[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Proposed Rules]
[Pages 15200-15205]
[FR Doc No: 2016-06438]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2015-0793; FRL-9944-08-Region 9]

Partial Approval and Partial Disapproval of Air Quality State
Implementation Plans; Arizona; Infrastructure Requirements To Address
Interstate Transport for the 2008 Ozone NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
partially approve and partially disapprove a State Implementation Plan
(SIP) revision submitted by the Arizona Department of Environmental
Quality on December 27, 2012, and supplemented on December 3, 2015, to
address the interstate transport requirements of Clean Air Act (CAA or
Act) section 110(a)(2)(D) with respect to the 2008 ozone
(O3) national ambient air quality standard (NAAQS). We are
proposing to approve the portion of the Arizona SIP pertaining to
significant contribution to

nonattainment or interference with maintenance in another state and
proposing to disapprove the portion of Arizona's SIP pertaining to
interstate transport visibility requirements. EPA's rationale for
proposing to partially approve and partially disapprove Arizona's
December 27, 2012 SIP revision and December 3, 2015 supplement is
described in this notice. EPA previously took two separate actions on
Arizona's December 27, 2012 submittal, on July 14, 2015 and August 10,
2015. We are taking comments on this proposal and plan to follow with a
final action no later than June 7, 2016.

DATES: Written comments must be received on or before April 21, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2015-0793 at http://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov, follow
the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, 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. The EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Maeve Clancy, EPA Region IX, (415)
947-4105<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, the terms ``we,''
``us,'' and ``our'' refer to EPA.

Table of Contents

I. Background
II. State Submittals
III. EPA's Assessment
IV. Proposed Action
V. Statutory and Executive Order Reviews

I. Background

    CAA sections 110(a)(1) and (2) require states to address basic SIP
requirements to implement, maintain and enforce the NAAQS no later than
three years after the promulgation of a new or revised standard.
Section 110(a)(2) outlines the specific requirements that each state is
required to address in this SIP submission that collectively constitute
the ``infrastructure'' of a state's air quality management program. SIP
submittals that address these requirements are referred to as
``infrastructure SIPs'' (I-SIP). In particular, CAA section
110(a)(2)(D)(i)(I) requires that each SIP for a new or revised NAAQS
contain adequate provisions to prohibit any source or other type of
emissions activity within the state from emitting air pollutants that
will ``contribute significantly to nonattainment'' (prong 1) or
``interfere with maintenance'' (prong 2) of the applicable air quality
standard in any other state. CAA section 110(a)(2)(D)(i)(II) requires
SIP provisions that prevent interference with measures required to be
included in the applicable implementation plan for any other State
under part C to prevent significant deterioration of air quality (prong
3) or to protect visibility (prong 4). This action addresses the
section 110(a)(2)(D)(i) requirements of prongs 1, 2 and 4 with respect
to Arizona's I-SIP submissions.
    On March 27, 2008, EPA issued a revised NAAQS for ozone.\1\ This
action triggered a requirement for states to submit an I-SIP to address
the applicable requirements of section 110(a)(2) within three years of
issuance of the revised NAAQS.
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    \1\ National Ambient Air Quality Standards for Ozone; Final
Rule, 73 FR 16436 (March 27, 2008).
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    On September 13, 2013, EPA issued ``Guidance on Infrastructure
State Implementation Plan (SIP) Elements under Clean Air Act Sections
110(a)(1) and 110(a)(2),'' which provides ``advice on the development
of infrastructure SIPs for the 2008 ozone NAAQS . . . as well as
infrastructure SIPs for new or revised NAAQS promulgated in the
future.'' \2\ EPA followed that guidance with an additional memo
specific to 110(a)(2)(D)(i)(I) (prongs 1 and 2) requirements for the
2008 O3 standard on January 22, 2015 entitled, ``Information
on the Interstate Transport ``Good Neighbor'' Provision for the 2008
Ozone NAAQS Under CAA Section 110(a)(2)(D)(i)(I)'' (2015 transport
memo).\3\ While this memo did not provide specific guidance to western
states on interstate transport, it did contain preliminary modeling
information for western states. This 2015 transport memo, following the
approach used in EPA's prior Cross-State Air Pollution Rule (CSAPR),\4\
provided data identifying ozone monitoring sites that were projected to
be in nonattainment or have maintenance problems for the 2008 ozone
NAAQS in 2018. Also, EPA provided the projected contribution estimates
from 2018 anthropogenic oxides of nitrogen (NOX) and
volatile organic compound (VOC) emissions in each state to ozone
concentrations at each of the projected sites.
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    \2\ Memorandum from Stephen D. Page, Director, Office of Air
Quality Planning and Standards, to Regional Air Division Directors,
Regions 1-10 (September 13, 2013).
    \3\ Memorandum from Stephen D. Page, Director, Office of Air
Quality Planning and Standards, to Regional Air Division Directors,
Regions 1-10 (January 22, 2015).
    \4\ Cross-State Air Pollution Rule, 76 FR 48208 (Aug. 8, 2011).
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    On August 4, 2015, EPA published a Federal Register Notice
entitled, ``Notice of Availability of the Environmental Protection
Agency's Updated Ozone Transport Modeling Data for the 2008 Ozone
NAAQS.'' \5\ This Notice of Data Availability (NODA) is an update of
the preliminary air quality modeling data that was released January 22,
2015. This NODA provided data identifying ozone monitoring sites that
are projected to be nonattainment or have maintenance problems
(following the CSAPR approach) for the 2008 ozone NAAQS in 2017.\6\
Also, EPA provided the projected ozone contribution estimates from 2017
anthropogenic NOX and VOC emissions in each state to ozone
concentrations at each of the projected monitoring sites. The 2017
modeling released in the NODA was used to support EPA's proposed update
to CSAPR to address CAA section 110(a)(2)(D)(i)(I) requirements with
respect to the 2008 ozone NAAQS in the eastern U.S. (``CSAPR Update
Rule'').\7\ CSAPR and its predecessor transport rules, the
NOX SIP Call and CAIR, were designed to address the
collective contributions from the 37 states in the eastern U.S. and
ozone contribution information was not calculated to or from the 11
states in the western U.S. The proposed CSAPR Update Rule and the
supportive

