[Federal Register Volume 85, Number 105 (Monday, June 1, 2020)]
[Notices]
[Pages 33162-33163]
[FR Doc No: 2020-11679]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-0626]

Proprietary Names for New Animal Drugs; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry #240 entitled
``Proprietary Names for New Animal Drugs.'' This guidance provides
recommendations to help new animal drug sponsors develop proprietary
names for new animal drugs that do not contribute to medication errors,
negatively impact safe use of the drug, or misbrand the drug. This
guidance proposes a framework for evaluating proposed proprietary names
before submitting them for review by the Center for Veterinary Medicine
(CVM or we). It also explains how new animal drug sponsors can request
that CVM evaluate a proposed proprietary name.

DATES: The announcement of the guidance is published in the Federal
Register on June 1, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2018-D-0626 for ``Proprietary Names for New Animal Drugs.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: For questions regarding this document,
contact Tom Modric, Center for Veterinary Medicine (HFV-216), Food and
Drug Administration, 7519 Standish Place, Rockville, Rockville, MD
20855,<PHONE_NUMBER><EMAIL_ADDRESS>or 6a2b1901293c272a0c0e0b44020219440d051c.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 12, 2018 (83 FR 10732), FDA
published the notice of availability for a draft guidance entitled
``Proprietary Names for New Animal Drugs,'' giving interested persons
until May 11, 2018, to comment on the draft guidance. FDA received
comments on the draft guidance, and those comments were considered as
the guidance was finalized. Changes made include revisions to the
definitions. In addition, editorial changes were made to improve
clarity. The guidance announced in this notice finalizes the draft
guidance dated March 2018.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on proprietary names for new animal drugs.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    FDA concludes that there are no collections of information under
the Paperwork Reduction Act of 1995. This guidance refers to previously
approved collections of information found in FDA regulations. These
collections of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3521). The collections of information in 21 CFR part
514 have been approved under OMB control numbers 0910-0032 and 0910-
0699; the collections of information in 21 CFR part 511 have been
approved under OMB control number 0910-0117.

IV. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or
https://www.regulations.gov.

    Dated: May 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11679 Filed 5-29-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Proposed Rules]
[Pages 42765-42774]
[FR Doc No: 2015-17733]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2013-0185; FRL-9930-87-Region 4]

Approval and Promulgation of Implementation Plans; Alabama;
Infrastructure Requirements for the 2008 Lead National Ambient Air
Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve in part, and disapprove, the November 4, 2011, State
Implementation Plan (SIP) submission, provided by the Alabama

Department of Environmental Management (ADEM) for inclusion into the
Alabama SIP. This proposal pertains to the Clean Air Act (CAA or the
Act) infrastructure requirements for the 2008 Lead national ambient air
quality standards (NAAQS). The CAA requires that each state adopt and
submit a SIP for the implementation, maintenance, and enforcement of
each NAAQS promulgated by EPA, which is commonly referred to as an
``infrastructure'' SIP. ADEM certified that the Alabama SIP contains
provisions that ensure the 2008 Lead NAAQS is implemented, enforced,
and maintained in Alabama. With the exception of provisions pertaining
to prevention of significant deterioration (PSD) permitting, which EPA
is proposing no action through this notice, and with the exception of
the provisions respecting state boards, for which EPA is proposing
disapproval, EPA is proposing to approve Alabama's infrastructure SIP
submission provided to EPA on November 4, 2011, as satisfying the
required infrastructure elements for the 2008 Lead NAAQS.

DATES: Written comments must be received on or before August 19, 2015.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2013-0185, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: ``EPA-R04-OAR-2013-0185,'' Air Regulatory Management
Section, (formerly the Regulatory Development Section), Air Planning
and Implementation Branch, (formerly the Air Planning Branch) Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960.
    5. Hand Delivery or Courier: Lynorae Benjamin, Chief, Air
Regulatory Management Section, Air Planning and Implementation Branch,
Air, Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Such deliveries are only accepted during the Regional
Office's normal hours of operation. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.
    Instructions: Direct your comments to Docket ID No. EPA-R04-OAR-
2013-0185. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit through www.regulations.gov or
email, information that you consider to be CBI or otherwise protected.
The 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 email
comment directly to EPA without going through www.regulations.gov, your
email 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.
    Docket: All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Zuri Farngalo, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. The telephone number is<PHONE_NUMBER>. Mr. Farngalo can be
reached via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. What elements are required under Sections 110(a)(1) and (2)?
III. What is EPA's approach to the review of infrastructure SIP
submissions?
IV. What is EPA's analysis of how Alabama addressed the elements of
Sections 110(a)(1) and (2) ``Infrastructure'' Provisions?
V. Proposed Action
VI. Statutory and Executive Order Reviews

I. Background

    On October 5, 1978, EPA promulgated a primary and secondary NAAQS
under section 109 of the Act. See 43 FR 46246. Both the primary and
secondary standards were set at a level of 1.5 micrograms per cubic
meter ([micro]g/m\3\), measured as Lead in total suspended particulate
matter (Pb-TSP), not to be exceeded by the maximum arithmetic mean
concentration averaged over a calendar quarter. This standard was based
on the 1977 Air Quality Criteria for Lead (USEPA, August 7, 1977). On
November 12, 2008 (75 FR 81126), EPA issued a final rule to revise the
primary and secondary Lead NAAQS. The revised primary and secondary
Lead NAAQS were revised to 0.15 [micro]g/m\3\. By statute, SIPs meeting
the requirements of sections 110(a)(1) and (2) are to be submitted by
states within three years after promulgation of a new or revised NAAQS.
Sections 110(a)(1) and (2) require states to address basic SIP
requirements, including emissions inventories, monitoring, and modeling
to assure attainment and maintenance of the NAAQS. States were required
to submit such SIPs to EPA no later than October 15, 2011, for the 2008
Lead NAAQS.\1\
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    \1\ In these infrastructure SIP submissions states generally
certify evidence of compliance with sections 110(a)(1) and (2) of
the CAA through a combination of state regulations and statutes,
some of which have been incorporated into the federally-approved
SIP. In addition, certain federally-approved, non-SIP regulations
may also be appropriate for demonstrating compliance with sections
110(a)(1) and (2). Throughout this rulemaking, unless otherwise
indicated, the term ``ADEM Administrative Code'' or ``ADEM Admin.
Code'' refers to regulations that have been approved into Alabama's
federally-approved SIP. The terms ``Alabama Code'' or ``Ala. Code''
indicate Alabama's state statutes, which are not a part of the SIP
unless otherwise indicated.

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    Today's action is proposing to in part approve and in part
disapprove portions of Alabama's infrastructure SIP submissions for the
applicable requirements of the 2008 Lead NAAQS. On March 18, 2015, EPA
approved Alabama's November 4, 2011, infrastructure SIP submission
regarding the PSD permitting requirements for major sources of sections
110(a)(2)(C), prong 3 of D(i) and (J) for the 2008 Lead NAAQS. See 80
FR 14019. Therefore, EPA is not proposing any action today pertaining
to the PSD permitting requirements for major sources of sections
110(a)(2)(C), prong 3 of D(i), and (J) for the 2008 Lead NAAQS. With
respect to Alabama's infrastructure SIP submissions related to section
110(a)(2)(E)(ii) requirements respecting the section 128 state board
requirements, EPA is proposing to disapprove this element of Alabama's
submissions in today's rulemaking. For the aspects of Alabama's
submittal proposed for approval today, EPA notes that the Agency is not
approving any specific rule, but rather proposing that Alabama's
already approved SIP meets certain CAA requirements.

