[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Rules and Regulations]
[Pages 22425-22430]
[FR Doc No: 2013-08817]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-R09-OAR-2013-0104; FRL-9802-6]

Designation of Areas for Air Quality Planning Purposes; State of
Nevada; Total Suspended Particulate

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action to delete certain area
designations for total suspended particulate within the State of Nevada
because the designations are no longer necessary. These designations
relate to the attainment or unclassifiable areas for total suspended
particulate in Clark County as well as the following nonattainment
areas for total suspended particulate elsewhere within the State of
Nevada: Carson Desert, Winnemucca Segment, Lower Reese Valley, Fernley
Area, Mason Valley, and Clovers Area. EPA is taking this action under
the Clean Air Act.

DATES: This rule is effective on June 17, 2013, unless EPA receives
adverse comment by May 16, 2013. If adverse comments are received, EPA
will publish a timely withdrawal of the direct final rule in the
Federal Register informing the public that the rule will not take
effect.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2013-0104, by one of the following methods:
    1. Federal eRulemaking Portal: www.regulations.gov: Follow the on-
line instructions for submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Mail or deliver: Karina O'Connor (AIR-2), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at www.regulations.gov,
including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through www.regulations.gov or email.
www.regulations.gov is an ``anonymous access'' system, and EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send email directly to EPA, your email
address will be automatically captured and included as part of the
public comment. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region
IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section below.

FOR FURTHER INFORMATION CONTACT: Karina O'Connor, EPA Region IX, (775)
434-8176<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Statutory and Regulatory Background
II. EPA's Evaluation of the Effect of Deleting Certain TSP Area
Designations
    A. General Considerations
    B. Deletion of TSP Attainment or Unclassifiable Area
Designations in Clark County
    C. Deletion of TSP Nonattainment Area Designations for Carson
Desert, Winnemucca Segment, Lower Reese Valley, Fernley Area, Mason
Valley, and Clovers Area
III. Final Action and Request for Comment
IV. Statutory and Executive Order Reviews

I. Statutory and Regulatory Background

    On April 30, 1971 (36 FR 8186), pursuant to section 109 of the
Clean Air Act (``Act'' or CAA), as amended in 1970, EPA promulgated the
original National Ambient Air Quality Standards (NAAQS) for the
``criteria'' pollutants, which included carbon monoxide, hydrocarbons,
nitrogen dioxide, photochemical oxidant, sulfur dioxide, and
particulate matter. The original NAAQS for particulate matter was
defined in terms of a reference method that called for measuring
particulate matter up to a nominal size of 25 to 45 micrometers or
microns. This fraction of total ambient particulate matter is referred
to as ``total suspended particulate'' or TSP. Within nine months
thereafter, each State was required under section 110 of the 1970
amended Act to adopt and submit to EPA a plan, referred to as a State
Implementation Plan (SIP), which provides for the implementation,
maintenance, and enforcement of the NAAQS within each State. The State
of Nevada submitted its SIP on January 28,

