[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Proposed Rules]
[Pages 36673-36678]
[FR Doc No: 2021-14853]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 86, No. 131 / Tuesday, July 13, 2021 /
Proposed Rules

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2021-0358; FRL-8686-01-R3]

Air Plan Approval; Pennsylvania; 1997 8-Hour Ozone National
Ambient Air Quality Standards Second Maintenance Plan for the Greene
County Area

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state implementation plan (SIP) revision submitted by the
Commonwealth of Pennsylvania. This revision pertains to the
Commonwealth's plan, submitted by the Pennsylvania Department of
Environmental Protection (PADEP), for maintaining the 1997 8-hour ozone
national ambient air quality standard (NAAQS) (referred to as the
``1997 ozone NAAQS'') in the Greene County, Pennsylvania area (Greene
County Area). This action is being taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before August 12, 2021.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2021-0358 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, 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 (e.g., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Adam Yarina, Planning & Implementation
Branch (3AD30), Air & Radiation Division, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, PA 19103. The
telephone number is<PHONE_NUMBER>. Mr. Yarina can also be reached via
electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On February 25, 2020, PADEP submitted a
revision to the Pennsylvania SIP to incorporate a plan for maintaining
the 1997 ozone NAAQS in the Greene County Area through April 20, 2029,
in accordance with CAA section 175A.

I. Background

    In 1979, under section 109 of the CAA, EPA established primary and
secondary NAAQS for ozone at 0.12 parts per million (ppm), averaged
over a 1-hour period. 44 FR 8202 (February 8, 1979). On July 18, 1997
(62 FR 38856),\1\ EPA revised the primary and secondary NAAQS for ozone
to set the acceptable level of ozone in the ambient air at 0.08 ppm,
averaged over an 8-hour period. EPA set the 1997 ozone NAAQS based on
scientific evidence demonstrating that ozone causes adverse health
effects at lower concentrations and over longer periods of time than
was understood when the pre-existing 1-hour ozone NAAQS was set.
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    \1\ In March 2008, EPA completed another review of the primary
and secondary ozone standards and tightened them further by lowering
the level for both to 0.075 ppm. 73 FR 16436 (March 27, 2008).
Additionally, in October 2015, EPA completed a review of the primary
and secondary ozone standards and tightened them by lowering the
level for both to 0.70 ppm. 80 FR 65292 (October 26, 2015).
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    Following promulgation of a new or revised NAAQS, EPA is required
by the CAA to designate areas throughout the nation as attaining or not
attaining the NAAQS. On April 30, 2004 (69 FR 23857), EPA designated
the Greene County Area as nonattainment for the 1997 ozone NAAQS,
effective June 15, 2004. The Greene County Area consists solely of
Greene County in Pennsylvania.
    Once a nonattainment area has three years of complete and certified
air quality data that has been determined to attain the NAAQS, and the
area has met the other criteria outlined in CAA section
107(d)(3)(E),\2\ the state can submit a request to EPA to redesignate
the area to attainment. Areas that have been redesignated by EPA from
nonattainment to attainment are referred to as ``maintenance areas.''
One of the criteria for redesignation is to have an approved
maintenance plan under CAA section 175A. The maintenance plan must
demonstrate that the area will continue to maintain the standard for
the period extending 10 years after redesignation, and it must contain
such additional measures as necessary to ensure maintenance as well as
contingency measures as necessary to assure that violations of the
standard will be promptly corrected.
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    \2\ The requirements of CAA section 107(d)(3)(E) include
attainment of the NAAQS, full approval under section 110(k) of the
applicable SIP, determination that improvement in air quality is a
result of permanent and enforceable reductions in emissions,
demonstration that the state has met all applicable section 110 and
part D requirements, and a fully approved maintenance plan under CAA
section 175A.
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    On March 19, 2009 (74 FR 11671, effective April 20, 2009), EPA
approved a redesignation request and maintenance plan from PADEP for
the Greene County Area. In accordance with CAA section 175A(b), at the
end of the eighth year after the effective date of the redesignation,
the state must also submit a second maintenance plan to ensure ongoing
maintenance of the standard for an additional 10 years.
    EPA's final implementation rule for the 2008 ozone NAAQS revoked
the 1997 ozone NAAQS and provided that one consequence of revocation
was that areas that had been redesignated to attainment (i.e.,
maintenance areas) for the 1997 ozone NAAQS no longer needed to submit
second 10-year maintenance plans under CAA section

