[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Pages 69857-69859]
[FR Doc No: 2014-27691]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1428]

Electronic Product Reporting for Human Drug Compounding
Outsourcing Facilities; Draft Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a revised draft guidance entitled
``Electronic Product Reporting for Human Drug Compounding Outsourcing
Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic
Act.'' The revised draft guidance addresses provisions in the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality
and Security Act (DQSA) and updates reporting instructions for drug
compounders that choose to register as outsourcing facilities. Such
compounders must report information on the drugs they have compounded
in Structured Product Labeling (SPL) format using FDA's electronic
submissions system. This revised draft guidance supersedes a draft
guidance entitled ``Interim Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.''

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency considers your comments on
this revised draft guidance, submit either electronic or written
comments on the revised draft guidance by January 23, 2015. Submit
either electronic or written comments concerning the collection of
information proposed in the revised draft guidance by January 23, 2015.

ADDRESSES: Submit written requests for single copies of the revised
draft guidance document to the Division of Drug Information, Center for
Drug Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your request. See the SUPPLEMENTARY INFORMATION
section for electronic access to the revised draft guidance.
    Submit electronic comments on the revised draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lysette Deshields, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a revised draft guidance for
industry entitled ``Electronic Product Reporting for Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.'' In the Federal Register of December 4,
2013 (78 FR 72897), FDA issued a notice announcing the availability of
an initial draft of this guidance entitled ``Interim Product Reporting
for Human Drug Compounding Outsourcing Facilities Under Section 503B of
the Federal Food, Drug, and Cosmetic Act.'' That draft guidance
addressed new provisions in the FD&C Act added by the DQSA and set
forth an interim submission method for human drug compounders that
choose to register as outsourcing facilities.
    The comment period on the initial draft guidance ended on February
3, 2014. FDA received six comments on the draft. In response to
received comments or on its own initiative, FDA made the following
changes and updates in the revised draft guidance: (1) Modified the
scope of the guidance to refer to product reports submitted in SPL
format; (2) clarified the following elements required in a product
report: ``Strength of the active ingredient per unit,'' ``package
description,'' and

``number of individual units produced''; (3) included language that
discusses the time period during which outsourcing facilities must
submit product reports; (4) included the appropriate SPL document type
category for outsourcing facilities submitting a product report and a
reference to detailed instructions on how to submit information using
SPL; (5) clarified that reports submitted under section 503B(b)(2) of
the FD&C Act (21 U.S.C. 353b(b)(2)) are exempt from inspection unless
the Secretary finds that such an exemption would be inconsistent with
the protection of the public health; and (6) made grammatical and other
minor editorial changes for clarity.
    In some cases, received comments raised issues that were not
directly pertinent to the topics addressed in the draft. This revised
draft guidance explains that registered outsourcing facilities must
provide reports to FDA on compounded drugs in SPL format using FDA's
electronic submissions system. It supersedes the draft guidance
entitled ``Interim Product Reporting for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.''
    Section 503B(b)(2)(B) of the FD&C Act provides that a facility that
elects to register with FDA as an outsourcing facility is required to
report to FDA information about the drugs compounded at that
outsourcing facility in the form and manner as FDA may ``prescribe by
regulation or guidance.'' Congress gave FDA explicit statutory
authority to establish binding requirements on this topic in guidance.
Therefore, this guidance is not subject to the usual restrictions in
FDA's good guidance practice regulations (e.g., the requirements that
guidances not establish legally enforceable responsibilities and that
guidances prominently display a statement of the document's nonbinding
effect); see 21 CFR 10.115(d)(1)).
    As provided in section 503B of the DQSA, this revised draft
guidance explains the form and manner in which registered outsourcing
facilities are required to submit drug reporting information. This
revised draft guidance, when finalized, will prescribe the form and
manner for submitting drug product reports to FDA under section 503B of
the FD&C Act and will have binding effect under section 503B(b)(2)(B).
Until this draft guidance is finalized, FDA will accept drug product
reports submitted in accordance with the form and manner described in
FDA's initial draft guidance on this subject. However, FDA strongly
encourages outsourcing facilities to submit drug product reports as
described in this revised draft guidance.
    Elsewhere in this issue of the Federal Register, FDA is making
available a final guidance on registration for human drug compounding
outsourcing facilities under section 503B of the FD&C Act.

II. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal Agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
document, FDA invites comments on the following topics: (1) Whether the
proposed information collected is necessary for the proper performance
of FDA's functions, including whether the information will have
practical utility; (2) the accuracy of FDA's estimated burden of the
proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Under the revised draft guidance, registered outsourcing facilities
must submit to FDA a report identifying all drugs compounded by the
facility during the previous 6-month period. The report must be
submitted upon initial registration as an outsourcing facility, once in
June, and once in December of each year. The report must include the
following information for all drugs compounded at the outsourcing
facility during the previous 6-month period:
     The active ingredient and strength of active ingredient
per unit
     The source of the active ingredient (bulk or finished)
     The National Drug Code (NDC) number of the source drug or
bulk active ingredient, if available
     The dosage form and route of administration
     The package description
     The number of individual units produced
     The NDC number of the final product, if assigned
    Product reports must be submitted to FDA electronically in SPL
format, as described in the revised draft guidance. Outsourcing
facilities can request a waiver from the electronic submission process
by submitting a written request to FDA explaining why the use of
electronic means is not reasonable for them.
    Based on our familiarity with outsourcing facilities, we estimate
that annually a total of approximately 50 outsourcing facilities
(``number of respondents'' in table 1, row 1) will submit to FDA at the
time of initial registration a report identifying all drugs compounded
in the facility. We also estimate that these outsourcing facilities
will submit a total of approximately 50 reports for compounded drugs
containing the information specified in the draft guidance (``total
annual responses'' in table 1, row 1). We estimate that preparing and
submitting this information electronically will take approximately 2
hours per report (``average burden per response'' in table 1, row 1).
We expect to receive no more than one waiver request from this
electronic submission process (``total annual responses'' in table 1,
row 2), and each request should take approximately 1 hour to prepare
and submit to us (``average burden per response'' in table 1, row 2).
    We also estimate that a total of approximately 50 outsourcing
facilities (``number of respondents'' in table 2, row 1) will submit to
FDA a report twice each year identifying all drugs compounded at the
facility. We estimate that these outsourcing facilities will submit a
total of approximately 50 reports in December and 50 reports in June
containing the information specified in the draft revised guidance
(``total annual responses'' in table 2, row 1). We estimate that
preparing and submitting this information electronically will take
approximately 2 hours per report (``average burden per response'' in
table 2, row 1). We expect to receive no more than one waiver request
from the electronic submission process (``total annual responses'' in
table 2, row 2), and each request should take approximately 1 hour to
prepare and submit to us (``average burden per response'' in table 2,
row 2).

