[Federal Register: June 3, 2008 (Volume 73, Number 107)]
[Notices]
[Page 31699-31700]
[DOCID:fr03jn08-52]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0306]

Preparation for International Cooperation on Cosmetics
Regulations Meetings in Washington, DC; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``International Cooperation on Cosmetics Regulations
(ICCR)--Preparation for ICCR Meetings in Washington, DC'' to provide
information and receive comments on the International Cooperation on
Cosmetics Regulations (ICCR) as well as the upcoming meetings in
Washington, DC. The topics to be discussed are the topics for
discussion at the forthcoming ICCR steering committee meeting. The
purpose of the meeting is to solicit public input prior to the next
steering committee and expert working group meetings in Washington, DC,
the week of July 28, 2008, at which the action items from the first
ICCR meeting are to be discussed.

DATES: The meeting will be held on June 19, 2008, from 3 p.m. to 4:30
p.m. Send

registration information and requests to make a presentation by June
16, 2008.

ADDRESSES: The meeting will be held at 5600 Fishers Lane, 3rd fl.,
Chesapeake Conference Room, Rockville, MD 20857. For security reasons,
all attendees must preregister 3 days prior to the meeting and are
asked to arrive no later than 2:50 p.m. because attendees will be
escorted from the front entrance of 5600 Fishers Lane to the Chesapeake
Conference Room.
    Comment Submissions: Submit written comments to the Divsion of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Tammie Bell, Office of International
Programs, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of the multilateral framework on the ICCR is to pave
the way for the removal of regulatory obstacles to international trade
while maintaining the highest level of global consumer protection.
    ICCR is a voluntary international group of cosmetics regulatory
authorities from the United States, Japan, the European Union, and
Canada. These regulatory authority members will enter into constructive
dialogue with their relevant cosmetics' industry trade associations.
Currently, the ICCR members are Health Canada; the European Commission
Directorate General for Enterprise and Industry; the Ministry of
Health, Labor, and Welfare of Japan; and the U.S. Food and Drug
Administration. All decisions made by the members of ICCR will be made
by consensus and will be compatible with the laws, policies, rules,
regulations, and directives of the respective administrations and
governments. Members will implement and/or promote actions or documents
within their own jurisdictions and seek convergence of regulatory
policies and practices. Successful implementation will require input
from stakeholders.

II. Registration and Requests for Oral Presentations

    Send registration information (including name, title, firm name,
address, telephone, and fax number), written material and requests to
make oral presentations, to the contact person
<EMAIL_ADDRESS>(see DATES).
    If you need special accommodations due to a disability, please
contact Tammie Bell at least 7 days in advance.
    Interested persons may present data, information, or views orally
or in writing, on issues pending at the public meeting. Oral
presentations from the public will be scheduled between approximately 4
p.m. and 4:30 p.m. Time allotted for oral presentations may be limited
to 10 minutes. Those desiring to make oral presentations should notify
the contact person<EMAIL_ADDRESS>(see DATES) and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses, phone number, fax, and e-mail
of proposed participants, and an indication of the approximate time
requested to make their presentation.

III. Transcripts

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.
It may be viewed at the Division of Dockets Management (see ADDRESSES).
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information (HFI-35), Office
of Management Programs, Food and Drug Administration, 5600 Fishers
Lane, rm. 6-30, Rockville, MD 20857.

IV. Comments

    Interested persons may submit written or electronic comments to the
Division of Dockets Management (see ADDRESSES). 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.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

V. Electronic Access

    The agenda for the public meeting will be made available via the
internet at http://www.cfsan.fda.gov/~lrd/vidtel.html

    Dated: May 28, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-12338 Filed 6-2-08; 8:45 am]

BILLING CODE 4160-01-S


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Monday, November 23, 2020 5:10 PM
To:
Katie Batten<EMAIL_ADDRESS>SINGLETON, KRIS E<EMAIL_ADDRESS>Cc:
Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
EPA responses to SunCoke's review of coke modeling file shell

 Hello Kris and Katie,

Thank you again for your review of the coke modeling file shell. Please see attached for EPA Responses to SunCoke's review of the coke modeling file shell. CokeOven_CategoryNonCategory_RTR_ModFile_20201015-Suncoke_comments_EPA-responses-11-23-20.xlsx.  Column F in this file has the EPA responses. Please provide any follow-up industry responses in Column E and also let us know if we have missed anything that already has been revised.

Color Key:
EPA concurs and will update
EPA has followup questions/does not concur

We noticed that SunCoke made revisions/comments to the model file shell in the following two main categories:
-Changing pushing&charging units from mobile line sources to point sources.
-Combining pushing&charging units that serve multiple batteries.

For EP-9 HNR Pushing (CD) line source units, the release point width will be the width of the stack. For fugitive pushing emissions, the source width will be the default width of 0.9 m (to represent edge of the battery where the escaping emissions would come from). For EP-8 HNR Charging (CD) line source units, the width will be the physical battery width.

This is the same protocol used for all mobile units and pushing fugitives in the by-product industry.

We hope you both have a good holiday, as best as possible under these unique circumstances.

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC 27711 Tele:<PHONE_NUMBER> Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated." - anon.
Pronouns - She/Her/Hers
Salutation - Dr./Ms.

<< CokeOven_CategoryNonCategory_RTR_ModFile_20201015-Suncoke_comments_EPA-responses-11-23-20.xlsx >>


[Federal Register Volume 86, Number 20 (Tuesday, February 2, 2021)]
[Notices]
[Page 7913]
[FR Doc No: 2021-02123]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-177, OMB Control No. 3235-0177]

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 6e-2 and Form N-6EI-1

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for extension of the previously approved
collection of information discussed below.
    Rule 6e-2 (17 CFR 270.6e-2) under the Investment Company Act of
1940 (``Act'') (15 U.S.C. 80a) is an exemptive rule that provides
separate accounts formed by life insurance companies to fund certain
variable life insurance products, exemptions from certain provisions of
the Act, subject to conditions set forth in the rule.
    Rule 6e-2 provides a separate account with an exemption from the
registration provisions of section 8(a) of the Act if the account files
with the Commission
    Form N-6EI-1 (17 CFR 274.301), a notification of claim of
exemption.
    The rule also exempts a separate account from a number of other
sections of the Act, provided that the separate account makes certain
disclosure in its registration statements (in the case of those
separate account that elect to register), reports to contract holders,
proxy solicitations, and submissions to state regulatory authorities,
as prescribed by the rule.
    Since 2008, there have been no filings of Form N-6EI-1 by separate
accounts. Therefore, there has been no cost or burden to the industry
since that time. The Commission requests authorization to maintain an
inventory of one burden hour for administrative purposes.
    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 control number.
    The public may view the background documentation for this
information collection at the following website, www.reginfo.gov.
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Cynthia
Roscoe, 100 F Street NE, Washington, DC 20549 or send an email to:
<EMAIL_ADDRESS>Written comments and recommendations for the
proposed information collection should be sent within 30 days of
publication of this notice to www.reginfo.gov/public/do/PRAMain. Find
this particular information collection by selecting ``Currently under
30-day Review--Open for Public Comments'' or by using the search
function.

    Dated: January 27, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-02123 Filed 2-1-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 163 (Tuesday, August 23, 2016)]
[Proposed Rules]
[Pages 57522-57531]
[FR Doc No: 2016-20118]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2015-0624; FRL-9951-27-Region 4]

Air Plan Approval; FL: Hillsborough Area; SO2 Attainment
Demonstration

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a State Implementation Plan (SIP) revision, submitted by the
State of Florida through the Florida Department of Environmental
Protection (FL DEP), to EPA on April 3, 2015, for the purpose of
providing for attainment of the 2010 Sulfur Dioxide (SO2)
National Ambient Air Quality Standards (NAAQS) in the Hillsborough
County SO2 nonattainment area (hereafter referred to as the
``Hillsborough Area'' or ``Area''). The Hillsborough Area is comprised
of a portion of Hillsborough County in Florida surrounding the Mosaic
Fertilizer, LLC Riverview plant (hereafter referred to as ``Mosaic'').
The attainment plan includes the base year emissions inventory, an
analysis of the reasonably available control technology (RACT) and
reasonably available control measures (RACM) requirements, a reasonable
further progress (RFP) plan, a modeling demonstration of SO2
attainment, and contingency measures for the Hillsborough Area. As a
part of approving the attainment demonstration, EPA is also proposing
to approve into the Florida SIP the SO2 emissions limits and
associated compliance parameters. This action is being taken in
accordance with Clean Air Act (CAA or Act) and EPA's guidance related
to SO2 attainment planning.

