientific or
medical journal articles, scientific or medical reference texts, or
CPGs (``total annual disclosures'' in table 1) that discuss unapproved
new uses for FDA-approved or -cleared products. FDA estimates that it
will take each firm approximately 4 hours (``hours per disclosure'' in
table 1) to make the disclosures recommended in this draft guidance.

                           Table 1--Estimated Annual Third Party Disclosure Burden \1\
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 Draft guidance on distributing
     scientific and medical          Number of        Number of      Total annual       Average
  information on unapproved new     respondents   disclosures  per    disclosures     burden per     Total hours
              uses                                   respondent                       disclosure
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Distribution of scientific and              400               100          40,000               4       160,000
 medical information on
 unapproved new uses............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Comments

    Interested persons may submit either electronic comments regarding
this document 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or http://www.regulations.gov.

    Dated: February 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04560 Filed 2-28-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 27 (Wednesday, February 10, 2016)]
[Proposed Rules]
[Pages 7046-7055]
[FR Doc No: 2016-02567]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R06-OAR-2015-0852; FRL-9942-13-Region 6]

Air Plan Approval and Designation of Areas; AR; Redesignation of
the Crittenden County, 2008 8-Hour Ozone Nonattainment Area to
Attainment

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: On December 10, 2015, the State of Arkansas, through the
Arkansas Department of Environmental Quality (ADEQ), submitted a
request for the Environmental Protection Agency (EPA) to redesignate
the portion of Arkansas that is within the Memphis, Tennessee-
Mississippi-Arkansas (Memphis, TN-MS-AR) 2008 8-hour ozone
nonattainment area (hereafter referred to as the ``Memphis, TN-MS-AR
Area'' or ``Area'') and to approve a State Implementation Plan (SIP)
revision containing a maintenance plan for the Area. EPA is proposing
to determine that the Memphis, TN-MS-AR Area is continuing to attain
the 2008 8-hour ozone national ambient air quality standards (NAAQS);
to approve the State's plan for maintaining attainment of the 2008 8-
hour ozone standard in the Area, including the motor vehicle emission
budgets (MVEBs) for nitrogen oxides (NOX) and volatile
organic compounds (VOC) for the years 2012 and 2027 for the Arkansas
portion of the Area, into the SIP; and to redesignate the Arkansas
portion of the Area to attainment for the 2008 8-hour ozone NAAQS. EPA
is also notifying the public of the status of EPA's adequacy
determination for the MVEBs for the Arkansas portion of the Memphis,
TN-MS-AR Area.

DATES: Comments must be received on or before March 11, 2016.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2015-0852, at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e. on the web, cloud, or other file sharing system). For
additional submission methods, please contact Jeffrey Riley, (214) 665-
8542<EMAIL_ADDRESS>For the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at the EPA
Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available at either location
(e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Jeffrey Riley,<PHONE_NUMBER>,
<EMAIL_ADDRESS>To inspect the hard copy materials, please
schedule an appointment with Mr. Riley or Mr. Bill Deese at 214-665-
7253.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What are the actions EPA is proposing to take?
II. What is the background for EPA's proposed actions?
III. What are the criteria for redesignation?
IV. Why is EPA proposing these actions?
V. What is EPA's analysis of the request?
VI. What is EPA's analysis of Arkansas' proposed NOX and
VOC MVEBs for the Arkansas portion of the area?
VII. What is the status of EPA's adequacy determination for the
proposed NOX and VOC MVEBs the arkansas portion of the
area?
VIII. What is the effect of EPA's proposed actions?
IX. Proposed Actions
X. Statutory and Executive Order Reviews

I. What are the actions EPA is proposing to take?

    EPA is proposing to take the following three separate but related
actions, one of which involves multiple elements: (1) To determine that
the Memphis, TN-MS-AR Area is continuing to attain the 2008 8-hour
ozone NAAQS; \1\ (2) to

approve Arkansas' plan for maintaining the 2008 8-hour ozone NAAQS
(maintenance plan), including the associated MVEBs for the Arkansas
portion of the Memphis, TN-MS-AR Area, into the SIP; and (3) to
redesignate the Arkansas portion of the Memphis, TN-MS-AR Area to
attainment for the 2008 8-hour ozone NAAQS. EPA is also notifying the
public of the status of EPA's adequacy determination for the MVEBs for
the Arkansas portion of the Memphis, TN-MS-AR Area. The Memphis, TN-MS-
AR Area consists of a portion of DeSoto County in Mississippi, all of
Shelby County in Tennessee and all of Crittenden County in Arkansas.
Today's proposed actions are summarized below and described in greater
detail throughout this notice of proposed rulemaking.
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    \1\ On August 27, 2015, EPA published a proposed rulemaking
entitled ``Determinations of Attainment by the Attainment Date,
Extensions of the Attainment Date, and Reclassification of Several
Areas Classified as Marginal for the 2008 Ozone National Ambient Air
Quality Standards'' where the Agency proposed to determine that the
Memphis, TN-MS-AR area had attained the 2008 8-hour ozone NAAQS, by
the applicable attainment date of July 20, 2015, based on 2012-2014
monitoring data. See 80 FR 51992. EPA is contemplating the final
action for this proposed rule under a separate rulemaking from
today's rulemaking.
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    EPA is proposing to make the determination that the Memphis, TN-MS-
AR Area is continuing to attain the 2008 8-hour ozone NAAQS based on
recent air quality data and proposing to approve Arkansas' maintenance
plan for its portion of the Memphis, TN-MS-AR Area as meeting the
requirements of section 175A (such approval being one of the Clean Air
Act (CAA or Act) criteria for redesignation to attainment status). The
maintenance plan is designed to keep the Memphis, TN-MS-AR Area in
attainment of the 2008 8-hour ozone NAAQS through 2027. The maintenance
plan includes 2012 and 2027 MVEBs for NOX and VOC for the
Arkansas portion of the Memphis, TN-MS-AR Area for transportation
conformity purposes. EPA is proposing to approve these MVEBs and
incorporate them into the Arkansas SIP.
    EPA also proposes to determine that the Arkansas portion of the
Memphis, TN-MS-AR Area has met the requirements for redesignation under
section 107(d)(3)(E) of the CAA. Accordingly, in this action, EPA is
proposing to approve a request to change the legal designation of
Crittenden County within the Arkansas portion of the Memphis, TN-MS-AR
Area, as found at 40 CFR part 81, from nonattainment to attainment for
the 2008 8-hour ozone NAAQS.
    EPA is also notifying the public of the status of EPA's adequacy
process for the 2012 and 2027 NOX and VOC MVEBs for the
Arkansas portion of the Memphis, TN-MS-AR Area. The Adequacy comment
period began on December 16, 2015, with EPA's posting of the
availability of Arkansas' submissions on EPA's Adequacy Web site
(http://www3.epa.gov/otaq/stateresources/transconf/currsips.htm). The
Adequacy comment period for these MVEBs closed on January 11, 2016. No
comments, adverse, or otherwise, were received during the Adequacy
comment period. Please see section VII of this proposed rulemaking for
further explanation of this process and for more details on the MVEBs.
    In summary, today's notice of proposed rulemaking is in response to
Arkansas' December 10, 2015, redesignation request and associated SIP
submission that address the specific issues summarized above and the
necessary elements described in section 107(d)(3)(E) of the CAA for
redesignation of the Arkansas portion of the Memphis, TN-MS-AR Area to
attainment for the 2008 8-hour ozone NAAQS.

