[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57919-57921]
[FR Doc No: 2016-20221]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1580]

Patient Preference Information--Voluntary Submission, Review in
Premarket Approval Applications, Humanitarian Device Exemption
Applications, and De Novo Requests, and Inclusion in Decision Summaries
and Device Labeling; Guidance for Industry, Food and Drug
Administration Staff and Other Stakeholders; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Patient Preference
Information--Voluntary Submission, Review in PMAs, HDE Applications,
and De Novo Requests, and Inclusion in Decision Summaries and Device
Labeling.'' This document explains the principal concepts that sponsors
and other stakeholders should consider when choosing to collect patient
preference information (PPI), which may inform FDA's benefit-risk
determinations in the premarket review of premarket approval
applications (PMAs), humanitarian device exemption (HDE) applications,
and de novo classification requests. This guidance also discusses FDA's
inclusion of PPI in its decision summaries and provides recommendations
for the inclusion of such information in device labeling for certain
devices. FDA is also issuing a Level 2 updated version of the guidance
document entitled ``Factors To Consider When Making Benefit-Risk
Determinations in Medical Device Premarket Approval and De Novo
Classifications,'' originally issued on March 28, 2012, that has been
edited to be consistent with this guidance document.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2015-D-1580 for ``Patient Preference Information--Voluntary
Submission, Review in PMAs, HDE Applications, and De Novo Requests, and
Inclusion in Decision Summaries and Device Labeling.'' If you are
making submissions that also address the edits to the Level 2 guidance,
the submissions received must include the Docket No. FDA-2011-D-0577
for ``Factors To Consider When Making Benefit-Risk Determinations in
Medical Device Premarket Approval and De Novo Classifications.''
Received comments will be placed in the docket(s) noted and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the

docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    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 a single hard copy of the guidance document entitled
``Patient Preference Information--Voluntary Submission, Review in PMAs,
HDE Applications, and De Novo Requests, and Inclusion in Decision
Summaries and Device Labeling'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, 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.

FOR FURTHER INFORMATION CONTACT: Anindita Saha, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5414, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>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, 240-402-
7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``Patient
Preference Information--Voluntary Submission, Review in PMAs, HDE
Applications, and De Novo Requests, and Inclusion in Decision Summaries
and Device Labeling.'' FDA believes that patients can and should bring
their own experiences to bear in helping the Agency to evaluate the
benefit-risk profiles of certain devices. This kind of input can be
important to consider during FDA's decisionmaking for these devices.
    This document explains the principal concepts that sponsors and
other stakeholders should consider when choosing to collect PPI, which
may inform FDA's benefit-risk determinations in the premarket review of
PMAs, HDE applications, and de novo requests. This guidance also
discusses FDA's inclusion of PPI in its decision summaries and provides
recommendations for the inclusion of such information in device
labeling for certain devices.
    The objectives of this guidance are: (1) To encourage submission of
PPI, if available, by sponsors or other stakeholders to FDA and to aid
in FDA decisionmaking; (2) to outline recommended qualities of patient
preference studies, which may result in valid scientific evidence; (3)
to provide recommendations for collecting and submitting PPI to FDA;
and (4) to discuss FDA's inclusion of PPI in its decision summaries and
provide recommendations for the inclusion of such information in device
labeling, where appropriate. The guidance also includes hypothetical
examples that illustrate how PPI may inform FDA's decisionmaking. The
guidance applies to both diagnostic and therapeutic devices that are
subject to these review processes. Additionally, this guidance may be
information to other stakeholders such as patient groups and academia
who may wish to conduct patient preference studies.
    In the Federal Register of May 18, 2015 (80 FR 28277), FDA
announced the availability of the draft of this guidance and interested
persons were invited to comment by August 17, 2015. FDA has considered
all of the public comments received in finalizing this guidance.
    FDA is also issuing a Level 2 update to the guidance document
entitled ``Factors To Consider When Making Benefit-Risk Determinations
in Medical Device Premarket Approval and De Novo Classifications,''
which was originally issued on March 28, 2012, to ensure consistency
with the terminology and concepts presented in this guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Patient Preference Information--Voluntary
Submission, Review in PMAs, HDE Applications, and De Novo Requests, and
Inclusion in Decision Summaries and Device Labeling.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryinformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to
download an electronic copy of ``Patient Preference Information--
Voluntary Submission, Review in PMAs, HDE Applications, and De Novo
Requests, and Inclusion in Decision Summaries and Device Labeling'' or
``Factors To Consider When Making Benefit-Risk Determinations in
Medical Device Premarket Approval and De Novo Classifications'' may
send an email request to<EMAIL_ADDRESS>to receive an
electronic copy of the document. Please use the document number 1500006
or 1772 respectively to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to currently 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 812.25(c) have been approved under
OMB control number 0910-0078; the collections of information in 21 CFR
part 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 814, subparts B and
E have been approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 814, subpart H have been
approved under OMB control number 0910-0332; the collections of
information in 21 CFR part 822 have been approved under OMB control
number 0910-0449; the collections of information in 21 CFR part 801
have been approved under OMB control number 0910-0485; and the
collections of information in the guidance document ``Requests for
Feedback on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff'' have been approved
under OMB control number 0910-0756.

    Dated: August 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20221 Filed 8-23-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 25 (Tuesday, February 7, 2012)]
[Notices]
[Pages 6112-6113]
[FR Doc No: 2012-2722]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9627-9]

Notice of Final National Pollutant Discharge Elimination System
(NPDES) General Permit for Discharges From Concentrated Animal Feeding
Operations (CAFOs) in Oklahoma (OKG010000)

AGENCY: Environmental Protection Agency (EPA), Region 6.

ACTION: Notice of NPDES general permit reissuance.

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SUMMARY: EPA Region 6 today is providing notice that an NPDES general
permit for discharges from eligible owners/operators of concentrated
animal feeding operations (CAFOs), in Oklahoma, except those discharges
on Indian Country was issued. Unless excluded by Part I.D or I.F of the
final permit, animal feeding operations that are defined as CAFOs or
designated as CAFOs by the permitting authority (See Part VII
Definitions, ``CAFOs'') and that are subject to 40 CFR part 412,
Subparts A (Horses and Sheep), C (Dairy Cows and Cattle Other than Veal
Calves), and D (Swine, Poultry, and Veal Calves) are eligible for
coverage under this permit. This permit covers the types of animal
feeding operations listed above which meet the definition of a CAFO and
discharge pollutants to waters of the United States.
    A copy of the Region's responses to comments and the final permit
may be obtained from the EPA Region 6 Internet site: http://www.epa.gov/region6/water/npdes/cafo/index.htm.

DATES: This permit shall be effective on February 1, 2012 and expire on
January 31, 2017. In accordance with 40 CFR part 23, this permit shall
be considered issued for the purpose of judicial review on February 21,
2012. Under section 509(b) of the Clean Water Act, judicial review of
this general permit can be had by filing a petition for review in the
United States Court of Appeals within 120 days after the permit is
considered issued for judicial review. Under section 509(b)(2) of the
Clean Water Act, the requirements in this permit may not be challenged
later in civil or criminal proceedings to enforce these requirements.
In addition, this permit may not be challenged in other agency
proceedings. Deadlines for submittal of notices of intent are provided
in Part I.E of the permit.