modeling released in the NODA include data relevant to the West but did
not evaluate potential interstate transport impacts in 11 western
states, including Arizona. In this action, we are utilizing these data
to evaluate the state's submittals and any interstate transport
obligations under section 110(a)(2)(D)(i)(I).
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    \5\ Notice of Availability of the Environmental Protection
Agency's Updated Ozone Transport Modeling Data for the 2008 Ozone
National Ambient Air Quality Standard (NAAQS), 80 FR 46271 (August
4, 2015).
    \6\ The EPA adopted 2017 as the analytic year for the updated
ozone modeling information. See 80 FR 46273.
    \7\ Cross-State Air Pollution Rule Update for the 2008 Ozone
NAAQS, 80 FR 75706 (December 3, 2015).
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    EPA is obligated, pursuant to a judgement issued by the Northern
District of California in Sierra Club vs. McCarthy, to take final
action on 110(a)(2)(D) prongs 1, 2, and 4 of Arizona's December 2012
SIP revision by June 7, 2016.\8\ In our July 2015 partial approval and
partial disapproval of Arizona's I-SIP submittals for the 2008 Pb and
2008 ozone NAAQS, for the I-SIP elements C, D, J, and K, EPA partially
approved and partially disapproved the submittals for purposes of
110(a)(2)(D)(i)(II) prong 3 and partially approved and partially
disapproved the submittals for purposes of 110(a)(2)(D)(ii) (relating
to CAA sections 115 and 126). We also stated our intention to propose
action on the I-SIP for the 2008 ozone NAAQS 110(a)(2)(D)(i) prongs 1,
2, and 4 in a separate action.\9\ We subsequently took action on I-SIP
elements A, B, E-H, L, and M for the 2008 Pb and 2008 ozone NAAQS in
August 2015.\10\
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    \8\ See Judgment, Sierra Club v. McCarthy, Case 4:14-cv-05091-
YGR (N.D. Cal. May 15, 2015).
    \9\ Partial Approval and Partial Disapproval of Air Quality
State Implementation Plans; Arizona; Infrastructure Requirements for
Lead and Ozone. 80 FR 40905 (July 14, 2015).
    \10\ Approval and Promulgation of State Implementation Plans;
Arizona; Infrastructure Requirements for the 2008 Lead (Pb) and the
2008 8-Hour Ozone National Ambient Air Quality Standards (NAAQS). 80
FR 47859 (August 10, 2015).
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II. State Submittals

    On December 27, 2012, the Arizona Department of Environmental
Quality (ADEQ) submitted its 2008 ozone NAAQS I-SIP (2012 submittal).
This submittal briefly summarized the CAA requirements of sections
110(a)(2)(D)(i), 110(a)(2)(D)(ii), and EPA's I-SIP action for the
previous 1997 ozone NAAQS, but as to prongs 1, 2, and 4 did not
identify or address any potential interstate transport impacts between
Arizona and other states or interstate transport visibility
requirements for the 2008 ozone NAAQS. On December 3, 2015, ADEQ
submitted a supplement to the 2012 submittal addressing 110(a)(2)(D)(i)
prongs 1, 2, and 4.\11\ For the purposes of this action, we will refer
to the supplemental submittal as the ``2015 submittal.'' The 2015
submittal represents ADEQ's comprehensive analysis of ozone transport
from Arizona to surrounding states and addresses potential interstate
transport linkages between Arizona and the El Centro, CA and Los
Angeles, CA nonattainment receptors that were identified in the 2015
ozone transport memo and the 2015 NODA. The 2015 submittal also
addresses the requirements of prong 4 (interstate transport visibility
requirements).
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    \11\ ``Arizona State Implementation Plan Revisions for 2008
Ozone and 2010 Nitrogen Dioxide Under Clean Air Act Section
110(a)(2)(D) . . .'' Signed December 3, 2015. And see email from
Heidi Haggerty of ADEQ. ``AZ 2015 Ozone Transport I-SIP Submittal
Clarification.'' Sent December 9, 2015.
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    In the 2015 submittal, ADEQ summarizes the state's impact on
downwind states. While Arizona's impact on the El Centro and Los
Angeles monitors is in each case above 1%, Arizona impacts only one of
the seven projected nonattainment or maintenance receptors in the Los
Angeles area, and contributes less than 1% to all other maintenance and
nonattainment receptors. ADEQ further states that, ``In eastern states,
the EPA has chosen a 1% of the standard threshold as a significant
contribution. However, Arizona considers the southwest to be
different.'' The state goes on to say that, ``It is unclear at this
point what threshold is significant for southwestern states.'' EPA's
assessment of these statements is described in the next section. The
submittal also summarizes sources of VOCs and NOX statewide,
outlining the controls on anthropogenic emission sources with a focus
on efforts to reduce NOX through controls implemented via
Arizona's Regional Haze SIP and EPA's Regional Haze Federal
Implementation Plan (FIP) and current and future Maricopa County
stationary source controls in the Arizona SIP. For more information on
Arizona's source categories and emissions controls, please see the
technical support document (TSD) associated with today's proposed
rulemaking.