DATES: Comments must be received on or before September 22, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2015-0624 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: D. Brad Akers, 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. Mr. Akers can be reached via electronic mail at
<EMAIL_ADDRESS>or via telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. What action is EPA proposing to take?
II. What is the background for EPA's proposed action?
III. What is included in Florida's attainment plan for the
Hillsborough Area?
IV. What is EPA's analysis of Florida's attainment plan for the
Hillsborough Area?
    A. Pollutants Addressed
    B. Emissions Inventory Requirements
    C. Air Quality Modeling
    D. RACM/RACT
    E. RFP Plan
    F. Contingency Measures
    G. Attainment Date
V. Proposed Action
VI. Statutory and Executive Order Reviews

I. What action is EPA proposing to take?

    EPA is proposing to approve Florida's SIP revision for the
Hillsborough Area,

as submitted through FL DEP to EPA on April 3, 2015, for the purpose of
demonstrating attainment of the 2010 1-hour SO2 NAAQS.
Specifically, EPA is proposing to approve the base year emissions
inventory, a modeling demonstration of SO2 attainment, an
analysis of RACM/RACT, a RFP plan, and contingency measures for the
Hillsborough Area. Additionally, EPA is proposing to approve specific
SO2 emission limits and compliance parameters established
for the two SO2 sources impacting the Hillsborough Area into
the Florida SIP.
    EPA has preliminarily determined that Florida's SO2
attainment plan for the 2010 1-hour SO2 NAAQS for
Hillsborough County meets the applicable requirements of the CAA and
EPA's SO2 Nonattainment Guidance.\1\ Moreover, the
Hillsborough Area is currently showing a design value below the 2010
SO2 NAAQS, having implemented most of the control measures
included in the SIP submittal. Thus, EPA is proposing to approve
Florida's attainment plan for the Hillsborough Area as submitted on
April 3, 2015. EPA's analysis for this proposed action is discussed in
Section IV of this proposed rulemaking.
---------------------------------------------------------------------------

    \1\ EPA's April 23, 2014 memorandum entitled ``Guidance for the
1-Hour SO2 Nonattainment Area SIP Submissions,''
hereafter referred to as the ``SO2 Nonattainment
Guidance.''
---------------------------------------------------------------------------

II. What is the background for EPA's proposed action?

    On June 2, 2010, the EPA Administrator signed a final rule
establishing a new SO2 NAAQS as a 1-hour standard of 75
parts per billion (ppb), based on a 3-year average of the annual 99th
percentile of 1-hour daily maximum concentrations. See 75 FR 35520
(June 22, 2010). This action also revoked the existing 1971 annual
standard and 24-hour standards, subject to certain conditions.\2\ EPA
established the NAAQS based on significant evidence and numerous health
studies demonstrating that serious health effects are associated with
short-term exposures to SO2 emissions ranging from 5 minutes
to 24 hours with an array of adverse respiratory effects including
narrowing of the airways which can cause difficulty breathing
(bronchoconstriction) and increased asthma symptoms. For more
information regarding the health impacts of SO2, please
refer to the June 22, 2010 final rulemaking. See 75 FR 35520. Following
promulgation of a new or revised NAAQS, EPA is required by the CAA to
designate areas throughout the United States as attaining or not
attaining the NAAQS; this designation process is described in section
107(d)(1) of the CAA. On August 5, 2013, EPA promulgated initial air
quality designations of 29 areas for the 2010 SO2 NAAQS (78
FR 47191), which became effective on October 4, 2013, based on
violating air quality monitoring data for calendar years 2009-2011,
where there was sufficient data to support a nonattainment
designation.\3\
---------------------------------------------------------------------------

    \2\ EPA's June 22, 2010 final action revoked the two 1971
primary 24-hour standard of 140 ppb and the annual standard of 30
ppb because they were determined not to add additional public health
protection given a 1-hour standard at 75 ppb. See 75 FR 35520.
However, the secondary 3-hour SO2 standard was retained.
Currently, the 24-hour and annual standards are only revoked for
those areas the EPA has already designated for the 2010 1-hour
SO2 NAAQS in August 2013 and June 30, 2016, including the
Hillsborough Area. See 40 CFR 50.4(e).
    \3\ EPA is continuing its designation efforts for the 2010
SO2 NAAQS. Pursuant to a court-ordered consent decree
finalized March 2, 2015, in the U.S. District Court for the Northern
District of California, EPA must complete the remaining designations
for the rest of the country on a schedule that contains three
specific deadlines. By July 2, 2016, EPA must designate areas
specified in the March 2, 2015 consent decree based on specific
emission criteria. Sierra Club, et al. v. Environmental Protection
Agency, 13-cv-03953-SI (2015). The last two deadlines for completing
designations, December 2017 and December 2020 are expected to be
informed by information required pursuant the ``Data Requirements
Rule for the 2010 1-Hour Sulfur Dioxide (SO2) Primary
National Ambient Air Quality Standard (NAAQS); Final Rule,'' or
``Data Requirements Rule.'' See 80 FR 51052 (August 21, 2015).
http://www.epa.gov/airquality/sulfurdioxide/designations/pdfs/201503Schedule.pdf. On June 30, 2016, EPA designated a total of 61
areas for the 2010 1-hour SO2 standard as part of the 2nd
round of designations pursuant to the March 2, 2015 consent decree.
---------------------------------------------------------------------------

    Effective on October 4, 2013, the Hillsborough Area was designated
as nonattainment for the 2010 SO2 NAAQS for an area that
encompasses the primary SO2 emitting source Mosaic
fertilizer plant and the nearby SO2 monitor (Air Quality
Site ID: 12-057-0109). The October 4, 2013, final designation triggered
a requirement for Florida to submit a SIP revision with a plan for how
the Area would attain the 2010 SO2 NAAQS as expeditiously as
practicable, but no later than October 4, 2018, in accordance with CAA
section 172(b).
    The required components of a nonattainment plan submittal are
listed in section 172(c) of part D of the CAA. The base year emissions
inventory (section 172(c)(3)) is required to show a ``comprehensive,
accurate, current inventory'' of all relevant pollutants in the
nonattainment area. The nonattainment plan must identify and quantify
any expected emissions from the construction of new sources to account
for emissions in the area that might affect RFP toward attainment, or
with attainment and maintenance of the NAAQS, and provide for a
nonattainment new source review (NNSR) program (section 172(c)(5)). The
attainment demonstration must include a modeling analysis showing that
the enforceable emissions limitations and other control measures taken
by the state will provide for expeditious attainment of the NAAQS
(section 172(c)). The nonattainment plan must include an analysis of
the RACM considered, including RACT (section 172(c)(1)). RFP for the
nonattainment area must be addressed in the submittal. Finally, the
nonattainment plan must provide for contingency measures (section
172(c)(9)) to be implemented in the case that RFP toward attainment is
not made, or the area fails to attain the NAAQS by the attainment date.

III. What is included in Florida's attainment plan for the Hillsborough
Area?

    In accordance with section 172(c) of the CAA, the Florida
attainment plan for the Hillsborough Area includes: (1) An emissions
inventory for SO2 for the plan's base year (2011); and (2)
an attainment demonstration. The attainment demonstration includes:
Technical analyses that locate, identify, and quantify sources of
emissions contributing to violations of the 2010 SO2 NAAQS;
a declaration that FL DEP is unaware of any future growth in the area
that would be subject to CAA 173,\4\ and the assertion that the NNSR
program approved in the SIP at Section 62-252.500, Florida
Administrative Code (F.A.C.) would account for any such growth; a
modeling analysis of an emissions control strategy for the primary
SO2 source, Mosaic, and a nearby source, the Tampa Electric
Company's (TECO's) Big Bend electric generating facility (hereafter
referred to

as ``TECO''), that attains the SO2 NAAQS by the October 4,
2018 attainment date; a determination that the control strategy for the
primary SO2 source within the nonattainment areas
constitutes RACM/RACT; adherence to a construction schedule to ensure
emissions reductions are achieved as expeditiously as practicable; a
request from FL DEP that emissions reduction measures including system
upgrades and/or emissions limitations with schedules for implementation
and compliance parameters be incorporated into the SIP; and contingency
measures.
---------------------------------------------------------------------------

    \4\ The CAA new source review (NSR) program is composed of three
separate programs: Prevention of significant deterioration (PSD),
NNSR, and Minor NSR. PSD is established in part C of title I of the
CAA and applies in areas that meet the NAAQS--``attainment areas''--
as well as areas where there is insufficient information to
determine if the area meets the NAAQS--``unclassifiable areas.'' The
NNSR program is established in part D of title I of the CAA and
applies in areas that are not in attainment of the NAAQS--
``nonattainment areas.'' The Minor NSR program addresses
construction or modification activities that do not qualify as
``major'' and applies regardless of the designation of the area in
which a source is located. Together, these programs are referred to
as the NSR programs. Section 173 of the CAA lays out the NNSR
program for preconstruction review of new major sources or major
modifications to existing sources, as required by CAA section
172(c)(5). The programmatic elements for NNSR include, among other
things, compliance with the lowest achievable emissions rate and the
requirement to obtain emissions offsets.
---------------------------------------------------------------------------

IV. What is EPA's analysis of Florida's attainment plan for the
Hillsborough Area?

    Consistent with CAA requirements (see, section 172), an attainment
demonstration for a SO2 nonattainment area must include a
showing that the area will attain the 2010 SO2 NAAQS as
expeditiously as practicable. The demonstration must also meet the
requirements of 40 Code of Federal Regulations (CFR) 51.112 and Part
51, Appendix W, and include inventory data, modeling results, and
emissions reduction analyses on which the state has based its projected
attainment. In the case of the Hillsborough Area, 2013-2015 quality-
assured and certified air quality data indicated a design value below
the 2010 1-hour SO2 NAAQS. EPA is proposing that the
attainment plan submitted by Florida is sufficient, and EPA is
proposing to approve the plan to assure ongoing attainment.