II. What is the background for EPA's proposed actions?

    On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of
0.075 parts per million (ppm). See 73 FR 16436 (March 27, 2008). Under
EPA's regulations at 40 CFR part 50, the 2008 8-hour ozone NAAQS is
attained when the 3-year average of the annual fourth highest daily
maximum 8-hour average ambient air quality ozone concentrations is less
than or equal to 0.075 ppm. See 40 CFR 50.15. Ambient air quality
monitoring data for the 3-year period must meet a data completeness
requirement. The ambient air quality monitoring data completeness
requirement is met when the average percent of days with valid ambient
monitoring data is greater than 90 percent, and no single year has less
than 75 percent data completeness as determined in Appendix I of part
50.
    Upon promulgation of a new or revised NAAQS, the CAA requires EPA
to designate as nonattainment any area that is violating the NAAQS,
based on the three most recent years of complete, quality assured, and
certified ambient air quality data at the conclusion of the designation
process. The Memphis, TN-MS-AR Area was designated nonattainment for
the 2008 8-hour ozone NAAQS on May 21, 2012 (effective July 20, 2012)
using 2008-2010 ambient air quality data. See 77 FR 30088 (May 21,
2012). At the time of designation, the Memphis, TN-MS-AR Area was
classified as a marginal nonattainment area for the 2008 8-hour ozone
NAAQS. In the final implementation rule for the 2008 8-hour ozone NAAQS
(SIP Implementation Rule),\2\ EPA established ozone nonattainment area
attainment dates based on Table 1 of section 181(a) of the CAA. This
rule established an attainment date three years after the July 20,
2012, effective date of designation for areas classified as marginal
for the 2008 8-hour ozone nonattainment designations.\3\ Therefore, the
Memphis, TN-MS-AR Area's attainment date was July 20, 2015.
---------------------------------------------------------------------------

    \2\ This rule, entitled Implementation of the 2008 National
Ambient Air Quality Standards for Ozone: State Implementation Plan
Requirements and published at 80 FR 12264 (March 6, 2015), addresses
a range of nonattainment area SIP requirements for the 2008 ozone
NAAQS, including requirements pertaining to attainment
demonstrations, reasonable further progress (RFP), reasonably
available control technology (RACT), reasonably available control
measures (RACM), major new source review (NSR), emission
inventories, and the timing of SIP submissions and of compliance
with emission control measures in the SIP. This rule also addresses
the revocation of the 1997 ozone NAAQS and the anti-backsliding
requirements that apply when the 1997 ozone NAAQS are revoked.
    \3\ The SIP Implementation Rule modified 40 CFR 51.1103 to
establish attainment dates that run from the effective date of
designation, i.e., July 20, 2012. This action was in response to the
D.C. Circuit's decision in NRDC v. EPA (D.C. Cir. No. 12-1321) (Dec.
23, 2014). The Court's decision held ``that the EPA's decision to
run the attainment periods from the end of the calendar year in
which areas were designated was unreasonable.'' 80 FR 12264, at
12268.
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III. What are the criteria for redesignation?

    The CAA provides the requirements for redesignating a nonattainment
area to attainment. Specifically, section 107(d)(3)(E) of the CAA
allows for redesignation providing that: (1) The Administrator
determines that the area has attained the applicable NAAQS; (2) the
Administrator has fully approved the applicable implementation plan for
the area under section 110(k); (3) the Administrator determines that
the improvement in air quality is due to permanent and enforceable
reductions in emissions resulting from implementation of the applicable
SIP and applicable Federal air pollutant control regulations and other
permanent and enforceable reductions; (4) the Administrator has fully
approved a maintenance plan for the area as meeting the requirements of
section 175A; and, (5) the state containing such area has met all
requirements applicable to the area for purposes of redesignation under
section 110 and part D of the CAA.
    On April 16, 1992, EPA provided guidance on redesignation in the
General Preamble for the Implementation of title I of the CAA
Amendments of 1990 (57 FR 13498), and supplemented this guidance on

April 28, 1992 (57 FR 18070). EPA has provided further guidance on
processing redesignation requests in the following documents:

    1. ``Ozone and Carbon Monoxide Design Value Calculations,''
Memorandum from Bill Laxton, Director, Technical Support Division,
June 18, 1990;
    2. ``Maintenance Plans for Redesignation of Ozone and Carbon
Monoxide Nonattainment Areas,'' Memorandum from G. T. Helms, Chief,
Ozone/Carbon Monoxide Programs Branch, April 30, 1992;
    3. ``Contingency Measures for Ozone and Carbon Monoxide (CO)
Redesignations,'' Memorandum from G. T. Helms, Chief, Ozone/Carbon
Monoxide Programs Branch, June 1, 1992;
    4. ``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' Memorandum from John Calcagni, Director, Air Quality
Management Division, September 4, 1992 (hereafter referred to as the
``Calcagni Memorandum'');
    5. ``State Implementation Plan (SIP) Actions Submitted in
Response to Clean Air Act (CAA) Deadlines,'' Memorandum from John
Calcagni, Director, Air Quality Management Division, October 28,
1992;
    6. ``Technical Support Documents (TSDs) for Redesignation of
Ozone and Carbon Monoxide (CO) Nonattainment Areas,'' Memorandum
from G. T. Helms, Chief, Ozone/Carbon Monoxide Programs Branch,
August 17, 1993;
    7. ``State Implementation Plan (SIP) Requirements for Areas
Submitting Requests for Redesignation to Attainment of the Ozone and
Carbon Monoxide (CO) National Ambient Air Quality Standards (NAAQS)
On or After November 15, 1992,'' Memorandum from Michael H. Shapiro,
Acting Assistant Administrator for Air and Radiation, September 17,
1993;
    8. ``Use of Actual Emissions in Maintenance Demonstrations for
Ozone and CO Nonattainment Areas,'' Memorandum from D. Kent Berry,
Acting Director, Air Quality Management Division, November 30, 1993;
    9. ``Part D New Source Review (Part D NSR) Requirements for
Areas Requesting Redesignation to Attainment,'' Memorandum from Mary
D. Nichols, Assistant Administrator for Air and Radiation, October
14, 1994; and
    10. ``Reasonable Further Progress, Attainment Demonstration, and
Related Requirements for Ozone Nonattainment Areas Meeting the Ozone
National Ambient Air Quality Standard,'' Memorandum from John S.
Seitz, Director, Office of Air Quality Planning and Standards, May
10, 1995.

IV. Why is EPA proposing these actions?

    On December 10, 2015, the State of Arkansas, through ADEQ,
requested that EPA redesignate the Arkansas portion of the Memphis, TN-
MS-AR Area to attainment for the 2008 8-hour ozone NAAQS. EPA's
evaluation indicates that the entire Memphis, TN-MS-AR Area has
attained the 2008 8-hour ozone NAAQS, and that the Arkansas portion of
the Memphis, TN-MS-AR Area meets the requirements for redesignation as
set forth in section 107(d)(3)(E), including the maintenance plan
requirements under section 175A of the CAA. As a result, EPA is
proposing to take the three related actions summarized in section I of
this notice.

V. What is EPA's analysis of the request?

    Our analysis of the State's request with respect to the five
redesignation criteria provided under CAA section 107(d)(3)(E) is
discussed in the following paragraphs of this section.

