[Federal Register Volume 79, Number 192 (Friday, October 3, 2014)]
[Notices]
[Pages 59779-59782]
[FR Doc No: 2014-23586]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0357]

Food and Drug Administration Notification and Medical Device
Reporting for Laboratory Developed Tests; Draft Guidance for Industry,
Food and Drug Administration Staff, and Clinical Laboratories;
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availability of the draft guidance entitled ``FDA Notification and
Medical Device Reporting for Laboratory Developed Tests (LDTs).'' This
draft guidance document is intended to describe the process for
clinical laboratories to notify FDA of the laboratory developed tests
(LDTs) they manufacture as well as to describe the Medical Device
Reporting (MDR) requirements for clinical laboratories manufacturing
LDTs. LDTs are those in vitro diagnostic devices that are intended for
clinical use and designed, manufactured, and used within a single
laboratory. This draft guidance is not final nor is it in effect at
this time.

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 comment 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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 2, 2015.

ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for single hard copies of the draft guidance document entitled
``FDA Notification and Medical Device Reporting for Laboratory
Developed Tests (LDTs)'' to the Office of the Center Director, Guidance
and Policy Development, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request. The guidance may also be obtained by mail by calling CBER
at 1-800-835-4709 or<PHONE_NUMBER>.
    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. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT<EMAIL_ADDRESS>or Katherine
Serrano, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5646, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    In 1976, Congress enacted the Medical Device Amendments (MDA)
(Public Law 94-295), which amended the

Federal Food, Drug, and Cosmetic Act (the FD&C Act) to create a
comprehensive system for the regulation of medical devices intended for
use in humans. At that time, the definition of a device was amended to
make explicit that it encompasses in vitro diagnostic devices (IVDs):
``The term `device' . . . means an instrument, apparatus, implement,
machine, contrivance, implant, in vitro reagent, or other similar or
related article. . . .'' (section 201(h) of the FD&C Act (21 U.S.C.
321(h)). The definition of device applies equally to IVDs manufactured
by conventional device manufacturers and those manufactured by
laboratories. An IVD, therefore, meets the device definition
irrespective of where and by whom it is manufactured.
    However, since the implementation of the MDA of 1976, FDA has
generally exercised enforcement discretion so that the Agency has
generally not enforced applicable provisions under the FD&C Act and FDA
regulations with respect to LDTs, a subset of IVDs that are intended
for clinical use and designed, manufactured, and used within a single
laboratory. Given a changing landscape in terms of the volume,
technology, and business model of IVDs offered as LDTs since 1976, in
combination with the increasingly important role of diagnostic devices,
including LDTs, in critical clinical treatment decisions, the FDA does
not believe that generally exercising enforcement discretion with
respect to the regulatory requirements for these devices remains
appropriate.
    Consistent with the draft guidance entitled ``Framework for
Regulatory Oversight of Laboratory Developed Tests (LDTs)'' that is
being distributed for comment contemporaneously with this document, FDA
intends to enforce certain medical device regulatory requirements for
LDTs and device-manufacturer requirements for laboratories that
manufacture, prepare, propagate, compound, assemble, or process LDTs.
FDA intends to collect information regarding LDTs currently being used
by laboratories through a notification process. In addition, FDA
intends to enforce the requirements under part 803 (21 CFR part 803)
for reporting safety issues related to LDTs, to provide a mechanism for
collecting information on any known or suspected adverse events related
to the use of an LDT. FDA believes that this is the appropriate
regulatory oversight approach to adopt initially in achieving the
desired public health goal of assuring that these IVDs used in the
provision of health care, regardless of the manufacturer, provide
reasonable assurance of safety and effectiveness.
    FDA welcomes comments on all aspects of this guidance, as well as
on the following specific issue: FDA notes that some laboratory
networks (i.e., more than one laboratory under the control of the same
parent entity) offer the same test in multiple laboratories throughout
their network. Although devices in this scenario do not meet FDA's
definition of an LDT (i.e., they are not designed, manufactured and
used within a single laboratory), FDA would like feedback on whether a
single notification from the laboratory network for that test is
sufficient, provided that the laboratory network indicates in the
notification to FDA that the test is offered at multiple sites.
Elsewhere in this issue of the Federal Register, FDA is issuing a
notice announcing the availability of the draft guidance entitled
``Framework for Regulatory Oversight of Laboratory Developed Tests
(LDTs)'' that also identifies specific issues for comment.
    Additionally, FDA intends to hold a public webinar in late October
2014 to summarize the proposed oversight framework and answer
clarification questions from stakeholders. The webinar will not require
registration and will be announced at least 1 week in advance on FDA's
Web site. It will be recorded and made available on FDA's Web site
shortly thereafter.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on FDA
notification and medical device reporting requirements for LDTs. 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 statute
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at
http://www.regulations.gov or on the CBER Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.
    Persons unable to download an electronic copy of ``FDA Notification
and Medical Device Reporting for Laboratory Developed Tests (LDTs)''
may send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document. Please use the document number 1738 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    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 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 concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on the following topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Notification for Laboratory Developed Tests (LDTs).
    FDA intends to collect information from laboratories regarding
their current LDTs and new LDTs through a notification process. This
information collection is needed to classify LDTs and to prioritize
enforcement of premarket review requirements for categories of LDTs
based on risk using a public process. Specifically, FDA plans to use
advisory panels to provide recommendations to the Agency on LDT risks,
classification and prioritization of enforcement of applicable
regulatory requirements on certain categories of LDTs, as appropriate.
Additionally, the notification information will be made

available in part to the laboratory community and interested
stakeholders to act as a resource for accessing information on the LDTs
currently being used by laboratories. If these data are not collected,
FDA and interested stakeholders will not have reliable data on the
types of LDTs currently used. Further, because notification data will
be used to classify LDTs and prioritize enforcement of premarket review
requirements based on risk, it will benefit laboratories to provide the
most accurate information possible to ensure that appropriate
classification is made.
    To facilitate future FDA regulatory activity for LDTs, clinical
laboratories should notify FDA of all of the LDTs manufactured,
prepared, propagated, compounded, assembled, or processed by their
laboratories. To appropriately notify FDA of all LDTs manufactured at
an establishment, the owner/operator should provide information on the
data elements identified in the following paragraph for each LDT
manufactured at their establishment. Laboratory owner/operators with
LDTs currently being used in their laboratories should begin to report
this information no later than 6 months after publication, in final
form, of the ``Framework for Regulatory Oversight of Laboratory
Developed Tests (LDTs)'' guidance document referred to in section I.
Background. Starting 6 months after publication of the final version of
the ``Framework for Regulatory Oversight of Laboratory Developed Tests
(LDTs)'' guidance, laboratories that intend to offer new LDTs should
provide notification prior to offering the LDT for clinical use. It
should be noted that when laboratories make a significant change to the
marketed intended use of an LDT for which they have previously provided
notification, the LDT will be considered by the FDA to be a new LDT
and, therefore, a new notification should be provided prior to offering
that LDT for clinical use.

Data Elements to be Reported \1\

     Laboratory Name
---------------------------------------------------------------------------

    \1\ Please refer to Appendix A of the draft guidance document
for a more detailed discussion of data elements.
---------------------------------------------------------------------------

     Laboratory Contact Email Address
     Test Name
     Monthly Test Volume
     Intended Use
     Clinical Use of Test
     What is measured or detected (i.e. analyte, measurand,
etc.)
     Disease/Condition for which the diagnostic device is
indicated
     Patient Population
     Does the patient population include pediatric patients?
(<21 years old)
     Sample Type
     Test Method
     Is the test a modification of an FDA cleared/approved
test?
     If the test is a modification of an FDA cleared/approved
test, what modifications were made?
    Respondents to this collection of information are manufacturers of
LDTs. FDA estimates the burden of this collection as follows.

