[Federal Register Volume 83, Number 209 (Monday, October 29, 2018)]
[Notices]
[Pages 54359-54360]
[FR Doc No: 2018-23577]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1726]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Circulatory System Devices
Panel of the Medical Devices Advisory Committee. The general function
of the committee is to provide advice and recommendations to the Agency
on FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will be held on December 4 and 5, 2018, from 8 a.m.
to 6 p.m.

ADDRESSES: Hilton Washington DC North/Gaithersburg, Salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone number
is<PHONE_NUMBER>; additional information available online at: https://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-north-gaithersburg-GAIGHHF/index.html. Answers to commonly asked questions
including information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993-0002,
[email protected],<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On December 4, 2018, the committee will discuss, make
recommendations, and vote on information regarding the premarket
application (PMA) for the OPTIMIZER SMART Implantable Pulse Generator
device, sponsored by Impulse Dynamics (USA), Inc. This first-of-a-kind
device is indicated to provide cardiac contractility modulation for
class III heart failure patients who are not responding to optimal
medical therapy.
    On December 5, 2018, the committee will discuss and make
recommendations regarding issues relating to the emergence of medical
devices, which aim to treat hypertension. Currently, clinical studies
to evaluate the safety and effectiveness of these devices are
progressing. FDA requests panel input regarding the potential
indications and labeling for devices intended to treat hypertension and
optimal study designs needed to

evaluate the potential benefits and risks while considering issues such
as medication compliance, patient perspective, and appropriate study
controls.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: FDA will work with affected industry, professional
organizations, and societies with an interest in medical devices
designed to treat hypertension, as well as members of those groups who
wish to make a presentation separate from the general open public
hearing; time slots are available on December 5, 2018. Representatives
from industry, professional organizations and societies interested in
making formal presentations to the committee should notify the contact
person on or before November 13, 2018.
    Interested persons may present data, information, or views, orally
or in writing, on issues pending before the committee. Written
submissions may be made to the contact person on or before November 21,
2018. Oral presentations from the public will be scheduled on December
4 and 5, between approximately 1 p.m. and 2 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before November 13, 2018.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by November 14, 2018.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Artair Mallett at [email protected] or<PHONE_NUMBER> at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23577 Filed 10-26-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: August 2, 2010 (Volume 75, Number 147)]
[Rules and Regulations]
[Page 45055-45057]
[DOCID:fr02au10-4]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0709]
RIN 1625-AA87

Security Zone; 2010 Seattle Seafair Fleet Week Moving Vessels,
Puget Sound, WA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The U.S. Coast Guard is establishing temporary moving security
zones surrounding the HMCS NANAIMO (NCSM 702), HMCS EDMONTON (NCSM
703), and the HMCS BRANDON (NCSM 710) which include all waters within
100 yards from the vessels while underway in the Puget Sound Captain of
the Port (COTP) Area of Responsibility (AOR). These security zones are
necessary to help ensure the security of the vessels from sabotage or
other subversive acts during Seafair Fleet Week and will do so by
prohibiting any person or vessel from entering or remaining in the
security zones unless authorized by the COTP, Puget Sound or Designated
Representative.

DATES: This rule is effective from 8 a.m. until 11:59 p.m. on August 4,
2010 unless canceled sooner by the COTP.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0709 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0709 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail LTJG Ian Hanna, Sector Seattle,
Waterways Management Division, US Coast Guard; telephone<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because publishing an NPRM would be
impracticable due to the inherent compromise to security resulting from
advertising in advance locations of naval vessels, both foreign and
domestic.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register because immediate action is
necessary to ensure security of visiting foreign vessels in the 2010
Seattle Seafair Fleet Week event.

Basis and Purpose

    Seattle's Seafair Fleet Week is an annual event which brings a
variety of foreign military vessels to Seattle. The event draws large
crowds and a number of vessels that are under inherent security risks
due to their military functions. This rule is necessary to ensure the
security of visiting foreign military vessels not covered under the
Naval Vessel Protection Zone (NVPZ), and provides similar security
measures while these vessels are transiting Puget Sound.

Discussion of Rule

    The temporary security zones established by this rule will prohibit
any person or vessel from entering or remaining within 100 yards of the
HMCS NANAIMO (NCSM 702), HMCS EDMONTON (NCSM 703), and the HMCS BRANDON
(NCSM 710) while underway in the Puget Sound COTP AOR unless authorized
by the COTP, Puget Sound, or Designated Representative. The security
zones will be enforced by Coast Guard personnel. The COTP may also be
assisted in the enforcement of the zones by other federal, state, or
local agencies.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    The Coast Guard bases this finding on the fact that the security
zones will be in place for a limited period of time and vessel traffic
will be able to transit around the security zones. Maritime traffic may
also request permission to transit through the zones from the COTP,
Puget Sound or Designated Representative.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities; the owners and operators of

vessels intending to operate in the waters covered by the security
zones while they are in effect. The rule will not have a significant
economic impact on a substantial number of small entities, however,
because the security zones will be in place for a limited period of
time and maritime traffic will still be able to transit around the
security zones. Maritime traffic may also request permission to transit
though the zones from the COTP, Puget Sound or Designated
Representative.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves the establishment of temporary
security zones. An environmental analysis checklist and a categorical
exclusion will be available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFT Part 165, as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for Part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub.
L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T13-157 to read as follows:

Sec.  165.T13-157  Security Zone; 2010 Seattle Seafair Fleet Week
Moving Vessels, Puget Sound, Washington

    (a) Location. The following areas are security zones: All waters
encompassed within 100 yards surrounding the HMCS NANAIMO (NCSM 702),
HMCS EDMONTON (NCSM 703), and the

