[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Proposed Rules]
[Pages 57810-57815]
[FR Doc No: 2020-19677]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2020-0355; FRL-10014-04-Region 3]

Air Plan Approval; Pennsylvania; 1997 8-Hour Ozone National
Ambient Air Quality Standards Second Maintenance Plan for the Johnstown
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 (DEP), for maintaining the 1997 8-hour ozone
national ambient air quality standard (NAAQS) (referred to as the
``1997 ozone NAAQS'') in the Johnstown, Pennsylvania area (Johnstown
Area). This action is being taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before October 16, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2020-0355 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 (i.e. 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: Ramesh Mahadevan, Planning &
Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-
2237. Mr. Mahadevan can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On February 27, 2020, DEP submitted a
revision to the Pennsylvania SIP to incorporate a plan for maintaining
the 1997 ozone NAAQS in the Johnstown Area through August 1, 2027, 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 23858), EPA designated
the Johnstown Area as nonattainment for the 1997 ozone NAAQS. The
Johnstown Area consists of Cambria 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 August 1, 2007 (72 FR 41903 effective August 1, 2007), EPA
approved a redesignation request (and maintenance plan) from DEP for
the Johnstown Area. In accordance with 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
Johnstown 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 27, 2020, DEP
submitted an LMP for the Johnstown Area, following EPA's LMP guidance
and demonstrating that the area will maintain the 1997 ozone NAAQS
through August 1, 2027, 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 Nonclassifiable 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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II. Summary of SIP Revision and EPA Analysis

    DEP's February 27, 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 Johnstown Area, DEP
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.\8\ Johnstown 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, DEP 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.\9\
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    \8\ For more information, see EPA's June 1, 2007 notice
proposing to redesignate the Johnstown Area to attainment for the
1997 ozone NAAQS (72 FR 30509).
    \9\ 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 Johnstown
                             Area (tons/day)
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                                          NOX  emissions
             Source category                              VOC  emissions
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Point...................................            7.37            0.31
Nonpoint................................            3.78            5.84
Onroad..................................            4.17            2.39
Nonroad.................................            1.07            1.55
Total...................................           16.39           10.09
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    The data shown in Table 1 is based on the 2014 National Emissions
Inventory (NEI) version 2.\10\ 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 DEP. 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 DEP 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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    \10\ 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

    In order 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 ppm 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),\11\ EPA
believes that if the most recent DV for the area is well below the
NAAQS (e.g. 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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    \11\ This resource document is included in the docket for this
rulemaking available online at https://www.regulations.gov, Docket
ID: EPA-R03-OAR-2020-0268 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, DEP provided 3-year DVs for the Johnstown 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. \12\ In
addition, EPA has reviewed the most recent ambient air quality
monitoring data for ozone in the Johnstown Area, as submitted by
Pennsylvania and recorded in EPA's Air Quality System (AQS). The most
recent DV (i.e. 2017-2019) is also shown in Table 2.\13\ There is one
ambient air quality monitor located in the Johnstown Area (AQS Site ID
42-021-0011).
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    \12\ See also Table II-2 of DEP's February 27, 2020 submittal,
included in the docket for this rulemaking available online at
https://www.regulations.gov, Docket ID: EPA-R03-OAR-2020-0355.
    \13\ This data is also included in the docket for this
rulemaking available online at https://www.regulations.gov, Docket
ID: EPA-R03-OAR-2020-02 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 Johnstown Area
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              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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0.074...............................        0.070        0.067        0.067        0.069        0.072        0.070        0.066        0.063        0.063        0.063        0.061        0.059
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    As can be seen in Table 2, DVs in the Johnstown Area have been well
below 85% of the 1997 ozone NAAQS (i.e., 0.071 ppm) since the 2011-2013
design value. The most recent DV (i.e. 2017-2019) in the Johnstown Area
is 0.059 ppm, which is well below 85% of the 1997 ozone NAAQS.
    Additionally, states can support the demonstration of continued
maintenance by showing stable or improving air quality trends.
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 for the area and add the maximum design
value increase (over one or more consecutive years) that has been
observed in the area over the past several years. A sum that does not
exceed the level of the 1997 ozone NAAQS may be a good indicator of
expected continued attainment. As