                            Table 1--Estimated Annual Reporting Burden First Year\1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
            Activity                Number of     responses per   Total annual     per response     Total hours
                                   respondents     respondent       responses       (in hours)
----------------------------------------------------------------------------------------------------------------
LDT Notification--Initial                   650               1             650              1               650
 notification..................
LDT Notification--Subsequent                650              16          10,400              0.5           5,200
 first year notifications......
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............  ..............  ...............           5,850
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                         Table 2--Estimated Annual Reporting Burden Subsequent Years \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
            Activity                Number of     responses per   Total annual     per response     Total hours
                                   respondents     respondent       responses       (in hours)
----------------------------------------------------------------------------------------------------------------
LDT Notification--Subsequent                650               1             650              0.5             325
 years.........................
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Upon publication of a final guidance based on this draft guidance,
FDA expects approximately 650 manufacturers to provide notification
information regarding approximately 17 LDTs each. The number of
respondents and total number of responses are based on information
provided by New York State. Specifically, in July 2014, New York State
indicated that it has reviewed 9,800 submissions from 565 labs. While
these numbers represent the best estimates available for the number of
LDTs currently on the market, FDA acknowledges that additional LDTs may
be offered to patients in the United States that are not currently
offered in New York State, and therefore, have not undergone review. To
take into account the possibility that the number of LDTs and number of
labs in New York State understate the totals for the United States, FDA
assumes that the nationwide totals are 10 percent higher and,
therefore, estimates that there are approximately 11,000 LDTs
manufactured in 650 labs. To corroborate our estimate of the total
number of responses, i.e., the total number of LDTs currently being
offered, we looked at National Institutes of Health Genetic Test
Registry data. In June 2014, the registry included approximately 7,600
genetic tests that are not FDA-approved or cleared, but are currently
offered. If we assume that genetic tests represent roughly 70 to 80
percent of all LDTs, this supports our estimate of 11,050 LDTs (total
annual responses in the first year).
    FDA estimates an average of 17 LDTs offered per laboratory based
upon the ratio of labs offering LDTs to the number of LDT submissions
received by New York State. We therefore estimate that there will be
650 respondents (manufacturers of LDTs) and 17 responses per respondent
(LDT notifications) in the first year. This results in 11,050 total
annual responses in the first year.

    FDA acknowledges that according to the CLIA (Clinical Laboratory
Improvement Amendments) program at CMS (August 2014), there are
approximately 11,000 CLIA-certified high complexity labs that have the
appropriate certifications to manufacture LDTs. However, FDA is not
aware of information describing the exact number of certified high
complexity laboratories currently offering LDTs. Therefore, FDA has
relied upon the information provided by New York State when creating
these estimates. FDA acknowledges that, without firm data on the number
of labs offering LDTs or the number of tests offered per lab, the
estimate of the number of respondents is necessarily uncertain.
    After the initial notification, respondents will only notify FDA of
new tests or modifications that affect performance or intended use. We
estimate the number of tests in subsequent years to be approximately 5
percent of the estimated number of initial notifications.
    FDA bases its estimate of the average burden per response on Agency
creation of a mock notification. We would expect labs to take up to an
hour for their first notification and only 30 minutes for subsequent
notifications, due to familiarity with the system.
    Therefore, we estimate the total reporting burden to respondents to
be 5,850 hours for the first year and 325 hours for subsequent years.
    This draft guidance also refers to previously approved collections
of information found in FDA regulations. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 803 (medical
device reporting) have been approved under OMB control numbers 0910-
0291 and 0910-0437; the collections of information in 21 CFR part 806
(reports of corrections and removals) have been approved under OMB
control number 0910-0359; and the collections of information in 21 CFR
part 807, subparts B and C (registration and listing) have been
approved under OMB control number 0910-0625.

V. 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.
    Comments will also be accepted at a public meeting, which will be
held prior to finalizing this draft guidance. A 2-day meeting is
tentatively scheduled for early January 2015 and will be announced
separately in the Federal Register.

    Dated: September 29, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-23586 Filed 9-30-14; 11:15 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Notices]
[Pages 50097-50098]
[FR Doc No: 2012-20312]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Commission Staff Attendance

    The Federal Energy Regulatory Commission hereby gives notice that
members of the Commission's staff may attend the following meetings
and/or teleconferences related to the transmission planning activities
of the Southwest Power Pool, Inc. (SPP):

Regional Tariff Working Group--August 15-16, 2012.
Regional Tariff Working Group--August 22-23, 2012.
Regional Tariff Working Group--August 29-30, 2012.

    The above-referenced Regional Tariff Working Group meeting will be
held at: AEP Office, 8th Floor Conference Room, 1015 Elm St., Dallas,
Texas 75201.
    The above-referenced meetings and teleconferences are open to the
public.
    Further information may be found at www.misoenergy.org.
    The discussions at the meeting described above may address matters
at issue in the following proceedings:

Docket No. ER09-35-001, Tallgrass Transmission, LLC.
Docket No. ER09-36-001, Prairie Wind Transmission, LLC.
Docket No. ER09-548-001, ITC Great Plains, LLC.
Docket No. ER09-659-002, Southwest Power Pool, Inc.
Docket No. ER11-4105-000, Southwest Power Pool, Inc.
Docket No. EL11-34-001, Midwest Independent Transmission System
Operator, Inc.
Docket No. ER12-1179-000, Southwest Power Pool, Inc.
Docket No. ER12-1401-000, Southwest Power Pool, Inc.
Docket No. ER12-1401-000, Southwest Power Pool, Inc.
Docket No. ER12-1415-000, Southwest Power Pool, Inc.
Docket No. ER12-1460-000, Southwest Power Pool, Inc.
Docket No. ER12-1610-000, Southwest Power Pool, Inc.
Docket No. ER12-1772-000, Southwest Power Pool, Inc.
Docket No. ER12-1779-000, Southwest Power Pool, Inc.
Docket No. ER12-2366-000, Southwest Power Pool, Inc.
Docket No. EL12-2-000, Southwest Power Pool, Inc.
Docket No. EL12-60-000, Southwest Power Pool, Inc., et al.

    For more information, contact Luciano Lima, Office of Energy
Markets

Regulation, Federal Energy Regulatory Commission at<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    Dated: August 9, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-20312 Filed 8-17-12; 8:45 am]
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[Federal Register: November 9, 2006 (Volume 71, Number 217)]
[Proposed Rules]
[Page 65764-65765]
[DOCID:fr09no06-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2006-0829, FRL-8235-1]

Revisions to the California State Implementation Plan, Lake
County Air Quality Management District, Monterey Bay Unified Air
Pollution Control District, San Joaquin Valley Unified Air Pollution
Control District, and Ventura County Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve revisions to the Lake County Air
Quality Management District (LCAQMD), Monterey Bay Unified Air
Pollution Control District (MBUAPCD), San Joaquin Valley Unified Air
Pollution Control District (SJVUAPCD), and Ventura County Air Pollution
Control District (VCAPCD) portions of the California State
Implementation Plan (SIP). Under authority of the Clean Air Act as
amended in 1990 (CAA or the Act), we are proposing to approve local
rules that address particulate matter (PM-10) emissions from open
burning, general area sources, cotton gins, incinerators, and fuel
burning equipment.

DATES: Any comments on this proposal must arrive by December 11, 2006.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2006-0829, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-

line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov,

including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through http://www.regulations.gov or e-mail.

http://www.regulations.gov is an ``anonymous access'' system, and EPA will not

know your identity or contact information unless you provide it in the
body of your comment. If you send e-mail directly to EPA, your e-mail
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA Region

IX, 75 Hawthorne Street, San Francisco, California. 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 in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Al Petersen, EPA Region IX, (415) 947-
4118<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposal addresses the following local
rules: LCAQMD Chapter VIII Section 1002 and Chapter VIII Table 8,
MBUAPCD Rule 403, SJVUAPCD Rule 4240, and VCAPCD Rules 57 and 57.1. In
the Rules and Regulations section of this Federal Register, we are
approving these into the SIP in a direct final action without prior
proposal because we believe these SIP revisions are not controversial.
If we receive adverse comments, however, we will publish a timely
withdrawal of the direct final rule and address the comments in
subsequent action based on this proposed rule. Please note that if we
receive adverse comment on an amendment, paragraph, or section of this
rule and if that provision may be severed from the remainder of the
rule, we may adopt as final those provisions of the rule that are not
the subject of an adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is

planned. For further information, please see the direct final action.