HMCS BRANDON (NCSM 710) while underway in the Puget Sound COTP Area of
Responsibility (AOR).
    (b) Regulations. In accordance with the general regulations in 33
CFR Part 165, Subpart D, no person or vessel may enter or remain in the
security zones without the permission of the COTP or Designated
Representative. See 33 CFR Part 165, Subpart D, for additional
requirements. The COTP may be assisted by other federal, state or local
agencies with the enforcement of the security zones.
    (c) Authorization. All vessel operators who desire to enter the
security zones must obtain permission from the COTP or Designated
Representative by contacting either the on-scene Coast Guard patrol
craft on VHF 13 or Ch 16. Requests must include the reason why movement
within the security zones is necessary. Vessel operators granted
permission to enter the security zones will be escorted by the on-scene
Coast Guard patrol craft until they are outside of the security zones.
    (d) Enforcement Period. This rule is effective from 8 a.m. until
11:59 p.m. on August 4, 2010 unless canceled sooner by the COTP.

    Dated: July 22, 2010.
S.W. Bornemann,
Captain, U. S. Coast Guard, Captain of the Port, Puget Sound.
[FR Doc. 2010-18945 Filed 7-30-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 82, Number 156 (Tuesday, August 15, 2017)]
[Proposed Rules]
[Pages 38660-38664]
[FR Doc No: 2017-17220]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2017-0360; FRL-9966-39-Region 4]

Air Plan Approval; Alabama: Prevention of Significant
Deterioration Updates

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve portions of revisions to Alabama's State Implementation Plan
(SIP), submitted by the State of Alabama, through the Alabama
Department of Environmental Management (ADEM), on May 8, 2013, and
August 23, 2016. The portions of these SIP revisions that EPA proposes
to approve relate to the State's Prevention of Significant
Deterioration (PSD) permitting program. This action is being proposed
pursuant to the Clean Air Act (CAA or Act).

DATES: Comments must be received on or before September 14, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No EPA-R04-
OAR-2017-0360 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-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Andres Febres of the 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 agency taking?

    On May 8, 2013, and August 23, 2016, ADEM submitted SIP revisions
for EPA's approval that include changes to Alabama's PSD permitting
regulations, among other changes.\1\ In this document, EPA is proposing
to approve certain portions of these submittals that make changes to
ADEM Administrative Code Rule 335-3-14-.04--``Air Permits Authorizing
Construction in Clean Areas (Prevention of Significant Deterioration
(PSD),'' which applies to the construction or modification of any major
stationary source in areas designated as attainment or unclassifiable
as required by part C of title I of the CAA.
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    \1\ EPA's regulations governing the implementation of New Source
Review (NSR) permitting programs are contained in 40 CFR 51.160-
51.166; 52.21, 52.24; and part 51, Appendix S. The CAA NSR program
is composed of three separate programs: PSD, NNSR, and Minor NSR.
PSD is established in part C of title I of the CAA and applies in
areas that meet the NAAQS--``attainment areas''--as well as areas
where there is insufficient information to determine if the area
meets the NAAQS--``unclassifiable areas.'' The NNSR program is
established in part D of title I of the CAA and applies in areas
that are not in attainment of the NAAQS--``nonattainment areas.''
The Minor NSR program addresses construction or modification
activities that do not qualify as ``major'' and applies regardless
of the designation of the area in which a source is located.
Together, these programs are referred to as the NSR programs.
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    Alabama's May 8, 2013 SIP submittal includes changes to Rule 335-3-
14-.04 to address the Federal rule entitled ``Implementation of the New
Source Review (NSR) Program for Particulate Matter Less Than 2.5
Micrometers (PM2.5):\2\ Amendment to the Definition of
`Regulated NSR Pollutant' Concerning Condensable Particulate Matter,''
77 FR 65107 (October 25, 2012) (hereinafter referred to as the
PM2.5 Condensables Correction Rule), and plantwide
applicability limits (PALs) for greenhouse gases (GHGs) as allowed in
the Federal rule entitled ``Prevention of Significant Deterioration and
Title V Greenhouse Gas Tailoring Rule Step 3 and GHG Plantwide
Applicability Limits,'' 77 FR 41051 (July 12, 2012) (hereinafter
referred to as the GHG Step 3 Rule). In addition, the SIP submittal
includes changes to the definition of GHGs in Rule 335-3-14-.04 and
Rule 335-3-16 (regarding major source operating permits) to address
EPA's July 20, 2011 rule deferring PSD requirements for carbon dioxide
(CO2) emissions from bioenergy and other biogenic sources
(hereinafter referred to as the ``Biomass Deferral Rule'').\3\
Alabama's May 8, 2013 SIP submission also includes the following
changes to other Alabama rules: changes to the definition of Volatile
Organic Compounds (VOCs) at Rule 335-3-1-.02; changes to the
incorporation by reference (IBR) of the Federal New Source Performance
Standards (NSPS) in Chapter 335-3-10 and National Emissions Standards
for Hazardous Air Pollutants (NESHAPs) in Chapter 335-3-11; and changes
regarding transportation conformity provisions at Rule Chapter 335-3-
16.
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    \2\ Airborne particulate matter (PM) with a nominal aerodynamic
diameter of 2.5 micrometers or less (a micrometer is one-millionth
of a meter, and 2.5 micrometers is less than one-seventh the average
width of a human hair) are considered to be ``fine particles'' and
are also known as PM2.5. Fine particles in the atmosphere
are made up of a complex mixture of components including sulfate;
nitrate; ammonium; elemental carbon; a great variety of organic
compounds; and inorganic material (including metals, dust, sea salt,
and other trace elements) generally referred to as ``crustal''
material, although it may contain material from other sources. The
health effects associated with exposure to PM2.5 include
potential aggravation of respiratory and cardiovascular disease
(i.e., lung disease, decreased lung function, asthma attacks and
certain cardiovascular issues). On July 18, 1997, EPA revised the
NAAQS for PM to add new standards for fine particles, using
PM2.5 as the indicator. Previously, EPA used
PM10 (inhalable particles smaller than or equal to 10
micrometers in diameter) as the indicator for the PM NAAQS. EPA
established health-based (primary) annual and 24-hour standards for
PM2.5, setting an annual standard at a level of 15.0
micrograms per cubic meter ([micro]g/m\3\) and a 24-hour standard at
a level of 65 [micro]g/m\3\ (62 FR 38652). At the time the 1997
primary standards were established, EPA also established welfare-
based (secondary) standards identical to the primary standards. The
secondary standards are designed to protect against major
environmental effects of PM2.5, such as visibility
impairment, soiling, and materials damage. On October 17, 2006, EPA
revised the primary and secondary 24-hour NAAQS for PM2.5
to 35 [micro]g/m\3\ and retained the existing annual
PM2.5 NAAQS of 15.0 [micro]g/m\3\ (71 FR 61236). On
January 15, 2013, EPA published a final rule revising the annual
PM2.5 NAAQS to 12 [micro]g/m\3\ (78 FR 3086).
    \3\ Emissions of CO2 from a stationary source
directly resulting from the combustion or decomposition of
biologically-based materials other than fossil fuels and mineral
sources of carbon (e.g., calcium carbonate) and biologically-based
material (non-fossilized and biodegradable organic material
originating from plants, animals or micro-organisms, including
products, by-products, residues and waste from agriculture, forestry
and related industries as well as the non-fossilized and
biodegradable organic fractions of industrial and municipal wastes,
including gases and liquids recovered from the decomposition of non-
fossilized and biodegradable organic material).
---------------------------------------------------------------------------

