[Federal Register Volume 82, Number 46 (Friday, March 10, 2017)]
[Rules and Regulations]
[Pages 13235-13243]
[FR Doc No: 2017-04771]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0399; FRL-9958-11-Region 9]

Air Plan Approval; Nevada, Lake Tahoe; Second 10-Year Carbon
Monoxide Limited Maintenance Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve a state implementation plan (SIP) revision
submitted by the State of Nevada (``State''). On April 3, 2012, the
State of Nevada submitted to the EPA a second 10-year limited
maintenance plan (LMP) for the Lake Tahoe Nevada Area (``Area'') for
the carbon monoxide (CO) national ambient air quality standards (NAAQS
or ``standards''). This LMP addresses maintenance of the CO NAAQS for a
second 10-year period beyond the original 10-year maintenance period.
On August 26, 2016, the State amended the 2012 submittal with a
supplemental SIP submittal (``2016 supplement'' or ``supplement''). The
EPA is also approving the 2011 emissions inventory, the 2024 projected
emissions inventory and the revised alternative monitoring strategy
included with the 2016 supplement. We are taking these actions under
the Clean Air Act (CAA or ``Act'').

DATES: This rule is effective on May 9, 2017 without further notice,
unless the EPA receives adverse comments by April 10, 2017. If we
receive such comments, we will publish a timely withdrawal in the
Federal Register to notify the public that this direct final rule will
not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2015-0399 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The 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. For
additional submission methods, the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: John Kelly, Planning Office (Air-2),
Air Division, Region IX, Environmental Protection Agency, 75 Hawthorne
Street, San Francisco, California 94105,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us,''
and ``our'' refer to the EPA.

Table of Contents

I. Background
    A. Lake Tahoe Nevada Area's CO Limited Maintenance Plan
    B. Alternative CO Monitoring Strategy
    C. Adjacent Maintenance Areas in California
    D. Transportation Conformity
II. The EPA's Evaluation of Nevada's Submittal
    A. Ambient Air Quality Monitoring Data
    B. Alternative Monitoring Strategy
    C. Attainment Emissions Inventory
    D. Maintenance Demonstration
    E. Transportation Conformity
    F. Ambient Air Quality Monitoring Network
    G. Verification of Continued Attainment
    H. Contingency Plan
III. Public Comment and Final Action
IV. Statutory and Executive Order Reviews

I. Background

A. Lake Tahoe Nevada Area's CO Limited Maintenance Plan

    Under the CAA Amendments of 1990, the Lake Tahoe Nevada Area was
designated as nonattainment and classified as a ``not classified'' CO
area. This was because the Area had been designated as nonattainment
before November 15, 1990, the date of enactment, but had not violated
the CO NAAQS in 1988 and 1989, prior to enactment. See 56 FR 56694
(November 6, 1991). On October 27, 2003, the State of Nevada submitted
a request to the EPA to redesignate the Area from nonattainment to
attainment for the CO NAAQS. Along with this request, the State
submitted a CAA section 175A(a) LMP that demonstrated that the Area
would maintain the CO NAAQS for 10 years following our approval of the
redesignation request. A LMP is an option whereby an area's maintenance
demonstration is considered to be satisfied for ``not classified''
areas if the monitoring data show the design value is at or below 7.65
parts per million (ppm), or 85 percent of the level of the 8-hour CO
NAAQS.\1\ We approved the

State's redesignation request and 10-year LMP on December 15, 2003,
effective February 13, 2004. See 68 FR 69611 (December 15, 2003).
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    \1\ See the EPA guidance memorandum, ``Limited Maintenance Plan
Option for Nonclassifiable CO Nonattainment Areas,'' from Joseph
Paisie, Group Leader, Integrated Policy and Strategies Group, Office
of Air Quality Planning and Standards (OAQPS), to Air Branch Chiefs,
October 6, 1995 (``CO LMP guidance''). Also note that the EPA uses
the terms ``nonclassifiable'' and ``not classified'' interchangeably
with respect to CO nonattainment areas. See e.g., 57 FR 13498, 13535
(April 16, 1992).
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    Eight years after the EPA redesignates an area to attainment, CAA
section 175A(b) requires the state to submit to the EPA a subsequent
maintenance plan covering a second 10-year period.\2\ This second
maintenance plan must demonstrate continued compliance with the NAAQS
during this second 10-year period. To fulfill this requirement of the
CAA, the State submitted to the EPA on April 3, 2012, the second 10-
year update of the Area's CO maintenance plan titled ``2012 Revision to
the Nevada State Implementation Plan: Updated Limited Maintenance Plan
for the Nevada Side of the Lake Tahoe Basin, Including Douglas, Carson
City and Washoe Counties'' (hereinafter, ``2012 plan'' or ``plan''). On
August 26, 2016, the State amended the plan with a supplemental
submittal. With this action, we are approving the 2012 plan, as amended
by the 2016 supplement.
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    \2\ In this case, the initial maintenance period extended
through 2014. Thus, the second 10-year period extends through 2024.
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    The 8-hour CO NAAQS of 9.0 ppm is attained when such value is not
exceeded more than once a year. See 40 CFR 50.8(a)(1). The Lake Tahoe
Nevada Area has attained the 8-hour CO NAAQS from 1979 to the present.
According to the CO LMP guidance, areas that have design values (2nd
highest maximum CO concentration) at or below 7.65 ppm (that is, at or
below 85 percent of the 8-hour CO NAAQS) for eight consecutive quarters
qualify to use the LMP option. The Area qualified for and used the
EPA's CO LMP option for the first 10-year maintenance period. See 68 FR
69611. For the 2012 plan, the State again used the LMP option to
demonstrate continued maintenance of the CO NAAQS in the Area. We have
determined that the Area continues to qualify for the LMP option
because the design value at the time the State adopted the plan was 3.1
ppm, based on eight consecutive quarters of certified data from 2010
and 2011.\3\
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    \3\ See Table 2. Additionally, according to the CO LMP guidance,
an area using the LMP option must continue to have a design value
``at or below 7.65 ppm until the time of final EPA action on the
redesignation.'' See CO LMP guidance, page 2. Although this action
is not a redesignation but merely approval of a second 10-year
maintenance plan, we note that the Area would meet this requirement
if it applied, even with the higher design value (i.e., 5.4 ppm for
2011-2012) measured after the State submitted the 2012 plan to the
EPA.
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B. Alternative CO Monitoring Strategy

    The State's 2012 plan included notification to the EPA that the
State intended to discontinue monitoring for CO at the Stateline,
Nevada location and that the State would submit a separate request to
discontinue CO monitoring. The 2012 plan included the State's
alternative monitoring strategy for monitoring continued attainment of
the CO NAAQS in the Area. The State submitted the alternative
monitoring strategy to enable it to conserve resources by discontinuing
the only remaining gaseous CO ambient monitor in the Lake Tahoe basin
(``basin''). The State's alternative monitoring strategy relies on
vehicle counts collected from automatic traffic recorders in the Area.
Gaseous CO ambient monitoring is triggered when a specified level of
higher vehicle counts is exceeded.
    Shortly after its submittal of the 2012 plan, the State submitted a
request to discontinue the CO monitor located at Harvey's Resort and
Hotel in Stateline, Nevada (hereinafter, the ``Harvey's monitor'').\4\
This action does not address the State's request to discontinue the
Harvey's monitor. The EPA intends to respond to the State's request in
a future action. In 2016, the State submitted the supplement to
include, among other things, a revised alternative CO monitoring
strategy.
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    \4\ The State's request to discontinue CO monitoring for the
Lake Tahoe Nevada Area was submitted to the EPA on April 25, 2012.
See letter from Rob Bamford, Chief, Bureau of Air Quality Planning,
Division of Environmental Protection, Department of Conservation and
Natural Resources, State of Nevada, to Matthew Lakin, Chief, Air
Quality Analysis Office, Air Division, U.S. EPA Region 9, subject
``Discontinuation of the SLAMS CO Monitor at Harvey's Resort and
Hotel, Stateline, Nevada (AQS ID #32-005-0009-4201-1).''
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C. Adjacent Maintenance Areas in California

    In addition to the Lake Tahoe Nevada Area, there are two adjacent
CO maintenance areas to the west just over the Nevada-California state
line. These two areas occupy the remainder of the basin on the
California side. The Lake Tahoe North Shore area and the Lake Tahoe
South Shore area are both California maintenance areas for CO. In 1998,
the EPA redesignated both areas to attainment and approved maintenance
plans for each as revisions to the California SIP. See 63 FR 15305
(March 31, 1998). At the conclusion of their initial 10-year
maintenance period, the EPA approved second 10-year maintenance plans
for each area as a revision to the California SIP, effective January
30, 2006. See 70 FR 71776 (November 30, 2005). The second 10-year
maintenance plans for each of the two California areas demonstrated
maintenance through 2018.