A. Pollutants Addressed

    Florida's SO2 attainment plan evaluates SO2
emissions for the area within the portion of Hillsborough County that
is designated nonattainment for the 2010 SO2 NAAQS. There
are no significant precursors to consider for the SO2
attainment plan. SO2 is a pollutant that arises from direct
emissions, and therefore concentrations are highest relatively close to
the source(s) and much lower at greater distances due to dispersion.
See SO2 Nonattainment Guidance. Thus, SO2
concentration patterns resemble those of other directly emitted
pollutants like lead and differ from those of photochemically-formed
(secondary) pollutants such as ozone. The two sources included in FL
DEP's SIP to address the Hillsborough Area and their operations are
briefly described later on in this preamble. As the Hillsborough Area
includes one such major point source of SO2 and one source
just outside the Area, it is expected that an attainment demonstration
addressing SO2 emissions at these two sources will
effectively ensure that the Area will attain by the attainment date of
October 4, 2018.

B. Emissions Inventory Requirements

    States are required under section 172(c)(3) of the CAA to develop
comprehensive, accurate and current emissions inventories of all
sources of the relevant pollutant or pollutants in the area. These
inventories provide a detailed accounting of all emissions and emission
sources by precursor or pollutant. In addition, inventories are used in
air quality modeling to demonstrate that attainment of the NAAQS is as
expeditious as practicable. The April 23, 2014, SO2
Nonattainment Guidance provides that the emissions inventory should be
consistent with the Air Emissions Reporting Requirements (AERR) at
Subpart A to 40 CFR part 51.\5\
---------------------------------------------------------------------------

    \5\ The AERR at Subpart A to 40 CFR part 51 cover overarching
federal reporting requirements for the states to submit emissions
inventories for criteria pollutants to EPA's Emissions Inventory
System. The EPA uses these submittals, along with other data
sources, to build the National Emissions Inventory.
---------------------------------------------------------------------------

    For the base year inventory of actual emissions, a ``comprehensive,
accurate and current,'' inventory can be represented by a year that
contributed to the three-year design value used for the original
nonattainment designation. The final SO2 Nonattainment
Guidance notes that the base year inventory should include all sources
of SO2 in the nonattainment area as well as any sources
located outside the nonattainment area which may affect attainment in
the area. Florida elected to use 2011 as the base year. Actual
emissions from all sources of SO2 in the Hillsborough Area
were reviewed and compiled for the base year emissions inventory
requirement. All stationary sources of SO2 emissions located
in the Hillsborough Area were estimated and included in the inventory,
and a source outside the Area that FL DEP determined caused or
contributed to elevated SO2 concentrations within the
nonattainment area was also included.
    The primary SO2-emitting point source located within the
Hillsborough Area is the Mosaic fertilizer plant, which produces acids
and fertilizers including sulfuric acid, phosphoric acid, ammonium
sulfate, diammonium phosphate, and monoammonium phosphate. Mosaic
consists of three main SO2 emitters and six smaller
emitters:
     Emissions Unit (EU) 004 (Mosaic EU 004) is the No. 7
sulfuric acid plant, which burns sulfur and oxygen to form
SO2, then catalytically converts the SO2 to
SO3, finally absorbing the SO3 into sulfuric
acid, and has a design capacity of 3,200 tons per day (tpd) of 100
percent sulfuric acid;
     Mosaic EU 005 is the No. 8 sulfuric acid plant, which
operates similar to Mosaic EU 004 and has a design capacity of 2,700
tpd of 100 percent sulfuric acid;
     Mosaic EU 006 is the No. 9 sulfuric acid plant, which
operates similar to Mosaic EU 004 and has a design capacity of 3,400
tpd of 100 percent sulfuric acid; and
     Mosaic EUs 007, 043, 055, 066, 067, and 068 provide
various services to other parts of the facility and combine for less
than 1 ton per year (tpy); for more information on these miscellaneous
units, see the April 3, 2015, submittal.

The emissions at all units for the Mosaic facility were recorded using
data collected from continuous emissions monitoring systems (CEMS) and
are quality-assured by FL DEP.
    The next largest SO2 source within the nonattainment
area is the Ajax Paving Industries, Inc., Plant No. 6 (Ajax), which
produces asphalt and recycles reclaimed asphalt. SO2
emissions from Ajax were 5.91 tons in 2011. Ajax asphalt plant consists
of two main SO2 emitters:
     Ajax EU 005 is a diesel engine and power generator for a
crusher; and
     Ajax EU 006 is the drum mix asphalt plant.
    The final SO2 source within the nonattainment area is
Harsco Minerals (Harsco), which recycles minerals and byproducts from
steel production. SO2 emissions from Harsco were 0.003 tons
in 2011. Harsco consists of one SO2 emitter:
     Harsco EU001 is a rotary slag dryer.
    The largest SO2 source within 25 kilometers (km) outside
the Hillsborough Area is TECO, which is an electric generating
facility. The TECO facility consists of four main SO2
emitters and four smaller SO2 emitters:
     TECO EUs 001, 002, 003, and 004 are fossil fuel fired
steam generators that fire coal or a coal-and-petroleum coke mixture
with no more than 20 percent petroleum coke by weight, or coal blended
with residual coal from the Polk Power Station and on-site generated
fly ash, and which are rated at 445 MW electrical production for EUs
001-003, and 486 MW for EU 004;
     TECO EUs 041, 042, 043, 044, provide energy via simple
cycle combustion and diesel generators and combine for less than 1 tpy;
for more information on these miscellaneous units, see the April 3,
2015, submittal.
    Emissions from the TECO facility were collected via CEMS or
calculated.

Specifically, TECO EUs 001--004, the only significant SO2
emitters at the facility, are equipped with CEMS, while the remaining
units were estimated based on fuel use and actual hour of operation.
    Pursuant to Florida's SIP-approved regulations at Chapter 62-
210.370, F.A.C., paragraph (3), FL DEP collects annual operating
reports (AORs), incorporated by reference into the SIP at 62-
210.900(5), from all major sources. These AORs were used to develop the
base year inventory for actual emissions for the point sources and
satisfy the AERR. FL DEP utilized EPA's 2011 National Emissions
Inventory (NEI), Version 2 to obtain estimates of the area and nonroad
sources. For onroad mobile source emissions, FL DEP utilized EPA's
Motor Vehicle Emissions Simulator (MOVES2014). A more detailed
discussion of the emissions inventory development for the Hillsborough
Area can be found in Florida's April 3, 2015, submittal.

    Table 1 shows the level of emissions, expressed in tpy, in the
Hillsborough Area for the 2011 base year by emissions source category.
The point source category includes all sources within the nonattainment
area as well as TECO, which is located outside the Hillsborough Area,
but determined by FL DEP to contribute to nonattainment.

                                          Table 1--2011 Base Year Emissions Inventory for the Hillsborough Area
                                                                          [tpy]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                Year                                      Point            Onroad          Nonroad            Area            Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
2011...............................................................       12,145.90             1.96             8.88             2.63        12,159.37
--------------------------------------------------------------------------------------------------------------------------------------------------------

    EPA has evaluated Florida's 2011 base year emissions inventory for
the Hillsborough Area and has made the preliminary determination that
this inventory was developed consistent with EPA's guidance. Therefore,
pursuant to section 172(c)(3), EPA is proposing to approve Florida's
2011 base year emissions inventory for the Hillsborough Area.
    The attainment demonstration also provides for a projected
attainment year inventory that includes estimated emissions for all
emission sources of SO2 which are determined to impact the
nonattainment area for the year in which the area is expected to attain
the standard. This inventory must address any future growth in the
Area. Growth means any potential increases in emissions of the
pollutant for which the Hillsborough Area is nonattainment
(SO2) due to the construction and operation of new major
sources, major modifications to existing sources, or increased minor
source activity. FL DEP included a statement in its April 3, 2015,
submittal declaring that FL DEP is unaware of any plans for the growth
of major sources in the Hillsborough Area, and that normal minor source
growth should not significantly impact the Area. FL DEP further asserts
that the NNSR program at Section 62-252.500, F.A.C., approved into the
SIP and last updated on June 27, 2008 (see 73 FR 36435), would address
any proposed new major sources or planned major modifications for
SO2 sources. The NNSR program includes lowest achievable
emissions rate, offsets, and public hearing requirements.
    FL DEP provided a 2018 projected emissions inventory for all known
sources included in the 2011 base year inventory, discussed previously,
that were determined to impact the Hillsborough County nonattainment
area. The projected 2018 emissions in Table 2 are estimated actual
emissions, representing a 49 percent reduction from the base year
SO2 emissions. The point source emissions were estimated by
multiplying the 2018 allowable emissions by the ratio of 2011 actual
emissions to allowable emissions. Per the SO2 Nonattainment
Guidance, the allowable emissions limits that FL DEP is requesting EPA
approve into the SIP as a control measure were modeled to show
attainment. These allowable emission limits are higher than the
projected actual emissions included in the future year inventory, and
therefore offer greater level of certainty that the NAAQS will be
protected under all operating scenarios. Emissions estimates for onroad
sources were re-estimated with MOVES2014. The nonroad and area source
emissions were scaled based on estimated population growth in the
Hillsborough Area portion of Hillsborough County.