                                Table 1--Estimated One-Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
      Product reporting for                          Number of                        Average
     compounding outsourcing         Number of     responses per   Total annual     burden per      Total hours
           facilities               respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Submission of Initial Product                 50               1              50               2             100
 Report.........................
Waiver Request from Electronic                 1               1               1               1               1
 Submission of Initial Product
 Report.........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             101
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
      Product reporting for                          Number of
     compounding outsourcing         Number of     responses per   Total annual   Average burden    Total hours
           facilities               respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Submission of December Product                50               1              50               2             100
 Report.........................
Submission of June Product                    50               1              50               2             100
 Report.........................
Waiver Request from Electronic                 1               1               1               1               1
 Submission of Product Reports..
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             201
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

III. Comments

    Interested persons can submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
can be viewed at the Division of Dockets Management between 9 a.m. and
4 p.m., Monday through Friday, and will be posted to the docket at
http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 18, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-27691 Filed 11-21-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 211 (Wednesday, October 31, 2018)]
[Notices]
[Pages 54743-54744]
[FR Doc No: 2018-23743]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OARM-2018-0124; FRL-9983-16-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Contractor Cumulative Claim and
Reconciliation (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Contractor Cumulative Claim and
Reconciliation (EPA ICR No. 0246.13, OMB Control No. 2030-0016) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through November 30,
2018. Public comments were previously requested via the Federal
Register on April 25, 2018, during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An Agency may not conduct or sponsor and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before November 30,
2018.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OARM-2018-0124, to (1) EPA online using www.regulations.gov (our
preferred method), by email to [email protected], or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB via email to
[email protected]. Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Thomas Valentino, Policy, Training and
Oversight Division, Office of Acquisition Management (3802R),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: All contractors who have completed an EPA cost-
reimbursement type contract will be required to submit EPA Form 1900-
10. EPA Form 1900-10 summarizes all costs incurred in performance of
the contract and sets forth the final indirect rates. This form is
reviewed by the contracting officer to determine the final costs
reimbursable to the contractor. The Federal Acquisition Regulation
(FAR) 52.216-7 states that the Government will pay only the costs
determined to be allowable by the contracting officer in accordance
with FAR Subpart 31.2. Furthermore, FAR 52.216-7 states that indirect
cost rates shall be established for each fiscal year at the close of a
contractor's fiscal year. EPA Form 1900-10 summarizes this information
for the entire contract period and provides a basis for cost review by
contracting, finance, and audit personnel. In addition, FAR 4.804-5
mandates that the office administering the contract shall ensure that
the costs and indirect cost rates are settled.
    Form Numbers: EPA Form 1900-10.

    Respondents/affected entities: All contractors who have completed
an EPA cost-reimbursement type contract.
    Respondent's obligation to respond: Mandatory (FAR 52.216-7).
    Estimated number of respondents: 5 (total).
    Frequency of response: Once, at the end of the contract.
    Total estimated burden: 32 hours (per year). Burden is defined at 5
CFR 1320.03(b).
    Total estimated cost: $4,602 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in the Estimates: There is no change in the hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018-23743 Filed 10-30-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: April 24, 2009 (Volume 74, Number 78)]
[Notices]
[Page 18736-18737]
[DOCID:fr24ap09-79]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0187]

Small Entity Compliance Guide on Prior Notice of Imported Food;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a small entity compliance guide (SECG) for the final
rule on prior notice of imported food. The final rule issued under the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 (the Bioterrorism Act), and it was published in the Federal
Register of November 7, 2008. The SECG is entitled ``What You Need to
Know About Prior Notice of Imported Food Shipments--A Small Entity
Compliance Guide,'' and it is intended to help all entities, especially
small businesses, better understand the prior notice regulation.

DATES: Submit written or electronic comments on the SECG at any time.

ADDRESSES: Submit written requests for single copies of the SECG to the
CFSAN Outreach and Information Center, Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 1-877-366-3322, or email your request
to<EMAIL_ADDRESS>    Submit written comments concerning the SECG to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
on the SECG to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to this SECG.

FOR FURTHER INFORMATION CONTACT: Laura Draski, Office of Regulatory
Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 7, 2008 (73 FR 66294), FDA
issued the prior notice final rule implementing section 307 of the
Bioterrorism Act. The prior notice final rule requires the submission
to FDA of prior notice of food, including animal feed, that is imported
or offered for import into the United States.
    FDA examined the economic implication of this final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612) and
determined that it would have a significant economic impact on a
substantial number of small entities.
    In compliance with section 212 of the Small Business Regulatory
Enforcement Fairness Act (Public Law 104-121), FDA is making available
this SECG that explains the requirements of this regulation.
    FDA is issuing this SECG as a level 2 guidance consistent with
FDA's good guidance practices regulation (21 CFR 10.115(c)(2)). This
SECG restates, in simplified format and language, FDA's current
requirements for prior notice of imported food. As guidance, this
document is not binding on either FDA or the public. FDA notes,
however, that the regulation that serves as the basis for this guidance
document establishes requirements for all covered activities. For this
reason, FDA strongly recommends that affected parties consult the
regulations at 21 CFR part 1, subpart I, in addition to reading this
SECG.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this SECG.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets

Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain this SECG at http://
www.cfsan.fda.gov/guidance.html.

    Dated: April 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9358 Filed 4-23-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 156 (Tuesday, August 15, 2017)]
[Proposed Rules]
[Pages 38654-38660]
[FR Doc No: 2017-17229]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2016-0634; FRL-9966-32-Region 4]

Air Plan Approval; Georgia; Regional Haze Progress Report

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision submitted by the
State of Georgia, Department of Natural Resources, through the Georgia
Environmental Protection Division (GA EPD) on January 8, 2014.
Georgia's January 8, 2014, SIP revision (Progress Report) addresses
requirements of the Clean Air Act (CAA or Act) and EPA's rules that
require each state to submit periodic reports describing progress
towards reasonable progress goals (RPGs) established for regional haze
and a determination of the adequacy of the state's existing SIP
addressing regional haze (regional haze plan). EPA is proposing to
approve Georgia's determination that the State's regional haze plan is
adequate to meet these RPGs for the first implementation period
covering through 2018 and requires no substantive revision at this
time.

DATES: Comments must be received on or before September 14, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2016-0634 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. 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 http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Michele Notarianni, 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. Ms. Notarianni can be reached by phone at<PHONE_NUMBER>
and via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    States are required to submit a progress report in the form of a
SIP revision during the first implementation period that evaluates
progress towards the RPGs for each mandatory Class I federal area \1\
(Class I area) within the state and for each Class I area outside the
state which may be affected by emissions from within the state. 40 CFR
51.308(g). In addition, the provisions of 40 CFR 51.308(h) require
states to submit, at the same time as the 40 CFR 51.308(g) progress
report, a determination of the adequacy of the state's existing
regional haze plan. The first progress report is due five years after
submittal of the initial regional haze plan. Georgia submitted its
first regional haze plan on February 11, 2010, and supplemented its
plan on November 19, 2010.\2\
---------------------------------------------------------------------------

    \1\ Areas designated as mandatory Class I federal areas consist
of national parks exceeding 6000 acres, wilderness areas and
national memorial parks exceeding 5000 acres, and all international
parks that were in existence on August 7, 1977. 42 U.S.C. 7472(a).
These areas are listed at 40 CFR part 81, subpart D.
    \2\ Georgia's February 11, 2010, regional haze plan as
supplemented on November 19, 2010, is hereinafter collectively
referred to as Georgia's regional haze plan unless otherwise
specified.
---------------------------------------------------------------------------

    Like many other states subject to the Clean Air Interstate Rule
(CAIR), Georgia relied on CAIR in its regional haze plan to meet
certain requirements of EPA's Regional Haze Rule, including best
available retrofit technology (BART) requirements for emissions of
sulfur dioxide (SO2) and nitrogen oxides (NOx) from certain
electric generating units (EGUs) in the State.\3\ This reliance was
consistent with EPA's regulations at the time that Georgia developed
its regional haze plan. See 70 FR 39104 (July 6, 2005). However, in
2008, the United States Court of Appeals for the District of Columbia
Circuit (D.C.