shown in Table 2, the largest increase in DVs from 2007 to 2019 was
0.003 ppm, which occurred between the 2009-2011 (0.069 ppm) and 2010-
2012 (0.072 ppm) DVs. Adding 0.003 ppm to the most recent DV of 0.059
ppm results in 0.062 ppm, a sum that is still well below the 1997 ozone
NAAQS.
    The Johnstown Area has maintained air quality levels well below the
1997 ozone NAAQS since the Area first attained the NAAQS in 2005.\14\
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 for the Johnstown
Area is expected to be 0.058 ppm.\15\ Therefore, EPA proposes to
determine that future violations of the 1997 ozone NAAQS in the
Johnstown Area are unlikely.
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    \14\ As explained in EPA's June 1, 2007 notice proposing to
redesignate the Johnstown Area as attainment for the 1997 ozone
NAAQS (72 FR 30509), the 2003-2005 DV for the Johnstown Area was
0.077 ppm.
    \15\ 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, in order to verify the area's attainment status. In the
February 27, 2020, submittal, DEP commits to continue to operate their
air monitoring network in accordance with 40 CFR part 58. DEP also
commits to track the attainment status of the Johnstown 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. DEP
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,
DEP will consider whether any further emission control measures should
be implemented for the Johnstown Area. EPA has analyzed the commitments
in DEP'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.
    DEP's February 27, 2020, submittal includes a contingency plan for
the Johnstown Area. In the event that the fourth highest eight-hour
ozone concentrations at a monitor in the Johnstown Area exceeds 84 ppb
(0.084 ppm) for two consecutive years, but prior to an actual violation
of the NAAQS, DEP will evaluate whether additional local emission
control measures should be implemented that may prevent a violation of
the NAAQS.\16\ 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, DEP will
begin the process of implementing selected measures so that they can be
implemented as expeditiously as practicable following a violation of
the NAAQS. In the event of a violation, DEP 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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    \16\ A violation of the NAAQS occurs when an area's 3-year
design value exceeds the NAAQS.
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    DEP will use the following criteria when considering additional
emission reduction measures to adopt to address a violation of the 1997
ozone NAAQS in the Johnstown 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 DEP would consider pursuing for
adoption in the Johnstown Area include, but are not limited to, those
summarized in Table 3. If additional emission reductions are necessary,
DEP commits to adopt additional emission reduction measures to attain
and maintain the 1997 ozone NAAQS.

  Table 3--Johnstown 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: \17\
    Additional control on consumer products \18\.
    Additional controls on portable fuel containers \19\.
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    \17\ 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.
    \18\ 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.
    \19\ 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.
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    The contingency plan includes schedules for the adoption and
implementation of both non-regulatory and regulatory contingency
measures, including schedules for adopting potential land use planning
strategies not listed in Table 3, which are summarized in Tables 4 and
5, respectively.

   Table 4--Implementation Schedule for Johnstown Area Non-Regulatory
                          Contingency Measures
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 Time after triggering event                     Action
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Within 2 months..............  DEP will identify stakeholders for
                                potential non-regulatory measures for
                                further development.
Within 3 months..............  If funding is necessary, DEP will
                                identify potential sources of funding
                                and the timeframe for when funds would
                                be available.
Within 6 months..............  DEP will work with the relevant planning
                                commission(s) to identify potential land
                                use planning strategies and projects
                                with quantifiable and timely emission
                                benefits. DEP will also work with the
                                Pennsylvania Department of Community and
                                Economic Development and other state
                                agencies to assist with these measures.
Within 9 months..............  If state loans or grants are required,
                                DEP will enter into agreements with
                                implementing organizations. DEP will
                                also quantify projected emission
                                benefits.
Within 12 months.............  DEP will submit revised SIP to EPA.
Within 12-24 months..........  DEP will implement strategies and
                                projects.
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     Table 5--Implementation Schedule for Johnstown Area Regulatory
                          Contingency Measures
------------------------------------------------------------------------
 Time after triggering event                     Action
------------------------------------------------------------------------
Within 1 month...............  DEP 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..............  DEP will publish regulatory measure in
                                the Pennsylvania Bulletin for comment as
                                proposed rulemaking.
Within 10 months.............  DEP 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 rulemaking.
Within 16 months.............  EQB meeting/action.
Within 17 months.............  The IRCC will take action on final
                                rulemaking
Within 18 months.............  Attorney General's review/action.
Within 19 months.............  DEP will publish the regulatory measure
                                as a final rulemaking 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 DEP's
February 27, 2020 submittal satisfies the pertinent requirements of CAA
section 175A(d). EPA notes that while six 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 Johnstown 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 or not 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). A 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 Johnstown Area remains
under the obligation to meet the applicable conformity requirements for
the 1997 ozone NAAQS.

