[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46963-46965]
[FR Doc No: 2013-18631]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0010]

Cooperative Agreement to Support the Food and Agriculture
Organization

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its
intention to receive and consider a single source application for award
of a cooperative agreement in fiscal year 2013 to the Food and
Agriculture Organization (FAO) of the United Nations to support global
strategies that address food safety and public health.
    The goal of this collaborative project between FDA and FAO is to
contribute to the knowledge base and development of food safety systems
globally due to the increasingly diverse and complex food supply. The
project is also designed to enhance and broaden FDA's ability to
address global food safety and public health issues associated with
food as well as provide opportunities to leverage additional resources
of other countries. The collaborative project will also support the
FDA's implementation of the FDA Food Safety Modernization Act (FSMA),
including FDA's International Food Safety Capacity Building Plan, which
emphasizes the concept of preventing food safety-related problems
before they occur and the importance of establishing strong
relationships and mutual support among all stakeholders, including
multilateral organizations, to improve worldwide food safety. In
addition, the collaborative project will support food safety,
nutrition, and public health programs that align with FDA's mission.

DATES: Important dates are as follows:
    1. The application due date is September 1, 2013.
    2. The anticipated start date is September 2013.
    3. The expiration date is September 2, 2013.

ADDRESSES: Submit electronic applications to: http://www.grants.gov.
For more information, see section III of the SUPPLEMENTARY INFORMATION
section.

FOR FURTHER INFORMATION CONTACT: Scientific/Programmatic Contact: Julie
Moss, Center for Food Safety and Applied Nutrition (HFS-550), Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740,
240-402-2031<EMAIL_ADDRESS>Grants Management Contact: Gladys

Melendez, Office of Acquisitions and Grant Services (HFA 500), Food and
Drug Administration, 5630 Fishers Lane, rm. 2032, Rockville, MD 20857,
301-827-7175<EMAIL_ADDRESS>    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at www.fda.gov/food/newsevents/default.htm.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

    93.103 RFA-FD-13-037

A. Background

    An intergovernmental organization, FAO has 191 Member Nations, two
associate members, and one member organization (the European Union).
Achieving food security for all is at the heart of FAO's efforts--to
make sure people have regular access to enough high-quality food to
lead active, healthy lives. FAO's mandate is to raise levels of
nutrition, improve agricultural productivity, better the lives of rural
populations, and contribute to the growth of the world economy. FAO's
activities comprise four main areas:
    Putting information within reach: FAO serves as a knowledge
network. The organization uses the expertise of its staff--agronomists,
foresters, fisheries and livestock specialists, nutritionists, social
scientists, economists, statisticians and other professionals--to
collect, analyze, and disseminate data that aid development.
    Sharing policy expertise: FAO lends its years of experience to
member countries in devising agricultural policy, supporting planning,
drafting effective legislation, and creating national strategies to
achieve rural development and hunger alleviation goals.
    Providing a meeting place for nations: As a neutral forum, experts
from around the globe convene at headquarters or in field offices to
forge agreements on major food and agriculture issues.
    Bringing knowledge to the field: FAO provides the technical know-
how and mobilizes and manages millions of dollars provided by
industrialized countries, development banks, and other sources to make
sure the projects achieve their goals.
    Capacity Development is a core function highlighted in FAO's new
strategic framework. Member Countries place strong emphasis on FAO
enhancing delivery in this area as they recently approved the Corporate
Strategy on Capacity Development. The Strategy was developed in
consultation with Member Countries and all FAO units worldwide. Taking
a corporate approach to Capacity Development allows FAO to learn from
its collective efforts and to support Member Countries in their own
Capacity Development activities. The new FAO Capacity Development
framework will guide FAO staff and their partners in analyzing
capacities in Member Countries and identifying the appropriate
intervention(s) for fostering sustainable development.
    FAO supports Member Countries in developing their capacities to
effectively manage food safety and quality as a key step to
safeguarding the health and well-being of people as well as to
accessing domestic, regional, and international markets. Capacity
Development in Food Safety and Quality is the process through which
relevant stakeholders from farm to table (including government
agencies, food enterprises, academia, and consumers) are able to better
perform their functions and to assume their responsibilities in
ensuring safety and quality of food for domestic consumption and
export.
    For the Food Safety and Quality Unit (AGN) within FAO, its overall
goal is to improve systems of food safety and quality management, based
on scientific principles, that lead to reduced foodborne illness and
support fair and transparent trade, thereby contributing to economic
development, improved livelihoods, and food security. This unit:
    1. Provides independent scientific advice on food safety and
nutrition, which serves as the basis for international food standards.
    2. Develops institutional and individual capacities for food
control and food safety management in many countries, including the
management of food safety emergencies.
    3. Supports processes for the development of food safety policy
frameworks.
    4. Facilitates global access to information and encourages and
supports the development of food safety/quality networks.
    While the specific projects to be undertaken under this agreement
will be determined following the agreement entering into force,
examples of the types of food safety projects of interest to FDA that
could be undertaken by the FAO include the following: Development of
policy support tools to guide planning and investment in national food
control systems; provision of technical advice for the development and
improvement of integrated and modern food control systems; enhancement
of effective participation in the work of the Codex Alimentarius
Commission and other international fora; addressing emerging food
safety issues; and development of technical tools and guides related to
various technical and managerial aspects of food control. In addition
to the aforementioned types of projects, FDA would also be interested
in supporting nutrition projects through this Agreement. Examples of
such projects include the FAO's Nutrition Education and Communication
project focusing on professional education, as well as assistance with
countries seeking to develop effective food-based dietary guidelines.
    AGN also houses the secretariat of the Joint FAO/World Health
Organization Codex Alimentarius Secretariat.