Criteria (1)--The Memphis, TN-MS-AR Area Has Attained the 2008 8-Hour
Ozone NAAQS

    For redesignating a nonattainment area to attainment, the CAA
requires EPA to determine that the area has attained the applicable
NAAQS (CAA section 107(d)(3)(E)(i)). For ozone, an area may be
considered to be attaining the 2008 8-hour ozone NAAQS if it meets the
2008 8-hour ozone NAAQS, as determined in accordance with 40 CFR 50.15
and Appendix I of part 50, based on three complete, consecutive
calendar years of quality-assured air quality monitoring data. To
attain the NAAQS, the 3-year average of the fourth-highest daily
maximum 8-hour average ozone concentrations measured at each monitor
within an area over each year must not exceed 0.075 ppm. Based on the
data handling and reporting convention described in 40 CFR part 50,
Appendix I, the NAAQS are attained if the design value is 0.075 ppm or
below. The data must be collected and quality-assured in accordance
with 40 CFR part 58 and recorded in the EPA Air Quality System (AQS).
The monitors generally should have remained at the same location for
the duration of the monitoring period required for demonstrating
attainment.
    EPA is proposing to determine that the Memphis, TN-MS-AR Area is
continuing to attain the 2008 8-hour ozone NAAQS. EPA reviewed ozone
monitoring data from monitoring stations in the Memphis, TN-MS-AR Area
for the 2008 8-hour ozone NAAQS for 2012-2014, and the design values
for each monitor in the Area are less than 0.075 ppm. These data have
been quality-assured, are recorded in Aerometric Information Retrieval
System (AIRS-AQS), and indicate that the Area is attaining the 2008 8-
hour ozone NAAQS. The fourth-highest 8-hour ozone values at each
monitor for 2012, 2013, 2014, and the 3-year averages of these values
(i.e., design values), are summarized in Table 1, below.

                  Table 1--2012-2014 Design Value Concentrations for the Memphis, TN-MS-AR Area
----------------------------------------------------------------------------------------------------------------
                                                       4th Highest 8-hour ozone value  (ppm)       3-Year design
                                                 ------------------------------------------------  values  (ppm)
           Location                   Site                                                       ---------------
                                                       2012            2013            2014          2012-2014
----------------------------------------------------------------------------------------------------------------
DeSoto, MS....................  Hernando........           0.075           0.065           0.067           0.069
Shelby, TN....................  Frayser.........           0.083           0.069           0.067           0.073
Shelby, TN....................  Orgill Park.....           0.084           0.063           0.065           0.070
Shelby, TN....................  Shelby Farms....           0.086           0.069           0.066           0.073
Crittenden, AR................  Marion..........           0.079           0.067           0.067           0.071
----------------------------------------------------------------------------------------------------------------

    The 3-year design value for 2012-2014 for the Memphis, TN-MS-AR
Area is 0.073 ppm,\4\ which meets the NAAQS. EPA has reviewed 2015
preliminary monitoring data for the Area.\5\ This preliminary data is
not yet certified to meet the QA requirements but continues to indicate
the area is meeting the NAAQS. In today's action, EPA is proposing to
determine that Memphis, TN-MS-AR Area is attaining the 2008 8-hour
ozone NAAQS. EPA will not take final action to approve the

redesignation if the 3-year design value exceeds the NAAQS prior to EPA
finalizing the redesignation. As discussed in more detail below, the
State of Arkansas has committed to continue monitoring in this Area in
accordance with 40 CFR part 58.
---------------------------------------------------------------------------

    \4\ The monitor with the highest 3-year design value is
considered the design value for the Area.
    \5\ 2012-2014 data and preliminary 2015 data is available at
EPA's air data Web site: http://aqsdr1.epa.gov/aqsweb/aqstmp/airdata/download_files.html#Daily.
---------------------------------------------------------------------------

Criteria (2)--Arkansas Has a Fully Approved SIP Under Section 110(k)
for the Arkansas Portion of the Memphis, TN-MS-AR Area; and Criteria
(5)--Arkansas Has Met All Applicable Requirements Under Section 110 and
Part D of Title I of the CAA

    For redesignating a nonattainment area to attainment, the CAA
requires EPA to determine that the state has met all applicable
requirements under section 110 and part D of title I of the CAA (CAA
section 107(d)(3)(E)(v)) and that the state has a fully approved SIP
under section 110(k) for the area (CAA section 107(d)(3)(E)(ii)). EPA
proposes to find that Arkansas has met all applicable SIP requirements
for the Arkansas portion of the Area under section 110 of the CAA
(general SIP requirements) for purposes of redesignation. Additionally,
EPA proposes to find that the Arkansas SIP satisfies the criterion that
it meets applicable SIP requirements for purposes of redesignation
under part D of title I of the CAA in accordance with section
107(d)(3)(E)(v). Further, EPA proposes to determine that the SIP is
fully approved with respect to all requirements applicable for purposes
of redesignation in accordance with section 107(d)(3)(E)(ii). In making
these determinations, EPA ascertained which requirements are applicable
to the Area and, if applicable, that they are fully approved under
section 110(k). SIPs must be fully approved only with respect to
requirements that were applicable prior to submittal of the complete
redesignation request.
a. The Arkansas Portion of the Memphis, TN-MS-AR Area Has Met All
Applicable Requirements Under Section 110 and Part D of the CAA
    General SIP requirements. General SIP elements and requirements are
delineated in section 110(a)(2) of title I, part A of the CAA. These
requirements include, but are not limited to, the following: Submittal
of a SIP that has been adopted by the state after reasonable public
notice and hearing; provisions for establishment and operation of
appropriate procedures needed to monitor ambient air quality;
implementation of a source permit program; provisions for the
implementation of part C requirements (Prevention of Significant
Deterioration (PSD)) and provisions for the implementation of part D
requirements (Nonattainment NSR permit programs); provisions for air
pollution modeling; and provisions for public and local agency
participation in planning and emission control rule development.
    Section 110(a)(2)(D) requires that SIPs contain certain measures to
prevent sources in a state from significantly contributing to air
quality problems in another state. To implement this provision, EPA has
required certain states to establish programs to address the interstate
transport of air pollutants. The section 110(a)(2)(D) requirements for
a state are not linked with a particular nonattainment area's
designation and classification in that state. EPA believes that the
requirements linked with a particular nonattainment area's designation
and classifications are the relevant measures to evaluate in reviewing
a redesignation request. The transport SIP submittal requirements,
where applicable, continue to apply to a state regardless of the
designation of any one particular area in the state. Thus, EPA does not
believe that the CAA's interstate transport requirements should be
construed to be applicable requirements for purposes of redesignation.
See 75 FR 2091, at 2095-2096.
    In addition, EPA believes other section 110 elements that are
neither connected with nonattainment plan submissions nor linked with
an area's attainment status are applicable requirements for purposes of
redesignation. The area will still be subject to these requirements
after the area is redesignated. The section 110 and part D requirements
that are linked with a particular area's designation and classification
are the relevant measures to evaluate in reviewing a redesignation
request. This approach is consistent with EPA's existing policy on
applicability (i.e., for redesignations) of conformity and oxygenated
fuels requirements, as well as with section 184 ozone transport
requirements. See Reading, Pennsylvania, proposed and final rulemakings
(61 FR 53174-53176, October 10, 1996), (62 FR 24826, May 7, 2008);
Cleveland-Akron-Loraine, Ohio, final rulemaking (61 FR 20458, May 7,
1996); and Tampa, Florida, final rulemaking at (60 FR 62748, December
7, 1995). See also the discussion on this issue in the Cincinnati,
Ohio, redesignation (65 FR 37890, June 19, 2000), and in the
Pittsburgh, Pennsylvania, redesignation (66 FR 50399, October 19,
2001).
    Title I, Part D, applicable SIP requirements. Section 172(c) of the
CAA sets forth the basic requirements of attainment plans for
nonattainment areas that are required to submit them pursuant to
section 172(b). Subpart 2 of part D, which includes section 182 of the
CAA, establishes specific requirements for ozone nonattainment areas
depending on the area's nonattainment classification. As provided in
Subpart 2, the specific requirements of section 182(a) apply in lieu of
the demonstration of attainment (and contingency measures) required by
section 172(c). 42 U.S.C. 7511a(a). A thorough discussion of the
requirements contained in sections 172(c) and 182 can be found in the
General Preamble for Implementation of Title I (57 FR 13498).
    Section 182(a) Requirements. Section 182(a)(1) requires states to
submit a comprehensive, accurate, and current inventory of actual
emissions from sources of VOC and NOX emitted within the
boundaries of the ozone nonattainment area. Arkansas provided an
emissions inventory for the Memphis, TN-MS-AR Area to EPA in an August
28, 2015 SIP submission. On January 14, 2016, EPA published a direct
final rule to approve this emissions inventory into the SIP. See 81 FR
1884.
    Under section 182(a)(2)(A), states with ozone nonattainment areas
that were designated prior to the enactment of the 1990 CAA amendments
were required to submit, within six months of classification, all rules
and corrections to existing VOC RACT rules that were required under
section 172(b)(3) of the CAA (and related guidance) prior to the 1990
CAA amendments. The Arkansas portion of the Memphis, TN-MS-AR Area is
not subject to the section 182(a)(2) RACT ``fix up'' because it was
designated as unclassifiable/attainment at that time.
    Section 182(a)(2)(B) requires each state with a marginal ozone
nonattainment area that implemented, or was required to implement, an
inspection and maintenance (I/M) program prior to the 1990 CAA
amendments to submit a SIP revision providing for an I/M program no
less stringent than that required prior to the 1990 amendments or
already in the SIP at the time of the amendments, whichever is more
stringent. The Arkansas portion of the Memphis, TN-MS-AR Area is not
subject to the section 182(a)(2)(B) because it was designated as
unclassifiable/attainment prior to 1990 and was not required to have an
I/M program.
    Regarding the permitting and offset requirements of section
182(a)(2)(C) and section 182(a)(4), Arkansas does have an approved part
D NSR program in place