175A(b).\3\ However, in South Coast Air Quality Management District v.
EPA \4\ (South Coast II), the United States Court of Appeals for the
District of Columbia (D.C. Circuit) vacated EPA's interpretation that,
because of the revocation of the 1997 ozone standard, second
maintenance plans were not required for ``orphan maintenance areas,''
(i.e., areas like the Greene County Area) that had been redesignated to
attainment for the 1997 ozone NAAQS and were designated attainment for
the 2008 ozone NAAQS. Thus, states with these ``orphan maintenance
areas'' under the 1997 ozone NAAQS must submit maintenance plans for
the second maintenance period.
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    \3\ See 80 FR 12315 (March 6, 2015).
    \4\ 882 F.3d 1138 (D.C. Cir. 2018).
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    As previously discussed, CAA section 175A sets forth the criteria
for adequate maintenance plans. In addition, EPA has published
longstanding guidance that provides further insight on the content of
an approvable maintenance plan, explaining that a maintenance plan
should address five elements: (1) An attainment emissions inventory;
(2) a maintenance demonstration; (3) a commitment for continued air
quality monitoring; (4) a process for verification of continued
attainment; and (5) a contingency plan. The 1992 Calcagni Memo \5\
provides that states may generally demonstrate maintenance by either
performing air quality modeling to show that the future mix of sources
and emission rates will not cause a violation of the NAAQS or by
showing that future emissions of a pollutant and its precursors will
not exceed the level of emissions during a year when the area was
attaining the NAAQS (i.e., attainment year inventory). See 1992
Calcagni Memo at p. 9. EPA further clarified in three subsequent
guidance memos describing ``limited maintenance plans'' (LMPs) \6\ that
the requirements of CAA section 175A could be met by demonstrating that
the area's design value \7\ was well below the NAAQS and that the
historical stability of the area's air quality levels showed that the
area was unlikely to violate the NAAQS in the future. Specifically, EPA
believes that if the most recent air quality design value for the area
is at a level that is below 85% of the standard, or in this case below
0.071 ppm, then EPA considers the state to have met the section 175A
requirement for a demonstration that the area will maintain the NAAQS
for the requisite period. Accordingly, on February 25, 2020, PADEP
submitted an LMP for the Greene County Area, following EPA's LMP
guidance and demonstrating that the area will maintain the 1997 ozone
NAAQS through April 20, 2029, i.e., through the entire 20-year
maintenance period.
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    \5\ ``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' Memorandum from John Calcagni, Director, Air Quality
Management Division, September 4, 1992 (1992 Calcagni Memo).
    \6\ See ``Limited Maintenance Plan Option for Nonclassifiable
Ozone Nonattainment Areas'' from Sally L. Shaver, Office of Air
Quality Planning and Standards (OAQPS), dated November 16, 1994;
``Limited Maintenance Plan Option for Non classifiable CO
Nonattainment Areas'' from Joseph Paisie, OAQPS, dated October 6,
1995; and ``Limited Maintenance Plan Option for Moderate
PM10 Nonattainment Areas'' from Lydia Wegman, OAQPS,
dated August 9, 2001.
    \7\ The ozone design value for a monitoring site is the 3-year
average of the annual fourth-highest daily maximum
    8-hour average ozone concentrations. The design value for an
ozone nonattainment area is the highest design value of any
monitoring site in the area.
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    After PADEP's submittal of this LMP, it was determined that the
most current certified design value period (2017-2019) was invalid due
to incomplete data. PADEP operates and maintains one ozone monitor at
the Holbrook ambient air monitoring station (AQS ID 42-059-0002) in
Greene County, PA. During the 2018 and 2019 ozone monitoring seasons,
the Holbrook ambient air monitoring station had missing ozone data for
35 and 39 days, respectively. The Holbrook ozone data was missing for a
total of 74 days in the two-year span because of several reasons,
including power outages and quality assurance criteria not being met.
As a result of the frequency of missing data, the total valid ozone
data capture at the Holbrook monitoring site was 86% in 2018 and 84% in
2019. With an ozone data capture of 93% in 2017, the three-year (2017-
2019) average was 88%. According to 40 CFR part 50 appendix P, section
2.3(b), three consecutive years of ambient air ozone data with data
availability of at least 90% of the days within the ozone monitoring
season, on average, are required, with a minimum data completeness in
any one year of at least 75% within the ozone monitoring season. Since
the 2019 ozone design value average data completeness was 88%, it did
not meet the 90% criteria outlined in 40 CFR part 50 appendix P,
section 2.3(b).
    PADEP submitted a data completeness substitution analysis for the
Holbrook monitor on March 3, 2021, which included data substitutions
for 41 of the missing days. The data substitution methodology relied on
meteorological data, historical records for the Holbrook ozone
monitoring site and surrounding monitoring sites, and daily maximum
regional ozone monitoring values for the 2015-2019 period. PADEP used a
conservative approach of replacing the missing data at Holbrook in 2018
and 2019 with the regional maximum 8-hour ozone concentration and
calculated updated design values for the 2017-2019 period. EPA analyzed
PADEP's submittal and found it acceptable and provided PADEP with
Regional Administrator review and approval as required by Appendix I on
March 24, 2021. PADEP's data substitution brings the data capture rate
to 90% for 2018, 91% for 2019, and 91% for the 2017-2019 design value,
which meets the requirements of 40 CFR part 50 appendix P, section
2.3(b). For more information on PADEP's data substitution analysis,
including PADEP's methodology, raw data, and design value calculations,
as well as EPA's review and approval, please see the rulemaking
docket.\8\
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    \8\ Specifically, the documents labeled ``PADEP Transmittal
Letter Greene County SIP,'' ``EPA RA Approval Letter for PADEP
Holbrook Missing Ozone Data Analysis,'' ``EPA Holbrook 2017-2019
Design Value Report,'' and ``EPA Holbrook 2018-2019 Raw Data
Qualifier Report'' in Docket ID # EPA-R03-OAR-2021-0358.
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II. Summary of SIP Revision and EPA Analysis

