Air Plan Approval; Ohio; Redesignation of the Cleveland, Ohio Area to Attainment of the 2008 Ozone Standard, 1603-1606 [2016-31634]
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Federal Register / Vol. 82, No. 4 / Friday, January 6, 2017 / Rules and Regulations
of 684 Patients,’’ Journal of Obstetrics and
Gynecology Research, 34(4):449–456, 2008.
5. Maher, C.F., et al., ‘‘Surgical
Management of Pelvic Organ Prolapse in
Women,’’ Cochrane Database of Systematic
Review, 4: CD004014, 2010.
6. Diwadkar, G.B., et al., ‘‘Complication
and Reoperation Rates After Apical Vaginal
Prolapse Surgical Repair: A Systematic
Review,’’ Obstetrics & Gynecology, 113(2 Pt.
1):67–73, 2009.
7. Maher, C.F., et al., ‘‘Laparoscopic Sacral
Colpopexy Versus Total Vaginal Mesh for
Vaginal Vault Prolapse: A Randomized
Trial,’’ American Journal of Obstetrics &
Gynecology, 204(4):360.e1–360.e7, 2011.
8. Altman, D., et al., ‘‘Anterior
Colporrhaphy Versus Transvaginal Mesh for
Pelvic-Organ Prolapse,’’ New England
Journal of Medicine, 364:1826–1836, 2011.
9. Iglesia, C.B., et al., ‘‘Vaginal Mesh for
Prolapse: A Randomized Controlled Trial,’’
Obstetrics & Gynecology, 116(2 Pt. 1):293–
303, 2010.
10. Withagen, M.I., et al., ‘‘Trocar-Guided
Mesh Compared With Conventional Vaginal
Repair in Recurrent Prolapse: A Randomized
Controlled Trial,’’ Obstetrics & Gynecology,
117(2 Pt. 1):242–250, 2011.
11. Sung, V.W., et al., Society of
Gynecologic Surgeons Systematic Review
Group. ‘‘Graft Use in Transvaginal Pelvic
Organ Prolapse and Urinary Incontinence,’’
Obstetrics & Gynecology, 112(5):1131–1142,
2008.
12. Hiltunen, R., et al., ‘‘Low-Weight
Polypropylene Mesh for Anterior Vaginal
Wall Prolapse: A Randomized Controlled
Trial,’’ Obstetrics & Gynecology, 110(2 Pt.
2):455–462, 2007.
13. Jia, X., et al., ‘‘Efficacy and Safety of
Using Mesh or Grafts in Surgery for Anterior
and/or Posterior Vaginal Wall Prolapse:
Systematic Review and Meta-Analysis,’’
British Journal of Obstetrics and Gynecology,
115:1350–1361, 2008.
14. Sivaslioglu, A.A., E. Unlubilgin, and I.
Dolen, ‘‘A Randomized Comparison of
Polypropylene Mesh Surgery With SiteSpecific Surgery in the Treatment of
Cystocoele,’’ International Urogynecology
Journal and Pelvic Floor Dysfunction,
19(4):467–471, 2008.
§ 884.4910 Specialized surgical
instrumentation for use with
urogynecologic surgical mesh.
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 52 and 81
■
(a) Identification. Specialized surgical
instrumentation for use with
urogynecologic surgical mesh is a
prescription device specifically
intended for use as an aid in the
insertion, placement, fixation, or
anchoring of surgical mesh during
urogynecologic procedures. These
procedures include transvaginal pelvic
organ prolapse repair, sacrocolpopexy
(transabdominal pelvic organ prolapse
repair), and treatment of female stress
urinary incontinence. Examples of
specialized surgical instrumentation
include needle passers and trocars,
needle guides, fixation tools, and tissue
anchors. This device is not a manual
gastroenterology-urology surgical
instrument and accessories (§ 876.4730)
or a manual surgical instrument for
general use (§ 878.4800).