D. Transportation Conformity

    Section 176(c) of the Act defines conformity as meeting the SIP's
purpose of eliminating or reducing the severity and number of
violations of the NAAQS and achieving expeditious attainment of such
standards. The Act further defines transportation conformity to mean
that no federal transportation activity will: (1) Cause or contribute
to any new violation of any standard in any area; (2) increase the
frequency or severity of any existing violation of any standard in any
area; or (3) delay timely attainment of any standard or any required
interim emission reductions or other milestones in any area. The
federal transportation conformity rule (i.e., 40 CFR part 93 subpart A)
sets forth the criteria and procedures for demonstrating and assuring
conformity of transportation plans, programs and projects that are
developed, funded or approved by the U.S. Department of Transportation,
and by metropolitan planning organizations or other recipients of
federal funds under Title 23 U.S.C. or the Federal Transit Laws.
    The transportation conformity rule applies within all nonattainment
and maintenance areas for transportation-related criteria pollutants.
See 40 CFR 93.102(b). As prescribed by the transportation conformity
rule, once an area has an applicable SIP with motor vehicle emissions
budgets (MVEBs or ``budgets''), the expected emissions from planned
transportation activities must be consistent with such established
budgets for that area.

II. The EPA's Evaluation of Nevada's Submittal

    The following are the key elements of an LMP for CO: Attainment
inventory, maintenance demonstration, monitoring network, verification
of continued attainment, contingency plan, and conformity
determinations.\5\ The 2012 plan contains the following sections to
address these elements: (1) An introductory section containing a
general discussion of plan approvals for the Area and its redesignation
to attainment; (2) a maintenance plan section including subsections on
monitoring data for the Area, air quality trends and background on the
State's intention to discontinue monitoring CO at the Harvey's site;
(3) a section titled ``Verification of Continued Attainment'' that
addresses population change, traffic volumes, meteorology and the
State's

surrogate monitoring method; (4) contingency measures for the Area; and
(5) transportation conformity requirements.
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    \5\ See CO LMP guidance, pp. 3-5.
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    The 2016 supplement revises several sections of the 2012 plan and
contains an emissions inventory. Below, we describe our evaluation of
the 2012 plan and 2016 supplement as they pertain to each of the
required LMP elements.
    The EPA evaluation sections that follow appear generally in the
order of appearance of each section in the State's 2012 plan.
Exceptions include the monitoring data, which the EPA includes first to
provide background and context for the State's submittal, and the
emissions inventory. The inventory is the first element listed in the
CO LMP guidance. It wasn't submitted as part of the 2012 plan but was
included in the 2016 supplement.

A. Ambient Air Quality Monitoring Data

    As noted previously, the primary NAAQS for CO are: 9 ppm (or 10
milligrams per cubic meter) for an 8-hour average concentration not to
be exceeded more than once per year and 35 ppm (or 40 milligrams per
cubic meter) for a 1-hour average concentration not to be exceeded more
than once per year. See 40 CFR 50.8(a).
    The 2012 plan includes a summary of 8-hour CO design values for the
years 1975 to 2011, the year prior to the State's submittal of the
plan. See 2012 plan, Table 2, pp. 5-6. Table 1 shows the complete,
quality assured and certified ambient air monitoring design values for
CO for the years 1998 to 2012.\6\ The first maintenance plan for the
Area covered the years 2004 to 2014. The 2012 plan covers the years
2014 to 2024. The year 2012 is the last year for which we have
complete, quality assured and certified design values for CO in the
Area.
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    \6\ Design values were derived from EPA's Air Quality System.
For 1-hour CO design values, see the Lake Tahoe Nevada 1-Hour CO
1975-2013 Maximum Values Report, dated September 26, 2016. For 8-
hour CO design values, see the Lake Tahoe Nevada 8-Hour CO 1975-2013
Maximum Values Report, dated September 21, 2016. Design values for
each two-year period were derived from the annual values shown in
these reports.
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    Since 1984, no Lake Tahoe Nevada Area CO monitor has registered an
8-hour design value greater than 6.6 ppm,\7\ which is 73 percent of the
9 ppm NAAQS, and since 2005, no monitor has registered a design value
greater than 5.4 ppm, 60 percent of the NAAQS.\8\ The EPA also notes
that the Area never violated the 1-hour CO NAAQS.
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    \7\ See 2012 plan, Table 2, pp. 5-6.
    \8\ See 2012 plan, Table 2, pp. 5-6. See also Table 1.

Table 1--Carbon Monoxide Design Values for Lake Tahoe Nevada Area, 1998-
                                  2012
------------------------------------------------------------------------
                                                          Design value
                                                              (ppm)
                         Years                         -----------------
                                                         1-hour   8-hour
------------------------------------------------------------------------
1998-99...............................................      9.5      4.3
1999-00...............................................     12.1      4.3
2000-01...............................................     12.1      4.2
2001-02...............................................     13.2      6.1
2002-03...............................................     13.2      6.5
2003-04...............................................     11.2      6.5
2004-05...............................................      9.4      4.4
2005-06...............................................      7.8      3.6
2006-07...............................................      7.5      3.7
2007-08...............................................      7.5      3.7
2008-09...............................................      7.6      2.6
2009-10...............................................      7.6      3.1
2010-11...............................................      6.8      3.1
2011-12...............................................      9.2      5.4
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B. Alternative Monitoring Strategy

    Citing the consistently low CO monitor values described above, and
expressing a desire to conserve monitoring resources, the State
requested in an April 25, 2012 letter that the EPA allow
discontinuation of ambient air CO monitoring in the Lake Tahoe Nevada
Area and instead use a surrogate monitoring method for monitoring
maintenance of the CO NAAQS (``surrogate method'' or ``surrogate'').\9\
This surrogate method was initially set forth in the 2012 plan. In its
2016 supplement, the State replaced the section on its surrogate
monitoring method described in the 2012 plan. See 2012 plan, section
3.2.4 on page 14 titled ``Surrogate Monitoring Method,'' and 2016
supplement, section I, titled ``Revision to Section 3.2.4 of the 2012
CO LMP,'' on page 1.
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    \9\ See footnote 4.
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    Under the EPA's monitoring regulations, a State and Local Air
Monitoring Station may be discontinued if the monitor in question has
not measured violations of the applicable NAAQS in the previous five
years, and the approved SIP provides for a specific, reproducible
approach to representing the air quality of the affected county in the
absence of actual monitoring data. See 40 CFR 58.14(c)(3). Accordingly,
the EPA has evaluated whether the surrogate method constitutes a
specific, reproducible approach to representing the air quality of the
Lake Tahoe Nevada Area.\10\ As noted previously, the State's surrogate
method relies on vehicle counts in the Area. The State reasons that
motor vehicles are the major contributor to CO pollution in the Area
and that vehicle miles traveled (VMT) is an indicator of growth and can
therefore be used as a surrogate for monitoring of CO.\11\ In
particular, the State points to the long-term downward trend in both CO
design values and annual average daily traffic (AADT) over the 2001-
2010 period.\12\ Citing in the supplement the potential for high
ambient air CO concentrations during winter months, the State presents
a surrogate approach that uses monthly average daily traffic counts
(MADT) during the CO ``season'' months (i.e., October 1 to March 31).
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    \10\ The EPA will evaluate whether the Harvey's monitor has
measured violations of the applicable NAAQS in the previous five
years when we take a separate action to approve or disapprove the
State's request to discontinue the Harvey's monitor under 40 CFR
58.14(c).
    \11\ The 2001 emissions inventory prepared by NDEP for the
original redesignation request and maintenance plan estimated actual
emissions during the peak CO season (specifically, the month of
January) from mobile sources, including on-road and non-road
vehicles. Stationary and area sources were not included in the
inventory but are considered de minimis considering the lack of
industrial activity in the area and the small residential
population. Therefore, the vehicle count is a reasonable surrogate
for overall CO emissions in the area.
    \12\ See 2012 Lake Tahoe plan, pp. 11-12.
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    Although both VMT and AADT are measures of traffic volume, AADT has
the advantage in representing air quality in that it is measured in the
Area on a daily basis and at two locations. While the State chose, in
the 2012 plan, to use annual AADT as the measure of traffic volume, in
the 2016 supplement the State chose to use the more narrowly focused
MADT, calculated from traffic counts during the CO season. The State
will perform an annual review utilizing MADT counts collected in the
Area by the Nevada Department of Transportation's permanent automatic
traffic recorders in Incline Village, NV to the north, and Stateline,
NV to the south.
    In the supplement, the State lists seasonal MADT levels measured at
these two traffic monitors from 2008 to 2015. See Table 2. Baseline
MADT levels for each site are calculated using the average of 2008-
2009, 2009-2010 and 2010-2011 seasonal MADT levels. These baseline
levels are 24,201 for Stateline and 10,260 for Incline Village. Each
spring, the State will compare the latest rolling 3-year average MADT
levels to those baselines and report the results to the EPA in the
Area's annual monitoring network plan.\13\
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    \13\ The Nevada Division of Environmental Protection (NDEP)
submitted AADT reports in a supplement to their ANPs for the initial
maintenance years 2012, 2013 and 2014 in a letter. See letter,
Phillip W. Shoopman, P.E., Chief, Bureau of Air Quality Planning,
NDEP, to Meredith Kurpius, Chief, Air Quality Analysis Office, Air
Division, U.S. EPA Region 9, dated July 22, 2015. Henceforth the
NDEP commits to submit annual AADT reports as part of their ANP for
the Area. The July 2015 ANP supplement shows that three-year average
AADT levels for 2009-2011, 2010-2012, 2011-2013 and 2012-2014 were
all below the 2008-2010 baseline level at both AADT station
(Stateline and Incline Village). Therefore ambient air monitoring
was not triggered.