    PADEP's February 25, 2020 SIP submittal outlines a plan for
continued maintenance of the 1997 ozone NAAQS which addresses the
criteria set forth in the 1992 Calcagni Memo as follows.

A. Attainment Emissions Inventory

    For maintenance plans, a state should develop a comprehensive and
accurate inventory of actual emissions for an attainment year which
identifies the level of emissions in the area which is sufficient to
maintain the NAAQS. The inventory should be developed consistent with
EPA's most recent guidance. For ozone, the inventory should be based on
typical summer day's emissions of oxides of nitrogen (NOX)
and volatile organic compounds (VOC), the precursors to ozone
formation. In the first maintenance plan for the Greene County Area,
PADEP used 2004 for the attainment year inventory because 2004 was one
of the years in the 2003-2005 three-year period when the area first
attained the 1997 ozone NAAQS.\9\ The Greene County Area continued to
monitor attainment of the 1997 ozone NAAQS in 2014. Therefore, the
emissions inventory from 2014 represents

emissions levels conducive to continued attainment (i.e., maintenance)
of the NAAQS. Thus, PADEP is using 2014 as representing attainment
level emissions for its second maintenance plan. Pennsylvania used 2014
summer day emissions from EPA's 2014 version 7.0 modeling platform as
the basis for the 2014 inventory presented in Table 1.\10\
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    \9\ For more information, see EPA's July 16, 2008 notice
proposing to redesignate the Greene County Area to attainment for
the 1997 ozone NAAQS (73 FR 40813).
    \10\ For more information, visit https://www.epa.gov/sites/production/files/2018-11/ozone_1997_naaqs_emiss_inv_data_nov_19_2018_0.xlsx.