III. Proposed Action

    EPA's review of DEP's February 27, 2020 submittal indicates that it
meets all applicable CAA requirements, specifically the requirements of
CAA section 175A. EPA is proposing to approve the second maintenance
plan for the Johnstown 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,
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 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);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     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 Johnstown 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, Intergovernmental relations, Nitrogen dioxide, Ozone,
Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: August 27, 2020.
Cosmo Servidio,
Regional Administrator, Region III.
[FR Doc. 2020-19677 Filed 9-15-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Notices]
[Pages 24128-24129]
[FR Doc No: 2018-11117]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-0412]

Anthrax: Developing Drugs for Prophylaxis of Inhalational
Anthrax; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Anthrax:
Developing Drugs for Prophylaxis of Inhalational Anthrax.'' The purpose
of this guidance is to assist sponsors in the development of new drugs
for the prophylaxis of inhalational anthrax. This guidance finalizes
the draft guidance of the same name issued on February 16, 2016.

DATES: The announcement of the guidance is published in the Federal
Register on May 24, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your

comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-0412 for ``Anthrax: Developing Drugs for Prophylaxis of
Inhalational Anthrax.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1400.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Anthrax: Developing Drugs for Prophylaxis of Inhalational
Anthrax.'' The purpose of this guidance is to assist sponsors in the
development of new drugs to be administered to people who have or may
have inhaled Bacillus anthracis spores, but who have not yet manifested
clinical evidence of disease, to prevent the development of
inhalational anthrax. This guidance clarifies that drugs for the
prophylaxis of inhalational anthrax are to be considered for approval
under the animal rule regulations because human efficacy trials are not
ethical or feasible (21 CFR part 314, subpart I, for drugs, and 21 CFR
part 601, subpart H, for biological products).
    This guidance finalizes the draft guidance of the same name issued
on February 16, 2016 (81 FR 7813). Changes made to the guidance took
into consideration written and verbal comments received. In addition to
changes primarily for clarification, the major changes are as follows:
Clarity in defining specific populations that would receive a drug for
prophylaxis of inhalational anthrax, for example, first responders who
anticipate exposure to Bacillus anthracis spores and initiate drug
therapy immediately before exposure. In addition, the guidance was
updated to provide consistency with the guidance for industry entitled
``Product Development Under the Animal Rule'' (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm399217.pdf).
    Issuance of this guidance fulfills a portion of the requirements of
Title VIII, section 804, of the Food and Drug Administration Safety and
Innovation Act (Pub. L. 112-144), which requires FDA to review and, as
appropriate, revise not fewer than three guidance documents per year
for the conduct of clinical trials with respect to antibacterial and
antifungal drugs.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on prophylaxis of inhalational anthrax. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: May 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11117 Filed 5-23-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Notices]
[Page 34147]
[FR Doc No: 2023-11238]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 5596-000]

Town of Bedford, Virginia; Notice of Authorization for Continued
Project Operation

    The license for the Bedford Hydroelectric Project No. 5596 was
issued for a period ending April 30, 2023.
    Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the
Commission, at the expiration of a license term, to issue from year-to-
year an annual license to the then licensee(s) under the terms and
conditions of the prior license until a new license is issued, or the
project is otherwise disposed of as provided in section 15 or any other
applicable section of the FPA. If the project's prior license waived
the applicability of section 15 of the FPA, then, based on section 9(b)
of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth
at 18 CFR 16.21(a), if the licensee of such project has filed an
application for a subsequent license, the licensee may continue to
operate the project in accordance with the terms and conditions of the
license after the minor or minor part license expires, until the
Commission acts on its application. If the licensee of such a project
has not filed an application for a subsequent license, then it may be
required, pursuant to 18 CFR 16.21(b), to continue project operations
until the Commission issues someone else a license for the project or
otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 5596 is issued to
the Town of Bedford, Virginia for a period effective May 1, 2023,
through April 30, 2024 or until the issuance of a new license for the
project or other disposition under the FPA, whichever comes first. If
issuance of a new license (or other disposition) does not take place on
or before April 30, 2024, notice is hereby given that, pursuant to 18
CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is
renewed automatically without further order or notice by the
Commission, unless the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that the Town of Bedford, Virginia. is authorized to
continue operation of the Bedford Hydroelectric Project under the terms
and conditions of the prior license until the issuance of a new license
for the project or other disposition under the FPA, whichever comes
first.