1972, and EPA approved Nevada's original SIP submittal later that year.
See 37 FR 10842 (May 31, 1972).
    Generally, SIPs were to provide for attainment of the NAAQS within
three years after EPA approval of the plan. However, many areas of the
country did not attain the NAAQS within the statutory period. In
response, Congress amended the Act in 1977 to establish a new approach,
based on area designations, for attaining the NAAQS. Under section
107(d) of the 1977 amended Act, States were to make recommendations for
all areas within their borders as attainment, nonattainment, or
unclassifiable for each of the NAAQS, including TSP, and EPA was to
designate areas based on those recommendations, as modified if
appropriate. For Nevada, the State recommended, and EPA approved, the
use of hydrographic areas as the geographic basis for designating air
quality planning areas. See 67 FR 12474 (March 19, 2002). For the TSP
NAAQS, EPA designated the following areas in Nevada as
``nonattainment'': Las Vegas Valley [hydrographic area (HA)
212], Carson Desert (HA 101), Winnemucca Segment (HA
70), Lower Reese Valley (HA 59), Gabbs Valley (HA
122), Fernley Area (HA 76), Truckee Meadows (HA
87), Mason Valley (HA 108), and Clovers Area (HA
64). See 43 FR 8962, at 9012 (March 3, 1978). EPA designated
all other areas in Nevada as attainment or unclassifiable for the TSP
NAAQS. The area designations for air quality planning purposes in
Nevada under the Clean Air Act are codified at 40 CFR 81.329.
    Since the establishment of the original designations in 1978, EPA
has taken three actions directly related to the Nevada TSP
designations. In 1980, we redesignated Gabbs Valley (HA 122)
from nonattainment to unclassifiable for the TSP NAAQS. See 45 FR 35327
(May 27, 1980). Later that same year, we approved a request from the
State of Nevada to reduce the size of the Carson Desert TSP
nonattainment area (HA 101) thereby creating a new
unclassifiable TSP area known as Packard Valley (HA 101A). See
45 FR 46807 (July 11, 1980). In 2002, we deleted certain attainment and
unclassifiable area designations for TSP. See 67 FR 68769 (November 13,
2002).
    The Clean Air Act, as amended in 1977, required States to revise
their SIPs by January 1979 for all designated nonattainment areas. The
various local entities and the State of Nevada responded by developing
and submitting attainment plans for the TSP nonattainment areas, and in
1981, EPA approved these plans on condition that the State submit,
within a prescribed period of time, revisions to correct certain
deficiencies. See 46 FR 21758 (April 14, 1981). In 1982, we found that
the State had submitted the required revisions correcting the
identified deficiencies, and we revoked the conditions placed on our
approval of the TSP plans. See 47 FR 15790 (April 13, 1982).
    In 1987, EPA revised the NAAQS for particulate matter, eliminating
TSP as the indicator for the NAAQS and replacing it with the
``PM10'' indicator. See 52 FR 24634 (July 1, 1987).
PM10 refers to particles with an aerodynamic diameter less
than or equal to a nominal 10 microns. We indicated in the preamble to
our regulations implementing the then-new PM10 NAAQS that we
would consider deletion of TSP area designations once EPA had reviewed
and approved revised SIPs that include control strategies for the
PM10 NAAQS and once EPA had promulgated PM10
increments for the prevention of significant deterioration (PSD)
program. See 52 FR 24672, at 24682 (July 1, 1987).
    Under our regulations for implementing the revised particulate
matter NAAQS (i.e., the PM10 NAAQS), EPA did not designate
areas as nonattainment, attainment, or unclassifiable but categorized
areas into three groups, referred to as Group I, Group II, or Group
III. Group I areas were those that had a probability of not attaining
the PM10 NAAQS (based on existing TSP data) of at least 90%.
Group I areas were required to submit SIP revisions that contain full
PM10 control strategies including a demonstration of
attainment. See 52 FR 24672, at 24681 (July 1, 1987). We identified the
Las Vegas (HA 212) and Reno (HA 87, known as
``Truckee Meadows'') planning areas as Group I areas. See 52 FR 29383
(August 7, 1987) and 55 FR 45799 (October 31, 1990).
    Group II areas were those that had a probability of not attaining
the PM10 NAAQS of between 20% and 95% based on available TSP
data. Group II areas were not required to submit SIP revisions that
contained full PM10 control strategies but were required to
submit SIP revisions that included enforceable commitments to gather
PM10 ambient data, analyze and verify the ambient
PM10 data and report any PM10 exceedances to EPA,
and to revise the SIP if the exceedances constitute violations of the
PM10 NAAQS. We identified the Battle Mountain area as a
Group II area. See 52 FR 29383 (August 7, 1987). The Battle Mountain
area is located in north-central Nevada and includes Lower Reese River
Valley and Clovers Area as well as Boulder Flat to the east. In 1990,
EPA approved the ``committal SIP'' for PM10 for the Battle
Mountain area. See 55 FR 18110 (May 1, 1990).
    Group III areas were those that had a probability of not attaining
the PM10 NAAQS of less than 20%. For Group III areas, EPA
presumed that the existing SIP that had been developed to address the
TSP NAAQS would be adequate to demonstrate attainment and maintenance
of the PM10 NAAQS. All areas of Nevada, i.e., other than Las
Vegas, Reno, and Battle Mountain, as discussed above, were categorized
as Group III.
    The Clean Air Act was significantly amended in 1990. Under the 1990
amended Act, Congress replaced the PM10 regulatory approach
established by EPA in 1987 with the area designation concept and
designated former ``Group I'' areas and certain other areas as
nonattainment areas for PM10 by operation of law. See
section 107(d)(4)(B) of the Act. All other areas were designated
unclassifiable for PM10 by operation of law. As former
``Group I'' areas, the Las Vegas and Reno planning areas were
designated as nonattainment areas for PM10 by operation of
law. See 56 FR 11101 (March 15, 1991). The rest of the State of Nevada,
including the former Group II area, Battle Mountain, was designated as
unclassifiable for PM10. See 57 FR 56762 (November 30,
1992).
    The 1990 Act amendments also provided for the continued transition
from TSP to PM10. Specifically, section 107(d)(4)(B) states
in relevant part: ``Any designation for particulate matter (measured in
terms of total suspended particulates) that the Administrator
promulgated pursuant to this subsection (as in effect immediately
before November 15, 1990) shall remain in effect for purposes of
implementing the maximum allowable increases in concentrations of
particulate matter (measured in terms of total suspended particulates)
pursuant to section 163(b) of this title, until the Administrator
determines that such designation is no longer necessary for that
purpose.''
    Section 166(f) of the 1990 amended Act authorizes EPA to replace
the TSP increments with PM10 increments, and in 1993, EPA
promulgated the PM10 increments and revised the PSD
regulations accordingly. See 58 FR 31622 (June 3, 1993). In our June
1993 final rule, we indicated that the replacement of the TSP
increments with PM10 increments negates the need for the TSP
attainment or unclassifiable area designations to be retained. We also
indicated that we would delete such