FOR FURTHER INFORMATION CONTACT: Ms. Diane Smith, Water Quality
Protection Division, EPA Region 6, 1445 Ross Avenue, Dallas, Texas
75202-2733, telephone:<PHONE_NUMBER>, or via email at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to section 402 of the Clean Water
Act (CWA), 33 U.S.C. section 1342, EPA proposed and solicited comments
on NPDES general permit OKG010000 at 74 FR 12849 (March 25, 2009). The
comment period was extended to May 26, 2009. See 74 FR 20296 (May 1,
2009).
    Region 6 received comments from Jean Public; Leo Byford; Oklahoma
Department of Agriculture, Food, and Forestry (ODAFF); Crawford Farms,
Inc.; Enviro-Ag Engineering; U.S. Fish and Wildlife Service (USFWS);
Oklahoma State University (OSU); Pride Feeders, LP; Oklahoma Farm
Bureau (OFB); Premium Beef Feeders, LLC; Tri-State Feeders, Inc.; Dairy
Producers of New Mexico (DPNM); Karen Brewer; Murphy-Brown LLC;
Seaboard Foods; Texas Cattle Feeders Association (TCFA); The Hanor
Company of Wisconsin, LLC; The Maschhoffs; Wheeler Brothers Grain
Company (WBGC); Hitch Enterprises (Jason Hitch); Hitch Enterprises
(Patricia Burt); JBS Five Rivers Cattle Feeding LLC, Oklahoma Pork
Council (OPC); Robert Bergner; Tyson Foods, Inc.; Richard Robinson.
    On September 15, 2010, the United States Fish and Wildlife Service
(USFWS) initiated formal consultation on the proposed permitting action
under section 7 of the Endangered Species Act. Due to the conclusion of
formal consultation with the USFWS and finalization of its Biological
Opinion (BO) on December 14, 2011, EPA has removed Part I.D.5 from the
permit. Additionally, consultation between EPA and the USFWS has
resulted in the addition and modification of certain permit conditions
designed with consideration for listed species and critical habitat.
    EPA Region 6 considered all comments received in reaching the final
permit decision. Additionally, the Oklahoma Department of Environmental
Quality provided EPA with a CWA Section 401 Certification on June 24,
2009, which included conditions of certification that were incorporated
into the final permit. An explicit option to submit notice of intent
documents electronically was removed from the final permit due to
unforeseen

difficulties in setting up such a system at this time. A summary of the
changes made to the proposed permit can be found in the response to
comments document on the aforementioned EPA Region 6 Internet site.

    Authority: Clean Water Act, 33 U.S.C. 1251 et seq.

    Dated: January 30, 2012.
William K. Honker,
Acting Director, Water Quality Protection Division, EPA Region 6.
[FR Doc. 2012-2722 Filed 2-6-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 23, 2010 (Volume 75, Number 120)]
[Notices]
[Page 35786]
[DOCID:fr23jn10-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL10-68-000]

Resale Power Group of Iowa, WPPI Energy v. ITC Midwest LLC,
Interstate Power and Light Company; Notice of Filing

June 16, 2010.
    Take notice that, on June 15, 2010, Resale Power Group of Iowa and
WPPI Energy filed a supplement to its complaint originally filed on May
18, 2010.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 6, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-15138 Filed 6-22-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 52 (Wednesday, March 18, 2015)]
[Rules and Regulations]
[Pages 14019-14024]
[FR Doc No: 2015-06112]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2014-0610; FRL-9924-47-Region 4]

Approval and Promulgation of Implementation Plans; Region 4
States; 2008 Lead, 2008 Ozone and 2010 Nitrogen Dioxide Prevention of
Significant Deterioration Infrastructure Plans

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving
portions of submissions from Alabama, Florida, Georgia, Kentucky,
Mississippi, South Carolina and Tennessee for inclusion into each
State's implementation plan. This action pertains to the Clean Air Act
(CAA or Act) infrastructure requirements for the 2008 Lead, 2008 Ozone
and 2010 Nitrogen Dioxide (NO2) National Ambient Air Quality
Standards (NAAQS). The CAA requires that each state adopt and submit a
state implementation plan (SIP) for the implementation, maintenance,
and enforcement of each NAAQS promulgated by EPA. These plans are
commonly referred to as ``infrastructure'' SIPs. Specifically, EPA is
approving the portions of the submissions from Alabama, Florida,
Georgia, Kentucky, Mississippi, South Carolina and Tennessee that
relate to the infrastructure SIP prevention of significant
deterioration (PSD) requirements. All other applicable infrastructure
requirements for the 2008 Lead, 2008 Ozone and 2010 NO2
NAAQS associated with these States are being addressed in separate
rulemakings.

DATES: This rule is effective on April 17, 2015.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2014-0610. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section (formerly Regulatory
Development Section), Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

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

I. Background

    By statute, SIPs meeting the requirements of sections 110(a)(1) and
(2) are to be submitted by states within three years after promulgation
of a new or revised NAAQS to provide for the implementation,
maintenance, and enforcement of the new or revised NAAQS. 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. Sections 110(a)(1) and (2) require
states to address basic SIP elements such as for monitoring, basic
program requirements and legal authority that are designed to assure
attainment and maintenance of the newly established or revised NAAQS.
More specifically, section 110(a)(1) provides the procedural and timing
requirements for SIPs. Section 110(a)(2) lists specific elements that
states must meet for the ``infrastructure'' SIP requirements related to
a newly established or revised NAAQS. The contents of an infrastructure
SIP submission may vary depending upon the data and analytical tools
available to the state, as well as the provisions already contained in
the state's implementation plan at the time in which the state develops
and submits the submission for a new or revised NAAQS.
    Through this action, EPA is approving the PSD requirements of
sections 110(a)(2)(C), 110(a)(2)(D)(i)(II) (prong 3) and 110(a)(2)(J)
(hereafter ``PSD Elements'') for various infrastructure SIP submissions
from the states of Alabama, Florida, Georgia, Kentucky, Mississippi,
South Carolina and Tennessee. As described further below, for some of
these states, EPA is approving the PSD Elements in the infrastructure
SIP submissions for the 2008 Lead, 2008 Ozone and 2010 NO2
NAAQS; whereas for other states, EPA is only approving the PSD Elements
of the infrastructure SIP submissions for a subset of these NAAQS. All
other applicable infrastructure requirements for the 2008 Lead, 2008
Ozone and 2010 NO2 NAAQS associated with these States are
being addressed in separate rulemakings.

a. 2008 Lead NAAQS

    For the 2008 Lead NAAQS, EPA is only approving the PSD Elements of
the infrastructure SIP submissions from Alabama (received November 4,
2011), Florida (received October 14, 2011), Georgia (received May 14,
2012), Kentucky (received July 17, 2012), Mississippi (received
November 17, 2011), and South Carolina (received September 20, 2011).
EPA notes that the Agency approved the PSD Elements of Tennessee's 2008
Lead infrastructure SIP submission on August 12, 2013 (78 FR 48806).