    Dated: May 19, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-11238 Filed 5-25-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61087-61089]
[FR Doc No: 2022-21862]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1427]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Hazard Analysis and Critical Control Point Procedures
for the Safe and Sanitary Processing and Importing of Juice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of our regulations mandating the application of hazard

analysis and critical control point (HACCP) principles to the
processing and importing of fruit and vegetable juices.

DATES: Either electronic or written comments on the collection of
information must be submitted by December 6, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 6, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-1427 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Hazard Analysis and Critical
Control Point Procedures for the Safe and Sanitary Processing and
Importing of Juice.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Hazard Analysis and Critical Control Point (HACCP) Procedures for the
Safe and Sanitary Processing and Importing of Juice--21 CFR Part 120
OMB Control Number 0910-0466--Extension

    This information collection supports regulations in part 120 (21
CFR part 120) which mandate the application of HACCP procedures to the
processing of fruit and vegetable juices. HACCP is a preventative
system of hazard control designed to help ensure the safety of foods.
The regulations were issued under FDA's statutory authority to regulate
food safety under section 402(a)(4) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 342(a)(4)). Under section
402(a)(4) of the FD&C Act, a food is adulterated if it is prepared,
packed, or held under

insanitary conditions whereby it may have been contaminated with filth
or rendered injurious to health. The Agency also has authority under
section 361 of the Public Health Service Act (42 U.S.C. 264) to issue
and enforce regulations to prevent the introduction, transmission, or
spread of communicable diseases from one State, territory, or
possession to another, or from outside the United States into this
country. Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA
is authorized to issue regulations for the efficient enforcement of the
FD&C Act.
    Under HACCP, processors of fruit and vegetable juices establish and
follow a preplanned sequence of operations and observations (the HACCP
plan) designed to avoid or eliminate one or more specific food hazards,
and thereby ensure that their products are safe, wholesome, and not
adulterated; in compliance with section 402 of the FD&C Act.
Information development and recordkeeping are essential parts of any
HACCP system. The information collection requirements are narrowly
tailored to focus on the development of appropriate controls and
document those aspects of processing that are critical to food safety.
    In an effort to reduce burden and assist respondents, our website
(https://www.fda.gov/food/hazard-analysis-critical-control-point-haccp/juice-haccp) offers guidance for industry, training and education, and
background information to assist the food industry in developing and
implementing a Juice HACCP. Included in this information are guidance
documents entitled ``Juice HACCP and the FDA Food Safety and
Modernization Act'' (December 2021) (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-haccp-and-fda-food-safety-modernization-act) and ``Juice HACCP
Hazards and Controls Guidance--First Edition'' (March 2004) (available
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-juice-hazard-analysis-critical-control-point-hazards-and-controls-guidance-first). All Agency guidance
documents are issued in accordance with our good guidance practice
regulations in 21 CFR 10.115, which provide for public comment at any
time.
    We estimate the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                     Average burden
    21 CFR section; activity        Number of      records per    Total annual         per          Total hours
                                  recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
120.6(c) and 120.12(a)(1) and             1,875             365         684,375  0.1 (6 minutes)          68,438
 (b); require written
 monitoring and correction
 records for Sanitation
 Standard Operating Procedures.
120.7; 120.10(a); and                     2,300             1.1           2,530  20.............          50,600
 120.12(a)(2), (b) and (c);
 require written hazard
 analysis of food hazards.
120.8(b)(7) and 120.12(a)(4)(i)           1,450          14,600      21,170,000  0.01 (1 minute)         211,700
 and (b); require a
 recordkeeping system that
 documents monitoring of the
 critical control points and
 other measurements as
 prescribed in the HACCP plan.
120.10(c) and 120.12(a)(4)(ii)            1,840              12          22,080  0.1 (6 minutes)           2,208
 and (b); require that all
 corrective actions taken in
 response to a deviation from a
 critical limit be documented.
120.11(a)(1)(iv) and (a)(2) and           1,840              52          95,680  0.1 (6 minutes)           9,568
 120.12 (a)(5) and (b); require
 records showing that process
 monitoring instruments are
 properly calibrated and that
 end-product or in-process
 testing is performed in
 accordance with written
 procedures.
120.11(b) and (c); and                    1,840               1           1,840  4..............           7,360
 120.12(a)(5) and (b); require
 that every processor record
 the validation that the HACCP
 plan is adequate to control
 food hazards that are likely
 to occur.
120.11(c) and 120.12(a)(5) and            1,840               1           1,840  4..............           7,360
 (b); require documentation of
 revalidation of the hazard
 analysis upon any changes that
 might affect the original
 hazard analysis (applies when
 a firm does not have a HACCP
 plan because the original
 hazard analysis did not reveal
 hazards likely to occur).
120.14(a)(2), (c), and (d) and              308               1             308  4..............           1,232
 120.12(b); require that
 importers of fruit or
 vegetable juices, or their
 products used as ingredients
 in beverages, have written
 procedures to ensure that the
 food is processed in
 accordance with our
 regulations in part 120.
120.8(a), 120.8(b), and                   1,560             1.1           1,716  60.............         102,960
 120.12(a)(3), (b), and (c);
 require written HACCP plan.
                                --------------------------------------------------------------------------------
    Total......................  ..............  ..............  ..............  ...............         461,426
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Table 1 provides our estimate for the next 3 years for the total
annual recordkeeping burden of our regulations in part 120. Based on
our experience with the information collection over the past 3 years,
our burden estimate remains unchanged since our last review of the
information collection.