(b) Classification. Class II (special
controls). The special controls for
specialized surgical instrumentation for
use with urogynecologic surgical mesh
are:
(1) The device must be demonstrated
to be biocompatible;
(2) The device must be demonstrated
to be sterile and, if reusable, it must be
demonstrated that the device can be
adequately reprocessed;
(3) Performance data must support the
shelf life of the device by demonstrating
package integrity and device
functionality over the requested shelf
life;
(4) Non-clinical performance testing
must demonstrate that the device meets
all design specifications and
performance requirements, and that the
device performs as intended under
anticipated conditions of use; and
(5) Labeling must include:
(i) Information regarding the mesh
design that may be used with the
device;
(ii) Detailed summary of the clinical
evaluations pertinent to use of the
device;
(iii) Expiration date; and
(iv) Where components are intended
to be sterilized by the user prior to
initial use and/or are reusable, validated
methods and instructions for
sterilization and/or reprocessing of any
reusable components.
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
Dated: December 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
List of Subjects in 21 CFR Part 884
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 884 is
amended as follows:
PART 884—OBSTETRICAL AND
GYNECOLOGICAL DEVICES
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1. The authority citation for part 884
continues to read as follows:
2. Add § 884.4910 to subpart E to read
as follows:
■
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[EPA–R05–OAR–2016–0396; FRL–9957–80–
Region 5]
Air Plan Approval; Ohio;
Redesignation of the Cleveland, Ohio
Area to Attainment of the 2008 Ozone
Standard
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) finds that the ClevelandAkron-Lorain, Ohio area (Cleveland
area) is attaining the 2008 ozone
National Ambient Air Quality Standard
(NAAQS or standard) and is
redesignating the area to attainment for
the 2008 ozone NAAQS, because the
area meets the statutory requirements
for redesignation under the Clean Air
Act (CAA). The Cleveland area includes
Ashtabula, Cuyahoga, Geauga, Lake,
Lorain, Medina, Portage, and Summit
counties. EPA is also approving, as a
revision to the Ohio State
Implementation Plan (SIP), the state’s
plan for maintaining the 2008 ozone
standard through 2030 in the Cleveland
area. Finally, EPA finds adequate and is
approving the state’s 2020 and 2030
volatile organic compound (VOC) and
oxides of nitrogen (NOX) Motor Vehicle
Emission Budgets (MVEBs) for the
Cleveland area. The Ohio
Environmental Protection Agency (Ohio
EPA) submitted the SIP revision and
redesignation request on July 6, 2016.
DATES: This final rule is effective
January 6, 2017.
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. EPA–R05–OAR–2016–0396. All
documents in the docket are listed in
the https://www.regulations.gov Web
site. Although listed in the index, some
information is not publicly available,
e.g., 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 through
https://www.regulations.gov, or please
contact the person identified in the FOR
FURTHER INFORMATION CONTACT section
for additional availability information.
FOR FURTHER INFORMATION CONTACT:
Jenny Liljegren, Physical Scientist,
Attainment Planning and Maintenance
Section, Air Programs Branch (AR–18J),
SUMMARY:
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Environmental Protection Agency,
Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604, (312) 886–6832,
Liljegren.Jennifer@epa.gov.
SUPPLEMENTARY INFORMATION:
Throughout this document whenever
‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, we mean
EPA.
I. What is being addressed in this
document?
This rule takes action on the July 6,
2016 submission from Ohio EPA
requesting redesignation of the
Cleveland area to attainment for the
2008 ozone standard. The background
for today’s action is discussed in detail
in EPA’s proposal, dated October 17,
2016 (81 FR 71444). In that rulemaking,
we noted that, under EPA regulations at
40 CFR part 50, the 2008 ozone NAAQS
is attained in an area when the 3-year
average of the annual fourth highest
daily maximum 8-hour average
concentration is equal to or less than
0.075 ppm, when truncated after the
thousandth decimal place, at all of the
ozone monitoring sites in the area. (See
40 CFR 50.15 and appendix P to 40 CFR
part 50.) Under the CAA, EPA may
redesignate nonattainment areas to
attainment if sufficient complete,
quality-assured data are available to
determine that the area has attained the
standard and if it meets the other CAA
redesignation requirements in section
107(d)(3)(E). The proposed rule, dated
October 17, 2016, provides a detailed
discussion of how Ohio has met these
CAA requirements.