b. 2008 Ozone NAAQS

    For the 2008 Ozone NAAQS, EPA is only approving the PSD Elements of
the infrastructure SIP submissions from Alabama (received August 20,
2012), Georgia (received March 6, 2012), Mississippi (received May 29,
2012; and resubmitted July 26, 2012), and South Carolina (received on
July 17, 2012). EPA notes that the Agency approved the PSD Elements of
the infrastructure SIP submissions for the 2008 Ozone NAAQS for
Kentucky on March 7, 2013 (78 FR 14691) and November 3, 2014 (79 FR
65143), and Tennessee on March 6, 2013 (78 FR 14450) and January 9,
2014 (79 FR 1593).

c. 2010 NO2 NAAQS

    For the 2010 NO2 NAAQS, EPA is approving the PSD
Elements of the infrastructure SIP submissions from Alabama (received
April 23, 2013), Florida (received January 22, 2013), Georgia (received
March 25, 2013), Kentucky (received April 26, 2013), Mississippi
(received February 28, 2013), South Carolina (received April 30, 2014),
and Tennessee (received March 13, 2014).
    EPA is acting upon the PSD Elements portions of SIP submissions
that address the infrastructure requirements of CAA sections 110(a)(1)
and 110(a)(2) for the 2008 Lead, 2008 Ozone and 2010 NO2
NAAQS for various states in Region 4. Section 110(a)(2) includes a list
of specific elements that ``[e]ach such plan'' submission must address.
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 new source review (NSR) pollutants,
including GHGs.
    On November 13, 2014, EPA published a proposed rulemaking to
approve the portions of the above-described infrastructure SIP
submissions from Alabama, Florida, Georgia, Kentucky, Mississippi,
South Carolina and Tennessee to address the PSD permitting requirements
of sections 110(a)(2)(C), 110(a)(2)(D)(i)(II) (prong 3) and
110(a)(2)(J) of the CAA. See 79 FR 67398. Comments on the proposed
rulemaking were due on or before December 15, 2014. No adverse comments
were received. EPA's November 13, 2014, proposed rulemaking contains
more detailed information regarding Alabama, Florida, Georgia,
Kentucky, Mississippi, South Carolina and Tennessee submissions to
address the PSD permitting requirements being approved today, and the
rationale for this final action.

II. What are states required to address under Sections 110(a)(2)(C),
110(a)(2)(D)(i)(II) (Prong 3) and 110(a)(2)(J) related to PSD?

    Section 110(a)(2)(C) has three components that must be addressed in
infrastructure SIP submissions: Enforcement, state-wide regulation of
new and modified minor sources and minor modifications of major
sources; and PSD permitting of major sources and major modifications in
areas designated attainment or unclassifiable for the subject NAAQS as
required by CAA title I part C (i.e., the major source PSD program).
    Section 110(a)(2)(D)(i) has two components; 110(a)(2)(D)(i)(I) and
110(a)(2)(D)(i)(II). Each of these components have two subparts
resulting in four distinct components, commonly referred to as
``prongs,'' that must be addressed in infrastructure SIP submissions.
The first two prongs, which are codified in section 110(a)(2)(D)(i)(I),
are provisions that prohibit any source or other type of emissions
activity in one state from contributing significantly to nonattainment
of the NAAQS in another state (``prong 1''), and interfering with
maintenance of the NAAQS in another state (``prong 2''). The third and
fourth prongs, which are codified in section 110(a)(2)(D)(i)(II), are
provisions that prohibit emissions activity in one state interfering
with measures required to prevent significant deterioration of air
quality in another state (``prong 3''), or to protect visibility in
another state (``prong 4'').
    Section 110(a)(2)(J) has four components that must be addressed in
infrastructure SIP submissions: (1) Consultation with government
officials, (2) public notification, (3) prevention of significant
deterioration, and (4) visibility protection.
    With respect to the PSD Elements of these sections, EPA interprets
the CAA to require each state to make, for each new or revised NAAQS,
an infrastructure SIP submission that demonstrates that the air agency
has a complete PSD permitting program meeting the current requirements
for all regulated NSR pollutants.
    See EPA's November 13, 2014, proposed rulemaking at 79 FR 67398 for
more detailed information on EPA's analysis of how the Alabama,
Florida, Georgia, Kentucky, Mississippi, South Carolina and Tennessee
infrastructure SIP submissions meet the requirements of the PSD
Elements for the NAAQS for which they were submitted. As mentioned
above, EPA did not receive any adverse comments on the November 13,
2014, proposed rulemaking. As such and based on EPA's analysis, the
Agency has made the determination that:
     Alabama's SIP and practices are adequate and comply with
PSD Elements for the 2008 Lead, 2008 Ozone and 2010 NO2
NAAQS;
     Florida's SIP and practices are adequate and comply with
PSD Elements for the 2008 Lead and 2010 NO2 NAAQS;
     Georgia's SIP and practices are adequate and comply with
the PSD Elements for the 2008 Lead, 2008 Ozone, and 2010 NO2
NAAQS;
     Kentucky's SIP and practices are adequate and comply with
the PSD Elements for the 2008 Lead and 2010 NO2 NAAQS;
     Mississippi's SIP and practices are adequate and comply
with the PSD Elements for the 2008 Lead, 2008 Ozone, and 2010
NO2 NAAQS;
     South Carolina's SIP and practices are adequate and comply
with the infrastructure SIP PSD Elements for the 2008 Lead, 2008 Ozone,
and 2010 NO2 NAAQS; and
     Tennessee's SIP and practices are adequate and comply with
the infrastructure SIP PSD Elements for the 2010 NO2 NAAQS.

III. Final Action

    As described above, EPA is approving the portions of the above-
described infrastructure SIP submissions from Alabama, Florida,
Georgia, Kentucky, Mississippi, South Carolina and Tennessee to address
the PSD permitting requirements of sections 110(a)(2)(C),
110(a)(2)(D)(i)(II) (prong 3) and 110(a)(2)(J) of the CAA. As described
above, for some of these states, EPA is approving the PSD Elements of
the infrastructure SIP submissions for the 2008 Lead, 2008 Ozone and
2010 Nitrogen NO2 NAAQS; whereas for other states, EPA is
only approving the PSD Elements of the infrastructure SIP submissions
for a subset of these NAAQS. EPA is approving these portions of these
submissions because they are consistent with section 110 of the CAA.
    EPA also notes that, at present, the Agency has preliminarily
determined that the Alabama, Florida, Georgia, Kentucky, Mississippi,
South Carolina and Tennessee SIPs are sufficient to satisfy the PSD
permitting requirements portion of section 110(a)(2)(C),
110(a)(2)(D)(i)(II), prong 3 and 110(a)(2)(J) with respect to GHGs
because the PSD permitting program previously-approved by EPA into the
SIP continues to require that PSD permits (otherwise required based on
emissions of pollutants other than GHGs) contain limitations on GHG
emissions based on the application of Best Available Control
Technology. Although the approved Alabama, Florida, Georgia, Kentucky,
Mississippi, South Carolina and Tennessee PSD permitting programs may
currently contain provisions that are no longer necessary in light of
the Supreme Court's Utility Air Regulatory Group v. Environmental
Protection Agency