(72 FR 18394, April 12, 2007). However, EPA has determined that areas
being redesignated need not comply with the requirement that a NSR
program be approved prior to redesignation, provided that the area
demonstrates maintenance of the NAAQS without part D NSR, because PSD
requirements will apply after redesignation. A more detailed rationale
for this view is described in a memorandum from Mary Nichols, Assistant
Administrator for Air and Radiation, dated October 14, 1994, entitled,
``Part D New Source Review Requirements for Areas Requesting
Redesignation to Attainment.'' Arkansas' PSD program will automatically
become applicable in the Memphis, TN-MS-AR Area upon redesignation to
attainment. Arkansas Regulation 31, Chapter 1, section 31.102
    Section 182(a)(3) requires states to submit periodic inventories
and emissions statements. Section 182(a)(3)(A) requires states to
submit a periodic inventory every three years. As discussed below in
the section of this notice titled Criteria (4)(e), Verification of
Continued Attainment, the State will continue to update its emissions
inventory at least once every three years. Under section 182(a)(3)(B),
each state with an ozone nonattainment area must submit a SIP revision
requiring emissions statements to be submitted to the state by sources
within that nonattainment area. Arkansas provided a SIP revision to EPA
on November 19, 2007, addressing the section 182(a)(3)(B) emissions
statements requirement, and on January 15, 2009, EPA published a final
rule to approve this SIP revision. See 74 FR 2383.
    Section 176 Conformity Requirements. Section 176(c) of the CAA
requires states to establish criteria and procedures to ensure that
federally supported or funded projects conform to the air quality
planning goals in the applicable SIP. The requirement to determine
conformity applies to transportation plans, programs, and projects that
are developed, funded, or approved under title 23 of the United States
Code (U.S.C.) and the Federal Transit Act (transportation conformity)
as well as to all other federally supported or funded projects (general
conformity). State transportation conformity SIP revisions must be
consistent with Federal conformity regulations relating to
consultation, enforcement, and enforceability that EPA promulgated
pursuant to its authority under the CAA.
    EPA interprets the conformity SIP requirements \6\ as not applying
for purposes of evaluating a redesignation request under section 107(d)
because state conformity rules are still required after redesignation
and Federal conformity rules apply where state rules have not been
approved. See Wall v. EPA, 265 F.3d 426 (6th Cir. 2001) (upholding this
interpretation); see also 60 FR 62748 (December 7, 1995) (redesignation
of Tampa, Florida). Crittenden County does not currently have fully
approved conformity rules, but as mentioned, the Federal conformity
rules apply, and a Memorandum of Agreement outlining interagency
consultation procedures is in place for transportation conformity
purposes.
---------------------------------------------------------------------------

    \6\ CAA section 176(c)(4)(E) requires states to submit revisions
to their SIPs to reflect certain Federal criteria and procedures for
determining transportation conformity. Transportation conformity
SIPs are different from the MVEBs that are established in control
strategy SIPs and maintenance plans.
---------------------------------------------------------------------------

    EPA proposes that the Arkansas portion of the Memphis, TN-MS-AR
Area has satisfied all applicable requirements for purposes of
redesignation under section 110 and part D of title I of the CAA.
b. The Arkansas Portion of the Memphis, TN-MS-AR Area Has a Fully
Approved Applicable SIP Under Section 110(k) of the CAA
    EPA has fully approved the applicable Arkansas SIP for the Memphis,
TN-MS-AR Area under section 110(k) of the CAA for all requirements
applicable for purposes of redesignation. EPA may rely on prior SIP
approvals in approving a redesignation request (see Calcagni Memorandum
at p. 3; Southwestern Pennsylvania Growth Alliance v. Browner, 144 F.3d
984, 989-90 (6th Cir. 1998); Wall, 265 F.3d 426) plus any additional
measures it may approve in conjunction with a redesignation action (see
68 FR 25426 (May 12, 2003) and citations therein). Arkansas has adopted
and submitted, and EPA has fully approved at various times, provisions
addressing the various SIP elements applicable for the ozone NAAQS. See
e.g. 77 FR 50033 (August 20, 2012).
    As indicated above, EPA believes that the section 110 elements that
are neither connected with nonattainment plan submissions nor linked to
an area's nonattainment status are not applicable requirements for
purposes of redesignation. EPA has approved all part D requirements
applicable for purposes of this redesignation.