III. EPA's Assessment

110(a)(2)(D)(i)(I) Prong 1 and Prong 2

    EPA proposes to approve Arizona's SIP submissions pertaining to CAA
section 110(a)(2)(D)(i)(I), prongs 1 and 2, with respect to the 2008
ozone NAAQS. As explained below, EPA's proposal is based on the state's
submission and EPA's analysis of several factors and available data.
    To determine whether the CAA section 110(a)(2)(D)(i)(I), prongs 1
and 2 requirement is satisfied, EPA first must determine whether a
state's emissions will contribute significantly to nonattainment or
interfere with maintenance of a NAAQS in other states. If a state is
determined not to make such contribution or interfere with maintenance
of the NAAQS, then EPA can conclude that the state's SIP complies with
the requirements of section 110(a)(2)(D)(i)(I). In several prior
federal rulemakings interpreting section 110(a)(2)(D)(i)(I), EPA has
evaluated whether a state will significantly contribute to
nonattainment or interfere with maintenance of a NAAQS by first
identifying downwind receptors that are expected to have problems
attaining or maintaining the NAAQS.\12\ EPA has then determined which
upwind states contribute to these identified air quality problems in
amounts sufficient to warrant further evaluation to determine if the
state can make emission reductions to reduce its contribution. CSAPR
and the proposed CSAPR Update used a screening threshold (1% of the
NAAQS) to identify such contributing upwind states warranting further
review and analysis. EPA's NODA used air quality modeling to evaluate
contributions from upwind states to downward receptors. Applying the
methodology used in CSAPR, the NODA modeling information indicates that
emissions from Arizona contribute amounts exceeding the CSAPR 1%
threshold at two projected downwind nonattainment sites in El Centro,
California, and Los Angeles, California.\13\
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    \12\ NOX SIP Call, Final Rule, 63 FR 57371 (October
27, 1998); Clean Air Interstate Rule (CAIR), Final Rule, 70 FR 25172
(May 12, 2005); Cross-State Air Pollution Rule (CSAPR), Final Rule,
76 FR 48208 (August 8, 2011); CSAPR Update Rule, Proposed Rule, 80
FR 75706 (Dec. 3, 2015).
    \13\ Data file with 2017 Ozone Contributions. Included in docket
for: Notice of Availability of the Environmental Protection Agency's
Updated Ozone Transport Modeling Data for the 2008 Ozone National
Ambient Air Quality Standard (NAAQS), 80 FR 46271 (August 4, 2015).
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    EPA notes that it disagrees with ADEQ's contention that it is
unclear what screening threshold is significant for southwestern states
when addressing interstate transport contributions. EPA believes
contribution from an individual state equal to or above 1% of the NAAQS
could be considered significant where the collective contribution of
emissions from one or more upwind states is responsible for a
considerable portion of the downwind air quality problem regardless of
where the receptor is geographically located.\14\
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    \14\ EPA has previously noted there may be additional criteria
to evaluate regarding collective contribution of transported air
pollution at certain locations in the West. See footnotes 4 and 7.
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    Accordingly, although EPA's modeling indicates that emissions from