Circuit) remanded CAIR to EPA without vacatur to preserve the
environmental benefits provided by CAIR. North Carolina v. EPA, 550
F.3d 1176, 1178 (D.C. Cir. 2008). On August 8, 2011 (76 FR 48208),
acting on the D.C. Circuit's remand, EPA promulgated CSAPR to replace
CAIR and issued Federal Implementation Plans (FIPs) to implement the
rule in CSAPR-subject states.\4\ Implementation of CSAPR was scheduled
to begin on January 1, 2012, when CSAPR would have superseded the CAIR
program. However, numerous parties filed petitions for review of CSAPR,
and at the end of 2011, the D.C. Circuit issued an order staying CSAPR
pending resolution of the petitions and directing EPA to continue to
administer CAIR. Order of December 30, 2011, in EME Homer City
Generation, L.P. v. EPA, D.C. Cir. No. 11-1302.
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    \3\ CAIR required certain states, including Georgia, to reduce
emissions of SO2 and NOX that significantly
contribute to downwind nonattainment of the 1997 National Ambient
Air Quality Standard (NAAQS) for fine particulate matter
(PM2.5) and ozone. See 70 FR 25162 (May 12, 2005).
    \4\ CSAPR requires 27 Eastern states to limit their statewide
emissions of SO2 and/or NOX in order to
mitigate transported air pollution unlawfully impacting other
states' ability to attain or maintain four NAAQS: The 1997 ozone
NAAQS, the 1997 annual PM2.5 NAAQS, the 2006 24-hour
PM2.5 NAAQS, and the 2008 8-hour ozone NAAQS. The CSAPR
emissions limitations are defined in terms of maximum statewide
budgets for emissions of annual SO2, annual
NOX, and/or ozone-season NOX by each covered
state's large EGUs.
---------------------------------------------------------------------------

    On June 28, 2012 (77 FR 38501), EPA finalized a limited approval of
Georgia's regional haze plan as meeting some of the applicable regional
haze requirements of the first implementation period for regional haze.
In a separate action published on June 7, 2012 (77 FR 33642), EPA
finalized a limited disapproval of Georgia's regional haze plan because
of deficiencies arising from the State's reliance on CAIR to satisfy
certain regional haze requirements. In the June 7, 2012, action, EPA
also promulgated FIPs to replace reliance on CAIR with reliance on
CSAPR to address deficiencies in CAIR-dependent regional haze plans of
several states, including Georgia's regional haze plan.
    On August 21, 2012, the D.C. Circuit issued its ruling on CSAPR,
vacating and remanding the Rule to EPA and ordering continued
implementation of CAIR. EME Homer City Generation, L.P. v. EPA, 696
F.3d 7, 38 (D.C. Cir. 2012). The D.C. Circuit's vacatur of CSAPR was
reversed by the United States Supreme Court on April 29, 2014, and the
case was remanded to the D.C. Circuit to resolve remaining issues in
accordance with the high court's ruling. EPA v. EME Homer City
Generation, L.P., 134 S. Ct. 1584 (2014). On remand, the D.C. Circuit
affirmed CSAPR in most respects, but invalidated without vacating some
of the CSAPR budgets as to a number of states. EME Homer City
Generation, L.P. v. EPA, 795 F.3d 118 (D.C. Cir. 2015). The remanded
budgets include the Phase 2 SO2 emissions budget for
Georgia. This litigation ultimately delayed implementation of CSAPR for
three years, from January 1, 2012, when CSAPR's cap-and-trade programs
were originally scheduled to replace the CAIR cap-and-trade programs,
to January 1, 2015. Thus, the rule's Phase 2 budgets, originally
promulgated to begin on January 1, 2014, began on January 1, 2017. On
July 26, 2017, Georgia submitted a SIP revision that adopts provisions
for participation in the CSAPR annual NOX and annual
SO2 trading programs, including annual NOX and
annual SO2 budgets that are equal to the budgets for Georgia
in EPA's CSAPR FIP.
    On January 8, 2014, Georgia submitted its Progress Report which,
among other things, details the progress made in the first period
toward implementation of the long term strategy outlined in the State's
regional haze plan; the visibility improvement measured at the three
Class I areas within its borders (Cohutta Wilderness Area, Okefenokee
Wilderness Area, and Wolf Island Wilderness Area) and at Class I areas
outside of the State potentially impacted by emissions from Georgia;
and a determination of the adequacy of the State's existing regional
haze plan. EPA is proposing to approve Georgia's January 8, 2014,
Progress Report for the reasons discussed below.

II. EPA's Evaluation of Georgia's Progress Report and Adequacy
Determination

A. Regional Haze Progress Report

    This section includes EPA's analysis of Georgia's Progress Report
and an explanation of the basis for the Agency's proposed approval.
1. Control Measures
    In its Progress Report, Georgia summarizes the status of the
emissions reduction measures that were included in the final iteration
of the Visibility Improvement State and Tribal Association of the
Southeast (VISTAS) regional haze emissions inventory and RPG modeling
used by the State in developing its regional haze plan. The measures
include, among other things, applicable federal programs (e.g., mobile
source rules and Maximum Achievable Control Technology standards) and
federal and state control strategies for EGUs. Georgia also described
the court decisions addressing CAIR and CSAPR at the time of Progress
Report development.
    As discussed above, a number of states, including Georgia,
submitted regional haze plans that relied on CAIR to meet certain
regional haze requirements. EPA finalized a limited disapproval of
Georgia's regional haze plan due to this reliance and promulgated a FIP
to replace reliance on CAIR with reliance on CSAPR. The D.C. Circuit
ultimately affirmed CSAPR in most respects, and CSAPR is now in effect.
EME Homer City Generation, L.P. v. EPA, 795 F.3d 118 (D.C. Cir. 2015).
Georgia notes in its Progress Report that CAIR was in effect due to the
D.C. Circuit's decisions at the time of submittal. Because CSAPR should
result in greater emissions reductions of SO2 and
NOX than CAIR throughout the affected region, EPA expects
Georgia to maintain and continue its progress towards its RPGs for 2018
through continued, and additional, SO2 and NOX
reductions. See generally 76 FR 48208 (August 8, 2011).
    In its Progress Report, Georgia identifies the status of
implementation of SO2 controls required by Georgia Rule 391-
3-1-.02(2)(sss)--``Multipollutant Rule'' (Rule (sss)) that were
scheduled to be installed at the time of the original regional haze
plan submittal. Rule (sss), enacted in response to CAIR, requires the
installation and operation of flue gas desulfurization (FGD) to control
SO2 emissions and selective catalytic reduction (SCR) to
control NOX emissions on the majority of the coal-fired EGUs
in Georgia. The State notes that these controls will reduce
NOX emissions from these EGUs by approximately 85 percent
and reduce SO2 emissions by at least 95 percent. The
implementation dates vary by EGU, starting on December 31, 2008, and
ending on December 31, 2015. To date, all planned controls have been
implemented either early or on time. By installing and operating FGD
and SCR controls in accordance with Rule (sss), Georgia EGUs also met
the requirements of CAIR. In its regional haze plan and Progress
Report, Georgia focuses its assessment on SO2 emissions from
EGUs because of VISTAS' findings that ammonium sulfate accounted for
more than 70 percent of the visibility-impairing pollution in the
VISTAS states \5\ and that SO2 point source emissions are
projected to represent more than 95 percent of the total SO2
emissions in the VISTAS states in