    Dated: October 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21862 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Page 40299]
[FR Doc No: 2016-14598]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 6731-013]

Coneross Power Corporation; Notice of Intent To File License
Application, Filing of Pre-Application Document, Approving Use of the
Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 6731-013.
    c. Date Filed: February 26, 2016.
    d. Submitted By: Coneross Power Corporation.
    e. Name of Project: Coneross Hydroelectric Project.
    f. Location: On Coneross Creek, in Oconee County, South Carolina.
No federal lands are occupied by the project works or located within
the project boundary.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Beth E. Harris, Enel Green Power
North America, Inc., 11 Anderson Street, Piedmont, SC 29673; (864) 846-
0042 ext. 100<EMAIL_ADDRESS>    i. FERC Contact: Adam Peer at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Coneross Power Corporation filed its request to use the
Traditional Licensing Process on February 26, 2016. Coneross Power
Corporation provided public notice of its request on March 1, 2016 and
March 9, 2016. In a letter dated June 10, 2016, the Director of the
Division of Hydropower Licensing approved Coneross Power Corporation's
request to use the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service under section 7 of the Endangered
Species Act and the joint agency regulations thereunder at 50 CFR, part
402. We are also initiating consultation with the South Carolina State
Historic Preservation Officer, as required by section 106, National
Historic Preservation Act, and the implementing regulations of the
Advisory Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Coneross Power Corporation
as the Commission's non-federal representative for carrying out
informal consultation pursuant to section 7 of the Endangered Species
Act and consultation pursuant to section 106 of the National Historic
Preservation Act.
    m. Coneross Power Corporation filed a Pre-Application Document
(PAD; including a proposed process plan and schedule) with the
Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(http://www.ferc.gov), using the ``eLibrary'' link. Enter the docket
number, excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 6731-013. Pursuant to 18
CFR 16.8, 16.9, and 16.10 each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by February 28,
2019.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: June 15, 2016.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2016-14598 Filed 6-20-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 42 (Tuesday, March 4, 2014)]
[Rules and Regulations]
[Pages 12057-12058]
[FR Doc No: 2014-04497]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-0552; Airspace Docket No. 13-ASO-14]

Amendment of Class E Airspace; Macon, GA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E Airspace at Macon, GA, as the Bay
Creek Non-Directional Beacon (NDB) has been decommissioned and airspace
reconfiguration is necessary for the safety and airspace management of
Instrument Flight Rules (IFR) operations at Perry-Houston County
Airport. This action also amends controlled airspace and updates the
name and geographic coordinates of Macon Downtown Airport and amends
controlled airspace for Middle Georgia Regional Airport.

