[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Proposed Rules]
[Pages 3101-3108]
[FR Doc No: 2018-01165]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2017-0597; FRL-9973- 22--Region 10]

Air Plan Approval; AK: Fine Particulate Matter Infrastructure
Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: Whenever a new or revised National Ambient Air Quality
Standard (NAAQS) is promulgated, the Clean Air Act (CAA) requires
states to submit a plan for the implementation, maintenance, and
enforcement of the standard, commonly referred to as infrastructure
requirements. The Environmental Protection Agency (EPA) is proposing to
approve the Alaska State Implementation Plan (SIP) as meeting specific
infrastructure requirements for the fine particulate matter
(PM2.5) NAAQS.

DATES: Comments must be received on or before February 22, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2017-0597, at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI),
or other information the disclosure of which 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, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Kristin Hall, Air Planning Unit,
Office of Air and Waste (OAW-150), Environmental Protection Agency--
Region 10, 1200 Sixth Ave, Seattle, WA 98101; telephone number: (206)
553-6357; email address: [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, it is intended to refer to the EPA.

Table of Contents

I. Background
II. Infrastructure Elements
III. EPA Approach To Review of Infrastructure SIP Submissions
IV. EPA Evaluation
V. Proposed Action
VI. Statutory and Executive Orders Review

I. Background

    On July 18, 1997, the EPA promulgated a new 24-hour and a new
annual NAAQS for fine particulate matter (PM2.5) (62 FR
38652). Subsequently, on October 17, 2006, the EPA tightened the 24-
hour PM2.5 NAAQS from 65 micrograms per cubic meter
([micro]g/m\3\) to 35 [micro]g/m\3\, and retained the annual
PM2.5 standard at 15 [micro]g/m\3\ (71 FR 61144). More
recently, on December 14, 2012, the EPA lowered the level of the
primary annual PM2.5 NAAQS to 12 [mu]g/m\3\ and retained the
remaining particulate matter standards (January 15, 2013, 78 FR 3086).
    After a new or revised NAAQS is promulgated, the CAA requires
states to submit infrastructure SIPs to meet basic elements required to
implement, maintain, and enforce the new or revised NAAQS. On March 10,
2016, the Alaska Department of Environmental Conservation (ADEC)
submitted a SIP revision to meet the 2012 PM2.5 NAAQS
infrastructure requirements, in addition to outstanding 1997 and 2006
PM2.5 NAAQS infrastructure elements not included in prior
submissions. Specifically, Alaska's March 10, 2016, submission
addresses the following infrastructure elements:
     CAA section 110(a)(2)(A) through (M) for the 2012
PM2.5 NAAQS;
     CAA section 110(a)(2)(G) for the 2006 PM2.5
NAAQS; and
     CAA section 110(a)(2)(G) for the 1997 PM2.5
NAAQS.
    We note that Alaska's March 10, 2016, submission addresses other
program areas, such as regional haze, transportation conformity, and
nonattainment planning. In this action, we are proposing to approve the
portion of the March 10, 2016, submission related to PM2.5
infrastructure requirements only.\1\ We previously approved other
portions of the submission on August 28, 2017 (82 FR 40712) and
September 8, 2017 (82 FR 42457), and we intend to address the remainder
of the submission in separate, future actions.
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    \1\ Consistent with past practice, the EPA intends to act on
requirements related to the CAA section 110(a)(2)(D)(i)(I)
interstate transport provisions in a separate action. See 79 FR
45103 (August 4, 2014).
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II. Infrastructure Elements

    CAA section 110(a)(1) provides the procedure and timing for SIP
submissions after a new or revised NAAQS is promulgated. CAA section
110(a)(2) lists specific elements that states must meet related to a
newly established or revised NAAQS. The EPA has issued guidance to help
states address these requirements, most recently on September 13, 2013
(2013 Guidance).\2\ The requirements, with their corresponding CAA
subsection, are listed below:
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    \2\ Stephen D. Page, Director, Office of Air Quality Planning
and Standards. ``Guidance on Infrastructure State Implementation
Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and
110(a)(2).'' Memorandum to EPA Air Division Directors, Regions 1-10,
September 13, 2013.
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     110(a)(2)(A): Emission limits and other control measures.
     110(a)(2)(B): Ambient air quality monitoring/data system.
     110(a)(2)(C): Program for enforcement of control measures.
     110(a)(2)(D): Interstate transport.
     110(a)(2)(E): Adequate resources.
     110(a)(2)(F): Stationary source monitoring system.
     110(a)(2)(G): Emergency episodes.
     110(a)(2)(H): Future SIP revisions.
     110(a)(2)(I): Areas designated nonattainment and
applicable requirements of part D.
     110(a)(2)(J): Consultation with government officials;
public notification; and Prevention of Significant Deterioration (PSD)
and visibility protection.
     110(a)(2)(K): Air quality modeling/data.
     110(a)(2)(L): Permitting fees.
     110(a)(2)(M): Consultation/participation by affected local
entities.
    The EPA's 2013 Guidance restated our interpretation that two
elements are not governed by the three-year submission deadline in CAA
section 110(a)(1) because SIPs incorporating necessary local
nonattainment area controls are due on separate schedules, pursuant to
CAA section 172 and the various pollutant-specific subparts 2 through 5
of part D. These are submissions required by: (i) CAA section
110(a)(2)(C), to the extent that subsection refers to a permit program
as required in part D, title I of the CAA, and (ii) CAA section
110(a)(2)(I). As a result, this action does not address CAA section
110(a)(2)(C) with respect to nonattainment new source review (NSR) or
CAA section 110(a)(2)(I). The EPA has also determined that the CAA
section 110(a)(2)(J) provision on visibility is not triggered by a new
NAAQS because the visibility requirements in part C, title I of the CAA
are not changed by a new NAAQS.

III. EPA Approach To Review of Infrastructure Submissions

    The EPA is proposing to approve Alaska's March 10, 2016, submission
as meeting certain PM2.5 NAAQS infrastructure requirements.
Our most recent action on an Alaska infrastructure submission was
published on May 12, 2017 (82 FR 22081). In the preamble of the action,
we published a discussion of the EPA's overall approach to review of
these types of submissions. Please see our July 20, 2016, proposed rule
for this discussion (81 FR 47103, at page 47104).

IV. EPA Evaluation

110(a)(2)(A): Emission Limits and Other Control Measures

    CAA section 110(a)(2)(A) requires SIPs to include enforceable
emission limits and other control measures, means or techniques
(including economic incentives such as fees, marketable permits, and
auctions of emissions rights), as well as schedules and timetables for
compliance, as may be necessary or appropriate to meet the applicable
requirements of the CAA.
    State submission: The submission cites regulations set forth at
Alaska Administrative Code Title 18 Environmental Conservation, Chapter
50 Air Quality Control (18 AAC 50). The relevant regulations are listed
below:
     18 AAC 50.010: Ambient Air Quality Standards.
     18 AAC 50.015: Air Quality Designations, Classifications,
and Control Regions.