B. Research Objectives

    With an increasingly diverse and complex global food supply, FDA's
interest is to strengthen food safety systems globally to prevent food
safety problems rather than merely reacting to problems after they
occur. FDA recognizes that it can't do this alone. By working with
other World Trade Organization member countries and partnering with the
FAO, FDA can broaden the reach of food safety capacity building
efforts.
    This Cooperative Agreement will allow FDA to deepen its
international food safety capacity building partnerships, provide a
wider scope of impact than exists currently, and merge resources with
other countries.
    This cooperative agreement will provide support so that the FAO can
meet the following projected milestones:
    1. Contribute to the knowledge base and development of food safety
systems due to the increasingly diverse and complex food supply.
    2. Enhance and broaden FDA's ability to address global food safety
and public health issues associated with food.
    3. Provide opportunities to leverage additional resources of other
countries.
    4. Support FSMA and its International Food Safety Capacity Building
Plan, which emphasizes the concept of preventing food safety-related
problems before they occur and the importance of establishing strong
relationships and mutual support among all stakeholders, including
multilateral organizations, to improve worldwide food safety.
    5. Support food safety, nutrition, and public health programs that
align with FDA's mission.

C. Eligibility Information

    Competition is limited to the FAO because, as a global organization
with a

well-established, trusted presence, access to 191 Member Nations, and
an ability to coordinate capacity building programs at a regional and
international level, it is uniquely qualified to further the global
food safety capacity building objectives of this cooperative agreement.
This ability to advance the objectives of this cooperative agreement
through Member Country engagement and leveraging is a requisite for
success.

II. Award Information/Funds Available

A. Award Amount

    The Center for Food Safety and Applied Nutrition intends to fund
one award up to $750,000 total costs (direct plus indirect costs) for
FY 2013. Future year amounts will depend on annual appropriations and
successful performance.

B. Length of Support

    The award will provide 1 year of support and include future
recommended support for 4 additional years, contingent upon
satisfactory performance in the achievement of project and program
reporting objectives during the preceding year and the availability of
Federal fiscal year appropriations.

III. Electronic Application, Registration, and Submission

    Only electronic applications will be accepted. To submit an
electronic application in response to this FOA, applicants should first
review the full announcement located at www.fda.gov/food/newsevents/default.htm. (FDA has verified the Web site addresses throughout this
document, but FDA is not responsible for any subsequent changes to the
Web sites after this document publishes in the Federal Register.) For
all electronically submitted applications, the following steps are
required.
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number
     Step 2: Register With System for Award Management (SAM)
     Step 3: Obtain Username & Password
     Step 4: Authorized Organization Representative (AOR)
Authorization
     Step 5: Track AOR Status
     Step 6: Register With Electronic Research Administration
(eRA) Commons
    Steps 1 through 5, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit electronic applications to: http://www.grants.gov.

    Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18631 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 82, Number 11 (Wednesday, January 18, 2017)]
[Proposed Rules]
[Pages 5482-5485]
[FR Doc No: 2017-01050]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2016-0836]
RIN 1625-AA00

Safety Zones; San Francisco, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to amend, add, and delete several
permanent safety zones located in the Captain of the Port San Francisco
zone that are established to protect public safety during annual
firework displays. These amendments will update listed events to
accurately reflect the firework display locations. This proposed
rulemaking would limit the movement of vessels within the established
firework display areas unless authorized by the Captain of the Port
(COTP) San Francisco or a designated representative. We invite your
comments on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before February 17, 2017.

ADDRESSES: You may submit comments identified by docket number USCG-
2016-0836 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of theSUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Lieutenant Junior Grade Christina
Ramirez, U.S. Coast Guard Sector San Francisco; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
PATCOM Patrol Commander
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    The Coast Guard is conducting this rulemaking under the authority
of 33 U.S.C. 1231. Fireworks displays are held annually on a recurring
basis on the navigable waters within the COTP San Francisco zone. One
of the published annual fireworks events that require safety zones does
not currently reflect the accurate location of the respective display
sites. Three annual fireworks events that require safety zones are not
published in 33 CFR 165.1191 and one published fireworks event has not
occurred since 2009. These safety zones are necessary to provide for
the safety of the crew, spectators, participants of the event,
participating vessels, and other users and vessels of the waterway from
the hazards associated with firework displays. The effect of these
proposed safety zones will be to restrict general navigation in the
vicinity of the events, from the start of each event until the
conclusion of that event. Except for the persons or vessels authorized
by the COTP San Francisco or a designated representative, no person or
vessel may enter or remain in the regulated area. These regulations are
needed to keep spectators and vessels a safe distance away from the
fireworks displays to ensure the safety of participants, spectators,
and transiting vessels.

III. Discussion of Proposed Rule

    The Coast Guard has reviewed 33 CFR 165.1191 for accuracy. The
Coast Guard is proposing to amend Table 1 in Sec.  1191 to modify one
event to reflect the current event locations, add three events, and
delete one outdated event.
    The event proposed to be modified is listed numerically in Table 1
of this section as item 9, ``Fourth of July Fireworks, City of
Richmond.'' The display location currently listed, Richmond Harbor, has
been deemed undesirable or hazardous by the event sponsors, and so it
is being changed to a barge located in the harbor, and the area of the
safety zone would be the area around the barge.
    We are also proposing to add three events to Table 1 of 33 CFR
165.1191, as items 28, 29, and 30. These events are titled Execpro
Services Fourth of July Fireworks, Monte Foundation Fireworks, Lake
Tahoe, and Sausalito Lighted Boat Parade Fireworks, respectively. The
events proposed to be added have taken place in 2011, 2013, and 2014,
and we believe that they will likely be regularly scheduled in the
future. For those reasons, we believe it is beneficial to include them
in the permanent regulation.
    Finally, we propose to remove item 2, ``KFOG KaBoom,'' as this
event is outdated. It is unlikely to reoccur and its continued
inclusion in the regulation offers the possibility of confusion.
    The Coast Guard proposes this rulemaking under authority in 33
U.S.C.

1231; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5;
Department of Homeland Security Delegation No. 0170.1.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This NPRM has not been designated
a ``significant regulatory action,'' under Executive Order 12866.
Accordingly, the NPRM has not been reviewed by the Office of Management
and Budget.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of each safety zone. Vessel traffic
would be able to safely transit around each safety zone which would
impact a small designated area of the COTP San Francisco zone for less
than 1 hour during the evening when vessel traffic is normally low.
Moreover, the Coast Guard would issue a Local Notice to Mariner and
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
zone, and the rule would allow vessels to seek permission to enter the
zones.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zones lasting less than 1 hour that would prohibit entry within 1,000
feet of a fireworks barge. Normally such actions are categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of
Commandant Instruction M16475.lD. A preliminary environmental analysis
checklist and Categorical Exclusion Determination are available in the
docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment

applies, and provide a reason for each suggestion or recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend to 33 CFR part 165 as follows:

0
1. The authority citation for Part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. In Sec.  165.1191, in Table 1 to Sec.  165.1191, remove and reserve
item 2, revise item 9, and add items 28, 29, and 30, to read as
follows:

Sec.  165.1191   Northern California and Lake Tahoe Area Annual
Fireworks Events.