                    Table 2--Projected 2018 SO2 Emissions Inventory for the Hillsborough Area
                                                      [tpy]
----------------------------------------------------------------------------------------------------------------
              Year                     Point          Onroad          Nonroad          Area            Total
----------------------------------------------------------------------------------------------------------------
2011............................       12,145.90            1.96            8.88            2.63       12,159.37
2018............................        6,211.08            0.75            9.75            2.89        6,224.47
----------------------------------------------------------------------------------------------------------------

C. Air Quality Modeling

    The SO2 attainment demonstration provides an air quality
dispersion modeling analysis to demonstrate that control strategies
chosen to reduce SO2 source emissions will bring the area
into attainment by the statutory attainment date of October 4, 2018.
The modeling analysis, outlined in Appendix W to 40 CFR part 51 (EPA's
Modeling Guidance),\6\ is used for the attainment demonstration to
assess the control strategy for a nonattainment area and establish
emission limits that will provide for attainment. The analysis requires
five years of meteorological data to simulate the dispersion of
pollutant plumes from multiple point, area, or volume sources across
the averaging times of interest. The modeling demonstration typically
also relies on maximum allowable emissions from sources in the
nonattainment area. Though the actual emissions are likely to be below
the allowable emissions, sources have the ability to run at higher
production rates or optimize controls such that emissions approach the
allowable emissions limits. A modeling

analysis that provides for attainment under all scenarios of operation
for each source must therefore consider the worst case scenario of both
the meteorology (e.g., predominant wind directions, stagnation, etc.)
and the maximum allowable emissions.
---------------------------------------------------------------------------

    \6\ 40 CFR part 51 Appendix W (EPA's Guideline on Air Quality
Models) (November 2005) located at http://www3.epa.gov/ttn/scram/guidance/guide/appw_05.pdf. EPA has proposed changes to Appendix W.
See 80 FR 45340 (July 29, 2015).
---------------------------------------------------------------------------

    FL DEP's modeling analysis was developed in accordance with EPA's
Modeling Guidance and the SO2 Nonattainment Guidance, and
was prepared using EPA's preferred dispersion modeling system, the
American Meteorological Society/Environmental Protection Agency
Regulatory Model (AERMOD) consisting of the AERMOD (version 14134)
model and two data input preprocessors AERMET (version 14134) and
AERMAP (version 11103). AERMINUTE meteorological preprocessor and
AERSURFACE surface characteristics preprocessor were also used to
develop inputs to AERMET. The Building Profile Input Program for Plume
Rise Model Enhancements (BPIP-PRIME) was also used in the downwash-
modeling. More detailed information on the AERMOD Modeling system, and
other modeling tools and documents can be found on the EPA Technology
Transfer Network Support Center for Regulatory Atmospheric Modeling
(SCRAM) (http://www3.epa.gov/ttn/scram/) and in Florida's April 3, 2015
SIP submittal in the docket for this proposed action (EPA-R04-OAR-2015-
0624) on www.regulations.gov. A brief description of the modeling used
to support Florida's attainment demonstration is provided later on in
this preamble.
1. Modeling Approach
    The following is an overview of the air quality modeling approach
used to demonstrate compliance with the 2010 SO2 NAAQS, as
submitted in Florida's April 3, 2015, submittal. The basic procedures
are outlined later on.
    i. FL DEP developed model inputs using the AERMOD modeling system
and processors.
    The pre-processors AERMET and AERMINUTE were used to process five
years (i.e., 2008-2012) of 1-minute meteorological data from the Tampa
National Weather Service Office (NWS) at the Tampa International
Airport, Tampa, Florida, surface level site, based on FL DEP's land use
classifications, in combination with twice daily upper-air
meteorological information from the same site. The Tampa International
Airport is located approximately 20 km northwest from the Hillsborough
Area. The AERMOD pre-processor AERMAP was used to generate terrain
inputs for the receptors, based on a digital elevation mapping database
from the National Elevation Dataset developed by the U.S. Geological
Survey. FL DEP used AERSURFACE to generate direction-specific land-use
surface characteristics for the modeling. The BPIP-PRIME preprocessor
was used to generate direction-specific building downwash parameters.
FL DEP developed a Cartesian receptor grid across the nonattainment
boundary (extending up to 8.5 km away from the violating monitor), with
100 meter spacing in ambient air to ensure maximum concentrations are
captured in the analysis. All other input options were also developed
commensurate with the Modeling Guidance.
    Next, FL DEP selected a background SO2 concentration
based on local SO2 monitoring data from monitoring station
No. 12-057-0109 for the period January 2012 to December 2013. This
background concentration from the nearby ambient air monitor is used to
account for SO2 impacts from all sources that are not
specifically included in the AERMOD modeling analysis. The data was
obtained from the Florida Air Monitoring and Assessment System. This
monitor is approximately 1.0 km to the southeast of Mosaic and 6.5 km
north of TECO. This monitor is also the nonattainment monitor. Due to
its close proximity to the Mosaic and TECO facilities, monitored
concentrations at this station are strongly influenced by emissions
from both facilities. As a result, the data was filtered to remove
measurements where the wind direction could transport pollutants from
Mosaic and TECO to the station. More specifically, the data was
filtered to remove measurements where hourly wind direction was between
275[deg] to 4[deg] or 153[deg] to 241[deg].
    ii. FL DEP performed current and post-control dispersion modeling
using the EPA-approved AERMOD modeling system.
    iii. Finally, FL DEP derived the 99th percentile maximum 1-hour
daily SO2 design value across the five year meteorological
data period.
    EPA's SO2 nonattainment implementation guidance provides
a procedure for establishing longer-term averaging times for
SO2 emission limits (up to a 30-day rolling averaging
time).\7\ In conjunction with states' CAA obligation to submit SIPs
that demonstrate attainment, EPA believes that air agencies that
consider longer term average times for a SIP emission limit should
provide additional justification for the application of such limits.
This justification involves determining the ``critical emission value''
\8\ or the 1-hour emission limit that modeling found to provide for
attainment and adjusting this rate downward to obtain a comparable
stringency to the modeled 1-hour average emission limit. A comparison
of the 1-hour limit and the proposed longer term limit, in particular
an assessment of whether the longer term average limit may be
considered to be of comparable stringency to a 1-hour limit at the
critical emission value, is critical for demonstrating that any longer
term average limits in the SIP will help provide adequate assurance
that the plan will provide for attainment and maintenance of the 1-hour
NAAQS. This allows states to develop control strategies that account
for variability in 1-hour emissions rates through emission limits with
averaging times that are longer than 1 hour, using averaging times as
long as 30 days, and still demonstrate attainment of the 2010
SO2 NAAQS.
---------------------------------------------------------------------------

    \7\ FL DEP is following the SO2 Nonattainment
Guidance on procedures for establishing emissions limits with
averaging periods longer than 1 hour.
    \8\ The hourly emission rate that the model predicts would
result in the 5-year average of the annual 99th percentile of daily
maximum hourly SO2 concentrations at the level of the
NAAQS.
---------------------------------------------------------------------------

    EPA's recommended procedure for determining longer term averaging
times, including calculating the adjustment factor between the 1-hour
critical emission value and the equivalent 30-day rolling average
emissions limit, are provided in Appendices B and C of the
SO2 Nonattainment Guidance. EPA is proposing to conclude
that FL DEP completed this analysis for both Mosaic and TECO facilities
to derive a SIP emission limit with a block 24-hour longer-term
averaging time and a rolling 30-day longer-term averaging time,
respectively, that are comparatively stringent to the 1-hour limit. For
more details, see Florida's April 3, 2015, SIP submittal and
accompanying appendices.
2. Modeling Results
    The SO2 NAAQS compliance results of the attainment
modeling are summarized in Table 3. Table 3 presents the results from
six sets of AERMOD modeling runs that were performed. The six modeling
runs were the result of using an uncontrolled, or pre-modification, run
and five different controlled, or post-modification, scenarios to
account for the proposed control strategy that involves a two-unit and
three-unit emissions cap at Mosaic, in addition to individual emissions