     18 AAC 50.040: Federal Standards Adopted by Reference.
     18 AAC 50.050: Incinerator Emission Standards.
     18 AAC 50.055: Industrial Processes and Fuel Burning
Equipment.
     18 AAC 50.065: Open Burning.
     18 AAC 50.070: Marine Vessel Visible Emission Standards.
     18 AAC 50.075: Solid Fuel-Fired Heating Device Visible
Emission Standards.
     18 AAC 50.076: Solid Fuel-Fired Heating Device Fuel
Requirements; Registration of Commercial Wood Sellers.
     18 AAC 50.077: Standards for Wood-Fired Heating Devices.
     18 AAC 50.301: Permit Continuity.
     18 AAC 50.302: Construction Permits.
     18 AAC 50.306: Prevention of Significant Deterioration
(PSD) Permits.
     18 AAC 50.345: Construction, Minor and Operating Permits:
Standard Permit Conditions.
     18 AAC 50.502: Minor Permits for Air Quality Protection.
     18 AAC 50.508: Minor Permits Requested by the Owner or
Operator.
     18 AAC 50.540: Minor Permit: Application.
     18 AAC 50.542: Minor Permit Review and Issuance.
     18 AAC 50.544: Minor Permits: Content.
     18 AAC 50.546: Minor Permits: Revisions.
     18 AAC 50.560: General Minor Permits.
    EPA analysis: Alaska regulates emissions of PM2.5 (and
nitrogen oxides (NOX) and sulfur dioxide (SO2) as
precursors to PM2.5) through its SIP-approved major and
minor new source review (NSR) permitting programs, and other rules
described below. The EPA recently approved numerous revisions to the
Alaska SIP, including updates to 18 AAC 50.010 Ambient Air Quality
Standards to reflect the most recent NAAQS revisions--the 2012
PM2.5 and 2015 ozone NAAQS (82 FR 42457, September 8, 2017;
82 FR 40712, August 28, 2017). As a result, Alaska's ambient air
quality standards in 18 AAC 50.010 are up-to-date with current NAAQS.
    Alaska has no areas designated nonattainment for the 2012
PM2.5 NAAQS. We note, however, that the EPA does not
consider SIP requirements triggered by the nonattainment area mandates
in part D, title I of the CAA to be governed by the submission deadline
of CAA section 110(a)(1). Regulations and other control measures for
purposes of attainment planning under part D, title I of the CAA are
due on a different schedule than infrastructure SIPs.
    Alaska's major NSR permitting rules in 18 AAC Chapter 50, Article 3
for attainment and unclassifiable areas, generally rely on the federal
PSD program regulations at 40 CFR 51.166 and 40 CFR 52.21, which are
incorporated by reference into the Alaska SIP, to implement its SIP-
approved PSD permitting program. The EPA most recently approved
revisions to Alaska's PSD rules on August 28, 2017 (82 FR 40712). The
current Alaska SIP-approved PSD program incorporates by reference
specific regulations at 40 CFR 52.21 and 40 CFR 51.166 as of December
28, 2015.
    Alaska regulates minor stationary sources of PM2.5 and
precursors through its federally-approved minor NSR permitting program.
Alaska's minor NSR rules in 18 AAC Chapter 50, Article 5 were
originally approved into the SIP on July 5, 1983, and the state has
made updates and revisions to the program since then. The EPA most
recently approved substantive revisions to the Alaska minor NSR rules
on September 19, 2014 (79 FR 56268) and August 28, 2017 (82 FR 40712).
    In addition to permitting requirements, Alaska's SIP contains rules
that limit particulate matter emissions. These controls include
incinerator emission standards, emission limits for specific industrial
processes and fuel burning equipment, open burning restrictions,
visible emission limits on marine vessel emissions, and requirements
for installing and operating solid fuel-fired devices. Therefore, we
are proposing to approve the Alaska SIP as meeting the requirements of
CAA section 110(a)(2)(A) for the 2012 PM2.5 NAAQS.

110(a)(2)(B): Ambient Air Quality Monitoring/Data System

    CAA section 110(a)(2)(B) requires SIPs to include provisions to
provide for the establishment and operation of ambient air quality
monitors, collecting and analyzing ambient air quality data, and making
these data available to the EPA upon request.
    State submission: The submission references Alaska statutory and
regulatory authority to conduct ambient air monitoring investigations.
Alaska Statutes (AS) 46.03.020 Powers of the department paragraph (5)
provides authority to undertake studies, inquiries, surveys, or
analyses essential to the accomplishment of the purposes of ADEC. AS
46.14.180 Monitoring provides authority to require sources to monitor
emissions and ambient air quality to demonstrate compliance with
applicable permit program requirements. 18 AAC 50.201 Ambient Air
Quality Investigation provides authority to require a source to do
emissions testing, reduce emissions, and apply controls to sources.
    The submission references ADEC's revised Quality Assurance Project
Plan for the State of Alaska Air Monitoring and Quality Assurance
Program, adopted by reference into the State Air Quality Control Plan
at 18 AAC 50.030(4). Validated State & Local Air Monitoring Stations,
and Special Purpose Monitoring ambient air quality monitoring data are
verified, and then electronically reported to the EPA through the Air
Quality System on a quarterly basis. The submission also references the
adoption of the federal reference and interpretation methods for
PM2.5. These methods are used by ADEC in its ambient air
quality monitoring program to determine compliance with the standards.
    EPA analysis: A comprehensive air quality monitoring plan to meet
CAA monitoring requirements was originally submitted by Alaska on
January 18, 1980 (40 CFR 52.70) and approved by the EPA on April 15,
1981 (46 FR 21994). The plan includes statutory and regulatory
authority to establish and operate an air quality monitoring network,
including PM2.5 monitoring. Alaska's SIP-approved
regulations in 18 AAC 50 Article 2 govern source-specific monitoring
and emissions testing for PM2.5 in accordance with federal
reference methods. Alaska regularly assesses the adequacy of the state
monitoring network and submits that assessment to the EPA for review.
In practice, Alaska operates a comprehensive PM2.5
monitoring network, compiles and analyzes collected data, and submits
the data to the EPA's Air Quality System on a quarterly basis. We are
therefore proposing to approve the Alaska SIP as meeting the
requirements of CAA section 110(a)(2)(B) for the 2012 PM2.5
NAAQS.

110(a)(2)(C): Program for Enforcement of Control Measures

    CAA section 110(a)(2)(C) requires states to include a program
providing for enforcement of all SIP measures and the regulation of
construction of new or modified stationary sources, including a program
to meet PSD and nonattainment NSR requirements.
    State submission: With respect to enforcement, the submission
states that a violation of the prohibitions in the regulations above,
or any permit condition, can result in civil actions (AS 46.03.760
Civil action for pollution; damages), administrative penalties (AS
46.03.761 Administrative penalties), or

criminal penalties (AS 46.03.790 Criminal penalties). In addition, the
submission references compliance order and enforcement proceeding
provisions found at 18 AAC Chapter 95 Administrative Enforcement.
    With respect to construction of new and modified stationary
sources, the submission points to ADEC's statutory authority
established in AS 46.14 Air Quality Control, Article 01 General
Regulations and Classifications and Article 02 Emission Control Permit
Program. The submission states that ADEC's PSD/NSR programs were
originally approved by the EPA on February 16, 1995 (60 FR 8943), and
revisions to the program were approved in 2007, 2011, and 2015.
Alaska's regulations for construction of new and modified major sources
in attainment and unclassifiable areas (PSD) are found at 18 AAC
50.306, and those for nonattainment areas (nonattainment NSR) are found
at 18 AAC 50.311. Minor stationary sources are permitted via minor NSR
regulations in 18 AAC 50 Article 5.
    EPA analysis: We are proposing to find that Alaska statute provides
ADEC authority to enforce air quality regulations, permits, and orders
promulgated pursuant to AS 46.03 and AS 46.14. ADEC staffs and
maintains an enforcement program to ensure compliance with SIP
requirements. ADEC has emergency order authority when there is an
imminent or present danger to health or welfare or potential for
irreversible or irreparable damage to natural resources or the
environment. Enforcement cases may be referred to the State Department
of Law. Therefore, we are proposing to approve the Alaska SIP as
meeting the requirements of CAA section 110(a)(2)(C) related to
enforcement for the 2012 PM2.5 NAAQS.
    To generally meet the requirements of CAA section 110(a)(2)(C) for
regulation of construction of new or modified stationary sources,
states are required to have PSD, nonattainment NSR, and minor NSR
permitting programs adequate to implement the 2012 PM2.5
NAAQS. As explained above, we are not evaluating nonattainment related
provisions, such as the nonattainment NSR program required by part D,
title I of the CAA.
    For the PSD portion of element 110(a)(2)(C) (as well as for the PSD
portions of elements (D)(i)(II) and (J)) the EPA interprets the CAA to
require an infrastructure submission that demonstrates a complete PSD
permitting program meeting current requirements for all regulated NSR
pollutants. Alaska has a SIP-approved PSD program that incorporates by
reference certain federal PSD program requirements at 40 CFR 52.21 and
40 CFR 51.166. We most recently approved updates to the program on
August 28, 2017 (82 FR 40712). The Alaska PSD rules meet current
requirements for all regulated NSR pollutants--we are therefore
proposing to approve element 110(a)(2)(C) for PSD.
    Turning to the minor NSR requirement, the EPA originally approved
Alaska's minor NSR program into the SIP on July 5, 1983 as meeting
federal minor NSR requirements at 40 CFR 51.160 through 40 CFR 51.164
(48 FR 30623). Over the years, we have approved revisions to the
program as consistent with the CAA and federal minor NSR requirements,
most recently on August 28, 2017 (82 FR 40712). We have determined that
the program regulates construction of new and modified minor sources
for purposes of the 2012 PM2.5 NAAQS consistent with CAA
requirements. Therefore, we are proposing to approve the Alaska SIP as
meeting the requirements of CAA section 110(a)(2)(C) for the 2012
PM2.5 NAAQS.