II. What elements are required under sections 110(a)(1) and (2)?

    Section 110(a) of the CAA requires states to submit SIPs to provide
for the implementation, maintenance, and enforcement of a new or
revised NAAQS within three years following the promulgation of such
NAAQS, or within such shorter period as EPA may prescribe. Section
110(a) imposes the obligation upon states to make a SIP submission to
EPA for a new or revised NAAQS, but the contents of that submission may
vary depending upon the facts and circumstances. In particular, the
data and analytical tools available at the time the state develops and
submits the SIP for a new or revised NAAQS affects the content of the
submission. The contents of such SIP submissions may also vary
depending upon what provisions the state's existing SIP already
contains. In the case of the 2008 Lead NAAQS, states typically have met
the basic program elements required in section 110(a)(2) through
earlier SIP submissions in connection with the 1978 Lead NAAQS.
    Section 110(a)(1) provides the procedural and timing requirements
for SIPs. Section 110(a)(2) lists specific elements that states must
meet for ``infrastructure'' SIP requirements related to a newly
established or revised NAAQS. As mentioned above, these requirements
include SIP infrastructure elements such as modeling, monitoring, and
emissions inventories that are designed to assure attainment and
maintenance of the NAAQS. The requirements that are the subject of this
proposed rulemaking are listed below \2\ and in EPA's October 14, 2011,
memorandum entitled ``Guidance on Infrastructure State Implementation
Plan (SIP) Elements Required Under Sections 110(a)(1) and 110(a)(2) for
the 2008 Lead (Pb) National Ambient Air Quality Standards (NAAQS)''
(2011 Lead Infrastructure SIP Guidance).
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    \2\ Two elements identified in section 110(a)(2) are not
governed by the three year submission deadline of section 110(a)(1)
because SIPs incorporating necessary local nonattainment area
controls are not due within three years after promulgation of a new
or revised NAAQS, but rather due at the time the nonattainment area
plan requirements are due pursuant to section 172. These
requirements are: (1) Submissions required by 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 (2) submissions required by
section 110(a)(2)(I) which pertain to the nonattainment planning
requirements of part D, Title I of the CAA. Today's proposed
rulemaking does not address infrastructure elements related to
section 110(a)(2)(I) or the nonattainment planning requirements of
110(a)(2)(C).

 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, PSD, and new source
review (NSR) \3\
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    \3\ This rulemaking only addresses requirements for this element
as they relate to attainment areas.
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 110(a)(2)(D)(i): Interstate transport provisions
 110(a)(2)(D)(ii): Interstate and International transport
provisions
 110(a)(2)(E): Adequate personnel, funding, and authority
 110(a)(2)(F): Stationary source monitoring and reporting
 110(a)(2)(G): Emergency episodes
 110(a)(2)(H): Future SIP revisions
 110(a)(2)(I): Nonattainment area plan or plan revision under
part D.\4\
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    \4\ As mentioned above, this element is not relevant to today's
proposed rulemaking.
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     110(a)(2)(J): Consultation with government officials,
public notification, 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

III. What is EPA's approach to the review of infrastructure SIP
submissions?

    EPA is acting upon the SIP submission from Alabama that addresses
the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2)
for the Lead NAAQS. The requirement for states to make a SIP submission
of this type arises out of CAA section 110(a)(1). Pursuant to section
110(a)(1), states must make SIP submissions ``within 3 years (or such
shorter period as the Administrator may prescribe) after the
promulgation of a national primary ambient air quality standard (or any
revision thereof),'' and these SIP submissions are to provide for the
``implementation, maintenance, and enforcement'' of such NAAQS. The
statute directly imposes on states the duty to make these SIP
submissions, and the requirement to make the submissions is not
conditioned upon EPA's taking any action other than promulgating a new
or revised NAAQS. Section 110(a)(2) includes a list of specific
elements that ``[e]ach such plan'' submission must address.
    EPA has historically referred to these SIP submissions made for the
purpose of satisfying the requirements of CAA sections 110(a)(1) and
110(a)(2) as ``infrastructure SIP'' submissions. Although the term
``infrastructure SIP'' does not appear in the CAA, EPA uses the term to
distinguish this particular type of SIP submission from submissions
that are intended to satisfy other SIP requirements under the CAA, such
as ``nonattainment SIP'' or ``attainment plan SIP'' submissions to
address the nonattainment planning requirements of part D of title I of
the CAA, ``regional haze SIP'' submissions required by EPA rule to
address the visibility protection requirements of CAA section 169A, and
nonattainment new source review permit program submissions to address
the permit requirements of CAA, title I, part D.
    Section 110(a)(1) addresses the timing and general requirements for
infrastructure SIP submissions, and section 110(a)(2) provides more
details concerning the required contents of these submissions. The list
of required elements provided in section 110(a)(2) contains a wide
variety of disparate provisions, some of which pertain to required
legal authority, some of which pertain to required substantive program
provisions, and some of which pertain to requirements for both
authority and substantive program provisions.\5\ EPA