As discussed in the proposed rule,
quality-assured and certified monitoring
data for 2013–2015 and preliminary
data for 2016 show that the Cleveland
area has attained and continues to attain
the 2008 ozone standard. In the
maintenance plan submitted for the
area, Ohio has demonstrated that the
ozone standard will be maintained in
the area through 2030. Finally, Ohio has
adopted 2020 and 2030 VOC and NOX
MVEBs for the Cleveland area that are
supported by Ohio’s maintenance
demonstration.
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II. What comments did we receive on
the proposed rule?
EPA provided a 30-day review and
comment period for the October 17,
2016, proposed rule. The comment
period ended on November 16, 2016.
During the comment period, comments
in support of the action were submitted
on behalf of the Ohio Utility Group and
its member companies. We received no
adverse comments on the proposed rule.
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III. What action is EPA taking?
EPA finds that the Cleveland
nonattainment area is attaining the 2008
ozone standard, based on qualityassured and certified monitoring data
for 2013–2015 and that the Ohio portion
of this area has met the requirements for
redesignation under section 107(d)(3)(E)
of the CAA. EPA is thus changing the
legal designation of the Cleveland area
from nonattainment to attainment for
the 2008 ozone standard. EPA is also
approving, as a revision to the Ohio SIP,
the state’s maintenance plan for the
area. The maintenance plan is designed
to keep the Cleveland area in attainment
of the 2008 ozone NAAQS through
2030. Finally, EPA finds adequate and
is approving the newly-established 2020
and 2030 MVEBs for the Cleveland area.
In accordance with 5 U.S.C. 553(d),
EPA finds there is good cause for these
actions to become effective immediately
upon publication. This is because a
delayed effective date is unnecessary
due to the nature of a redesignation to
attainment, which relieves the area from
certain CAA requirements that would
otherwise apply to it. The immediate
effective date for this action is
authorized under both 5 U.S.C.
553(d)(1), which provides that
rulemaking actions may become
effective less than 30 days after
publication if the rule ‘‘grants or
recognizes an exemption or relieves a
restriction,’’ and section 553(d)(3),
which allows an effective date less than
30 days after publication ‘‘as otherwise
provided by the agency for good cause
found and published with the rule.’’
The purpose of the 30-day waiting
period prescribed in section 553(d) is to
give affected parties a reasonable time to
adjust their behavior and prepare before
the final rule takes effect. Today’s rule,
however, does not create any new
regulatory requirements such that
affected parties would need time to
prepare before the rule takes effect.
Rather, today’s rule relieves the state of
planning requirements for this ozone
nonattainment area. For these reasons,
EPA finds good cause under 5 U.S.C.
553(d)(3) for these actions to become
effective on the date of publication of
these actions.
IV. Statutory and Executive Order
Reviews
Under the CAA, redesignation of an
area to attainment and the
accompanying approval of a
maintenance plan under section
107(d)(3)(E) are actions that affect the
status of a geographical area and do not
impose any additional regulatory
requirements on sources beyond those
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imposed by state law. A redesignation to
attainment does not in and of itself
create any new requirements, but rather
results in the applicability of
requirements contained in the CAA for
areas that have been redesignated to
attainment. Moreover, the Administrator
is required to approve a SIP submission
that complies with the provisions of the
CAA 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 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).
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
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Indian country, this rule does not have
tribal implications as specified by
Executive Order 13175 (65 FR 67249,
November 9, 2000), because
redesignation is an action that affects
the status of a geographical area and
does not impose any new regulatory
requirements on tribes, impact any
existing sources of air pollution on
tribal lands, nor impair the maintenance
of ozone national ambient air quality
standards in tribal lands.
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 March 7, 2017. 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
40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Oxides of nitrogen, Ozone, Volatile
organic compounds.
40 CFR Part 81
Environmental protection,
Administrative practice and procedure,
Air pollution control, Designations and
classifications, Intergovernmental
relations, Nitrogen oxides, Ozone,
Reporting and recordkeeping
requirements, Volatile organic
compounds.
Dated: December 21, 2016.
Robert A. Kaplan
Acting Regional Administrator, Region 5.
§ 52.1885
Control strategy: Ozone.