* * * * *

                       Table 1 to Sec.   165.1191
------------------------------------------------------------------------

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

                              * * * * * * *
------------------------------------------------------------------------
                              2. [Reserved]
------------------------------------------------------------------------

                              * * * * * * *
------------------------------------------------------------------------
              9. Fourth of July Fireworks, City of Richmond
------------------------------------------------------------------------
Sponsor......................  Various Sponsors.
Event Description............  Fireworks Display.
Date.........................  Week of July 4th.
Location.....................  A barge located in Richmond Harbor in
                                approximate position 37[deg]54'40'' N,
                                122[deg]21'05'' W, Richmond, CA.
Regulated Area...............  100-foot radius around the fireworks
                                barge during the loading, transit,
                                setup, and until the commencement of the
                                scheduled display. Increases to a 560-
                                foot radius upon commencement of the
                                fireworks display.

                              * * * * * * *
------------------------------------------------------------------------
              28. Execpro Services Fourth of July Fireworks
------------------------------------------------------------------------
Sponsor......................  Execpro Services Inc.
Event Description............  Fireworks Display.
Date.........................  Week of July 4th.
Location.....................  Off-shore from Incline Village, NV.
Regulated Area...............  100-foot radius around the fireworks
                                barge during the loading, transit,
                                setup, and until the commencement of the
                                scheduled display. Increases to a 1,000-
                                foot radius upon commencement of the
                                fireworks display.
------------------------------------------------------------------------
               29. Monte Foundation Fireworks, Lake Tahoe
------------------------------------------------------------------------
Sponsor......................  Monte Foundation.
Event Description............  Fireworks Display.
Date.........................  Week of Labor Day.
Location.....................  Carnelian Bay, Lake Tahoe, CA.
Regulated Area...............  100-foot radius around the fireworks
                                barge during the loading, transit,
                                setup, and until the commencement of the
                                scheduled display. Increases to a 1,000-
                                foot radius upon commencement of the
                                fireworks display.
------------------------------------------------------------------------
               30. Sausalito Lighted Boat Parade Fireworks
------------------------------------------------------------------------
Sponsor......................  Various Sponsors.
Event Description............  Fireworks Display.
Date.........................  A Saturday or Sunday in December.
Location.....................  Off-shore from Sausalito Point,
                                Sausalito, CA.
Regulated Area...............  100-foot radius around the fireworks
                                barge during the loading, transit,
                                setup, and until the commencement of the
                                scheduled display. Increases to a 1,000-
                                foot radius upon commencement of the
                                fireworks display.
------------------------------------------------------------------------

    Dated: December 13, 2016.
Anthony J. Ceraolo,
Captain, U.S. Coast Guard,Captain of the Port San Francisco.
[FR Doc. 2017-01050 Filed 1-17-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: January 25, 2008 (Volume 73, Number 17)]
[
Notices]
[Page 4580]
[DOCID:fr25ja08-79]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Anesthetic and Life Support Drugs Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Anesthetic and Life Support Drugs Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 11, 2008, from
8:30 a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, Maryland Ballroom,
8727 Colesville Rd., Silver Spring, MD. The hotel phone number is 301-
589-5200.
    Contact Person: Mimi Phan, Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville, MD 20857,<PHONE_NUMBER>, FAX:
301-827-6776,e-mail<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in Washington, DC area),
code<PHONE_NUMBER>. Please call the Information Line for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the agency's Web site
and call the appropriate advisory committee hotline/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: The committee will discuss the new drug application (NDA)
22-225, sugammadex sodium injection (proposed tradename BRIDION),
Organon USA Inc., for the proposed indication of routine reversal of
shallow and profound neuromuscular blockade (NMB) induced by rocuronium
or vecuronium and immediate reversal of NMB at three minutes after
administration of rocuronium. FDA intends to make background material
available to the public no later than 2 business days before the
meeting. If FDA is unable to post the background material on its Web
site prior to the meeting, the background material will be made
publicly available at the location of the advisory committee meeting,
and the background material will be posted on FDA's Web site after the
meeting. Background material is available at http://www.fda.gov/ohrms/
dockets/ac/acmenu.htm
, click on the year 2008 and scroll down to the

appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
February 26, 2008. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those desiring to make formal
oral presentation should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before February 15, 2008. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by February
19, 2008.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Mimi Phan at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm
 for procedures on public conduct during advisory committee

meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-1239 Filed 1-24-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 79, Number 36 (Monday, February 24, 2014)]
[Notices]
[Pages 10142-10143]
[FR Doc No: 2014-03859]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0130; FRL-9906-18]

