[Federal Register Volume 76, Number 198 (Thursday, October 13, 2011)]
[Proposed Rules]
[Pages 63575-63581]
[FR Doc No: 2011-26346]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 93

[EPA-HQ-OAR-2011-0393; FRL-9477-9]
RIN 2060-AR03

Transportation Conformity Rule: MOVES Regional Grace Period
Extension

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to extend the grace period before the MOtor
Vehicle Emission Simulator model (currently MOVES2010a) is required for
regional emissions analyses for transportation conformity
determinations (``regional conformity analyses''). This proposal would
provide an additional year to the previously established two-year
conformity grace period, so that MOVES2010a would not be required for
regional conformity analyses until March 2, 2013. This proposal would
not affect EPA's previous approval of the use of MOVES in official
state air quality implementation plan (SIP) submissions or the existing
grace period before MOVES2010a is required for carbon monoxide and
particulate matter hot-spot analyses for project-level conformity
determinations.

DATES: Written comments on this proposal must be received on or before
November 14, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-OAR-
2011-0393, by one of the following methods:
     http://www.regulations.gov: Follow the online instructions
for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>
     Mail: Air Docket, Environmental Protection Agency,
Mailcode: 2822T, 1200 Pennsylvania Ave., NW., Washington, DC 20460,
Attention Docket ID No. EPA-HQ-OAR-2011-0393. Please include a total of
two copies.
     Hand Delivery: Air Docket, Environmental Protection
Agency: EPA West Building, EPA Docket Center (Room 3334), 1301
Constitution Ave., NW., Washington, DC, Attention Docket ID No. EPA-HQ-
OAR-2011-0393. Please include two copies. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2011-0393. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or e-mail. The http://www.regulations.gov Web site is an ``anonymous
access'' system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://www.regulations.gov your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. 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. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
For additional instructions on submitting comments, go to Section I. of
the SUPPLEMENTARY INFORMATION section of this document.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Air and Radiation
Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER> and the telephone
number for the Air and Radiation Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Meg Patulski, State Measures and
Conformity Group, Transportation and Regional Programs Division,
Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI
48105; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>or Astrid Larsen, State Measures
and Conformity Group, Transportation and Regional Programs Division,
Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI
48105; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The content of this preamble are listed in
the following outline:

I. General Information

II. Background
III. Extension of MOVES2010a Regional Conformity Grace Period
IV. Conformity SIPs
V. Statutory and Executive Order Reviews

Availability of MOVES2010a and Support Materials

    Copies of the official version of the MOVES2010a motor vehicle
emissions model, along with user guides and supporting documentation,
are available on EPA's MOVES Web site: http://www.epa.gov/otaq/models/moves/index.htm. Guidance on how to apply MOVES2010a for SIPs and
transportation conformity purposes, including ``Policy Guidance on the
Use of MOVES2010 for State Implementation Plan Development,
Transportation Conformity, and Other Purposes'' (EPA-420-B-09-046,
December 2009) and ``Technical Guidance on the Use of MOVES2010 for
Emission Inventory Preparation in State Implementation Plans and
Transportation Conformity'' (EPA-420-B-10-023, April 2010) can be found
on the EPA's transportation conformity Web site at: http://www.epa.gov/otaq/stateresources/transconf/policy.htm.

I. General Information

A. Does this action apply to me?

    Entities potentially regulated by the transportation conformity
rule are those that adopt, approve, or fund transportation plans,
programs, or projects under title 23 U.S.C. or title 49 U.S.C. Chapter
53. Regulated categories and entities affected by today's action
include:

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                                                 Examples of regulated
                   Category                             entities
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Local government.............................  Local transportation and
                                                air quality agencies,
                                                including metropolitan
                                                planning organizations
                                                (MPOs).
State government.............................  State transportation and
                                                air quality agencies.
Federal government...........................  Department of
                                                Transportation (Federal
                                                Highway Administration
                                                (FHWA) and Federal
                                                Transit Administration
                                                (FTA)).
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    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
proposal. This table lists the types of entities of which EPA is aware
that potentially could be regulated by the transportation conformity
rule. Other types of entities not listed in the table could also be
regulated. To determine whether your organization is regulated by this
action, you should carefully examine the applicability requirements in
40 CFR 93.102. If you have questions regarding the applicability of
this action to a particular entity, consult the persons listed in the
preceding FOR FURTHER INFORMATION CONTACT section.

B. What should I consider as I prepare my comments for EPA?

1. Submitting CBI
    Do not submit this information to EPA through http://www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR Part 2.
2. Tips for Preparing Your Comments
    When submitting comments, remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree, suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.
3. Docket Copying Costs
    You may be required to pay a reasonable fee for copying docket
materials.

C. How do I get copies of this proposed rule and other documents?

1. Docket
    EPA has established an official public docket for this action under
Docket ID No. EPA-HQ-OAR-2011-0393. You can get a paper copy of this
Federal Register document, as well as the documents specifically
referenced in this action, any public comments received, and other
information related to this action at the official public docket. See
the ADDRESSES section for its location.
2. Electronic Access
    You may access this Federal Register document electronically
through EPA's Transportation Conformity Web site at http://www.epa.gov/otaq/stateresources/transconf/index.htm. You may also access this
document electronically under the Federal Register listings at http://www.epa.gov/fedrgstr/.
    An electronic version of the official public docket is available
through http://www.regulations.gov. You may use http://www.regulations.gov to submit or view public comments, access the index
listing of the contents of the official public docket, and to access
those documents in the public docket that are available electronically.
Once in the system, select ``search,'' then key in the appropriate
docket identification number.
    Certain types of information will not be placed in the electronic
public docket. Information claimed as CBI and other information for
which disclosure is restricted by statute is not available for public
viewing in the electronic public docket. EPA's policy is that
copyrighted material will not be placed in the electronic public docket
but will be available only in printed, paper form in the official
public docket.
    To the extent feasible, publicly available docket materials will be
made available in the electronic public docket. When a document is
selected from the index list in EPA Dockets, the system will identify
whether the document is available for viewing in the electronic public
docket. Although not all docket materials may be available

electronically, you may still access any of the publicly available
docket materials through the docket facility identified in the
ADDRESSES section. EPA intends to provide electronic access in the
future to all of the publicly available docket materials through the
electronic public docket.
    Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to the electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in the electronic public docket. Where practical,
physical objects will be photographed, and the photograph will be
placed in the electronic public docket along with a brief description
written by the docket staff.
    For additional information about the electronic public docket,
visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