decision, these previous approvals do not render the infrastructure SIP
submission inadequate to satisfy sections 110(a)(2)(C),
110(a)(2)(D)(i)(II) (prong 3) and 110(a)(2)(J). The SIPs contain the
necessary PSD requirements at this time, and the application of those
requirements is not impeded by the presence of other previously-
approved provisions regarding the permitting of sources of GHGs that
EPA does not consider necessary at this time in light of the Supreme
Court decision. Accordingly, the Supreme Court decision does not affect
EPA's approval of Alabama, Florida, Georgia, Kentucky, Mississippi,
South Carolina and Tennessee's infrastructure SIPs as to the PSD
permitting requirements of sections 110(a)(2)(C), 110(a)(2)(D)(i)(II)
(prong 3) and 110(a)(2)(J).

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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).
    With the exception of South Carolina, the SIPs involved in this
action are not approved to apply on any Indian reservation land or in
any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.'' With respect to
this action as it relates to South Carolina, EPA notes that the Catawba
Indian Nation Reservation is located within South Carolina and pursuant
to the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120,
``all state and local environmental laws and regulations apply to the
Catawba Indian Nation and Reservation and are fully enforceable by all
relevant state and local agencies and authorities.'' Thus, the South
Carolina SIP applies to the Catawba Reservation, however, because this
action is not approving any specific rule into the South Carolina SIP,
but rather proposing that the State's already approved SIP meets
certain CAA requirements, EPA has determined that there are no
substantial direct effects on the Catawba Indian Nation. EPA has also
determined that these revisions will not impose any substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by May 18, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. See section 307(b)(2).

List of Subjects in 40 CFR Part 52

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

    Dated: March 6, 2015.
Heather McTeer Toney,
Regional Administrator, Region 4.
    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart B--Alabama

0
2. Section 52.50(e), is amended by adding three new entries for
``110(a)(1) and (2) Infrastructure Requirements for the 2008 Lead
NAAQS'', ``110(a)(1) and (2) Infrastructure Requirements for the 2008
Ozone NAAQS'', and ``110(a)(1) and (2) Infrastructure Requirements for
the 2010 NO2 NAAQS'' at the end of the table to read as
follows:

Sec.  52.50  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Alabama Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                    Applicable
  Name of  nonregulatory SIP      geographic or         State
           provision              nonattainment    submittal date/    EPA Approval date         Explanation
                                       area        effective date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
110(a)(1) and (2)               Alabama..........       11/4/2011  3/18/2015 Federal       Addressing the PSD
 Infrastructure Requirements                                        Register citation.      permitting
 for the 2008 Lead NAAQS.                                                                   requirements of
                                                                                sections
                                                                                110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only.
110(a)(1) and (2)               Alabama..........       8/20/2012  3/18/2015 [Insert       Addressing the PSD
 Infrastructure Requirements                                        Federal Register        permitting
 for the 2008 Ozone NAAQS.                                          citation].              requirements of
                                                                                sections
                                                                                110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only.
110(a)(1) and (2)               Alabama..........       4/23/2013  3/18/2015 [Insert       Addressing the PSD
 Infrastructure Requirements                                        Federal Register        permitting
 for the 2010 NO2 NAAQS.                                            citation].              requirements of
                                                                                sections
                                                                                110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only.
----------------------------------------------------------------------------------------------------------------

Subpart K--Florida

0
3. Section 52.520(e), is amended by adding two new entries for
``110(a)(1) and (2) Infrastructure Requirements for the 2008 Lead
NAAQS'' and ``110(a)(1) and (2) Infrastructure Requirements for the
2010 NO2 NAAQS'' at the end of the table to read as follows:

Sec.  52.520  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Florida Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                        State       EPA Approval     Federal Register
            Provision              effective date       date              notice               Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
110(a)(1) and (2) Infrastructure       10/14/2011       3/18/2015  [Insert Federal      Addressing the PSD
 Requirements for the 2008 Lead                                     Register citation].  permitting requirements
 NAAQS.                                                                                of sections
                                                                                110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only.
110(a)(1) and (2) Infrastructure        1/22/2013       3/18/2015  [Insert Federal      Addressing the PSD
 Requirements for the 2010 NO2                                      Register citation].  permitting requirements
 NAAQS.                                                                                of sections
                                                                                110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only.
----------------------------------------------------------------------------------------------------------------

Subpart L--Georgia

0
4. Section 52.570(e), is amended by adding three new entries for
``110(a)(1) and (2) Infrastructure Requirements for the 2008 Lead
NAAQS'', ``110(a)(1) and (2) Infrastructure Requirements for the 2008
Ozone NAAQS'', and ``110(a)(1) and (2) Infrastructure Requirements for
the 2010 NO2 NAAQS'' at the end of the table to read as
follows:

Sec.  52.570  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Georgia Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                    Applicable
  Name of  nonregulatory SIP      geographic or         State
           provision              nonattainment    submittal date/    EPA Approval date         Explanation
                                       area        effective date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
110(a)(1) and (2)               Georgia..........       5/14/2012  3/18/2015 [Insert       Addressing the PSD
 Infrastructure Requirements                                        Federal Register        permitting
 for the 2008 Lead NAAQS.                                           citation].              requirements of
                                                                                sections
                                                                                110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only.
110(a)(1) and (2)               Georgia..........        3/6/2012  3/18/2015 [Insert       Addressing the PSD
 Infrastructure Requirements                                        Federal Register        permitting
 for the 2008 Ozone NAAQS.                                          citation].              requirements of
                                                                                sections
                                                                                110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only.

110(a)(1) and (2)               Georgia..........       3/25/2013  3/18/2015 [Insert       Addressing the PSD
 Infrastructure Requirements                                        Federal Register        permitting
 for the 2010 NO2 NAAQS.                                            citation].              requirements of
                                                                                sections
                                                                                110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only.
----------------------------------------------------------------------------------------------------------------

Subpart S--Kentucky

0
5. Section 52.920(e), is amended by adding two new entries ``110(a)(1)
and (2) Infrastructure Requirements for the 2008 Lead NAAQS'' and
``110(a)(1) and (2) Infrastructure Requirements for the 2010
NO2 NAAQS'' at the end of the table to read as follows:

Sec.  52.920  Identification of plan.