*
*
*
*
*
(pp) * * *
(3) Approval—On July 6, 2016, the
Ohio Environmental Protection Agency
submitted a request to redesignate the
Cleveland area to attainment of the 2008
ozone NAAQS. As part of the
redesignation request, the State
submitted a maintenance plan as
required by section 175A of the Clean
Air Act. Elements of the section 175
maintenance plan include a contingency
plan and an obligation to submit a
subsequent maintenance plan revision
in eight years as required by the Clean
Air Act. The 2020 motor vehicle
emissions budgets for the Cleveland
area are 38.85 tons per summer day
(TPSD) for VOC and 61.56 TPSD for
NOX. The 2030 motor vehicle emissions
budgets for the Cleveland area are 30.80
TPSD for VOC and 43.82 TPSD for NOX.
PART 81—DESIGNATION OF AREAS
FOR AIR QUALITY PLANNING
PURPOSES
Parts 52 and 81, chapter I, title 40 of
the Code of Federal Regulations is
amended as follows:
■
3. The authority citation for part 81
continues to read as follows:
■
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
Authority: 42 U.S.C. 7401 et seq.
4. Section 81.336 is amended by
revising the entry for Cleveland-AkronLorain, OH in the table entitled ‘‘Ohio2008 8-Hour Ozone NAAQS (Primary
and secondary)’’ to read as follows:
■
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
2. Section 52.1885 is amended by
adding paragraph (pp)(3) to read as
follows:
■
§ 81.336
*
*
Ohio.
*
*
*
OHIO—2008 8-HOUR OZONE NAAQS
[Primary and secondary]
Designation
Classification
Designated area
Date 1
*
*
*
*
Cleveland, OH: 2 Ashtabula County, Cuyahoga County, Geauga County,
Lake County, Lorain County, Medina County, Portage County, Summit
County.
*
1 This
*
*
*
Date 1
Type
*
1/6/2017
*
*
*
date is July 20, 2012, unless otherwise noted.
Indian country located in each area, unless otherwise noted.
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Attainment.
2 Excludes
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[FR Doc. 2016–31634 Filed 1–5–17; 8:45 am]
BILLING CODE 6560–50–P
CORPORATION FOR NATIONAL AND
COMMUNITY SERVICE
45 CFR Parts 1230 and 2554
RIN 3045–AA67
Annual Civil Monetary Penalties
Inflation Adjustment
Corporation for National and
Community Service.
ACTION: Interim final rule.
AGENCY:
The Corporation for National
and Community Service (CNCS) is
updating its regulations to reflect
required annual inflation-related
increases to the civil monetary penalties
in its regulations, pursuant to the
Federal Civil Penalties Inflation
Adjustment Act Improvements Act of
2015.
SUMMARY:
Effective date: This rule is
effective January 15, 2017.
Comment due date: Technical
comments may be submitted until
February 6, 2017.
ADDRESSES: You may send your
comments electronically through the
Federal government’s one-stop
rulemaking Web site at
www.regulations.gov. Also, you may
mail or deliver your comments to
Phyllis Green, Executive Assistant,
Office of General Counsel, at the
Corporation for National and
Community Service, 250 E Street SW.,
Washington, DC 20525. Due to
continued delays in CNCS’s receipt of
mail, we strongly encourage comments
to be submitted online electronically.
The TDD/TTY number is 800 833–3722.
You may request this notice in an
alternative format for the visually
impaired.
DATES:
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FOR FURTHER INFORMATION CONTACT:
Phyllis Green, Executive Assistant,
Office of General Counsel, at 202–606–
6709 or email to pgreen@cns.gov.
Individuals who use a
telecommunications device for the deaf
(TTY–TDD) may call 800–833–3722
between 8:00 a.m. and 8:00 p.m. Eastern
Time, Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
The Corporation for National and
Community Service (CNCS) is a federal
agency that engages more than five
million Americans in service through its
AmeriCorps, Senior Corps, Social
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Innovation Fund, and Volunteer
Generation Fund programs to further its
mission to improve lives, strengthen
communities, and foster civic
engagement through service and
volunteering. For more information,
visit NationalService.gov.
The Federal Civil Penalties Inflation
Adjustment Act Improvements Act of
2015 (Sec. 701 of Pub. L. 114–74) (the
‘‘Act’’), which is intended to improve
the effectiveness of civil monetary
penalties and to maintain the deterrent
effect of such penalties, requires
agencies to adjust the civil monetary
penalties for inflation annually.