2018.\6\ As discussed below in Section II.A.5, Georgia determined that
sulfates continue to be the largest contributor to regional haze for
Class I areas in the State.
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    \5\ Sulfate levels on the 20 percent worst days account for 60-
70 percent of the visibility impairment at Georgia's Class I areas.
For additional information, see Georgia's February 11, 2010,
regional haze plan submittal at page 13.
    \6\ For additional information, see Georgia's February 11, 2010,
regional haze plan submittal at page 76.
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    Georgia also reviewed the status of SO2 controls for 11
non-EGU emissions units at seven facilities in the State which were
included in the universe of emissions units initially determined
eligible for a reasonable progress control analysis.\7\ Of these 11
emissions units, six units at three facilities accepted permit limits
to exempt out of being subject to a reasonable progress control
analysis; \8\ the State determined that the BART-related controls for
three units at two facilities satisfied reasonable progress; \9\ and
for the remaining two units at two facilities, Georgia required
additional controls.\10\ At the time of Progress Report submission, all
units have required permit limits in place and have met or are expected
to meet the required control due dates.\11\
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    \7\ See Table 2-3 of Georgia's Progress Report, pp.20-22. This
table excludes EGU and non-EGU units where existing controls or CAIR
controls were determined to satisfy reasonable progress for the
first implementation period.
    \8\ The following six units in Georgia have permit limits which
exempt them from being eligible for a reasonable progress analysis:
Packaging Corporation of America C E Boiler; Rayonier Performance
Fibers--Jessup Mill Power Boilers 2 and 3 and Recovery Furnaces 1
and 4; and Southern States Phosphate and Fertilizer Sulfuric Acid
Plant 2.
    \9\ The following three units in Georgia have implemented BART-
related controls by the required due dates: Georgia Pacific Cedar
Springs--Power Boilers U500 and U501 (BART exemption limits) and
Interstate Paper Power Boiler F1 (BART control limits).
    \10\ The following two units in Georgia are applying additional
control measures to meet their permit limits which satisfy
reasonable progress: Georgia Pacific Brunswick Cellulose Power
Boiler No. 4 and International Paper--Savannah Mill Power Boiler 13.
    \11\ See Table 2-3 of Georgia's Progress Report, pp.20-22.
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    In addition, the State discusses the status of several measures
that were not included in the final VISTAS emissions inventory and were
not relied upon in the initial regional haze plan to meet RPGs,
including EPA's Mercury and Air Toxics Rule, a 2011 federal consent
agreement with the Tennessee Valley Authority, and EGU retirements and
fuel conversions that have occurred or are planned to occur before
2018. Georgia Power decertified and retired 15 fossil fuel fired EGUs
(10 coal-fired, three oil-fired, and two gas-fired units) between 2013
and 2016.\12\ Further, Georgia Power's Yates Steam Electric Generating
Plant converted Units 6 and 7 from coal to natural gas.\13\ The State
notes that the emissions reductions from these measures will help
ensure that Class I areas impacted by Georgia sources achieve their
RPGs.
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    \12\ See page 24 of Georgia's Progress Report and a November 18,
2016, email from Georgia to EPA documenting these EGU retirements.
The Progress Report, email from the State, and associated
documentation of these retirements and fuel conversions are located
in the docket for this proposed action.
    \13\ Id.
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    Regarding the impact of sources outside of the State on Class I
areas in Georgia, GA EPD sent letters to Florida, South Carolina, and
Tennessee pertaining to emissions units within these states that it
believes contribute to visibility impairment at Georgia's Class I areas
using the State's methodology for determining sources eligible for a
reasonable progress control determination.\14\ Georgia consulted with
these states regarding these sources and opted not to rely upon any
additional emissions reductions from sources located outside the
State's boundaries beyond those already identified in the State's
regional haze plan.\15\
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    \14\ See 77 FR 11474-11475.
    \15\ See 77 FR 11475.
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    Regarding the impact of Georgia's sources on Class I areas outside
of the State, Georgia applied its area of influence methodology to
identify sources in the State that have emissions units with impacts
large enough to potentially warrant further evaluation and analysis
because, at the time of Georgia's SIP development, many of these states
had not yet defined their criteria for identifying sources to evaluate
for reasonable progress. The State identified eight emissions units in
Georgia within the area of influence of seven Class I areas in five
neighboring states. Georgia determined that there are no additional
control measures for these Georgia emissions units that would be
reasonable to implement to mitigate visibility impacts in Class I areas
in the five neighboring states.\16\
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    \16\ In its regional haze plan, the State identified, through an
area of influence modeling analysis based on back trajectories,
seven Class I areas in five neighboring states potentially impacted
by Georgia sources using the State's reasonable progress eligibility
criteria as a screening tool: Sipsey Wilderness Area (AL), Saint
Marks Wilderness Area (FL), Shining Rock Wilderness Area (NC),
Swanquarter Wilderness Area (NC), Great Smoky Mountains National
Park (NC/TN), Joyce Kilmer-Slickrock Wilderness Area (NC/TN), and
Cape Romain Wilderness Area (SC). See 77 FR 11474 (February 27,
2012). Georgia evaluated the 20 percent worst day visibility
conditions for these areas. See pages 42-43 and Appendix D of
Georgia's Progress Report.
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    EPA proposes to find that Georgia adequately addressed the
applicable provisions under 40 CFR 51.308(g) regarding the
implementation of control measures for the reasons discussed below. The
State documents the implementation status of measures from its regional
haze plan in addition to describing additional measures not originally
accounted for in the final VISTAS emissions inventory that came into
effect since the VISTAS analyses for the regional haze plan were
completed. Georgia reviewed the status of BART requirements for the two
BART-subject non-EGU sources in the State and reviewed the status of
additional reasonable progress controls for these two sources. The
State's Progress Report also discusses the status of existing and
future expected SO2 controls for Georgia's EGUs because, in
its regional haze plan, Georgia identified SO2 emissions
from coal-fired EGUs as the key contributor to regional haze in the
VISTAS region.
2. Emissions Reductions
    As discussed above, Georgia focused its assessment on
SO2 emissions from EGUs because of VISTAS' findings that
ammonium sulfate is the primary component of visibility-impairing
pollution in the VISTAS states. In its Progress Report, Georgia
presents SO2 emissions data for 23 coal-fired EGUs at seven
facilities in the State that, at the time the State submitted its
February 11, 2010, regional haze plan, were scheduled to install
SO2 controls as a result of Rule (sss).\17\ Eleven of these
coal-fired EGUs were identified by Georgia as having visibility impacts
at one or more neighboring Class I areas. As of the time that Georgia
developed its Progress Report, all planned controls had been
implemented either early or on time and the requirements for controls
in 2013 or later are still in place. Georgia Power--Plant McDonough
retired Units 1 and 2 prior to their control dates in 2012 and 2011,
respectively, for FGD controls.
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    \17\ See Table 2-2 on pages 15-18 of Georgia's Progress Report.
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    Based on EGU emissions projections from its regional haze plan,
Georgia notes that the estimated total SO2 emission
reductions for these coal-fired EGUs from 2002 to 2018 would be 441,989
tons per year (tpy) and from 2002 to 2009 would be 161,949 tpy. Actual
SO2 emissions reductions implemented by the end of 2009
totaled 184,215 tpy of SO2, over 20,000 tpy greater than
originally projected through 2009 in Georgia's regional haze plan.
Georgia also estimates in its Progress Report that an additional 93,000
tons of SO2 emissions reductions were achieved from 2010
through 2012.\18\
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    \18\ See page 14 of Georgia's Progress Report.