therefore believes that while the timing requirement in section
110(a)(1) is unambiguous, some of the other statutory provisions are
ambiguous. In particular, EPA believes that the list of required
elements for infrastructure SIP submissions provided in section
110(a)(2) contains ambiguities concerning what is required for
inclusion in an infrastructure SIP submission.
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    \5\ For example: Section 110(a)(2)(E)(i) provides that states
must provide assurances that they have adequate legal authority
under state and local law to carry out the SIP; section 110(a)(2)(C)
provides that states must have a SIP-approved program to address
certain sources as required by part C of title I of the CAA; and
section 110(a)(2)(G) provides that states must have legal authority
to address emergencies as well as contingency plans that are
triggered in the event of such emergencies.
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    The following examples of ambiguities illustrate the need for EPA
to interpret some section 110(a)(1) and section 110(a)(2) requirements
with respect to infrastructure SIP submissions for a given new or
revised NAAQS. One example of ambiguity is that section 110(a)(2)
requires that ``each'' SIP submission must meet the list of
requirements therein, while EPA has long noted that this literal
reading of the statute is internally inconsistent and would create a
conflict with the nonattainment provisions in part D of title I of the
Act, which specifically address nonattainment SIP requirements.\6\
Section 110(a)(2)(I) pertains to nonattainment SIP requirements and
part D addresses when attainment plan SIP submissions to address
nonattainment area requirements are due. For example, section 172(b)
requires EPA to establish a schedule for submission of such plans for
certain pollutants when the Administrator promulgates the designation
of an area as nonattainment, and section 107(d)(1)(B) allows up to two
years, or in some cases three years, for such designations to be
promulgated.\7\ This ambiguity illustrates that rather than apply all
the stated requirements of section 110(a)(2) in a strict literal sense,
EPA must determine which provisions of section 110(a)(2) are applicable
for a particular infrastructure SIP submission.
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    \6\ See, e.g., ``Rule To Reduce Interstate Transport of Fine
Particulate Matter and Ozone (Clean Air Interstate Rule); Revisions
to Acid Rain Program; Revisions to the NOX SIP Call;
Final Rule,'' 70 FR 25162, at 25163-65 (May 12, 2005) (explaining
relationship between timing requirement of section 110(a)(2)(D)
versus section 110(a)(2)(I)).
    \7\ EPA notes that this ambiguity within section 110(a)(2) is
heightened by the fact that various subparts of part D set specific
dates for submission of certain types of SIP submissions in
designated nonattainment areas for various pollutants. Note, e.g.,
that section 182(a)(1) provides specific dates for submission of
emissions inventories for the ozone NAAQS. Some of these specific
dates are necessarily later than three years after promulgation of
the new or revised NAAQS.
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    Another example of ambiguity within sections 110(a)(1) and
110(a)(2) with respect to infrastructure SIPs pertains to whether
states must meet all of the infrastructure SIP requirements in a single
SIP submission, and whether EPA must act upon such SIP submission in a
single action. Although section 110(a)(1) directs states to submit ``a
plan'' to meet these requirements, EPA interprets the CAA to allow
states to make multiple SIP submissions separately addressing
infrastructure SIP elements for the same NAAQS. If states elect to make
such multiple SIP submissions to meet the infrastructure SIP
requirements, EPA can elect to act on such submissions either
individually or in a larger combined action.\8\ Similarly, EPA
interprets the CAA to allow it to take action on the individual parts
of one larger, comprehensive infrastructure SIP submission for a given
NAAQS without concurrent action on the entire submission. For example,
EPA has sometimes elected to act at different times on various elements
and sub-elements of the same infrastructure SIP submission.\9\
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    \8\ See, e.g., ``Approval and Promulgation of Implementation
Plans; New Mexico; Revisions to the New Source Review (NSR) State
Implementation Plan (SIP); Prevention of Significant Deterioration
(PSD) and Nonattainment New Source Review (NNSR) Permitting,'' 78 FR
4339 (January 22, 2013) (EPA's final action approving the structural
PSD elements of the New Mexico SIP submitted by the State separately
to meet the requirements of EPA's 2008 PM2.5 NSR rule),
and ``Approval and Promulgation of Air Quality Implementation Plans;
New Mexico; Infrastructure and Interstate Transport Requirements for
the 2006 PM2.5 NAAQS,'' (78 FR 4337) (January 22, 2013)
(EPA's final action on the infrastructure SIP for the 2006
PM2.5 NAAQS).
    \9\ On December 14, 2007, the State of Tennessee, through the
Tennessee Department of Environment and Conservation, made a SIP
revision to EPA demonstrating that the State meets the requirements
of sections 110(a)(1) and (2). EPA proposed action for
infrastructure SIP elements (C) and (J) on January 23, 2012 (77 FR
3213) and took final action on March 14, 2012 (77 FR 14976). On
April 16, 2012 (77 FR 22533) and July 23, 2012 (77 FR 42997), EPA
took separate proposed and final actions on all other section
110(a)(2) infrastructure SIP elements of Tennessee's December 14,
2007 submittal.
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    Ambiguities within sections 110(a)(1) and 110(a)(2) may also arise
with respect to infrastructure SIP submission requirements for
different NAAQS. Thus, EPA notes that not every element of section
110(a)(2) would be relevant, or as relevant, or relevant in the same
way, for each new or revised NAAQS. The states' attendant
infrastructure SIP submissions for each NAAQS therefore could be
different. For example, the monitoring requirements that a state might
need to meet in its infrastructure SIP submission for purposes of
section 110(a)(2)(B) could be very different for different pollutants
because the content and scope of a state's infrastructure SIP
submission to meet this element might be very different for an entirely
new NAAQS than for a minor revision to an existing NAAQS.\10\
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    \10\ For example, implementation of the 1997 PM2.5
NAAQS required the deployment of a system of new monitors to measure
ambient levels of that new indicator species for the new NAAQS.
---------------------------------------------------------------------------

    EPA notes that interpretation of section 110(a)(2) is also
necessary when EPA reviews other types of SIP submissions required
under the CAA. Therefore, as with infrastructure SIP submissions, EPA
also has to identify and interpret the relevant elements of section
110(a)(2) that logically apply to these other types of SIP submissions.
For example, section 172(c)(7) requires that attainment plan SIP
submissions required by part D have to meet the ``applicable
requirements'' of section 110(a)(2). Thus, for example, attainment plan
SIP submissions must meet the requirements of section 110(a)(2)(A)
regarding enforceable emission limits and control measures and section
110(a)(2)(E)(i) regarding air agency resources and authority. By
contrast, it is clear that attainment plan SIP submissions required by
part D would not need to meet the portion of section 110(a)(2)(C) that
pertains to the PSD program required in part C of title I of the CAA,
because PSD does not apply to a pollutant for which an area is
designated nonattainment and thus subject to part D planning
requirements. As this example illustrates, each type of SIP submission
may implicate some elements of section 110(a)(2) but not others.
    Given the potential for ambiguity in some of the statutory language
of section 110(a)(1) and section 110(a)(2), EPA believes that it is
appropriate to interpret the ambiguous portions of section 110(a)(1)
and section 110(a)(2) in the context of acting on a particular SIP
submission. In other words, EPA assumes that Congress could not have
intended that each and every SIP submission, regardless of the NAAQS in
question or the history of SIP development for the relevant pollutant,
would meet each of the requirements, or meet each of them in the same
way. Therefore, EPA has adopted an approach under which it reviews
infrastructure SIP submissions against the list of elements in section
110(a)(2), but only to the extent each element applies for that
particular NAAQS.
    Historically, EPA has elected to use guidance documents to make
recommendations to states for infrastructure SIPs, in some cases
conveying needed interpretations on newly arising issues and in some
cases conveying interpretations that have already been developed and
applied to