Kasugamycin; Receipt of Application for Emergency Exemption for
Use on Apples in Michigan; Solicitation of Public Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received a specific exemption request from the
Michigan Department of Agriculture to use the pesticide kasugamycin to
treat up to 10,000 acres of apples to control fire blight. The
applicant proposes the use of a new chemical which has not been
registered by EPA. EPA is soliciting public comment before making the
decision whether or not to grant the exemption.

DATES: Comments must be received on or before March 11, 2014.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2014-0130, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about

dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    1. Submitting CBI. Do not submit this information to EPA through
www.regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticide
discussed in this document, compared to the general population.

II. What action is the agency taking?

    Under section 18 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the EPA
Administrator, a Federal or State agency may be exempted from any
provision of FIFRA if the EPA Administrator determines that emergency
conditions exist which require the exemption. Michigan Department of
Agriculture has requested the EPA Administrator to issue a specific
exemption for the use of kasugamycin on apples to control fire blight
(Erwinia amylovora). Information in accordance with 40 CFR part 166 was
submitted as part of this request.
    As part of this request, the applicant asserts that kasugamycin is
needed to control streptomycin-resistant strains of Erwinia amylovora,
the causal pathogen of fire blight, due to the lack of available
alternatives and effective control practices; and significant economic
losses will occur if this pest is not controlled.
    The applicant proposes to make no more than three applications of
Kasumin 2 (L) on not more than 10,000 acres of apples between April 1
and May 31, 2014 in Antrim, Berrien, Cass, Grand Traverse, Ionia, Kent,
Leelanau, Montcalm, Newaygo, Oceana, Ottawa, and Van Buren counties. As
currently proposed, the maximum amount of product to be applied would
be 15,000 gallons.
    This notice does not constitute a decision by EPA on the
application itself. The regulations governing FIFRA section 18 require
publication of a notice of receipt of an application for a specific
exemption proposing use of a new chemical (i.e., an active ingredient)
which has not been registered by EPA. The notice provides an
opportunity for public comment on the application.
    The Agency will review and consider all comments received during
the comment period in determining whether to issue the specific
exemption requested by the Michigan Department of Agriculture.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: February 11, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2014-03859 Filed 2-21-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Proposed Rules]
[Pages 39970-39975]
[FR Doc No: 2018-17362]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2017-0060; FRL-9982-11--Region 5]

Air Plan Approval; Minnesota; Infrastructure SIP Requirements for
the 2012 PM2.5 NAAQS; Multistate Transport

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve elements of the State Implementation Plan (SIP) submission from
Minnesota regarding the infrastructure requirements of section 110 of
the Clean Air Act (CAA) for the 2012 annual fine particulate matter
(PM2.5) National Ambient Air Quality Standard (NAAQS or
standard). The infrastructure requirements are designed to ensure that
the structural components of each state's air quality management
program are adequate to meet the state's responsibilities under the
CAA. This action pertains specifically to infrastructure requirements
concerning interstate transport provisions.

DATES: Comments must be received on or before September 12, 2018.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2017-0060 at https://www.regulations.gov, or via email to
[email protected]. For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, 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, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on

making effective comments, please visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Anthony Maietta, Environmental
Protection Specialist, Control Strategies Section, Air Programs Branch
(AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is the background of this SIP submission?
II. What guidance and memoranda is EPA using to evaluate this SIP
submission?
III. EPA's Review
IV. What action is EPA taking?
V. Statutory and Executive Order Reviews