TSP designations in 40 CFR part 81 upon the occurrence of, among other
circumstances, EPA's approval of a State's or local agency's revised
PSD program containing the PM10 increments. See 58 FR 31622,
at 31635 (June 3, 1993).
    In November 2002, we deleted the TSP attainment or unclassifiable
area designations throughout the State of Nevada, except for those in
Clark County. See 67 FR 68769 (November 13, 2002). In our November 2002
final rule, we did not delete any nonattainment area designations for
the TSP NAAQS. In today's action, we are deleting all of the remaining
TSP attainment or unclassifiable area designations in the State of
Nevada and are deleting all of the TSP nonattainment area designations
except for the Las Vegas planning area (i.e., HA 212, Las
Vegas Valley) and the Reno planning area (i.e., HA 87, Truckee
Meadows).\1\
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    \1\ In June 1992, the State of Nevada requested that we
reclassify the eight existing TSP nonattainment areas in Nevada to
``unclassifiable'' status. See letter from L.H. Dodgion,
Administrator, NDEP, to Daniel W. McGovern, Regional Administrator,
EPA Region IX, dated June 15, 1992. We believe that deletion of the
TSP nonattainment designations for the six areas addressed in this
action is administratively more efficient than redesignation of the
six areas to unclassifiable. We will consider deletion of the two
TSP area designations that will remain after our action today, i.e.,
the TSP designations for Las Vegas (HA 212, Las Vegas
Valley) and Reno (HA 87, Truckee Meadows), in future
rulemakings.
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II. EPA's Evaluation of the Effect of Deleting Certain TSP Area
Designations

A. General Considerations

    Consistent with section 107(d)(4)(B), we have considered the
continued necessity for retaining the remaining TSP area designations
in Nevada, and as discussed in more detail in the following
subsections, we have decided that the TSP attainment or unclassifiable
area designations we specifically retained in our November 2002 final
rule and the TSP nonattainment designations for Carson Desert (HA
101), Winnemucca Segment (HA 70), Lower Reese Valley
(HA 59), Fernley Area (HA 76), Mason Valley (HA
108), and Clovers Area (HA 64), are no longer
necessary. As a result, we are deleting them from the TSP table in 40
CFR 81.329.
    To evaluate whether the TSP area designations should be retained or
can be deleted, we have relied upon the final rule implementing the
PM10 NAAQS (see 52 FR 24634, July 1, 1987), a policy
memorandum on TSP redesignations (see memo dated May 20, 1992 from
Joseph W. Paisie, Acting Chief, SO2/Particulate Matter
Programs Branch, EPA Office of Air Quality Planning and Standards, to
Chief, Air Branch, Regions I-X, entitled ``TSP Redesignation
Request''), and our proposed and final rules establishing maximum
allowable increases in concentrations (also known as ``increments'')
for PM10 (see the proposed rule at 54 FR 41218, October 5,
1989, and the final rule at 58 FR 31622, June 3, 1993).
    Based on the above references, we believe that the relevant
considerations for evaluating whether the necessity of retaining the
TSP area designations depend upon the status of a given area with
respect to TSP and PM10. For areas that are attainment or
unclassifiable for TSP and also unclassifiable for PM10, we
generally find that the TSP designations are no longer necessary and
can be deleted when EPA (1) approves a State's revised PSD program
containing the PM10 increments, (2) promulgates the
PM10 increments into a State's SIP where the State chooses
not to adopt the increments on their own, or (3) approves a State's
request for delegation of PSD responsibility under 40 CFR section
52.21(u). See 58 FR 31622, at 31635 (June 3, 1993).
    For areas that are nonattainment for TSP but unclassifiable for
PM10, an additional consideration is whether deletion of the
TSP designations would automatically relax any emissions limitations,
control measures or programs approved into the SIP. If such a
relaxation would occur automatically with deletion of the TSP area
designations, then we will not delete the designations until we are
satisfied that the resulting SIP relaxation would not interfere with
any applicable requirement concerning attainment, reasonable further
progress (RFP), or maintenance of the NAAQS or any other requirement of
the Clean Air Act in the affected areas. See section 110(l) of the Act.