    Dated: October 12, 2006.
Alexis Strauss,
Acting Regional Administrator, Region IX.
 [FR Doc. E6-18875 Filed 11-8-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 198 (Tuesday, October 14, 2014)]
[Notices]
[Pages 61633-61635]
[FR Doc No: 2014-24296]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PF14-17-000]

Louisiana LNG Energy, LLC; Notice of Intent To Prepare an
Environmental Impact Statement for the Proposed Mississippi River Lng
Project, Request for Comments on Environmental Issues, and Notice of
Public Scoping Meeting

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental impact statement (EIS) that
will discuss the environmental impacts of the Mississippi River
Liquefied Natural Gas (LNG) Project (Project) involving construction
and operation of a LNG facility by Louisiana LNG Energy, LLC (LLNGE) in
Plaquemines Parish, Louisiana. Under the proposed Project, LLNGE would
construct, own, and operate a liquefaction terminal for the export of
LNG. The terminal would include four liquefaction trains, each with a
capacity of 74,380 cubic feet per day; two 100,000 cubic meter (m\3\)
full containment LNG storage tanks; 1.9 miles of 24-inch-diameter
pipeline; and 1.6 miles of 12-inch-diameter pipeline.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the Project. Your input will help the Commission staff
determine what issues they need to evaluate in the EIS. Please note
that the scoping period will close on November 3, 2014. The Commission
will use this EIS in its decision-making process to determine whether
the Project is in the public interest. Details on how to submit
comments are in the Public Participation section of this notice.
    This notice is being sent to the Commission's current environmental
mailing list for this Project. State and local government
representatives should notify their constituents of this proposed
Project and encourage them to comment on their areas of concern.
    You may submit comments in written form or verbally. Further
details on how to submit written comments are in the Public
Participation section of this notice. In lieu of or in addition to
sending written comments, the Commission invites you to attend the
public scoping meeting scheduled as follows:

------------------------------------------------------------------------
               Date and time                          Location
------------------------------------------------------------------------
October 23, 2014, 6:00 PM (CST)...........  Belle Chasse Auditorium,
                                             8398 Hwy. 23, Belle Chasse,
                                             LA 70037,<PHONE_NUMBER>.
------------------------------------------------------------------------

    This public meeting is designed to provide you with more detailed
information and another opportunity to offer your comments on the
Project. Interested groups and individuals are encouraged to attend the
meeting and present comments on the issues they believe should be
addressed in the EIS. A transcript of the meeting will be made so that
your comments will be accurately recorded.
    If you are a landowner receiving this notice, a company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed pipeline facilities. The
company would seek to negotiate a mutually acceptable agreement.
However, if the Commission approves the Project, that approval conveys
with it the right of eminent domain. Therefore, if easement
negotiations fail to produce an agreement, the pipeline company could
initiate condemnation proceedings where compensation would be
determined in accordance with state law.
    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility on My Land? What Do I Need To Know?'' is available for
viewing on the FERC Web site (www.ferc.gov). This fact sheet addresses
a number of typically-asked questions, including the use of eminent
domain and how to participate in the Commission's proceedings.

Summary of the Proposed Project

    LLNGE plans to construct, own, and operate a liquefaction terminal
in Plaquemines Parish, Louisiana to enable it to liquefy natural gas
for use along the lower Mississippi River and in offshore Louisiana
bunker markets, as well as for export to foreign countries. The planned
facility would have an export capacity of approximately two million
metric tons per year (MTPY). The Project would use the planned
facilities to liquefy domestic natural gas delivered via interconnects
with an existing interstate natural gas pipeline. The LNG would be
stored in onsite storage tanks before being loaded onto LNG carriers at
the planned marine berthing and LNG transfer facilities. Construction
of the Project is planned to begin in February 2016 and operations are
planned to begin in the second quarter of 2018; however, LLNGE is
considering a phased construction that would allow operations to
commence in the second quarter of 2017. Phased construction would allow
for operations to begin before construction of the storage tanks by
transferring liquefied natural gas directly into a berthed LNG vessel.
The Mississippi River LNG Project would include the following
facilities:
     A natural gas liquefaction terminal located along the east
bank of the Mississippi River in Plaquemines Parish, Louisiana that
would include:
    [ssquf] four liquefaction trains, each with a capacity of 74,380
cubic feet per day;
    [ssquf] two 100,000 cubic meter (m\3\), full-containment LNG
storage tanks;
    [ssquf] marine loading facilities capable of berthing one LNG
carrier up to 175,000 m\3\, as well as LNG bunker barges;
    [ssquf] truck loading facilities capable of concurrently loading
two trucks;
    [ssquf] a 180 megawatt on-site electrical power generation facility
with 3 gas turbines; and
    [ssquf] ancillary gas treatment and liquefaction systems;
     1.9 miles of 24-inch-diameter pipeline, with an associated
meter station, that would deliver gas from the High Point Gas
Transmission (HPGT) interstate pipeline system to the proposed
terminal;
     1.6-miles of 12-inch-diameter pipeline, with an associated
meter station, that would extend from the HPGT interconnection to the
Gulf South Pipeline interstate pipeline system; and
     Construction of one new compressor station located within
the terminal fenceline.
    A map depicting the general location of the Project facilities is
included in Appendix 1.\1\
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice are not being
printed in the Federal Register. Copies of appendices were sent to
all those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary'' or from the
Commission's Public Reference Room, 888 First Street NE.,
Washington, DC 20426, or call<PHONE_NUMBER>. For instructions on
connecting to eLibrary, refer to the last page of this notice.
---------------------------------------------------------------------------

Land Requirements for Construction

    The planned construction would impact a 200-acre site on the east
bank of the Mississippi River in Plaquemines Parish, Louisiana, which
would include the liquefaction trains, LNG storage tanks, marine and
truck loading facilities, the electrical power station, and ancillary
facilities. The full 200-acre site would be fenced and retained for
operations of the planned Project. Construction of the two pipeline
segments and associated meter stations would require approximately 42
acres of land, 22 of which would be

permanently impacted during operations. LLNGE is still in the planning
phase for the Project and requirements for construction workspaces,
access roads, and pipe storage/contractor yards would be determined
during engineering and design.

The EIS Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the authorization of LNG
facilities. NEPA also requires us \2\ to discover and address concerns
the public may have about proposals. This process is referred to as
``scoping.'' The main goal of the scoping process is to focus the
analysis in the EIS on the important environmental issues. By this
notice, the Commission requests public comments on the scope of the
issues to address in the EIS. We will consider all filed comments
during the preparation of the EIS.
---------------------------------------------------------------------------

    \2\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    In the EIS we will discuss impacts that could occur as a result of
the construction and operation of the proposed Project under these
general headings:
     Geology and soils;
     water resources;
     wetlands and vegetation;
     fish and wildlife, including migratory birds;
     threatened and endangered species;
     land use, recreation, and visual resources;
     air quality and noise;
     cultural resources;
     socioeconomics;
     reliability and safety;
     engineering and design material; and
     cumulative environmental impacts.
    We will also evaluate reasonable alternatives to the planned
Project or portions of the Project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    Although no formal application has been filed by LLNGE, we have
initiated our NEPA review under the Commission's pre-filing process.
The purpose of the pre-filing process is to encourage the early
involvement of interested stakeholders and to identify and resolve
issues before the FERC receives an application. As part of our pre-
filing review, we have begun to contact some federal and state agencies
to discuss their involvement in the scoping process and the preparation
of the EIS.
    The EIS will present our independent analysis of the issues. We
will publish and distribute the draft EIS for public comment. After the
comment period, we will consider all timely comments and revise the
document, as necessary, before issuing a final EIS. To ensure we have
the opportunity to consider and address your comments, please carefully
follow the instructions in the Public Participation section below.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues of
this Project to formally cooperate with us in the preparation of the
EIS.\3\
---------------------------------------------------------------------------

    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Sec.  1501.6.
---------------------------------------------------------------------------

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with the Louisiana Office of Historic Preservation (State Historic
Preservation Office [SHPO]), and to solicit their views and those of
other government agencies, interested Indian tribes, and the public on
the Project's potential effects on historic properties.\4\ We will
define the Project-specific Area of Potential Effects (APE) in
consultation with the SHPO as the Project develops. On natural gas
facility projects, the APE at a minimum encompasses all areas subject
to ground disturbance (examples include the terminal plot, construction
right-of-way, contractor/pipe storage yards, compressor stations, and
access roads). Our EIS for this Project will document our findings on
the impacts on historic properties and summarize the status of
consultations with the Louisiana Office of Historic Preservation under
section 106.
---------------------------------------------------------------------------

    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the Project. Your comments should focus on
the potential environmental effects, reasonable alternatives, and
measures to avoid or lessen environmental impacts. The more specific
your comments, the more useful they will be. To ensure that your
comments are timely and properly recorded, please send your comments so
that the Commission receives them in Washington, DC on or before
November 3, 2014.
    For your convenience, there are three methods which you can use to
submit your comments to the Commission. In all instances please
reference the Project docket number (PF14-17-000) with your submission.
The Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for interested persons to
submit brief, text-only comments on a project;
    (2) You can file your comments electronically using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.