   Table 2--Seasonal MADT Counts for Lake Tahoe Nevada Area, 2008-2015
------------------------------------------------------------------------
                                                              Incline
                                           Stateline, NV    Village, NV
------------------------------------------------------------------------
2008-2009 Season........................          24,791          10,276
2009-2010 Season........................          24,212          10,109
2010-2011 Season........................          23,600          10,396
2011-2012 Season........................          23,122          10,125
2012-2013 Season........................          22,848          10,154
2013-2014 Season........................          23,333          10,348
2014-2015 Season........................          24,319          10,618
Baseline (average of 2008-11)...........          24,201          10,260
Initial Trigger (baseline plus 25                 30,251          12,825
 percent)...............................
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    As an initial matter, if the State's annual MADT report shows an
average at either site that is 25 percent or more above the baseline at
that site (that is, equal to or greater than 30,251 for Stateline and
12,825 for Incline Village), the State will conduct, concurrent with
continued MADT counting, ambient CO monitoring at the Harvey's monitor
during the following CO season. The State commits to retain the
Harvey's monitor site intact so that ambient monitoring can be resumed
soon after being triggered. See 2016 supplement, page 2. These levels
(i.e., 30,251 for Stateline and 12,825 for Incline Village) represent
the initial ``trigger'' for ambient air quality monitoring. Once
triggered, the State will determine whether to continue ambient air
monitoring. The State has developed a matrix for this purpose. See
Table 3.
    After the initial trigger and upon discontinuation of the first
instance of ambient air monitoring that it triggered, the State
identifies subsequent, incrementally larger triggers for future ambient
air monitoring that would then apply. These subsequent triggers would
apply at incremental 5 percent MADT average levels above the first
trigger. That is, after the initial trigger where MADT exceeds 25
percent of the baseline, ambient monitoring would be triggered a second
time if the Area measured more than 30 percent above the MADT baseline,
and then again at 35 percent, etc.
    It is important to note that the trigger levels to initiate ambient
air monitoring are independent of the matrix table for continued air
monitoring, and that the triggering MADT level will be followed by a
new rolling average MADT by the time monitoring of the subsequent CO
season is complete. To illustrate, the initial MADT trigger in CO
season 1 requires air monitoring in CO season 2. MADT monitoring
continues during CO season 2 (and throughout the maintenance period).
The State then has two possible triggers for ambient air monitoring in
season 3. First, if the MADT level in season 2 is higher than baseline
plus 25 percent, plus 5 percent, the State will monitor ambient air in
season 3. Independent of that, however, the criteria in Table 3 could
indicate continued air monitoring. To emphasize this point, we note
that even a MADT level 20 percent above baseline can trigger continued
ambient air monitoring in season 3 (or in any maintenance period CO
season, where ambient air monitoring was performed in the prior
season), if season 2 air monitoring yielded concentrations in excess of
75 percent of the CO NAAQS.
    The decision matrix in Table 3 provides conditions for
discontinuing ambient air monitoring, once such monitoring is
triggered, in order to return to a surrogate-only approach. The matrix
is structured such that, if the MADT rises above the baseline and the
2nd-high CO concentration also rises to approach the level of the
standard, ambient air monitoring is continued during the next CO
season. Conversely, as MADT and CO concentrations decline, the State
would rely on the MADT surrogate method alone. This approach minimizes
the amount of ambient air monitoring needed and State resources used in
such monitoring when CO concentrations are low with respect to the
standard, while ensuring that ambient air quality is directly monitored
when conditions indicate that concentrations may be trending to
elevated levels closer to the standard.

                    Table 3--Decision Matrix To Determine Whether To Continue CO Monitoring *
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                                                   2nd-high 8-hour average CO concentration as percent of NAAQS
    Percent change in 3-year rolling average     ---------------------------------------------------------------
         seasonal MADT from the baseline               <=50        >50 but <=65    >65 but <=65         >75
----------------------------------------------------------------------------------------------------------------
<=20............................................               S               S               S               M
>20 but <=25....................................               S               S               M               M
>25 but <=30....................................               S               M               M               M
>30.............................................               S               M               M               M
----------------------------------------------------------------------------------------------------------------
Source: see 2016 supplement, Table 6, page 3.
Key: S = surrogate method only; M = monitoring of ambient air continues in following CO season (in addition to
  ongoing MADT surrogate method).
* Assumes ambient air monitoring has been triggered. This matrix is used to determine whether the State will
  continue ambient air monitoring, once triggered.

    If the MADT review or the decision matrix indicates that ambient
air quality monitoring must be performed, the monitoring data will be
submitted to the EPA's Air Quality System. See Supplement, page 2. The
State will

include in its Annual Network Plan (ANP) a report on MADT, as
previously stated. After the initial CO season air monitoring is
completed, the State will summarize the results of such monitoring in
the next ANP.
    Also, in each instance where ambient air monitoring has been
triggered by MADT levels, once the ambient air monitoring has been
performed during the next CO season, the State will also include in its
ANP the results of its assessment of which conditions in the matrix
apply so as to determine whether to continue ambient air monitoring. If
such monitoring is indicated, the State would conduct the air
monitoring and then again report in the following ANP the results of
its assessment with regard to the air monitoring performed and which
conditions of the matrix apply.
    We note that the Area benefits from the adjacent Lake Tahoe North
Shore and the Lake Tahoe South Shore maintenance areas on the CA side
of the basin. In both of these areas, the State of California's ongoing
motor vehicle program continues to be implemented, including the
State's low-emission vehicles and clean fuels programs.\14\
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    \14\ See 2012 Lake Tahoe plan, p. 12.
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    The EPA finds that the Nevada Division of Environmental
Protection's (NDEP) surrogate monitoring method constitutes a specific,
reproducible approach to representing the air quality of the Area.
Specific traffic volume targets are listed by the State, and comparison
of future traffic volumes to the trigger volumes are reproducible in
that the State is using data from permanent traffic counters and
comparing that data to specific percent-above-baseline MADT trigger
levels. If air monitoring is triggered, the matrix provides a specific
set of conditions for the State to determine whether to continue air
monitoring.
    Given the long history of low CO concentrations in the Area, the
relationship between CO levels and MADT and the triggers for both re-
starting ambient air monitoring and, once re-started, to discontinue
that monitoring, the EPA considers NDEP's surrogate to be adequate to
represent CO concentrations in the Area. We also note that the EPA has
previously approved similar traffic volume-based monitoring
alternatives for CO in other LMPs.\15\ Accordingly, the EPA is
approving the surrogate monitoring method into the Nevada SIP.
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    \15\ See, e.g., final approval of LMP and alternative monitoring
strategy for Billings, Montana CO maintenance area, 80 FR 16571
(March 30, 2015); final approval of LMP and alternative monitoring
strategy for Great Falls, Montana CO maintenance area, 80 FR 17331
(April 1, 2015).
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C. Attainment Emissions Inventory