B. Deletion of TSP Attainment or Unclassifiable Area Designations in
Clark County

    This subsection addresses the 28 TSP attainment or unclassifiable
areas that are located either partially or entirely within the Clark
County, Nevada. These 28 areas are designated as unclassifiable for
PM10.
    In our November 2002 final rule deleting certain TSP attainment or
unclassifiable area designations in Nevada, we indicated that we would
delete the TSP attainment or unclassifiable area designations partially
or entirely located in Clark County once we approve revisions to the
Clark County pre-construction stationary source permit program
(referred to as ``new source review'') that implement the
PM10 increments. See 67 FR 68769, at 68776 (November 13,
2002). (In Clark County, the agency responsible for the stationary
source control program is the Clark County Department of Air Quality
and Environmental Management.) In September 2004, we approved such
revisions as part of our approval of comprehensive revisions to the
Clark County new source review program. See 69 FR 54006 (September 7,
2004). Thus, we now find that the 28 TSP attainment or unclassifiable
area designations either partially or entirely located within Clark
County are no longer necessary and can be deleted. These areas include
the Colorado River Valley (HA 213) and 27 other hydrographic
areas included within the shorthand term, ``rest of county,'' in the
``Nevada-TSP'' table in 40 CFR 81.329.

C. Deletion of TSP Nonattainment Area Designations for Carson Desert,
Winnemucca Segment, Lower Reese Valley, Fernley Area, Mason Valley, and
Clovers Area

    This subsection addresses the deletion of the TSP nonattainment
designations for Carson Desert (HA 101), Winnemucca Segment
(HA 70), Lower Reese Valley (HA 59), Fernley Area (HA
76), Mason Valley (HA 108), and Clovers Area (HA
64). These six TSP nonattainment areas are designated as
unclassifiable for PM10.
    With respect to protection of the PM10 increments, the
TSP nonattainment designations are no longer necessary in these six
areas because they are designated as unclassifiable for
PM10, and as such, have been subject to the PM10
increments established in our 1993 final rule as of the effective date
of that rule, i.e., June 3, 1994, through EPA's PSD pre-construction
permit program promulgated at 40 CFR 52.21. See 40 CFR 52.1485(b) and
note that these six areas lie outside of Clark County.
    To ensure that deletion of the TSP nonattainment designations for
these six areas would not result in any automatic relaxations in SIP
emissions limitations, control measures or programs that would be
interfere with attainment, RFP or maintenance of the NAAQS (including
PM10) or any other requirement of the Act, we reviewed the
applicable portions of the SIP, with particular focus on the TSP
control strategy attainment plans that were approved for these TSP
nonattainment areas. These plans include the Carson Desert Air Quality
Implementation Plan (AQIP), the Winnemucca Segment AQIP, the Lander
County Air Quality