Criteria (3)--The Air Quality Improvement in the Memphis, TN-MS-AR Area
Is Due to Permanent and Enforceable Reductions in Emissions Resulting
From Implementation of the SIP and Applicable Federal Air Pollution
Control Regulations and Other Permanent and Enforceable Reductions

    For redesignating a nonattainment area to attainment, the CAA
requires EPA to determine that the air quality improvement in the area
is due to permanent and enforceable reductions in emissions resulting
from implementation of the SIP, applicable Federal air pollution
control regulations, and other permanent and enforceable reductions
(CAA section 107(d)(3)(E)(iii)). EPA has preliminarily determined that
Arkansas has demonstrated that the observed air quality improvement in
the Memphis, TN-MS-AR Area is due to permanent and enforceable
reductions in emissions resulting from Federal measures and from state
measures adopted into the SIP. EPA does not have any information to
suggest that the decrease in ozone concentrations in the Memphis, TN-
MS-AR Area is due to unusually favorable meteorological conditions.
    Federal measures enacted in recent years have resulted in permanent
emission reductions. Most of these emission reductions are enforceable
through regulations. The Federal measures that have been implemented
include the following:
    Tier 2 vehicle and fuel standards. Implementation began in 2004 and
requires all passenger vehicles in any manufacturer's fleet to meet an
average standard of 0.07 grams of NOX per mile.
Additionally, in January 2006 the sulfur content of gasoline was
required to be on average 30 ppm which assists in lowering the
NOX emissions. Most gasoline sold in Eastern Arkansas prior
to January 2006 had a sulfur content of about 300 ppm (65 FR 6698,
February 10, 2000).\7\
---------------------------------------------------------------------------

    \7\ Arkansas also identified Tier 3 Motor Vehicle Emissions and
Fuel Standards as a federal measure. EPA issued this rule in April
28, 2014, which applies to light duty passenger cars and trucks. EPA
promulgated this rule to reduce air pollution from new passenger
cars and trucks beginning in 2017. Tier 3 emission standards will
lower sulfur content of gasoline and lower the emissions standards.
---------------------------------------------------------------------------

    Large non-road diesel engines rule. This rule was promulgated in
2004, and was phased in between 2008 through 2014 (69 FR 38958, June
29, 2004). This rule reduces the sulfur content in the nonroad diesel
fuel, and also reduces NOX, VOC, particulate matter, and
carbon monoxide emissions. These emission reductions are federally
enforceable. This rule applies to diesel

engines used in industries, such as construction, agriculture, and
mining. It is estimated that compliance with this rule will cut
NOX emissions from non-road diesel engines by up to 90
percent nationwide.
    Heavy-duty gasoline and diesel highway vehicle standards. EPA
issued this rule in January 2001 (66 FR 5002). This rule includes
standards limiting the sulfur content of diesel fuel, which went into
effect in 2004. A second phase took effect in 2007, which further
reduced the highway diesel fuel sulfur content to 15 ppm, leading to
additional reductions in combustion NOX and VOC emissions.
EPA expects that this rule will achieve a 95 percent reduction in
NOX emissions from diesel trucks and buses and will reduce
NOX emissions by 2.6 million tons by 2030 when the heavy-
duty vehicle fleet is completely replaced with newer heavy-duty
vehicles that comply with these emission standards.\8\
---------------------------------------------------------------------------

    \8\ 66 FR 5002, 5012 (January 18, 2001).
---------------------------------------------------------------------------

    Nonroad spark-ignition engines and recreational engines standards.
The nonroad spark-ignition and recreational engine standards, effective
in January 2003, regulate NOX, hydrocarbons, and carbon
monoxide from groups of previously unregulated nonroad engines (67 FR
68242, November 8, 2002). These engine standards apply to large spark-
ignition engines (e.g., forklifts and airport ground service
equipment), recreational vehicles (e.g., off-highway motorcycles and
all-terrain-vehicles), and recreational marine diesel engines sold in
the United States and imported after the effective date of these
standards. When all of the nonroad spark-ignition and recreational
engine standards are fully implemented, an overall 72 percent reduction
in hydrocarbons, 80 percent reduction in NOX, and 56 percent
reduction in carbon monoxide emissions are expected by 2020. These
controls reduce ambient concentrations of ozone, carbon monoxide, and
fine particulate matter.
    National Program for greenhouse gas (GHG) emissions and Fuel
Economy Standards. The federal GHG and fuel economy standards apply to
light-duty cars and trucks in model years 2012-2016 (phase 1) (75 FR
25324, May 7, 2010) and 2017-2025 (phase 2) (proposed at 80 FR 40138,
July 13, 2015). The final standards are projected to result in an
average industry fleet-wide level of 163 grams/mile of carbon dioxide
which is equivalent to 54.5 miles per gallon if achieved exclusively
through fuel economy improvements. The fuel economy standards result in
less fuel being consumed, and therefore less NOX emissions
released.
    Point Sources. Emissions reductions from industries in Crittenden
County contribute to the area's improvement in air quality. Stationary
point source emissions data is collected annually from sources that
meet reporting requirements outlined in 40 CFR part 51, subpart A--Air
Emissions Reporting Requirement. These point sources include, but are
not limited to, refineries, chemical plants, bulk terminals, and
utilities.
    In 2010, Trojan Luggage Company/Americo was reclassified from a
major source for Title V to a minor source and currently operates under
Minor NSR Permit No. 1523-AR-2. With this action, allowable VOC
emissions decreased by 0.1 tons per year (tpy) due to the modification
of inks used at the printer. In addition, two facilities previously
permitted to emit VOCs shut down and had their Title V and NSR permits
voided, currently have no active air permit, and have been removed from
the State's emissions inventory: Crittenden County Landfill, previously
permitted to emit 55.2 tpy of VOC, had its Title V air permit voided in
2009. Automated Conveyer Systems, previously permitted to emit 84.0 tpy
of VOC, had its Title V air permit voided in 2010.

Criteria (4)--The Arkansas Portion of the Memphis, TN-MS-AR Area Has a
Fully Approved Maintenance Plan Pursuant to Section 175A of the CAA

    For redesignating a nonattainment area to attainment, the CAA
requires EPA to determine that the area has a fully approved
maintenance plan pursuant to section 175A of the CAA (CAA section
107(d)(3)(E)(iv)). In conjunction with its request to redesignate the
Arkansas portion of the Memphis, TN-MS-AR Area to attainment for the
2008 8-hour ozone NAAQS, ADEQ submitted a SIP revision to provide for
the maintenance of the 2008 8-hour ozone NAAQS for at least 10 years
after the effective date of redesignation to attainment. EPA believes
that this maintenance plan meets the requirements for approval under
section 175A of the CAA.
a. What is required in a maintenance plan?
    Section 175A of the CAA sets forth the elements of a maintenance
plan for areas seeking redesignation from nonattainment to attainment.
Under section 175A, the plan must demonstrate continued attainment of
the applicable NAAQS for at least 10 years after the Administrator
approves a redesignation to attainment. Eight years after the
redesignation, the state must submit a revised maintenance plan
demonstrating that attainment will continue to be maintained for the 10
years following the initial 10-year period. To address the possibility
of future NAAQS violations, the maintenance plan must contain
contingency measures as necessary to assure prompt correction of any
future 2008 8-hour ozone violations. The Calcagni Memorandum provides
further guidance on the content of a maintenance plan, explaining that
a maintenance plan should address five requirements: The attainment
emissions inventory, maintenance demonstration, monitoring,
verification of continued attainment, and a contingency plan. As is
discussed more fully below, EPA is proposing to determine that
Arkansas' maintenance plan includes all the necessary components and is
thus proposing to approve it as a revision to the Arkansas SIP.
b. Attainment Emissions Inventory
    EPA is proposing to determine that the Memphis, TN-MS-AR Area has
attained the 2008 8-hour ozone NAAQS based on quality-assured
monitoring data for the 3-year period from 2012-2014, and is continuing
to attain the standard based on preliminary 2015 data. Arkansas
selected 2012 as the base year (i.e., attainment emissions inventory
year) for developing a comprehensive emissions inventory for
NOX and VOC, for which projected emissions could be
developed for 2017, 2020 and 2027. The attainment inventory identifies
a level of emissions in the Area that is sufficient to attain the 2008
8-hour ozone NAAQS. Arkansas began development of the attainment
inventory by first generating a baseline emissions inventory for the
State's portion of the Memphis, TN-MS-AR Area. The projected summer day
emission inventories have been estimated using projected rates of
growth in population, traffic, economic activity, and other parameters.
In addition to comparing the final year of the plan (2027) to the base
year (2012), Arkansas compared interim years to the baseline to
demonstrate that these years are also expected to show continued
maintenance of the 2008 8-hour ozone standard.
    The emissions inventory is composed of four major types of sources:
Point, area, on-road mobile, and non-road mobile. The complete
descriptions of how the inventories were developed are discussed in the
Appendix A through Appendix C of the December 10, 2015, submittal,
which can be found in the