    Alabama's August 23, 2016 SIP submittal includes changes to Rule
335-3-14-.04 and Rule Chapter 335-3-16 to remove the treatment of GHGs
as an air pollutant for the specific purpose of determining whether a
source is a major source (or a modification thereof) in PSD and title V
permitting requirements for the reasons discussed in Section II.A,
below. The submittal also withdraws the portion of the State's May 8,
2013 SIP submittal that revises Rule 335-3-14-.04 to address the
Biomass Deferral Rule and makes changes to the GHG Step 3 language
proposed in Alabama's May 8, 2013 submittal.
    Currently, EPA is only proposing to approve the portions of the May
8, 2013 submittal that make changes to the GHG

PAL provisions pursuant to the GHG Step 3 rule and the portions of the
August 23, 2016 submittal that discontinue regulation of GHGs as an air
pollutant for the specific purpose of determining whether a source is a
major source (or a modification thereof) in PSD and title V permitting
requirements and that make changes to the GHG Step 3 language proposed
in Alabama's May 8, 2013 submittal. EPA is not acting on the remaining
portions of these submittals for the following reasons:
     EPA previously acted upon the changes to the definition of
VOCs at Rule 335-3-1-.02. See 81 FR 63701 (September 16, 2016).
     The revisions that address the Regulated PM2.5
Condensables Correction Rule are unnecessary because the errors
corrected by the Rule were never incorporated into Alabama's SIP.\4\
See 77 FR 59100 (September 26, 2012).
---------------------------------------------------------------------------

    \4\ In a May 2, 2011 SIP revision, Alabama requested that EPA
incorporate the term ``Particulate matter (PM)'' emissions into its
SIP-approved definition of ``regulated NSR pollutant'' at Rule 335-
3-14-.04(2)(ww)5, among other changes. Following EPA's proposed
approval of the PM2.5 Condensables Correction Rule,
Alabama submitted a supplemental letter on June 18, 2012, requesting
that EPA not approve the proposed change at 335-3-14-.04(2)(ww)5
when taking action on the May 2, 2011, SIP revision.
---------------------------------------------------------------------------

     EPA will act on the transportation conformity revisions in
a separate action.
     In its August 23, 2016 SIP revision, Alabama withdrew the
portion of its May 8, 2013 SIP revision that addressed the Biomass
Deferral Rule.
     ADEM Administrative Code Chapter 335-3-10--``Standards of
Performance for New Stationary Sources,'' Chapter 335-3-11--``National
Emission Standards for Hazardous Air Pollutants,'' and Chapter 335-3-
16--``Major Source Operating permits,'' are not part of Alabama's SIP;
therefore, EPA cannot make the changes to these regulations.

II. Background

    On January 2, 2011, GHG emissions were, for the first time, covered
by the PSD and title V operating permit programs.\5\ To establish a
process for phasing in the permitting requirements for stationary
sources of GHGs under the CAA PSD and title V programs, on June 3,
2010, EPA published a final rule entitled ``Prevention of Significant
Deterioration and Title V Greenhouse Gas Tailoring Rule'' (hereinafter
referred to as the GHG Tailoring Rule). See 75 FR 31514. In Step 1 of
the GHG Tailoring Rule, which began on January 2, 2011, EPA limited
application of PSD and title V requirements to sources and
modifications of GHG emissions, but only if they were subject to PSD or
title V ``anyway'' due to their emissions of pollutants other than
GHGs. These sources are referred to as ``anyway sources.''
---------------------------------------------------------------------------

    \5\ See the rule entitled ``Reconsideration of Interpretation of
Regulations that Determine Pollutants Covered by Clean Air Act
Permitting Programs,'' Final Rule, 75 FR 17004 (April 2, 2010).
---------------------------------------------------------------------------