caps. Maximum allowable permitted emissions limits were used for the
Hillsborough Area modeling demonstration. These emissions limits and
other control measures were established in construction permits issued
by FL DEP, to be incorporated in title V operating permits upon
renewal. FL DEP is requesting that these emissions limits and operating
conditions, detailed in Section IV.D. of this proposed rulemaking, be
adopted into the SIP to become federally enforceable upon approval of
the nonattainment plan, prior to the renewal of the title V operating
permits for both the Mosaic and TECO facilities. The five post-control
runs help to identify the worst possible scenario of emissions
distributions between the three units EUs 004-006, the sulfuric acid
plants at the Mosaic facility. Under one modeling scenario, an
emissions cap of 600 pounds per hour (lb/hr) SO2 for Mosaic
EUs 004-006 is evaluated based on the highest possible impact based on
catalyst limitations and maximum sulfuric acid production. This overall
cap was then scaled as a 24-hour limit, maintaining comparative
stringency with the 1-hour limit (577.8 lb/hr). FL DEP rounded down the
limit for an additional buffer from the maximum impact, resulting in a
24-hour limit of 575 lb/hr, which compares to a 1-hour limit of 597 lb/
hr. This three-unit emissions cap was then modeled in several
configurations to mimic variability in emissions possible under this
scenario, apportioning emissions based on each unit emitting at their
current individual emissions limit with the remainder of the cap
distributed to the other units based on their relative production
capacities. The highest impact is presented as the three-unit emissions
cap scenario. FL DEP also evaluated a two-unit emissions caps, assuming
at any time that two units are operating. The six possible two-unit
operating scenarios were evaluated by each unit operating at its
current individual emission limit, while the remainder of the 597 lb/hr
limit is distributed to the one remaining operating unit. Again, the
highest possible impact is presented as the two-unit operating
scenario. For the three remaining scenarios, each sulfuric acid plant
is assumed to operate alone at its individual emissions cap.
    The modeling utilized five years (2008-2012) of meteorological data
from the NWS site in Tampa, Florida, as processed through AERMET,
AERMINTE and AERSURFACE. This procedure was used since this site
represented the nearest site with complete data.
    Table 3 shows that the maximum 1-hour average across all five years
of meteorological data (2008-2012) is less than or equal to the 2010
SO2 NAAQS of 75 ppb for the five post-control AERMOD
modeling runs. For more details, see Florida's April 3, 2015 SIP
submittal.

                             Table 3--Maximum Modeled SO2 Impacts in the Hillsborough Area, Micrograms per Cubic Meter (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Maximum predicted impact
          Model scenario                Averaging time    --------------------------------------     Background           Total            SO2 NAAQS
                                                                 Mosaic              TECO
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pre-modification..................  1-hour...............     425.50 (162.4)        0.82 (0.31)        20.40 (7.8)     446.72 (170.5)
Three-unit........................  1-hour...............      118.90 (45.4)       55.90 (21.3)        21.44 (8.2)      196.24 (74.9)
Two-unit..........................  1-hour...............      123.59 (47.2)       52.22 (19.9)        18.83 (7.2)      194.65 (74.3)         196.4 (75)
EU 004 only.......................  1-hour...............        0.33 (0.12)      170.84 (65.2)        17.26 (6.6)      188.43 (71.9)
EU 005 only.......................  1-hour...............        0.25 (0.10)      170.84 (65.2)        17.26 (6.6)      188.35 (71.9)
EU 006 only.......................  1-hour...............        0.33 (0.12)      170.84 (65.2)        17.26 (6.6)      188.43 (71.9)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The pre-control analysis resulted in a predicted impact of 170.5
ppb. The post-control analysis resulted in a worst-case predicted
impact of 74.9 ppb. EPA is preliminarily determining that this data
indicates sufficient reductions in air quality impact with the future
implementation of the post-construction control plan for the Mosaic and
TECO facilities. Furthermore, EPA is preliminarily concluding that this
data also supports FL DEP's analysis that the controls for Mosaic
represent RACM and RACT for the SIP. The control strategy for Mosaic,
as reflected in its construction Air Permit No. 0570008-080-AC,
includes eliminating fuel oil except during periods of natural gas
curtailment or disruption; changing the catalyst used to convert
SO2 to SO3 for improved performance; increasing
stack heights for all three sulfuric acid plants from 150 feet (ft) to
at least 213.25 ft; and restricting the collective SO2
emissions to 550 lb/hr under two-unit operating scenarios, and 575 lb/
hr under three-unit operating scenarios. The result of increasing a
stack height is that the plume has a better opportunity for greater
dispersion across an area, minimizing stagnation and local impacts from
higher concentrations, primarily due to the avoidance of building
downwash effects.\9\ Mosaic's allowable SO2 emissions (total
from all three controlled units) will be reduced from 1,140 lb/hr
(based on total individual unit emission limits) to a maximum of 575
lb/hr, representing at least a 49 percent allowable emissions decrease.
The State will issue a revised title V permit to incorporate the Mosaic
construction permit, and meanwhile is proposing the stack height
increases and emission limits and operating scenarios related to those
various limits be adopted into the SIP for immediate effectiveness
authorizing Mosaic to operate in accordance with those conditions.
---------------------------------------------------------------------------

    \9\ See EPA's June 1985 guidance document, ``Guideline for
Determination of Good Engineering Practice Stack Height (Technical
Support Document For the Stack Height Regulations),'' which can be
found at: http://www3.epa.gov/scram001/guidance/guide/gep.pdf.
---------------------------------------------------------------------------

    The control strategy for TECO, as reflected in its construction Air
Permit No. 0570039-074-AC, includes the following operational changes
to the four largest SO2-emitting units: Switching fuel oil
to natural gas during startup, shutdown and flame stabilization at all
four fossil fuel fired steam generators; and a combined emission limit
from all four units of 3,162 lb/hr, to become effective no later than
June 1, 2016. Florida will incorporate the operational change for TECO
into its title V permit upon renewal. TECO's new combined allowable
SO2 emissions from TECO EUs 001-004 will be reduced from
6587.6 lb/hr (based on total individual unit emission limits) \10\ to
3,162 lb/hr representing a 52 percent allowable emissions decrease. The
modeling results included in Table 3 prove that TECO should be included
in the considerations of controls because with several post-control
modeling scenarios, TECO would contribute to over 90

percent of the total impact to the Hillsborough Area, and in the worst
possible post-control modeling scenario, 28 percent of the total
predicted impact on the Hillsborough Area would stem from TECO.
Therefore, if no controls were implemented at TECO, the Area would not
likely attain and maintain the 2010 SO2 NAAQS. The
collective emission limit and related compliance parameters have been
proposed for incorporation into the SIP to make these changes federally
enforceable. More details on the pre- and post-construction operations
at the facilities are included in Florida's SIP submission. FL DEP
asserts that the proposed control strategy significantly lowers the
modeled SO2 impacts from the TECO facility and is sufficient
for the Hillsborough Area to attain 2010 SO2 NAAQS.
---------------------------------------------------------------------------

    \10\ The individual emission limits were included in the April
3, 2015, submittal.
---------------------------------------------------------------------------

    EPA has reviewed the modeling that Florida submitted to support the
attainment demonstration for the Hillsborough Area and has
preliminarily determined that this modeling is consistent with CAA
requirements, Appendix W and EPA's guidance for SO2
attainment demonstration modeling.

D. RACM/RACT

    CAA section 172(c)(1) requires that each attainment plan provide
for the implementation of all reasonably available control measures as
expeditiously as practicable and attainment of the NAAQS. EPA
interprets RACM, including RACT, under section 172, as measures that a
state determines to be both reasonably available and contribute to
attainment as expeditiously as practicable ``for existing sources in
the area.''
    Florida's analysis is found in Section 3 of the FL DEP attainment
demonstration within the April 3, 2015, SIP submittal. The State
determined that controls for SO2 emissions at Mosaic are
appropriate in the Hillsborough Area for purposes of attaining the 2010
SO2 NAAQS. CAA section 172(c)(1) says that the plan shall
provide for RACM, including RACT for ``existing sources in the area.''
Accordingly, Florida only completed a RACM/RACT analysis for Mosaic,
since it is the only significant point source within the boundaries of
the nonattainment area. The Ajax and Harsco sources resulted in less
than 6 tpy between them. FL DEP included TECO in its attainment and
impact modeling because of the source's proximity to the Hillsborough
Area (within 5 km) and its likelihood of contributing to violations of
the SO2 NAAQS within the area. In a modeling-based
attainment demonstration, the means of considering impacts of sources
outside the nonattainment area would depend on whether the sources
cause significant concentration gradients. Florida proposed a control
strategy for the TECO facility, but does not assert that those controls
constitute ``the lowest emission limitation that a particular source is
capable of meeting by the application of control technology that is
reasonably available considering technological and economic
feasibility'' \11\ because section 172(c)(1) provides for the
implementation of RACT for existing sources in the area. However, an
analysis of attainment needs to consider all potential sources, both
inside and outside the nonattainment area that could reasonably cause
or contribute to violations of the NAAQS within the area. FL DEP
affirms the implementation of controls at TECO significantly lowers the
modeled SO2 impact from the facility and is sufficient to
attain 2010 SO2 NAAQS in the Hillsborough Area. The control
measures at both sources are summarized later on in this preamble.
---------------------------------------------------------------------------

    \11\ Strelow, Roger. ``Guidance for Determining the
Acceptability of SIP Regulations in Non-Attainment Areas.'' Memo to
Regional Administrators. Office of Air and Waste Management,
Environmental Protection Agency. Washington, DC December 9, 1976.
Located at: http://www.epa.gov/ttn/naaqs/aqmguide/collection/cp2/19761209_strelow_ract.pdf.
---------------------------------------------------------------------------