II. Background

A. What is transportation conformity?

    Transportation conformity is required under Clean Air Act (CAA)
section 176(c) (42 U.S.C. 7506(c)) to ensure that transportation plans,
transportation improvement programs (TIPs), and federally supported
highway and transit projects are consistent with the purpose of the
SIP. Conformity to the purpose of the SIP means that transportation
activities will not cause or contribute to new air quality violations,
worsen existing violations, or delay timely attainment of the relevant
national ambient air quality standard (NAAQS) or required interim
milestones.
    Transportation conformity (hereafter, ``conformity'') applies to
areas that are designated nonattainment, and those areas redesignated
to attainment after 1990 (``maintenance areas'') for transportation-
related criteria pollutants: Ozone, particulate matter
(PM2.5 and PM10) \1\, carbon monoxide (CO), and
nitrogen dioxide (NO2). EPA's conformity rule (40 CFR Parts
51 and 93) establishes the criteria and procedures for determining
whether transportation activities conform to the SIP. EPA first
promulgated the conformity rule on November 24, 1993 (58 FR 62188) and
subsequently published several other amendments. The Department of
Transportation (DOT) is EPA's federal partner in implementing the
conformity regulation. EPA has coordinated with DOT, and they concur
with this proposal.
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    \1\ 40 CFR 93.102(b)(1) defines PM2.5 and
PM10 as particles with an aerodynamic diameter less than
or equal to a nominal 2.5 and 10 micrometers, respectively.
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B. What is MOVES2010a, and how has it been implemented to date?

    The MOtor Vehicle Emission Simulator model (MOVES) is EPA's state-
of-the-art model for estimating emissions from highway vehicles, based
on analyses of millions of emission test results and considerable
advances in the Agency's understanding of vehicle emissions. MOVES is
currently EPA's official emissions model for state and local agencies
to estimate volatile organic compounds (VOCs), nitrogen oxides
(NOX), PM, CO, and other precursors from cars, trucks,
buses, and motorcycles for SIP purposes and conformity determinations
outside of California. MOVES' database-centered design allows EPA to
update emissions data more frequently and allows users much greater
flexibility in organizing input and output data.
    MOVES2010a is the latest official version of MOVES that EPA has
approved for SIP and conformity purposes. EPA originally announced the
release of MOVES2010 in the Federal Register on March 2, 2010 (75 FR
9411) and subsequently released MOVES2010a on September 8, 2010.
MOVES2010a includes minor revisions that enhance model performance and
did not significantly affect criteria pollutant emissions results.
Since these are minor revisions to MOVES2010, MOVES2010a is not
considered a ``new model'' under section 93.111 of the conformity rule,
as described further below.
    MOVES2010a is a significant improvement over the previous emissions
model, MOBILE6.2,\2\ in terms of quality of results and overall
functionality. It incorporates the latest emissions data, more
sophisticated calculation algorithms, increased user flexibility, new
software design, and significant new capabilities. While these changes
improve the quality of on-road mobile source inventories, the overall
degree of change in the model's function also adds to the start-up time
required for the transition from MOBILE6.2 to MOVES2010a.
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    \2\ EPA announced the release of MOBILE6.2 in 2004 (69 FR
28830).
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    EPA developed MOVES as a completely new model. Whereas MOBILE6.2
was written in FORTRAN and used simple text files for data input and
output, MOVES2010a is written in JAVA and uses a relational database
structure in MYSQL to handle input and output as data tables. These
changes make MOVES more flexible, and the analysis of new data
incorporated within MOVES will enhance state and local agency
understanding of how on-road mobile sources contribute to emissions
inventories and the relative effectiveness of various control
strategies. However, this new model framework has created a significant
learning curve for state and local agency staff that are required to
use MOVES.\3\
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    \3\ Some states also purchased computers with additional
capacity and features for running MOVES.
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    In addition to the challenges of learning new software, state and
local agencies also have to make substantial changes in the processes
they have developed to create model input and apply model output. While
there were incremental changes between each previous version of the
MOBILE model, the basic input and output structure of that model was
essentially unchanged since the early 1980s. Over time, state and local
agencies developed their own methods for incorporating local inputs in
MOBILE format and for post-processing MOBILE results for inventory
development and air quality modeling. To help state and local agencies
with this part of the current transition, EPA created a number of tools
that take input data formatted for MOBILE6.2 and convert that data for
use in MOVES2010a.
    EPA anticipated many of these challenges when it released MOVES. In
order to assist in this model transition, EPA and DOT have already
provided hands-on MOVES training in many states.\4\ Additional MOVES
training for regional inventories has been requested, and will continue
to be offered for the foreseeable future. EPA continues to provide
other technical assistance to state and local agencies via on-going
conference calls with user groups, e-mail and phone support, a
frequently asked questions web page, and web-based presentations. All
of these efforts are helping state and local agencies make the
transition to MOVES2010a, and many agencies are making significant
progress in applying the model for official purposes. However, other
state and local agencies are still developing the technical capacity to
use MOVES2010a, and need more time to transition to the model and then
evaluate whether SIPs and their motor vehicle emissions budgets, or
transportation plans and TIPs, should be

revised for future conformity determinations.
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    \4\ To date, EPA and DOT staff have provided a 2-day hands-on
MOVES course for regional emissions inventories (including regional
conformity analyses) at over 30 locations around the country.
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C. Why is EPA conducting this rulemaking?