    In Step 2 of the GHG Tailoring Rule, which applied as of July 1,
2011, the PSD and title V permitting requirements applied to some
sources that were classified as major sources based solely on their GHG
emissions or potential to emit GHGs. Step 2 also applied PSD permitting
requirements to modifications of otherwise major sources that would
increase only GHG emissions above the level in EPA regulations. EPA
generally described the sources covered by PSD during Step 2 of the
Tailoring Rule as ``Step 2 sources'' or ``GHG-only sources.''
    Subsequently, EPA published the GHG Step 3 Rule on July 12, 2012.
See 77 FR 41051. In this rule, EPA decided against further phase-in of
the PSD and title V requirements for sources emitting lower levels of
GHG emissions. Thus, the thresholds for determining PSD applicability
based on emissions of GHGs remained the same as established in Steps 1
and 2 of the Tailoring Rule.
    The GHG PALs portion of the July 12, 2012 final rule revised EPA
regulations under 40 CFR part 52 for establishing PALs for GHG
emissions. A PAL establishes a site-specific plantwide emission level
for a pollutant that allows the source to make changes at the facility
without triggering the requirements of the PSD program, provided that
its actual emissions at the facility do not exceed the PAL level. Prior
to the July 12, 2012 rule, PALs were available for non-GHG pollutants
and for GHGs on a mass basis. EPA's rule revised the PAL regulations to
allow for GHG PALs to be established on a carbon dioxide equivalent
(CO2e)\6\ basis, as well as a mass basis. See 77 FR 41051
(July 12, 2012). These regulatory changes provided sources with
flexibility in implementing PALs for GHGs.
---------------------------------------------------------------------------

    \6\ CO2e emissions refers to emissions of six
recognized GHGs other than CO2 which are scaled to
equivalent CO2 emissions by relative global warming
potential values, then summed with CO2 to determine a
total equivalent emissions value. See 40 CFR 51.166(48)(ii) and
52.21(49)(ii).
---------------------------------------------------------------------------

    On June 23, 2014, the U.S. Supreme Court addressed the application
of stationary source permitting requirements to GHG emissions in
Utility Air Regulatory Group (UARG) v. EPA, 134 S. Ct. 2427 (2014). The
Supreme Court upheld EPA's regulation of GHG Step 1--or ``anyway''
sources--but held that EPA may not treat GHGs as air pollutants for the
purpose of determining whether a source is a major source (or is
undergoing a major modification) and thus require the source to obtain
a PSD or title V permit. Therefore, the Court invalidated PSD and title
V permitting requirements for GHG Step 2 sources.
    In accordance with the Supreme Court decision, on April 10, 2015,
the D.C. Circuit issued an Amended Judgment vacating the regulations
that implemented Step 2 of the GHG Tailoring Rule, but not the
regulations that implement Step 1 of the GHG Tailoring Rule. Coalition
for Responsible Regulation, Inc. v. EPA, 606 Fed. Appx. 6, 7 (D.C. Cir.
2015). The D.C. Circuit's Judgment specifically vacated the EPA
regulations under review (including 40 CFR 51.166(b)(48)(v) and 40 CFR
52.21(b)(49)(v)) ``to the extent they require a stationary source to
obtain a PSD permit if greenhouse gases are the only pollutant (i) that
the source emits or has the potential to emit above the applicable
major source thresholds, or (ii) for which there is a significant
emissions increase from a modification.'' Id. at 7-8.
    EPA promulgated a good cause final rule on August 19, 2015,
entitled ``Prevention of Significant Deterioration and Title V
Permitting for Greenhouse Gases: Removal of Certain Vacated Elements.''
See 80 FR 50199 (August 19, 2015) (hereinafter referred to as the Good
Cause GHG Rule). The rule removed from the Federal regulations the
portions of the PSD permitting provisions for Step 2 sources that were
vacated by the D.C. Circuit (i.e., 40 CFR 51.166(b)(48)(v) and
52.21(b)(49)(v)). EPA therefore no longer has the authority to conduct
PSD permitting for Step 2 sources, nor can the Agency approve
provisions submitted by a state for inclusion in their SIP providing
this authority. In addition, on October 3, 2016, EPA proposed to revise
provisions in the PSD permitting regulations applicable to GHGs to
address the GHG applicability threshold for PSD in order to fully
conform with UARG and the Amended Judgment, but those revisions have
not been finalized. See 81 FR 68110.

III. Analysis of the State's Submittals

A. Alabama's May 8, 2013 Submittal

    Alabama's May 8, 2013 SIP submittal seeks to add to the Alabama SIP
elements of EPA's July 12, 2012 rule implementing Step 3 of the phase-
in of PSD permitting requirements for GHGs

described in the GHG Step 3 Rule by modifying a PAL provision at Rule
335-3-14-.04(23)(b)4.\7\ As explained in Section II above, a PAL
establishes a site-specific plantwide emission level for a pollutant
that allows the source to make changes to units at the facility without
triggering the requirements of the PSD program, provided that facility-
wide emissions do not exceed the PAL.
---------------------------------------------------------------------------

    \7\ As discussed in Section I above, EPA is not acting on the
remaining portions of this submittal.
---------------------------------------------------------------------------