individual SIP submissions for particular elements.\11\ EPA issued the
Lead Infrastructure SIP Guidance on October 14, 2011.\12\ EPA developed
this document to provide states with up-to-date guidance for the 2008
Lead infrastructure SIPs. Within this guidance, EPA describes the duty
of states to make infrastructure SIP submissions to meet basic
structural SIP requirements within three years of promulgation of a new
or revised NAAQS. EPA also made recommendations about many specific
subsections of section 110(a)(2) that are relevant in the context of
infrastructure SIP submissions. The guidance also discusses the
substantively important issues that are germane to certain subsections
of section 110(a)(2). Significantly, EPA interprets sections 110(a)(1)
and 110(a)(2) such that infrastructure SIP submissions need to address
certain issues and need not address others. Accordingly, EPA reviews
each infrastructure SIP submission for compliance with the applicable
statutory provisions of section 110(a)(2), as appropriate.\13\
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    \11\ EPA notes, however, that nothing in the CAA requires EPA to
provide guidance or to promulgate regulations for infrastructure SIP
submissions. The CAA directly applies to states and requires the
submission of infrastructure SIP submissions, regardless of whether
or not EPA provides guidance or regulations pertaining to such
submissions. EPA elects to issue such guidance in order to assist
states, as appropriate.
    \12\ ``Guidance on Infrastructure State Implementation Plan
(SIP) Elements Required under Clean Air Act Sections 110(a)(1) and
110(a)(2) for the 2008 Lead (Pb) National Ambient Air Quality
Standards (NAAQS),'' Memorandum from Stephen D. Page, October 14,
2001.
    \13\ Although not intended to provide guidance for purposes of
infrastructure SIP submissions for the 2008 Lead NAAQS, EPA notes,
that following the 2011 Lead Infrastructure SIP Guidance, EPA issued
the ``Guidance on Infrastructure State Implementation Plan (SIP)
Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2).''
Memorandum from Stephen D. Page, September 13, 2013. This 2013
guidance provides recommendations for air agencies' development and
the EPA's review of infrastructure SIPs for the 2008 ozone primary
and secondary NAAQS, the 2010 primary nitrogen dioxide
(NO2) NAAQS, the 2010 primary sulfur dioxide
(SO2) NAAQS, and the 2012 primary fine particulate matter
(PM2.5) NAAQS, as well as infrastructure SIPs for new or
revised NAAQS promulgated in the future.
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    EPA's approach to review of infrastructure SIP submissions is to
identify the CAA requirements that are logically applicable to that
submission. EPA believes that this approach to the review of a
particular infrastructure SIP submission is appropriate, because it
would not be reasonable to read the general requirements of section
110(a)(1) and the list of elements in 110(a)(2) as requiring review of
each and every provision of a state's existing SIP against all
requirements in the CAA and EPA regulations merely for purposes of
assuring that the state in question has the basic structural elements
for a functioning SIP for a new or revised NAAQS. Because SIPs have
grown by accretion over the decades as statutory and regulatory
requirements under the CAA have evolved, they may include some outmoded
provisions and historical artifacts. These provisions, while not fully
up to date, nevertheless may not pose a significant problem for the
purposes of ``implementation, maintenance, and enforcement'' of a new
or revised NAAQS when EPA evaluates adequacy of the infrastructure SIP
submission. EPA believes that a better approach is for states and EPA
to focus attention on those elements of section 110(a)(2) of the CAA
most likely to warrant a specific SIP revision due to the promulgation
of a new or revised NAAQS or other factors.
    Finally, EPA believes that its approach with respect to
infrastructure SIP requirements is based on a reasonable reading of
sections 110(a)(1) and 110(a)(2) because the CAA provides other avenues
and mechanisms to address specific substantive deficiencies in existing
SIPs. These other statutory tools allow EPA to take appropriately
tailored action, depending upon the nature and severity of the alleged
SIP deficiency. Section 110(k)(5) authorizes EPA to issue a ``SIP
call'' whenever the Agency determines that a state's SIP is
substantially inadequate to attain or maintain the NAAQS, to mitigate
interstate transport, or to otherwise comply with the CAA.\14\ Section
110(k)(6) authorizes EPA to correct errors in past actions, such as
past approvals of SIP submissions.\15\ Significantly, EPA's
determination that an action on a state's infrastructure SIP submission
is not the appropriate time and place to address all potential existing
SIP deficiencies does not preclude EPA's subsequent reliance on
provisions in section 110(a)(2) as part of the basis for action to
correct those deficiencies at a later time. For example, although it
may not be appropriate to require a state to eliminate all existing
inappropriate director's discretion provisions in the course of acting
on an infrastructure SIP submission, EPA believes that section
110(a)(2)(A) may be among the statutory bases that EPA relies upon in
the course of addressing such deficiency in a subsequent action.\16\
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    \14\ For example, EPA issued a SIP call to Utah to address
specific existing SIP deficiencies related to the treatment of
excess emissions during SSM events. See ``Finding of Substantial
Inadequacy of Implementation Plan; Call for Utah State
Implementation Plan Revisions,'' 74 FR 21639 (April 18, 2011).
    \15\ EPA has used this authority to correct errors in past
actions on SIP submissions related to PSD programs. See ``Limitation
of Approval of Prevention of Significant Deterioration Provisions
Concerning Greenhouse Gas Emitting-Sources in State Implementation
Plans; Final Rule,'' 75 FR 82536 (December 30, 2010). EPA has
previously used its authority under CAA section 110(k)(6) to remove
numerous other SIP provisions that the Agency determined it had
approved in error. See, e.g., 61 FR 38664 (July 25, 1996) and 62 FR
34641 (June 27, 1997) (corrections to American Samoa, Arizona,
California, Hawaii, and Nevada SIPs); 69 FR 67062 (November 16,
2004) (corrections to California SIP); and 74 FR 57051 (November 3,
2009) (corrections to Arizona and Nevada SIPs).
    \16\ See, e.g., EPA's disapproval of a SIP submission from
Colorado on the grounds that it would have included a director's
discretion provision inconsistent with CAA requirements, including
section 110(a)(2)(A). See, e.g., 75 FR 42342 at 42344 (July 21,
2010) (proposed disapproval of director's discretion provisions); 76
FR 4540 (Jan. 26, 2011) (final disapproval of such provisions).
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IV. What is EPA's analysis of how Alabama addressed the elements of
sections 110(a)(1) and (2) ``infrastructure'' provisions?

    The Alabama infrastructure submission addresses the provisions of
sections 110(a)(1) and (2) as described below.
    1. 110(a)(2)(A): Emission limits and other control measures:
Several regulations within Alabama's SIP are relevant to air quality
control regulations. The regulations described below have been
federally approved in the Alabama SIP and include enforceable emission
limitations and other control measures. Alabama's infrastructure SIP
submission cites provisions of the Administrative Code that provide
ADEM with the necessary authority to adopt and enforce air quality
controls such as Administrative Codes 335-3-1-.03, ``Ambient Air
Quality Standards,'' 335-3-1.05 ``Sampling and Testing,'' 335-3-1-.06
``Compliance Schedule,'' 335-3-14-.03(1)(g) ``Standards for Granting
Permits'' and 335-3-4-.15 ``Secondary Lead Smelters.'' EPA has made the
preliminary determination that the provisions contained in these
chapters and Alabama's practices are adequate to protect the 2008 Lead
NAAQS in the State.
    In this action, EPA is not proposing to approve or disapprove any
existing State provisions with regard to excess emissions during
startup, shutdown and malfunction (SSM) of operations at a facility.
EPA believes that a number of states have SSM provisions which are
contrary to the CAA and existing EPA guidance, ``State Implementation
Plans: Policy Regarding Excess Emissions During Malfunctions, Startup,
and Shutdown'' (September 20, 1999), and