    If finalized, today's action would provide additional time that may
be critical for nonattainment and maintenance areas to learn and apply
MOVES2010a for regional conformity analyses.\5\ EPA has been contacted
by several state and local transportation and air quality agencies and
associations that are concerned that there has not been sufficient
transition time for using MOVES2010a in regional conformity analyses.
These concerns revolve around the time needed to build technical
capacity for using MOVES2010a as well as completing necessary SIP and/
or transportation plan/TIP changes to assure conformity in the future.
Further details on today's action are provided below.
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    \5\ MPOs conduct regional conformity analyses to demonstrate
that transportation plans and TIPs are consistent with the air
quality purposes of the SIP. Regional conformity analyses are also
conducted in ``isolated rural nonattainment and maintenance areas''
(defined by 40 CFR 93.101).
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    Today's proposal would not affect EPA's previous approval of
MOVES2010a for official SIP submissions developed outside of
California.\6\ Today's rulemaking would also not affect the existing
grace period before MOVES2010a is required for PM2.5,
PM10, and CO hot-spot analyses for project-level conformity
determinations (75 FR 79370). EPA coordinated closely with DOT in
developing today's action, and DOT concurs on this proposed rule.
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    \6\ MOVES is not approved for use in California. EPA approved
and announced the latest version of California's EMFAC model
(EMFAC2007) for SIP development and regional conformity analyses in
that state on January 18, 2008 (73 FR 3464).
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III. Extension of MOVES2010a Regional Conformity Grace Period

A. Background

    CAA section 176(c)(1) states that ``* * * [t]he determination of
conformity shall be based on the most recent estimates of emissions,
and such estimates shall be determined from the most recent population,
employment, travel, and congestion estimates * * *.'' To meet this
requirement, section 93.111 of the conformity rule requires that
conformity determinations be based on the latest motor vehicle
emissions model approved by EPA. When EPA approves a new emissions
model, EPA consults with DOT to establish a grace period before the
model is required for conformity analyses (40 CFR 93.111(b)). EPA must
consider many factors when establishing a grace period for conformity
determinations (40 CFR 93.111(b)(2)). The length of the grace period
will depend on the degree of change in the model and the scope of re-
planning likely to be necessary for MPOs in order to assure conformity.
The conformity rule provides for a grace period for new emissions
models of between three and 24 months (40 CFR 93.111(b)(1)).
    In the preamble to the original 1993 conformity rule, EPA
articulated its intentions for establishing the length of conformity
grace period for a new emissions model (58 FR 62211):

    ``EPA and DOT will consider extending the grace period if the
effects of the new emissions model are so significant that previous
SIP demonstrations of what emission levels are consistent with
attainment would be substantially affected. In such cases, states
should have an opportunity to revise their SIPs before MPOs must use
the model's new emissions factors. EPA encourages all agencies to
inform EPA of the impacts of new emissions models in their area, and
EPA may pause to seek such input before determining the length of
the grace period.''

Section 93.111 conformity requirements have not changed since 1993, and
have been implemented successfully for many previous model transitions.
    On March 2, 2010, EPA announced the official release of MOVES2010
and established a two-year grace period before this model was required
for new regional conformity analyses (75 FR 9411). Although the
original grace period was established for MOVES2010, EPA clarified in
September 2010 that the same grace period for regional conformity
analyses also applies to MOVES2010a.\7\ EPA based its decision to
establish a two-year conformity grace period on the factors under
section 93.111(b)(2), and advised areas to use the interagency
consultation process to examine the impact of using MOVES in their
future regional conformity analyses.
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    \7\ See ``EPA Releases MOVES2010a Mobile Source Emissions Model
Update: Questions and Answers'' (EPA-420-F-10-050, August 2010) at:
http://www.epa.gov/otaq/models/moves/MOVES2010a/420f10050.pdf.
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    Without further EPA action, MOVES2010a would be required for
regional conformity analyses that begin after March 2, 2012. As
discussed further in today's action, the special circumstances of the
transition from MOBILE to MOVES2010a require a reevaluation of the
length of this conformity grace period.

B. Description of Proposed Rule

    In today's action, EPA is proposing to provide an additional year
before MOVES2010a is required for regional conformity analyses. If
finalized, MOVES2010a would be required for new regional conformity
analyses that begin after March 2, 2013. State and local agencies
outside California would use MOVES2010a for regional conformity
analyses earlier than March 2, 2013, if desired, and would be required
to do so under limited circumstances such as after MOVES2010a SIP motor
vehicle emissions budgets have been found adequate or approved for
conformity purposes.
    Due to the unique circumstances presented by the transition from
MOBILE6.2 to MOVES2010a, EPA is proposing to add a new paragraph (b)(3)
to section 93.111 of the conformity rule. This provision would only
apply to MOVES2010a and any future minor revisions to this model that
EPA releases before March 2, 2013. Such minor revisions would not start
a new grace period for regional conformity analyses and could include
performance enhancements that reduce MOVES run time or model
improvements to reduce errors in operating the model. Any major model
updates, such as an update that significantly changes MOVES results for
criteria pollutant emissions, would be evaluated separately as a ``new
model'' under conformity rule section 93.111, pursuant to previously
established requirements.
    Before the end of the extended conformity grace period (March 2,
2013), areas would use the interagency consultation process to examine
how MOVES2010a would impact their future MPO transportation plan/TIP
conformity determinations. Isolated rural areas would also consider the
impact of using MOVES2010a on future regional conformity analyses. If
finalized, agencies should carefully consider whether the SIP and its
motor vehicle emissions budgets should be revised with MOVES2010a or if
transportation plans and TIPs should be revised before the end of the
conformity grace period, since doing so may be necessary to ensure
conformity in the future.
    The proposal would allow regional conformity analyses that are
started during the grace period to be based on either MOBILE6.2 or
MOVES2010a. If the grace period ended on March 2, 2013, MOVES2010a
would become the only approved motor vehicle emissions model for
regional conformity analyses outside California at that time. This
would mean that all new regional conformity analyses started after the
end of the grace period must be based on MOVES2010a, even if the SIP is
based