  Table 1--2014 Typical Summer Day NOX and VOC Emissions for the Greene
                               County Area
                               [tons/day]
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             Source category               NOX emissions   VOC emissions
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Point...................................            0.52            0.69
Nonpoint................................            8.55           10.89
Onroad..................................            3.30            1.08
Nonroad.................................            1.45            0.59
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    The data shown in Table 1 is based on the 2014 National Emissions
Inventory (NEI) version 2.\11\ The inventory addresses four
anthropogenic emission source categories: Stationary (point) sources,
stationary nonpoint (area) sources, nonroad mobile, and onroad mobile
sources. Point sources are stationary sources that have the potential
to emit (PTE) more than 100 tons per year (tpy) of VOC, or more than 50
tpy of NOX, and which are required to obtain an operating
permit. Data are collected for each source at a facility and reported
to PADEP. Examples of point sources include kraft mills, electrical
generating units (EGUs), and pharmaceutical factories. Nonpoint sources
include emissions from equipment, operations, and activities that are
numerous and in total have significant emissions. Examples include
emissions from commercial and consumer products, portable fuel
containers, home heating, repair and refinishing operations, and
crematories. The onroad emissions sector includes emissions from
engines used primarily to propel equipment on highways and other roads,
including passenger vehicles, motorcycles, and heavy-duty diesel
trucks. The nonroad emissions sector includes emissions from engines
that are not primarily used to propel transportation equipment, such as
generators, forklifts, and marine pleasure craft. EPA reviewed the
emissions inventory submitted by PADEP and proposes to conclude that
the plan's inventory is acceptable for the purposes of a subsequent
maintenance plan under CAA section 175A(b).
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    \11\ The NEI is a comprehensive and detailed estimate of air
emissions of criteria pollutants, criteria precursors, and hazardous
air pollutants from air emissions sources. The NEI is released every
three years based primarily upon data provided by State, Local, and
Tribal air agencies for sources in their jurisdictions and
supplemented by data developed by EPA.
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B. Maintenance Demonstration

    To attain the 1997 ozone NAAQS, the three-year average of the
fourth-highest daily average ozone concentrations (design value, or
``DV'') at each monitor within an area must not exceed 0.08 ppm. Based
on the rounding convention described in 40 CFR part 50, appendix I, the
standard is attained if the DV is 0.084 or below. CAA section 175A
requires a demonstration that the area will continue to maintain the
NAAQS throughout the duration of the requisite maintenance period.
Consistent with the prior guidance documents discussed previously in
this document as well as EPA's November 20, 2018 ``Resource Document
for 1997 Ozone NAAQS Areas: Supporting Information for States
Developing Maintenance Plans'' (2018 Resource Document),\12\ EPA
believes that if the most recent DV for the area is well below the
NAAQS (i.e., below 85%, or in this case below 0.071 ppm), the section
175A demonstration requirement has been met, provided that Prevention
of Significant Deterioration (PSD) requirements, any control measures
already in the SIP, and any Federal measures remain in place through
the end of the second 10-year maintenance period (absent a showing
consistent with section 110(l) that such measures are not necessary to
assure maintenance).
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    \12\ This resource document is included in the docket for this
rulemaking available online at https://www.regulations.gov, Docket
ID: EPA-R03-OAR-2020-0316 and is also available at https://www.epa.gov/sites/production/files/2018-11/documents/ozone_1997_naaqs_lmp_resource_document_nov_20_2018.pdf.
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    For the purposes of demonstrating continued maintenance with the
1997 ozone NAAQS, PADEP provided 3-year DVs at the monitor located in
the Greene County Area from 2007 to 2018. This includes DVs for 2005-
2007, 2006-2008, 2007-2009, 2008-2010, 2009-2011, 2010-2012, 2011-2013,
2012-2014, 2013-2015, 2014-2016, 2015-2017, and 2016-2018, which are
shown in Table 2.\13\ In addition, EPA has reviewed the most recent
ambient air quality monitoring data for ozone in the Greene County
Area, as submitted by Pennsylvania and recorded in EPA's Air Quality
System (AQS). The most recent DVs (i.e., 2017-2019) at monitors located
in the Greene County Area are also shown in Table 2.\14\
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    \13\ See also Table II-2 of PADEP's February 25, 2020 submittal,
included in the docket for this rulemaking available online at
https://www.regulations.gov, Docket ID: EPA-R03-OAR-2021-0358.
    \14\ This data is also included in the docket for this
rulemaking available online at https://www.regulations.gov, Docket
ID: EPA-R03-OAR-2021-0358 and is also available at https://www.epa.gov/air-trends/air-quality-design-values#report .