II. Method of Calculation
CNCS has two civil monetary
penalties in its regulations. A civil
monetary penalty under the Act is a
penalty, fine, or other sanction that is
for a specific monetary amount as
provided by Federal law or has a
maximum amount provided for by
Federal law and is assessed or enforced
by an agency pursuant to Federal law
and is assessed or enforced pursuant to
an administrative proceeding or a civil
action in the Federal courts. (See 28
U.S.C. 2461 note).
The inflation adjustment for each
applicable civil monetary penalty is
determined using the percent increase
in the Consumer Price Index for all
Urban Consumers (CPI–U) for the month
of October of the year in which the
amount of each civil money penalty was
most recently established or modified.
In the December 16, 2016, OMB Memo
for the Heads of Executive Agencies and
Departments, M–17–11, Implementation
of the 2017 annual adjustment pursuant
to the Federal Civil Penalties Inflation
Adjustment Act Improvements Act of
2015, OMB published the multiplier for
the required annual adjustment. The
cost-of-living adjustment multiplier for
2017, based on the CPI–U for the month
of October 2016, not seasonally
adjusted, is 1.01636.
CNCS identified two civil penalties in
its regulations: (1) The penalty
associated with Restrictions on
Lobbying (45 CFR 1230.400) and (2) the
penalty associated with the Program
Fraud Civil Remedies Act (45 CFR
2554.1).
The civil monetary penalties related
to Restrictions on Lobbying (Section
319, Pub. L. 101–121; 31 U.S.C. 1352)
range from $18,936 to $189,361. Using
the 2017 multiplier, the new range of
possible civil monetary penalties is from
$19,246 to $192,459.
The Program Fraud Civil Remedies
Act of 1986 (Pub. L. 99–509) civil
monetary penalty has an upper limit of
$10,781. Using the 2017 multiplier, the
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new upper limit of the civil monetary
penalty is $10,957.
III. Summary of Final Rule
This final rule adjusts the civil
monetary penalty amounts related to
Restrictions on Lobbying (45 CFR
1230.400) and the Program Fraud Civil
Remedies Act of 1986 (45 CFR 2554.1).
The range of civil monetary penalties
related to Restrictions on Lobbying
increase from ‘‘$18,936 to $189,361’’ to
‘‘$19,246 to $192,459.’’ The civil
monetary penalties for the Program
Fraud Civil Remedies Act of 1986
increase from ‘‘up to $10,781’’ to ‘‘up to
$10,957.’’
IV. Regulatory Procedures
A. Determination of Good Cause for
Publication Without Notice and
Comment
CNCS finds, under 5 U.S.C.
553(b)(3)(B), that there is good cause to
except this rule from the public notice
and comment provisions of the
Administrative Procedure Act, 5 U.S.C.
553(b). Because CNCS is implementing
a final rule pursuant to the Federal Civil
Penalties Inflation Adjustment Act
Improvements Act of 2015, which
requires CNCS to update its regulations
based on a prescribed formula, CNCS
has no discretion in the nature or
amount of the change to the civil
monetary penalties. Therefore, notice
and comment for these proscribed
updates is impracticable and
unnecessary. As an interim final rule,
no further regulatory action is required
for the issuance of this legally binding
rule. If you would like to provide
technical comments, however, they may
be submitted until February 6, 2017.
B. Review Under Procedural Statutes
and Executive Orders
CNCS has determined that making
technical changes to the amount of civil
monetary penalties in its regulations
does not trigger any requirements under
procedural statutes and Executive
Orders that govern rulemaking
procedures.
V. Effective Date
This rule is effective January 15, 2017.
The adjusted civil penalty amounts
apply to civil penalties assessed on or
after January 15, 2017, when the
violation occurred after November 2,
2015. If the violation occurred prior to
November 2, 2015, or a penalty was
assessed prior to August 1, 2016, the
pre-adjustment civil penalty amounts in
effect prior to August 1, 2106, will
apply.