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    Georgia's Progress Report also includes SO2 and
NOX emissions data from 2002-2011 for EGUs in the State and
for EGUs in the VISTAS region that are subject to reporting under the
Acid Rain Program. This data shows a decline in these emissions over
this time period. From 2002-2011, SO2 emissions from these
EGUs in Georgia decreased by 325,795 tons annually. Table 1 shows
actual SO2 emissions from Georgia EGUs obtained from EPA's
Clean Air Markets Division (CAMD) database. EGU SO2
emissions dropped from 2007 to 2011 by 448,625 tons.

                                  Table 1--Georgia EGU SO2 Emissions From CAMD
                                                   [2007-2011]
----------------------------------------------------------------------------------------------------------------
      SO2 Emissions (tons)             2007            2008            2009            2010            2011
----------------------------------------------------------------------------------------------------------------
CAMD EGU Emissions..............         635,484         514,539         262,337         218,904         186,859
Change from 2007................               0         120,945         373,147         416,580         448,625
----------------------------------------------------------------------------------------------------------------

    EPA proposes to conclude that Georgia has adequately addressed 40
CFR 51.308(g). As discussed above, the State provides estimates, and
where available, actual emissions reductions of SO2 and
NOX at EGUs in the State.
3. Visibility Progress
    In its Progress Report, Georgia provides figures with visibility
monitoring data for the State's three Class I areas. Georgia reported
current conditions as the 2006-2010 five-year time period and used the
2000-2004 baseline period for its Class I areas.\19\ Table 2 shows the
current visibility conditions and the difference between current
visibility conditions and baseline visibility conditions. Table 3 shows
the changes in visibility from 2005-2010 in terms of five-year
averages.
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    \19\ For the first regional haze plans, ``baseline'' conditions
were represented by the 2000-2004 time period. See 64 FR 35730 (July
1, 1999). Wolf Island Wilderness Area does not have a visibility
monitor; therefore, visibility data from Okefenokee Wilderness Area
is used for both areas given their proximity. For more information,
see 77 FR 11459.

      Table 2--Baseline Visibility, Current Visibility, and Visibility Changes in Class I Areas in Georgia
----------------------------------------------------------------------------------------------------------------
                                                  Baseline (2000- Current (2006-
                  Class I area                         2004)           2010)        Difference      RPG (2018)
----------------------------------------------------------------------------------------------------------------
20% Worst Days
Cohutta.........................................           30.25           26.18           -4.07           22.80
Okefenokee......................................           27.13           25.01           -2.13           23.82
Wolf Island.....................................           27.13           25.01           -2.13           23.82
20% Best Days
Cohutta.........................................           13.77           12.18           -1.59           11.75
Okefenokee......................................           15.23           14.19           -1.04           13.92
Wolf Island.....................................           15.23           14.19           -1.04           13.92
----------------------------------------------------------------------------------------------------------------

                                            Table 3--Changes in Five-Year Visibility Averages From 2005-2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Change (2010-
              Class I area                     2005            2006            2007            2008            2009            2010            2005)
--------------------------------------------------------------------------------------------------------------------------------------------------------
20% Worst Days
Cohutta \20\............................           30.43           30.52           30.43           29.63           28.01           26.18           -4.24
Okefenokee..............................           27.14           27.24           27.21           26.88           26.00           25.01           -2.13
Wolf Island.............................           27.14           27.24           27.21           26.88           26.00           25.01           -2.13
20% Best Days
Cohutta \21\............................           13.88           13.63           13.62           13.43            12.5           12.18           -1.70
Okefenokee..............................           14.95           15.03           14.90           14.90           14.46           14.19           -0.75
Wolf Island.............................           14.95           15.03           14.90           14.90           14.46           14.19           -0.75
--------------------------------------------------------------------------------------------------------------------------------------------------------

    All Georgia Class I areas saw an improvement in visibility between
baseline and 2006-2010 conditions and an overall decline in the five-
year visibility averages from 2006-2010.
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    \20\ There is no annual average for Cohutta for the year 2006.
    \21\ Id.
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    EPA proposes to find that Georgia has adequately addressed the
applicable provisions under 40 CFR 51.308(g) regarding visibility
conditions because the State provided baseline visibility conditions
(2000-2004), current conditions based on the most recently available
visibility monitoring data available at the time of Progress Report
development, and the change in visibility impairment from 2006-2010.
4. Emissions Tracking
    In its Progress Report, Georgia includes data from a statewide
actual emissions inventory for 2007 and compares this data to the
baseline emissions inventory for 2002 (actual and typical emissions)
from its regional haze plan.\22\ The pollutants inventoried include
volatile organic compounds (VOC), ammonia (NH3),
NOX, coarse particulate matter (PM10), fine

particulate matter (PM2.5), and SO2.\23\ The
emissions inventories include the following source classifications:
Point, area, biogenics, non-road mobile, and on-road mobile sources.
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    \22\ For the typical 2002 stationary point source emissions
inventory, Georgia adjusted the EGU emissions for a typical year so
that if sources were shut down or operating above or below normal,
the emissions are normalized to a typical emissions inventory year.
The purpose is to smooth out potential anomalies in EGU emissions
(related to meteorology, economic, and outage factors) in a given
year. The typical year data is used to develop projected typical
future year emissions inventories.
    \23\ See Appendices F through I of Georgia's Progress Report for
inventories of these pollutants.
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    Georgia's Progress Report narrative includes the actual and typical
emissions inventories from its regional haze plan for 2002, and
summarizes actual emissions data for SO2, NOX,
and PM2.5 from 2007.\24\ Although EPA's 2008 National
Emissions Inventory was available, Georgia believes that the 2007
inventory was a more accurate and more detailed inventory because
additional work was done to improve and verify its accuracy. Georgia
estimated on-road mobile source emissions in the 2007 inventory using
EPA's MOVES model. This model tends to estimate higher emissions for
NOX and PM than its previous counterpart, EPA's MOBILE6.2
model, used by the State to estimate on-road mobile source emissions
for the 2002 inventories. Georgia also included projected emissions
data from its February 11, 2010, regional haze plan submittal for these
visibility-impairing pollutants for the years 2009 and 2018.
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    \24\ Georgia focuses on the visibility-impairing pollutants of
SO2, NOX, and PM2.5 in its Progress
Report narrative because VISTAS performed modeling sensitivity
analyses which demonstrated that anthropogenic emissions of VOC and
NH3 do not significantly impair visibility in the VISTAS
region, including Georgia. See 77 FR 11456, 11460 (February 27,
2012).
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    Table 4 shows that actual emissions of PM2.5 in 2007 are
slightly higher than 2002 emissions. Both the 2002 and 2007 actual
emissions inventories are lower than the projected emissions for 2009
and 2018 from Georgia's regional haze plan. The State notes that the
increase in on-road mobile PM2.5 emissions from 2002 to 2007
is due to the change from MOBILE 6.2 to the MOVES model and that the
decrease in area source PM2.5 emissions from 2002 to 2007 is
mainly due to a change in the methodology used for calculating this
sector's emissions.