* * * * *
    (e) * * *

                                 EPA-Approved Kentucky Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                     Applicable           State
  Name of  non-regulatory  SIP      geographic or    submittal date/  EPA Approval date        Explanations
           provision             nonattainment area  effective date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
110(a)(1) and (2)                Kentucky..........       7/17/2012  3/18/2015 [Insert   Addressing the PSD
 Infrastructure Requirements                                          Federal Register    permitting
 for the 2008 Lead NAAQS.                                             citation].          requirements of
                                                                                sections 110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only
110(a)(1) and (2)                Kentucky..........       4/26/2013  3/18/2015 [Insert   Addressing the PSD
 Infrastructure Requirements                                          Federal Register    permitting
 for the 2010 NO2 NAAQS.                                              citation].          requirements of
                                                                                sections 110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only
----------------------------------------------------------------------------------------------------------------

Subpart Z--Mississippi

0
6. Section 52.1270(e), is amended by adding three new entries for
``110(a)(1) and (2) Infrastructure Requirements for the 2008 Lead
NAAQS'', ``110(a)(1) and (2) Infrastructure Requirements for the 2008
Ozone NAAQS'', and ``110(a)(1) and (2) Infrastructure Requirements for
the 2010 NO2 NAAQS'' at the end of the table to read as
follows:

Sec.  52.1270  Identification of plan.

* * * * *
    (e) * * *

                               EPA-Approved Mississippi Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                     Applicable           State
  Name of  nonregulatory  SIP       geographic or    submittal date/  EPA Approval date        Explanation
           provision             nonattainment area  effective date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
110(a)(1) and (2)                Mississippi.......      11/17/2011  3/18/2015.........  Addressing the PSD
 Infrastructure Requirements                                         [Insert Federal      permitting
 for the 2008 Lead NAAQS.                                             Register            requirements of
                                                                      citation].          sections 110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only.
110(a)(1) and (2)                Mississippi.......   5/29/2012 and  3/18/2015.........  Addressing the PSD
 Infrastructure Requirements                          amended on 7/  [Insert Federal      permitting
 for the 2008 Ozone NAAQS.                                  26/2012   Register            requirements of
                                                                      citation].          sections 110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only.
110(a)(1) and (2)                Mississippi.......       2/28/2013  3/18/2015.........  Addressing the PSD
 Infrastructure Requirements                                         [Insert Federal      permitting
 for the 2010 NO2 NAAQS.                                              Register            requirements of
                                                                      citation].          sections 110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only.
----------------------------------------------------------------------------------------------------------------

Subpart PP--South Carolina

0
7. Section 52.2120(e), is amended by adding three new entries for
``110(a)(1) and (2) Infrastructure Requirements for the 2008 Lead
NAAQS'', ``110(a)(1) and (2) Infrastructure Requirements for the 2008
Ozone NAAQS'', and ``110(a)(1) and (2) Infrastructure Requirements for
the 2010 NO2 NAAQS'' at the end of the table to read as
follows:

Sec.  52.2120  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
                                             State
               Provision                effective date      EPA Approval date               Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
110(a)(1) and (2) Infrastructure             9/20/2011  3/18/2015................  Addressing the PSD permitting
 Requirements for the 2008 Lead NAAQS.                  [Insert Federal Register    requirements of sections
                                                         citation].                 110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II) (prong
                                                                                3) and 110(a)(2)(J) only.
110(a)(1) and (2) Infrastructure             7/17/2012  3/18/2015................  Addressing the PSD permitting
 Requirements for the 2008 Ozone NAAQS.                 [Insert Federal Register    requirements of sections
                                                         citation].                 110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II) (prong
                                                                                3) and 110(a)(2)(J) only.
110(a)(1) and (2) Infrastructure             4/30/2014  3/18/2015................  Addressing the PSD permitting
 Requirements for the 2010 NO2 NAAQS.                   [Insert Federal Register    requirements of sections
                                                         citation].                 110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II) (prong
                                                                                3) and 110(a)(2)(J) only.
----------------------------------------------------------------------------------------------------------------

Subpart RR--Tennessee

0
8. Section 52.2220(e), is amended by adding a new entry for ``110(a)(1)
and (2) Infrastructure Requirements for the 2010 NO2 NAAQS''
at the end of the table to read as follows:

Sec.  52.2220  Identification of plan.

* * * * *
    (e) * * *

                                EPA-Approved Tennessee Non-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                     Applicable
  Name of  non-regulatory  SIP      geographic or         State       EPA Approval date        Explanation
           provision             nonattainment area  effective date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
110(a)(1) and (2)                Tennessee.........       3/13/2014  3/18/2015 [Insert   Addressing the PSD
 Infrastructure Requirements                                          Federal Register    permitting
 for the 2010 NO2 NAAQS.                                              citation].          requirements of
                                                                                sections 110(a)(2)(C),
                                                                                110(a)(2)(D)(i)(II)
                                                                                (prong 3) and
                                                                                110(a)(2)(J) only.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-06112 Filed 3-17-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: December 9, 2005 (Volume 70, Number 236)]
[Notices]
[Page 73218]
[DOCID:fr09de05-52]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-111-000]

Iroquois Gas Transmission System, L.P.; Notice of Proposed
Changes in FERC Gas Tariff

December 2, 2005.
    Take notice that on November 30, 2005, Iroquois Gas Transmission
System, L.P. (Iroquois) tendered for filing the following revised sheet
to its FERC Gas Tariff, First Revised Volume No. 1, to be effective on
December 30, 2005:

Seventh Revised Sheet No. 51,
Second Revised Sheet No. 116,
Seventh Revised Sheet No. 181,
Fourth Revised Sheet No. 190.

    On a periodic basis, Iroquois reviews the provisions in its tariff
for consistency and accuracy. During a recent review of the tariff,
Iroquois staff discovered that the term ``Transporter's Transportation
Log'', referenced in four different sections of the tariff, is no
longer valid due to advancements made to the company's Web site
information gathering system and requests said reference to be deleted.
    Iroquois states that copies of its filing were served on all
jurisdictional customers and interested state regulatory agencies and
all parties to the proceeding.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E5-7147 Filed 12-8-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 218 (Tuesday, November 12, 2013)]
[Notices]
[Pages 67459-67460]
[FR Doc No: 2013-27026]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2013-0186]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 36 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions will enable these individuals to operate CMVs in
interstate commerce.

DATES: The exemptions are effective November 12, 2013. The exemptions
expire on November 12, 2015.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Room
W64-224, Department of Transportation, 1200 New Jersey Avenue SE.,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316).

Background

    On September 16, 2013, FMCSA published a notice of receipt of
Federal diabetes exemption applications from 36 individuals and
requested comments from the public (78 FR 56988). The public comment
period closed on October 16, 2013, and three comments were received.
    FMCSA has evaluated the eligibility of the 36 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 36 applicants have had ITDM over a range of 1 to 30 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the September 16, 2013, Federal
Register notice and they will not be repeated in this notice.