Arizona contribute above the 1% threshold to two projected downwind air
quality problems, EPA examined several factors to determine whether
Arizona should be considered to significantly contribute to
nonattainment or interfere with maintenance of the NAAQS at those
sites, including the air quality and contribution modeling, receptor
data, and the statewide measures reducing emissions of VOCs and
NOX. EPA notes that no single piece of information is by
itself dispositive of the issue for purposes of this analysis. Instead,
EPA has considered the total weight of all the evidence taken together
to evaluate whether Arizona significantly contributes to nonattainment
or interferes with maintenance of the 2008 ozone NAAQS in those areas.
    One such factor that EPA considers relevant to determining the
nature of a projected receptor's interstate transport problem is the
magnitude of ozone attributable to transport from all upwind states
collectively contributing to the air quality problem. In CSAPR and the
CSAPR Update Rule, EPA used the 1% air quality threshold to identify
linkages between upwind states and downwind maintenance receptors.
States whose contributions to a specific receptor meet or exceed the
threshold were considered to be linked to that receptor. The linked
states' emissions (and available emission reductions) were then
analyzed further as a second step to EPA's contribution analysis.
States whose contributions to all receptors were below the 1% threshold
did not require further evaluation to address interstate transport and
we therefore found those states were determined to make insignificant
contributions to downwind air quality. Therefore, the states below the
threshold do not significantly contribute to nonattainment or interfere
with maintenance of the NAAQS in other states. EPA used the 1%
threshold in the East because prior analysis showed that, in general,
nonattainment problems result from a combined impact of relatively
small individual contributions from upwind states, along with
contributions from in-state sources. EPA has observed that a relatively
large portion of the air quality problem at most ozone nonattainment
and maintenance receptors in the East is the result of the collective
contribution from a number of upwind states.
    Specifically, EPA found the total upwind states' contribution to
ozone concentration (from linked and unlinked states) based on modeling
for 2017 ranges from 17% to 67% to identified downwind air quality
problems in the East, with between 4 and 12 states each contributing
above 1% to the downwind air quality problem.15 16 Thus,
irrespective of the 1% air quality threshold in the East, EPA has found
that the collective contributions from upwind states represent a large
portion of the ozone concentrations at projected air quality problems.
Further, in the East, EPA found that the 1% threshold is appropriate to
capture a high percentage of the total pollution transport affecting
downwind receptors. By comparison, according to EPA's modeling, the
total upwind (linked or unlinked) states' contribution to ozone
concentration at the projected nonattainment sites in El Centro,
California and Los Angeles, California, is comparatively small, with
only one state contributing above 1% to the downwind air quality
problem.
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    \15\ The stated range is based on the highest nonattainment or
maintenance receptor in each area. All nonattainment and maintenance
receptors had upwind contributions of well over 17%, except for some
receptors in Dallas and Houston.
    \16\ Memo to Docket from EPA, Air Quality Policy Division.
``Contribution Analysis of Receptors in the Updated CSAPR
Proposal.'' March 10, 2016.
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    Arizona is the only state that contributes greater than the 1%
threshold to the projected 2017 levels of the 2008 ozone NAAQS at the
El Centro receptor. The total contribution from all states to the El
Centro receptor is 4.4% of the total ozone concentration at this
receptor. Arizona is also the only state that contributes greater than
1% to the projected 2017 levels of the 2008 ozone NAAQS at the Los
Angeles receptor, and the total contribution from all states is 2.5% of
the ozone concentration at this receptor. EPA believes that a 4.4% and
2.5% cumulative ozone contribution from all upwind states is
negligible, particularly when compared to the relatively large
contributions from upwind states in the East or in certain other areas
of the West. For these reasons, EPA believes the emissions that result
in transported ozone from upwind states have limited impacts on the
projected air quality problems in El Centro, California and Los
Angeles, California, and therefore should not be treated as receptors
for purposes of determining the interstate transport obligations of
upwind states under section 110(a)(2)(D)(i)(I).
    Additionally, EPA has evaluated the Arizona VOC and NOX
emissions inventory and emissions projections and agrees that emissions
will be decreasing over time. Given that emissions within the state are
expected to decrease over time due to regional haze measures, Federal
engine and fuel standards, and other Federal, State, and local
rules,\17\ EPA believes that the Arizona SIP contains adequate
provisions to ensure that air emissions in Arizona do not significantly
contribute to nonattainment or interfere with maintenance of the 2008
ozone NAAQS in California or any other state in the future.
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    \17\ See TSD for details on other emissions control measures.
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    The modeling data show that Arizona contributes either less than 1%
of the NAAQS to projected air quality problems in other states, or
where it contributes above 1% of the NAAQS to a projected downwind air
quality problem in California, EPA proposes to find, based on the
overall weight of evidence, that these particular receptors are not
significantly impacted by transported ozone from upwind states.
Emissions reductions from Arizona are not necessary to address
interstate transport because the total collective upwind state ozone
contribution to these receptors is relatively low compared to the air
quality problems typically addressed by the good neighbor provision.
Additionally, Arizona has demonstrated that both VOC and NOX
emissions are going down and will continue to go down. EPA therefore
believes that Arizona's contributions to downwind receptors in
California are considered insignificant. EPA proposes to find that
Arizona does not significantly contribute to nonattainment or interfere
with maintenance of the 2008 ozone NAAQS in other states.