on MOBILE6.2 or earlier versions of MOBILE.
    For complete explanations of how MOVES2010a is to be implemented
for transportation conformity, including details about using MOVES2010a
during the grace period, refer to EPA's existing MOVES policy
guidance.\8\
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    \8\ ``Policy Guidance on the Use of MOVES2010 for State
Implementation Plan Development, Transportation Conformity, and
Other Purposes'' (EPA-420-B-09-046, December 2009) can be found on
the EPA's transportation conformity Web site at: http://www.epa.gov/otaq/stateresources/transconf/policy.htm.
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C. Rationale

    MOVES2010a is EPA's best tool for estimating criteria pollutant
emissions, and it is a significant improvement over previous MOBILE
models. State and local agencies have made significant progress to date
in using MOVES2010a, and EPA supports these efforts and encourages that
they continue. However, as discussed above, challenges related to
start-up and model application have been much greater in the transition
to MOVES2010a, compared to past transitions between MOBILE model
versions. As a result, EPA has determined that a one-year extension of
the MOVES2010a grace period is necessary for state and local agencies
to complete the current transition. Today's action would ensure that
state and local governments have the necessary time to implement the
conformity rule as originally intended.
    Since 1993, the fundamental purpose of section 93.111(b) of the
conformity rule has been to provide a sufficient amount of time for
MPOs and other state and local agencies to adapt to using new emissions
tools. As discussed above, the transition to a new emissions model for
conformity involves more than learning to use the new model and
preparing input data and model output. After model start-up is
complete, state and local agencies also need to consider how the model
affects regional conformity analysis results and whether SIP and/or
transportation plan/TIP changes are necessary to assure future
conformity determinations. EPA believes that the proposed one-time
extension of the current MOVES2010a regional grace period is critical
to assure future conformity determinations based on MOVES2010a.
    EPA has the discretion to establish an extended grace period for
MOVES2010a, and today's action is consistent with CAA section 176(c)(1)
requirements. EPA believes that the proposal to provide one additional
year is appropriate due to this unique transition from MOBILE6.2 to
MOVES2010a. This decision is consistent with the existing conformity
criteria in section 93.111(b)(2) of the conformity rule that requires
the length of the grace period to be based on ``the degree of change in
the model and the scope of re-planning likely to be necessary by MPOs
in order to assure conformity.''
    Today's proposal would not delay the use of MOVES2010a in SIP
development or slow down past progress toward using the new model for
regional conformity analyses. As noted above, many state and local
agencies are already learning and applying MOVES2010a. Some are
revising existing SIP budgets using the new model, while others may be
incorporating MOVES2010a into new maintenance plans or clean data
determinations. Under EPA's existing MOVES policy guidance, new or
revised SIP budgets must still be based on MOVES2010a. For example,
MOVES2010a continues to be required for attainment SIPs for the 2006
24-hour PM2.5 NAAQS. Under the proposal, MOVES2010a would
also be required for any regional conformity analyses prior to March 2,
2013 if SIP budgets based on MOVES2010 or MOVES2010a are approved or
found adequate sooner.\9\
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    \9\ See Questions 5, 6, and 11 of ``Policy Guidance on the Use
of MOVES2010 for State Implementation Plan Development,
Transportation Conformity, and Other Purposes'' (EPA-420-B-09-046,
December 2009).
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    In addition, today's action would not change the current MOVES2010a
grace period for new PM2.5, PM10, and CO hot-spot
analyses for project-level conformity determinations. EPA noted
previously that a two-year conformity grace period was necessary to
apply MOVES2010a for hot-spot analyses (75 FR 79370). However, the
transition to MOVES2010a for project-level hot-spot analyses does not
involve the complexity associated with the regional level, where SIP
budgets and/or transportation plans/TIPs may need to be revised before
regional conformity analyses based on MOVES2010a can be completed.
    Finally, in issuing this proposal, EPA is not proposing to proceed
pursuant to or reopen as a general matter the process and length of
conformity grace periods for future emissions model approvals, which
were previously established in 1993 (58 FR 62211). The unique set of
circumstances involved in the current transition warrants the proposed
additional state and local flexibility before MOVES2010a is required
for regional conformity analyses.