Discussion of Comments

    FMCSA received three comments in this proceeding. The comments are
considered and discussed below.
    The three comments were from the Pennsylvania Department of
Transportation, who is in favor of granting an exemption to Vincent
Terrizzi, Sr., George J. Ehnot, and Andrew W. Sprester after reviewing
their driving histories.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and

reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

Conclusion

    Based upon its evaluation of the 36 exemption applications, FMCSA
exempts Charles E. Anderson (MN), Ross D. Barker (UT), Phillip B.
Blythe (IL), Jay H. Byers (IN), Ryan T. Byndas (AZ), Winfred G.
Clemenson (WA), Chad P. Colligan (NY), Michael C. Crewse (IL), James D.
Crosson, Jr. (MN), James de la Garza, Sr. (CA), Jerry W. Downey (OH),
George J. Ehnot (PA), Bruce E. Feltenbarger (MI), Charles A. Fleming,
Jr. (VA), Brian W. Hannah (UT), Michael P. Huck (MI), Van K. Jarrett
(KY), Keith W. Lewis (MO), Richard G. McGee, Jr. (WV), Eugene M. Mikell
(NH), Ronny J. Moreau (NH), James M. O'Rourke (MA), Joshua T. Paumer
(MT), Kent F. Peters (KS), Vladimir B. Petkov (MO), Luther S. Pickell
(KS), Robert Pulliam (AZ), Juanita Ringeisen (IN), Justin W. Robinson
(IN), Freddie Antonio Velez Silvagnoli (MN), Richard A. Smith (WA),
Andrew W. Sprester (PA), Vincent J. Terrizzi, Sr. (PA), Daniel C. Theis
(FL), Richard A. White (TN), and Mark A. Winning (IL) from the ITDM
requirement in 49 CFR 391.41(b)(3), subject to the conditions listed
under ``Conditions and Requirements'' above.
    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption will
be valid for two years unless revoked earlier by FMCSA. The exemption
will be revoked if the following occurs: (1) The person fails to comply
with the terms and conditions of the 1/exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: November 1, 2013.
 Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2013-27026 Filed 11-8-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Proposed Rules]
[Pages 3381-3384]
[FR Doc No: 2019-01880]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2018-0078; FRL-9989-37--Region 4]

Air Plan Approval; North Carolina; Miscellaneous Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve changes to the North Carolina State Implementation Plan (SIP)
submitted by the State of North Carolina, through the North Carolina
Department of Environmental Quality (NCDEQ), through letters dated
April 4, 2017, August 22, 2017, and September 28, 2018. These SIP
revisions make amendments, most of which are structural and minor, to
North Carolina's source testing rules. This action is being taken
pursuant to the Clean Air Act (CAA or Act).

DATES: Comments must be received on or before March 14, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2018-0078 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-pa-dockets.

FOR FURTHER INFORMATION CONTACT: Andres Febres, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. Mr. Febres can be reached by telephone at<PHONE_NUMBER> or
via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What action is the EPA taking today?

    Through letters dated April 4, 2017, August 22, 2017, and September
28, 2018, the State of North Carolina, through NCDEQ, submitted three
SIP revisions for EPA approval.\1\ These SIP revisions include
structural amendments to 15A North Carolina Administrative Code (NCAC)
02D Section .0501--Compliance with Emission Control Standards, and
typographical amendments to 15A NCAC 02D Section .0536--Particulate
Emissions from Electric Utility Boilers.\2\ Additionally, the SIP
revisions incorporate, for primarily structural, organizational
reasons, four new rules: 15A NCAC 02D Sections .2609--Particulate
Testing Method, .2610--Opacity, .2611--Sulfur Dioxide Testing Methods,
and .2617--Total Reduced Sulfur. EPA has preliminarily determined that
a number of these changes to the North Carolina SIP are either
structural or minor and ministerial and do not alter the meaning of any
SIP provisions, that others are SIP-strengthening, and that all are
consistent with federal regulations regarding source testing and are
approvable pursuant to section 110 of the CAA. The changes that are the
subject of this proposed rulemaking are described in further detail in
section III below.
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    \1\ EPA received the SIP revisions on April 28, 2017, September
6, 2017, and October 10, 2018, respectively.
    \2\ In the table of North Carolina regulations federally
approved into the SIP at 40 CFR 52.1770(c), 15A NCAC 02D is referred
to as ``Subchapter 2D Air Pollution Control Requirements.''
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II. Background

    On November 19, 2008, North Carolina submitted to EPA for approval
a SIP revision which restructured the way the SIP identified source
testing methods. The November 19, 2008, SIP revision removed all
references to required source testing methods from the source-category
rules of the SIP and compiled them into a new section: Subchapter 2D
Section .2600, Source Testing. This new rule section consolidated North
Carolina's testing protocols with federal air source testing methods
formerly located throughout DEQ's rules and amended existing source-
category standards to add cross-references to the applicable testing
rules in the new section, 2D Section .2600. EPA partially approved the
November 19, 2008, SIP revision, together with several other SIP
revisions, but did not act on some of the proposed amendments at the
time. See 78 FR 27065 (May 9, 2013).
    Through a letter dated April 4, 2017, North Carolina submitted a
request to withdraw some of the proposed changes from the November 19,
2008, SIP revision and to resubmit these changes

for EPA's approval. In its request, North Carolina withdrew amendments
to 2D Sections .0501--Compliance with Emission Control Standards,
.0536--Particulate Emissions from Electric Utility Boilers, and .2609--
Particulate Testing Methods, as well as one rule under Subchapter 2Q,
Section .0523--Changes Not Requiring Permit Revisions and resubmitted
these changes with an updated redline strikeout of each section.
    Similarly, through a letter dated August 22, 2017, North Carolina
withdrew from the November 19, 2008, SIP revision, new provisions found
at 2D Sections .2610--Opacity, .2611--Sulfur Dioxide Testing Methods,
and .2617--Total Reduced Sulfur, and resubmitted these new provisions
with an updated redline strikeout of each new section.
    Lastly, in letters dated September 28, 2018, North Carolina
submitted: (1) An additional SIP withdrawal and revision, and (2) a
separate withdrawal. Specifically, the September 28, 2018, SIP revision
withdrew the changes to 2D Sections .0501 and addition of .2609 from
the April 4, 2017, SIP revision, and concurrently resubmitted these for
incorporation into the SIP with updated redline strikeouts. In the
separate withdrawal letter, also dated September 28, 2018, North
Carolina withdrew 2Q Section .0523 from the April 4, 2017, SIP
revision.\3\ North Carolina decided not to resubmit 2Q Section .0523
because this provision applies to North Carolina's Title V permitting
program and is not appropriate for approval into the SIP.
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    \3\ The September 28, 2018, withdrawal letter can be found in
the docket for this proposed rulemaking.
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    The changes proposed for approval herein are a part of North
Carolina's strategy to attain and maintain the national ambient air
quality standards (NAAQS), and EPA has preliminarily determined that
they are approvable pursuant to section 110 of the CAA. The changes
that are the subject of this proposed rulemaking and EPA's rationale
for proposing to approve them are described in further detail below.

III. Analysis of the State Submittal

    EPA is proposing to approve into the North Carolina SIP amendments
to Subchapter 2D Sections .0501--Compliance with Emission Control
Standards, and .0536--Particulate Emissions from Electric Utility
Boilers, as well as the addition of four new rules, Sections .2609--
Particulate Testing Methods, .2610--Opacity, .2611--Sulfur Dioxide
Testing Methods, and .2617--Total Reduced Sulfur. Below is a
description of these changes and our rationale for proposing to approve
them.