I. What is the background of this SIP submission?

    This rulemaking addresses a submission from the Minnesota Pollution
Control Agency dated January 23, 2017, which describes its
infrastructure SIP for the 2012 annual PM2.5 NAAQS.
Specifically, this rulemaking addresses the portion of the submission
dealing with interstate pollution transport under CAA Section
110(a)(2)(D)(i), otherwise known as the ``good neighbor'' provision.
The requirement for states to make a SIP submission of this type arises
from Section 110(a)(1) of the CAA. Pursuant to Section 110(a)(1),
states must submit ``within 3 years (or such shorter period as the
Administrator may prescribe) after the promulgation of a national
primary ambient air quality standard (or any revision thereof),'' a
plan that provides for the ``implementation, maintenance, and
enforcement'' of such NAAQS. The statute directly imposes on states the
duty to make these SIP submissions, and the requirement to make the
submissions is not conditioned upon EPA's taking any action other than
promulgating a new or revised NAAQS. Section 110(a)(2) includes a list
of specific elements that ``[e]ach such plan'' submission must address.
EPA commonly refers to such state plans as ``infrastructure SIPs.''

II. What guidance and memoranda is EPA using to evaluate this SIP
submission?

    EPA highlighted the statutory requirement to submit infrastructure
SIPs within three years of promulgation of a new NAAQS in an October 2,
2007 guidance document titled ``Guidance on SIP Elements Required Under
Sections 110(a)(1) and (2) for the 1997 8-hour Ozone and
PM2.5 National Ambient Air Quality Standards'' (2007
guidance). EPA has issued additional guidance documents and memoranda,
including a September 13, 2013 guidance document titled ``Guidance on
Infrastructure State Implementation Plan (SIP) Elements under Clean Air
Act Sections 110(a)(1) and 110(a)(2)'' (2013 guidance).
    The most recent relevant document is a memorandum published on
March 17, 2016, titled ``Information on the Interstate Transport ``Good
Neighbor'' Provision for the 2012 Fine Particulate Matter National
Ambient Air Quality Standards under Clean Air Act Section
110(a)(2)(D)(i)(I)'' (2016 memorandum). The 2016 memorandum describes
EPA's consistent approach over the years to address interstate
transport, and provides EPA's general review of relevant modeling data
and air quality projections as they relate to the 2012 annual
PM2.5 NAAQS. The 2016 memorandum provides information
relevant to EPA Regional office review of the CAA section 110
(a)(2)(D)(i)(I) ``good neighbor'' provision in infrastructure SIPs with
respect to the 2012 annual PM2.5 NAAQS. Minnesota's
submittal and this rulemaking consider information provided in that
memorandum.
    The 2016 memorandum provides states and EPA Regional offices with
future year annual PM2.5 design values for monitors in the
United States based on quality-assured and certified ambient monitoring
data and air quality modeling. The 2016 memorandum further describes
how these projected potential design values can be used to help
determine which monitors should be further evaluated to potentially
address whether emissions from other states will significantly
contribute to nonattainment or interfere with maintenance of the 2012
annual PM2.5 NAAQS at those sites. The 2016 memorandum
explains that, for purposes of addressing interstate transport for the
2012 annual PM2.5 NAAQS, it may be appropriate to evaluate
projected air quality in 2021, which is the attainment deadline for
2012 annual PM2.5 NAAQS nonattainment areas classified as
Moderate. Accordingly, because the available data includes 2017 and
2025 projected average and maximum PM2.5 design values
calculated through the CAMx photochemical model, the 2016 memorandum
suggests approaches that states might use to interpolate
PM2.5 values at sites in 2021. The 2016 memorandum indicates
that it may be reasonable to assume receptors projected to have average
and/or maximum design values above the NAAQS in both 2017 and 2025 are
also likely to be either nonattainment or maintenance receptors in
2021. Similarly, the 2016 memorandum indicates that it may be
reasonable to assume that receptors that are projected to attain the
NAAQS in both 2017 and 2025 are also likely to be attainment receptors
in 2021. However, where a potential receptor is projected to be
nonattainment or maintenance in 2017, but projected to be attainment in
2025, the 2016 memorandum suggests that further analysis of the
emissions and modeling may be needed to make a further judgement
regarding the receptor status in 2021.
    The 2016 memorandum indicates that for all but one monitor site in
the eastern United States with at least one complete and valid
PM2.5 design value for the annual average 2012 annual
PM2.5 NAAQS in the 2009-2013 period, the modeling data shows
that monitors are expected to both attain and maintain the 2012 annual
PM2.5 NAAQS in both 2017 and 2025. The modeling results
provided in the 2016 memorandum show that out of seven PM2.5
monitors located in Allegheny County, Pennsylvania, one monitor is
expected to be above the 2012 annual PM2.5 NAAQS in 2017.
Further, that monitor, the Liberty monitor (ID number 420030064), is
projected to be above the NAAQS only under the model's maximum
projected conditions (used in EPA's interstate transport framework to
identify maintenance receptors), and is projected to both attain and
maintain the NAAQS (along with all Allegheny County monitors) in 2025.
The 2016 memorandum therefore indicates that under such a condition
(where EPA's photochemical modeling indicates an area will maintain the
2012 annual PM2.5 NAAQS in 2025 but not attain in 2017)
further analysis of the site should be performed to determine if the
site may be a nonattainment or maintenance receptor in 2021 (the
attainment deadline for moderate PM2.5 areas).
    The 2016 memorandum indicates that based on modeling projections,
there are 17 potential nonattainment or maintenance receptors in
California, located in the San Joaquin Valley and South Coast
nonattainment areas, and one potential receptor in Shoshone County,
Idaho.
    The 2016 memorandum indicates that for certain states with
incomplete ambient monitoring data, additional information including
the latest available data, should be analyzed to determine whether
there are potential downwind air quality problems that may be impacted
by transported