docket for this action. The 2012 NOX and VOC emissions for
the Arkansas portion of the Memphis, TN-MS-AR Area, as well as the
emissions for other years, were developed consistent with EPA guidance
and are summarized in Tables 2 through 4 of the following subsection
discussing the maintenance demonstration.
c. Maintenance Demonstration
    The maintenance plan associated with the redesignation request
includes a maintenance demonstration that:
    (i) Shows compliance with and maintenance of the 2008 8-hour ozone
NAAQS by providing information to support the demonstration that
current and future emissions of NOX and VOC remain at or
below 2012 emissions levels.
    (ii) Uses 2012 as the attainment year and includes future emissions
inventory projections for 2017, 2020 and 2027.
    (iii) Identifies an ``out year'' at least 10 years after the time
necessary for EPA to review and approve the maintenance plan. Per 40
CFR part 93, NOX and VOC MVEBs were established for the last
year (2027) of the maintenance plan (see section VII below).
    (iv) Provides actual (2012) and projected emissions inventories, in
tons per summer day (tpsd), for the Arkansas portion of the Memphis,
TN-MS-AR Area, as shown in Tables 2 and 3, below.

 Table 2--Actual and Projected Average Summer Day NOX Emissions (tpsd) for the Arkansas Portion of the Memphis,
                                                  TN-MS-AR Area
----------------------------------------------------------------------------------------------------------------
                     Sector                            2012            2017            2020            2027
----------------------------------------------------------------------------------------------------------------
Point...........................................            3.65            3.08            2.87            2.26
Area............................................            3.22            2.85            2.65            2.10
Non-road........................................            1.97            1.48            1.28            0.73
On-road.........................................           13.04            9.48            7.68            5.18
                                                 ---------------------------------------------------------------
    Total.......................................           21.88           16.89           14.48           10.27
----------------------------------------------------------------------------------------------------------------

 Table 3--Actual and Projected Average Summer Day VOC Emissions (tpsd) for the Arkansas Portion of the Memphis,
                                                  TN-MS-AR Area
----------------------------------------------------------------------------------------------------------------
                     Sector                            2012            2017            2020            2027
----------------------------------------------------------------------------------------------------------------
Point...........................................            0.78            0.73            0.68            0.53
Area............................................            7.90            7.57            7.46            7.15
Non-road........................................            3.26            2.27            2.03            1.36
On-road.........................................            2.35            1.55            1.39            0.98
                                                 ---------------------------------------------------------------
    Total.......................................           14.29           12.12           11.56           10.01
----------------------------------------------------------------------------------------------------------------

    Tables 2 and 3 summarize the 2012 and future projected emissions of
NOX and VOC from the Arkansas portion of the Memphis, TN-MS-
AR Area, as reflected in Section 4.1, Table 4 of the State's submittal.
In situations where local emissions are the primary contributor to
nonattainment, such as the Memphis, TN-MS-AR Area if the future
projected emissions in the nonattainment area remain at or below the
baseline emissions in the nonattainment area, then the ambient air
quality standard should not be exceeded in the future. Arkansas has
projected emissions as described previously and determined that
emissions in the Arkansas portion of the Memphis, TN-MS-AR Area will
remain below those in the attainment year inventory for the duration of
the maintenance plan.
    As discussed in section VI of this proposed rulemaking, a safety
margin is the difference between the attainment level of emissions
(from all sources) and the projected level of emissions (from all
sources) in the maintenance plan. The attainment level of emissions is
the level of emissions during one of the years in which the area met
the NAAQS. Arkansas selected 2012 as the attainment emissions inventory
year for the Arkansas portion of the Memphis, TN-MS-AR Area. The State
has allocated a portion of the 2027 safety margin to its 2027 MVEBs for
the Memphis, TN-MS-AR Area.

 Table 4--Total Safety Margins for the Arkansas Portion of the Memphis,
                       TN-MS-AR Area Tons per Day
                                  [tpd]
------------------------------------------------------------------------
                    Year                           VOC           NOX
------------------------------------------------------------------------
2027........................................         4.28         11.61
------------------------------------------------------------------------

    The State has decided to allocate a portion of the available safety
margin to the 2027 MVEBs to allow for unanticipated growth in VMT,
changes and uncertainty in vehicle mix assumptions, etc., that will
influence the emission estimations. ADEQ has allocated 6.29 tpd of the
safety margin to the 2027 NOX MVEB and 1.10 tpd of the
safety margin to the 2027 VOC MVEB. After allocation of the available
safety margin, the remaining safety margin was calculated as 5.32 tpd
for NOX and 3.18 tpd for VOC. This allocation and the
resulting available safety margin for the Arkansas portion of the
Memphis, TN-MS-AR Area are discussed further in section VI of this
proposed rulemaking along with the MVEBs to be used for transportation
conformity proposes.
d. Monitoring Network
    There currently are 5 monitors measuring ozone in the Memphis, TN-
MS-AR Area, one of which is in the Arkansas portion of the Memphis, TN-
MS-AR Area. The State of Arkansas, through ADEQ, has committed to
continue operation of the monitor in the Arkansas portion of the
Memphis, TN-MS-AR Area in compliance with 40 CFR part 58 and have thus
addressed the requirement for monitoring. EPA approved Arkansas'
monitoring plan on November 16, 2015. Mississippi and Tennessee have
made similar commitments in their maintenance