110(a)(2)(D)(i)(II) Prong 4

    EPA believes that ozone precursor emissions of NOX may
contribute to visibility impairment in Class I areas. EPA's 2013 I-SIP
guidance clarifies that a state can rely upon a fully EPA-approved
Regional Haze SIP to satisfy the requirements of this sub-element.
Arizona's Regional Haze SIP shows that sources in Arizona impact
visibility in Colorado (Great Sand Dunes National Monument, Mesa Verde
National Park, Black Canyon of the Gunnison National Park, La Garita
Wilderness, and Weminuche Wilderness), New Mexico (Bandelier National
Monument, San Pedro Parks Wilderness, Pecos Wilderness, Bosque del
Apache National Wildlife Reserve, and Gila Wilderness), and Utah (Zion
National Park, Bryce Canyon National Park, Capitol Reef National Park,
Canyonlands National Park, and Arches

National Park).\18\ Arizona's Regional Haze SIP is not fully approved
by EPA. Instead, Arizona's 2012 and 2015 submittals rely, in part, on
regulations imposed by FIPs to address visibility impairment in Class 1
Areas caused by NOX, SO2, and PM. These
regulations include emission limits on the following facilities:
Arizona Public Service Cholla Power Plant,\19\ Salt River Project
Coronado Generating Station,\20\ Freeport McMoran Miami Smelter,\21\
ASARCO Hayden Smelter,\22\ Sundt Generating Station Unit 4,\23\ and
Nelson Lime Plant Kilns 1 and 2.\24\ Emissions limits have been
incorporated into the state SIP, replacing a previous FIP, at AEPCO
Apache Station Units 1, 2, and 3.\25\
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    \18\ Arizona State Implementation Plan, Regional Haze Under
Section 308 of the Federal Regional Haze Rule (January 2011),
section 12.4.1.
    \19\ FIP promulgated at 77 FR 72514 (December 5, 2012).
    \20\ Id.
    \21\ FIP promulgated at 79 FR 5240 (September 3, 2014).
    \22\ Id.
    \23\ Id.
    \24\ Id.
    \25\ SIP approval promulgated for Unit 1 and FIP promulgated for
Units 2 and 3 at 77 FR 72511 (December 5, 2012). SIP revision for
emissions limits for Unit 1 and SIP approval for Units 2 and 3
promulgated at 80 FR 19220 (April 10, 2015).
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    Because Arizona's 2012 and 2015 submittals rely in part on FIPs to
address interstate transport visibility requirements, they do not meet
the requirements of prong 4 for the 2008 ozone NAAQS. However, because
FIPs are already in place, no additional FIP obligation would be
triggered by a final disapproval of this portion of Arizona's
infrastructure SIP. EPA will continue to work with Arizona to
incorporate emission limits to address the requirements of the Regional
Haze Rule into the Arizona SIP. For further discussion of our analysis
of prong 4, please see the TSD associated with this proposal and in the
docket for today's rulemaking.

IV. Proposed Action

    EPA is proposing to approve Arizona's SIP as meeting the interstate
transport requirements of CAA section 110(a)(2)(D)(i)(I) prongs 1 and 2
for the 2008 ozone NAAQS. EPA is proposing this approval based on the
overall weight of evidence from information and analysis provided by
Arizona, as well as the recent air quality modeling released in EPA's
August 4, 2015 NODA, and other data analysis that confirms that
emissions from Arizona will not contribute significantly to
nonattainment or interfere with maintenance of the 2008 ozone NAAQS in
California or any other state.
    EPA is proposing to disapprove Arizona's SIP with respect to the
interstate transport requirements of CAA section 110(a)(2)(D)(i)(II)
prong 4 for the 2008 ozone NAAQS. Because Arizona's 2012 and 2015
submittals rely, in part, on FIPs to address interstate transport
visibility requirements, they do not meet the requirements of this
portion of CAA Sec.  110(a)(2)(D) for the 2008 ozone NAAQS. However,
because FIPs are already in place, no additional FIP obligation would
be triggered by a final disapproval of this portion of Arizona's
infrastructure SIP. EPA will continue to work with Arizona to
incorporate emission limits to address the requirements of the Regional
Haze Rule into the Arizona SIP.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA because this action does not impose additional requirements
beyond those imposed by state law.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities beyond those
imposed by state law.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action does not impose additional requirements
beyond those imposed by state law. Accordingly, no additional costs to
State, local, or tribal governments, or to the private sector, will
result from this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will 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.

F. Executive Order 13175: Coordination With Indian Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175, because 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, and will not
impose substantial direct costs on tribal governments or preempt tribal
law. Thus, Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not impose additional
requirements beyond those imposed by state law.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA directs the EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or otherwise impractical. The EPA
believes that this action is not subject to the requirements of section
12(d) of the NTTAA because application of those requirements would be
inconsistent with the CAA.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Population

    The EPA lacks the discretionary authority to address environmental
justice in this rulemaking.

List of Subjects in 40 CFR Part 52

    Air pollution control, Approval and promulgation of implementation
plans, Environmental protection, Incorporation by reference, Oxides of
nitrogen, Ozone, and Volatile organic compounds.