Environmental Mailing List

    The environmental mailing list includes Federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for Project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the Project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed Project.

    When we publish and distribute the EIS, copies will be sent to the
environmental mailing list for public review and comment. If you would
prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (Appendix 2).

Becoming an Intervenor

    Once LLNGE files its application with the Commission, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the User's Guide under the ``e-filing'' link on the Commission's Web
site. Please note that the Commission will not accept requests for
intervenor status at this time. You must wait until the Commission
receives a formal application for the project.

Additional Information

    Additional information about the Project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., PF14-
17). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: October 3, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-24296 Filed 10-10-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 43 (Tuesday, March 5, 2013)]
[Notices]
[Pages 14314-14315]
[FR Doc No: 2013-05081]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2013-0090]

Towing Safety Advisory Committee; Meetings

AGENCY: Coast Guard, DHS.

ACTION: Notice of Federal Advisory Committee Meetings.

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

SUMMARY: The Towing Safety Advisory Committee will meet in New York
City, New York, March 21 and 22, 2013, to review and discuss
recommendations from its subcommittees, and to receive tasking and
briefs listed in the agenda in the SUPPLEMENTARY INFORMATION section
below. The subcommittees will meet March 20, 2012, and work on seven
assigned tasks listed in the referenced agenda. All meetings will be
open to the public.

DATES: Subcommittees will meet on Wednesday, March 20, 2013 from 8:30
a.m. to 5:30 p.m. The full Committee will meet on Thursday, March 21,
2013, from 8 a.m. to 5 p.m. and again on Friday, March 22, 2013, from 8
a.m. to 12 noon. These meetings may close early if all business is
completed. Written statements and requests to make oral presentations
at the meetings should reach the Coast Guard on or before March 14,
2013.

ADDRESSES: The meetings will be held at the Alexander Hamilton U.S.
Customs House, One Bowling Green, New York, NY 10004. Information on
and directions to the Custom House may be found at its Web site at
www.gsa.gov/portal/content/102466. If you are planning to attend the
meeting, you will be required to pass through a security checkpoint and
show your state-issued photo identification. Please arrive at least 30
minutes before the planned start of the meeting in order to pass
through security.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the individuals listed in the FOR FURTHER INFORMATION CONTACT section
as soon as possible.
    To facilitate public participation, we are inviting public comment
on the issues to be considered by the committee as listed in the
``Agenda'' section below. Written comments must be identified by the
Docket Number USCG-2013-0090 and submitted via one of the following
methods:
     Federal Rulemaking Portal: http://www.regulations.gov.
    Follow the instructions for submitting comments.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001. We encourage use of
electronic submissions because security screening may delay the
delivery of mail.
     Fax:<PHONE_NUMBER>.

     Hand Delivery: Same as mail address above, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
    Instruction: All submissions received must include the words
``Department of Homeland Security'' and the docket number of this
action. All comments submitted will be posted on www.regulations.gov
without alteration and will contain any personal information you
provided. You may review a Privacy Act notice regarding our public
dockets in the January 17, 2008, issue of the Federal Register (73 FR
3316).
    Docket: For access to the docket to read documents or comments
related to this notice, go to http://www.regulations.gov, insert USCG-
2013-0090 in the Search Box, press Enter, and then click on the item
you are interested in viewing.

FOR FURTHER INFORMATION CONTACT: Commander Robert L. Smith Jr.,
Designated Federal Officer (DFO) for TSAC, by Phone<PHONE_NUMBER>, fax
202-372-1926, or email<EMAIL_ADDRESS>or Mr. William J.
Abernathy, Alternate DFO TSAC; by Phone<PHONE_NUMBER>, fax<PHONE_NUMBER>,
or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice of these meetings is given under the
Federal Advisory Committee Act (FACA), 5 U.S.C. App. (PL 92-463). This
Committee is established in accordance with and operates under the
provisions of the FACA. The Towing Safety Advisory Committee provides
advice and recommendations to the Secretary of the Department of
Homeland Security on matters and actions concerning shallow-draft
inland and coastal waterway navigation and towing safety. See 33 U.S.C.
1231a.

Agenda of Meetings

    The subcommittees will meet on March 20 from 8:30 a.m. to 5 p.m. to
work on their specific task assignments:
    (1) Task Statement 12-01, Recommendations for the Prevention of
Towing Vessel Crewmember Falls Overboard.
    (2) Task Statement 12-02, Review and Recommendations for the
Revision of NVIC 1-95, Voluntary Training Standards for Entry-Level
Personnel on Towing Industry Vessels.
    (3) Task Statement 12-03, Recommendations for the Enhancement of
Towing Vessel Operational Stability.
    (4) Task Statement 12-04, Recommendations for Safety Standards of
Portable Facility Vapor Control Systems Used for Marine Operations.
    (5) Task Statement 12-05, Recommendations to Enhance Fire
Prevention and Containment aboard Towing Vessels.
    (6) Task Statement 13-01, Recommendations to Automatic
Identification System (AIS) Encoding for Towing Vessels.
    (7) Task Statement 13-02, Recommendations Regarding Manning of
Inspected Towing Vessels.
    On March 21, 2013 from 8 a.m. to 5:30 p.m. and on March 22, 2013
from 8 a.m. until 12 noon, TSAC will meet to receive oral and written
reports from its subcommittees on the following issues:
    (1) Recommendations for the Prevention of Towing Vessel Crewmember
Falls Overboard. A final report will be given.
    (2) Review and Recommendations for the Revision of NVIC 1-95,
Voluntary Training Standards for Entry-Level Personnel on Towing
Industry Vessels. A final report will be given.
    (3) Recommendations for the Enhancement of Towing Vessel
Operational Stability. A final report will be given.
    (4) Recommendations for Safety Standards of Portable Facility Vapor
Control Systems Used for Marine Operations. A final report will be
given.
    (5) Recommendations to Enhance Fire Prevention and Containment
aboard Towing Vessels. An interim report will be given.
    (6) AIS encoding for Towing Vessels. An interim report will be
given.
    (7) Recommendations regarding Manning of Inspected Towing Vessels.
An interim report will be given.
    There will be a comment period for TSAC and a comment period for
public after each report, but before each recommendation is formulated.
The committee will review the information presented on each issue,
deliberate on any recommendations presented in the subcommittees'
reports, and formulate recommendations for the Department's
consideration. A copy of each report will be available at http://homeport.uscg.mil/TSAC.
    The committee will also receive taskings from the Designated
Federal Officer on the following:
    (1) Recommendations on the Designation of Narrow Channels;
    (2) Recommendations for the Standardization of Tug/Towboat
Definitions, and;
    (3) Recommendations for Wake and Surge Attenuation Systems for
Marinas Situated Near Commercial Navigation Channels.
    The Committee will receive briefs on the following topics:
    (1) A bi-annual report on the status of TSAC recommendations;
    (2) The Coast Guard's Towing Vessel National Center of Expertise;
    (3) The Coast Guard's Investigations National Center of Expertise;
    (4) The National Maritime Center concerning Medical Screening for
Licensure; and
    (5) The Use of Liquefied Natural Gas (LNG) as a Commercial Marine
Fuel.