plans. Mississippi's monitoring plan was approved by EPA on November 7,
2014; whereas Tennessee's monitoring plan was approved by EPA on
January 13, 2015.
e. Verification of Continued Attainment
    The State of Arkansas, through ADEQ, has the legal authority to
enforce and implement the maintenance plan for the Arkansas portion of
the Area. This includes the authority to adopt, implement, and enforce
any subsequent emissions control contingency measures determined to be
necessary to correct future ozone attainment problems.
    Large stationary sources are required to submit an emissions
inventory annually to ADEQ. ADEQ commits to review these emissions
inventories to determine if any unexpected growth in NOX
emissions in the Area may endanger the maintenance of the 2008 8-hour
ozone NAAQS.
    Additionally, under the Consolidated Emissions Reporting Rule
(CERR) and Air Emissions Reporting Requirements (AERR), ADEQ is
required to develop a comprehensive, annual, statewide emissions
inventory every three years that is due twelve to eighteen months after
the completion of the inventory year. The AERR inventory years match
the base year and final year of the inventory for the maintenance plan,
and are within one or two years of the interim inventory years of the
maintenance plan. Therefore, ADEQ commits to compare the CERR and AERR
inventories as they are developed with the maintenance plan to
determine if additional steps are necessary for continued maintenance
of the 2008 8-hour ozone NAAQS in this Area.
f. Contingency Measures in the Maintenance Plan
    Section 175A of the CAA requires that a maintenance plan include
such contingency measures as EPA deems necessary to assure that the
state will promptly correct a violation of the NAAQS that occurs after
redesignation. The maintenance plan should identify the contingency
measures to be adopted, a schedule and procedure for adoption and
implementation, and a time limit for action by the state. A state
should also identify specific indicators to be used to determine when
the contingency measures need to be implemented. The maintenance plan
must include a requirement that a state will implement all measures
with respect to control of the pollutant that were contained in the SIP
before redesignation of the area to attainment in accordance with
section 175A(d).
    In the December 10, 2015, submittal, Arkansas affirms that all
programs instituted by the State and EPA will remain enforceable and
that sources are prohibited from decreasing emissions controls
following the redesignation of the Area. The contingency plan included
in the submittal includes a triggering mechanism to determine when
contingency measures are needed and a process of developing and
implementing appropriate control measures. The primary trigger of the
contingency plan will be a violation of the 2008 8-hour ozone NAAQS
(i.e., when the three-year average of the 4th highest values is equal
to or greater than 0.076 ppm at a monitor in the Area). The trigger
date will be the date that the State observes a 4th highest value that,
when averaged with the two previous ozone seasons' fourth highest
values, would result in a three-year average equal to or greater than
0.076 ppm. The secondary trigger will apply where no actual violation
of the 2008 8-hour ozone NAAQS has occurred, but when ADEQ forecasts
ozone levels above the 2008 8-hour ozone NAAQS.
    Once the primary or secondary trigger is activated, the ADEQ, shall
commence analyses including trajectory analyses of high ozone days and
an emissions inventory assessment to determine those emission control
measures that will be required for attaining or maintaining the 2008 8-
hour ozone NAAQS. ADEQ commits \9\ to adopt and implement at least one
of the following contingency measures listed in Table 5 as
expeditiously as practicable, but no later than 24 months after a
primary triggering event.
---------------------------------------------------------------------------

    \9\ On January 20, 2016, ADEQ clarified ADEQ's commitment is to
adopt and implement contingency measures upon a violation-triggering
event if it is determined that the violation is caused by a source
or sources within Crittenden County. Clarification Letter from
Stuart Spencer to Ron Curry, January 20, 2016 (Clarification
Letter). A copy is contained in the docket for this rulemaking.

         Table 5--Crittenden County Contingency Measure Options
------------------------------------------------------------------------

-------------------------------------------------------------------------
 Reasonable Available Control Technology (RACT) for VOC and NOX
 sources;
 Anti-idling ordinances;
 Open burning restrictions during peak ozone season;
 Diesel retrofit/replacement incentives;
 Programs or incentives to decrease motor vehicle use;
 Trip reduction ordinances;
 Requirements for additional emissions reductions from
 stationary sources;
 Enhancement of inspection of stationary sources to ensure
 emissions control equipment is functioning properly;
 Fuel programs, including incentives for alternative fuels;
 Employer-based transportation management plans, including
 incentives;
 Limitation/restriction of vehicle use in downtown areas, or
 other areas of high emissions concentration, particularly during
 periods of peak use;
 New construction and major reconstruction of paths for use by
 pedestrians or by non-motorized vehicles when economically feasible and
 in the public interest; and
 Other currently unspecified control measures that might prove
 to be advantageous.
------------------------------------------------------------------------

    EPA proposes to conclude that the maintenance plan adequately
addresses the five basic components of a maintenance plan: The
attainment emissions inventory, maintenance demonstration, monitoring,
verification of continued attainment, and a contingency plan.
Therefore, EPA proposes that the maintenance plan SIP revision
submitted by Arkansas for the State's portion of the Area meets the
requirements of section 175A of the CAA and is approvable.

VI. What is EPA's analysis of Arkansas' proposed NOX and VOC
MVEBs for the Arkansas portion of the area?

    Under section 176(c) of the CAA, new transportation plans,
programs, and projects, such as the construction of new highways, must
``conform'' to (i.e., be consistent with) the part of the state's air
quality plan that addresses pollution from cars and trucks. Conformity
to the SIP means that transportation activities will not cause new air
quality violations, worsen existing violations, or delay timely
attainment of the NAAQS or any interim milestones. If a transportation
plan does not conform, most new projects that would expand the capacity
of roadways cannot go forward. Regulations at 40 CFR part 93 set forth
EPA policy, criteria, and procedures for demonstrating and assuring
conformity of such transportation activities to a SIP. The regional
emissions analysis is one, but not the only, requirement for
implementing transportation conformity. Transportation conformity is a
requirement for nonattainment and maintenance areas. Maintenance areas
are areas that were previously nonattainment for a particular NAAQS but
have since been redesignated to attainment with an approved maintenance
plan for that NAAQS.
    Under the CAA, states are required to submit, at various times,
control strategy SIPs and maintenance plans for

nonattainment areas. These control strategy SIPs, including maintenance
plans, create MVEBs (or in this case sub-area MVEBs) for criteria
pollutants and/or their precursors to address pollution from cars and
trucks. Per 40 CFR part 93, a MVEB must be established for the last
year of the maintenance plan. A state may adopt MVEBs for other years
as well. The MVEB is the portion of the total allowable emissions in
the maintenance demonstration that is allocated to highway and transit
vehicle use and emissions. See 40 CFR 93.101. The MVEB serves as a
ceiling on emissions from an area's planned transportation system. The
MVEB concept is further explained in the preamble to the November 24,
1993, Transportation Conformity Rule (58 FR 62188). The preamble also
describes how to establish the MVEB in the SIP and how to revise the
MVEB.
    As part of the interagency consultation process on setting MVEBs,
ADEQ held discussions to determine what years to set MVEBs for the
Memphis, TN-MS-AR maintenance plan. According to the transportation
conformity rule, a maintenance plan must establish MVEBs for the last
year of the maintenance plan (in this case, 2027). See 40 CFR 93.118.
Arkansas also provided MVEBs for 2012. Table 6 below provides the
NOX and VOC MVEBs in tpd for 2012 and 2027, as reflected in
Section 4.2, Table 6 of the State's submittal.

                         Table 6--Arkansas' Portion of the Memphis, TN-MS-AR Area MVEBs
                                                      [tpd]
----------------------------------------------------------------------------------------------------------------
                                                               2012                            2027
                                                 ---------------------------------------------------------------
                                                        NOX             VOC             NOX             VOC
----------------------------------------------------------------------------------------------------------------
Base Emissions..................................           13.04            2.35            5.18            0.98
Safety Margin Allocated to MVEB.................             N/A             N/A            6.29            1.10
Conformity MVEB.................................           13.04            2.35           11.47            2.08
----------------------------------------------------------------------------------------------------------------

    As mentioned above, Arkansas has chosen to allocate a portion of
the available safety margin to the NOX and VOC MVEBs for
2027. As discussed in section V of this proposed rulemaking, a safety
margin is the difference between the attainment level of emissions
(from all sources) and the projected level of emissions (from all
sources) in the maintenance plan. The attainment level of emissions is
the level of emissions during one of the years in which the area met
the NAAQS. As discussed above, Arkansas has selected 2012 as the base
year.
    Through this rulemaking, EPA is proposing to approve the MVEBs for
NOX and VOC for 2012 and 2027 for the Arkansas portion of
the Memphis, TN-MS-AR Area because EPA believes that the Area maintains
the 2008 8-hour ozone NAAQS with the emissions at the levels of the
budgets. Once the MVEBs for the Arkansas portion of the Memphis, TN-MS-
AR Area are approved or found adequate (whichever is completed first),
they must be used for future conformity determinations.