IV. Conformity SIPs

    The proposed MOVES2010a regional grace period extension would apply
on the effective date of a final rule in all nonattainment and
maintenance areas. Section 51.390(a) of the conformity rule states that
the federal rule applies for the portion of the requirements that are
not included in a state's approved conformity SIP.\10\ Section
51.390(b) further allows state conformity provisions to contain
criteria and procedures that are more stringent than the federal
requirements. However, in the case of states with conformity SIPs that
include the grace period provision in 40 CFR 93.111(b)(1), EPA
concludes that such states did not intend to require a shorter grace
period than EPA, in consultation with DOT, believes is needed.
Therefore, since the MOVES2010a grace period extension would be a new
provision being added to the conformity rule, it is not included in any
current state conformity SIP and therefore would apply immediately, if
finalized, in all areas pursuant to section 51.390(a).
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    \10\ A conformity SIP is required by the CAA and contains a
state's conformity requirements, including the state's specific
interagency consultation procedures.
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    In addition, section 51.390(c) of the conformity rule requires
states to submit a new or revised conformity SIP to EPA within 12
months of the Federal Register publication date of final conformity
rules in certain situations. States with approved conformity SIPs that
are prepared in accordance with current CAA requirements would not be
required to submit new conformity SIP revisions under a final rule,
since section 93.111 of the conformity rule is not contained in these
SIPs. A conformity SIP prepared in accordance with current CAA
requirements contains only the state's criteria and procedures for
interagency consultation (40 CFR 93.105) and two additional provisions
related to written commitments for certain control and mitigation
measures (40 CFR 93.122(a)(4)(ii) and 93.125(c)). However, states with
approved conformity SIPs that include section 93.111 from a previous
rulemaking would be required to submit a SIP revision within 12 months
of the publication date of any final rule, although EPA strongly
encourages these states to submit a SIP revision with only the three
required provisions.\11\ A state without an approved conformity SIP
would not be required to submit a new conformity SIP

within one year of a final rule, but previous conformity SIP deadlines
continue to apply.
---------------------------------------------------------------------------

    \11\ The conformity SIP may contain provisions more stringent
than the federal requirements, and in these cases, states would
specify this intention in its original conformity SIP submission.
---------------------------------------------------------------------------

    For additional information on conformity SIPs, please refer to the
January 2009 guidance entitled, ``Guidance for Developing
Transportation Conformity State Implementation Plans'' available on
EPA's Web site at: http://www.epa.gov/otaq/stateresources/transconf/policy/420b09001.pdf.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is a ``significant regulatory action.'' Accordingly, EPA
submitted this action to the Office of Management and Budget (OMB) for
review under Executive Orders 12866 and 13563 (76 FR 3821, January 21,
2011) and any changes made in response to OMB recommendations have been
documented in the docket for this action.

B. Paperwork Reduction Act

    This action would not impose any new information collection burden.
The information collection requirements of EPA's existing
transportation conformity regulations and the proposed revisions in
today's action are already covered by EPA information collection
request (ICR) entitled, ``Transportation Conformity Determinations for
Federally Funded and Approved Transportation Plans, Programs and
Projects.'' OMB has previously approved the information collection
requirements contained in the existing regulations at 40 CFR Part 93
under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et
seq. and has assigned OMB control number 2060-0561. The OMB control
numbers for EPA's regulations in 40 CFR are listed in 40 CFR Part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an Agency
to prepare a regulatory flexibility analysis of rules subject to
notice-and-comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the Agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small not-for-profit organizations and small government jurisdictions.
    For purposes of assessing the impacts of today's proposal on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's (SBA) regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise that is independently owned and operated
and is not dominant in its field.
    After considering the economic impacts of today's proposed rule on
small entities, I certify that this action would not have a significant
economic impact on a substantial number of small entities. This
proposal would directly affect federal agencies and MPOs that, by
definition, are designated under federal transportation laws only for
metropolitan areas with a population of at least 50,000. These
organizations do not constitute small entities within the meaning of
the RFA. Therefore, this proposal would not impose any requirements on
small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This proposal does not contain a Federal mandate that may result in
expenditures of $100 million or more for state, local, and tribal
governments, in the aggregate, or the private sector in any one year.
This rule would merely implement already established law that imposes
conformity requirements and would not itself impose requirements that
may result in expenditures of $100 million or more in any year. Thus,
today's proposal is not subject to the requirements of sections 202 and
205 of the UMRA.
    This proposal is also not subject to the requirements of section
203 of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. This proposal would
not significantly or uniquely impact small governments because it
directly affects federal agencies and MPOs that, by definition, are
designated under federal transportation laws only for metropolitan
areas with a population of at least 50,000.

E. Executive Order 13132: Federalism

    This proposal does not have federalism implications. It would not
have substantial direct effects on states, on the relationship between
the national government and states, or on the distribution of power and
responsibilities among the various levels of government, as specified
in Executive Order 13132. The CAA requires conformity to apply in
certain nonattainment and maintenance areas as a matter of law, and
today's action would merely revise one provision for transportation
planning entities in subject areas to follow in meeting their existing
statutory obligations. Thus, Executive Order 13132 does not apply to
this proposal.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). The CAA requires
transportation conformity to apply in any area that is designated
nonattainment or maintenance by EPA. Because today's proposal would not
significantly or uniquely affect the communities of Indian tribal
governments, Executive Order 13175 does not apply to this action.

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

    This proposal is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not economically significant as defined
in Executive Order 12866, and because the Agency does not believe the
environmental health or safety risks addressed by this action present a
disproportionate risk to children.

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

    This proposal is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 18355 (May 22, 2001)), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy. It would not create a serious
inconsistency or otherwise interfere with an action taken or planned by
another agency regarding energy. This action is not subject to
Executive Order 13211 because it does not have any adverse energy
effects.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., material specifications, test methods,

sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards. This
proposal does not involve technical standards. Therefore, EPA is not
considering the use of any voluntary consensus standards.

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

    Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this action would not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations. The proposed rule
involves a minor revision that provides administrative relief but does
not change the conformity rule's underlying requirements for regional
conformity analyses.

List of Subjects in 40 CFR Part 93

    Administrative practice and procedure, Air pollution control,
Carbon monoxide, Clean Air Act, Environmental protection, Highways and
roads, Intergovernmental relations, Mass transportation, Nitrogen
dioxide, Ozone, Particulate matter, Transportation, Volatile organic
compounds.