Procedural

    All meetings are open to the public. Please note that the meetings
may close early if all business is complete. An opportunity for oral
comments by the public will be provided during the meetings on March 21
and March 22. Speakers are requested to limit their comments to 5
minutes. Please note that the public oral comment period may end before
the end of the stated meeting times if the committee has finished its
business. If you would like to make an oral presentation at a meeting,
please notify the DFO, listed above in the ``For Further Information
Contact'' section, no later than March 14, 2013. Written statements (20
copies) for distribution at a meeting should reach the Coast Guard no
later than March 14, 2013.

Minutes

    Minutes from the meeting will be available for public review within
90 days following the close of the meeting and can be accessed from the
Coast Guard Homeport Web site http://homeport.uscg.mil/TSAC.

    Dated: February 28, 2013.
J. G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2013-05081 Filed 3-4-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 96 (Monday, May 19, 2014)]
[Proposed Rules]
[Pages 28659-28663]
[FR Doc No: 2014-11432]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2014-0317; FRL-9911-02-Region-9]

Approval and Promulgation of State Implementation Plans; Hawaii;
Infrastructure Requirements for the 2008 8-Hour Ozone and the 2010
Nitrogen Dioxide National Ambient Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve elements of a State Implementation Plan (SIP) revision
submitted by the State of Hawaii on April 04, 2014, pursuant to the
requirements of the Clean Air Act (CAA or the Act) for the 2008 8-Hour
Ozone and the 2010 Nitrogen Dioxide national ambient air quality
standards (NAAQS). The CAA requires that each state adopt and submit a
SIP for the implementation, maintenance, and enforcement of each NAAQS
promulgated by EPA. We are taking comments on this proposal and plan to
follow with a final action.

DATES: Written comments must be received on or before June 18, 2014.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R09-OAR-2014-0317, by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail or deliver: Dawn Richmond, Air Planning Office (AIR-2),
U.S. Environmental Protection Agency, Region IX, 75 Hawthorne Street,
San Francisco, CA 94105-3901. Deliveries are only accepted during the
Regional Office's normal hours of operation.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes Confidential Business Information (CBI) or
other information whose disclosure is restricted by statute.
Information that you consider CBI or otherwise protected should be
clearly identified as such and should not be submitted through http://www.regulations.gov or email. http://www.regulations.gov is an
anonymous access system, and EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send email directly to EPA, your email address will be automatically
captured and included as part of the public comment. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California. 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 in either location
(e.g., CBI). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed
directly below.

FOR FURTHER INFORMATION CONTACT: Dawn Richmond, Air Planning Office
(AIR-2), U.S. Environmental Protection Agency, Region IX, (415) 972-
3207<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, the terms ``we,''
``us,'' and ``our'' refer to EPA.

Table of Contents

I. Background
    A. Statutory Framework
    B. Regulatory History
II. EPA's Approach to the Review of Infrastructure SIP Submissions
III. State Submittal and EPA Action
IV. EPA's Evaluation and Proposed Action
V. Statutory and Executive Order Reviews

I. Background

A. Statutory Framework

    Section 110(a)(1) of the CAA requires states to make a SIP
submission within 3 years after the promulgation of a new or revised
primary NAAQS. Section 110(a)(2) includes a list of specific elements
that ``[e]ach such plan'' submission must include. Many of the section
110(a)(2) SIP elements relate to the general information and
authorities that constitute the ``infrastructure'' of a state's air
quality management program and SIP submittals that address these
requirements are referred to as ``infrastructure SIPs.'' These
infrastructure SIP elements are as follows:
     Section 110(a)(2)(A): Emission limits and other control
measures.
     Section 110(a)(2)(B): Ambient air quality monitoring/data
system.
     Section 110(a)(2)(C): Program for enforcement of control
measures and regulation of new stationary sources.
     Section 110(a)(2)(D)(i): Interstate pollution transport.
     Section 110(a)(2)(D)(ii): Interstate and international
pollution abatement.
     Section 110(a)(2)(E): Adequate resources and authority,
conflict of interest, and oversight of local governments and regional
agencies.
     Section 110(a)(2)(F): Stationary source monitoring and
reporting.
     Section 110(a)(2)(G): Emergency episodes.
     Section 110(a)(2)(H): SIP revisions.
     Section 110(a)(2)(J): Consultation with government
officials, public notification, and prevention of significant
deterioration (PSD) and visibility protection.
     Section 110(a)(2)(K): Air quality modeling and submission
of modeling data.
     Section 110(a)(2)(L): Permitting fees.
     Section 110(a)(2)(M): Consultation/participation by
affected local entities.
    Two elements identified in section 110(a)(2) are not governed by
the three-year submission deadline of section 110(a)(1) and are
therefore not addressed in this action. These elements relate to part D
of title I of the CAA, and submissions to satisfy them are not due
within three years after promulgation of a new or revised NAAQS, but
rather are due at the same time nonattainment area plan requirements
are due under section 172. The two elements are: (1) Section
110(a)(2)(C) to the extent it refers to permit programs required under
part D (nonattainment New Source Review (NSR)), and (2) section
110(a)(2)(I), pertaining to the nonattainment planning requirements of
part D. As a result, this action does not address infrastructure
elements related to the nonattainment NSR portion of section
110(a)(2)(C) or related to section 110(a)(2)(I).

B. Regulatory Background

    On March 12, 2008, EPA issued a revised NAAQS for ozone.\1\ On
January 22, 2010, EPA issued a revised NAAQS for nitrogen dioxide.\2\
These revisions to

the ozone and nitrogen dioxide NAAQS, triggered requirements for states
to submit infrastructure SIPs to address the applicable requirements of
section 110(a)(2) within three years of issuance of each of these
revised NAAQS.
---------------------------------------------------------------------------

    \1\ 73 FR 16436 (March 27, 2008). EPA revised the previous 8-
hour primary ozone standard of 0.08 parts per million (ppm) to 0.075
ppm. EPA also revised the secondary 8-hour standard to the level of
0.075 ppm making it identical to the revised primary standard. In
September 2009, EPA announced it would reconsider the 2008 8-hour
ozone NAAQS. However, in September 2011, EPA announced its decision
to merge the reconsideration of the 2008 NAAQS with the next
scheduled 5-year review of the ozone NAAQS, and advised the states
that the 2008 NAAQS would be implemented.
    \2\ 75 FR 6474 (February 9, 2010). EPA established a 1-hour
standard of 100 parts per billion (ppb), based on the 3-year average
of the 98th percentile of the yearly distribution of 1-hour daily
maximum concentrations, to supplement the existing annual standard.
EPA set the annual NO2 standard to 0.053 ppm.
---------------------------------------------------------------------------

    On January 15, 2013, EPA found that Hawaii had failed to make a
submittal for the 2008 ozone NAAQS to satisfy the requirements of
section 110(a)(2)(A), (B), (C) to the extent it refers to enforcement,
to permitting programs for minor sources and to PSD permitting programs
required by part C of title I of the CAA, 110(a)(2)(D)(i)(II),
110(a)(2)(D)(ii), 110(a)(2)(E) through (H) and 110(a)(2)(J) through
(M).\3\ We explained that ``sections 110(a)(2)(C), (D)(i)(II), (D)(ii)
and (J) (in all four subsections for the PSD-related and notification-
related requirements only) are already addressed for Hawaii through an
existing PSD FIP that remains in place. Therefore, this action will not
trigger any additional FIP obligations with respect to the PSD-related
and notification-related requirements in these four subsections.'' \4\
---------------------------------------------------------------------------

    \3\ 78 FR 2882.
    \4\ Id. at 2889.
---------------------------------------------------------------------------

    We also explained that we were not issuing findings of failure to
submit a SIP addressing section 110(a)(2)(D)(i)(I) of the CAA, due to
the D.C. Circuit's recent opinion in EME Homer City Generation v. EPA,
696 F.3d 7, 31 (D.C. Cir. 2012).