                                                            Table 2--1997 Ozone NAAQS Design Values (ppm) for the Greene County Area
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            County                 AQS Site ID     2005-2007  2006-2008  2007-2009  2008-2010  2009-2011  2010-2012  2011-2013  2012-2014  2013-2015  2014-2016  2015-2017  2016-2018  2017-2019
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Greene........................  42-059-0002......       .08       .076       .072       .072       .069       .071       .067       .068       .067       .067       .068       .066       .063
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    The data in Table 2 show that the DVs for the Greene County Area
have been below 85% of the 1997 ozone NAAQS (i.e., less than or equal
to 0.071 ppm) since the 2009-2011 period. The highest DV for the 2017-
2019 period at the

monitor in the Greene County Area is 0.064 ppm, which is well below 85%
of the 1997 ozone NAAQS.
    States can also support the demonstration of continued maintenance
by showing stable or improving air quality trends, and according to
EPA's 2018 Resource Document, several kinds of analyses can be
performed by states wishing to make such a showing. One approach is to
take the most recent DV at a monitor located in the area and add the
maximum DV increase over one or more consecutive years that has been
observed in the area over the past several years. A sum of these two
values that does not exceed the level of the 1997 ozone NAAQS may be a
good indicator of expected continued attainment. The data in Table 2 of
this document show that the largest DV increase at the monitor located
in the Greene County Area was 0.002 ppm, which occurred between the
2009-2011 (0.069 ppm) and 2010-2012 (0.071 ppm) DVs. Adding 0.002 ppm
to the DV for the 2017-2019 period (0.064 ppm) results in 0.066 ppm, a
sum that is still below the 1997 ozone NAAQS.
    The Greene County Area has maintained air quality levels below the
1997 ozone NAAQS since the Area first attained the NAAQS in 2009, and
maintained air quality levels at or below 85% of the NAAQS since
2011.\15\ Additional supporting information that the area is expected
to continue to maintain the standard can be found in projections of
future year DVs that EPA recently completed to assist states with the
development of interstate transport SIPs for the 2015 8-hour ozone
NAAQS. Those projections, made for the year 2023, show that the DV at
the monitor located in the Greene County Area is expected to be 0.0565
ppm.\16\ Therefore, EPA proposes to determine that future violations of
the 1997 ozone NAAQS in the Greene County Area are unlikely.
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    \15\ As explained in EPA's July 16, 2008 notice proposing to
redesignate the Greene County Area as attainment for the 1997 ozone
NAAQS (73 FR 40813), the 2003-2005 DV for the Greene County Area was
0.081 ppm.
    \16\ See U.S. EPA, ``Air Quality Modeling Technical Support
Document for the Updated 2023 Projected Ozone Design Values,''
Office of Air Quality Planning and Standards, dated June 2018,
available at https://www.epa.gov/airmarkets/air-quality-modeling-technical-support-document-updated-2023-projected-ozone-design.
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C. Continued Air Quality Monitoring and Verification of Continued
Attainment

    Once an area has been redesignated to attainment, the state remains
obligated to maintain an air quality network in accordance with 40 CFR
part 58 to verify the area's attainment status. In the February 25,
2020 submittal, PADEP commits to continue to operate their air
monitoring network in accordance with 40 CFR part 58. PADEP also
commits to track the attainment status of the Greene County Area for
the 1997 ozone NAAQS through the review of air quality and emissions
data during the second maintenance period. This includes an annual
evaluation of vehicles miles traveled (VMT) and stationary source
emissions data compared to the assumptions included in the LMP. PADEP
also states that it will evaluate the periodic (i.e., every three
years) emission inventories prepared under EPA's Air Emission Reporting
Requirements (40 CFR part 51, subpart A). Based on these evaluations,
PADEP will consider whether any further emission control measures
should be implemented for the Greene County Area. EPA has analyzed the
commitments in PADEP's submittal and is proposing to determine that
they meet the requirements for continued air quality monitoring and
verification of continued attainment.