    The Federal PSD regulations currently include PAL provisions that
apply to GHG-only, or Step 2, sources. However, some of these
provisions may no longer be applicable in light of the Supreme Court's
decision in UARG and the D.C. Circuit's Amended Judgment. The Supreme
Court determined that sources and modifications may not be defined as
``major'' solely on the basis of GHGs emitted or increased, and
consequently PALs for GHGs may no longer be authorized in instances in
which a source has triggered PSD based on GHG emissions alone. EPA has
proposed action in an October 3, 2016 proposed rule to clarify the GHG
PAL rules. See 81 FR 68110. However, PALs for GHGs may still have a
role to play in determining whether a source that is already subject to
PSD for a pollutant other than GHGs should also be subject to PSD for
GHGs. The existing GHG PALs regulations do not add new requirements for
sources or modifications that only emit or increase GHGs above the
major source threshold, or the 75,000 ton per year (tpy) GHG level in
40 CFR 52.21(b)(49)(iv), but rather provide increased flexibility to
sources that wish to manage their GHG emissions by way of a PAL.
    In its May 8, 2013 SIP submittal, Alabama seeks to modify the
definition of ``major emissions unit'' in its SIP-approved PAL
regulations by adding the phrase ``any emissions unit that has the
potential to emit 100,000 tons per year of GHG as CO2e.'' The State
subsequently revised this threshold from 100,000 tpy to 75,000 tpy as
part of its August 23, 2016 submittal, as discussed below. Given this
subsequent revision, the text that EPA is proposing to add to the SIP-
approved definition of ``major emissions unit'' at Rule 335-3-
14-.04(23)(b)4. reads as follows: ``any emissions unit that has the
potential to emit 75,000 tons per year of GHG as CO2e'' into the SIP-
approved definition of ``major emissions unit'' at Rule 335-3-
14-.04(23)(b)4.
    EPA has preliminarily concluded that approving these changes into
the SIP will not interfere with any applicable requirement concerning
attainment and reasonable further progress (as defined in section 171),
or any other applicable requirement of the CAA. EPA discussed the
effects of PALs in the Supplemental Analysis of the Environmental
Impact of the 2002 Final NSR Improvement Rules (November 21, 2002)
(2002 Supplemental Analysis). The Supplemental Analysis explained,
``[t]he EPA expects that the adoption of PAL provisions will result in
a net environmental benefit. Our experience to date is that the
emissions caps found in PAL-type permits result in real emissions
reductions, as well as other benefits.'' Supplemental Analysis at 6;
see also 76 FR 49313, 49315 (August 10, 2011). EPA further discussed
the effects of PALs in the GHG Step 3 Rule, including the benefits of
GHG PALs. See 77 FR 41059-60. EPA is therefore proposing to approve the
changes to the PAL provisions into the Alabama SIP, as amended in the
August 23, 2016 submittal discussed below.

B. Alabama's August 23, 2016 Submittal

    Alabama's August 23, 2016 SIP submittal makes further changes to
the State's PSD permitting regulation at Rule 335-3-14-.04. This
submittal revises the GHG PALs threshold in Rule 335-3-14-.04(23)(b)4
proposed in the May 8, 2013, submittal from 100,000 tpy to 75,000 tpy,
as mentioned in section III.A above.\8\ The SIP submittal also revises
the applicability of PSD for GHGs by removing language regulating GHG-
only (i.e., Step 2) sources in Rules 335-3-14-.04(1)(k) and 335-3-
14-.04(2)(a) to align with current federal requirements, as discussed
below.
---------------------------------------------------------------------------

    \8\ As discussed in Section I, above, EPA is not acting on the
remaining portions of this submittal. The submittal also withdraws
the change proposed to Rule 335-3-14-.04(2)(zz) in the State's May
8, 2013 SIP submittal to address the Biomass Deferral Rule.
---------------------------------------------------------------------------

    Alabama modifies its applicability language for GHGs to regulate
only ``anyway'' sources. The State revises Rule 335-3-14-.04(1)(k) in
its PSD applicability regulations and the definition of ``Major
Stationary Source'' at Rule 335-3-14-.04(2)(a) by removing language
that would subject a source to PSD requirements through GHG emissions
alone. The proposed revision to subparagraph (2)(a) removes the
following text from the definition of ``major stationary source'':
``(iii) For GHGs, any stationary source which emits or has the
potential to emit: (I) GHGs on a total mass rate in accordance with
either subparagraph 2(a)1. or (2)(a)1.(i), and (II) GHGs of 100,000
tons per year or more CO2e.'' The proposed revision to Rule
335-3-14-.04(1)(k) replaces subparagraph (k) with the following text:

    (k) Greenhouse gases (GHGs)
    1. GHGs, as defined in Subparagraph (2)(zz) of this Rule,\9\
shall not be utilized in determining if a source is a major
stationary source, as defined in Subparagraph (2)(a) of this Rule,
or in determining if a modification is a major modification, as
defined in Subparagraph (2)(b) of this Rule.
---------------------------------------------------------------------------

    \9\ Subparagraph (2)(zz) defines ``greenhouse gases'' as ``the
aggregate of: Carbon dioxide, nitrous oxide, methane,
hydrofluorocarbons, perfluorocarbons, and sulfur hexafluoride.''
---------------------------------------------------------------------------

    2. GHGs shall only be subject to the requirements of this Rule
if:
    (i) A new major stationary source or major modification causes a
significant emissions increase of GHGs, as defined in subparagraph
(2)(mm) of this rule,\10\ and a significant net emissions increase
of GHGs, as defined in subparagraphs (2)(c) and (2)(w) of this
rule,\11\ and
---------------------------------------------------------------------------

    \10\ Pursuant to subparagraph (2)(mm), ``significant emissions
increase means, for a regulated NSR pollutant, an increase in
emissions that is significant (as defined in subparagraph (2)(w) of
this rule) for that pollutant.''
    \11\ As it relates to GHGs, subparagraph (2)(w) defines
``significant,'' in reference to a net emissions increase or
potential to emit, at a rate of 75,000 tpy of GHGs on a CO2e basis.
This definition of ``significant'' was previously approved by EPA on
December 29, 2010. See 75 FR 81863.
---------------------------------------------------------------------------

    (ii) The new major stationary source or major modification is
required to obtain a permit subject to the requirements of this Rule
as a result of emissions of regulated NSR pollutants other than
GHGs.