II. EPA's Approach to the Review of Infrastructure SIP Submissions

    EPA is acting upon the SIP submission from Hawaii that addresses
the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2)
for the 2008 8-Hour Ozone and the 2010 Nitrogen Dioxide NAAQS. The
requirement for states to make a SIP submission of this type arises out
of CAA section 110(a)(1). Pursuant to section 110(a)(1), states must
make SIP submissions ``within 3 years (or such shorter period as the
Administrator may prescribe) after the promulgation of a national
primary ambient air quality standard (or any revision thereof),'' and
these SIP submissions are to provide for the ``implementation,
maintenance, and enforcement'' of such NAAQS. The statute directly
imposes on states the duty to make these SIP submissions, and the
requirement to make the submissions is not conditioned upon EPA's
taking any action other than promulgating a new or revised NAAQS.
Section 110(a)(2) includes a list of specific elements that ``[e]ach
such plan'' submission must address.
    EPA has historically referred to these SIP submissions made for the
purpose of satisfying the requirements of CAA sections 110(a)(1) and
110(a)(2) as ``infrastructure SIP'' submissions. Although the term
``infrastructure SIP'' does not appear in the CAA, EPA uses the term to
distinguish this particular type of SIP submission from submissions
that are intended to satisfy other SIP requirements under the CAA, such
as ``nonattainment SIP'' or ``attainment plan SIP'' submissions to
address the nonattainment planning requirements of part D of title I of
the CAA, ``regional haze SIP'' submissions required by EPA rule to
address the visibility protection requirements of CAA section 169A, and
nonattainment new source review permit program submissions to address
the permit requirements of CAA, title I, part D.
    Section 110(a)(1) addresses the timing and general requirements for
infrastructure SIP submissions, and section 110(a)(2) provides more
details concerning the required contents of these submissions. The list
of required elements provided in section 110(a)(2) contains a wide
variety of disparate provisions, some of which pertain to required
legal authority, some of which pertain to required substantive program
provisions, and some of which pertain to requirements for both
authority and substantive program provisions.\5\ EPA therefore believes
that while the timing requirement in section 110(a)(1) is unambiguous,
some of the other statutory provisions are ambiguous. In particular,
EPA believes that the list of required elements for infrastructure SIP
submissions provided in section 110(a)(2) contains ambiguities
concerning what is required for inclusion in an infrastructure SIP
submission.
---------------------------------------------------------------------------

    \5\ For example: Section 110(a)(2)(E)(i) provides that states
must provide assurances that they have adequate legal authority
under state and local law to carry out the SIP; section 110(a)(2)(C)
provides that states must have a SIP-approved program to address
certain sources as required by part C of title I of the CAA; and
section 110(a)(2)(G) provides that states must have legal authority
to address emergencies as well as contingency plans that are
triggered in the event of such emergencies.
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    The following examples of ambiguities illustrate the need for EPA
to interpret some section 110(a)(1) and section 110(a)(2) requirements
with respect to infrastructure SIP submissions for a given new or
revised NAAQS. One example of ambiguity is that section 110(a)(2)
requires that ``each'' SIP submission must meet the list of
requirements therein, while EPA has long noted that this literal
reading of the statute is internally inconsistent and would create a
conflict with the nonattainment provisions in part D of title I of the
Act, which specifically address nonattainment SIP requirements.\6\
Section 110(a)(2)(I) pertains to nonattainment SIP requirements and
part D addresses when attainment plan SIP submissions to address
nonattainment area requirements are due. For example, section 172(b)
requires EPA to establish a schedule for submission of such plans for
certain pollutants when the Administrator promulgates the designation
of an area as nonattainment, and section 107(d)(1)(B) allows up to two
years, or in some cases three years, for such designations to be
promulgated.\7\ This ambiguity illustrates that rather than apply all
the stated requirements of section 110(a)(2) in a strict literal sense,
EPA must determine which provisions of section 110(a)(2) are applicable
for a particular infrastructure SIP submission.
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    \6\ See, e.g., ``Rule To Reduce Interstate Transport of Fine
Particulate Matter and Ozone (Clean Air Interstate Rule); Revisions
to Acid Rain Program; Revisions to the NOX SIP Call;
Final Rule,'' 70 FR 25162, at 25163-65 (May 12, 2005) (explaining
relationship between timing requirement of section 110(a)(2)(D)
versus section 110(a)(2)(I)).
    \7\ EPA notes that this ambiguity within section 110(a)(2) is
heightened by the fact that various subparts of part D set specific
dates for submission of certain types of SIP submissions in
designated nonattainment areas for various pollutants. Note, e.g.,
that section 182(a)(1) provides specific dates for submission of
emissions inventories for the ozone NAAQS. Some of these specific
dates are necessarily later than three years after promulgation of
the new or revised NAAQS.
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    Another example of ambiguity within sections 110(a)(1) and
110(a)(2) with respect to infrastructure SIPs pertains to whether
states must meet all of the infrastructure SIP requirements in a single
SIP submission, and whether EPA must act upon such SIP submission in a
single action. Although section 110(a)(1) directs states to submit ``a
plan'' to meet these requirements, EPA interprets the CAA to allow
states to make multiple SIP submissions separately addressing
infrastructure SIP elements for the same NAAQS. If states elect to make
such multiple SIP submissions to meet the infrastructure SIP
requirements, EPA can elect to act on such submissions either
individually or in a larger combined action.\8\

Similarly, EPA interprets the CAA to allow EPA to take action on the
individual parts of one larger, comprehensive infrastructure SIP
submission for a given NAAQS without concurrent action on the entire
submission. For example, EPA has sometimes elected to act at different
times on various elements and sub-elements of the same infrastructure
SIP submission.\9\
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    \8\ See, e.g., ``Approval and Promulgation of Implementation
Plans; New Mexico; Revisions to the New Source Review (NSR) State
Implementation Plan (SIP); Prevention of Significant Deterioration
(PSD) and Nonattainment New Source Review (NNSR) Permitting,'' 78 FR
4339 (January 22, 2013) (EPA's final action approving the structural
PSD elements of the New Mexico SIP submitted by the State separately
to meet the requirements of EPA's 2008 PM2.5 NSR rule),
and ``Approval and Promulgation of Air Quality Implementation Plans;
New Mexico; Infrastructure and Interstate Transport Requirements for
the 2006 PM2.5 NAAQS,'' (78 FR 4337, January 22, 2013)
(EPA's final action on the infrastructure SIP for the 2006
PM2.5 NAAQS).
    \9\ On December 14, 2007, the State of Tennessee, through the
Tennessee Department of Environment and Conservation, made a SIP
revision to EPA demonstrating that the State meets the requirements
of sections 110(a)(1) and (2). EPA proposed action for
infrastructure SIP elements (C) and (J) on January 23, 2012 (77 FR
3213) and took final action on March 14, 2012 (77 FR 14976). On
April 16, 2012 (77 FR 22533) and July 23, 2012 (77 FR 42997), EPA
took separate proposed and final actions on all other section
110(a)(2) infrastructure SIP elements of Tennessee's December 14,
2007 submittal.
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    Ambiguities within sections 110(a)(1) and 110(a)(2) may also arise
with respect to infrastructure SIP submission requirements for
different NAAQS. Thus, EPA notes that not every element of section
110(a)(2) would be relevant, or as relevant, or relevant in the same
way, for each new or revised NAAQS. The states' attendant
infrastructure SIP submissions for each NAAQS therefore could be
different. For example, the monitoring requirements that a state might
need to meet in its infrastructure SIP submission for purposes of
section 110(a)(2)(B) could be very different for different pollutants,
for example because the content and scope of a state's infrastructure
SIP submission to meet this element might be very different for an
entirely new NAAQS than for a minor revision to an existing NAAQS.\10\
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    \10\ For example, implementation of the 1997 PM2.5
NAAQS required the deployment of a system of new monitors to measure
ambient levels of that new indicator species for the new NAAQS.
---------------------------------------------------------------------------