    For maintenance plans, a state should develop a comprehensive,
accurate inventory of actual emissions for an attainment year to
identify the level of emissions that are sufficient to maintain the
NAAQS. A state should develop this inventory consistent with the EPA's
most recent guidance on emissions inventory development. For CO, the
inventory should reflect typical wintertime conditions. Further, the
EPA's CO LMP guidance recommends that an LMP include an attainment
emissions inventory that represents emissions during the time period
associated with the monitoring data showing attainment.\16\ The NDEP
submitted such an inventory for 2001 as part of the original Lake Tahoe
Nevada Area redesignation request and maintenance plan that the EPA
approved in 2003.\17\ The NDEP did not include an attainment emissions
inventory in the 2012 plan. They reasoned it wasn't needed because they
provide CO point source emissions data to the EPA as part of the
National Emission Inventory (NEI) process each year and submits
emissions model inputs that enable EPA to develop a comprehensive
emissions inventory every third year.
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    \16\ See CO LMP guidance, page 3.
    \17\ See 68 FR 69611, 69614 (December 15, 2003).
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    Subsequently however, in its 2016 supplement, the NDEP provided the
EPA with a 2011 emissions inventory for the Area. The Area continued to
maintain the NAAQS in 2011, immediately prior to submittal of the 2012
plan (see Table 1) and, as such, 2011 is an appropriate year for which
to provide the EPA with an emissions inventory in support of the second
maintenance plan.
    The supplement also provided a projected emissions inventory for
2024, with a least conservative and most conservative projection. As
noted in the supplement, mobile sources account for the vast majority
of CO emissions in the Area. The State's initial 10-year maintenance
plan included an emissions inventory for onroad and nonroad mobile
sources.\18\ Therefore, the supplement provides a similar inventory for
the second 10-year maintenance plan.\19\
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    \18\ See 68 FR 69611, 69615 (December 15, 2003).
    \19\ The State included an attachment to its 2016 supplement
titled ``Mobile Source Emissions Inventory and Future Year
Projections for the 2012 Lake Tahoe Basin Carbon Monoxide Limited
Maintenance Plan,'' and requested that the EPA append the attachment
to its 2012 plan. See 2016 Supplement, page 4 and Attachment A.
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    Starting with the NEI CO emissions in 2011 for Carson City, Douglas
and Washoe counties, each of which accounts for a portion of the basin,
the State developed a 2011 inventory for the Area. The NEI provides
countywide annual emissions for both onroad and nonroad source
categories. The State adjusted NEI annual emissions from the three
counties to represent the Area's emissions by applying ratios of either
county-to-area VMT (for onroad) or county-to-area population (for
nonroad), and then adjusted the resulting Area annual emissions to
seasonal emissions. In order to provide a sense of trending emissions
over time, the State used the same methodology to provide emissions
inventories for the Area for 2002, 2005 and 2008, and also presented
the emissions for 2001 from the Area's first 10-year maintenance plan.
    The State also prepared a future year inventory for 2024, the last
year of the second 10-year maintenance plan. The State developed the
projected inventory with input and data from the Tahoe Regional
Planning Agency (TRPA). TRPA used a travel demand model to estimate
both 2010 and 2020 AADT under five development scenarios. The State
used the difference between the AADT for 2010 and 2020 to develop
onroad emissions inventories from 2011 to 2024 for the five TRPA
development scenarios, resulting in a ``least-conservative'' and a
``most-conservative'' projection of emissions in 2024.
    Table 4 is the summary of mobile source emissions inventories
between 2001 and 2024, contained in the 2016 supplement. See 2016
supplement, Appendix A, page A-6. As shown in Table 4, the State
estimates both that emissions in 2011 were 23 percent lower than in
2001, and that emissions in 2024 are projected to be between 13 percent
and 25 percent lower than in 2001. These declining emissions levels are
consistent with the traffic-based methodology the State chose for its
surrogate method to monitor air quality in the Area.

                                          Table 4--Lake Tahoe Nevada Area CO Season Mobile Emissions Inventory
                                                                     [Tons per year]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Year                         2001            2002            2005            2008            2011           2024LC          2024MC
--------------------------------------------------------------------------------------------------------------------------------------------------------
Onroad Emissions........................           5,832           5,832           5,766           3,496           4,529           4,396           5,089
Nonroad Emissions.......................             375             375             323             252             207             178             190
Total Emissions.........................           6,207           6,207           6,089           3,748           4,736           4,574           5,279
--------------------------------------------------------------------------------------------------------------------------------------------------------
Key: LC = least conservative; MC = most conservative.
Source: 2016 supplement, page A-6.

    The EPA finds that the attainment emissions inventory in the 2012
plan, as amended by the 2016 supplement, is adequate.

D. Maintenance Demonstration

    We consider the maintenance demonstration requirement to be
satisfied for areas that qualify for and use the LMP option.\20\ As
mentioned above, a maintenance area is qualified to use the LMP option
if that area's maximum 8-hour CO design value for eight consecutive
quarters does not exceed 7.65 ppm (85 percent of the CO NAAQS). EPA
maintains that if an area begins the maintenance period with a design
value no greater than 7.65 ppm, the combination of prevention of
significant deterioration permit requirements, the control measures
already in the SIP, and federal measures should provide adequate
assurance of maintenance over the 10-year maintenance period.
Therefore, the EPA does not require areas using the LMP option to
project emissions over the maintenance period. Because CO design values
in the Lake Tahoe Nevada Area are consistently well below the LMP
threshold (see Table 1), the EPA finds that the State has adequately
demonstrated that the Area will continue to maintain the CO NAAQS in
the future.
---------------------------------------------------------------------------

    \20\ See CO LMP guidance, page 3.
---------------------------------------------------------------------------

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. See CAA section 176(c)(1)(B). The
EPA's conformity rule at 40 CFR part 93, subpart A requires that
transportation plans, programs and projects conform to SIPs and
establish the criteria and procedures for determining whether or not
they conform. To effectuate its purpose, the conformity rule generally
requires a demonstration that emissions from the Regional
Transportation Plan (RTP) and the Transportation Improvement Program
(TIP) are consistent with the MVEB contained in the control strategy
SIP revision or maintenance plan. See 40 CFR 93.101, 93.118, and
93.124. An MVEB is defined as the level of mobile source emissions of a
pollutant relied upon in the attainment or maintenance demonstration to
attain or maintain compliance with the NAAQS in the nonattainment or
maintenance area.\21\
---------------------------------------------------------------------------

    \21\ Further information concerning the EPA's interpretations
regarding MVEBs can be found in the preamble to the EPA's November
24, 1993, transportation conformity rule. See 58 FR 62193--62196
(November 24, 1993).
---------------------------------------------------------------------------

    However, under the CO LMP guidance and the EPA's conformity rule,
budgets are treated as essentially not constraining for the length of
the maintenance period. While the guidance does not exempt an area from
the need to determine conformity, it explains that the area may
demonstrate conformity without submitting a MVEB because it is
unreasonable to expect that an LMP area will experience so much growth
in that period that a violation of the CO NAAQS would result.\22\
Therefore, for the Lake Tahoe Nevada Area, all actions that require
conformity determinations for CO under our conformity rule provisions
are considered to have already satisfied the regional emissions
analysis and budget test requirements in 40 CFR 93.118.\23\ However,
since 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
determinations, RTPs, TIPs and projects must still demonstrate that
they are fiscally constrained (see 40 CFR 93.108) and that they meet
the criteria for consultation and Transportation Control Measure
implementation (see 40 CFR 93.112 and 40 CFR 93.113, respectively). In
addition, projects in LMP areas are required to meet the applicable
criteria for CO hot spot analyses to satisfy project level conformity
determinations (see 40 CFR 93.116 and 40 CFR 93.123), which must also
incorporate the latest planning assumptions and models available (see
40 CFR 93.110 and 40 CFR 93.111, respectively).\24\
---------------------------------------------------------------------------

    \22\ See CO LMP guidance, p. 4. See also 69 FR 40004, page 40063
(July 1, 2004), explaining revisions to make the conformity rule
consistent with the EPA's existing limited maintenance plan
policies.
    \23\ See 40 CFR 93.109(e).
    \24\ See 40 CFR 93.109(b), Table 1.
---------------------------------------------------------------------------