                                            Table 4--PM2.5 Emissions
                                                     [tons]
----------------------------------------------------------------------------------------------------------------
             Sector                 2002 Actual    2002 Typical     2007 Actual   2009 Projected  2018 Projected
----------------------------------------------------------------------------------------------------------------
Point...........................          22,401          22,532          25,058          29,890          36,297
Area............................         103,726         103,726          83,594         111,924         123,610
On-road.........................           5,168           5,168          13,681           3,840           2,380
Non-road........................           8,226           8,226           6,608           7,175           5,730
Fires...........................          57,293          55,712          68,766          57,087          57,087
                                 -------------------------------------------------------------------------------
    Total.......................         196,814         195,364         197,707         209,916         225,104
----------------------------------------------------------------------------------------------------------------

    Table 5 shows that actual emissions of NOX in 2007 are
slightly higher than 2002 emissions. With the exception of area
sources, both the 2002 and 2007 actual emissions inventories for all
other source categories remain higher than or approximately equal to
the projected emissions for 2009 and 2018 from Georgia's regional haze
plan. Georgia notes that the increase in on-road mobile NOX
emissions from 2002 to 2007 is due to the change to the MOVES model;
the decrease in area source NOX emissions is mainly due to a
change in the methodology used for calculating this sector's emissions
and the decrease in point source NOX is due to the
installation of emissions controls. Georgia notes in its Progress
Report that if there was no change in the mobile model used, the State
would expect that 2007 emissions would be less than the 2002 base year
emissions for NOX.

                                             Table 5--NOX Emissions
                                                     [tons]
----------------------------------------------------------------------------------------------------------------
             Sector                 2002 Actual    2002 Typical     2007 Actual   2009 Projected  2018 Projected
----------------------------------------------------------------------------------------------------------------
Point...........................         196,767         197,377         154,041         148,850         125,680
Area............................          36,105          36,105          12,351          37,689          41,282
On-road.........................         307,732         307,732         396,837         209,349         102,179
Non-road........................          97,961          97,961          91,081          85,733          64,579
Fires...........................          14,203          13,882          19,429          14,236          14,236
                                 -------------------------------------------------------------------------------
    Total.......................         652,768         653,057         673,739         495,857         347,956
----------------------------------------------------------------------------------------------------------------

    Table 6 shows that actual emissions of SO2 from point
sources and fires are higher in 2007 than 2002. Georgia notes that the
decrease in area source SO2 emissions is mainly due to a
change in the methodology used for calculating this sector's emissions
and that the increase in point source SO2 emissions from
2002 to 2007 is due to increased electricity generation. Despite the
increase from 2002 to 2007 in point source emissions of SO2,
significant emissions reductions occurred in this sector from 2007 to
2011 (as summarized in Table 1, above). The State attributes these
decreased emissions to FGD being installed at several of the coal-fired
EGUs in Georgia.

                                             Table 6--SO2 Emissions
                                                     [tons]
----------------------------------------------------------------------------------------------------------------
             Sector                 2002 Actual    2002 Typical     2007 Actual   2009 Projected  2018 Projected
----------------------------------------------------------------------------------------------------------------
Point...........................         568,731         571,411         683,358         462,666         127,864
Area............................          57,555          57,555           4,858          57,692          59,724
On-road.........................          12,184          12,184           6,407           1,585           1,457
Non-road........................           9,005           9,005           5,983           2,725           1,709
Fires...........................           3,372           2,815           4,492           2,912           2,912
                                 -------------------------------------------------------------------------------
    Total.......................         650,847         652,970         705,098         527,580         193,666
----------------------------------------------------------------------------------------------------------------

    EPA proposes to find that Georgia adequately addressed the
provisions of 40 CFR 51.308(g) regarding emissions tracking because the
State compared the most recent updated emission inventory data
available at the time of Progress Report development with the baseline
emissions used in the modeling for the regional haze plan.
5. Assessment of Changes Impeding Visibility Progress
    In its Progress Report, Georgia documented that sulfates, which are
formed from SO2 emissions, continue to be the biggest single
contributor to regional haze for Class I areas in the VISTAS states,
including Georgia, and therefore focused its analysis on large
SO2 emissions from point sources. Specifically, Georgia
provided data showing the composition of PM2.5 (``speciated
data'') for Class I areas in the VISTAS region and bordering areas,
including Cohutta and Okefenokee, for the years 2001 through 2010. This
speciated data shows that ammonium sulfate continues to be the most
important contributor to visibility impairment and fine particle mass
on the 20 percent worst and 20 percent best visibility days at all of
Georgia's Class I areas.\25\ The State notes that there are no
significant changes in anthropogenic emissions that have impeded
progress in reducing emissions and improving visibility in Class I
areas impacted by Georgia sources, and refers to decreases in point
source SO2 emissions from 2002 to 2011. Given the heat input
data reported by CAMD, the State concludes that these reductions are
not attributable to reduced power demand. Furthermore, the Progress
Report shows that the State is on track to meeting its 2018 RPGs for
Class I areas in Georgia.
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    \25\ See Appendices A and B of Georgia's Progress Report.
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    EPA proposes to find that Georgia has adequately addressed the
provisions of 40 CFR 51.308(g) regarding an assessment of significant
changes in anthropogenic emissions. EPA preliminarily agrees with
Georgia's conclusion that there have been no significant changes in
emissions of visibility-impairing pollutants which have limited or
impeded progress in reducing emissions and improving visibility in
Class I areas impacted by the State's sources.
6. Assessment of Current Strategy
    The State believes that it is on track to meet the 2018 RPGs for
Georgia Class I areas and will not impede Class I areas outside of
Georgia from meeting their RPGs based on the trends in visibility and
emissions presented in its Progress Report. As noted above, Georgia
provided speciated data for the period 2006 to 2010 for the 20 percent
best and worst days at Class I areas in and surrounding the VISTAS
region, including Okefenokee and Cohutta, showing that sulfates
continue to be the largest contributor to visibility impairment at
these Class I areas.\26\ Georgia's Progress Report shows that
SO2 emissions from EGUs in Georgia have decreased from 2002
to 2011 by 325,795 tons; that visibility has improved on the 20 percent
worst days for the State's Class I areas and the Class I areas
potentially impacted by the State's sources (Cape Romain National
Wilderness Area in South Carolina, Shining Rock and Swanquarter
Wilderness Areas in North Carolina, Joyce Kilmer--Slick Rock Wilderness
Area and Great Smoky Mountains National Park in North Carolina and
Tennessee, St. Marks National Wilderness Area in Florida, and Sipsey
Wilderness Area in Alabama); and that these areas are on track to
achieve their RPGs by 2018.\27\
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    \26\ See Figures 1-2, 1-3, 1-4, and 1-5 of Georgia's Progress
Report on pages 5-7.
    \27\ See pages 42-43 of the narrative and Appendix D of
Georgia's Progress Report.
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    As discussed in Section II.A.1, above, CAIR was implemented during
the time period evaluated by Georgia for its Progress Report, but has
now been replaced by CSAPR. At the present time, the requirements of
CSAPR apply to sources in Georgia under the terms of a FIP. Georgia's
regional haze plan accordingly does not contain sufficient provisions
to ensure that the RPGs of Class I areas in nearby states will be
achieved. The term ``implementation plan,'' however, is defined for
purposes of the Regional Haze Rule to mean ``any [SIP], [FIP], or
Tribal Implementation Plan.'' 40 CFR 51.301. Measures in any issued
FIP, as well as those in a state's regional haze plan, may therefore be
considered in assessing the adequacy of the ``existing implementation
plan.'' As noted above, Georgia submitted a SIP revision on July 26,
2017, that adopts provisions for participation in the CSAPR annual
NOX and annual SO2 trading programs, including
annual NOX and annual SO2 budgets that are equal
to the budgets for Georgia in EPA's CSAPR FIP.
    EPA proposes to find that Georgia has adequately addressed the
provisions of 40 CFR 51.308(g) regarding the strategy assessment. In
its Progress Report, Georgia described the improving visibility trends
using data from the IMPROVE network and the downward emissions trends
in NOX and SO2 emissions from EGUs in the State.
These trends support the State's determination that its regional haze
plan is sufficient to meet RPGs for Class I areas within and outside
the State potentially impacted by Georgia sources. EPA finds that
Georgia's conclusion regarding the sufficiency of its regional haze
plan is appropriate because CAIR was in effect in Georgia through 2014,
providing the emission reductions relied upon in Georgia's regional
haze plan through that date. CSAPR is now being implemented, and by
2018, the end of the first regional haze implementation period, CSAPR
will reduce emissions of SO2 and NOX from EGUs in
Georgia by the same amount assumed by EPA when it issued the CSAPR FIP
for Georgia. Because CSAPR will ensure the control of SO2
and NOX emissions reductions relied upon by Georgia and
other states in setting their RPGs beginning in January 2015 at least
through the