Improvement Plan (which covers both the Lower Reese Valley and Clovers
areas), and the Mason Valley and Fernley Area AQIP.
    These four plans (which cover the six areas) were submitted by the
State of Nevada to EPA on December 29, 1978. We also reviewed the
materials that the State of Nevada submitted to EPA to supplement these
plans, including the paving schedules as submitted on July 24, 1979 for
the city of Fallon (Carson Desert), the city of Winnemucca (Winnemucca
Segment), and the cities of Fernley and Yerington (Mason Valley and
Fernley areas); a resolution adopted by Lander County (Lower Reese
Valley and Clovers areas) as submitted on July 24, 1979; and the
State's nonattainment new source review rule (Article 13.1.3) as
submitted on March 17, 1980. We approved all four plans, as
supplemented, on April 14, 1981 (at 46 FR 21758), on condition that the
State identify and commit the monetary and manpower resources necessary
for implementation of these plans. The State identified the necessary
resources in a letter submitted to EPA on October 21, 1981. This letter
provided the basis on April 13, 1982 (at 47 FR 15790) for EPA to revoke
the condition placed on full approval of the four TSP plans.
    A review of these four plans, as supplemented and approved, reveals
that the TSP problems in these areas were caused by similar types of
sources and that attainment of the TSP NAAQS (projected for 1982)
relied upon a similar mix of control measures. While the relative
proportions of the various source categories vary somewhat among the
four areas, the emissions inventories prepared for these plans indicate
that the principal sources of TSP in these areas are fugitive sources,
such as travel over unpaved roads and construction activities, and
industrial processing activities. As such, the control strategies set
forth in all of the plans rely on local dust ordinances, completion of
local road paving projects, and regulation of emissions from industrial
processing activities.
    Among the local dust ordinances referred to in these four plans,
only one, the Lander County Dust Ordinance (LC8-78), was submitted and
approved by EPA as a revision to the Nevada SIP. None of the provisions
in the Lander County Dust Ordinance are contingent upon the
continuation of a TSP nonattainment designation, and thus deletion of
the designation would not automatically relax any of the dust control
requirements set forth therein. Likewise, none of the road paving
project commitments in the TSP nonattainment areas is contingent upon
the continuation of the TSP nonattainment designations, and by their
own terms, all of these projects were to have been completed 20+ years
ago.
    With respect to industrial sources, the TSP plans rely upon the
Nevada Division of Environmental Protection (NDEP) to implement and
enforce rules adopted by the State Environmental Commission (SEC) that
establish emissions limitations on existing sources (referred to as
``prohibitory'' rules) and that establish pre-construction permitting
requirements for new or modified stationary sources (referred to as
``new source review''). NDEP is the agency directly responsible for
regulation of stationary sources of air pollution throughout the State
of Nevada with the exception of Clark and Washoe counties and is the
applicable air quality agency in the six TSP nonattainment areas
addressed in this action. The air pollution control rules administered
by NDEP were originally codified as ``Articles'' of the State of Nevada
Air Quality Regulations (NAQR), but the original SIP rules have largely
been superseded by subsequently submitted (and approved) rules that
have been codified in chapter 445, then later, in chapter 445B, of the
Nevada Administrative Code (NAC).
    Thus, we reviewed the relevant State prohibitory rules approved by
EPA as revisions to the Nevada SIP. These rules include NAC 445B.22017
(``Visible emissions: Maximum opacity; determination and monitoring of
opacity''), NAC 445B.22067 (``Open burning''), NAC 445B.2207
(``Incinerator burning''), NAQR Article <IP_ADDRESS> (source-specific
particulate matter limits for Milchem Incorporated near Battle
Mountain), NAC 445.730 (``Colemanite flotation processing plants''),
NAC 445B.2203 (``Emissions of particulate matter: Fuel-burning
equipment''), NAC 445B.22033 (``Emissions of particulate matter:
Sources not otherwise limited''), NAC 445B.22037 (``Emissions of
particulate matter: Fugitive dust''), NAQR article <IP_ADDRESS> and
<IP_ADDRESS> (opacity standards for portland cement plants), NAC 445.808
(source-specific particulate and opacity limits for certain barite
processing facilities), and NAC 445.816 (source-specific particulate
and opacity limits for certain precious metal ore processing
facilities). None of the provisions in these various rules are
contingent upon continuation of the TSP nonattainment designations and
thus deletion of the TSP designations would not automatically relax any
standard.
    Lastly, we reviewed the relevant EPA-approved new source review
rules (i.e., pre-construction permitting rules for new or modified
stationary sources), in particular NAQR Article 13, section 13.1.3,
which we approved in 1981 (see 46 FR 21758, April 14, 1981). We note
that the specific requirements of paragraph (2) of section 13.1.3,
including a control technology requirement for the lowest achievable
emission rate (LAER) and the provision for offsets, apply to certain
new point sources (those for which an Environmental Evaluation (EE)
must be prepared) in ``any designated nonattainment area'' for ``each
nonattainment pollutant.''
    The term ``nonattainment area'' is defined in the Nevada SIP (see
NAC 445B.112) and may well continue to apply to TSP designations that
remain in 40 CFR 81.329. However, the term ``nonattainment pollutant''
is not defined in the Nevada SIP but can be assumed to relate to the
pollutants for which ambient air quality standards are established
because area designations, such as the designation of
``nonattainment,'' follow from the establishment of such standards for
a given air pollutant. Such pollutants are often referred to as
``criteria air pollutants.'' The Nevada SIP lists criteria air
pollutants and associated ambient air quality standards in NAC
445B.22097 (``Standards of quality for ambient air''), which we
approved on March 27, 2006 (71 FR 15040). The prior SIP rule, NAC
445.843, that was replaced by NAC 445B.22097, had listed the TSP NAAQS,
but NAC 445B.22097 does not. With respect to particulate matter, NAC
445B.22097 lists only one pollutant, PM10. Thus, at least
since the effective date of our March 2006 final rule (i.e., April 26,
2006), ``nonattainment pollutant'' no longer refers to TSP for the
purposes of NAQR article 13.1.3. Thus, deletion of the six TSP
nonattainment designations would have no effect on new source review in
those six areas.
    In summary, because the deletion of the TSP nonattainment
designations for the six TSP areas would not automatically relax any
emissions limitation or control measure in the Nevada SIP, we find that
the TSP nonattainment designations are no longer necessary and can be
deleted. Based on the above discussion and evaluation, therefore, we
are deleting Carson Desert (HA 101), Winnemucca Segment (HA
70), Lower Reese Valley (HA 59), Fernley Area (HA
76), Mason Valley (HA 108), and Clovers Area (HA
64) from the ``Nevada-TSP'' table in 40 CFR 81.329.