    Dated: March 15, 2016.
Jared Blumenfeld,
Regional Administrator, Region IX.
[FR Doc. 2016-06438 Filed 3-21-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 130 (Friday, July 6, 2018)]
[Notices]
[Pages 31631-31633]
[FR Doc No: 2018-14028]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA--2017-0196]

60-Day Notice of Proposed Information Collection: Pilot Program
To Allow 18- to 21-Year-Old Persons With Military Driving Experience To
Operate Commercial Motor Vehicles (CMVs) in Interstate Commerce

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice and request for comments.

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SUMMARY: FMCSA is seeking approval from the Office of Management and
Budget (OMB) for the information collection described below. In
accordance with the Paperwork Reduction Act, FMCSA is requesting
comment from all interested parties on the proposed collection of
information. The purpose of this notice is to allow for 60 days of
public comment.
    Pursuant to Section 5404 of the Fixing America's Surface
Transportation Act, 2015 (FAST Act), FMCSA proposes a 3-year period of
information collection to determine whether the safety outcomes (to
include crashes, moving violations, inspection violations, and safety
critical events as available) of drivers under the age of 21 with
military experience in the operation of heavy vehicles (i.e., ``covered
drivers'') participating in interstate commerce are similar to the
safety outcomes of commercial motor vehicle drivers (CMV) drivers
between the ages of 21 and 24 operating freight-carrying CMVs, and how
training and experience impact the safety of the 18- to 20-year-old
driving population. FMCSA proposed this pilot program and solicited
public comment on August 22, 2016. The prior 60-day notice sought
comment on program operations, including whether any additional
safeguards are needed to ensure that the pilot program provides a level
of safety equivalent to current safety levels. Additional details on
the broader pilot program are available through a separate notice
published in today's Federal Register.

DATES: Comments must be received on or before September 4, 2018.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2017-0196 using any of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Operations, U.S. Department of
Transportation, 1200 New Jersey Ave. SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: 1200 New Jersey Avenue SE, West
Building, Ground Floor, Room W12-140, Washington, DC 20590 between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and the
docket number. For detailed instructions on submitting comments, see
the Public Participation heading below. Note that all comments received
will be posted without change to http://www.regulations.gov, including
any personal information provided. Please see the Privacy Act heading
below.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and follow the
online instructions for accessing the dockets, or go to the street
address listed above.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. 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 www.dot.gov/privacy.
    Public Participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You can obtain electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal website. If you want us to notify you
that we received your comments, please include a self-addressed,
stamped envelope or postcard, or print the acknowledgement page that
appears after submitting comments online. Comments received after the
comment closing date will be included in the docket and will be
considered to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Nicole Michel, Research Division,
Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, by email at [email protected], or by
telephone at<PHONE_NUMBER>. If you have questions on viewing or
submitting material to the docket, contact Docket Services, telephone
(202) 366-9826.

SUPPLEMENTARY INFORMATION:
    Title: Proposed Information Collection for a Pilot Program to Allow
18- to 21-Year-Old Persons with Military Driving Experience to Operate
CMVs in Interstate Commerce.
    OMB Control Number: 2126-00XX.
    Type of Request: New information collection.
    Respondents: Motor carriers; 21- to 24-year-old entry-level CMV
drivers with valid commercial drivers' licenses (CDLs) operating in
freight-carrying interstate commerce (control group drivers); 18- to
20-year-old freight-carrying CMV drivers with a valid CDL operating in
intrastate commerce (intrastate group drivers); 18- to 20-year-old
current or former military personnel with training in heavy-duty
vehicle operations (covered drivers) and valid CDLs with a K-
restriction.
    Estimated Number of Respondents: 1,570. [Motor carriers: 70 in
total; 50 at any given time. Control group drivers: 1,500 in total
(Year 1 = 300; Year 2 = 100; Year 3 = 100; Annualized = 166.7).
Intrastate group drivers: 500 in total (Year 1 = 300; Year 2 = 100;
Year 3 = 100; Annualized = 166.7). Covered group drivers: 500 in total
(Year 1 = 300; Year 2 = 100; Year 3 = 100; Annualized = 166.7).]
    Estimated Time per Response: Motor Carriers: application--20
minutes (one-time response); monthly data submission--45 minutes (per
participating driver); miscellaneous additional data submissions--60
minutes per month (e.g. notification of a crash with injury or
fatality, notification of a driver leaving the carrier or study);
monthly supporting information--15 minutes (per sponsored participating
driver, monthly; e.g., optional on-board monitoring system [OBMS] logs,
investigation findings for crashes). Drivers: background information
and informed consent forms--20 minutes (one-time response).
    Expiration Date: N/A. This is a new information collection request
(ICR).
    Frequency of Response: This is a one-time pilot program that will
span a 3-year period of data collection. Throughout the 3-year pilot
program, the response frequencies are: Motor-carrier applications: one-
time response. Driver demographic and release forms: one-time response.
Motor carrier driver data submission: monthly (see ``Estimated Time per
Response'' for more details).
    Estimated Total Annual Burden: 7,974.5 hours annualized. [This
includes 7.8 hours annualized for motor carrier applications; 166.67
hours annualized for driver information and informed consent forms;
5,400 hours annualized for monthly driver activity and safety data; 600
hours annualized for miscellaneous tasks; and 1,800 hours annualized
for additional supporting data]