110(a)(2)(D)(i): Interstate Transport

    CAA section 110(a)(2)(D)(i) requires state SIPs to include
provisions prohibiting any source or other type of emissions activity
in one state from contributing significantly to nonattainment, or
interfering with maintenance of the NAAQS in another state (CAA section
110(a)(2)(D)(i)(I)). Further, this section requires state SIPs to
include provisions prohibiting any source or other type of emissions
activity in one state from interfering with measures required to
prevent significant deterioration (PSD) of air quality, or from
interfering with measures required to protect visibility (i.e. measures
to address regional haze) in any state (CAA section
110(a)(2)(D)(i)(II)).
    State submission: Alaska's March 10, 2016, submission addresses
110(a)(2)(D)(i)(I) for the 2012 PM2.5 NAAQS, however, we
intend to evaluate the requirement in a separate, future action. For
purposes of CAA section 110(a)(2)(D)(i)(II), the submission references
the Alaska SIP-approved PSD program and the Alaska Regional Haze Plan.
    EPA analysis: CAA section 110(a)(2)(D)(i)(II) requires state SIPs
to contain adequate provisions prohibiting emissions which will
interfere with any other state's required measures to prevent
significant deterioration (PSD) of its air quality (prong 3), and
adequate provisions prohibiting emissions which will interfere with any
other state's required measures to protect visibility (prong 4). As
noted above for section 110(a)(2)(C), Alaska's SIP-approved PSD
program, last revised on August 28, 2017, incorporates by reference
current federal PSD requirements (82 FR 40712). We are therefore
proposing to approve the Alaska SIP as meeting the requirements of CAA
section 110(a)(2)(D)(i)(II) with respect to PSD (prong 3) for the 2012
PM2.5 NAAQS.
    To address whether emissions from sources in Alaska interfere with
any other state's required measures to protect visibility, the
submission references the Alaska regional haze SIP, submitted on March
29, 2011, and approved by the EPA on February 14, 2013 (78 FR 10546).
The EPA believes, as noted in the 2013 Guidance, that with respect to
the 110(a)(2)(D)(i)(II), where a state's regional haze SIP has been
approved as meeting all current obligations, a state may rely upon
those provisions in support of its demonstration for the visibility
sub-element. Because the Alaska regional haze SIP was found to meet
federal requirements, we are proposing to approve the Alaska SIP as
meeting the requirements of CAA section 110(a)(2)(D)(i)(II) as it
applies to visibility for the 2012 PM2.5 NAAQS (prong 4).

110(a)(2)(D)(ii): Interstate and International Transport Provisions

    CAA section 110(a)(2)(D)(ii) requires SIPs to include provisions
ensuring compliance with the applicable requirements of CAA sections
126 and 115 (relating to interstate and international pollution
abatement). CAA section 126 requires notification to neighboring states
of potential impacts from a new or modified major stationary source,
and specifies how a state may petition the EPA when a major source or
group of stationary sources in a state is thought to contribute to
certain pollution problems in another state. CAA section 115 governs
the process for addressing air pollutants emitted in the United States
that cause or contribute to air pollution that may reasonably be
anticipated to endanger public health or welfare in a foreign country.
    State submission: The submission references Alaska's SIP-approved
PSD program and certifies that Alaska has no pending obligations under
CAA section 115 or 126.
    EPA analysis: At 18 AAC 50.306(b), Alaska's PSD program
incorporates by reference the general provisions of 40 CFR 51.166(q)(2)
to describe the public participation procedures for PSD permits,
including requiring notice to states whose lands may be affected by

the emissions of sources subject to PSD. As a result, Alaska's PSD
regulations provide for notice consistent with CAA section 126(a) and
federal requirements. We confirm that Alaska has no pending obligations
under section 115 or 126(b) of the CAA. Therefore, we are proposing to
approve the Alaska SIP as meeting the requirements of CAA section
110(a)(2)(D)(ii) for the 2012 PM2.5 NAAQS.

110(a)(2)(E): Adequate Resources

    CAA section 110(a)(2)(E) requires each state to provide (i)
necessary assurances that the state will have adequate personnel,
funding, and authority under state law to carry out the SIP (and is not
prohibited by any provision of federal or state law from carrying out
the SIP or portion thereof), (ii) requirements that the state comply
with the requirements respecting state boards under CAA section 128 and
(iii) necessary assurances that, where the state has relied on a local
or regional government, agency, or instrumentality for the
implementation of any SIP provision, the state has responsibility for
ensuring adequate implementation of such SIP provision.
    State submission: The submission asserts that ADEC maintains
adequate personnel, funding, and authority to implement the SIP. The
submission refers to AS 46.14.030 State Air Quality Control Plan which
provides ADEC statutory authority to act for the state and adopt
regulations necessary to implement the state air plan. The submission
also references 18 AAC 50.030 State Air Quality Control Plan which
provides regulatory authority to implement and enforce the SIP.
    With respect to CAA section 110(a)(2)(E)(ii), Alaska's regulations
on conflict of interest are found in Title 2 Administration, Chapter 50
Alaska Public Offices Commission: Conflict of Interest, Campaign
Disclosure, Legislative Financial Disclosure, and Regulations of
Lobbying (2 AAC 50.010-2 AAC 50.920). Regulations concerning financial
disclosure are found in Title 2, Chapter 50, Article 1--Public Official
Financial Disclosure. These regulations were previously adopted and
approved into the SIP. There are no state air quality boards in Alaska.
The ADEC commissioner, however, as an appointed official and the head
of an executive agency, is required to file a financial disclosure
statement annually with the Alaska Public Offices Commission (APOC).
These disclosures are publically available through APOC's Anchorage
office.
    With respect to CAA section 110(a)(2)(E)(iii) and assurances that
the state has responsibility for ensuring adequate implementation of
the plan where the state has relied on local or regional government
agencies, the submission references statutory authority and
requirements for establishing local air pollution control programs
found at AS 46.14.400 Local air quality control programs.
    The submission also states that ADEC provides technical assistance
and regulatory oversight to the Municipality of Anchorage, Fairbanks
North Star Borough, and other local jurisdictions to ensure that the
State Air Quality Control Plan and SIP objectives are satisfactorily
carried out. ADEC has a Memorandum of Understanding with the
Municipality of Anchorage and Fairbanks North Star Borough that allows
the local entities to operate air quality control programs in their
respective jurisdictions. The South Central Clean Air Authority has
been established to aid the Municipality of Anchorage and the
Matanuska-Susitna Borough in pursuing joint efforts to control
emissions and improve air quality in the air-shed common to the two
jurisdictions.
    EPA analysis: We are proposing to find that the Alaska SIP meets
the adequate personnel, funding and authority requirements of CAA
section 110(a)(2)(E)(i). Alaska receives sections 103 and 105 grant
funds from the EPA and provides matching funds necessary to carry out
SIP requirements. For purposes of CAA section 110(a)(2)(E)(ii), we
previously approved Alaska's conflict of interest disclosure and ethics
regulations as meeting the requirements of CAA section 128 on October
22, 2012 (77 FR 64427). Finally, we are proposing to find that Alaska
has provided necessary assurances that, where the state has relied on a
local or regional government, agency, or instrumentality for the
implementation of any SIP provision, the state has responsibility for
ensuring adequate implementation of the SIP as required by CAA section
110(a)(2)(E)(iii). Therefore, we are proposing to approve the Alaska
SIP as meeting the requirements of CAA section 110(a)(2)(E) for the
2012 PM2.5 NAAQS.