III. Final Action and Request for Comment

    For the reasons given above, EPA is taking action, under section
107(d)(4)(B) of the Clean Air Act, as amended in 1990, to delete all of
the remaining area designations for total suspended particulate within
the State of Nevada [except for Las Vegas Valley (HA 121) and
Truckee Meadows (HA 87)] because the designations are no
longer necessary. To codify this action, the chart in 40 CFR 81.329
entitled ``Nevada-TSP'' is being modified to delete the entries for
Colorado River Valley and ``Rest of County'' under Clark County as well
as the entries for Carson Desert, Winnemucca Segment, Lower Reese
Valley, Fernley Area, Mason Valley, and Clovers Area, effective June
17, 2013.
    EPA is publishing this rule without prior proposal because we view
this as a non-controversial action and anticipate no adverse comments.
However, in the Proposed Rules section of this Federal Register, we are
publishing a separate document that will serve as a proposal to delete
the Nevada TSP area designations discussed above if relevant adverse
comments are received. This rule will be effective on June 17, 2013
without further notice unless we receive adverse comment by May 16,
2013. If we receive adverse comments, we will publish a timely
withdrawal in the Federal Register informing the public that the rule
will not take effect. We will address all public comments in a
subsequent final rule based on the proposed rule. We will not institute
a second comment period on this action. Any parties interested in
commenting must do so now. Please note that if we receive adverse
comment on an amendment, paragraph, or section of this rule and if that
provision may be severed from the remainder of the rule, we may adopt
as final those provisions of the rule that are not the subject of an
adverse comment.

IV. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely deletes certain area designations that had been established for
air quality planning purposes but that are no longer necessary and
imposes no additional requirements. Accordingly, the Administrator
certifies that this rule will not have a significant economic impact on
a substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.). Because this rule deletes certain area
designations that had been established for air quality planning
purposes but that are no longer necessary and does not impose any
additional enforceable duty, it does not contain any unfunded mandate
or significantly or uniquely affect small governments, as described in
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action merely deletes certain area
designations that had been established for air quality planning
purposes but that are no longer necessary, and does not alter the
relationship or the distribution of power and responsibilities
established in the Clean Air Act. This rule also is not subject to
Executive Order 13045 ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997), because
it is not economically significant as defined in Executive Order 12866,
and because the Agency does not have reason to believe the
environmental health or safety risks addressed by this rule present a
disproportionate risk to children.
    This rule does not involve establishment of technical standards,
and thus, the requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply.
This rule does not impose an information collection burden under the
provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.).
    The Congressional Review Act, 5 U.S.C. section 801 et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
rule 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.
section 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 June 17, 2013. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule 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 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 section 307(b)(2).)