    Our approval of the 2012 plan, as amended by the 2016 supplement,
effectively affirms our adequacy finding \25\ such that no regional
emissions analyses for future transportation CO conformity
determinations are required for the CO LMP period and beyond. The other
transportation conformity requirements listed above continue to apply.
---------------------------------------------------------------------------

    \25\ See 68 FR 69611 (December 15, 2003).
---------------------------------------------------------------------------

F. Ambient Air Quality Monitoring Network

    As noted previously, the EPA is approving the State's surrogate
monitoring method for the Lake Tahoe Nevada Area as part of this
action. We conclude that this method is adequate to verify continued
attainment of the CO NAAQS in the Lake Tahoe Nevada Area. Accordingly,
we find that the 2012 plan contains adequate monitoring provisions.
    Prior to making their submittal of the 2012 plan, the State ran a
CO monitoring network that consisted of the Harvey's monitor. The State
provided ANPs to the EPA according to requirements in 40 CFR part
58.\26\ The EPA approved these ANPs.\27\ The EPA also performed
Technical System

Audits (TSAs) on a periodic basis. The last TSA the EPA performed for
NDEP that included CO was in 2011 (``2011 TSA Report'').\28\ In the
2011 TSA Report, the EPA made no findings specific to CO.\29\
---------------------------------------------------------------------------

    \26\ There are four ANPs relevant to this action, covering each
of the three years prior to submittal of the 2012 plan, as well as
the year 2012, the last year that the State monitored CO in the
Area. See NDEP's ANPs for years 2009, 2010, 2011 and 2012.
    \27\ The EPA sent NDEP approval letters pertaining to 2009,
2010, 2011 and 2012 ANPs. See letters from Joseph Lapka, Acting
Chief, Air Quality Analysis Office, U.S. EPA Region 9 Air Division,
to Leo Drozdoff, Administrator, NDEP, dated October 30, 2009; from
Matthew Lakin, Air Quality Analysis Office, U.S. EPA Region 9 Air
Division, to Greg Remer, Chief, Bureau of Air Quality Planning,
NDEP, dated November 1, 2010; from Matthew Lakin, Air Quality
Analysis Office, U.S. EPA Region 9 Air Division, to Rob Bamford,
Chief, Bureau of Air Quality Planning, NDEP, dated November 1, 2011;
and from Matthew Lakin, Air Quality Analysis Office, U.S. EPA Region
9 Air Division, to Rob Bamford, Chief, Bureau of Air Quality
Planning, NDEP, dated February 28, 2013, respectively.
    \28\ The EPA's final TSA prior to CO monitor discontinuation was
performed in 2011. See letter and 2011 TSA Report enclosure from
Deborah Jordan, Director, U.S. EPA Region 9 Air Division, to Colleen
Cripps, Administrator, NDEP, dated August 1, 2013.
    \29\ Ibid, p. 24.
---------------------------------------------------------------------------

G. Verification of Continued Attainment

    The CO LMP guidance indicates that an LMP should contain provisions
for continued operation of ``an appropriate, EPA-approved air quality
monitoring network'' in the maintenance area, in accordance with 40 CFR
part 58 (the EPA's air quality monitoring regulations). The guidance
explains that verifying continued maintenance is especially important
for an LMP since the area will not have a cap on emissions.\30\
---------------------------------------------------------------------------

    \30\ See CO LMP guidance, p. 4, section c, ``Monitoring Network/
Verification of Continued Attainment.''
---------------------------------------------------------------------------

    The Lake Tahoe Nevada Area has discontinued air quality monitoring
for CO. In today's action, the EPA is approving, in accordance with
part 58, a surrogate CO monitoring method that relies on traffic
counts. Since 2012, when air quality monitoring was discontinued,
reports for traffic counts in the Area have shown no significant (25
percent or greater) increase. The State commits to maintaining
readiness of the Harvey's monitoring site during the maintenance
period, in case air monitoring is triggered by traffic counts. The
State further has provided a decision matrix for continued operation of
the monitor, in the event that either CO concentrations or traffic
counts are elevated, in order to ensure both that any violation of the
CO NAAQS is monitored directly, as well as to ensure that contingency
measures are implemented at the level approved in the first 10-year
maintenance plan, at 85 percent of the NAAQS. The State has already
commenced, and commits to continue during the maintenance period,
reporting annually to the EPA the traffic counts in north and south
portions of the Area. The EPA therefore determines that the LMP
satisfies this element of the CO LMP guidance.

H. Contingency Plan

    Section 175A(d) of the CAA requires that a maintenance plan include
contingency provisions, as necessary, to promptly correct any violation
of the NAAQS that occurs after redesignation of an area. Under 175A(d),
contingency measures do not have to be fully adopted at the time of
redesignation. However, the contingency plan is considered to be an
enforceable part of the SIP and should ensure that the contingency
measures are adopted expeditiously once they are triggered by a
specific event. The EPA's CO LMP guidance recommends that, to meet the
contingency plan requirement, a state should identify appropriate
contingency measures along with a schedule for the development and
implementation of such measures.\31\
---------------------------------------------------------------------------

    \31\ See CO LMP guidance, p. 4, section d, ``Contingency Plan.''
---------------------------------------------------------------------------

    The State's contingency plan for the Area was approved in the first
10-year LMP. Section 4 of the 2012 plan addresses a contingency plan
for the Area for the second 10-year maintenance period. However, the
2016 supplement requests that the EPA replace section 4 of the 2012
plan with a paragraph in section II of the 2016 supplement. Section II,
``Revision to Section 4 of the 2012 CO LMP,'' indicates that the
contingency plan in the first 10-year maintenance plan will apply for
the second 10-year maintenance period.
    The contingency plan in the first 10-year maintenance plan contains
a detailed, multi-step process for addressing any potential CO NAAQS
violations. First, the plan provides a triggering mechanism through
which NDEP will determine when a pre-violation action level is reached.
Second, the plan spells out the procedures that will be followed if the
pre-violation action level is reached, including activation of a multi-
agency Conformity Task Force, analysis of monitoring data and
development of recommendations for action. Finally, the plan provides
for these recommendations to be implemented by NDEP and/or the
appropriate local jurisdictions in the Area, all of which have
committed to implementing expeditiously any and all measures necessary
to achieve emissions reductions needed to maintain the CO NAAQS.\32\
---------------------------------------------------------------------------

    \32\ As we noted in our approval of the first 10-year
maintenance plan, the following local jurisdictions have passed
resolutions promising to adhere to the provisions of the contingency
plan in the 2003 Lake Tahoe Nevada Limited Maintenance Plan: The
Tahoe Metropolitan Planning Organization, the Washoe County District
Health Department and the State of Nevada Department of
Transportation, which is a participant in the Interagency
Consultation Procedures established by the Tahoe Metropolitan
Planning Organization. See 68 FR 69611, 69615, footnote 4.
---------------------------------------------------------------------------

    We find that the contingency plan the EPA approved in the first 10-
year LMP, which the State indicates in the 2016 supplement will
continue to apply during the second 10-year maintenance period, is
sufficient to meet the requirements of section 175A(d) of the CAA and
the CO LMP guidance.

III. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, the EPA is fully
approving the State of Nevada's second 10-year maintenance plan for the
Area, titled ``2012 Revision to the Nevada State Implementation Plan:
Updated Limited Maintenance Plan for the Nevada Side of the Lake Tahoe
Basin, Including Douglas, Carson City and Washoe Counties,'' submitted
to the EPA on April 3, 2012, and as amended by a submittal on August
26, 2016, titled ``2016 Supplement to Nevada's 2nd 10-Year Maintenance
Plan at Lake Tahoe.''
    Consistent with the State's request in the 2016 supplement, we are
approving two sections of the 2016 supplement as revisions to the 2012
plan and therefore take no action on the original, 2012 versions of
those sections. First, we are not acting on section 3.2.4 of the 2012
plan, containing the State's alternative CO monitoring strategy and
contingency plan, because we are instead approving into the SIP the
revised section 3.2.4 included in the 2016 supplement, still titled
``3.2.4 Surrogate Method for Tracking CO Concentrations.'' Second, we
are not acting on section 4 of the 2012 plan, titled ``4. Contingency
Measures,'' because we are instead approving into the SIP the revised
section 4 included in the 2016 supplement, titled ``II. Revision to
Section 4 of the 2012 CO LMP.''
    Other parts of the 2016 supplement that we are approving are the
2011 emissions inventory and 2024 projected emissions inventory (i.e.,
Attachment A, titled ``Mobile Source Emissions Inventory and Future
Year Projections for the 2012 Lake Tahoe Basin Carbon Monoxide Limited
Maintenance Plan''), evidence of public participation (i.e., Attachment
B, titled ``Evidence of Public Participation'') and revised table of
contents for the 2012 submittal (i.e., Attachment F, titled
``Replacement for 2012 CO LMP Contents Page'').
    Also consistent with the State's request in the 2016 supplement,
our approval takes no action on the 2016 supplement's Attachments C, D
and E, titled respectively ``Statistical Support for Criteria Used to
Determine Whether to Continue CO Monitoring,'' ``Surrogate Method
Report for Tracking Carbon Monoxide at Lake Tahoe, Nevada, 2011-2015,''
and ``Inventory Preparation Plan for the Mobile Source Emissions
Inventory and Future Year Projections for the 2012 Lake Tahoe Basin
Carbon