    On January 15, 2015, FL DEP issued construction Air Permit No.
0570008-080-AC to Mosaic for additional proposed control measures to
reduce SO2 emissions. The specified limits and conditions
from this construction permit, which will be adopted into the title V
operating permit upon renewal, reflecting RACT controls, are included
in the April 3, 2015, SIP submittal for incorporation into the SIP. The
title V permit renewal is currently under review at the State, and is
expected to be final by the end of calendar year 2016. The
SO2 Nonattainment Guidance discusses an anticipated control
compliance date of January 1, 2017. Areas that implement attainment
plan control strategies by this date are expected to be able to show a
year of quality-assured air monitoring data showing attainment of the
NAAQS and a year of compliance information, which when modeled, would
also show attainment of the NAAQS. In accordance with the schedule in
the construction permit, Mosaic is required to implement emissions
limits by December 15, 2016, complete final increased stack height
construction and catalyst changes by November 2017, and the elimination
of fuel oil by January 1, 2018. This date, though later than the date
suggested in the SO2 Nonattainment Guidance, provides for 9
months of compliance information by the October 4, 2018 attainment
date, including a semiannual compliance report in July 2018. Finally,
the Hillsborough Area is currently showing an attaining design value
for 2013-2015, which means that attainment of the NAAQS is as
expeditious as practicable. FL DEP included in its SIP the required
RACT controls listed in the permit and summarized in Table 4:

            Table 4--Summary of RACT Controls for Mosaic\12\
------------------------------------------------------------------------
         Description of measure                    Explanation
------------------------------------------------------------------------
Mosaic EUs 004-006: The sulfuric acid    Mosaic was authorized to
 plants undergo construction and          construct at current stacks
 operational changes to: Increase stack   for each sulfuric acid plant,
 heights; change catalysts for sulfuric   increasing the stack height
 acid production; and meet two-unit and   from the existing level of 150
 three-unit enforceable emission limits.  ft to at least 213.25 ft.
                                         Mosaic was authorized to change
                                          catalysts and system
                                          augmentation to ensure
                                          compliance with new emission
                                          limits.
                                         Mosaic has new emission
                                          limitations, lowering the
                                          allowable SO2 from all three
                                          sulfuric acid plants
                                          collectively from 1140 lb/hr
                                          to a maximum of 575 lb/hr as a
                                          block 24-hour average.\13\
                                          These emission limits cover
                                          various operating scenarios,
                                          including individual unit
                                          emissions limits, which remain
                                          unchanged from the current
                                          permit, along with two-unit
                                          and three-unit total limits.
                                          All emission limits will be
                                          incorporated into the title V
                                          operating permit upon renewal
                                          and are proposed for
                                          incorporation into the SIP.

Plantwide: Mosaic is required to         By January 1, 2018, Mosaic will
 eliminate fuel oil use.                  not be authorized to use fuel
                                          oil, except during periods of
                                          natural gas curtailment or
                                          disruption. This condition is
                                          included in the construction
                                          permit.
------------------------------------------------------------------------

    On February 26, 2015, construction Air Permit No. 0570039-074-AC
was issued to TECO for additional proposed control measures to reduce
SO2 emissions. The specified limits and conditions from this
construction permit are to be adopted into the title V operating permit
upon renewal, and are intended to supplement the RACT adopted for
Mosaic in the Hillsborough Area to help with attainment and maintenance
of the 2010 SO2 NAAQS. These controls are included in the
April 3, 2015, SIP submittal for incorporation into the SIP. TECO is
required to implement the controls on or before June 1, 2016. The
construction is complete and the emission limit is currently in effect.
The title V permit renewal is under review at the State currently, and
is expected to be final by the end of calendar year 2016. Therefore,
the additional control strategy for TECO is in effect. The supplemental
control measures at TECO are summarized in Table 4:
---------------------------------------------------------------------------

    \12\ The information was pulled from the April 3, 2015
submittal, in which the original construction permit is included.
None of these changes authorize an increased production rate at the
facility.
    \13\ See previous discussion on longer-term emission limits. For
more information, see the April 3, 2015 submittal.

       Table 4--Summary of Supplemental Control Measures for TECO
------------------------------------------------------------------------
         Description of measure                    Explanation
------------------------------------------------------------------------
TECO EUs 001-004 \14\: The fossil fuel   By June 1, 2016, TECO will
 fired steam generators undergo an        comply with a 3,162 lb/hr SO2
 operational change to meet a             emission limitation as a 30-
 collective enforceable emission limit.   day rolling average. This
                                          collective limit, or cap, will
                                          be incorporated into the title
                                          V operating permit upon
                                          scheduled renewal and is
                                          proposed for incorporation
                                          into the SIP.
------------------------------------------------------------------------

    EPA is proposing to approve Florida's determination that the
proposed controls for SO2 emissions at Mosaic constitute
RACM/RACT for that source in the Hillsborough Area based on the
analysis described previously. Additionally, EPA proposes to approve
Florida's determination that the supplemental control measures
initiated at TECO help to bring the area into attainment of the 2010
SO2 NAAQS as expeditiously as practicable. Further, EPA
determines that no further controls would be required at Mosaic, and
that the proposed controls are sufficient for RACM/RACT purposes for
the Hillsborough Area at this time. EPA, therefore, proposes to approve
Florida's April 3, 2015, SIP submission as meeting the RACM/RACT
requirements of the CAA.
---------------------------------------------------------------------------

    \14\ Additional controls not requested for incorporation into
the SIP for TECO EUs 001-004 include the elimination of fuel oil
usage as of 180 days prior to June 1, 2016.
---------------------------------------------------------------------------

    Based on FL DEPs modeling demonstration, the Hillsborough Area is
projected to begin showing attaining monitoring values for the 2010
SO2 NAAQS by the 2018 attainment date. As noted previously,
some of the control measures will not be in place a full year prior to
the attainment date as recommended in the 2014 SO2
Nonattainment Guidance; a recommendation intended to provide data to
evaluate the effect of the control strategy on air quality. Because the
Area is currently attaining the 2010 SO2 NAAQS, EPA proposes
to find that the full control strategy will be in place for an adequate
time prior to the attainment date to ensure attainment of the NAAQS. In
addition, by approving the RACM/RACT for Mosaic, and the supplemental
controls for TECO, for the purposes of Florida's attainment planning,
the control measures outlined in Tables 3 and 4 will become permanent
and enforceable SIP measures to meet the requirements of the CAA.

E. RFP Plan

    Section 172(c)(2) of the CAA requires that an attainment plan
includes a demonstration that shows reasonable further progress for
meeting air quality standards will be achieved through generally linear
incremental improvement in air quality. Section 171(1) of the Act
defines RFP as ``such annual incremental reductions in emissions of the
relevant air pollutant as are required by this part (part D) or may
reasonably be required by EPA for the purpose of ensuring attainment of
the applicable NAAQS by the applicable attainment date.'' As stated
originally in the 1994 SO2 Guideline Document \15\ and
repeated in the 2014 SO2 Nonattainment Guidance, EPA
continues to believe that this definition is most appropriate for
pollutants that are emitted from numerous and diverse sources, where
the relationship between particular sources and ambient air quality are
not directly quantified. In such cases, emissions reductions may be
required from various types and locations of sources. The relationship
between SO2 and sources is much more defined, and usually
there is a single step between pre-control nonattainment and post-
control attainment. Therefore, EPA interpreted RFP for SO2
as adherence to an ambitious compliance schedule in both the 1994
SO2 Guideline Document and the 2014 SO2
Nonattainment Guidance. The control measures for attainment of the 2010
SO2 NAAQS included in the State's submittal have been
modeled to achieve attainment of the NAAQS. The permits and the
adoption of specific emissions limits and compliance parameters require
these control measures and resulting emissions reductions to be
achieved as expeditiously as practicable. As a result of an ambitious
compliance schedule, projected to yield a sufficient reduction in
SO2 emissions from the Mosaic and TECO facilities,

and resulting in modeled attainment of the SO2 NAAQS, EPA
has preliminarily determined that FL DEP's SO2 attainment
plan for the 2010 SO2 NAAQS fulfills the RFP requirements
for the Hillsborough Area. Currently, the monitored SO2
design value for the Hillsborough Area is below the NAAQS, and because
of the modeled attainment with the selected control strategies, EPA
does not anticipate future nonattainment, or that the Area will not
meet the statutory October 4, 2018, attainment date. EPA therefore
proposes to approve Florida's attainment plan with respect to the RFP
requirements.
---------------------------------------------------------------------------

    \15\ SO2 Guideline Document, U.S. Environmental
Protection Agency, Office of Air Quality Planning and Standards,
Research Triangle Park, N.C. 27711, EPA-452/R-94-008, February 1994.
Located at: http://www.epa.gov/ttn/oarpg/t1pgm.html.
---------------------------------------------------------------------------