    Dated: October 4, 2011.
Lisa P. Jackson,
Administrator.
[FR Doc. 2011-26346 Filed 10-12-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Notices]
[Pages 29275-29277]
[FR Doc No: 2016-11098]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1092]

Over-the-Counter Monograph User Fees: Public Meeting; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to gather stakeholder input on the potential development of a
user-fee program for nonprescription (over-the-counter or OTC)
monograph drugs. A user-fee program would provide funding to supplement
congressional non-user-fee appropriations, and would support timely and
efficient FDA review of the efficacy and safety of ingredients included
in or proposed for inclusion in a monograph. FDA invites public comment
on a potential OTC monograph user-fee program and also invites
suggestions regarding the features such a user-fee program should
include.

DATES: The public meeting will be held on Friday, June 10, 2016, from 9
a.m. to 5 p.m. EDT. However, depending on the level of public
participation, the meeting may be extended or may end early.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus,
Bldg. 31 Conference Center, 10903 New Hampshire Ave., the Great Room
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information refer to http://www.fda.gov/aboutfda/workingatfda/buildingsandfacilities/whiteoakcampusinformation/ucm241740.htm.
    Comments: Regardless of participation at the public meeting,
interested persons may submit electronic or written comments regarding
this document. To provide adequate time for parties to submit comments
before and after the public meeting, the docket will remain open 30
days after the public meeting.
    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-2016-N-1092 for ``Over-the-Counter Monograph User Fees: Public
Meeting; Requests for Comments.'' 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.

FOR FURTHER INFORMATION CONTACT: Amy Bertha, Office of Executive
Programs, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903-0002,
301-796-1647, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public meeting to obtain input on a potential
OTC monograph user-fee program. The Prescription Drug User Fee Act
(PDUFA) and other FDA user-fee programs for medical products provide
vital resources that have enabled more timely evaluation of the safety
and efficacy of many prescription drugs, biologics and devices, with
consequent benefits to public health through the expanded availability
of products to treat and manage a wide variety of conditions. However,
no user-fee program exists for hundreds of thousands of drug products
marketed under OTC drug monographs. Millions of American consumers
every year use monograph drug products to self-manage numerous
conditions. The efficacy and safety of these drugs is important to
public health, but FDA is critically under-resourced in this regulatory
area.
    In the United States, OTC drugs are marketed in two different
ways--under an approved marketing application (new drug application
(NDA) or abbreviated new drug application (ANDA)) or under the OTC
monograph system, which was set up to review the safety and efficacy of
drug products that were marketed OTC in the United States prior to the
current statutory NDA process. When sponsors submit marketing
applications, FDA reviews these applications and approves those drugs
that are found to be safe and effective under their proposed conditions
of use with benefits that outweigh their risks. However, at the time of
establishment of the statutory efficacy requirement, there were
hundreds of thousands of OTC products on the market. Withdrawing all
those products and requiring submission of a new drug application for
each one was undesirable for public health, and would have resulted in
an overwhelming number of individual applications for review. Instead,
in 1972, FDA established the OTC drug review process. In that process,
expert advisory review panels were established to evaluate evidence of
safety and efficacy for ingredients in broad therapeutic classes of OTC
drug products. These panels reviewed data submissions and provided
reports to FDA. Those reports made recommendations regarding whether or
not the ingredients were ``generally recognized as safe and effective
(GRASE)'' for use in self-treatment. The review panels also reviewed
claims and recommended appropriate labeling. Based on the panels'
reviews, FDA published in the Federal Register advanced notices of
proposed rulemaking and, after additional Agency review and public
comment, tentative final monographs. Subsequently, final regulations in
the form of individual drug monographs were established for various
therapeutic areas; these monographs establish conditions of use under
which ingredients are considered GRASE for inclusion in an OTC drug.
Conditions of use can include, for example, indications for use, dosage
form, and route of administration. Products that conform to all
applicable regulations, including all aspects of the relevant
monograph, will be GRASE and not misbranded if marketed without an
approved marketing application. GRASE determinations were made, and
monographs proposed and finalized, for many ingredients for many drug
products. However, the process has not been completed for all
ingredients, nor for all OTC conditions of use. In many cases, the data
submitted to the advisory panels were inadequate for a final GRASE
determination; these ingredients are referred to as ``Category III''
ingredients in OTC products. Many products containing Category III
ingredients without a GRASE determination continue to be marketed. By
contrast, ingredients with a final determination of ``not GRASE'' need
an approved marketing application to be legally marketed.
    The OTC monograph drug review process remains one of the largest
and most complex regulatory programs ever undertaken at FDA. There are
approximately 88 simultaneous rulemakings in 26 broad therapeutic areas
encompassing hundreds of thousands of products. There are approximately
800 active ingredients for over 1,400 different therapeutic uses. FDA
needs additional resources to work toward finalization of the monograph
review process and to address safety issues in a more efficient and
timely manner. Additional resources would also better enable the Agency
to consider innovations for drug products containing monograph
ingredients, such as the development of new dosage forms for
ingredients under existing monographs.
    There are some important differences between marketing through
approved applications and marketing under the monographs. NDAs and
ANDAs are product-based; an application typically is submitted with
data for a single drug product to be marketed by a single sponsor, and
that application will be approved or not approved. By contrast, the
monograph system is ingredient-based; numerous sponsors may make the
same ingredient for the same use, and all may market drug products made
with this ingredient as long as they comply with all applicable
regulations, including the conditions of the monograph. Sponsors of
monograph drugs are not required to seek FDA approval prior to
marketing a product under the monograph. In addition, the monograph
system, where ingredients are determined to be GRASE or not, is a
public process. Data are submitted to public dockets, and anyone may
provide input. By contrast, while FDA typically makes NDA information
public after approval of a product, it generally cannot do so before.
    At this time, once a monograph has been established, additional
rulemaking is required for changes to that monograph. FDA is working on
multiple policy reforms to streamline and modernize the monograph
system; those policy reforms are not the topic of this public meeting.
Funds from other user-fee programs cannot be used to fund monograph
activities, and FDA receives