D. Contingency Plan

    The contingency plan provisions are designed to promptly correct or
prevent a violation of the NAAQS that might occur after redesignation
of an area to attainment. Section 175A of the CAA requires that a
maintenance plan include such contingency measures as EPA deems
necessary to assure that the state will promptly correct a violation of
the NAAQS that occurs after redesignation. The maintenance plan should
identify the contingency measures to be adopted, a schedule and
procedure for adoption and implementation of the contingency measures,
and a time limit for action by the state. The state should also
identify specific indicators to be used to determine when the
contingency measures need to be adopted and implemented. The
maintenance plan must require that the state will implement all
pollution control measures that were contained in the SIP before
redesignation of the area to attainment. See section 175(A)(d) of the
CAA.
    PADEP's February 25, 2020 submittal includes a contingency plan for
the Greene County Area. In the event that the fourth highest eight-hour
ozone concentrations at a monitor in the Greene County Area exceeds 84
parts per billion (ppb) (equivalent to 0.084 ppm) for two consecutive
years, but prior to an actual violation of the NAAQS, PADEP will
evaluate whether additional local emission control measures should be
implemented that may prevent a violation of the NAAQS.\17\ After
analyzing the conditions causing the excessive ozone levels, evaluating
the effectiveness of potential corrective measures, and considering the
potential effects of Federal, state, and local measures that have been
adopted but not yet implemented, PADEP will begin the process of
implementing selected measures so that they can be enacted as
expeditiously as practicable following a violation of the NAAQS. In the
event of a violation, PADEP commits to adopting additional emission
reduction measures as expeditiously as practicable in accordance with
the schedule included in the contingency plan as well as the CAA and
applicable Pennsylvania statutory requirements.
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    \17\ A violation of the NAAQS occurs when an area's 3-year
design value exceeds the NAAQS.
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    PADEP will use the following criteria when considering additional
emission reduction measures to adopt to address a violation of the 1997
ozone NAAQS in the Greene County Area: (1) Air quality analysis
indicating the nature of the violation, including the cause, location,
and source; (2) emission reduction potential, including extent to which
emission generating sources occur in the nonattainment area; (3)
timeliness of implementation in terms of the potential to return the
area to attainment as expeditiously as practicable; and (4) costs,
equity, and cost-effectiveness. The measures PADEP would consider
pursuing for adoption in the Greene County Area include, but are not
limited to, those summarized in Table 3. If additional emission
reductions are necessary, PADEP commits to adopt additional emission
reduction measures to attain and maintain the 1997 ozone NAAQS.

Table 3--Greene County Area Second Maintenance Plan Contingency Measures
------------------------------------------------------------------------

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Non-Regulatory Measures
    Voluntary diesel engine ``chip reflash'' (installation software to
     correct the defeat device option on certain heavy-duty diesel
     engines).
    Diesel retrofit (including replacement, repowering or alternative
     fuel use) for public or private local onroad or offroad fleets.

    Idling reduction technology for Class 2 yard locomotives.
    Idling reduction technologies or strategies for truck stops,
     warehouses, and other freight-handling facilities.
    Accelerated turnover of lawn and garden equipment, especially
     commercial equipment, including promotion of electric equipment.
    Additional promotion of alternative fuel (e.g., biodiesel) for home
     heating and agricultural use.
Regulatory Measures \18\
    Additional control on consumer products. \19\
    Additional controls on portable fuel containers. \20\
------------------------------------------------------------------------

    The contingency plan includes schedules for the adoption and
implementation of both non-regulatory and regulatory contingency
measures, which are summarized in Tables 4 and 5, respectively.
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    \18\ These regulatory measures were considered potential cost-
effective and timely control strategies by the Ozone Transport
Commission (OTC) as well as the Mid-Atlantic Regional Air Management
Association and the Mid-Atlantic/Northeast Visibility Union. The OTC
is a multi-state organization responsible for developing regional
solutions to ground-level ozone pollution in the Northeast and Mid-
Atlantic, including the development of model rules that member
states may adopt. OTC member states include: Connecticut, Delaware,
the District of Columbia, Maine, Maryland, Massachusetts, New
Hampshire, New Jersey, New York, Pennsylvania, Rhode Island,
Vermont, and Virginia. For more information on the OTC, visit
https://otcair.org/index.asp. To view the model rules developed by
the OTC, including those for consumer products and portable fuel
containers, visit https://otcair.org/document.asp?fview=modelrules.
    \19\ Pennsylvania's existing controls on consumer products are
under 25 Pa. Code Chapter 130, Subchapters B and C (38 Pa.B. 5598).
This contingency measure includes the adoption of additional
controls on consumer products such as VOC limits for adhesive
removers.
    \20\ Existing controls on portable fuel containers can be found
under 40 CFR part 59, subpart F--Control of Evaporative Emissions
From New and In-Use Portable Fuel Containers.