110(a)(2)(F): Stationary Source Monitoring System

    CAA section 110(a)(2)(F) requires (i) the installation,
maintenance, and replacement of equipment, and the implementation of
other necessary steps, by owners or operators of stationary sources to
monitor emissions from such sources, (ii) periodic reports on the
nature and amounts of emissions and emissions-related data from such
sources, and (iii) correlation of such reports by the state agency with
any emission limitations or standards established pursuant to the CAA,
which reports shall be available at reasonable times for public
inspection.
    State submission: The submission states that ADEC has general
statutory authority in AS 46.14 Air Quality Control to regulate
stationary sources via an air permitting program which includes permit
reporting requirements, completeness determinations, administrative
actions, and stack source monitoring requirements. The submission
states ADEC has regulatory authority to determine compliance with these
statutes via information requests (18 AAC 50.200) and ambient air
quality investigations (18 AAC 50.201). Monitoring protocols and test
methods for stationary sources are adopted by reference, including the
federal reference and interpretation methods for PM2.5. The
submission also references the SIP-approved Alaska PSD program. Ambient
air quality and meteorological data that are collected for PSD purposes
by stationary sources are reported to ADEC on a quarterly and annual
basis.
    EPA analysis: The Alaska SIP establishes compliance requirements
for sources subject to major and minor source permitting to monitor
emissions, keep and report records, and collect ambient air monitoring
data. 18 AAC 50.200 Information Requests provides ADEC authority to
issue information requests to an owner, operator, or permittee for
purposes of ascertaining compliance. 18 AAC 50.201 Ambient Air Quality
Investigations provides authority to require an owner, operator, or
permittee to evaluate the effect emissions from the source have on
ambient air quality. In addition, 18 AAC 50.306 Prevention of
Significant Deterioration Permits and 18 AAC 50.544 Minor Permits:
Content provide for establishing permit conditions to require the
permittee to install, use and maintain monitoring equipment, sample
emissions, provide source test reports, monitoring data, emissions
data, and information from analysis, keep records and make periodic
reports on process operations and emissions. This information is made
available to the public through public processes outlined in these SIP-
approved rules.
    Additionally, states are required to submit emissions data to the
EPA for purposes of the National Emissions Inventory (NEI). The NEI is
the EPA's central repository for air emissions data. All states are
required to submit a comprehensive emissions inventory every three
years and report emissions for certain larger sources annually through
the EPA's online Emissions

Inventory System. As required, Alaska reports emissions data for the
six criteria pollutants and their associated precursors--nitrogen
oxides, sulfur dioxide, ammonia, lead, carbon monoxide, particulate
matter, and volatile organic compounds. The EPA compiles the emissions
data, supplementing it where necessary, and releases it to the general
public through the website https://www.epa.gov/air-emissions-inventories. Based on the above analysis, we are proposing to approve
the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(F)
for the 2012 PM2.5 NAAQS.

110(a)(2)(G): Emergency Episodes

    CAA section 110(a)(2)(G) requires states to provide for authority
to address activities causing imminent and substantial endangerment to
public health, including contingency plans to implement the emergency
episode provisions in their SIPs.
    State submission: We note that Alaska's submission addresses not
only the 2012 PM2.5 NAAQS for this element, but also the
1997 and 2006 PM2.5 NAAQS. Alaska cites statutory authority
including AS 46.03.820 Emergency powers which provides ADEC with
emergency order authority where there is an imminent or present danger
to the health or welfare of the people of the state or would result in
or be likely to result in irreversible or irreparable damage to the
natural resources or environment. The submission references 18 AAC
50.246 Air Quality Episodes and Advisories for PM2.5 which authorizes
ADEC to declare an air alert, air warning, or air advisory to notify
the public and prescribe and publicize curtailment action, including
restrictions on open burning under 18 AAC 50.065 and limits on visible
emissions from solid fuel-fired heating devices under 18 AAC 50.075.
The submission states that ADEC has also worked with the Fairbanks
North Star Borough (FNSB) to develop an emergency episode plan for
PM2.5 applicable in the FNSB area. This plan was adopted
into the state plan at 18 AAC 50.030.
    EPA analysis: Section 303 of the CAA provides authority to the EPA
Administrator to restrain any source from causing or contributing to
emissions which present an ``imminent and substantial endangerment to
public health or welfare, or the environment.'' The EPA finds that AS
46.03.820 Emergency Powers provides emergency order authority
comparable to CAA Section 303. We also find that Alaska's emergency
episode rule at 18 AAC 50.246 Air Quality Episodes and Advisories for
PM2.5, in conjunction with 18 AAC 50.065 Open Burning and 18 AAC 50.075
Solid Fuel-Fired Device Visible Emission Standards, most recently
approved by the EPA on September 8, 2017 (82 FR 40712), are consistent
with the requirements of 40 CFR part 51 subpart H for PM2.5
(prevention of air pollution emergency episodes, sections 51.150
through 51.153). Based on the foregoing, we are proposing to approve
the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(G)
for the 1997, 2006, and 2012 PM2.5 NAAQS.

110(a)(2)(H): Future SIP Revisions

    CAA section 110(a)(2)(H) requires that SIPs provide for revision of
the plan (i) from time to time as may be necessary to take account of
revisions of a national primary or secondary ambient air quality
standard or the availability of improved or more expeditious methods of
attaining the standard, and (ii), except as provided in paragraph
110(a)(3)(C), whenever the Administrator finds that the SIP is
substantially inadequate to attain the NAAQS which it implements or to
otherwise comply with any additional requirements under the CAA.
    State submission: The submission refers to statutory authority to
adopt regulations in order to implement the CAA and the state air
quality control program at AS 46.03.020(10)(A) Powers of the Department
and AS 46.14.010(a) Emission Control Regulations.
    EPA analysis: As cited above, the Alaska SIP provides for
revisions, and in practice, Alaska regularly submits SIP revisions to
the EPA to take into account changes to the NAAQS and other
requirements. We have taken action on revisions to the Alaska SIP on
many occasions in the past, most recently on September 8, 2017 (82 FR
42457), August 28, 2017 (82 FR 40712), May 19, 2016 (81 FR 31511),
March 18, 2015 (80 FR 14038), and September 19, 2014 (79 FR 56268). We
are proposing to approve the Alaska SIP as meeting the requirements of
CAA section 110(a)(2)(H) for the 2012 PM2.5 NAAQS.

110(a)(2)(I): Nonattainment Area Plan Revision Under Part D

    EPA analysis: There are two elements identified in CAA section
110(a)(2) not governed by the three-year submission deadline of CAA
section 110(a)(1), because SIPs incorporating necessary local
nonattainment area controls are due on a different timeline, pursuant
to section 172 and the various pollutant specific subparts 2 through 5
of part D. As a result, this action does not address CAA section
110(a)(2)(C) with respect to nonattainment NSR or CAA section
110(a)(2)(I).