very few resources that it can allocate to monograph review work.
    The potential benefits of additional resources from a monograph
user-fee program include benefits to public health and sponsors of
monograph drug products, such as the following:
     Ability to address safety issues of currently marketed
products in an efficient and timely manner.
     Timely determination on the safety and efficacy of
monograph ingredients under the conditions of the monograph, helping to
assure appropriate marketing of thousands of nonprescription products
used daily by U.S. consumers.
     Increased availability of certain monograph product
innovations proposed by industry.
     Streamlined ability to update monographs to allow modern
testing methods in several areas, potentially reducing the need for
animal testing, and simplifying and speeding product development.
     Development of information technology infrastructure to
speed numerous parts of the monograph review process, and enable a
modern robust system for submission of materials and archiving of
documents.
     Development of a modern, useful, and transparent FDA
monograph Web site to provide the public and industry with access to
important information.
     Ability to hold more public meetings on important
monograph issues.
     Increased ability of FDA to respond to monograph-related
concerns and questions from the public and industry.
     Establishment of additional infrastructure for the
efficient continued conduct of monograph activities in the longer term.

II. Purpose of Public Meeting

    The purpose of the meeting is to obtain input from industry and
other interested stakeholders regarding a potential OTC monograph user-
fee program. There are several factors that FDA considers important in
developing a user-fee program. First, to achieve a program's goals of
efficient and timely oversight of a category of products, FDA must be
able to rely on a stable and predictable source of adequate funding.
Funding sources that result in unpredictable revenue cause uncertainty
about FDA's ability to continue supporting activities over time which
disrupts the Agency's regulatory operations and contributes to
difficulties in conducting long-range planning. Second, the assessment
of fees can create certain incentives or disincentives for the activity
that is the subject of the fee. For example, a sponsor who currently
has an unmarketed product has an incentive to pay a fee to seek FDA
approval to market the product. However, once the product is approved
and marketed, there is less incentive to pay a fee for additional
specific activities regarding the product that are otherwise not
required. If those activities are important from a public health
perspective, assessing a fee for them would be undesirable because the
fee could discourage entities to undertake those activities. With these
considerations in mind, FDA seeks input on the following questions and
welcomes any other relevant information the public would like to share.
     What types of user fees (e.g. product listing fees,
facility fees, application fees, other types of fees) might be
appropriate for a potential monograph user-fee program? Consider the
following in your answer:
    [cir] For monograph products (unlike for products currently covered
by user-fee programs), premarket applications are not generally
submitted, and thus the approach regarding application-based fees might
be expected to be different for a monograph user fee program compared
to other user fee programs.
    [cir] Desirable industry activities or behavior that might be
discouraged by the assessment of fees.
    [cir] The stability and predictability of the funding provided by
the user-fee type.
     In conjunction with receiving user fees, FDA typically
commits to certain performance goals related to the Agency's activities
with respect to the relevant products. What types of performance goals
might be important to consider from a public health and sponsor
perspective? What parameters could be measured to gauge the success of
a user-fee program?

III. Meeting Attendance and Participation

    The public meeting is free and seating will be on a first-come,
first-served basis. FDA is seeking participation (i.e., attendance and
oral presentations) at the public meeting by all interested parties. In
general the meeting format may include, but will not be limited to,
presentations by FDA staff, scientific and academic experts, health
care professionals, representatives of patient and consumer advocacy
groups, and representatives of the OTC monograph industry. If you wish
to attend the public meeting either in person or by viewing the web
cast, FDA asks that you please register through Eventbrite by Tuesday,
May 31, 2016, in order for FDA to estimate the number of attendees
(https://www.eventbrite.com/e/over-the-counter-monograph-user-fees-public-meeting-tickets-21565448838).
    If you wish to make an oral presentation at the public meeting, you
must register through Eventbrite by Tuesday, May 31, 2016 (https://www.eventbrite.com/e/over-the-counter-monograph-user-fees-public-meeting-tickets-21565448838). FDA encourages individuals and
organizations with common interests to coordinate and give a joint,
consolidated presentation. FDA will try to accommodate all persons who
wish to make a presentation; however, FDA may limit both the number of
participants from individual organizations and the total number of
attendees based on space and time limitations. FDA will notify
registered presenters of their scheduled presentation times. Persons
registered to speak should check in before the meeting and are
encouraged to arrive early to ensure their designated order of
presentation. Participants who are not present when called may not be
permitted to speak at a later time. FDA will post an agenda of the
public meeting and other background material at least 3 days before the
public meeting and additional information will be available at: http://www.fda.gov/Drugs/NewsEvents/ucm499390.htm.
    This public meeting will be web cast and the URL will be posted at
http://www.fda.gov/Drugs/NewsEvents/ucm499390.htm at least 1 day before
the meeting. A video record of the public meeting will be available at
the same Web site address for 1 year. If you need special
accommodations because of disability, please contact Amy Bertha (see
FOR FURTHER INFORMATION CONTACT) no later than Friday, May 27, 2016.

IV. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD. A
transcript will also be available in either hardcopy or on CD-ROM after
submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov.