 Table 4--Implementation Schedule for Greene County Area Non-Regulatory
                          Contingency Measures
------------------------------------------------------------------------
 Time after triggering event                     Action
------------------------------------------------------------------------
Within 2 months..............  PADEP will identify stakeholders for
                                potential non-regulatory measures for
                                further development.
Within 3 months..............  If funding is necessary, PADEP will
                                identify potential sources of funding
                                and the timeframe for when funds would
                                be available.
Within 9 months..............  If state loans or grants are required,
                                PADEP will enter into agreements with
                                implementing organizations. PADEP will
                                also quantify projected emission
                                benefits.
Within 12 months.............  PADEP will submit revised SIP to EPA.
Within 12-24 months..........  PADEP will implement strategies and
                                projects.
------------------------------------------------------------------------

Table 5-- Implementation Schedule for Greene Area Regulatory Contingency
                                Measures
------------------------------------------------------------------------
 Time after triggering event                     Action
------------------------------------------------------------------------
Within 1 month...............  PADEP will submit request to begin
                                regulatory development process.
Within 3 months..............  Request will be reviewed by the Air
                                Quality Technical Advisory Committee
                                (AQTAC), Citizens Advisory Council, and
                                other advisory committees as
                                appropriate.
Within 6 months..............  Environmental Quality Board (EQB) meeting/
                                action.
Within 8 months..............  PADEP will publish regulatory measure in
                                the Pennsylvania Bulletin for comment as
                                proposed rulemaking.
Within 10 months.............  PADEP will hold a public hearing and
                                comment period on proposed rulemaking.
Within 11 months.............  House and Senate Standing Committee and
                                Independent Regulatory Review Commission
                                (IRCC) comment on proposed rulemaking.
Within 13 months.............  AQTAC, Citizens Advisory Council, and
                                other committees will review responses
                                to comment(s), if applicable, and the
                                draft final rule.
Within 16 months.............  EQB meeting/action.
Within 17 months.............  The IRCC will take action on final rule
Within 18 months.............  Attorney General's review/action.
Within 19 months.............  PADEP will publish the regulatory measure
                                as a final rule in the Pennsylvania
                                Bulletin and submit to EPA as a SIP
                                revision. The regulation will become
                                effective upon publication in the
                                Pennsylvania Bulletin.
------------------------------------------------------------------------

    EPA proposes to find that the contingency plan included in PADEP's
February 25, 2020 submittal satisfies the pertinent requirements of CAA
section 175A(d). EPA notes that while five of the potential contingency
measures included in the Commonwealth's second maintenance plan are
non-regulatory, their inclusion among other measures is overall SIP-
strengthening, and their inclusion does not alter EPA's proposal to
find the LMP is fully approvable. EPA also finds that the submittal
acknowledges Pennsylvania's continuing requirement to implement all
pollution control measures that were contained in the SIP before
redesignation of the Greene County Area to attainment.

E. Transportation Conformity

    Transportation conformity is required by section 176(c) of the CAA.
Conformity to a SIP means that transportation activities will not
produce new air quality violations, worsen existing violations, or
delay timely attainment of the NAAQS (CAA 176(c)(1)(B)). EPA's
conformity rule at 40 CFR part 93 requires that transportation plans,
programs and projects conform to SIPs and establish the criteria and
procedures for determining whether they conform. The conformity rule
generally requires a demonstration that emissions from the Regional
Transportation Plan (RTP) and Transportation Improvement Program (TIP)
are consistent with the motor vehicle emissions budget (MVEB) contained
in the control strategy SIP revision or maintenance plan (40 CFR

93.101, 93.118, and 93.124). An MVEB is defined as ``that portion of
the total allowable emissions defined in the submitted or approved
control strategy implementation plan revision or maintenance plan for a
certain date for the purpose of meeting reasonable further progress
milestones or demonstrating attainment or maintenance of the NAAQS, for
any criteria pollutant or its precursors, allocated to highway and
transit vehicle use and emissions (40 CFR 93.101).''
    Under the conformity rule, LMP areas may demonstrate conformity
without a regional emission analysis (40 CFR 93.109(e)). However,
because LMP areas are still maintenance areas, certain aspects of
transportation conformity determinations still will be required for
transportation plans, programs, and projects. Specifically, for such
determination, RTPs, TIPs, and transportation projects still will have
to demonstrate that they are fiscally constrained (40 CFR 93.108), meet
the criteria for consultation (40 CFR 93.105 and 93.112) and
transportation control measure implementation in the conformity rule
provisions (40 CFR 93.113). Additionally, conformity determinations for
RTPs and TIPs must be determined no less frequently than every four
years, and conformity of plan and TIP amendments and transportation
projects is demonstrated in accordance with the timing requirements
specified in 40 CFR 93.104. In addition, for projects to be approved,
they must come from a currently conforming RTP and TIP (40 CFR 93.114
and 93.115). The Greene County Area remains under the obligation to
meet the applicable conformity requirements for the 1997 ozone NAAQS.