F. Contingency Measures

    In accordance with section 172(c)(9) of the CAA, contingency
measures are required as additional measures to be implemented in the
event that an area fails to meet the RFP requirements or fails to
attain a standard by its attainment date. These measures must be fully
adopted rules or control measures that can be implemented quickly and
without additional EPA or state action if the area fails to meet RFP
requirements or fails to meet its attainment date and should contain
trigger mechanisms and an implementation schedule. However,
SO2 presents special considerations. As stated in the final
2010 SO2 NAAQS promulgation on June 22, 2010 (75 FR 35520)
and in the 2014 SO2 Nonattainment Guidance, EPA concluded
that because of the quantifiable relationship between SO2
sources and control measures, it is appropriate that state agencies
develop a ``comprehensive program to identify sources of violations of
the SO2 NAAQS and undertake an aggressive follow-up for
compliance and enforcement.''
    Based on all the control measures that are planned for Mosaic and
completed for TECO, FL DEP believes that the 2010 SO2 NAAQS
can be achieved on a consistent basis. However, if a fourth exceedance
of the SO2 NAAQS occurs during any calendar year, or upon a
determination that the Hillsborough Area has failed to attain the NAAQS
by the attainment date, Mosaic and TECO will immediately undertake full
system audits of controlled SO2 emissions. Within 10 days,
each source will independently submit a report to FL DEP summarizing
all operating parameters for four 10-day periods up to and including
the dates of the exceedances. These sources are required to deploy
provisional SO2 emission control strategies within this 10-
day period and include ``evidence that these control strategies have
been deployed, as appropriate'' in the report to FL DEP. FL DEP will
then begin a 30-day evaluation of these reports to determine the cause
of the exceedances, followed by a 30-day consultation period with the
sources to develop and implement appropriate operational changes
necessary to prevent any future violation of the NAAQS. Explicit
measures addressed in Florida's April 3, 2015, SIP submittal are:
     Fuel switching to reduce or eliminate the use of sulfur-
containing fuels; and/or
     physical or operational reduction of production capacity.
    Florida may consider other options for additional controls if these
measures are not deemed to be the most appropriate to address air
quality issues in the Area.
    If a permit modification might be required to conform to applicable
air quality standards, Florida will make use of the State's authority
in Rule 62-4.080 to require permittees to comply with new or additional
conditions. This authority would allow Florida to work directly with
the source(s) expeditiously to make changes to permits. Subsequently,
Florida would submit any relevant permit change to EPA as a source-
specific SIP revision to make the change permanent and enforceable. EPA
notes that a contingency measure involving a revised permit or source-
specific SIP revision as an acceptable additional step, but according
to CAA section 172(c)(9), a measure requiring further action by FL DEP
or EPA (e.g., necessitating a revised permit and SIP revision) could
not serve as the primary contingency measure.
    EPA is proposing to find that Florida's April 3, 2015, SIP
submittal includes a comprehensive program to expeditiously identify
the source of any violation of the SO2 NAAQS and for
aggressive follow-up. Therefore, EPA proposes that the contingency
measures submitted by Florida follow the 2014 SO2
Nonattainment Guidance and meet the section 172(c)(9). EPA notes that
Florida has further committed to pursue additional actions that may
require a SIP revision if needed to address the exceedances.

G. Attainment Date

    Florida's modeling indicates that the Hillsborough Area will begin
attaining the 2010 SO2 NAAQS by January 1, 2018, once the
control strategy is completely implemented. This modeling does not
provide for an attaining three-year design value by the proposed
attainment date of October 4, 2018. However, expeditious implementation
of the additional controls for the TECO source, combined with the
actual emissions and implementation of scheduled RACM/RACT for the
Mosaic source, has already provided for an attaining design value of 66
ppb considering 2013-2015 data, and exhibited improved data in the
years leading up to 2015.\16\ The recent design value is well under the
NAAQS, and the ongoing compliance schedule for Mosaic control measures
will help to assure that the area maintains the NAAQS in the future.
Therefore, the area has attained the 2010 SO2 NAAQS, and is
expected to continue to attain the NAAQS by the attainment date.
---------------------------------------------------------------------------

    \16\ The most recent quality-assured design values for each
NAAQS are publicly available at https://www.epa.gov/air-trends/air-quality-design-values.
---------------------------------------------------------------------------

V. Proposed Action

    EPA is proposing to approve Florida's SO2 attainment
plan for the Hillsborough Area. EPA has preliminarily determined that
the SIP meets the applicable requirements of the CAA. Specifically, EPA
is proposing to approve Florida's April 3, 2015, SIP submission, which
includes the base year emissions inventory, a modeling demonstration of
SO2 attainment, an analysis of RACM/RACT, a RFP plan, and
contingency measures for the Hillsborough Area. Additionally, EPA is
proposing to approve into the Florida SIP specific SO2
emission limits and compliance parameters established for the two
SO2 point sources impacting the Hillsborough Area.

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. 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 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 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, Reporting and recordkeeping requirements, Sulfur oxides.

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

    Dated: August 15, 2016.
Heather McTeer Toney,
Regional Administrator, Region 4.
[FR Doc. 2016-20118 Filed 8-22-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50886-50887]
[FR Doc No: 2021-19689]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0104]

PolyMedica Industries Inc., et al.; Withdrawal of Approval of
Three New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of three new drug applications (NDAs) from multiple holders of those
NDAs. The basis for the withdrawal is that these NDA holders have
repeatedly failed to file required annual reports for those NDAs.

DATES: Approval is withdrawn as of September 13, 2021.

FOR FURTHER INFORMATION CONTACT: Kimberly S. Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The holder of an approved application to
market a new drug for human use is required to submit annual reports to
FDA concerning its approved application in accordance with Sec.  314.81
(21 CFR 314.81).
    In the Federal Register of March 3, 2021 (86 FR 12474), FDA
published a notice offering an opportunity for a hearing (NOOH) on a
proposal to withdraw approval of those NDAs because the holders of
those NDAs had repeatedly failed to submit the required annual reports
for those NDAs. The holders of the NDAs identified in table 1 did not
respond to the NOOH. Failure to file a written notice of participation
and request for hearing as required by Sec.  314.200 (21 CFR 314.200)
constitutes an election by those holders of the NDAs not to make use of
the opportunity for a hearing concerning the proposal to withdraw
approval of their NDAs and a waiver of any contentions concerning the
legal status of the drug products. Therefore, FDA is withdrawing
approval of the three applications listed in table 1.

     Table 1--Approved NDAs for Which Required Reports Have Not Been
                                Submitted
------------------------------------------------------------------------
      Application No.                Drug                NDA Holder
------------------------------------------------------------------------
NDA 016401................  Neopap                 PolyMedica Industries
                             (acetaminophen)        Inc., 2 Constitution
                             Suppositories, 120     Way, Woburn, MA
                             milligrams (mg).       01801.
NDA 050266................  Achromycin             Storz Ophthalmics
                             (tetracycline          Inc. (subsidiary of
                             hydrochloride (HCl))   American Cyanamid
                             Ophthalmic Ointment,   Co.), 401 North
                             10 mg/gram.            Middletown Rd.,
                                                    Pearl River, NY
                                                    10965.
NDA 050268................  Achromycin             Do.
                             (tetracycline HCl)
                             Ophthalmic
                             Suspension, 1%.
------------------------------------------------------------------------

    FDA finds that the holders of the NDAs listed in table 1 have
repeatedly failed to submit reports required by Sec.  314.81. In
addition, under Sec.  314.200, FDA finds that the holders of the NDAs
have waived any contentions concerning the legal status of the drug
products. Therefore, under these findings, approval of the NDAs listed
in table 1 and all amendments and supplements thereto is hereby
withdrawn as of September 13, 2021.

    Dated: September 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19689 Filed 9-10-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Notices]
[Page 76828]
[FR Doc No: 2013-30214]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER14-195-001.
    Applicants: Duke Energy Florida, Inc.
    Description: Duke Energy Florida, Inc. submits CBR Name Change
Correction Filing to be effective 12/27/2013.
    Filed Date: 12/11/13.
    Accession Number: 20131211-5100.
    Comments Due: 5 p.m. ET 12/18/13.

    Docket Numbers: ER14-196-001.
    Applicants: Duke Energy Florida, Inc.
    Description: Duke Energy Florida, Inc. submits Cancellation of Duke
Energy Florida OATT Certificate of Concurrence to be effective 12/27/
2013.
    Filed Date: 12/11/13.
    Accession Number: 20131211-5127.
    Comments Due: 5 p.m. ET 12/18/13.

    Docket Numbers: ER14-197-000.
    Applicants: Duke Energy Florida, Inc.
    Description: Duke Energy Florida, Inc. submits OATT Name Change
Correction to be effective N/A.
    Filed Date: 12/11/13.
    Accession Number: 20131211-5134.
    Comments Due: 5 p.m. ET 12/18/13.

    Docket Numbers: ER14-198-001.
    Applicants: Duke Energy Florida, Inc.
    Description: Duke Energy Florida, Inc. submits Rate Schedules Name
Change Filing No. 1 Correction to be effective 12/27/2013.
    Filed Date: 12/11/13.
    Accession Number: 20131211-5050.
    Comments Due: 5 p.m. ET 12/18/13.

    Docket Numbers: ER14-596-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits Distribution of
Penalty Revenues to be effective 12/11/2013.
    Filed Date: 12/11/13.
    Accession Number: 20131211-5146.
    Comments Due: 5 p.m. ET 1/2/14.