    Dated: May 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11098 Filed 5-10-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Notices]
[Pages 45529-45531]
[FR Doc No: 2015-18679]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP15-492-000]

Dominion Transmission, Inc.; Notice of Intent To Prepare an
Environmental Assessment for the Proposed Leidy South Project and
Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Leidy South Expansion Project
involving construction and operation of facilities by Dominion
Transmission, Inc. (DTI) in Clinton, Centre, and Franklin Counties,
Pennsylvania, Frederick County, Maryland, and Loudoun and Fauquier
Counties, Virginia. The Commission will use this EA in its decision-
making process to determine whether the project is in the public
convenience and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the project. You can make a difference by providing us with
your specific comments or concerns about the project. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
Your input will help the Commission staff determine what issues they
need to evaluate in the EA. To ensure that your comments are timely and
properly recorded, please send your comments so that the Commission
receives them in Washington, DC on or before August 22, 2015.
    If you sent comments on this project to the Commission before the
opening of this docket on May 15th, 2015, you will need to file those
comments in Docket No. CP15-492-000 to ensure they are considered as
part of this proceeding.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of your property
in order to construct, operate, and maintain the proposed facilities.
The company would seek to negotiate a mutually acceptable agreement.
However, if the Commission approves the project, that approval conveys
with it the right of eminent domain. Therefore, if property
negotiations fail to produce an agreement, the pipeline company could
initiate condemnation proceedings where compensation would be
determined in accordance with state law.
    DTI provided landowners with a fact sheet prepared by the FERC
entitled ``An Interstate Natural Gas Facility On My Land? What Do I
Need To Know?'' This fact sheet addresses a number of typically asked
questions, including the use of eminent domain and how to participate
in the Commission's proceedings. It is also available for viewing on
the FERC Web site (www.ferc.gov).

Public Participation

    For your convenience, there are three methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has expert staff available to assist you at
(202) 502-8258 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' If you are filing a comment on a particular project,
please select ``Comment on a Filing'' as the filing type; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project docket number
(CP15-492-000) with your submission: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Room 1A,
Washington, DC 20426.

Summary of the Proposed Project

    DTI proposes to construct, install, own, operate, and maintain
compression or appurtenant facilities located in Clinton, Franklin, and
Centre Counties, Pennsylvania; Frederick County, Maryland; and Loudoun
and Fauquier counties, Virginia.
    The Leidy South Project would consist of the following facilities:
     11,000 horsepower (hp) of additional compression at the
Finnefrock Compressor Station in Clinton County, Pennsylvania;
     upgrade filter separators at the Centre Compressor Station
in Centre County, Pennsylvania;
     13,220 hp of additional compression at the Chambersburg
Compressor Station in Franklin County, Pennsylvania;
     15,900 hp of additional compression, installation of a
selective catalytic reduction systems, and modifications to existing
compressor unit at the Myersville Compressor Station in Frederick
County, Maryland;
     8,000 hp additional electric compression at the Leesburg
Compressor Station in Loudoun County, Virginia;
     installation of a new cooler and filter separator at the
Quantico Compressor Station in Fauquier County, Virginia; and
     construction of a new metering and regulation station at
the Panda

Stonewall Meter Station, in Loudoun County, Virginia.
    The Leidy South Project would provide about 155 million standard
cubic feet of natural gas per day to existing and new electric power
generation facilities. The general location of the project facilities
is shown in appendix 1.\1\
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    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called ``eLibrary'' or from the Commission's Public
Reference Room, 888 First Street NE., Washington, DC 20426, or call
(202) 502-8371. For instructions on connecting to eLibrary, refer to
the last page of this notice.
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Land Requirements for Construction

    Construction of the proposed facilities would temporarily disturb
about 124.1 acres of land within DTI's or the Leidy Storage facility
property boundaries, including 34.7 acres within existing compressor
station fence lines. Following construction, DTI would maintain about
56.4 acres for permanent operation of the project's facilities; the
remaining acreage would be restored and revert to former uses.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\2\ to discover and address concerns the public may have about
proposals. This process is referred to as ``scoping.'' The main goal of
the scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
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    \2\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
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    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the proposed project under these
general headings:
     Geology and soils;
     land use;
     water resources, fisheries, and wetlands;
     cultural resources;
     vegetation and wildlife;
     air quality and noise;
     endangered and threatened species;
     public safety;
     socioeconomics; and
     cumulative impacts
    We will also evaluate reasonable alternatives to the proposed
project or portions of the project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. Depending on
the comments received during the scoping process, we may also publish
and distribute the EA to the public for an allotted comment period. We
will consider all comments on the EA before making our recommendations
to the Commission. To ensure we have the opportunity to consider and
address your comments, please carefully follow the instructions in the
Public Participation section, beginning on page 2.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues of
this project to formally cooperate with us in the preparation of the
EA.\3\ Agencies that would like to request cooperating agency status
should follow the instructions for filing comments provided under the
Public Participation section of this notice.
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    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
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Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with the applicable State Historic Preservation Offices (SHPO), and to
solicit their views and those of other government agencies, interested
Indian tribes, and the public on the project's potential effects on
historic properties.\4\ We will define the project-specific Area of
Potential Effects (APE) in consultation with the SHPOs as the project
develops. On natural gas facility projects, the APE at a minimum
encompasses all areas subject to ground disturbance (examples include
construction right-of-way, contractor/pipe storage yards, compressor
stations, and access roads). Our EA for this project will document our
findings on the impacts on historic properties and summarize the status
of consultations under section 106.
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    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
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Currently Identified Environmental Issues

    We have already identified several issues that we think deserve
attention based on a preliminary review of the proposed facilities and
the environmental information provided by DTI. This preliminary list of
issues may be changed based on your comments and our analysis.

 Visual
 Air and noise; and
 Cumulative impacts

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed project.
    If we publish and distribute the EA, copies of the EA will be sent
to the environmental mailing list for public review and comment. If you
would prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the User's Guide under the ``e-filing'' link on the Commission's Web
site.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP15-
492). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

Kimberly D. Bose,
 Secretary.
[FR Doc. 2015-18679 Filed 7-29-15; 8:45 am]
 BILLING CODE 6717-01-P