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: April 1, 2013.
Jared Blumenfeld,
Regional Administrator, Region IX.

    Part 81, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
1. The authority citation for part 81 continues to read as follows:

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

Subpart C--Section 107 Attainment Status Designations

0
2. In Sec.  81.329, the table ``Nevada--TSP'' is revised to read as
follows:

Sec.  81.329  Nevada.

                                                   Nevada--TSP
----------------------------------------------------------------------------------------------------------------
                                                  Does not meet    Does not meet                    Better than
              Designated Area \1\                    primary         secondary       Cannot be       national
                                                    standards        standards      classified       standards
----------------------------------------------------------------------------------------------------------------
(Township Range):
    Las Vegas Valley (212) (15-24S, 56-64E)....               X
    Truckee Meadows (87) (17-20N, 18-21E)......               X
----------------------------------------------------------------------------------------------------------------
\1\ ``Designated area'' refers to hydrographic areas identified by number as shown on the State of Nevada
  Division of Water Resources' map titled Water Resources and Inter-basin Flows (September 1971). Township and
  Range is shown for general information purposes only.

* * * * *
[FR Doc. 2013-08817 Filed 4-15-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 23 (Friday, February 5, 2021)]
[Notices]
[Page 8480]
[FR Doc No: 2021-02364]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2005-21179]

Petition for Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on December 3, 2020, Union
Pacific Railroad Company (UPRR) petitioned the Federal Railroad
Administration (FRA) for an extension of a waiver of compliance from
certain provisions of the Federal railroad safety regulations contained
at 49 CFR part 229, Railroad Locomotive Safety Standards, and part 232,
Brake System Safety Standards for Freight and Other Non-Passenger
Trains and Equipment; End-Of-Train Devices. FRA assigned the petition
Docket Number FRA-2005-21179.
    Specifically, UPRR requests to extend its relief from 49 CFR
229.49, Main reservoir systems, and 49 CFR 232.103, General
Requirements for All Train Brake Systems, for locomotives having a
safety valve on the main reservoir, which prevents accumulation of more
than 25 psi above maximum working pressure. UPRR states it has been
operating under the requirements set forth in this waiver for 15 years
and has found no adverse effect on the safety of operations.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested parties
desire an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Website: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation (DOT), 1200 New Jersey Ave. SE, W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Ave. SE, Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by March 22, 2021 will be considered by FRA
before final action is taken. Comments received after that date will be
considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better
inform its processes. DOT posts these comments, without edit, including
any personal information the commenter provides, to
www.regulations.gov, as described in the system of records notice (DOT/
ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacyNotice for the
privacy notice of regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2021-02364 Filed 2-4-21; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9219-9220]
[FR Doc No: 2014-03382]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0588]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Exceptions or Alternatives to Labeling Requirements
for Products Held by the Strategic National Stockpile

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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
requirements related to the exceptions or alternatives to labeling
requirements for products held by the Strategic National Stockpile
(SNS).

DATES: Submit either electronic or written comments on the collection
of information by April 21, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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.

Exceptions or Alternatives to Labeling Requirements for Products Held
by the Strategic National Stockpile--(OMB Control Number 0910-0614)--
Extension

    Under the Public Health Service Act (PHS Act), the Department of
Health and Human Services stockpiles medical products that are
essential to the health security of the nation (see PHS Act, 42 U.S.C.
247d-6b). This collection of medical products for use during national
health emergencies, known as the SNS, is to ``provide for the emergency
health security of the United States, including the emergency health
security of children and other vulnerable populations, in the event of
a bioterrorist attack or other public health emergency.''
    It may be appropriate for certain medical products that are or will
be held in the SNS to be labeled in a manner that would not comply with
certain FDA labeling regulations given their anticipated circumstances
of use in an emergency. However, noncompliance with these labeling
requirements could render such products misbranded under section 502 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352).
    Under Sec. Sec.  201.26, 610.68, 801.128, and 809.11 (21 CFR
201.26, 610.68, 801.128, and 809.11), the appropriate FDA Center
Director may grant a request for an exception or alternative to certain
regulatory provisions pertaining to the labeling of human drugs,
biological products, medical devices, and in vitro diagnostics that
currently are or will be included in the SNS if certain criteria are
met. The appropriate FDA Center Director may grant an exception or
alternative to certain FDA labeling requirements if compliance with
these labeling requirements could adversely