VII. What is the status of EPA's adequacy determination for the
proposed NOX and VOC MVEBs for the Arkansas portion of the
area?

    When reviewing submitted ``control strategy'' SIPs or maintenance
plans containing MVEBs, EPA may affirmatively find the MVEB contained
therein adequate for use in determining transportation conformity. The
adequacy process, as described below, is generally faster than approval
of the controls strategy revision thus allowing submitted MVEBs to be
used sooner. EPA is evaluating the adequacy of the submitted MVEBs in
parallel to this proposed approval action on the redesignation request
and maintenance plan. Once EPA affirmatively finds the submitted MVEB
is adequate for transportation conformity purposes, that MVEB must be
used by state and Federal agencies in determining whether proposed
transportation projects conform to the SIP as required by section
176(c) of the CAA.
    EPA's substantive criteria for determining adequacy of a MVEB are
set out in 40 CFR 93.118(e)(4). The process for determining adequacy
consists of three basic steps: public notification of a SIP submission,
a public comment period, and EPA's adequacy determination. This process
for determining the adequacy of submitted MVEBs for transportation
conformity purposes was initially outlined in EPA's May 14, 1999,
guidance, ``Conformity Guidance on Implementation of March 2, 1999,
Conformity Court Decision.'' EPA adopted regulations to codify the
adequacy process in the Transportation Conformity Rule Amendments for
the ``New 8-Hour Ozone and PM2.5 National Ambient Air
Quality Standards and Miscellaneous Revisions for Existing Areas;
Transportation Conformity Rule Amendments--Response to Court Decision
and Additional Rule Change,'' on July 1, 2004 (69 FR 40004). Additional
information on the adequacy process for transportation conformity
purposes is available in the proposed rule entitled, ``Transportation
Conformity Rule Amendments: Response to Court Decision and Additional
Rule Changes,'' 68 FR 38974, 38984 (June 30, 2003).
    As discussed earlier, Arkansas' maintenance plan includes
NOX and VOC MVEBs for the Arkansas portion of the Memphis,
TN-MS-AR Area for 2012 as well as 2027, the last year of the
maintenance plan. EPA is reviewing the NOX and VOC MVEBs
through the adequacy process. The NOX and VOC MVEBs for the
Arkansas portion of the Memphis, TN-MS-AR Area, opened for public
comment on EPA's adequacy Web site on December 16, 2015, found at:
http://www3.epa.gov/otaq/stateresources/transconf/currsips.htm.
    EPA intends to make its determination on the adequacy of the 2012
and 2027 MVEBs for the Arkansas portion of the Memphis, TN-MS-AR Area
for transportation conformity purposes in the near future by completing
the adequacy process that was started on December 16, 2015. After EPA
finds the 2012 and 2027 MVEBs adequate or approves them, the new MVEBs
for NOX and VOC must be used for future transportation
conformity determinations. For required regional emissions analysis
years between 2012 and 2027, the applicable budgets will be the new
2012 MVEBs established in the maintenance plan, as defined in section
VI of this proposed rulemaking. For analysis years 2027 and beyond, the
applicable budgets will be the new 2027 MVEBs established in the
maintenance plan.

VIII. What is the effect of EPA's proposed actions?

    EPA's proposed actions establish the basis upon which EPA may take
final

action on the issues being proposed for approval today. Approval of
Arkansas' redesignation request would change the legal designation of
the portion of Crittenden County that is within the Memphis, TN-MS-AR
Area, as found at 40 CFR part 81, from nonattainment to attainment for
the 2008 8-hour ozone NAAQS. Approval of Arkansas' associated SIP
revision would also incorporate a plan for maintaining the 2008 8-hour
ozone NAAQS in the Memphis, TN-MS-AR Area through 2027 into the SIP.
This maintenance plan includes contingency measures to remedy any
future violations of the 2008 8-hour ozone NAAQS and procedures for
evaluation of potential violations. The maintenance plan also
establishes NOX and VOC MVEBs for 2012 and 2027 for the
Arkansas portion of the Memphis, TN-MS-AR Area. The MVEBs are listed in
Table 6 in section VI. Additionally, EPA is notifying the public of the
status of EPA's adequacy determination for the newly-established
NOX and VOC MVEBs for 2012 and 2027 for the Arkansas portion
of the Memphis, TN-MS-AR Area.

IX. Proposed Actions

    EPA is taking three separate but related actions regarding the
redesignation and maintenance of the 2008 8-hour ozone NAAQS for the
Arkansas portion of the Memphis, TN-MS-AR Area. EPA is proposing to
determine that the entire Memphis, TN-MS-AR Area is attaining the 2008
8-hour ozone NAAQS. EPA is also proposing to approve the maintenance
plan (including the Clarification Letter) for the Arkansas portion of
the Area, including the NOX and VOC MVEBs for 2012 and 2027,
into the Arkansas SIP (under CAA section 175A). The maintenance plan
demonstrates that the Area will continue to maintain the 2008 8-hour
ozone NAAQS through 2027 and that the budgets meet all of the adequacy
criteria contained in 40 CFR 93.118(e)(4) and (5). Further, as part of
today's action, EPA is describing the status of its adequacy
determination for the NOX and VOC MVEBs for 2012 and 2027 in
accordance with 40 CFR 93.118(f)(2). Within 24 months from the
effective date of EPA's adequacy determination for the MVEBs or the
publication date for the final rule for this action, whichever is
earlier, the transportation partners will need to demonstrate
conformity to the new NOX and VOC MVEBs pursuant to 40 CFR
93.104(e)(3).
    Additionally, EPA is proposing to determine that the Arkansas
portion of the Memphis, TN-MS-AR Area has met the criteria under CAA
section 107(d)(3)(E) for redesignation from nonattainment to attainment
for the 2008 8-hour ozone NAAQS. On this basis, EPA is proposing to
approve Arkansas' redesignation request for the Arkansas portion of the
Memphis, TN-MS-AR Area. If finalized, approval of the redesignation
request would change the official designation of the portion of
Crittenden County that is within the Memphis, TN-MS-AR Area, as found
at 40 CFR part 81, from nonattainment to attainment for the 2008 8-hour
ozone NAAQS.

X. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to attainment and the
accompanying approval of a maintenance plan under section 107(d)(3)(E)
are actions that affect the status of a geographical area and do not
impose any additional regulatory requirements on sources beyond those
imposed by state law. A redesignation to attainment does not in and of
itself create any new requirements, but rather results in the
applicability of requirements contained in the CAA for areas that have
been redesignated to attainment. Moreover, 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, these proposed actions merely propose to approve state law
as meeting Federal requirements and do not impose additional
requirements beyond those imposed by state law. For this reason, these
proposed actions:
     Are not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     are 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.);
     do 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);
     do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     are 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
     do 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).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects

40 CFR Part 52

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

40 CFR Part 81

    Environmental protection, Air pollution control.

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

    Dated: January 27, 2016.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2016-02567 Filed 2-9-16; 8:45 am]
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