    EPA notes that interpretation of section 110(a)(2) is also
necessary when EPA reviews other types of SIP submissions required
under the CAA. Therefore, as with infrastructure SIP submissions, EPA
also has to identify and interpret the relevant elements of section
110(a)(2) that logically apply to these other types of SIP submissions.
For example, section 172(c)(7) requires that attainment plan SIP
submissions required by part D have to meet the ``applicable
requirements'' of section 110(a)(2). Thus, for example, attainment plan
SIP submissions must meet the requirements of section 110(a)(2)(A)
regarding enforceable emission limits and control measures and section
110(a)(2)(E)(i) regarding air agency resources and authority. By
contrast, it is clear that attainment plan SIP submissions required by
part D would not need to meet the portion of section 110(a)(2)(C) that
pertains to the PSD program required in part C of title I of the CAA,
because PSD does not apply to a pollutant for which an area is
designated nonattainment and thus subject to part D planning
requirements. As this example illustrates, each type of SIP submission
may implicate some elements of section 110(a)(2) but not others.
    Given the potential for ambiguity in some of the statutory language
of sections 110(a)(1) and 110(a)(2), EPA believes that it is
appropriate to interpret the ambiguous portions of sections 110(a)(1)
and 110(a)(2) in the context of acting on a particular SIP submission.
In other words, EPA assumes that Congress could not have intended that
each and every SIP submission, regardless of the NAAQS in question or
the history of SIP development for the relevant pollutant, would meet
each of the requirements, or meet each of them in the same way.
Therefore, EPA has adopted an approach under which it reviews
infrastructure SIP submissions against the list of elements in section
110(a)(2), but only to the extent each element applies for that
particular NAAQS.
    Historically, EPA has elected to use guidance documents to make
recommendations to states for infrastructure SIPs, in some cases
conveying needed interpretations on newly arising issues and in some
cases conveying interpretations that have already been developed and
applied to individual SIP submissions for particular elements.\11\ EPA
most recently issued guidance for infrastructure SIPs on September 13,
2013 (2013 Guidance).\12\ EPA developed this document to provide states
with up-to-date guidance for infrastructure SIPs for any new or revised
NAAQS. Within this guidance, EPA describes the duty of states to make
infrastructure SIP submissions to meet basic structural SIP
requirements within three years of promulgation of a new or revised
NAAQS. EPA also made recommendations about many specific subsections of
section 110(a)(2) that are relevant in the context of infrastructure
SIP submissions.\13\ The guidance also discusses the substantively
important issues that are germane to certain subsections of section
110(a)(2). Significantly, EPA interprets sections 110(a)(1) and
110(a)(2) such that infrastructure SIP submissions need to address
certain issues and need not address others. Accordingly, EPA reviews
each infrastructure SIP submission for compliance with the applicable
statutory provisions of section 110(a)(2), as appropriate.
---------------------------------------------------------------------------

    \11\ EPA notes, however, that nothing in the CAA requires EPA to
provide guidance or to promulgate regulations for infrastructure SIP
submissions. The CAA directly applies to states and requires the
submission of infrastructure SIP submissions, regardless of whether
or not EPA provides guidance or regulations pertaining to such
submissions. EPA elects to issue such guidance in order to assist
states, as appropriate.
    \12\ ``Guidance on Infrastructure State Implementation Plan
(SIP) Elements under Clean Air Act Sections 110(a)(1) and
110(a)(2),'' Memorandum from Stephen D. Page, September 13, 2013.
    \13\ EPA's September 13, 2013, guidance did not make
recommendations with respect to infrastructure SIP submissions to
address section 110(a)(2)(D)(i)(I). EPA issued the guidance shortly
after the U.S. Supreme Court agreed to review the D.C. Circuit
decision in EME Homer City, 696 F.3d7 (D.C. Cir. 2012) which had
interpreted the requirements of section 110(a)(2)(D)(i)(I). In light
of the uncertainty created by ongoing litigation, EPA elected not to
provide additional guidance on the requirements of section
110(a)(2)(D)(i)(I) at that time. As the guidance is neither binding
nor required by statute, whether EPA elects to provide guidance on a
particular section has no impact on a state's CAA obligations.
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    As an example, section 110(a)(2)(E)(ii) is a required element of
section 110(a)(2) for infrastructure SIP submissions. Under this
element, a state must meet the substantive requirements of section 128,
which pertain to state boards that approve permits or enforcement
orders and heads of executive agencies with similar powers. Thus, EPA
reviews infrastructure SIP submissions to ensure that the state's SIP
appropriately addresses the requirements of section 110(a)(2)(E)(ii)
and section 128. The 2013 Guidance explains EPA's interpretation that
there may be a variety of ways by which states can appropriately
address these substantive statutory requirements, depending on the
structure of an individual state's permitting or enforcement program
(e.g., whether permits and enforcement orders are approved by a multi-
member board or by a head of an executive agency). However they are
addressed by the state, the substantive requirements of section 128 are
necessarily included in EPA's evaluation of infrastructure SIP
submissions because section 110(a)(2)(E)(ii) explicitly requires that
the state satisfy the provisions of section 128.
    As another example, EPA's review of infrastructure SIP submissions
with respect to the PSD program requirements in sections 110(a)(2)(C),

110(a)(2)(D)(i)(II), and 110(a)(2)(J) focuses upon the structural PSD
program requirements contained in part C and EPA's PSD regulations.
Structural PSD program requirements include provisions necessary for
the PSD program to address all regulated sources and NSR pollutants,
including GHGs. By contrast, structural PSD program requirements do not
include provisions that are not required under EPA's regulations at 40
CFR 51.166 but are merely available as an option for the state, such as
the option to provide grandfathering of complete permit applications
with respect to the 2012 PM2.5 NAAQS. Accordingly, the
latter optional provisions are types of provisions EPA considers
irrelevant in the context of an infrastructure SIP action.
    For other section 110(a)(2) elements, however, EPA's review of a
state's infrastructure SIP submission focuses on assuring that the
state's SIP meets basic structural requirements. For example, section
110(a)(2)(C) includes, inter alia, the requirement that states have a
program to regulate minor new sources. Thus, EPA evaluates whether the
state has an EPA-approved minor new source review program and whether
the program addresses the pollutants relevant to that NAAQS. In the
context of acting on an infrastructure SIP submission, however, EPA
does not think it is necessary to conduct a review of each and every
provision of a state's existing minor source program (i.e., already in
the existing SIP) for compliance with the requirements of the CAA and
EPA's regulations that pertain to such programs.
    With respect to certain other issues, EPA does not believe that an
action on a state's infrastructure SIP submission is necessarily the
appropriate type of action in which to address possible deficiencies in
a state's existing SIP. These issues include: (1) Existing provisions
related to excess emissions from sources during periods of startup,
shutdown, or malfunction that may be contrary to the CAA and EPA's
policies addressing such excess emissions (``SSM''); (2) existing
provisions related to ``director's variance'' or ``director's
discretion'' that may be contrary to the CAA because they purport to
allow revisions to SIP-approved emissions limits while limiting public
process or not requiring further approval by EPA; and (3) existing
provisions for PSD programs that may be inconsistent with current
requirements of EPA's ``Final NSR Improvement Rule,'' 67 FR 80186
(December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (``NSR
Reform''). Thus, EPA believes it may approve an infrastructure SIP
submission without scrutinizing the totality of the existing SIP for
such potentially deficient provisions and may approve the submission
even if it is aware of such existing provisions.\14\ It is important to
note that EPA's approval of a state's infrastructure SIP submission
should not be construed as explicit or implicit re-approval of any
existing potentially deficient provisions that relate to the three
specific issues just described.
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    \14\ By contrast, EPA notes that if a state were to include a
new provision in an infrastructure SIP submission that contained a
legal deficiency, such as a new exemption for excess emissions
during SSM events, then EPA would need to evaluate that provision
for compliance against the rubric of applicable CAA requirements in
the context of the action on the infrastructure SIP.
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    EPA's approach to review of infrastructure SIP submissions is to
identify the CAA requirements that are logically applicable to that
submission. EPA believes that this approach to the review of a
particular infrastructure SIP submission is appropriate, because it
would not be reasonable to read the general requirements of section
110(a)(1) and the list of elements in 110(a)(2) as requiring review of
each and every provision of a state's existing SIP against all
requirements in the CAA and EPA regulations merely for purposes of
assuring that the state in question has the basic structural elements
for a functioning SIP for a new or revised NAAQS. Because SIPs have
grown by accretion over the decades as statutory and regulatory
requirements under the CAA have evolved, they may include some outmoded
provisions and historical artifacts. These provisions, while not fully
up to date, nevertheless may not pose a significant problem for the
purposes of ``implementation, maintenance, and enforcement'' of a new
or revised NAAQS when EPA evaluates adequacy of the infrastructure SIP
submission. EPA believes that a better approach is for states and EPA
to focus attention on those elements of section 110(a)(2) of the CAA
most likely to warrant a specific SIP revision due to the promulgation
of a new or revised NAAQS or other factors.
    For example, EPA's 2013 Guidance gives simpler recommendations with
respect to carbon monoxide than other NAAQS pollutants to meet the
visibility requirements of section 110(a)(2)(D)(i)(II), because carbon
monoxide does not affect visibility. As a result, an infrastructure SIP
submission for any future new or revised NAAQS for carbon monoxide need
only state this fact in order to address the visibility prong of
section 110(a)(2)(D)(i)(II).
    Finally, EPA believes that its approach with respect to
infrastructure SIP requirements is based on a reasonable reading of
sections 110(a)(1) and 110(a)(2) because the CAA provides other avenues
and mechanisms to address specific substantive deficiencies in existing
SIPs. These other statutory tools allow EPA to take appropriately
tailored action, depending upon the nature and severity of the alleged
SIP deficiency. Section 110(k)(5) authorizes EPA to issue a ``SIP
call'' whenever the Agency determines that a state's SIP is
substantially inadequate to attain or maintain the NAAQS, to mitigate
interstate transport, or to otherwise comply with the CAA.\15\ Section
110(k)(6) authorizes EPA to correct errors in past actions, such as
past approvals of SIP submissions.\16\ Significantly, EPA's
determination that an action on a state's infrastructure SIP submission
is not the appropriate time and place to address all potential existing
SIP deficiencies does not preclude EPA's subsequent reliance on
provisions in section 110(a)(2) as part of the basis for action to
correct those deficiencies at a later time. For example, although it
may not be appropriate to require a state to eliminate all existing
inappropriate director's discretion provisions in the course of acting
on an infrastructure SIP submission, EPA believes that section
110(a)(2)(A) may be among the statutory bases that EPA relies upon in
the course of addressing such deficiency in a subsequent action.\17\
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    \15\ For example, EPA issued a SIP call to Utah to address
specific existing SIP deficiencies related to the treatment of
excess emissions during SSM events. See ``Finding of Substantial
Inadequacy of Implementation Plan; Call for Utah State
Implementation Plan Revisions,'' 76 FR 21639 (April 18, 2011).
    \16\ EPA has used this authority to correct errors in past
actions on SIP submissions related to PSD programs. See ``Limitation
of Approval of Prevention of Significant Deterioration Provisions
Concerning Greenhouse Gas Emitting-Sources in State Implementation
Plans; Final Rule,'' 75 FR 82536 (December 30, 2010). EPA has
previously used its authority under CAA section 110(k)(6) to remove
numerous other SIP provisions that the Agency determined it had
approved in error. See, e.g., 61 FR 38664 (July 25, 1996) and 62 FR
34641 (June 27, 1997) (corrections to American Samoa, Arizona,
California, Hawaii, and Nevada SIPs); 69 FR 67062 (November 16,
2004) (corrections to California SIP); and 74 FR 57051 (November 3,
2009) (corrections to Arizona and Nevada SIPs).
    \17\ See, e.g., EPA's disapproval of a SIP submission from
Colorado on the grounds that it would have included a director's
discretion provision inconsistent with CAA requirements, including
section 110(a)(2)(A). See, e.g., 75 FR 42342 at 42344 (July 21,
2010) (proposed disapproval of director's discretion provisions); 76
FR 4540 (Jan. 26, 2011) (final disapproval of such provisions).