    Although these proposed changes to the Alabama SIP are structured
differently than EPA's federal rules, the primary practical effect of
both is the same: PSD requirements do not apply to GHG emissions from
an ``anyway source'' unless the source emits GHGs at or above the
75,000 tpy CO2e threshold.
    EPA has preliminarily concluded that proposing approval of these
change into the SIP will not interfere with any applicable requirement
concerning attainment and reasonable further progress (as defined in
section 171), or any other applicable requirement of the CAA. Step 2 of
the GHG Tailoring Rule was invalidated. As mentioned above, EPA
discussed the effects of PALs in the 2002 Supplemental Analysis and the
GHG Step 3 Rule.

IV. Incorporation by Reference

    In accordance with requirements of 1 CFR 51.5, EPA is proposing the
incorporation by reference of ADEM Administrative Code Rules 335-3-
14-.04(1)(k), 335-3-14-.04(2)(a)(ii), and 335-3-14-.04(b)4, state
effective on November 25, 2014. Therefore, EPA is proposing approval
for inclusion of these materials in Alabama's State implementation
plan. Once final, and these materials have been incorporated

by reference by EPA into that plan, they are fully Federally
enforceable under sections 110 and 113 of the CAA as of the effective
date of the final rulemaking of EPA's approval, and will be
incorporated by reference by the Director of the Federal Register in
the next update to the SIP compilation.\12\ EPA has made, and will
continue to make, these materials generally available through
www.regulations.gov and/or at the EPA Region 4 Office (please contact
the person identified in the ``For Further Information Contact''
section of this preamble for more information).
---------------------------------------------------------------------------

    \12\ See 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

V. Proposed Action

    EPA is proposing to approve the portions of Alabama's May 8, 2013
and August 23, 2016 SIP submittals that revise the PSD permitting
program at Rule 335-3-14-.04--``Air Permits Authorizing Construction in
Clean Areas (Prevention of Significant Deterioration (PSD))'' by
removing language regulating GHG-only (i.e., Step 2) sources and by
adding language to the PAL provisions. EPA believes that these changes
are consistent with the requirements of the CAA.

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. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive 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 (Public Law 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).
    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, Nitrogen dioxide, Ozone, Particulate Matter, Volatile
organic compounds.

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

    Dated: August 7, 2017.
V. Anne Heard,
Acting Regional Administrator, Region 4.
[FR Doc. 2017-17220 Filed 8-14-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Proposed Rules]
[Pages 33458-33460]
[FR Doc No: 2015-14348]

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

40 CFR Part 52

[EPA-R05-OAR-2009-0805; EPA-R05-OAR-2011-0969; FRL-9928-55-Region 5]

Illinois; Disapproval of State Board Infrastructure SIP
Requirements for the 2006 PM[bdi2].[bdi5] and 2008 Ozone
NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
disapprove an element of State Implementation Plan (SIP) submissions
from Illinois regarding the infrastructure requirements of section 110
of the Clean Air Act (CAA) for the 2006 fine particulate matter
(PM2.5) and 2008 ozone National Ambient Air Quality
Standards (NAAQS). The infrastructure requirements are designed to
ensure that the structural components of each state's air quality
management program are adequate to meet the state's responsibilities
under the CAA. This action pertains specifically to infrastructure
requirements concerning state board requirements.

DATES: Comments must be received on or before July 13, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2009-0805 (2006 PM2.5 infrastructure elements) and EPA-
R05-OAR-2011-0969 (2008 ozone infrastructure elements) by one of the
following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Douglas Aburano, Chief, Attainment Planning and
Maintenance Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Douglas Aburano, Chief, Attainment Planning and
Maintenance Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604.
Such deliveries are only accepted during the Regional Office normal
hours of operation, and special arrangements should be made for
deliveries of boxed information. The Regional Office official hours of
business are Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.
    Instructions: Direct your comments to Docket ID. EPA-R05-OAR-2009-
0805 (2006 PM2.5 infrastructure elements) and EPA-R05-OAR-
2011-0969 (2008 ozone infrastructure elements). EPA's policy is that
all comments received will be included in the public docket without
change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes information claimed to be Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Do not submit information that you consider to be CBI or otherwise
protected through www.regulations.gov or email. The www.regulations.gov
Web site is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an email comment directly to EPA
without going through www.regulations.gov your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the U.S. Environmental
Protection Agency, Region 5, Air and Radiation Division, 77 West
Jackson Boulevard, Chicago, Illinois 60604. This facility is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding Federal
holidays. We recommend that you telephone Sarah Arra, Environmental
Scientist, at<PHONE_NUMBER> before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Sarah Arra, Environmental Scientist,
Attainment Planning and Maintenance Section, Air Programs Branch (AR-
18J), U.S. Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What should I consider as I prepare my comments for EPA?
II. What is the background of these SIP submissions?
III. What is EPA's review of these SIP submissions?
IV. What action is EPA taking?
V. Statutory and Executive Order Reviews

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

    When submitting comments, remember to:
    1. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date, and page number).
    2. Follow directions--EPA may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    3. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    4. Describe any assumptions and provide any technical information
and/or data that you used.
    5. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    6. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    7. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    8. Make sure to submit your comments by the comment period deadline
identified.

II. What is the background of these SIP submissions?

    This rulemaking addresses August 9, 2011, and December 31, 2012,
submissions from the Illinois Environmental Protection Agency (Illinois
EPA) intended to address all applicable infrastructure requirements for
the 2006 PM2.5 and 2008 ozone NAAQS.
    The requirement for states to make a SIP submission of this type
arises out of CAA section 110(a)(1). Pursuant to section 110(a)(1),
states must make SIP submissions ``within 3 years (or such shorter
period as the Administrator may prescribe) after the promulgation of a
national primary ambient air quality standard (or any revision
thereof),'' and

these SIP submissions are to provide for the ``implementation,
maintenance, and enforcement'' of such NAAQS. The statute directly
imposes on states the duty to make these SIP submissions, and the
requirement to make the submissions is not conditioned upon EPA's
taking any action other than promulgating a new or revised NAAQS.
Section 110(a)(2) includes a list of specific elements that ``[e]ach
such plan'' submission must address.
    This specific rulemaking is only taking action on the CAA section
110(a)(2)(E)(ii) requirement of these submittals. The majority of the
other infrastructure elements were approved October 29, 2012 (77 FR
65478) and October 16, 2014 (79 FR 62042), rulemakings.