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[Federal Register Volume 82, Number 4 (Friday, January 6, 2017)]
[Rules and Regulations]
[Pages 1603-1606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31634]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 52 and 81
[EPA-R05-OAR-2016-0396; FRL-9957-80-Region 5]
Air Plan Approval; Ohio; Redesignation of the Cleveland, Ohio
Area to Attainment of the 2008 Ozone Standard
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) finds that the
Cleveland-Akron-Lorain, Ohio area (Cleveland area) is attaining the
2008 ozone National Ambient Air Quality Standard (NAAQS or standard)
and is redesignating the area to attainment for the 2008 ozone NAAQS,
because the area meets the statutory requirements for redesignation
under the Clean Air Act (CAA). The Cleveland area includes Ashtabula,
Cuyahoga, Geauga, Lake, Lorain, Medina, Portage, and Summit counties.
EPA is also approving, as a revision to the Ohio State Implementation
Plan (SIP), the state's plan for maintaining the 2008 ozone standard
through 2030 in the Cleveland area. Finally, EPA finds adequate and is
approving the state's 2020 and 2030 volatile organic compound (VOC) and
oxides of nitrogen (NOX) Motor Vehicle Emission Budgets
(MVEBs) for the Cleveland area. The Ohio Environmental Protection
Agency (Ohio EPA) submitted the SIP revision and redesignation request
on July 6, 2016.
DATES: This final rule is effective January 6, 2017.
ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2016-0396. All documents in the docket are listed in
the https://www.regulations.gov Web site. Although listed in the index,
some information is not publicly available, e.g., 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 through
https://www.regulations.gov, or please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section for additional availability
information.
FOR FURTHER INFORMATION CONTACT: Jenny Liljegren, Physical Scientist,
Attainment Planning and Maintenance Section, Air Programs Branch (AR-
18J),
[[Page 1604]]
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604, (312) 886-6832, Liljegren.Jennifer@epa.gov.
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.
I. What is being addressed in this document?
This rule takes action on the July 6, 2016 submission from Ohio EPA
requesting redesignation of the Cleveland area to attainment for the
2008 ozone standard. The background for today's action is discussed in
detail in EPA's proposal, dated October 17, 2016 (81 FR 71444). In that
rulemaking, we noted that, under EPA regulations at 40 CFR part 50, the
2008 ozone NAAQS is attained in an area when the 3-year average of the
annual fourth highest daily maximum 8-hour average concentration is
equal to or less than 0.075 ppm, when truncated after the thousandth
decimal place, at all of the ozone monitoring sites in the area. (See
40 CFR 50.15 and appendix P to 40 CFR part 50.) Under the CAA, EPA may
redesignate nonattainment areas to attainment if sufficient complete,
quality-assured data are available to determine that the area has
attained the standard and if it meets the other CAA redesignation
requirements in section 107(d)(3)(E). The proposed rule, dated October
17, 2016, provides a detailed discussion of how Ohio has met these CAA
requirements.
As discussed in the proposed rule, quality-assured and certified
monitoring data for 2013-2015 and preliminary data for 2016 show that
the Cleveland area has attained and continues to attain the 2008 ozone
standard. In the maintenance plan submitted for the area, Ohio has
demonstrated that the ozone standard will be maintained in the area
through 2030. Finally, Ohio has adopted 2020 and 2030 VOC and
NOX MVEBs for the Cleveland area that are supported by
Ohio's maintenance demonstration.
II. What comments did we receive on the proposed rule?
EPA provided a 30-day review and comment period for the October 17,
2016, proposed rule. The comment period ended on November 16, 2016.
During the comment period, comments in support of the action were
submitted on behalf of the Ohio Utility Group and its member companies.
We received no adverse comments on the proposed rule.
III. What action is EPA taking?
EPA finds that the Cleveland nonattainment area is attaining the
2008 ozone standard, based on quality-assured and certified monitoring
data for 2013-2015 and that the Ohio portion of this area has met the
requirements for redesignation under section 107(d)(3)(E) of the CAA.
EPA is thus changing the legal designation of the Cleveland area from
nonattainment to attainment for the 2008 ozone standard. EPA is also
approving, as a revision to the Ohio SIP, the state's maintenance plan
for the area. The maintenance plan is designed to keep the Cleveland
area in attainment of the 2008 ozone NAAQS through 2030. Finally, EPA
finds adequate and is approving the newly-established 2020 and 2030
MVEBs for the Cleveland area.
In accordance with 5 U.S.C. 553(d), EPA finds there is good cause
for these actions to become effective immediately upon publication.