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III. State Submittal and EPA Action

    On April 4, 2014, the Hawaii Department of Health (HDOH) submitted
the ``Hawaii State Implementation Plan Revision for 2008 Ozone and 2010
Nitrogen Dioxide National Ambient Air Quality Standard Clean Air Act
section 110(a)(1) & (2)'' (Hawaii Ozone and Nitrogen Dioxide
Infrastructure SIP), which includes (1) a ``Proposed Certification of
Adequacy Table'' (Attachment 1), (2) a ``Proposed List of Revisions to
Regulatory and Statutory Provisions in the Hawaii State Implementation
Plan'' (Attachment 2); (3) Summary of Public Participation Proceedings
(Attachment 3); (4) Hawaii Revised Statutes Title 19, Health Chapter
342B, Air Pollution Control Sections 4 and 5 (Appendix A); (5) Hawaii
Administrative Rules, Chapter 11-60.1, Section 31(Appendix B); and (6)
other supporting materials.\18\
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    \18\ A copy of the complete Hawaii ozone and nitrogen dioxide
Infrastructure SIP submittal has been placed in the docket for this
action and is available online at http://www.regulations.gov, docket
number EPA-R09-OAR-2014-0317.
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    On April 21, 2014, EPA determined that the SIP revision was
complete, except for the following sub-elements: 110(a)(2)(C) sub-
element 3 (preconstruction PSD permitting of major sources);
110(a)(2)(D); and 110(a)(2)(J) sub-elements 1 (consultation with
identified officials on certain air agency actions) and 3 (PSD).

IV. EPA's Evaluation and Proposed Action

    EPA has evaluated the Hawaii Ozone and Nitrogen Dioxide
Infrastructure SIP in relation to the infrastructure SIP requirements
of CAA section 110(a)(2) and the applicable implementing regulations in
40 CFR part 51. The Technical Support Document (TSD) for this action,
which is available in the docket to this action, includes our
evaluation for each element, as well as our evaluation of various
statutory and regulatory provisions. In particular, we evaluated Hawaii
Administrative Rules (HAR) section 11-60.1-31 Hawaii Revised Statutes
(HRS) sections 342B-4 342B-5 for approval into the Hawaii SIP and HRS
sections 342-14, 342-18 and 342-19 for removal from the SIP.
    Based upon this analysis, EPA proposes to approve HAR section 11-
60.1-31 and HRS sections 342B-4 and 342B-5 into the Hawaii SIP and to
remove HRS sections 342-14, 342-18 and 342-19 from the SIP. We also
propose to approve the Hawaii Ozone and Nitrogen Dioxide Infrastructure
SIP with respect to the following CAA requirements:
     Section 110(a)(2)(A): Emission limits and other control
measures.
     Section 110(a)(2)(B): Ambient air quality monitoring/data
system.
     Section 110(a)(2)(C) (in part): Program for enforcement of
control measures and regulation of new stationary sources (minor NSR
program).
     Section 110(a)(2)(E): Adequate resources and authority,
conflict of interest, and oversight of local governments and regional
agencies.
     Section 110(a)(2)(F): Stationary source monitoring and
reporting.
     Section 110(a)(2)(G): Emergency episodes.
     Section 110(a)(2)(H): SIP revisions.
     Section 110(a)(2)(J) (in part): Public notification (sub-
element 2).
     Section 110(a)(2)(K): Air quality modeling and submission
of modeling data.
     Section 110(a)(2)(L): Permitting fees.
     Section 110(a)(2)(M): Consultation/participation by
affected local entities.
    As explained above, we previously found the Hawaii Ozone and
Nitrogen Dioxide Infrastructure SIP incomplete with respect to various
sub-elements. Where EPA determines that a portion of a SIP submission
is incomplete, ``the State shall be treated as not having made the
submission (or, in the Administrator's discretion, part thereof.)''\19\
Accordingly, we are not proposing to act on the Hawaii Ozone and
Nitrogen Dioxide Infrastructure SIP with respect to 110(a)(2)(C) sub-
element 3 (preconstruction PSD permitting of major sources);
110(a)(2)(D) all sub-elements; and 110(a)(2)(J) sub-elements 1
(consultation with identified officials on certain air agency actions)
and 3 (PSD).
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    \19\ CAA section 110(k)(1)(C).
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V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations (42 U.S.C. 7410(k), 40 CFR 52.02(a)). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves some state law as meeting federal
requirements; this proposed action does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999); is not an
economically significant regulatory action based on health or safety
risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and,
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Oxides of nitrogen, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: April 25, 2014.
Jared Blumenfeld,
Regional Administrator, EPA Region 9.
[FR Doc. 2014-11432 Filed 5-16-14; 8:45 am]
BILLING CODE 6560-50-P