Monoxide Limited Maintenance Plan.'' These three attachments each have
header text that includes the statement ``Not for inclusion in Nevada's
SIP.''
    We do not think anyone will object to these approvals, so we are
finalizing them without proposing them in advance. However, in the
Proposed Rules section of this Federal Register, we are simultaneously
proposing approval of the same submitted plans. If we receive adverse
comments by April 10, 2017, we will publish a timely withdrawal in the
Federal Register to notify the public that the direct final approval
will not take effect and we will address the comments in a subsequent
final action based on the proposal. If we do not receive timely adverse
comments, the direct final approval will be effective without further
notice on May 9, 2017.
    This action incorporates the 2012 plan, as amended by the 2016
supplement, and specific portions of the 2016 supplement itself, into
the federally enforceable SIP. Together, these two submittals meet the
applicable CAA requirements, and the EPA has determined they are
sufficient to provide for maintenance of the CO NAAQS over the course
of the second 10-year maintenance period through 2024.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. See 42 U.S.C. 7410(k) and 40 CFR 52.02(a). Thus,
in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. Accordingly,
this action merely approves state law as meeting federal requirements
and does not impose additional requirements beyond those imposed by
state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866
(see 58 FR 51735, October 4, 1993) and 13563 (see 76 FR 3821, January
21, 2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (see 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 (see 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 (see Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (see 64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (see 62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (see 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 (see 15 U.S.C.
272 note) because application of those requirements would be
inconsistent with the Clean Air Act; and
     does not provide the 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 (see 59 FR 7629, February 16,
1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175. See 65 FR 67249 (November 9,
2000).
    The Congressional Review Act (see 5 U.S.C. 801 et seq.), as added
by the Small Business Regulatory Enforcement Fairness Act of 1996,
generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. The EPA will submit a report containing
this action and other required information to the U.S. Senate, the U.S.
House of Representatives, and the Comptroller General of the United
States prior to publication of the rule in the Federal Register. A
major rule cannot take effect until 60 days after it is published in
the Federal Register. This action is not a ``major rule'' as defined by
5 U.S.C. 804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by May 9, 2017. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. Parties with objections to this direct final
rule are encouraged to file a comment in response to the parallel
notice of proposed rulemaking for this action published in the Proposed
Rules section of today's Federal Register, rather than file an
immediate petition for judicial review of this direct final rule, so
that the EPA can withdraw this direct final rule and address the
comment in the proposed rulemaking. This action may not be challenged
later in proceedings to enforce its requirements. See CAA section
307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements.

    Dated: December 22, 2016.
Deborah Jordan,
Acting Regional Administrator, Region IX.
    Chapter I, title 40 of the Code of Federal Regulations is amended
as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart DD--Nevada

0
2. In Sec.  52.1470, paragraph (e) is amended by adding, under the
table heading ``Air Quality Implementation Plan for the State of
Nevada,'' two entries ``2012 Revision to the Nevada State
Implementation Plan for Carbon Monoxide, April 2012'' and ``2016
Supplement to Nevada's 2nd 10-Year CO Limited Maintenance Plan at Lake
Tahoe, August 26, 2016'' after the entry ``Addendum to the October 27,
2003 letter of transmittal of the redesignation request and maintenance
plan,'' to read as follows:

Sec.  52.1470  Identification of plan.

* * * * *
    (e) * * *

                   EPA-Approved Nevada Nonregulatory Provisions and Quasi-Regulatory Measures
----------------------------------------------------------------------------------------------------------------
                                     Applicable
     Name of SIP provision          geographic or         State       EPA approval date        Explanation
                                 nonattainment area  submittal date
----------------------------------------------------------------------------------------------------------------
                           Air Quality Implementation Plan for the State of Nevada \1\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
2012 Revision to the Nevada      Nevada portion of         4/3/2012  [Insert Federal     Adopted on 4/3/2012.
 State Implementation Plan for    Lake Tahoe Basin--                  Register            Approval excludes
 Carbon Monoxide, April 2012.     portions of                         citation] 3/10/     sections 3.2.4 and 4.
                                  Carson City,                        2017).              With 2016 supplement,
                                  Douglas and                                             fulfills requirement
                                  Washoe counties.                                        for second ten-year
                                                                                maintenance plan.
2016 Supplement to Nevada's 2nd  Nevada portion of        8/26/2016  [Insert Federal     Adopted on 8/26/2016.
 10-Year CO Limited Maintenance   Lake Tahoe Basin--                  Register            Approval includes
 Plan at Lake Tahoe, August 26,   portions of                         citation] (3/10/    revised sections 3.2.4
 2016.                            Carson City,                        2017).              and 4 (alternative CO
                                  Douglas and                                             monitoring strategy
                                  Washoe counties.                                        and contingency plan),
                                                                                2011 emissions
                                                                                inventory and 2024
                                                                                projected emissions
                                                                                inventory (Attachment
                                                                                A), evidence of public
                                                                                participation
                                                                                (Attachment B) and
                                                                                revised table of
                                                                                contents for 2012
                                                                                submittal (Attachment
                                                                                F). Excludes
                                                                                Attachments C, D and
                                                                                E.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
 * * * * * * *
\1\ The organization of this table generally follows from the organization of the State of Nevada's original
  1972 SIP, which was divided into 12 sections. Nonattainment and maintenance plans, among other types of plans,
  are listed under Section 5 (Control Strategy). Lead SIPs and Small Business Stationary Source Technical and
  Environmental Compliance Assistance SIPs are listed after Section 12 followed by nonregulatory or quasi-
  regulatory statutory provisions approved into the SIP. Regulatory statutory provisions are listed in 40 CFR
  52.1470(c).

[FR Doc. 2017-04771 Filed 3-9-17; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: November 30, 2007 (Volume 72, Number 230)]
[Notices]
[Page 67765-67767]
[DOCID:fr30no07-95]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 7d-1; SEC File No. 270-176; OMB Control No. 3235-0311

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission
(``Commission'') has submitted to the Office of Management and Budget a
request for extension of the previously approved collection of
information discussed below.
    Section 7(d) of the Investment Company Act of 1940 (15 U.S.C. 80a-
7(d)) (the ``Act'' or ``Investment Company Act'') requires an
investment company (``fund'') organized outside the United States
(``foreign fund'') to obtain an order from the Commission allowing the
fund to register under the Act before making a public offering of its
securities through the United States mail or any means of interstate
commerce. The Commission may issue an order only if it finds that it is
both legally and practically feasible effectively to enforce the
provisions of the Act against the foreign fund, and that the
registration of the fund is consistent with the public interest and
protection of investors.
    Rule 7d-1 (17 CFR 270.7d-1) under the Act, which was adopted in
1954, specifies the conditions under which a Canadian management
investment company (``Canadian fund'') may request an order from the
Commission permitting it to register under the Act. Although rule 7d-1
by its terms applies only to Canadian funds, other foreign funds
generally have agreed to comply with the requirements of rule 7d-1 as a
prerequisite to receiving an order permitting the foreign fund's
registration under the Act.
    The rule requires a Canadian fund proposing to register under the
Act to file an application with the Commission that contains various
undertakings and agreements of the fund. Certain of these undertakings
and agreements, in turn, impose the following additional information
collection requirements:
    (1) The fund must file agreements between the fund and its
directors, officers, and service providers requiring them to comply
with the fund's charter and bylaws, the Act, and certain other