the Agency is addressing such state regulations in a separate
action.\17\ In the meantime, EPA encourages any state having a
deficient SSM provision to take steps to correct it as soon as
possible.
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    \17\ On May 22, 2015, the EPA Administrator signed a final
action entitled, ``State Implementation Plans: Response to Petition
for Rulemaking; Restatement and Update of EPA's SSM Policy
Applicable to SIPs; Findings of Substantial Inadequacy; and SIP
Calls to Amend Provisions Applying to Excess Emissions During
Periods of Startup, Shutdown, and Malfunction.'' The prepublication
version of this rule is available at http://www.epa.gov/airquality/urbanair/sipstatus/emissions.html.
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    Additionally, in this action, EPA is not proposing to approve or
disapprove any existing State rules with regard to director's
discretion or variance provisions. EPA believes that a number of states
have such provisions which are contrary to the CAA and existing EPA
guidance (52 FR 45109 (November 24, 1987)), and the Agency plans to
take action in the future to address such state regulations. In the
meantime, EPA encourages any state having a director's discretion or
variance provision which is contrary to the CAA and EPA guidance to
take steps to correct the deficiency as soon as possible.
    2. 110(a)(2)(B) Ambient air quality monitoring/data system: SIPs
are required to provide for the establishment and operation of ambient
air quality monitors; the compilation and analysis of ambient air
quality data; and the submission of these data to EPA upon request.
ADEM Administrative Code, 335-3-1-.03 ``Ambient Air Quality
Standards,'' and 335-3-1-.04 ``Monitoring Records and Reporting,''
along with the Alabama Network Description and Ambient Air Network
Monitoring Plan, provide for an ambient air quality monitoring system
in the State. Annually, States develop and submit to EPA for approval
statewide ambient monitoring network plans consistent with the
requirements of 40 CFR parts 50, 53, and 58. The annual network plan
involves an evaluation of any proposed changes to the monitoring
network, includes the annual ambient monitoring network design plan and
a certified evaluation of the agency's ambient monitors and auxiliary
support equipment.\18\ The latest monitoring network plan for Alabama
was submitted on July 17, 2014, and on March 6, 2015, EPA approved this
plan. Alabama's approved monitoring network plan can be accessed at
www.regulations.gov using Docket ID No. EPA-R04-OAR-2013-0185. EPA has
made the preliminary determination that Alabama's SIP and practices are
adequate for the ambient air quality monitoring and data system related
to the 2008 Lead NAAQS.
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    \18\ On occasion, proposed changes to the monitoring network are
evaluated outside of the network plan approval process in accordance
with 40 CFR part 58.
---------------------------------------------------------------------------

    3. 110(a)(2)(C) Program for enforcement, PSD, and NSR: This element
consists of three sub-elements; enforcement, state-wide regulation of
new and modified minor sources and minor modifications of major
sources; and preconstruction permitting of major sources and major
modifications in areas designated attainment or unclassifiable for the
subject NAAQS as required by CAA title I part C (i.e., the major source
PSD program). To meet these obligations, Alabama cited ADEM
Administrative Codes 335-3-14-.01 ``General Provisions,'' 335-3-14-.02
``Permit Procedure,'' 335-3-14-.03 ``Standards for Granting Permits,''
335-3-14.04 ``Prevention of Significant Deterioration in Permitting,''
and 335-3-14-.05 ``Air Permits Authorizing Construction in or Near
Nonattainment Areas'' of Alabama's SIP. ADEM is able to regulate
sources of lead through these above cited provisions of Alabama's SIP.
In this action, EPA is only proposing to approve the enforcement and
the regulation of new minor sources and minor modifications aspects of
Alabama's section 110(a)(2)(C) infrastructure SIP submission.
    Enforcement: ADEM's above-described, SIP-approved regulations meet
the requirements for enforcement of lead emission limits and control
measures and construction permitting for new or modified stationary
sources.
    Preconstruction PSD Permitting for Major Sources: With respect to
Alabama's November 4, 2011 infrastructure SIP submission related to the
preconstruction PSD permitting requirements for major sources of
section 110(a)(2)(C), EPA took final action to approve this provision
for the 2008 Lead NAAQS on March 18, 2015. See 80 FR 14019.
    Regulation of minor sources and modifications: Section 110(a)(2)(C)
also requires the SIP to include provisions that govern a minor source
pre-construction program that regulates emissions of the 2008 Lead
NAAQS. ADEM Administrative Code 335-3-14-.03 ``Standards for Granting
Permits'' governs the preconstruction permitting of modifications and
construction of minor stationary sources in the State.
    EPA has made the preliminary determination that Alabama's SIP and
practices are adequate for program enforcement of control measures and
regulation of minor sources and modifications related to the 2008 Lead
NAAQS.
    4. 110(a)(2)(D)(i) Interstate transport provisions: Section
110(a)(2)(D)(i) has two components; 110(a)(2)(D)(i)(I) and
110(a)(2)(D)(i)(II). Each of these components have two subparts
resulting in four distinct components, commonly referred to as
``prongs,'' that must be addressed in infrastructure SIP submissions.
The first two prongs, which are codified in section 110(a)(2)(D)(i)(I),
are provisions that prohibit any source or other type of emissions
activity in one state from contributing significantly to nonattainment
of the NAAQS in another state (``prong 1''), and interfering with
maintenance of the NAAQS in another state (``prong 2''). The third and
fourth prongs, which are codified in section 110(a)(2)(D)(i)(II), are
provisions that prohibit emissions activity in one state interfering
with measures required to prevent significant deterioration of air
quality in another state (``prong 3''), or to protect visibility in
another state (``prong 4''). Section 110(a)(2)(D)(ii) requires SIPs to
include provisions insuring compliance with sections 115 and 126 of the
Act, relating to interstate and international pollution abatement.
    110(a)(2)(D)(i)(I)--prongs 1 and 2: Section 110(a)(2)(D)(i)
requires infrastructure SIP submissions 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. The physical properties of
lead prevent lead emissions from experiencing that same travel or
formation phenomena as PM2.5 and ozone for interstate
transport as outlined in prongs 1 and 2. More specifically, there is a
sharp decrease in the lead concentrations, at least in the coarse
fraction, as the distance from a lead source increases. EPA believes
that the requirements of prongs 1 and 2 can be satisfied through a
state's assessment as to whether a lead source located within its State
in close proximity to a state border has emissions that contribute
significantly to the nonattainment or interfere with maintenance of the
NAAQS in the neighboring state. For example, EPA's experience with the
initial Lead designations suggest that sources that emit less than 0.5
tpy or are located more than two miles from the state border generally
appear unlikely to contribute significantly to the nonattainment in
another state. Alabama has one lead source that has emissions of lead
over 0.5 tons per year (tpy), but because the source is located well
beyond two miles from the State