affect the safety, effectiveness, or availability of products that are
or will be included in the SNS. An exception or alternative granted
under the regulations may include conditions or safeguards so that the
labeling for such products includes appropriate information necessary
for the safe and effective use of the product given the product's
anticipated circumstances of use. Any grant of an exception or
alternative will only apply to the specified lots, batches, or other
units of medical products in the request. The appropriate FDA Center
Director may also grant an exception or alternative to the labeling
provisions specified in the regulations on his or her own initiative.
    Under Sec.  201.26(b)(1)(i) (human drug products), Sec.
610.68(b)(1)(i) (biological products), Sec.  801.128(b)(1)(i) (medical
devices), and Sec.  809.11(b)(1)(i) (in vitro diagnostic products for
human use), an SNS official or any entity that manufactures (including
labeling, packing, relabeling, or repackaging), distributes, or stores
such products that are or will be included in the SNS may submit, with
written concurrence from an SNS official, a written request for an
exception or alternative to certain labeling requirements to the
appropriate FDA Center Director. Except when initiated by an FDA Center
Director, a request for an exception or alternative must be in writing
and must:
     Identify the specified lots, batches, or other units of
the affected product;
     Identify the specific labeling provisions under this rule
that are the subject of the request;
     Explain why compliance with the specified labeling
provisions could adversely affect the safety, effectiveness, or
availability of the product subject to the request;
     Describe any proposed safeguards or conditions that will
be implemented so that the labeling of the product includes appropriate
information necessary for the safe and effective use of the product
given the anticipated circumstances of use of the product;
     Provide copies of the proposed labeling of the specified
lots, batches, or other units of the affected product that will be
subject to the exception or alternative; and
     Provide any other information requested by the FDA Center
Director in support of the request.
    If the request is granted, the manufacturer may need to report to
FDA any resulting changes to the New Drug Application, Biologics
License Application, Premarket Approval Application, or Premarket
Notification (510(k)) in effect, if any. The submission and grant of an
exception or an alternative to the labeling requirements specified in
this rule may be used to satisfy certain reporting obligations relating
to changes to product applications under 21 CFR 314.70 (human drugs),
21 CFR 601.12 (biological products), 21 CFR 814.39 (medical devices
subject to premarket approval), or 21 CFR 807.81 (medical devices
subject to 510(k) clearance requirements). The information collection
provisions in Sec. Sec.  314.70, 601.12, 807.81, and 814.39 have been
approved under OMB control numbers 0910-0001, 0910-0338, 0910-0120, and
0910-0231 respectively. On a case-by-case basis, the appropriate FDA
Center Director may also determine when an exception or alternative is
granted that certain safeguards and conditions are appropriate, such as
additional labeling on the SNS products, so that the labeling of such
products would include information needed for safe and effective use
under the anticipated circumstances of use.
    Respondents to this collection of information are entities that
manufacture (including labeling, packing, relabeling, or repackaging),
distribute, or store affected SNS products. Based on the number of
requests for an exception or alternative received by FDA in fiscal
years 2012-13, FDA estimates an average of one request annually. FDA
estimates an average of 24 hours preparing each request. The average
burden per response for each submission is based on the estimated time
that it takes to prepare a supplement to an application, which may be
considered similar to a request for an exception or alternative. To the
extent that labeling changes not already required by FDA regulations
are made in connection with an exception or alternative granted under
the final rule, FDA is estimating one occurrence annually in the event
FDA would require any additional labeling changes not already covered
by FDA regulations. FDA estimates 8 hours to develop and revise the
labeling to make such changes. The average burden per response for each
submission is based on the estimated time to develop and revise the
labeling to make such changes.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  Number of        Number of responses      Total annual       Average burden per
              21 CFR Section                     respondents         per respondent           responses             response             Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
201.26(b)(1)(i), 610.68(b)(1)(i),                              1                     1                     1                    24                    24
 801.128(b)(1)(i), and 809.11(b)(1)(i)....
201.26(b)(1)(i), 610.68(b)(1)(i),                              1                     1                     1                     8                     8
 801.128(b)(1)(i), and 809.11(b)(1)(i)....
    Total.................................                    32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: February 11, 2014.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2014-03382 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P