A. Section .0501--Compliance With Emission Control Standards

    Section .0501 is amended by removing all language regarding testing
methods for determining compliance with emission control standards,
which was previously found in paragraphs (b) and (c)(1) through
(c)(18). As mentioned in Section II, above, North Carolina's November
19, 2008, SIP revision included a new set of rules at 2D Section .2600,
Source Testing. As described in more detail below, the operative
portions of the deleted language from Section .0501 have all been
relocated to the appropriate subsections of 2D Section .2600, some of
which were previously approved into the SIP in 2013. See 78 FR 27065
(May 9, 2013). Other subsections of 2D Section .2600 are now being
proposed for SIP approval through the April 4, 2017, August 22, 2017,
and September 28, 2018, SIP revisions. In addition, all of the
corresponding deletions of Section .0501 language are now being
proposed for SIP approval. Further details on the proposed deletions of
the Section .0501 testing methods and their current or new locations
are presented below.
    1. Whereas the relocation of Section .0501's testing methods to
Section .2600 was previously approved in the 2013 final rule for the
November 19, 2008, SIP revision, the corresponding deletion of the
paragraphs from Section .0501 now being proposed for approval is as
follows \4\:
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    \4\ Paragraph (c)(9) language is found in Section .2616--
Fluorides, and paragraph (c)(11) language is found in Section
.2618--Mercury, but these Sections are currently not part of the
North Carolina SIP. Sections .2616 and .2618 have not been
incorporated into the SIP because North Carolina withdrew its
request to adopt them into its SIP on September 1, 2016, letter.
These rules pertain to CAA section 111(d) or 129 plans and not CAA
section 110.
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     Paragraphs (b), (c)(14), and (c)(18) language is found in
current Section .2602--General Provisions on Test Methods and
Procedures.
     Paragraph (c)(1) language is found in current Section
.2604--Number of Test Points.
     Paragraph (c)(2) language is found in current Section
.2605--Velocity and Volume Flow Rate.
     Paragraph (c)(7) language is found in current Section
.2612--Nitrogen Oxide Testing Methods.
     Paragraph (c)(12) language is found in current Section
.2608--Number of Runs and Compliance Determination.
     Paragraph (c)(13) language is found in current Section
.2606--Molecular Weight.
     Paragraph (c)(15) language is found in current Section
.2621--Determination of Fuel Heat Content Using F-Factor.
     Paragraph (c)(17) language is found in current Section
.2613--Volatile Organic Compound Testing Methods.
    2. Deletion being proposed for approval through the April 4, 2017,
SIP revisions:
     Paragraph (c)(3) and (c)(16) language is found in new
Section .2609--Particulate Testing Methods.
    3. Deletion being proposed for approval through the August 22,
2017, SIP revision:
     Paragraph (c)(4), (c)(5), and (c)(6) language is found in
new Section .2611--Sulfur Dioxide Testing Methods.
     Paragraph (c)(8) language is found in new Section .2610--
Opacity.
     Paragraph (c)(10) language is found in new Section .2617--
Total Reduced Sulfur.
    If EPA finalizes this proposed approval, all of the necessary
testing methods will have been deleted from Section .0501 and relocated
to one of the current or new subsections in Section .2600. EPA has
reviewed these changes to Section .0501 and has preliminarily
determined that they are approvable pursuant to section 110 of the CAA
because they are structural in nature and the deleted language is
relocated and retained in 2D Section .2600 of the North Carolina SIP.

B. Section .0536--Particulate Emissions From Electric Utility Boilers

    Section .0536 is amended by updating cross-references that identify
the location of the testing method procedures and requirements.
Previously, Section .0536 referred to Section .0501 to identify the
applicable procedures and requirements for stack testing when measuring
emission rates for electric utility boilers. Because North Carolina has
relocated all language regarding testing methods to Section .2600,
amendments to Section .0536 substitute all cross-references to Section
.0501 with cross-references to Section .2600.
    Additionally, North Carolina is adding a reference in Section .0536
to its quality assurance program found in Section .0613 and making a
minor typographical change by substituting the word ``director'' with
``Director'' throughout Section .0536.
    EPA has reviewed these changes and has preliminarily determined
that the amendments to Section .0536 are minor ministerial changes that
do not result in a change to the existing source testing

requirements in the North Carolina SIP and are approvable pursuant to
section 110 of the Act.

C. Section .2609--Particulate Testing Methods

    As noted in Section III.A.2, above, most of the language of new
Section .2609 was previously found in paragraphs (c)(3) and (c)(16) of
Section .0501, which are now being proposed for deletion. Section .2609
adopts the federal testing Method 5 of Appendix A of 40 CFR part 60,
and Method 202 of Appendix M of 40 CFR part 51, which are meant to
demonstrate compliance with particulate matter (PM) emission standards.
As an alternative to Method 5, Section .2609 also adopts Method 17 of
Appendix A of 40 CFR part 60, which can be used under certain testing
conditions. For steam generators that use soot blowing as a routine
method of cleaning heat transfer surfaces, Section .2609 also
establishes specific testing requirements to account for the soot's
contribution to particulate emissions. Lastly, paragraph (f) of Section
.2609 establishes requirements for sources to use Method 201 or 201A,
in combination with Method 202, to demonstrate compliance specifically
for PM10 emission standards.
    Method 5 and Method 17, which are meant to measure filterable PM,
were testing method options previously found in Section .0501 that are
now relocated to new Section .2609. A source's total particulate
emissions, however, also includes condensable PM, and is measured using
different testing methods. The additional requirement in .2609 to use
Method 202 to demonstrate compliance with particulate emission
standards, as well as the option to use a combination of Methods 201 or
201A in conjunction with Method 202 for PM10 compliance, are
new provisions to this rule that require testing of condensable PM as
well as filterable PM. North Carolina requires the use of testing
methods for both filterable and condensable PM to capture total
particulate emissions.
    EPA has reviewed this change and has preliminarily determined that
the addition of Section .2609, including the additional test methods,
is consistent with federal regulations. The addition of new Section
.2609 both retains and strengthens the existing source testing
requirements of the North Carolina SIP.

D. Section .2610--Opacity

    As noted in Section III.A.3, above, most of the language of new
Section .2610 was previously found in paragraph (c)(8) of Section
.0501, which is being proposed for deletion. Section .2610 adopts the
federal Method 9 of Appendix A of 40 CFR part 60, which is meant to
determine compliance with opacity standards by visual observation, and
Method 22 of Appendix A of 40 CFR part 60, which is meant to determine
compliance with opacity standards when they are based upon the
frequency of fugitive emissions from stationary sources as specified in
an applicable rule.
    The requirement to use Method 9 when determining opacity by visual
observation was previously found in Section .0501 and is now relocated
to new Section .2610. A new provision not found in Section .0501 is the
option to use Method 22 for determining compliance with opacity
standards based upon the frequency of fugitive emissions from
stationary sources. The use of Method 22, as described in Section
.2609, is allowed only in cases where this method is required by a
permit condition or another applicable regulation.
    EPA has reviewed this change and has preliminarily determined that
the addition of new Section .2610, including the option to use Method
22, is consistent with federal regulations. The addition of new Section
.2610 both retains and strengthens the existing source testing
requirements of the North Carolina SIP.