    Docket Numbers: ER14-597-000.
    Applicants: Northern Pass Transmission LLC.
    Description: Northern Pass Transmission LLC submits NPT--HRE
Amendment to TSA to be effective 2/14/2014.
    Filed Date: 12/11/13.
    Accession Number: 20131211-5148.
    Comments Due: 5 p.m. ET 1/2/14.

    Docket Numbers: ER14-598-000.
    Applicants: South Carolina Electric & Gas Company.
    Description: South Carolina Electric & Gas Company submits OATT
Order No. 784 to be effective 12/27/2013.
    Filed Date: 12/12/13.
    Accession Number: 20131212-5022.
    Comments Due: 5 p.m. ET 1/2/14.

    Docket Numbers: ER14-599-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. submits First Revised
Service Agreement No. 3410; Queue No. W4-029 & Y1-075 to be effective
11/14/2013.
    Filed Date: 12/12/13.
    Accession Number: 20131212-5041.
    Comments Due: 5 p.m. ET 1/2/14.

    Docket Numbers: ER14-600-000.
    Applicants: Florida Power & Light Company.
    Description: Florida Power & Light Company submits FPL OATT Order
No. 784 Compliance Filing to be effective 12/27/2013.
    Filed Date: 12/12/13.
    Accession Number: 20131212-5062.
    Comments Due: 5 p.m. ET 1/2/14.

    Docket Numbers: ER14-601-000.
    Applicants: Anahau Energy, LLC.
    Description: Anahau Energy, LLC submits Revisions to Category
Status under Market-Based Rate Tariff to be effective 12/13/2013.
    Filed Date: 12/12/13.
    Accession Number: 20131212-5078.
    Comments Due: 5 p.m. ET 1/2/14.

    Docket Numbers: ER14-602-000.
    Applicants: Quest Energy, LLC.
    Description: Quest Energy, LLC submits Cancel Tariff to be
effective 12/12/2013.
    Filed Date: 12/12/13.
    Accession Number: 20131212-5081.
    Comments Due: 5 p.m. ET 1/2/14.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 12, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-30214 Filed 12-18-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Notices]
[Pages 30017-30018]
[FR Doc No: 2012-12209]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0437]

International Capacity Building With Respect to Food Safety;
Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

    The Food and Drug Administration (FDA or Agency) is announcing a
public meeting entitled ``International Capacity Building with Respect
to Food Safety.'' This public meeting will provide interested persons
an opportunity to discuss FDA's comprehensive plan to expand the
technical, scientific, and regulatory capacity of foreign governments
and their respective food industries in countries that export foods to
the United States (the ``capacity-building plan''). FDA is developing
this plan under the Food Safety Modernization Act (FSMA). More
specifically, the public will have an opportunity to provide
information and share views that will inform FDA's development of the
capacity-building plan. FDA is also establishing a docket to collect
comments, data, and information relevant to the capacity-building plan.
    Date and Time: See section III. ``How to Participate in the Public
Meeting'' in the SUPPLEMENTARY INFORMATION section of this document for
dates and times of the public meeting, closing dates for advance
registration, and information on deadlines for submitting either
electronic or written comments to FDA's Division of Dockets Management.
    Contact Persons: For questions about registering for the meeting,
to register orally, or to submit a notice of participation by mail,
Fax, or email: Courtney Treece, Planning Professionals, Ltd., 1210 West
McDermott, Suite 111, Allen, TX 75013,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>,
email<EMAIL_ADDRESS>    For questions about the content of the public meeting or if special
accommodations are needed due to a disability, contact Juanita Yates,
Center for Food Safety and Applied Nutrition (HFS-009), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1731, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FSMA (Pub. L. 111-353) establishes the foundation for a modernized
food safety system that provides FDA with more authorities to address
the increasingly globalized food supply and prevent problems before
they occur. The legislation comes at a time when FDA has identified
strengthening the safety and integrity of the global supply chain as a
key Agency priority. Indeed, two recent reports have focused on the
challenges of global supply chains: FDA's ``Pathway to Global Product
Safety and Quality,'' and the Institute of Medicine's report ``Ensuring
Safe Foods and Medical Products through Regulatory Systems Abroad,''
which was commissioned by FDA. FSMA enhances FDA's efforts to increase
the safety of the global supply chain, by, among other things,
recognizing the importance of partnerships in the area of imports.
Critically, the legislation directs FDA to focus on international food
safety capacity--a key prevention-oriented activity. FSMA requires that
the Secretary (by delegation, FDA) develop a plan to increase the
technical, scientific, and regulatory food safety capacity of foreign
governments and their respective food industries in countries that
export foods to the United States (Pub. L. 111-353, sec. 305). (To see
the full text of section 305 of FSMA, visit: http://www.fda.gov/Food/FoodSafety/FSMA/ucm247548.htm#SEC305.).
    Further, FDA is required to develop the capacity-building plan in
consultation with certain stakeholders, including representatives of
the food industry, foreign government officials, nongovernmental
organizations that represent the interests of consumers, and certain
Federal officials. The Federal officials include the Secretary of
Agriculture, the Secretary of State, the Secretary of the Treasury, the
Secretary of Homeland Security, the U.S. Trade Representative, and the
Secretary of Commerce. FDA is also required to consult with other
stakeholders.
    The capacity-building plan must include, as appropriate:
    1. Recommendations for bilateral and multilateral arrangements and
agreements, including providing for responsibilities of exporting
countries to ensure food safety;
    2. Provisions for secure electronic data sharing;
    3. Provisions for mutual recognition of inspection reports;
    4. Training of foreign governments and food producers on U.S.
requirements for safe food;
    5. Recommendations on whether and how to harmonize requirements
under the Codex Alimentarius; and
    6. Provisions for multilateral acceptance of laboratory methods and
testing and detection techniques.
    The public meeting is an opportunity for interested persons and
stakeholders to share views concerning how FDA should address the six
elements in the capacity-building plan. Although section 305 identified
these six elements, the list need not be exclusive. Therefore,
interested persons may also share views as to whether FDA should
consider additional issues in developing the plan. Furthermore, the
public meeting is an opportunity for FDA to share the Agency's current
thinking on the capacity-building plan. FDA encourages interested
persons to provide feedback on any proposals that FDA presents at the
public meeting. FDA is also establishing a docket to obtain comments,
data, and evidence that will inform the Agency's development of the
capacity-building plan. FDA will make available the agenda and other
documents prior to the public meeting.

II. Purpose and Format of the Meeting

    FDA is holding the public meeting to receive input from the public
and from stakeholders to inform FDA's development of the capacity-
building plan. This 1-day public meeting will open with a discussion of
the context for international food safety capacity building and then
proceed with more specific discussions about the capacity-building
plan. Throughout the meeting, FDA will provide opportunities for
individuals to share their views.
    Prior to the public meeting, FDA will post the agenda for the
meeting on the Agency's Web site. Interested persons may access the
agenda at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. In addition to posting the
agenda, FDA may also make available additional information about the
capacity-building plan at this Web site. For general information,
interested persons may visit FDA's FSMA International Capacity Building
Web page located at http://www.fda.gov/Food/FoodSafety/FSMA/ucm301708.htm.

III. How to Participate in the Public Meeting

    Stakeholders and interested persons will have the opportunity to
provide oral comments. The public meeting will be held from 9 a.m. to 5
p.m. on June 19, 2012, at the L'Enfant Plaza Hotel, 480 L'Enfant Plaza
SW., Washington, DC The meeting is open to the public and on-site
registration will be available, beginning at 8 a.m. However, attendees
are encouraged to register in advance because seating is limited.
Individuals who wish to attend the meeting can obtain information on
how to register online at http://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. There is no fee for
registration.
    Regardless of attendance at the public meeting, individuals may
also share their views by submitting electronic or written comments to
FDA's Division of Dockets Management. The deadline for submitting
comments to the docket is July 20, 2012. Please note the following
important dates:
     June 11, 2012: Closing date for advance registration and
requesting special accommodations due to a disability.
     July 20, 2012: Closing date to submit either electronic or
written comments to FDA's Division of Dockets Management.

IV. Request for Comments

    When submitting electronic or written comments to FDA's Division of
Dockets Management, please include the docket number found in brackets
in the heading of this document. All comments received by the Agency
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.

V. Transcripts and Recorded Video

    Please be advised that as soon as a transcript is available, it
will be accessible at http://www.regulations.gov and at FDA's FSMA Web
site at: http://www.fda.gov/Food/FoodSafety/FSMA/ucm301708.htm. It may
also be viewed at the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. A transcript will also be available in either hardcopy or on CD-
ROM, after submission of a Freedom of Information request. Written
requests are to be sent to the Division of Freedom of Information
(ELEM-1029), 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Additionally, FDA will be video recording the public meeting. Once the
recorded video is available, it will be accessible at FDA's FSMA Web
site at http://www.fda.gov/Food/FoodSafety/FSMA/ucm301708.htm.

    Dated: May 10, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12209 Filed 5-18-12; 8:45 am]
BILLING CODE 4160-01-P