III. What is EPA's review of these SIP submissions?

    On September 13, 2013, EPA issued ``Guidance on Infrastructure
State Implementation Plan (SIP) Elements under Clean Air Act Sections
110(a)(1) and 110(a)(2)'' (2013 Memo). This guidance provides, among
other things, advice on the development of infrastructure SIPs for the
2006 PM2.5 and 2008 ozone NAAQS. As noted in the 2013 Memo,
pursuant to CAA section 110(a), states must provide reasonable notice
and opportunity for public hearing for all infrastructure SIP
submissions. Illinois EPA provided public comment opportunities on both
submittals. EPA is also soliciting comment on our evaluation of the
state's infrastructure SIP submission in this notice of proposed
rulemaking. Illinois provided a detailed synopsis of how various
components of its SIP meet each of the applicable requirements in
section 110(a)(2) for the 2006 PM2.5 and 2008 ozone NAAQS,
as applicable. The following review only evaluates the state's
submissions for CAA section 110(a)(2)(E)(ii) requirements.

Section 110(a)(2)(E)(ii)--Compliance With State Board Requirements of
Section 128

    Section 110(a)(2)(E)(ii) requires each SIP to contain provisions
that comply with the state board requirements of section 128 of the
CAA. That provision contains two explicit requirements: (1) That any
board or body which approves permits or enforcement orders under this
chapter shall have at least a majority of members who represent the
public interest and do not derive any significant portion of their
income from persons subject to permits and enforcement orders under
this chapter, and (2) that any potential conflicts of interest by
members of such board or body or the head of an executive agency with
similar powers be adequately disclosed. The 2013 Memo specifies that
the provisions that implement CAA section 128 would need to be
contained within the SIP. ``EPA would not approve an infrastructure SIP
submission that only provides a narrative description of existing air
agency laws, rules, and regulations that are not approved into the SIP
to address CAA section 128 requirements.'' 2013 Memo at 42.
    After reviewing Illinois' SIP, EPA has made the preliminary
determination that it does not contain provisions to comply with
section 128 of the CAA, and thus Illinois' August 9, 2011, and December
31, 2012, infrastructure SIP submissions do not meet the requirements
of the CAA. While Illinois has state statutes that may address, in
whole or in part, requirements related to state boards at the state
level, these provisions are not included in the SIP as required by the
CAA. Based on an evaluation of the Federally-approved Illinois SIP, EPA
is proposing to disapprove Illinois' infrastructure SIP submission in
regards to meeting the requirements of section 110(a)(2)(E)(ii) of the
CAA for the 2006 PM2.5 and 2008 ozone NAAQS.

IV. What action is EPA taking?

    EPA is proposing to disapprove a portion of submissions from
Illinois certifying that its current SIP is sufficient to meet the
required infrastructure element under CAA section 110(a)(2)(E)(ii) for
the 2006 PM2.5 and 2008 ozone NAAQS.

V. Statutory and Executive Order Reviews

Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and, therefore, is
not subject to review by the Office of Management and Budget.

Paperwork Reduction Act

    This proposed rule does not impose an information collection burden
under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.).

Regulatory Flexibility Act

    This action merely proposes to disapprove state law as not meeting
Federal requirements and imposes no additional requirements beyond
those imposed by state law. Accordingly, the Administrator certifies
that this proposed rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.).

Unfunded Mandates Reform Act

    Because this rulemaking proposes to disapprove pre-existing
requirements under state law and does not impose any additional
enforceable duty beyond that required by state law, it 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).

Executive Order 13132: Federalism

    This action also does not have Federalism implications because it
does not have substantial direct effects on the states, on the
relationship between the national government and the states, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). This action merely proposes to disapprove a state rule, and
does not alter the relationship or the distribution of power and
responsibilities established in the CAA.

Executive Order 13175: Consultation and Coordination With Indian Tribal
Governments

    In addition, 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 proposed rule does not have tribal implications and will
not impose substantial direct costs on tribal governments or preempt
tribal law as specified by Executive Order 13175 (65 FR 67249, November
9, 2000).

Executive Order 13045: Protection of Children From Environmental Health
and Safety Risks

    This rulemaking also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it proposes to
disapprove a state rule.

Executive Order 13211: Actions That Significantly Affect Energy Supply,
Distribution, or Use

    Because it is not a ``significant regulatory action'' under
Executive Order 12866 or a ``significant energy action,'' this action
is also not subject to Executive Order 13211, ``Actions Concerning
Regulations That Significantly Affect Energy Supply,

Distribution, or Use'' (66 FR 28355, May 22, 2001).

National Technology Transfer Advancement Act

    In reviewing state submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. In this
context, in the absence of a prior existing requirement for the state
to use voluntary consensus standards (VCS), EPA has no authority to
disapprove a state submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a state
submission, to use VCS in place of a state submission that otherwise
satisfies the provisions of the CAA. Thus, the requirements of section
12(d) of the National Technology Transfer and Advancement Act of 1995
(15 U.S.C. 272 note) do not apply.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Particulate matter,
Reporting and recordkeeping requirements.