E. Section .2611--Sulfur Dioxide Testing Methods

    As noted in Section III.A.3, above, the language of this new
provision, Section .2611, was previously found in paragraphs (c)(4),
(5), and (6) of Section .0501, which are being proposed for deletion.
Section .2611 establishes testing methods and methodologies for sulfur
dioxide in different types of sources, specifically:
    a. If compliance is to be demonstrated for a combustion source
through stack sampling, the procedures described in Method 6 or Method
6C of Appendix A of 40 CFR part 60 shall be used. When using Method 6
procedures to demonstrate compliance, compliance shall be determined by
averaging six 20-minute samples taken over such a period of time that
no more than 20 minutes elapses between any two consecutive samples.
The 20-minute run requirement applies to Method 6 only, not to Method
6C. Method 6C is an instrumental method and the sampling is done
continuously.
    b. Fuel burning sources not required to use continuous emissions
monitoring to demonstrate compliance with sulfur dioxide emission
standards may determine compliance with sulfur dioxide emission
standards by stack sampling or by analyzing the sulfur content of the
fuel.
    c. For stationary gas turbines, Method 20 of 40 CFR part 60 shall
be used to demonstrate compliance with applicable sulfur dioxide
emissions standards.
    d. When compliance is to be demonstrated for a combustion source by
analysis of sulfur in fuel, sampling, preparation, and analysis of
fuels shall be according to American Society of Testing and Materials
(ASTM) methods. The Director may approve ASTM methods different from
those described in the regulation if they will provide equivalent or
more reliable results. The Director may prescribe alternate ASTM
methods on an individual basis if that action is necessary to secure
reliable test data. Paragraph (d)(1) of Section .2611 outlines specific
ASTM methods for Coal Sampling, and paragraph (d)(2) outlines specific
ASTM methods for Oil Sampling.
    e. When compliance is shown for sulfuric acid manufacturing plants
or spodumene ore roasting plants through stack sampling using the
methods provided in Sections .0517 and .0527, respectively, the
procedures described in Method 8 of Appendix A of 40 CFR part 60 shall
be used. When Method 8 of Appendix A of 40 CFR part 60 is used to
determine compliance, compliance shall be determined by averaging
emissions measured by three one-hour test runs unless otherwise
specified in the applicable rule or subpart of 40 CFR part 60.
    f. When compliance is shown for a combustion source emitting sulfur
dioxide not covered under paragraphs (a) through (e) of Section .2611
through stack sampling, the procedures described in Method 6 or Method
6C of Appendix A of 40 CFR part 60 shall be used. When using Method 6
procedures to demonstrate compliance, compliance shall be determined by
averaging six 20-minute samples taken over such a period of time that
no more than 20 minutes elapses between any two consecutive samples.
The 20-minute run requirement applies to Method 6 only, not to Method
6C. Method 6C is an instrumental method and the sampling is done
continuously.
    All of the above the testing methods identified in Section .2611
were previously found in Section .0501, with the exception of Method
6C. This new alternative method allows for the use of a sampling
instrument that tests continuously rather than periodically.
    EPA has reviewed this change and has preliminarily determined that
the addition of new Section .2611, including the addition of Method 6C
as

an alternative method, is consistent with federal regulations. The
addition of new Section .2611 both retains and strengthens the existing
source testing requirements of the North Carolina SIP.

F. Section .2617--Total Reduced Sulfur

    As noted in Section III.A.3, above, the language of this new
provision, Section .2617, was previously found in paragraph (c)(10) of
Section .0501, which is being proposed for deletion. Section .2617
adopts the use of federal testing Method 16 of Appendix A of 40 CFR
part 60 or Method 16A of Appendix A of 40 CFR part 60 to demonstrate
compliance with total reduced sulfur emissions standards. The rule also
adopts the federal testing Method 15 of Appendix A of 40 CFR part 60 to
be used as an alternative to determine total reduced sulfur emissions
from tail gas control units of sulfur recovery plants, hydrogen sulfide
in fuel gas for fuel gas combustion devices, and where specified in
other applicable subparts of 40 CFR part 60.
    The requirement to use Method 16 or 16A was previously found in
Section .0501 and is now relocated to new Section .2617. The option to
use Method 15 in certain circumstances is a new provision to this rule.
Although Method 15 has a slightly different process of testing for
reduced sulfur, the resulting conclusions are the same. Additionally,
consistent with section 1.2.1 of Method 15 in the CFR, Section .2617
provides that Method 15 may be used only as an alternative in certain
specified sources, as described in the paragraph above, or where
specified in other applicable federal subparts.
    EPA has reviewed this change and has preliminarily determined that
the addition of Section .2617, including the addition of Method 15 for
certain sources, is consistent with federal regulations. EPA is
proposing to approve all changes in this section of this rulemaking
pursuant to section 110 of the Act.

IV. Incorporation by Reference

    In this rule, EPA is proposing to include in a final EPA rule,
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference under Subchapter 2D, of the North Carolina SIP, Sections
.0501--Compliance with Emission Control Standards, .0536--Particulate
Emissions from Electric Utility Boilers, .2609--Particulate Testing
Methods, .2610--Opacity, .2611--Sulfur Dioxide Testing Methods, and
.2617--Total Reduced Sulfur, state effective June 1, 2008. EPA has
made, and will continue to make, these materials generally available
through www.regulations.gov and at the EPA Region 4 office (please
contact the person identified in the For Further Information Contact
section of this preamble for more information).

V. Proposed Actions

    EPA is proposing to approve North Carolina's April 4, 2017, August
22, 2017, and September 28, 2018, SIP revisions. Specifically, EPA is
proposing to approve under Subchapter 2D of the North Carolina SIP, the
adoption of new Sections .2609, .2610, .2611, and .2617, as well as
amendments to existing Sections .0501 and .0536. EPA is proposing to
approve these revisions under section 110 of the CAA, including section
110(l), for the reasons stated above.\5\
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    \5\ Section 110(l) requires that a revision to the SIP not
interfere with any applicable requirement concerning attainment and
reasonable further progress (as defined in section 171), or any
other applicable requirement of the Act.
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VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. These actions merely
propose to approve state law as meeting Federal requirements and do not
impose additional requirements beyond those imposed by state law. For
that reason, these proposed actions:
     Are not significant regulatory actions subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Are not Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory actions because SIP approvals are exempted under
Executive Order 12866;
     Do not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Are certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Do not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Do not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Are not economically significant regulatory actions based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Are not significant regulatory actions subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Are not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Do not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

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

    Dated: December 21, 2018.
Mary S. Walker,
Acting Regional Administrator, Region 4.
[FR Doc. 2019-01880 Filed 2-11-19; 8:45 am]
 BILLING CODE 6560-50-P