border,\19\ EPA believes it is unlikely to contribute significantly to
the nonattainment or interfere with maintenance of the NAAQS in another
state. Therefore, EPA has made the preliminary determination that
Alabama's SIP meets the requirements of section 110(a)(2)(D)(i)(I).
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    \19\ There is one facility in Alabama that has Lead emissions
greater than 0.5 tpy. The facility is Sanders Lead Co, Inc., which
is located at 100 Sanders Rd Troy, AL 36079. This location is about
45 miles from the Georgia border.
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    110(a)(2)(D)(i)(II)--prong 3: With respect to Alabama's
infrastructure SIP submission related to the interstate transport
requirements for PSD of prong 3 of section 110(a)(2)(D)(i), EPA took
final action to approve Alabama's November 4, 2011 infrastructure SIP
submission for the 2008 Lead NAAQS on March 18, 2015. See 80 FR 14019.
    110(a)(2)(D)(i)(II)--prong 4: With regard to section
110(a)(2)(D)(i)(II), the visibility sub-element, referred to as prong
4, significant visibility impacts from stationary source lead emissions
are expected to be limited to short distances from the source. Lead
stationary sources in Alabama are located distances from Class I areas
such that visibility impacts are negligible. The 2011 Lead
Infrastructure SIP Guidance notes that the lead constituent of PM would
likely not travel far enough to affect Class 1 areas and that the
visibility provisions of the CAA do not directly regulate lead.
Accordingly, EPA has preliminarily determined that the Alabama SIP
meets the relevant visibility requirements of prong 4 of section
110(a)(2)(D)(i).
    5. 110(a)(2)(D)(ii) Interstate and international transport
provisions: Section 110(a)(2)(D)(ii) requires SIPs to include
provisions insuring compliance with sections 115 and 126 of the Act,
relating to interstate and international pollution abatement. ADEM
Admin. Code 335-3-14-.04--Prevention of Significant Deterioration in
Permitting describes how Alabama notifies neighboring states of
potential emission impacts from new or modified sources applying for
PSD permits. This regulation requires ADEM to provide an opportunity
for a public hearing to the public, which includes State or local air
pollution control agencies, ``whose lands may be affected by emissions
from the source or modification'' in Alabama. Additionally, Alabama
does not have any pending obligation under sections 115 and 126 of the
CAA. Accordingly, EPA has made the preliminary determination that
Alabama's SIP and practices are adequate for insuring compliance with
the applicable requirements relating to interstate and international
pollution abatement for the 2008 Lead NAAQS.
    6. 110(a)(2)(E) Adequate personnel, funding, and authority: Section
110(a)(2)(E) requires that each implementation plan provide (i)
necessary assurances that the State will have adequate personnel,
funding, and authority under state law to carry out its implementation
plan, (ii) that the State comply with the requirements respecting State
Boards pursuant to section 128 of the Act, and (iii) necessary
assurances that, where the State has relied on a local or regional
government, agency, or instrumentality for the implementation of any
plan provision, the State has responsibility for ensuring adequate
implementation of such plan provisions. EPA is proposing to approve
Alabama's SIP as meeting the requirements of sections 110(a)(2)(E)(i)
and 110(2)(E)(iii) but disapprove for element 110(2)(E)(ii). EPA's
rationale for today's proposals respecting each section of 110(a)(2)(E)
is described in turn below.
    To satisfy the requirements of section 110(a)(2)(E)(i) and (iii),
ADEM's infrastructure SIP submission describes Alabama Code section 22-
28-11, which authorizes ADEM to adopt emission requirements though
regulations that are necessary to prevent, abate, or control air
pollution. Also, Alabama Code section 22-28-9 authorizes the Department
to employ necessary staff to carry out responsibilities. The funding
requirements are met through the 105 grants and the title V fee
process. As further evidence of the adequacy of ADEM's resources, EPA
submitted a letter to Alabama on April 24, 2014, outlining 105 grant
commitments and the current status of these commitments for fiscal year
2014. The letter EPA submitted to Alabama can be accessed at
www.regulations.gov using Docket ID No. EPA-R04-OAR-2013-0185.
Annually, states update these grant commitments based on current SIP
requirements, air quality planning, and applicable requirements related
to the NAAQS. Alabama satisfactorily met all commitments agreed to in
the Air Planning Agreement for fiscal year 2014, therefore Alabama's
grants were finalized. EPA has made the preliminary determination that
Alabama has adequate resources for implementation of the 2008 Lead
NAAQS.
    To satisfy the requirements of section 110(a)(2)(E)(ii), states
must comply with the requirements respecting State Boards pursuant to
section 128 of the Act. Section 110(a)(2)(E)(ii) requires that the
state comply with section 128 of the CAA. Section 128 requires that the
SIP contain provisions that provide: (1) The majority of members of the
state board or body which approves permits or enforcement orders
represent the public interest and do not derive any significant portion
of their income from persons subject to permitting or enforcement
orders under the CAA; and (2) any potential conflicts of interest by
such board or body, or the head of an executive agency with similar
powers be adequately disclosed. After reviewing Alabama's SIP, EPA has
made the preliminary determination that the State's implementation plan
does not contain provisions to comply with section 128 of the Act, and
thus Alabama's November 4, 2011, infrastructure SIP submission does not
meet the requirements of the Act. While Alabama has state statutes that
may address, in whole or in part, requirements related to state boards
at the state level, these provisions are not included in the SIP as
required by the CAA. Based on an evaluation of the federally-approved
Alabama SIP, EPA is proposing to disapprove Alabama's infrastructure
SIP submission as meeting the requirements of 110(a)(2)(E)(ii) of the
CAA for the 2008 Lead NAAQS. The submitted provisions which purport to
address 110(a)(2)(E)(ii) are severable from the other portions of
ADEM's infrastructure SIP submission, therefore, EPA is proposing to
disapprove those provisions which relate only to sub-element
110(a)(2)(E)(ii).
    7. 110(a)(2)(F) Stationary source monitoring system: ADEM's
infrastructure SIP submission describes the establishment of
requirements for compliance testing by emissions sampling and analysis,
and for emissions and operation monitoring to ensure the quality of
data in the State. The Alabama infrastructure SIP submission also
describes how the major source and minor source emission inventory
programs collect emission data throughout the State and ensure the
quality of such data. Alabama meets these requirements through ADEM
Admin. Codes 335-3-1-.04 ``Monitoring, Records, and Reporting,'' and
335-3-12 ``Continuous Monitoring Requirements for Existing Sources.''
ADEM Admin. Code 335-3-1-.04, details how sources are required as
appropriate to establish and maintain records; make reports; install,
use, and maintain such monitoring equipment or methods and provide
periodic emission reports as the regulation requires. These reports and
records are required to be compiled, and submitted on forms furnished
by the State. Additionally, ADEM Admin. Code 335-3-12-.02