obligations relating to the undertakings and agreements in the
application;
    (2) The fund and each of its directors, officers, and investment
advisers that is not a U.S. resident, must file an irrevocable
designation of the fund's custodian in the United States as agent for
service of process;
    (3) The fund's charter and bylaws must provide that (a) the fund
will comply with certain provisions of the Act applicable to all funds,
(b) the fund will maintain originals or copies of its books and records
in the United States, and (c) the fund's contracts with its custodian,
investment adviser, and principal underwriter, will contain certain
terms, including a requirement that the adviser maintain originals or
copies of pertinent records in the United States;
    (4) The fund's contracts with service providers will require that
the provider perform the contract in accordance with the Act, the
Securities Act of 1933 (15 U.S.C. 77a-77z-3), and the Securities
Exchange Act of 1934 (15 U.S.C. 78a-78mm), as applicable; and
    (5) The fund must file, and periodically revise, a list of persons
affiliated with the fund or its adviser or underwriter.
    Under section 7(d) of the Act the Commission may issue an order
permitting a foreign fund's registration only if the Commission finds
that ``by reason of special circumstances or arrangements, it is both
legally and practically feasible effectively to enforce the provisions
of the (Act).'' The information collection requirements are necessary
to assure that the substantive provisions of the Act may be enforced as
a matter of contract right in the United States or Canada by the fund's
shareholders or by the Commission.
    Certain information collection requirements in rule 7d-1 are
associated with complying with the Act's provisions. These information
collection requirements are reflected in the information collection
requirements applicable to those provisions for all registered funds.
    The Commission believes that one fund is registered under rule 7d-1
and currently active. Apart from requirements under the Act applicable
to all registered funds, rule 7d-1 imposes ongoing burdens to maintain
records in the United States, and to update, as necessary, the foreign
fund's list of affiliated persons. The Commission staff estimates that
the active registrant makes one response each year under the rule
update its list of affiliated persons.\1\ Commission staff estimates
that the response to update the list of affiliated persons requires 2
hours of compliance clerk time at a cost of $56 per hour, for a total
annual burden of 2 hours at a cost of $112.\2\ The estimated number of
2 burden hours is a reduction of 23.25 hours from the current
allocation. The reduction is a result of the registrant's elimination
of duplicative records in the United States. All of the registrant's
records are only maintained in the United States.
---------------------------------------------------------------------------

    \1\ The rule requires an applicant to maintain records in the
United States (which, without the requirement, could be available
only in Canada or another foreign jurisdiction), which facilitates
routine inspections and any special investigations of the fund by
Commission staff. The registrant, however, only maintains its
records in the United States and in no other jurisdiction.
Therefore, the registrant's maintenance of records in the United
States does not impose an additional burden beyond the fund's
compliance with the Act's requirements. This recordkeeping
requirement is reflected in the information collection burdens
applicable to those requirements for all registered funds.
    \2\ The $56/hour figure for a Compliance Clerk is from the SIA
Report on Office Salaries in the Securities Industry 2006, modified
to account for an 1800-hour work-year and multiplied by 2.93 to
account for bonuses, firm size, employee benefits and overhead.
---------------------------------------------------------------------------

    If a foreign fund were to file an application under the rule, the
Commission estimates that the rule would impose initial information
collection burdens (for filing an application, preparing the specified
charter, bylaw, and contract provisions, designations of agents for
service of process, and an initial list of affiliated persons, and
establishing a means of keeping records in the United States) of
approximately 90 hours for the fund and its associated persons. The
Commission is not including these hours in its calculation of the
annual burden because no fund has applied under rule 7d-1 to register
under the Act in the last three years.
    After registration, a foreign fund may file a supplemental
application seeking special relief designed for the fund's particular
circumstances. Because rule 7d-1 does not mandate these applications
and the fund determines whether to submit an application, the
Commission has not allocated any burden hours for these applications.
    These estimates of average burden hours are made solely for the
purposes of the Paperwork Reduction Act. The estimate is not derived
from a comprehensive or even a representative survey or study of
Commission rules.
    If a Canadian or other foreign fund in the future applied to
register under the Act under rule 7d-1, the fund initially might have
capital and start-up costs (not including hourly burdens) of an
estimated $17,280 to comply with the rule's initial information
collection requirements. These costs include legal and processing-
related fees for preparing the required documentation (such as the
application, charter, bylaw, and contract provisions), designations for
service of process, and the list of affiliated persons. Other related
costs would include fees for establishing arrangements with a custodian
or other agent for maintaining records in the United States, copying
and transportation costs for records, and the costs of purchasing or
leasing computer equipment, software, or other record storage equipment
for records maintained in electronic or photographic form.
    The Commission expects that a foreign fund and its sponsors would
incur these costs immediately, and that the annualized cost of the
expenditures would be $17,280 in the first year. Some expenditures
might involve capital improvements, such as computer equipment, having
expected useful lives for which annualized figures beyond the first
year would be meaningful. These annualized figures are not provided,
however, because, in most cases, the expenses would be incurred
immediately rather than on an annual basis. The Commission is not
including these costs in its calculation of the annualized capital/
start-up costs because no investment company has applied under rule 7d-
1 to register under the Act pursuant to rule 7d-1 in the last three
years.
    These estimates of average costs are made solely for the purposes
of the Paperwork Reduction Act. The estimate is not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. Please direct general comments
regarding the above information to the following persons: (i) Desk
Officer for the Securities and Exchange Commission, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503 or e-mail to<EMAIL_ADDRESS>and
(ii) R. Corey Booth, Director/Chief Information Officer, Securities and
Exchange Commission, C/O Shirley Martinson, 6432 General Green Way,
Alexandria, VA 22312; or send an e-mail to<EMAIL_ADDRESS>
Comments must be submitted to OMB within 30 days of this notice.

    Dated: November 26, 2007.
Nancy M. Morris,
Secretary.
[FR Doc. E7-23208 Filed 11-29-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Notices]
[Pages 27236-27238]
[FR Doc No: 2012-11112]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0475]

Daphne I. Panagotacos; Denial of Hearing; Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying a request
for a hearing submitted by Daphne I. Panagotacos and is issuing an
order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
debarring Panagotacos for 5 years from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Panagotacos was
convicted of a misdemeanor under Federal law for conduct relating to
the regulation of a drug product under the FD&C Act and that the type
of conduct underlying the conviction undermines the process for the
regulation of drugs. In determining the appropriateness and period of
Panagotacos's debarment, FDA has considered the relevant factors listed
in the FD&C Act. Panagotacos has failed to file with the Agency
information and analyses sufficient to create a basis for a hearing
concerning this action.

DATES: The order is effective May 9, 2012.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: G. Matthew Warren, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 4210, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 18, 2007, the United States District Court for the
Central District of California entered judgment against Panagotacos, a
physician, who pled guilty to a misdemeanor under the FD&C Act.
Specifically, Panagotacos pled guilty to receiving in interstate
commerce and delivering a misbranded drug in violation of sections
301(c), 502(f) and 303(a)(1) of the FD&C Act (21 U.S.C. 331(c), 352(f),
333(a)(1)). The basis for this conviction was conduct surrounding her
injection of patients with TRI-toxin, an unapproved drug product
purported to be botulinum toxin type A and distributed by Toxic
Research International, Inc. (TRI), in Arizona. According to the
records of the criminal proceedings, from January 2004 until November
2004, Panagotacos ordered 19 vials of TRI-toxin for her practice in
California and used the TRI-toxin on herself, her employees, and her
patients. As alleged in the criminal information to which she pled
guilty, the TRI-toxin was misbranded in that it failed to bear adequate
directions for use under section 502(f) of the FD&C Act.
    Panagotacos is subject to debarment based on a finding, under
section 306(b)(2)(B)(i) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)),
(1) that she was convicted of a misdemeanor under Federal law relating
to the regulation of a drug product under the FD&C Act and (2) that the
type of conduct underlying the conviction undermines the process for
the regulation of drugs. By letters dated February 22, 2011, and March
14, 2011, FDA notified Panagotacos of a proposal to debar her for 5
years from providing services in any capacity to a person having an
approved or pending drug product application. In a letter dated April
11, 2011, through counsel, Panagotacos requested a hearing on the
proposal. In her request for a hearing, Panagotacos acknowledges the
fact of her conviction under Federal law, as alleged by FDA. However,
she argues that the conduct underlying her conviction does not warrant
debarment.
    Hearings are granted only if there is a genuine and substantial
issue of fact. Hearings will not be granted on issues of policy or law,
on mere allegations, denials, or general descriptions of positions and
contentions, or on data and information insufficient to justify the
factual determination urged (see 21 CFR 12.24(b)).
    The Chief Scientist and Deputy Commissioner for Science and Public
Health has considered Panagotacos's arguments and concludes that they
are unpersuasive and fail to raise a genuine and substantial issue of
fact requiring a hearing.