remainder of the first implementation period in 2018, EPA is proposing
to approve Georgia's finding that the plan elements and strategies in
its implementation plan are sufficient to achieve the RPGs for the
Class I area in the State and for Class I areas in nearby states
potentially impacted by sources in the State.
7. Review of Current Monitoring Strategy
    Georgia's Progress Report summarizes the existing monitoring
network in the State to monitor visibility in Georgia's Class I areas
and concludes that no modifications to the existing visibility
monitoring strategy are necessary. The primary monitoring network for
regional haze, both nationwide and in Georgia, is the IMPROVE network.
There are currently two IMPROVE sites in Georgia. One is located in the
Cohutta Wilderness Area. The other monitor is located in the Okefenokee
Wilderness area and serves as the monitoring site for both the
Okefenokee and Wolf Island Wilderness Areas.
    The State also explains the importance of the IMPROVE monitoring
network for tracking visibility trends at Class I areas in Georgia,
noting that because IMPROVE monitoring data from 2000-2004 serve as the
baseline for the regional haze program, the future regional haze
monitoring strategy should be based on IMPROVE data (or data directly
comparable to IMPROVE data). Georgia also highlights that the IMPROVE
measurements provide the only long-term record available for tracking
visibility improvement or degradation. The Visibility Information
Exchange Web System Web site has been maintained by VISTAS and the
other Regional Planning Organizations to provide ready access to the
IMPROVE data and data analysis tools.
    EPA proposes to find that Georgia has adequately addressed the
applicable provisions of 40 CFR 51.308(g) regarding monitoring strategy
because the State reviewed its visibility monitoring strategy and
determined that no further modifications to the strategy are necessary.

B. Determination of Adequacy of Existing Regional Haze Plan

    In its Progress Report, Georgia submitted a declaration to EPA that
the existing regional haze plan requires no further substantive
revision at this time to achieve the RPGs for Class I areas affected by
the State's sources. The basis for the State's declaration is the
findings from the Progress Report, including the findings that: The
control measures in Georgia's regional haze plan are on track to meet
their implementation schedules; reduction of SO2 emissions
continues to be the appropriate strategy for improvement of visibility
in Georgia's Class I areas; EGU SO2 emissions dropped from
2002 to 2011 by 325,795 tons,\28\ and the actual change in visibility
through 2010 for Georgia's Class I areas is better than the what the
State predicted for 2010 and is exceeding the uniform rate of progress.
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    \28\ See page 39 of Georgia's Progress Report.
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    EPA proposes to find that Georgia has adequately addressed 40 CFR
51.308(h) because the visibility trends at the Class I areas in the
State and at Class I areas outside the State potentially impacted by
sources within Georgia and the emissions trends of the largest emitters
of visibility-impairing pollutants in the State indicate that the
relevant RPGs will be met.

III. Proposed Action

    EPA is proposing to approve Georgia's Regional Haze Progress Report
SIP revision, submitted by the State on January 8, 2014, as meeting the
applicable regional haze requirements set forth in 40 CFR 51.308(g) and
51.308(h).

IV. 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. See 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 proposes to approve 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 CAA; 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, Nitrogen oxides, Particulate
matter, Reporting and recordkeeping requirements, Sulfur dioxide,
Volatile organic compounds.

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

    Dated: August 7, 2017.
V. Anne Heard,
Acting Regional Administrator, Region 4.
[FR Doc. 2017-17229 Filed 8-14-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)]
[Notices]
[Pages 4897-4898]
[FR Doc No: 2014-01866]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 13948-002; 13994-002]

Public Utility District No. 1 of Snohomish County; Notice of
Scoping Meetings and Environmental Site Review and Soliciting Scoping
Comments

    Take notice that the following hydroelectric applications have been
filed with Commission and are available for public inspection:
    a. Type of Application: New Major License.
    b. Project Nos.: 13948-002 and 13994-002.
    c. Date filed: August 1, 2013.
    d. Applicant: Public Utility District No. 1 of Snohomish County
(SnoPUD).
    e. Name of Projects: Calligan Creek Hydroelectric Project and
Hancock Creek Hydroelectric Project.
    f. Location: The Calligan Creek Hydroelectric Project would be
located on Calligan Creek in King County, approximately 9 miles
northeast of North Bend, Washington. It would not occupy any federal
lands.
    The Hancock Creek Hydroelectric Project would be located on Hancock
Creek in King County, approximately 9 miles northeast of North Bend,
Washington. It would not occupy any federal lands.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Kim D. Moore, P.E., Assistant General Manager
of Generation, Water and Corporate Services; Public Utility District
No. 1 of Snohomish County, 2320 California Street, P.O. Box 1107,
Everett, WA 98206-1107;<PHONE_NUMBER><EMAIL_ADDRESS>    i. FERC Contact: Kelly Wolcott<EMAIL_ADDRESS>(202) 502-
6480.
    j. Deadline for filing scoping comments: March 29, 2014.
    The Commission strongly encourages electronic filing. Please file
scoping comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket numbers P-13948-002 and/or P-13994-002.
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. This application is not ready for environmental analysis at this
time.
    l. The Calligan Creek Hydroelectric Project would consist of the
following new facilities: (1) An approximately 130-foot-long, 15-foot-
wide diversion structure traversing Calligan Creek, consisting of a 45-
foot-long, 8-foot-high spillway and two 14-foot-high wingwalls; (2) a
1.04-acre-foot impoundment; (3) an intake equipped with a 220-square-
foot fish screen with 0.125-inch-wide openings, a trashrack, and a
sluice gate; (4) a 1.2-mile-long, approximately 41-inch-diameter buried
penstock; (5) approximately 1.2 miles of buried power and fiber optic
cable providing power to the intake area for monitoring the remote
sensors and operating screens and gates; (6) a powerhouse containing a
single 6-MW two-jet horizontal-shaft Pelton turbine/generator; (7) a
135-foot-long rip-rap-lined tailrace channel discharging into Calligan
Creek; (8) two access roads totaling 300 feet long; (9) a 2.5-mile-
long, 34.5-kilovolt buried transmission line connecting to the existing
Black Creek Hydroelectric Project (P-6221) switching vault; and (10)
appurtenant facilities. No federal lands are included in the project.
    The Hanock Creek Hydroelectric Project would consist of the
following new facilities: (1) An approximately 130-foot-long, 10.7-
foot-wide diversion structure traversing Hancock Creek, consisting of a
45-foot-long, 6-foot-high spillway and two 12-foot-high wingwalls; (2)
a 0.85-acre-foot impoundment; (3) a 25-foot-wide, 12-foot-high, 53-
foot-long intake with a trashrack, a 220-square-foot fish screen, and a
sluice gate; (4) a 1.5-mile-long, approximately 40-inch-diameter buried
penstock; (5) approximately 1.5 miles of buried power and fiber optic
cable providing power to the intake area for monitoring the remote
sensors and operating screens and gates; (6) a powerhouse containing a
single 6-MW two-jet horizontal-shaft Pelton turbine/generator; (7) a
12-foot-wide, approximately 100-foot-long rip-rap-lined tailrace
channel discharging into Hancock Creek; (8) two existing logging roads
totaling 1,210 feet long; (9) three new access roads totaling 1,220
feet long; (10) a 0.3-mile-long, 34.5-kilovolt buried transmission line
connecting to the existing Black Creek Hydroelectric Project (P-6221)
switching vault; and (11) appurtenant facilities. No federal lands are
included in the project.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available