110(a)(2)(J): Consultation With Government Officials

    CAA section 110(a)(2)(J) requires states to provide a process for
consultation with local governments and federal land managers with
respect to NAAQS implementation requirements pursuant to section 121.
CAA section 110(a)(2)(J) further requires states to notify the public
if NAAQS are exceeded in an area and to enhance public awareness of
measures that can be taken to prevent exceedances. Lastly, CAA section
110(a)(2)(J) requires states to meet applicable requirements of part C,
title I of the CAA related to prevention of significant deterioration
and visibility protection.
    State submission: The submission refers to statutory authority to
consult and cooperate with officials of local governments, state and
federal agencies, and non-profit groups found at AS 46.030.020 Powers
of the department paragraphs (3) and (8). The submission states that
municipalities and local air quality districts seeking approval for a
local air quality control program shall enter into a cooperative
agreement with ADEC according to AS 46.14.400 Local air quality control
programs, paragraph (d). ADEC can adopt new CAA regulations only after
a public hearing as per AS 46.14.010 Emission control regulations,
paragraph (a). In addition, the submission notes that public notice and
public hearing regulations for SIP submission and air quality discharge
permits are found at 18 AAC 15.050 and 18 AAC 15.060. Finally, the
submission also references the SIP-approved Alaska PSD program.
    EPA analysis: The EPA finds that the Alaska SIP, including the
Alaska rules for major source permitting, contains provisions for
consulting with government officials as specified in CAA section 121.
Alaska's PSD program provides opportunity and procedures for public
comment and notice to appropriate federal, state and local agencies. We
most recently approved updates to the Alaska PSD program on August 28,
2017 (82 FR 40712). In addition, we most recently approved the Alaska
rules that define transportation conformity consultation on September
8, 2015 (80 FR 53735) and regional haze interagency planning on
February 14, 2013, (78 FR 10546).
    ADEC routinely coordinates with local governments, states, federal
land managers and other stakeholders on air quality issues including
transportation conformity and regional haze, and provides notice to
appropriate agencies

related to permitting actions. Alaska regularly participates in
regional planning processes including the Western Regional Air
Partnership, which is a voluntary partnership of states, tribes,
federal land managers, local air agencies and the EPA, whose purpose is
to understand current and evolving regional air quality issues in the
West. Therefore, we are proposing to approve the Alaska SIP as meeting
the requirements of CAA section 110(a)(2)(J) for consultation with
government officials for the 2012 PM2.5 NAAQS.
    Section 110(a)(2)(J) also requires the public to be notified if
NAAQS are exceeded in an area and to enhance public awareness of
measures that can be taken to prevent exceedances. ADEC is a partner in
the EPA's AIRNOW and Enviroflash Air Quality Alert programs, which
provide air quality information to the public for five major air
pollutants regulated by the CAA: Ground-level ozone, particulate
matter, carbon monoxide, sulfur dioxide, and nitrogen dioxide. Alaska
also provides real-time air monitoring information to the public on the
ADEC air quality website, in addition to air advisory information.
During the summer months, the Fairbanks North Star Borough prepares a
weekly Air Quality forecast for the Fairbanks area on its website. We
are proposing to approve the Alaska SIP as meeting the requirements of
CAA section 110(a)(2)(J) for public notification for the 2012
PM2.5 NAAQS.
    Turning to the requirement in CAA section 110(a)(2)(J) that the SIP
meet the applicable requirements of part C of title I of the CAA, we
have evaluated this requirement in the context of CAA section
110(a)(2)(C) and permitting. The EPA most recently approved updates to
Alaska's PSD program on August 28, 2017 (82 FR 40712). As discussed in
section 110(a)(2)(C), the program meets current federal requirements.
Therefore, we are proposing to approve the Alaska SIP as meeting the
requirements of CAA section 110(a)(2)(J) for PSD for the 2012
PM2.5 NAAQS.
    With respect to visibility protection under element (J), the EPA
recognizes that states are subject to visibility and regional haze
program requirements under part C of the CAA. In the event of the
establishment of a new NAAQS, however, the visibility and regional haze
program requirements under part C do not change. Thus we find that
there is no new applicable requirement related to visibility triggered
under CAA section 110(a)(2)(J) when a new NAAQS becomes effective.
Based on the analysis above, we are proposing to approve the Alaska SIP
as meeting the requirements of CAA section 110(a)(2)(J) for the 2012
PM2.5 NAAQS.

110(a)(2)(K): Air Quality Modeling/Data

    CAA section 110(a)(2)(K) requires that SIPs provide for (i) the
performance of air quality modeling as the Administrator may prescribe
for the purpose of predicting the effect on ambient air quality of any
emissions of any air pollutant for which the Administrator has
established a NAAQS, and (ii) the submission, upon request, of data
related to such air quality modeling to the Administrator.
    State submission: The submission states that air quality modeling
is regulated under 18 AAC 50.215(b) Ambient Air Quality Analysis
Methods. Estimates of ambient concentrations and visibility impairment
must be based on applicable air quality models, databases, and other
requirements specified in the EPA's Guideline on Air Quality Models are
adopted by reference in 18 AAC 50.040 Federal Standards Adopted by
Reference. Baseline dates and maximum allowable increases are found in
Table 2 and Table 3, respectively, at 18 AAC 50.020 Baseline Dates and
Maximum Allowable Increases.
    EPA analysis: On August 28, 2017, we approved revisions to 18 AAC
50.215 Ambient Air Quality Analysis Methods and 18 AAC 50.040 Federal
Standards Adopted by Reference (82 FR 40712). 18 AAC 50.040, at
paragraph (f), incorporates by reference the EPA regulations at 40 CFR
part 51, Appendix W Guidelines on Air Quality Models revised as of July
1, 2015. Therefore, we are proposing to approve the Alaska SIP as
meeting the requirements of CAA section 110(a)(2)(K) for the 2012
PM2.5 NAAQS.

110(a)(2)(L): Permitting Fees

    CAA section 110(a)(2)(L) directs SIPs to require each major
stationary source to pay permitting fees to cover the cost of
reviewing, approving, implementing and enforcing a permit.
    State submission: The submission states that ADEC's statutory
authority to assess and collect permit fees is established in AS
46.14.240 Permit Administration Fees and AS 46.14.250 Emission Fees.
The permit fees for stationary sources are assessed and collected by
the Air Permits Program according to 18 AAC 50, Article 4. ADEC is
required to evaluate emission fee rates at least every four years and
provide a written evaluation of the findings (AS 46.14.250(g); 18 AAC
50.410).
    EPA analysis: The EPA fully-approved Alaska's title V program on
July 26, 2001 (66 FR 38940). While Alaska's operating permit program is
not formally approved into the SIP, it is a legal mechanism the state
can use to ensure that ADEC has sufficient resources to support the air
program, consistent with the requirements of the SIP. Before the EPA
can grant full title V approval, a state must demonstrate the ability
to collect adequate fees. The Alaska title V program included a
demonstration the state will collect a fee from title V sources above
the presumptive minimum in accordance with 40 CFR 70.9(b)(2)(i).
    In addition, Alaska SIP-approved regulations at 18 AAC 50.306(d)(2)
and 18 AAC 50.311(d)(2) require fees for purposes of major new source
permitting as specified in 18 AAC 50.400 through 18 AAC 50.499.
Therefore, we are proposing to conclude that Alaska has satisfied the
requirements of CAA section 110(a)(2)(L) for the 2012 PM2.5
NAAQS.