I. Background

Applicable Regulations

    Drivers of CMVs engaged in interstate commerce must be at least 21
years of age (49 CFR 391.11(b)(1)). This includes CMVs for which CDLs
are required and certain other CMVs for which a CDL is not required.
    In the May 9, 2011, final rule on ``Commercial Driver's License
Testing and Commercial Learner's Permit Standards,'' (76 FR 26854), the
Agency set a minimum age of 18 for an individual to obtain a CDL. A CDL
holder under the age of 21 must have a ``K'' restriction on their CDL,
which limits the driver to operating in intrastate commerce. Therefore,
the proposed pilot program requires that participating drivers be
provided relief from sections of 49 CFR parts 383 and 391 concerning
minimum age requirements so that the covered drivers may operate in
interstate commerce.

FAST Act Requirements

    On December 4, 2015, the FAST Act was signed into law. Section 5404
of the FAST Act (Pub. L. 114-94, 129 Stat. 1312, 1549, Dec. 4, 2015)
requires the Secretary of Transportation to conduct a commercial driver
pilot program to ``. . . study the feasibility, benefits, and safety
impacts of allowing a covered driver to operate a commercial motor
vehicle in interstate commerce.'' A ``covered driver'' is defined as a
current or former member of the armed forces or reserve components
between the ages of 18 and 21, who is qualified in a Military
Occupational Specialty (MOS) to operate a CMV or similar vehicle.
    Section 5404 of the FAST Act requires the establishment of a data
collection program to collect and analyze data regarding crashes
involving covered drivers participating in the pilot program and
drivers under the age of 21 operating CMVs in intrastate commerce. A
report detailing the findings will be submitted to Congress no later
than one year after completing data collection.

II. Purpose of Proposed ICR

    The primary purpose of the proposed ICR is to support research to
determine whether the safety outcomes of covered drivers participating
in interstate commerce are similar to the safety outcomes of older
entry-level drivers (i.e., CDL drivers between the ages of 21 and 24)
and how training and experience impact the safety of the 18- to 20-
year-old driving population. For the purposes of this ICR, safety
outcomes refer to crashes, driver moving violations, total number of
inspections for the month, violations from inspections, and any safety-
critical events captured via OBMS, such as hard braking or sudden lane
changes. This research effort will allow FMCSA to fulfill the
requirements of Section 5404 of the FAST Act.

III. Data Collection Plan

    Details of the data collection plan for this pilot program are
subject to change based on comments to the docket and further review by
analysts. FMCSA will encourage motor carriers to participate in the
pilot who will then identify and employ covered, intrastate, and/or
control group drivers and report participating drivers' safety and
activity data to the project team.
    The plan for the data collection task is to have approximately 50
motor carriers participating in the pilot program at a time (some
carriers may wish to depart the study before the 3-year data collection
period is complete; FMCSA intends to replace them as needed and as
possible) who will then identify and employ at least one covered group
driver, as well as intrastate drivers, and/or control group drivers and
report their safety and activity data to FMCSA. Note that while only 50
carriers are expected to participate at

any given time, an estimated 70 carriers will participate throughout
the 3-year study due to carriers leaving the study and needing to be
replaced.
    FMCSA expects to include an average of 600 drivers in the study per
year (200 control group, 200 intrastate, and 200 covered drivers).
Because of relatively high turnover in the motor carrier industry and
given that many covered drivers will turn 21 through the course of the
pilot program (and therefore no longer be considered covered drivers),
participating motor carriers will need to work with the project team to
add additional drivers to the program over time. An estimated 300
replacement drivers (100 control group, 100 intrastate, and 100
covered) will participate during each year of the 3-year program due to
expected turnover.
    The information collection can be summarized by the following:
     A motor carrier application (completed once at the time of
application) for participation in the pilot program will provide the
project team with the carrier's contact information and demographic
data.
     Each participating driver will need to complete a driver
background information form and sign an informed consent form, which
the motor carrier will submit on the driver's behalf. This is a one-
time task for each driver.
     On a monthly basis, carriers will submit data on driver
activity (e.g., duty hours, driving hours, off-duty time, restart
breaks), safety outcomes (e.g., crashes, violations, and safety-
critical events) and any additional supporting information (e.g., OBMS
logs, investigative reports from previous crashes).
     Carriers will be required to notify FMCSA within 24 hours
of: any injury or fatality crashes involving a participating driver, a
participating driver receiving an alcohol-related citation (e.g.,
driving under the influence, driving while intoxicate), a participating
driver choosing to leave the pilot program, a participating driver
leaving the carrier, or a participating driver failing a random or
post-crash drug/alcohol test.
    This pilot limits the definition of CMVs to large trucks and does
not include passenger-carrying vehicles, such as buses. In addition,
the definition of CMVs is limited to trucks not in special
configurations or involved in the transport of hazardous materials.