DATES: Effective 0901 UTC, May 29, 2014. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On August 22, 2013, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend Class E airspace in
Macon, GA, (78 FR 52114). Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9X dated August 7, 2013, and effective September 15,
2013, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends Class E airspace extending upward from 700 feet above
the surface within a 7.8-mile radius of Middle Georgia Regional
Airport, Macon, GA; and within a 9.8-mile radius of Perry-Houston
County Airport; and within a 7-mile radius of Robins AFB; and within a
8.8-mile radius of Macon Downtown Airport formerly called Herbert Smart
Downtown Airport. Airspace reconfiguration is necessary due to the
decommissioning of the Bay Creek NDB and cancellation of the NDB
approach, and for continued safety and management of IFR operations at
the airports. Also, the geographic coordinates of Macon Downtown
Airport are adjusted to coincide with the FAAs aeronautical database.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act. The FAA's authority to
issue rules regarding aviation safety is found in Title 49 of the
United States Code. Subtitle I, Section 106 describes the authority of
the FAA Administrator. Subtitle VII, Aviation Programs, describes in
more detail the scope of the agency's authority. This rulemaking is
promulgated under the authority described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it amends
controlled airspace in the Macon, GA, area.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment:

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR Part 71 as follows:

PART 71 --DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS;
AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for Part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9X, Airspace Designations and Reporting
Points, dated August 7, 2013, effective September 15, 2013, is amended
as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO GA E5 Macon, GA [Amended]

Middle Georgia Regional Airport, GA
    (Lat. 32[deg]41'34'' N., long. 83[deg]38'57'' W.)
Macon Downtown Airport
    (Lat. 32[deg]49'18'' N., long. 83[deg]33'43'' W.)
Robins AFB
    (Lat. 32[deg]38'25'' N., long. 83[deg]35'31'' W.)
Perry-Houston County Airport
    (Lat. 32[deg]30'38'' N., long. 83[deg]46'02'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7.8-mile radius of Middle Georgia Regional Airport, and
within a 8.8-mile radius of Macon Downtown Airport, and within a 7-
mile radius of Robins AFB, and within a 9.8-mile radius of Perry-
Houston County Airport.

    Issued in College Park, Georgia, on February 21, 2014.
Eric Fox,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2014-04497 Filed 3-3-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 163 (Friday, August 21, 2020)]
[Notices]
[Pages 51693-51694]
[FR Doc No: 2020-18367]

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

[ER-FRL-9052-4]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or https://www.epa.gov/nepa.

Weekly receipt of Environmental Impact Statements (EIS)
Filed August 10, 2020, 10 a.m. EST Through August 17, 2020, 10 a.m. EST
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-enepa-public/action/eis/search.

EIS No. 20200168, Draft, FAA, CA, Bob Hope Hollywood Burbank Airport
Replacement Passenger Terminal Project, Comment Period Ends: 10/05/
2020, Contact: Edvige B. Mbakoup<PHONE_NUMBER>.
EIS No. 20200169, Final, USAF, TX, F-35A Operational Beddown--Air Force
Reserve Command, Review Period Ends: 09/21/2020, Contact: Mr. Hamid
Kamalpour 210-925-273.
EIS No. 20200170, Draft, FAA, NY, LaGuardia Airport Access Improvement
Project, Comment Period Ends: 10/05/2020, Contact: Andrew Brooks 718-
553-2511.
EIS No. 20200171, Final, USACE, CA, Malibu Creek Ecosystem Restoration
Study, Review Period Ends: 09/21/2020, Contact: Larry Smith 213-452-
3846.

Amended Notice

EIS No. 20200165, Draft, USFS, ID, Stibnite Gold Project, Comment
Period Ends: 10/13/2020, Contact: Brian Harris<PHONE_NUMBER>.

    Revision to FR Notice Published 08/14/2020; Correction to Comment
Period Due Date from September 28, 2020 to October 13, 2020; Correction
to Lead Agency Contact Phone Number from<PHONE_NUMBER> to<PHONE_NUMBER>.

    Dated: August 17, 2020.
Cindy S. Barger,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2020-18367 Filed 8-20-20; 8:45 am]
BILLING CODE 6560-50-P