110(a)(2)(M): Consultation/Participation by Affected Local Entities

    CAA section 110(a)(2)(M) requires states to provide for
consultation and participation in SIP development by local political
subdivisions affected by the SIP.
    State submission: The submission asserts ADEC has authority to
consult and cooperate with officials and representatives of any
organization in the state; and persons, organization, and groups,
public and private using, served by, interested in, or concerned with
the environment of the state. The submission refers to AS 46.030.020
Powers of the department paragraphs (3) and (8) which provide authority
to ADEC to consult and cooperate with affected state and local
entities.
    EPA analysis: The EPA finds that the Alaska provisions cited above
provide for local and regional authorities to participate and consult
in the SIP development process. Therefore, we are proposing to approve
the Alaska SIP as meeting the requirements of CAA section 110(a)(2)(M)
for the 2012 PM2.5 NAAQS.

V. Proposed Action

    We are proposing to approve the Alaska SIP as meeting the following
CAA section 110(a)(2) infrastructure elements for the 2012
PM2.5 NAAQS: (A), (B), (C), (D)(i)(II), (D)(ii), (E), (F),
(H), (J), (K), (L), and (M). We are also proposing to approve the
Alaska SIP as meeting CAA section 110(a)(2)(G) for the 1997, 2006, and
2012 PM2.5 NAAQS.

VI. Statutory and Executive Orders Review

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely approves state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because it does not involve technical standards; and
     Does not provide the EPA with the discretionary authority
to address, as appropriate, disproportionate human health or
environmental effects, using practicable and legally permissible
methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Sulfur
oxides, Volatile organic compounds.

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

    Dated: January 11, 2018.
Chris Hladick,
Regional Administrator, Region 10.
[FR Doc. 2018-01165 Filed 1-22-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 90 (Wednesday, May 9, 2012)]
[Notices]
[Pages 27230-27234]
[FR Doc No: 2012-11067]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0449]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Sun Protection Factor
Labeling and Testing Requirements and Drug Facts Labeling for Over-the-
Counter Sunscreen Drug Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by June 8,
2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910--New and
title ``SPF Labeling and Testing Requirements and Drug Facts Labeling
for Over-the-Counter Sunscreen Drug Products.'' Also include the FDA
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of
Information Management, Food and

Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850,
301-796-7651<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

SPF Labeling and Testing Requirements for Over-the-Counter Sunscreen
Products Containing Specified Active Ingredients and Marketed Without
Approved Applications, and Drug Facts Labeling for All Over-the-Counter
Sunscreen Products--21 CFR 201.327(a)(1) and (i), 21 CFR 201.66(c) and
(d)

    In the Federal Register of June 17, 2011 (76 FR 35620), FDA
published a final rule establishing labeling and effectiveness testing
requirements for certain over-the-counter (OTC) sunscreen products
containing specified active ingredients and marketed without approved
applications (2011 sunscreen final rule; Sec.  201.327 (21 CFR
201.327)). The rule also lifts the delay of implementation date of the
Drugs Facts regulation (21 CFR 201.66) for all OTC sunscreens. This
rule is not yet in effect. It is intended to be effective June 18,
2012.

SPF Labeling and Testing for OTC Sunscreens Containing Specified Active
Ingredients and Marketed Without Approved Applications

    Section 201.327(a)(1) requires the principal display panel (PDP)
labeling of a sunscreen covered by the rule to include the sun
protection factor (SPF) value determined by conducting the SPF test
outlined in Sec.  201.327(i). Therefore, this provision will result in
an information collection with a third-party disclosure burden for
manufacturers of OTC sunscreens covered by the rule. Products need only
complete the testing and labeling required by the rule one time, and
then continue to utilize the resultant labeling (third party
disclosure) going forward, without additional burden.
    In the Federal Register of June 17, 2011 (76 FR 35665), we
announced the availability of a draft guidance and stated that we do
not intend to initiate enforcement action before June 17, 2013, if an
OTC sunscreen subject to Sec.  201.327 that was initially marketed
prior to June 17, 2011, the date of publication of the final rule,
continues to include an SPF value in its labeling that was determined
prior to that date according to either the SPF test method described in
the May 21, 1999, final rule (64 FR 27666 at 27689 through 27693) or
the SPF test method described in the August 27, 2007, proposed rule (72
FR 49070 at 49114 through 49119). We believe that the majority of
currently marketed OTC sunscreen formulations will meet this standard
and, therefore, may defer their conduct of new SPF testing. However,
this one-time testing will nonetheless need to be conducted within the
first 3 years after publication of the 2011 final rule for all OTC
sunscreens covered by that rule. We therefore do not anticipate that
the draft guidance will alter the annualized burden associated with
Sec.  201.327(a)(1) and (i) as estimated here. We provide a separate
PRA analysis in the notice of availability for the draft guidance to
address the information collections provisions that result from it.
    Our estimate of third-party disclosure burden includes the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information. We have estimated that there are
approximately 100 manufacturers of OTC sunscreen drug products. We
estimate that these 100 manufacturers are currently producing as many
as 2,350 OTC sunscreen formulations and that these formulations are
available in approximately 3,600 stock keeping units (SKUs) (see 2010
sunscreen final rule--indicating recent data supports estimate of up to
2,348 formulations and 3,591 SKUs).\1\
---------------------------------------------------------------------------

    \1\ Document No. FDA-1978-N-0018-0693 in Docket No. FDA-1978-N-
0018.
---------------------------------------------------------------------------

    Our estimates on the conduct of SPF testing are based on the
estimated number of formulations because, if the same formulation is
sold under different SKUs, the formulation will only have to be
retested one time in order to develop the labeling for multiple
marketed SKUs. However, our estimates on labeling are based on the
number of SKUs because, although each SKU will not need to be tested to
establish its SPF value, the labeling of each SKU has to be considered.
    To determine the SPF value required in Sec.  201.327(a)(1),
manufacturers will have to conduct SPF tests according to Sec.
201.327(i). We estimate that all 100 manufacturers will have to retest
currently marketed sunscreen formulations. We estimate that there are
approximately 2,350 existing sunscreen formulations that will require
retesting. We further estimate that it will take 24 hours (i.e., three
8-hour days) to complete SPF testing for each of the formulations. This
estimate assumes SPF testing of a high SPF sunscreen that includes 80
minutes of water resistance testing, which reflects products requiring
the most time to test. Therefore, a total of 56,400 hours will be
required as the one-time burden to retest existing sunscreen products
in accordance with Sec.  201.327(i) to provide the SPF value required
to be disclosed to the public in labeling under Sec.  201.327(a)(1). In
accordance with FDA's enforcement policy guidance, retesting of
currently marketed sunscreen products should be completed within 2
years after the date of publication of the final rule, so if this one-
time burden is annualized across that time period, the result is a
burden of 28,200 hours in each of the first 2 years to complete
retesting of existing sunscreen products.
    Once manufacturers have tested their products to determine the SPF
value, to comply with the third party disclosure (labeling)
requirements in Sec.  201.327(a)(1), the manufacturers will need to
insert the SPF value after the term ``SPF'' in either the statement
``SPF'' or ``Broad Spectrum SPF,'' as applicable. We estimate that each
of the 100 manufacturers will spend no more than 0.5 hours per SKU to
prepare, complete, and review the labeling for each of 3,600 currently
marketed SKUs. Therefore, we estimate that a total of no more than
1,800 hours will be required as a one time burden to relabel currently
marketed OTC sunscreens containing specified ingredients and marketed
without approved applications (3,600 SKUs times 0.5 hours per SKU). In
accordance with FDA's enforcement policy guidance, relabeling of
currently marketed sunscreen products should be completed within 2
years after the date of publication of the final rule, so if this one-
time burden is annualized across that time period, the result is a
burden of 900 hours in each of the first 2 years to complete relabeling
of existing sunscreen products.
    In addition, new products may also be introduced each year, and
these products will have to be tested and labeled with the SPF value
determined in the test. We estimate that as many as 60 new OTC
sunscreen products (SKUs) may be introduced each year. As discussed in
this document, there are currently approximately 1.53 SKUs marketed for
every sunscreen spray formulation (3,600 SKUs divided by 2,350
formulations). Therefore, we estimate that the 60 new sunscreen SKUs
will represent 39 new formulations annually. We expect the burden of
testing the 39 new formulations marketed each year will require 936
hours per year (39