IV. Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520)
prohibits agencies from conducting information collection (IC)
activities until they analyze the need for the collection of
information and how the collected data will be managed. Agencies must
also analyze whether technology could be used to reduce the burden
imposed on those providing the data. The Agency must estimate the time
burden required to respond to the IC requirements, such as the time
required to complete a particular form. The Agency submits its IC
analysis and burden estimate to OMB as a formal ICR; the Agency cannot
conduct the information collection until OMB approves the ICR.

V. Request for Public Comments

    FMCSA asks for comment on the IC requirements of this pilot.
Comments can be submitted to the docket as outlined under ADDRESSES at
the beginning of this notice. You are asked to comment on any aspect of
this information collection, including:
    1. Whether there are specific criteria that should make a driver
ineligible to participate in the program.
    2. Whether there are specific criteria that should make a carrier
ineligible to participate in the program.
    3. Whether the proposed collection is necessary for the performance
of FMCSA's functions.
    4. Whether additional items should be reported to FMCSA within 24
hours other than a driver being involved in a crash with injury or
fatality, a driver receiving an alcohol-related citation, a driver
choosing to leave the study, a driver leaving a carrier, or a driver
failing a random or post-crash drug/alcohol test.
    5. The accuracy of the estimated burdens.
    6. Ways for FMCSA to enhance the quality, usefulness, and clarity
of the collected information.
    7. Ways that the burden could be minimized without reducing the
quality of the collected information.
    8. Whether the data collection efforts proposed for carriers and
drivers are burdensome enough to discourage their participation.
    9. Whether a comparison of the control group, intrastate driver
group, and covered driver group is likely to produce valid conclusions.

    Issued under the authority of 49 CFR 1.87 on: June 15, 2018.
Kelly Regal,
Associate Administrator, Office of Research and Information Technology.
[FR Doc. 2018-14028 Filed 7-3-18; 4:15 pm]
 BILLING CODE 4910-EX-P


[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Pages 66011-66013]
[FR Doc No: 2015-27361]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0007]

Product Development Under the Animal Rule; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Product
Development Under the Animal Rule.'' When human efficacy studies are
not ethical and field trials are not feasible, FDA may rely on adequate
and well-controlled animal efficacy studies to support approval of a
drug or licensure of a biological product under the Animal Rule. This
guidance finalizes the 2014 revised draft guidance for industry
``Product Development Under the Animal Rule.'' It is intended to help
potential stakeholders (industry, academia, and government) understand
FDA's expectations for product development under the Animal Rule.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2009-D-0007 for ``Product Development Under the Animal Rule;
Guidance for Industry; Availability.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. This guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Rosemary Roberts, Counter-Terrorism
and Emergency Coordination Staff, Office of the Center Director, Center
for Drug Evaluation and Research, Food and Drug Administration, 10001
New Hampshire Ave., Hillandale Building, Rm. 2155, Silver Spring, MD
20993-0002,<PHONE_NUMBER>; or Cynthia Kelley, Office of the Director,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave. Bldg. 71, Rm. 7204, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Product Development Under the Animal Rule.'' In the Federal
Register of June 3, 2014 (79 FR 31950), FDA announced the availability
of a revised draft guidance for industry entitled ``Product Development
Under the Animal Rule,'' intended to help potential stakeholders
understand FDA's expectations for product development under the Animal
Rule (see 21 CFR 314.600 through 314.650 for drugs and 21 CFR 601.90
through 601.95 for biological products). The 2014 revised draft
guidance replaced the 2009 draft guidance for industry entitled
``Animal Models--Essential Elements to Address Efficacy Under the
Animal Rule'' (74 FR 3610) and addressed a broader scope of issues for
products developed under the Animal Rule. The comment period for the
revised draft guidance closed on August 4, 2014. We reviewed all
comments received and considered them in finalizing the revised draft
guidance. This guidance finalizes the revised draft guidance issued on
June 3, 2014.\1\
---------------------------------------------------------------------------

    \1\ Adequate and well-controlled animal efficacy studies are
required under the Animal Rule. As a policy, FDA is committed to the
exploration of non-animal testing methods.
---------------------------------------------------------------------------

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on product development under the Animal Rule.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995

(44 U.S.C. 3501-3520). The collection of information in 21 CFR part 312
(investigational new drug applications) has been approved under OMB
control number 0910-0014. The collection of information in 21 CFR part
314 (new drug applications) has been approved under OMB control number
0910-0001. The collection of information resulting from special
protocol assessments has been approved under OMB control number 0910-
0470. The collection of information resulting from formal meetings
between applicants and FDA has been approved under OMB control number
0910-0429. The collection of information resulting from good laboratory
practices has been approved under OMB control number 0910-0119. The
collection of information resulting from current good manufacturing
practices has been approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the Internet may obtain the document
athttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/RegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov.

    Dated: October 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27361 Filed 10-27-15; 8:45 am]
 BILLING CODE 4164-01-P