requires owners and operators of emissions sources to ``install,
calibrate, operate and maintain all monitoring equipment necessary for
continuously monitoring the pollutants.'' \20\ ADEM Admin. Code 335-3-
1-.13 ``Credible Evidence,'' makes allowances for owners and/or
operators to utilize ``any credible evidence or information relevant''
to demonstrate compliance with applicable requirements if the
appropriate performance or compliance test had been performed, for the
purpose of submitting compliance certification and can be used to
establish whether or not an owner or operator has violated or is in
violation of any rule or standard. Accordingly, EPA is unaware of any
provision preventing the use of credible evidence in the Alabama SIP.
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    \20\ ADEM Admin. Code 335-3-12-.02 establishes that data
reporting requirements for sources required to conduct continuous
monitoring in the state should comply with data reporting
requirements set forth at 40 CFR part 51, Appendix P. Section 40 CFR
part 51, Appendix P includes that the averaging period used for data
reporting should be established by the state to correspond to the
averaging period specified in the emission test method used to
determine compliance with an emission standard for the pollutant/
source category in question.
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    Additionally, Alabama is required to submit emissions data to EPA
for purposes of the National Emissions Inventory (NEI). The NEI is
EPA's central repository for air emissions data. EPA published the Air
Emissions Reporting Rule (AERR) on December 5, 2008, which modified the
requirements for collecting and reporting air emissions data (73 FR
76539). The AERR shortened the time states had to report emissions data
from 17 to 12 months, giving states one calendar year to submit
emissions data. All states are required to submit a comprehensive
emissions inventory every three years and report emissions for certain
larger sources annually through EPA's online Emissions Inventory
System. States report 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. Many states also voluntarily report emissions of
hazardous air pollutants. Alabama made its latest update to the 2013
NEI on January 13, 2015. EPA compiles the emissions data, supplementing
it where necessary, and releases it to the general public through the
Web site http://www.epa.gov/ttn/chief/eiinformation.html. EPA has made
the preliminary determination that Alabama's SIP and practices are
adequate for the stationary source monitoring systems related to the
2008 Lead NAAQS.
    8. 110(a)(2)(G) Emergency episodes: This section of the CAA
requires that states demonstrate authority comparable with section 303
of the CAA and adequate contingency plans to implement such authority.
ADEM Admin. Code 335-3-2 ``Air Pollution Emergency'' provides for the
identification of air pollution emergency episodes, episode criteria,
and emissions reduction plans. Alabama's compliance with section 303 of
the CAA and adequate contingency plans to implement such authority is
also met by Ala. Code section 22-28-21 ``Air Pollution Emergencies.''
Ala. Code section 22-28-21 provides ADEM the authority to order the
``person or persons responsible for the operation or operations of one
or more air contaminants sources'' causing ``imminent danger to human
health or safety in question to reduce or discontinue emissions
immediately.'' The order triggers a hearing no later than 24-hours
after issuance before the Environmental Management Commission which can
affirm, modify or set aside the Director's order. Additionally, the
Governor can, by proclamation, declare, as to all or any part of said
area, that an air pollution emergency exists and exercise certain
powers in whole or in part, by the issuance of an order or orders to
protect the public health. EPA has made the preliminary determination
that Alabama's SIP, state laws and practices are adequate to satisfy
the infrastructure SIP obligations for emergency powers related to the
2008 Lead NAAQS.
    9. 110(a)(2)(H) Future SIP revisions: As previously discussed, ADEM
is responsible for adopting air quality rules and revising SIPs as
needed to attain or maintain the NAAQS. Alabama has the ability and
authority to respond to calls for SIP revisions, and has provided a
number of SIP revisions over the years for implementation of the NAAQS.
These requirements are met through ADEM Administrative Codes 335-1-
1-.03 ``Organization and Duties of the Commission,'' \21\ which
provides ADEM with the authority to establish, adopt, promulgate,
modify, repeal and suspend rules, regulations, or environmental
standards which may be applicable to Alabama or ``any of its geographic
parts'' and 335-3-1-.03 ``Ambient Air Quality Standards,'' which
provides ADEM the authority to amend, revise, and incorporate the NAAQS
into its SIP. Alabama currently has one area designated nonattainment
for the 2008 Lead NAAQS located in Troy, Alabama related to the Sanders
Lead Company. ADEM submitted an attainment demonstration for this area
on November 9, 2012. EPA approved this attainment demonstration on
January 28, 2014. See 79 FR 4407. Accordingly, EPA has made the
preliminary determination that Alabama's SIP and practices adequately
demonstrate a commitment to provide future SIP revisions related to the
2008 Lead NAAQS, when necessary.
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    \21\ This regulation has not been incorporated into the
federally-approved SIP.
---------------------------------------------------------------------------

    10. 110(a)(2)(J) Consultation with government officials, public
notification, PSD, and visibility protection: EPA is proposing to
approve Alabama's infrastructure SIP submission for the 2008 Lead NAAQS
with respect to the general requirement in section 110(a)(2)(J) to
include a program in the SIP that provides for meeting the applicable
consultation requirements of section 121, the public notification
requirements of section 127; and visibility protection requirements of
part C of the Act. With respect to Alabama's infrastructure SIP
submission related to the preconstruction PSD permitting requirements
of section 110(a)(2)(J), EPA took final action to approve Alabama's
November 4, 2011 2008 Lead NAAQS infrastructure SIP for these
requirements on March 18, 2015. See 80 FR 14019. EPA's rationale for
its proposed action regarding applicable consultation requirements of
section 121, the public notification requirements of section 127, and
visibility protection requirements is described below.
    Consultation with government officials (121 consultation): Section
110(a)(2)(J) of the CAA requires states to provide a process for
consultation with local governments, designated organizations and
federal land managers (FLMs) carrying out NAAQS implementation
requirements pursuant to section 121 relative to consultation. ADEM
Admin. Code 335-3-1-.03 ``Ambient Air Quality Standards,'' as well as
its Regional Haze Implementation Plan (which allows for continued
consultation with appropriate state, local, and tribal air pollution
control agencies as well as the corresponding FLMs), provide for
consultation with government officials whose jurisdictions might be
affected by SIP development activities. Specifically, Alabama adopted
state-wide consultation procedures for the implementation of
transportation conformity which includes the development of mobile
inventories for SIP development. These consultation procedures were
developed in