III. Proposed Action

    EPA's review of PADEP's February 25, 2020 submittal indicates that
it meets all applicable CAA requirements, specifically the requirements
of section 175A. EPA is proposing to approve the second maintenance
plan for the Greene County Area as a revision to the Pennsylvania SIP.
EPA is soliciting public comments on the issues discussed in this
document. These comments will be considered before taking final action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the 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 if
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 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 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rulemaking, proposing approval of
Pennsylvania's second maintenance plan for the Greene County Area, does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), because the SIP is not approved to apply
in Indian country located in the State, and EPA notes that it will not
impose substantial direct costs on tribal governments or preempt tribal
law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Volatile organic compounds.

    Dated: July 7, 2021.
Diana Esher,
Acting Regional Administrator, Region III.
[FR Doc. 2021-14853 Filed 7-12-21; 8:45 am]
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[Federal Register Volume 77, Number 116 (Friday, June 15, 2012)]
[Notices]
[Pages 35985-35986]
[FR Doc No: 2012-14633]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0528]

Determination That PARAPLATIN (Carboplatin) Injection and SUSTIVA
(Efavirenz) Capsules Were Not Withdrawn From Sale for Reasons of Safety
or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined that the
two drug products listed in this document were not withdrawn from sale
for reasons of safety or effectiveness. This determination means that
FDA will not begin procedures to withdraw approval of abbreviated new

drug applications (ANDAs) that refer to the drug products, and it will
allow FDA to continue to approve ANDAs that refer to the products as
long as they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Mark Geanacopoulos, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993-0002, 301-
796-6925.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors must, with certain exceptions, show that the drug for which
they are seeking approval contains the same active ingredient in the
same strength and dosage form as the ``listed drug,'' which is a
version of the drug that was previously approved. Sponsors of ANDAs do
not have to repeat the extensive clinical testing otherwise necessary
to gain approval of a new drug application (NDA). The only clinical
data required in an ANDA are data to show that the drug that is the
subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is generally known as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness, or if FDA determines that the
listed drug was withdrawn from sale for reasons of safety or
effectiveness (21 CFR 314.162).
    Under Sec.  314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) Before an ANDA that refers to that listed
drug may be approved; (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved; and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was removed from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
    FDA has become aware that the drug products listed in table 1 of
this document are no longer being marketed.

                                 Table 1--Drug Products No Longer Being Marketed
----------------------------------------------------------------------------------------------------------------
            Application No.                           Drug                               Applicant
----------------------------------------------------------------------------------------------------------------
NDA 20-972............................  SUSTIVA (efavirenz) Capsule, 100  Bristol Myers Squibb.
                                         milligrams (mg).
NDA 20-452............................  PARAPLATIN (carboplatin)          Do.
                                         Injection, 50 mg, 150 mg, 450
                                         mg, and 600 mg.
----------------------------------------------------------------------------------------------------------------

    FDA has reviewed its records and, under Sec.  314.161, has
determined that the drug products listed in this document were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list the drug products listed
in this document in the ``Discontinued Drug Product List'' section of
the Orange Book. The ``Discontinued Drug Product List'' identifies,
among other items, drug products that have been discontinued from
marketing for reasons other than safety or effectiveness.
    Approved ANDAs that refer to the NDAs listed in this document are
unaffected by the discontinued marketing of the products subject to
those NDAs. Additional ANDAs for the products may also be approved by
the Agency if they comply with relevant legal and regulatory
requirements. If FDA determines that labeling for these drug products
should be revised to meet current standards, the Agency will advise
ANDA applicants to submit such labeling.

    Dated: June 11, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14633 Filed 6-14-12; 8:45 am]
BILLING CODE 4160-01-P