for inspection and reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Scoping Process
    The Commission intends to prepare an Environmental assessment (EA)
on the project in accordance with the National Environmental Policy
Act. The EA will consider both site-specific and cumulative
environmental impacts and reasonable alternatives to the proposed
action.

Scoping Meetings

    FERC staff will conduct one agency scoping meeting and one public
meeting. The agency scoping meeting will focus on resource agency and
non-governmental organization concerns, while the public scoping
meeting is primarily for public input. All interested individuals,
organizations, and agencies are invited to attend one or both of the
meetings, and to assist the staff in identifying the scope of the
environmental issues that should be analyzed in the EA.
    The scoping meetings and the site review for both projects will be
conducted jointly since these projects are in close proximity to each
other. At the scoping meetings, we will discuss the Calligan Creek
Project first, followed by the Hancock Creek Project.
    The times and locations of these meetings are as follows:

Agency Scoping Meeting

    Date: Thursday, February 27, 2014.
    Time: 9:00 a.m. (PST).
    Place: North Bend Rail Depot.
    Address: 205 McClellan Street, North Bend, Washington.

Public Scoping Meeting

    Date: Wednesday, February 26, 2014.
    Time: 7:00 p.m. (PST).
    Place: North Bend Rail Depot.
    Address: 205 McClellan Street, North Bend, Washington.
    Copies of the Scoping Document (SD1) outlining the subject areas to
be addressed in the EA were distributed to the parties on the
Commission's mailing list. Copies of the SD1 will be available at the
scoping meeting or may be viewed on the web at http://www.ferc.gov
using the ``eLibrary'' link (see item m above).

Environmental Site Review

    The Applicant and FERC staff will conduct a project Environmental
Site Review beginning at 8:00 a.m. (PST) on Wednesday, February 26,
2014. All interested individuals, organizations, and agencies are
invited to attend. All participants should meet at Snoqualmie Falls
Project parking area, across from the Salish Lodge. The address for the
Snoqualmie Falls Project parking area is: 6501 Railroad Avenue,
Snoqualmie, Washington. All participants are responsible for their own
transportation to the site. Anyone with questions about the
Environmental Site Review should contact Ms. Dawn Presler of SnoPUD at
(425) 783-1709.

Objectives

    At the scoping meetings, the staff will: (1) Summarize the
environmental issues tentatively identified for analysis in the EA; (2)
solicit from the meeting participants all available information,
especially quantifiable data, on the resources at issue; (3) encourage
statements from experts and the public on issues that should be
analyzed in the EA, including viewpoints in opposition to, or in
support of, the staff's preliminary views; (4) determine the resource
issues to be addressed in the EA; and (5) identify those issues that
require a detailed analysis, as well as those issues that do not
require a detailed analysis.

Procedures

    The meetings are recorded by a stenographer and become part of the
formal record of the Commission proceeding on the project.
    Individuals, organizations, and agencies with environmental
expertise and concerns are encouraged to attend the meeting and to
assist the staff in defining and clarifying the issues to be addressed
in the EA.

    Dated: January 24, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-01866 Filed 1-29-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 18, 2006 (Volume 71, Number 137)]
[Notices]
[Page 40715]
[DOCID:fr18jy06-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-395-001]

Iroquois Gas Transmission System, L.P.; Notice of Change to FERC
Gas Tariff

July 12, 2006.
    Take notice that on July 10, 2006, Iroquois Gas Transmission
System, L.P. (Iroquois) tendered for filing the following revised
sheets to its FERC Gas Tariff, First Revised Volume No. 1, to be
effective on July 20, 2006:

Second Revised Sheet No. 49A
Fourth Revised Sheet No. 59A
Third Revised Sheet No. 80

    Iroquois states that copies of its filing were served on all
jurisdictional customers and interested state regulatory agencies and
all parties to the proceeding.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-11356 Filed 7-17-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 9 (Monday, January 14, 2013)]
[Notices]
[Page 2706]
[FR Doc No: 2013-00538]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-9378; 34-68603; File No. 265-28]

Dodd-Frank Investor Advisory Committee

AGENCY: Securities and Exchange Commission.

ACTION: Notice of Meeting of Securities and Exchange Commission Dodd-
Frank Investor Advisory Committee.

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SUMMARY: The Securities and Exchange Commission Investor Advisory
Committee, established pursuant to Section 911 of the Dodd-Frank Wall
Street Reform and Consumer Protection Act of 2010, is providing notice
that it will hold a public meeting on Friday, January 18, 2013, in
Multi-Purpose Room LL-006 at the Commission's headquarters, 100 F
Street NE., Washington, DC 20549. The meeting will begin at 10:00 a.m.
(EDT) and end at 4:00 p.m. and will be open to the public, except
during portions of the meeting reserved for meetings of the Committee's
subcommittees. The meeting will be webcast on the Commission's Web site
at www.sec.gov. Persons needing special accommodations to take part
because of a disability should notify the contact person listed below.
The public is invited to submit written statements to the Committee.
The agenda for the meeting includes: Introductory remarks from Chairman
Walter and Commissioners; introductory remarks from Committee officers;
discussion of administrative matters; and reports from the four
Investor Advisory Committee subcommittees (the Investor as Owner
subcommittee, the Investor as Purchaser subcommittee, the Investor
Education subcommittee, and the Market Structure subcommittee).

DATES: Written statements should be received on or before January 18,
2013.

ADDRESSES: Written statements may be submitted by any of the following
methods:

Electronic Statements

    [ssquf] Use the Commission's Internet submission form (http://www.sec.gov/rules/other.shtml); or
    [ssquf] Send an email message to<EMAIL_ADDRESS>Please
include File No. 265-28 on the subject line; or

Paper Statements

    [ssquf] Send paper statements in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, Stop 1090, 100 F Street
NE., Washington, DC 20549--1090.

All submissions should refer to File No. 265-28. This file number
should be included on the subject line if email is used. To help us
process and review your statement more efficiently, please use only one
method.
    Statements also will be available for Web site viewing and printing
in the Commission's Public Reference Room, 100 F Street NE., Room 1580,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. All statements received will be posted without
change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

FOR FURTHER INFORMATION CONTACT: M. Owen Donley, Chief Counsel, at
(202) 551-6322, Office of Investor Education and Advocacy, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549.

    Dated: January 9, 2013.
Elizabeth M. Murphy,
Committee Management Officer.
[FR Doc. 2013-00538 Filed 1-11-13; 8:45 am]
BILLING CODE 8011-01-P