coordination with the transportation partners in the State and are
consistent with the approaches used for development of mobile
inventories for SIPs. Required partners covered by Alabama's
consultation procedures include federal, state and local transportation
and air quality agency officials. EPA has made the preliminary
determination that Alabama's SIP and practices adequately demonstrate
consultation with government officials related to the 2008 Lead NAAQS
when necessary.
    Public notification (127 public notification): To meet the public
notification requirements of section 110(a)(2)(J), ADEM cites Alabama
Code Sec.  22-28-21 ``Air Pollution Emergencies'' and ADEM
Administrative Code 335-3-14-.01(7) ``Public Participation,'' which
requires that ADEM notify the public of any air pollution alert,
warning, or emergency. The ADEM Web site also sites air quality summary
data and air quality index reports. Alabama maintains a public Web site
on which daily air quality index forecasts and summary data are posted.
This Web site can be accessed at: http://adem.alabama.gov/programs/air/airquality.cnt. EPA has made the preliminary determination that
Alabama's SIP and practices adequately demonstrate the State's ability
to provide public notification related to the 2008 Lead NAAQS when
necessary. Accordingly, EPA is proposing to approve Alabama's
infrastructure SIP submission with respect to section 110(a)(2)(J)
public notification.
    Visibility Protection: The 2011 Lead Infrastructure SIP Guidance
notes that the lead constituent of PM would likely not travel far
enough to affect Class I areas and that the visibility provisions of
the CAA do not directly regulate lead. EPA recognizes that states are
subject to visibility protection and regional haze program requirements
under Part C of the Act (which includes sections 169A and 169B).
However, in the event of the establishment of a new primary NAAQS, the
visibility protection and regional haze program requirements under part
C of the CAA do not change. EPA thus does not expect states to address
visibility for this element in Lead infrastructure submittals. Thus,
EPA concludes there are no new applicable visibility protection
obligations under section 110(a)(2)(J) as a result of the 2008 Lead
NAAQS. Accordingly, EPA is proposing to approve section 110(a)(2)(J) of
ADEM's infrastructure SIP submission with respect to visibility.
    EPA has made the preliminary determination that Alabama's SIP and
practices adequately demonstrate the State's ability to meet the
general requirement in section 110(a)(2)(J) to include a program in the
SIP that provides for meeting the applicable consultation requirements
of section 121, the public notification requirements of section 127 and
visibility protection associated with regional haze. EPA has also
preliminarily determined that it is appropriate approve the State's
Lead infrastructure SIP submission with respect to the visibility
aspects of section 110(a)(2)(J). EPA is making no determinations with
respect the PSD requirements of section 110(a)(2)(J), which will be
addressed in a different notice.
    11. 110(a)(2)(K) Air quality modeling/data: Section 110(a)(2)(K) of
the CAA requires that SIPs provide for performing air quality modeling
so that effects on air quality of emissions from NAAQS pollutants can
be predicted and submission of such data to the USEPA can be made. ADEM
Administrative Code 335-3-1-.04 ``Monitoring Records and Reporting''
and 335-3-14-.04 ``Prevention of Significant Deterioration Permitting''
which incorporates 40 CFR part 51, Appendix W ``Guideline on Air
Quality Models,'' demonstrate that Alabama has the authority to provide
relevant data for the purpose of predicting the effect on ambient air
quality of the 2008 Lead NAAQS. Additionally, Alabama supports a
regional effort to coordinate the development of emissions inventories
and conduct regional modeling for several NAAQS, including the 2008
Lead NAAQS, for the southeastern states. Taken as a whole, Alabama's
air quality regulations and practices demonstrate that ADEM has the
authority to provide relevant data for the purpose of predicting the
effect on ambient air quality of the Lead NAAQS. EPA has made the
preliminary determination that Alabama's SIP and practices adequately
demonstrate the State's ability to provide for air quality and
modeling, along with analysis of the associated data, related to the
2008 Lead NAAQS when necessary.
    12. 110(a)(2)(L) Permitting fees: This section requires the owner
or operator of each major stationary source to pay to the permitting
authority, as a condition of any permit required under the CAA, a fee
sufficient to cover (i) the reasonable costs of reviewing and acting
upon any application for such a permit, and (ii) if the owner or
operator receives a permit for such source, the reasonable costs of
implementing and enforcing the terms and conditions of any such permit
(not including any court costs or other costs associated with any
enforcement action), until such fee requirement is superseded with
respect to such sources by the Administrator's approval of a fee
program under title V. To satisfy these requirements, ADEM's
infrastructure SIP submission cites ADEM Admin. Code 335-1-6
``Application Fees,'' \22\ which are State regulations authorized by
legislation. Also, ADEM has an approved Title V program with a fee
structure established in ADEM Admin. Code 335-1-7 ``Air Division
Operating Permit Fees.'' \23\ The Title V fees cover the reasonable
cost of implementation and enforcement of PSD and NNSR permits after
they have been issued. EPA has made the preliminary determination that
Alabama's SIP and practices adequately provide for permitting fees
related to the Lead NAAQS, when necessary.
---------------------------------------------------------------------------

    \22\ This regulation has not been incorporated into the
federally-approved SIP.
    \23\ Title V program regulations are federally approved but not
incorporated into the federally-approved SIP.
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    12. 110(a)(2)(M) Consultation/participation by affected local
entities: This element requires states to provide for consultation and
participation in SIP development by local political subdivisions
affected by the SIP. Alabama Administrative Code 335-3-14-.01(17)
``Public Participation,'' 335-3-14-.04(6) ``Public Participation,'' and
335-3-14-.05(13) ``Public Participation, ``of the Alabama SIP requires
that ADEM notify the public of an application, preliminary
determination, the activity or activities involved in the permit
action, any emissions change associated with any permit modification,
and the opportunity for comment prior to making a final permitting
decision. ADEM worked closely with local political subdivisions during
the development of its Transportation Conformity SIP and Regional Haze
Implementation Plan. Required partners covered by Alabama's
consultation procedures include federal, state and local transportation
and air quality agency officials. The state and local transportation
agency officials are most directly impacted by transportation
conformity requirements and are required to provide public involvement
for their activities including the analysis demonstrating how they meet
transportation conformity requirements. Alabama has worked with the
FLMs as a requirement of its regional haze rule. EPA has made the
preliminary determination that Alabama's SIP and practices adequately
demonstrate consultation with affected

local entities related to the 2008 Lead NAAQS when necessary.

V. Proposed Action

    With the exception of the PSD permitting requirements for major
sources of sections 110(a)(2)(C), prong 3 of (D)(i) and (J), and the
state board requirements of section 110(a)(2)(E)(ii), EPA is proposing
to approve that ADEM's infrastructure SIP submission, submitted
November 4, 2011, for the 2008 Lead NAAQS meets the above described
infrastructure SIP requirements. EPA is proposing to disapprove section
110(a)(2)(E)(ii) of Alabama's infrastructure submission because the
State's implementation plan does not contain provisions to comply with
section 128 of the Act, and thus Alabama's November 4, 2011,
infrastructure SIP submission does not meet the requirements of the
Act. This proposed approval in part and disapproval in part, however,
does not include the PSD permitting requirements for major sources of
section 110(a)(2)(C), prong 3 of (D)(i) and (J) because the Agency has
taken final action on these requirements for 2008 Lead NAAQS for
Alabama in a separate rulemaking.
    Under section 179(a) of the CAA, final disapproval of a submittal
that addresses a requirement of a CAA Part D Plan or is required in
response to a finding of substantial inadequacy as described in CAA
section 110(k)(5) (SIP call) starts a sanctions clock. The portion of
section 110(a)(2)(E)(ii) provisions (the provisions being proposed for
disapproval in today's notice) were not submitted to meet requirements
for Part D or a SIP call, and therefore, if EPA takes final action to
disapprove this submittal, no sanctions will be triggered. However, if
this disapproval action is finalized, that final action will trigger
the requirement under section 110(c) that EPA promulgate a federal
implementation plan (FIP) no later than 2 years from the date of the
disapproval unless the State corrects the deficiency, and EPA approves
the plan or plan revision before EPA promulgates such FIP.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, 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);
     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 application of those requirements would be inconsistent
with the Clean Air Act; and
     does not provide 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).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where 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 as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Lead, and Recordkeeping
requirements.

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

    Dated: July 6, 2015.
Heather McTeer Toney,
Regional Administrator, Region 4.
[FR Doc. 2015-17733 Filed 7-17-15; 8:45 am]
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[Federal Register: April 27, 2010 (Volume 75, Number 80)]
[Notices]
[Page 22151]
[DOCID:fr27ap10-76]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1894-DR; Docket ID FEMA-2010-0002]

Rhode Island; Amendment No. 4 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Rhode Island (FEMA-1894-DR), dated March 29, 2010, and
related determinations.

DATES: Effective Date: April 12, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this disaster is closed effective April 12, 2010.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-9727 Filed 4-26-10; 8:45 am]
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