    Dated: May 19, 2015.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2015-14348 Filed 6-11-15; 8:45 am]
 BILLING CODE 6560-50-P


          List of Documents Included in Docket EPA-R09-OAR-2021-0368

Approval and Promulgation of Implementation Plans; Maintenance Plan Revision, Air
Quality Planning Purposes; Nevada; Clark County, Maintenance Plan, 8-hr ozone
                      (Docket No. EPA-R09-OAR-2021-0368)
Docket Index Table of Contents
A. U.S. EPA Guidance Documents, Policies, and Rulemakings
B. State Plans, Rules, Support Documents, Reports, and Correspondence
C. Additional Documents for Proposed Rulemaking
D. Notices of Proposed Rulemaking and Technical Support Document
E. Public Comments and Related Documents
F. Additional Documents Considered for Final Plan Action
G. Notice of Final Rulemaking, Plan Action

 EPA Policy, Guidance, Rulemaking Documents, and Correspondence
Note: Federal Register notices published in 1994 [check to see if earlier years are currently available] and after are readily available online at www.federalregister.gov. Links to individual notices published 1994 and after are included in this index, below. Electronic copies of notices published prior to 1994 are included in this docket.
A-1.	Air Plan Approval; Nevada: Revisions to Clark County Ozone Maintenance Plan; Final Rule, 84 FR 44699 (August 27, 2019).

A-2	National Ambient Standard for Ozone, Final Rule, 62 FR 38856 (July 18, 1997).

A-3	Air Quality Designations and Classifications for the 8-Hour Ozone National Ambient Air Quality Standards; Early Action Compact Areas With Deferred Effective Dates, Final Rule, 69 FR 23858 (April 30, 2004).

A-4	Final Rule To Implement the 1997 8-Hour Ozone National Ambient Air Quality Standard: Classification of Areas That Were Initially Classified Under Subpart 1; Revision of the AntiBacksliding Provisions To Address 1-Hour Contingency Measure Requirements; Deletion of Obsolete 1-Hour Ozone Standard Provision, Final Rule, 77 FR 28424,  (May 14, 2012).

A-5	Air Quality Designations and Classifications for the 8-Hour Ozone National Ambient Air Quality
Standards; Las Vegas, NV Nonattainment Area, Final Rule, 69 FR 55956 (September 17, 2004).

A-6	Final Rule To Implement the 8-Hour Ozone National Ambient Air Quality Standard -- Phase 2, Final Rule, 70 FR 71612 (November 29, 2005).

A-7	Implementation Plans; Nevada; Determination of Attainment for the Clark County 8-Hour Ozone
Nonattainment Area, Direct Final Rule, 76 FR 17343 (March 29, 2011).

A-8	Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality Planning
Purposes; State of Nevada; Redesignation of Clark County to Attainment for the 1997 8-Hour Ozone Standard, Final Rule, 78 FR 1149 (January 8, 2013).

A-9	National Ambient Air Quality Standards for Ozone, Final Rule, 73 FR 16436 (March 27, 2008).

A-10	Air Quality Designations for the 2008 Ozone National Ambient Air Quality Standards, Final Rule, 77 FR 30088 (May 21, 2012).

A-11	National Ambient Air Quality Standards for Ozone, Final Rule, 80 FR 65292 (October 26, 2015).

A-12	Additional Air Quality Designations for the 2015 Ozone National Ambient Air Quality Standards, Final Rule, 83 FR 25776 (June 4, 2018).

A-13	Approval and Promulgation of Implementation Plans; Nevada-Las Vegas Valley PM-10 Nonattainment Area; Serious Area Plan for Attainment of the Annual and 24-Hour PM-10 Standards, Final Rule, 69 FR 32273 (June 9, 2004).

A-14	Approval of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; Las Vegas Valley, Nevada; Redesignation to Attainment for PM10, Proposed Rule, 79 FR 42258 (July 21, 2014).

A-15	Approval of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; Las Vegas Valley, Nevada; Redesignation to Attainment for PM10, Final Rule, 79 FR 60078 (October 6, 2014).

B. State Plans, Rules, Support Documents, Reports, and Correspondence
Include all SIP documents, rules, Governing Board minutes, staff reports associated with rules or SIPs, State or District resolutions, letters or electronic mails from the State or District regarding any aspects of your SIP action.

B-1.	Revision to Motor Vehicle Emissions Budgets in Ozone Redesignation Request and Maintenance Plan: Clark County, Nevada, August 2020

B-2	Letter from Greg Lovato, Administrator, NDEP to Elizabeth Adams, Director, Air Division, EPA Region IX, September 25, 2020 with enclosures.

B-3.	Revision to Motor Vehicle Emissions Budgets in Ozone Redesignation Request and Maintenance Plan: Clark County, Nevada, October 2018.

B-4	Ozone Redesignation Request and Maintenance Plan, Clark County, Nevada, March 2011.

 Additional Documents for Proposed Rulemaking
Include any other documents like Congressional reports, other SIPs you have cited, technical reports, academic and journal articles, rules from other districts or states, memos to docket, AQS monitoring data reports.
C-1	2017 Ozone Design Values Report.
C-2	2020 Ozone Design Values Report
C-2	Memo to file Air Plan Approval; Revisions to the Clark County Ozone Maintenance Plan, April 20, 2021.
C-3	MOVES2014b Questions and Answers, EPA-420-F-18-014, August 2018.
C-4	Coordinating Research Council, Inc., Improvement of Default Inputs for MOVES and SMOKE-MOVES, Final Report, February 2017.
C-5	Eastern Research Group, Inc., Clark County On-road Vehicle Classification Study, Final Report, June 29, 2018.
C-6	Emissions Inventory Guidance for Implementation of Ozone and Particulate Matter National Ambient Air Quality Standards (NAAQS) and Regional Haze Regulations, EPA-454/B-17-002, May 2017

D. Notice of Proposed Rulemaking and Technical Support Document
Cite published rule.
E. Public Comments and Related Documents
[Reserved]
F. Additional Documents Considered for Final Plan Action
[Reserved]
G.	Notice of Final Rulemaking, Plan Action
[Reserved]