II. Arguments

    In support of her hearing request, Panagotacos first disputes the
finding in the proposal to debar her that her misdemeanor conviction
was based on conduct related to the regulation of drug products under
the FD&C Act and that the conduct underlying her conviction undermined
the process for the regulation of drugs. In support of this argument,
Panagotacos asserts that her conviction under the FD&C Act was strict
liability and that, based on assurances from TRI, she acted on the good
faith belief that that TRI-toxin was a permissible generic form of
BOTOX/BOTOX Cosmetic (BOTOX). As noted in this document, however,
Panagotacos admitted, during her criminal proceedings, to receiving a
misbranded drug in interstate commerce and delivering it to patients in
violation of sections 301(c), 502(f) and 303(a)(1) of the FD&C Act.
    Her conduct clearly related to the regulation of drug products
under the FD&C Act because it was in direct violation of the FD&C Act's
requirements for drug products. The conduct also undermined the process
for the regulation of drugs in that it permitted an unapproved drug,
TRI-toxin, to be administered to patients. With respect to
Panagotacos's assertion that her offense was strict liability, section
306(b)(2)(B)(i) of the FD&C Act specifically provides for the debarment
of individuals convicted of Federal misdemeanors related to the
regulation of drug products under the FD&C Act. Given that a
misdemeanor violation of the FD&C Act itself is a strict liability
offense for which lack of criminal intent is no defense, criminal
intent is not required to subject an individual to debarment under
section 306(b)(2)(B)(i). Accordingly, Panagotacos is subject to
debarment under section 306(b)(2)(B)(i).
    Panagotacos next challenges the manner in which the proposal to
debar applied the considerations under section 306(c)(3) of the FD&C
Act in determining the appropriateness and period of her debarment.
Section 306(c)(3) of the FD&C Act explicitly requires FDA to consider,
``where applicable,'' certain factors ``[i]n determining the
appropriateness and the period of debarment'' for any permissive
debarment. The proposal to debar Panagotacos set forth four applicable
considerations under section 306(c)(3): (1) The nature and seriousness
of her offense under section 306(c)(3)(A); (2) the nature and extent of
management participation in the offense under section 306(c)(3)(B); (3)
the nature and extent of voluntary steps taken to mitigate the impact
on the public under section 306(c)(3)(C); and (4) prior convictions
involving matters within the jurisdiction of FDA under section
306(c)(3)(F). In the proposal, FDA found that the first two
considerations weigh in favor of debarring Panagotacos and noted that
the third and fourth considerations would be treated as favorable
factors for Panagotacos. In making all of its findings under section
306(c)(3), FDA relied on records from Panagotacos's criminal
proceedings.
    Panagotacos first challenges the finding in the proposal to debar
her that the nature and seriousness of her offense, under section
306(c)(3)(A) of the FD&C Act, weigh in favor of debarment. She argues
that ``[t]he nature and seriousness of the offense are in fact a
favorable factor based on [her] diligent efforts to ascertain the truth
and the plain evidence that she herself was a victim of fraud.''
Panagotacos's characterization of the conduct underlying her conviction
is refuted by the criminal record. Her admissions during her criminal
proceedings do not demonstrate that the nature and seriousness of her
offense is a favorable factor because she made ``diligent efforts to
ascertain the truth'' or because TRI made her a ``victim of fraud.''
    The charge in the information to which Panagotacos pled guilty
alleged that she ordered a misbranded drug from a source outside of her
own state and used it on her patients. In a sentencing memorandum
submitted to the criminal court on her behalf, Panagotacos also stated
that she ``and her staff talked to representatives from TRI and were
told that [TRI-toxin] was a safe generic form of [BOTOX] and that FDA
approval was pending''. In the same sentencing memorandum, she also
admitted to trying TRI-toxin on herself and on her staff and family to
determine it was safe and effective before using it on patients. In a
letter submitted in support of that memorandum, she further stated that
``the label on the bottle [of TRI-toxin] said that it was for research
purposes only.'' In light of Panagotacos's admissions during her
criminal proceedings that she knew TRI-toxin was an unapproved drug
warranting further testing before she used it on her regular patients,
the Chief Scientist and Deputy Commissioner for Science and Public
Health finds, consistent with the proposal to debar, that the nature
and seriousness of her offense weigh in favor of debarment.
Panagotacos's mere assertion that TRI provided different information
and convinced her that TRI-toxin was a

permissible generic form of BOTOX does not create a genuine and
substantial issue of fact.
    In her request for a hearing, Panagotacos further emphasizes that
she not only stopped using TRI-toxin upon learning that TRI was being
prosecuted for conduct related to its marketing of the drug product,
she also took ``the extraordinary step'' of coming ``forward
proactively to assist the investigation by providing information''
before she was contacted by investigators. Indeed, the criminal record
discloses that she sent a letter to the prosecutor in which she stated
that TRI had convinced her to purchase and use TRI-toxin on her
patients but that she had stopped using the drug and was returning the
product to TRI. She also offered in the letter to provide information
to the prosecutor. In the Agency's proposal to debar, however, FDA took
into account the circumstances Panagotacos now cites and considered her
cooperation with government investigators as a favorable factor under
section 306(c)(3)(C) of the FD&C Act. Therefore, her arguments
affirming the circumstances and extent of her cooperation do not create
a genuine and substantial issue of fact suitable for a hearing.
    Panagotacos next challenges the manner in which FDA weighed the
four factors that the Agency considered in the proposal to debar. She
notes that, although FDA counted two of the four factors in her favor,
it appears that the Agency did not take them into account because the
proposal to debar found that she should be debarred for the maximum
period of 5 years. Consistent with the proposal to debar, however,
Panagotacos pled guilty to a misdemeanor under the FD&C Act for conduct
related to her knowing purchase and use of an unapproved drug on her
patients. She did so as a licensed physician with her own medical
practice and thus held a position of authority relative to the offense
of which she was convicted. The considerations in sections 306(c)(3)(A)
and (B) of the FD&C Act weigh in favor of debarring Panagotacos for a
maximum period of 5 years. Although the record establishes that
Panagotacos took voluntary steps to mitigate the effect on the public
health once she learned that there was a criminal investigation
involving the company from which she purchased the unapproved drug (see
section 306(c)(3)(C)), and although she appears to have no previous
criminal convictions related to matters within the jurisdiction of FDA
(see section 306(c)(3)(F)), these considerations do not counter to a
sufficient degree the conduct underlying her misdemeanor conviction to
warrant decreasing the period of debarment from 5 years.

III. Findings and Order

    Therefore, the Chief Scientist and Deputy Commissioner for Science
and Public Health, under section 306(b)(2)(B)(i) of the FD&C Act and
under authority delegated to him, finds that Panagotacos has been
convicted of a misdemeanor under Federal law for conduct relating to
the development or approval of a drug product or otherwise relating to
the regulation of a drug product under the FD&C Act and that the
conduct underlying the conviction undermines the regulation of drugs.
The Chief Scientist has considered the relevant factors listed in
section 306(c)(3) of the FD&C Act and determined that a debarment of 5
years is appropriate.
    As a result of the foregoing findings, Panagotacos is debarred for
5 years from providing services in any capacity to a person with an
approved or pending drug product application under section 505, 512, or
802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351
of the Public Health Service Act (42 U.S.C. 262), effective May 9, 2012
(see 21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) and 21 U.S.C. 321(dd)).
Any person with an approved, or pending, drug product application who
knowingly uses the services of Panagotacos, in any capacity during her
period of debarment, will be subject to civil money penalties. If
Panagotacos, during her period of debarment, provides services in any
capacity to a person with an approved or pending drug product
application, she will be subject to civil money penalties. In addition,
FDA will not accept or review any abbreviated new drug applications
submitted by or with the assistance of Panagotacos during her period of
debarment.
    Any application by Panagotacos for termination of debarment under
section 306(d) of the FD&C Act should be identified with Docket No.
FDA-2010-N-0475 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Persons with access to the Internet may obtain documents in the Docket
at http://www.regulations.gov/.

    Dated: April 16, 2012.
Jesse L. Goodman,
Chief Scientist and Deputy Commissioner for Science and Public Health.
[FR Doc. 2012-11112 Filed 5-8-12; 8:45 am]
BILLING CODE 4160-01-P