formulations times 24 hours testing per formulation). We estimate that
labeling of the 60 new SKUs marketed each year will require 30 hours
per year (60 SKUs times 0.5 hours per SKU).
    The sunscreen 2011 final rule published on June 17, 2011. In
accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for
public comment in the Federal Register of June 17, 2011, concerning the
collection of information imposed by the final rule and allowed 60 days
for public comment on the notice (76 FR 35678-35681). FDA created a
public docket for submission of these comments (i.e., FDA-2011-N-0449).
FDA received three comments to this docket, but only two of them
concerned the collection of information in the 2011 sunscreen final
rule (i.e., FDA-2011-N-0449-0002, FDA-2011-N-0449-0003).
    These comments were submitted by: (1) Consumers Union (see
Attachment 2 of the Consumers Union comments), which publishes Consumer
Reports and (2) The Personal Care Products Council (PCPC) jointly with
The Consumer Healthcare Products Association (CHPA) (see Attachment 3
of the PCPC/CHPA comments), which are trade associations for the OTC
personal care products industry and the cosmetics industry in the
United States, respectively.
    The Consumers Union comment states that the collection of
information in the 2011 sunscreen final rule is practical and necessary
for FDA's functions. Although the comment disagrees with the 2011
sunscreen final rule's removal of a proposed in vivo ultraviolet A
(UVA) protection test, that test has no bearing upon FDA's estimate of
the third-party disclosure burden. Therefore, FDA is not making any
modifications to our estimates of burden based upon the Consumers Union
comment.
    The PCPC/CHPA comment states that FDA underestimated the burden to
industry, including the third-party disclosure burden. However, ``the
burden to industry'' is not the same as ``the third-party disclosure
burden.'' This document only addresses the third-party disclosure
burden. Table 1 of this document compares PCPC/CHPA's estimates with
FDA's estimates.

         Table 1--Comparison of PCPC/CHPA's and FDA's Estimates
------------------------------------------------------------------------
                                  PCPC/CHPA                FDA
------------------------------------------------------------------------
Sunscreen product              >364...........  100.
 manufacturers.
Existing sunscreen products    4,528; 2,943...  3,591; 2,350.
 (SKUs formulations).
New sunscreen products (SKUs;  1,262; 824 per   60; 39 per year.
 formulations).                 year.
Hours per response (SPF        170.5 per        24 per formulation.
 testing).                      formulation.
Hours per response (principal  70.5 per SKU...  0.5 per SKU.
 display panel label).
Hours per response (Drug       70.5 per SKU...  12 per SKU.
 Facts label).
------------------------------------------------------------------------

    PCPC/CHPA's estimates of the number of sunscreen products and
sunscreen product manufacturers are taken from brief letters submitted
to PCPC/CHPA from the three market research organizations (Symphony IRI
Group, The NPD Group, and Mintel). These letters are included in PCPC/
CHPA's comment. PCPC/CHPA's estimated number of existing sunscreen
products and sunscreen product manufacturers were calculated by adding
the estimated numbers from the Symphony IRI Group letter (i.e., 3,289
products, 197 manufacturers) and The NPD Group letter (i.e., 1,239
products, 167 manufacturers). PCPC/CHPA's estimated number of new
sunscreen products is taken from Mintel's letter (i.e., 1,262
products). However, how the exact numbers were derived from their
databases was not provided, nor were any potential references that may
have been used for their calculations and estimates. PCPC/CHPA's
estimate of the hours required to conduct SPF testing and create
principal display panel labels are based upon PCPC/CHPA's survey of its
members. FDA describes the bases for its estimates in the 60-day notice
concerning the collection of information imposed by the 2011 sunscreen
final rule (76 FR 35620 at 35678 through 35681).
    In conclusion, FDA does not consider the data submitted sufficient
to merit revising its estimates of third-party disclosure burden as
described in the following paragraphs. Details on how the survey was
conducted and the number of hours required to conduct SPF testing and
create principal display panel labels were not provided. In addition,
no data was submitted to support their conclusions. The market research
organizations letters provided little information about how they
derived their data regarding number of products and manufacturers.
Market research organizations also explicitly state that there is no
guarantee of the accuracy of their numbers. Therefore, FDA cannot
assess the quality of the data upon which PCPC/CHPA's estimates were
based. FDA discusses its consideration of PCPC/CHPA's estimates in the
following paragraphs.
    Estimates of sunscreen products and sunscreen product
manufacturers. FDA notes that all of PCPC/CHPA's estimates of sunscreen
products and sunscreen product manufacturers are higher than FDA's
estimates. The disparity between PCPC/CHPA's estimates and FDA's
estimates remain unclear due to the lack of information about how their
numbers were derived. PCPC/CHPA's estimate of new sunscreen products
(i.e., 1,262 products per year) is much higher than FDA's estimate
(i.e., 60 products per year). PCPC/CHPA states that its estimate of
1,262 new products includes ``new products,'' ``new variety/range
extensions,'' ``new formulations,'' ``new packaging,'' and
``relaunches.'' Many of these products may not be considered new
products (i.e., new SKUs) by FDA. For example, FDA would consider a
minor labeling change on a particular 8 fluid ounce size bottle of a
brand-name product to be a replacement of the same SKU, whereas PCPC/
CHPA considers the relabeled product to be a ``new product'' due to
``new packaging'' as stated in their submission. Because the submitted
data do not allow for verification of PCPC/CHPA's higher estimates and
the market research organizations themselves will not guarantee the
accuracy of these estimates, FDA is not revising its estimates of
sunscreen products and sunscreen product manufacturers.
    Estimate of time required for SPF testing. FDA also notes that
PCPC/CHPA's estimate of the time required to conduct SPF testing is
much higher than FDA's estimate. PCPC/CHPA explains that FDA's estimate
failed to consider the time required by good clinical practices (e.g.,
quality assurance testing, revision control, internal release of
samples, documentation release, and shipment authorization). However,
PCPC/CHPA does not provide time estimates for these procedures. Also,
compliance with good clinical practices is a standard regulatory
requirement and

does not constitute an additional burden resulting from the 2011
sunscreen final rule. Regulations controlling paperwork burdens on the
public in 5 CFR 1320.3(b)(2) state that the ``time, effort, and
financial resources necessary to comply with a collection of
information that would be incurred by persons in the normal course of
their activities will be excluded from the ``burden'' if the Agency
demonstrates that the reporting, recordkeeping, or disclosure
activities needed to comply are usual and customary.'' PCPC/CHPA also
explains that conducting the SPF test for a water-resistant product
requires 3 to 4 weeks, instead of FDA's estimate of 24 hours (i.e., 3
days, 8 hours/day). However, PCPC/CHPA does not adequately describe the
``testing timelines'' section for conducting the SPF test. Even
consideration of extra time required for data analysis fails to account
for the difference between PCPC/CHPA's and FDA's estimate. Therefore,
FDA is not revising its estimate of the time required to conduct SPF
testing.
    Estimate of the time required to create principal display labeling.
FDA's estimate of the time required to create principal display panel
labeling (e.g., 0.5 hours/SKU) differs from PCPC/CHPA's estimate (70.5
hours/SKU) because the estimates are based upon different tasks. FDA's
estimate refers to the time required to insert the SPF value on the
principal display panel, whereas PCPC/CHPA's estimate appears to be the
time required to create the entire principal display panel and the Drug
Facts panel. Only the insertion of the SPF value constitutes a third-
party disclosure burden. The remainder of the principal display panel
labeling constitutes ``public disclosure of information originally
supplied by the Federal Government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)), and, therefore, is not
considered a collection of information. Therefore, FDA is not revising
its estimate.
    Estimate of the time required to comply with Drug Facts labeling
requirements. FDA's estimate of the time required to comply with Drug
Facts labeling requirements (12 hours/SKU) differs from PCPC/CHPA's
estimate of (70.5 hours/SKU). FDA's estimate is based upon estimated
times to comply with Drug Facts requirements that were submitted in
public comments for various OTC drug products, including OTC sunscreen
products. PCPC/CHPA breaks down its estimate for complying with Drug
Facts requirements into 12 sequential steps and provides a one-sentence
description of each step. Presumably, the time estimated for each step
represents the average reported by PCPC/CHPA's members. Obtaining
averages for data has the potential for changing the outcome due to
outliers. In addition, the individual estimates from each of PCPC/
CHPA's members are not provided in the PCPC/CHPA's comment in order to
validate calculations made. Therefore, FDA cannot determine how
representative PCPC/CHPA's estimate is of its members or how variable
the estimate is between its members. In summary, FDA does not have
sufficient data to assess the validity of the estimated times for each
of these steps. Therefore, FDA does not consider the currently
available data adequate to revise its estimate.
    FDA estimates the burden of this collection of information as
follows:

                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
            Activity                respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
Conduct SPF testing in                       100           11.75           1,175              24          28,200
 accordance with Sec.
 201.327(i) for existing
 sunscreen formulations \2\.....
Conduct SPF testing in                        20            1.95              39              24             936
 accordance with Sec.
 201.327(i) for new sunscreen
 formulations...................
Create PDP labeling in                       100             180           1,800             0.5             900
 accordance with Sec.
 201.327(a)(1) for existing
 sunscreen SKUs \2\.............
Create PDP labeling in                        20               3              60             0.5              30
 accordance with Sec.
 201.327(a)(1) for new sunscreen
 SKUs...........................
                                 -------------------------------------------------------------------------------
    Total burden in years one     ..............  ..............  ..............  ..............          30,066
     and two....................
    Total burden in each          ..............  ..............  ..............  ..............             966
     subsequent year............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Burden for each of first and second years for currently marketed OTC sunscreens.

Drug Facts Labeling for OTC Sunscreens

    Because the 2011 sunscreen final rule also lifts the delay of
implementation date for Drug Facts regulations (21 CFR 201.66) for OTC
sunscreens, the rule will also modify the information collection
associated with Sec.  201.66 (currently approved under OMB control
number 0910-0340) and result in additional third-party disclosure
burden resulting from requiring OTC sunscreen products to comply with
Drug Facts regulations. In the Federal Register of March 17, 1999 (64
FR 13254), we amended our regulations governing requirements for human
drug products to establish standardized format and content requirements
for the labeling of all marketed OTC drug products, codified in Sec.
201.66 (the 1999 Drug Facts labeling final rule). Section 201.66 sets
requirements for the Drug Facts portion of labels on OTC drug products,
requiring such labeling to include uniform headings and subheadings,
presented in a standardized order, with minimum standards for type size
and other graphical features. In the Federal Register of September 3,
2004 (69 FR 53801), we delayed the Sec.  201.66 implementation date for
OTC sunscreen products indefinitely, pending future rulemaking to amend
the substance of labeling for these products. The 2011 sunscreen final
rule lifts this stay for OTC sunscreens. Therefore, currently marketed
OTC sunscreen products will incur a one-time burden to comply with the
requirements in Sec.  201.66(c) and (d).
    We estimate that there are 3,600 currently marketed OTC sunscreen
drug product SKUs, and we assume for purposes of this estimate that
none of them have yet complied with the 1999 Drug Facts labeling final
rule. These 3,600 SKUs will need to implement the new labeling format
by the implementation date included in the 2011 sunscreen final rule.
We estimate that these 3,600 SKUs are marketed by

100 manufacturers and that approximately 12 hours will be spent on each
label. The number of hours per label (response) is based on the most
recent estimate used for other OTC drug products to comply with the
1999 Drug Facts labeling final rule, including public comments received
on this estimate in 2010 that addressed sunscreens. If an average of 12
hours is spent preparing, completing, and reviewing each of the
estimated 3,600 sunscreen SKUs, the total number of hours dedicated to
the one-time relabeling of currently marketed OTC sunscreen products,
as necessary to comply with Sec.  201.66 would be 43,200 (3,600 SKUs
times 12 hours/SKU).
    In addition to this one-time burden, we estimate that 60 new
sunscreen SKUs marketed each year will have a third-party disclosure
burden to comply with Drug Facts regulations equal to 720 hours
annually (60 SKUs times 12 hours/SKU). We estimate that these new SKUs
will be marketed by 20 manufacturers. We do not expect any OTC
sunscreens to apply for exemptions or deferrals of the Drug Facts
regulations in Sec.  201.66(e).
    FDA estimates the burden of this collection of information as
follows:

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
            Activity                respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
Format labeling in accordance                100              36           3,600              12          43,200
 with Sec.   201.66(c) and (d)
 for existing sunscreen SKUs \2\
Format labeling in accordance                 20               3              60              12             720
 with Sec.   201.66(c) and (d)
 for new sunscreen SKUs \3\.....
                                 -------------------------------------------------------------------------------
    Total first year burden.....  ..............  ..............  ..............  ..............          43,920
    Total burden for each         ..............  ..............  ..............  ..............             720
     subsequent year............
----------------------------------------------------------------------------------------------------------------
\1\ FDA estimates a one-time medium capital cost of 6.1 million dollars will result from preparing labeling
  content and format for OTC sunscreens in accordance with Sec.   201.66. There are no operating or maintenance
  costs associated with this collection of information.
\2\ First-year burden for currently marketed OTC sunscreens.
\3\ Burden for first and second years for currently marketed OTC sunscreens.

    With the exception of the PDP statement of SPF value in Sec.
201.327(a)(1), the labeling requirements in Sec.  201.327(a) through
(h), which provide other elements of the PDP, as well as specific
content for indications, directions, and warnings, are a ``public
disclosure of information originally supplied by the Federal Government
to the recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)) and, therefore, are not collections of information. These
provisions are thus not subject to OMB review under the PRA.

    Dated: May 3, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11067 Filed 5-8-12; 8:45 am]
BILLING CODE 4160-01-P


Clean Air Interstate Rule Presentation to the A& WMA's 98th Annual Conference & Exhibition By the U. S. Environmental Protection Agency Office of Air and Radiation June 23, 2005 CAIR: Capacity w/ Advanced Pollution Controls 2015 2030 2030 2030 2004 Projected Coal Capacity w/ FGD ( GW)

22 22 28 88 94 89 0.2 0.3 36 61 81 21  50 100 150 200 250 2010 2015 2020 Base Case ( Title IV/ State Rules) Outside CAIR Region Base Case ( Title IV/ State Rules) CAIR Region New Coal Capacity CAIR Retrofits Projected Coal Capacity w/ SCR ( GW)

8 6 6 104 112 115 0.2 0.3 14 32 31 21  50 100 150 200 250 2010 2015 2020 Base Case ( Title IV/ State Rules) Outside CAIR Region Base Case ( Title IV/ State Rules) CAIR Region New Coal Capacity CAIR Retrofits Projected Coal Capacity in the CAIR Region w/

Advanced SO2 and NOx Controls ( GW)

81 114 123 33 31 37 41 34 26 0.2 0.3 21  50 100 150 200 250 2010 2015 2020 Both FGD & SCR ( Existing Units) FGD Only SCR Only Both FGD & SCR ( New Units) 318 302 302 National 252 243 244 CAIR Region 2020 2015 2010 Coal Capacity ( GW)