This is because a delayed effective date is unnecessary due to the
nature of a redesignation to attainment, which relieves the area from
certain CAA requirements that would otherwise apply to it. The
immediate effective date for this action is authorized under both 5
U.S.C. 553(d)(1), which provides that rulemaking actions may become
effective less than 30 days after publication if the rule ``grants or
recognizes an exemption or relieves a restriction,'' and section
553(d)(3), which allows an effective date less than 30 days after
publication ``as otherwise provided by the agency for good cause found
and published with the rule.'' The purpose of the 30-day waiting period
prescribed in section 553(d) is to give affected parties a reasonable
time to adjust their behavior and prepare before the final rule takes
effect. Today's rule, however, does not create any new regulatory
requirements such that affected parties would need time to prepare
before the rule takes effect. Rather, today's rule relieves the state
of planning requirements for this ozone nonattainment area. For these
reasons, EPA finds good cause under 5 U.S.C. 553(d)(3) for these
actions to become effective on the date of publication of these
actions.
IV. Statutory and Executive Order Reviews
Under the CAA, redesignation of an area to attainment and the
accompanying approval of a maintenance plan under section 107(d)(3)(E)
are actions that affect the status of a geographical area and do not
impose any additional regulatory requirements on sources beyond those
imposed by state law. A redesignation to attainment does not in and of
itself create any new requirements, but rather results in the
applicability of requirements contained in the CAA for areas that have
been redesignated to attainment. Moreover, the Administrator is
required to approve a SIP submission that complies with the provisions
of the CAA 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 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).
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
[[Page 1605]]
Indian country, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because redesignation is an action that affects the status of a
geographical area and does not impose any new regulatory requirements
on tribes, impact any existing sources of air pollution on tribal
lands, nor impair the maintenance of ozone national ambient air quality
standards in tribal lands.
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 March 7, 2017. 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
40 CFR Part 52
Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Oxides of nitrogen, Ozone,
Volatile organic compounds.
40 CFR Part 81
Environmental protection, Administrative practice and procedure,
Air pollution control, Designations and classifications,
Intergovernmental relations, Nitrogen oxides, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.
Dated: December 21, 2016.
Robert A. Kaplan
Acting Regional Administrator, Region 5.
0
Parts 52 and 81, chapter I, title 40 of the Code of Federal Regulations
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.
0
2. Section 52.1885 is amended by adding paragraph (pp)(3) to read as
follows:
Sec. 52.1885 Control strategy: Ozone.
* * * * *
(pp) * * *
(3) Approval--On July 6, 2016, the Ohio Environmental Protection
Agency submitted a request to redesignate the Cleveland area to
attainment of the 2008 ozone NAAQS. As part of the redesignation
request, the State submitted a maintenance plan as required by section
175A of the Clean Air Act. Elements of the section 175 maintenance plan
include a contingency plan and an obligation to submit a subsequent
maintenance plan revision in eight years as required by the Clean Air
Act. The 2020 motor vehicle emissions budgets for the Cleveland area
are 38.85 tons per summer day (TPSD) for VOC and 61.56 TPSD for
NOX. The 2030 motor vehicle emissions budgets for the
Cleveland area are 30.80 TPSD for VOC and 43.82 TPSD for
NOX.
PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES
0
3. The authority citation for part 81 continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
0
4. Section 81.336 is amended by revising the entry for Cleveland-Akron-
Lorain, OH in the table entitled ``Ohio-2008 8-Hour Ozone NAAQS
(Primary and secondary)'' to read as follows:
Sec. 81.336 Ohio.
* * * * *
Ohio--2008 8-Hour Ozone NAAQS
[Primary and secondary]
----------------------------------------------------------------------------------------------------------------
Designation Classification
Designated area ---------------------------------------------------------------------------------
Date \1\ Type Date \1\ Type
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Cleveland, OH: \2\ Ashtabula 1/6/2017 Attainment. .................... ....................
County, Cuyahoga County,
Geauga County, Lake County,
Lorain County, Medina County,
Portage County, Summit County.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ This date is July 20, 2012, unless otherwise noted.
\2\ Excludes Indian country located in each area, unless otherwise noted.
[[Page 1606]]
* * * * *
[FR Doc. 2016-31634 Filed 1-5-17; 8:45 am]
BILLING CODE 6560-50-P