emissions. These states include all or portions of Florida, Illinois,
Idaho (outside of Shoshone County), Tennessee and Kentucky. With the
exception of four counties in Florida, the data quality problems have
subsequently been resolved for these areas, and these areas now have
current design values below the 2012 annual PM2.5 NAAQS and
are expected to maintain the NAAQS due to downward emission trends for
NOX and SO2.
    Minnesota's submittal indicates that the state used data from the
2016 memorandum in its analysis. EPA considered the analysis from
Minnesota, as well as additional analysis conducted by EPA, in its
review of the Minnesota submittal. More information contained in our
review can be found in the technical support document (TSD) in the
docket, ``[Technical Support Document for Docket #EPA-R05-OAR-2017-
0060].''

III. EPA's Review

    This rulemaking proposes action on the portion of Minnesota's
January 23, 2017 SIP submission addressing the good neighbor provision
requirements of CAA Section 110(a)(2)(D)(i). State plans must address
four requirements of the good neighbor provisions (commonly referred to
as ``prongs''), including:
    --Prohibiting any source or other type of emissions activity in one
state from contributing significantly to nonattainment of the NAAQS in
another state (prong one);
    --Prohibiting any source or other type of emissions activity in one
state from interfering with maintenance of the NAAQS in another state
(prong two);
    --Prohibiting any source or other type of emissions activity in one
state from interfering with measures required to prevent significant
deterioration (PSD) of air quality in another state (prong three); and
    --Protecting visibility in another state (prong four).
    This rulemaking is evaluating Minnesota's January 23, 2017
submission, to determine whether Minnesota's interstate transport
provisions in its PM2.5 infrastructure SIP meet prongs one
and two of the good neighbor requirements of the CAA. Prongs three and
four will be evaluated in a separate rulemaking.
    EPA has developed a consistent framework for addressing the
interstate transport requirements required by prongs one and two with
respect to the PM2.5 NAAQS in several previous Federal
rulemakings. The four basic steps of that framework include:
    (1) Identifying downwind receptors that are expected to have
problems attaining or maintaining the NAAQS; (2) identifying which
upwind states contribute to these identified problems in amounts
sufficient to warrant further review and analysis; (3) for states
identified as contributing to downwind air quality problems,
identifying upwind emissions reductions necessary to prevent an upwind
state from significantly contributing to nonattainment or interfering
with maintenance of the NAAQS downwind; and (4) for states that are
found to have emissions that significantly contribute to nonattainment
or interfere with maintenance of the NAAQS downwind, reducing the
identified upwind emissions through adoption of permanent and
enforceable measures. This framework was most recently applied with
respect to PM2.5 in the August 8, 2011 Cross-State Air
Pollution Rule (CSAPR) (76 FR 48208), designed to address both the 1997
and 2006 PM2.5 standards, as well as the 1997 and 2008 ozone
standards.
    Minnesota's January 23, 2017 submission indicates that the
Minnesota SIP contains the following major programs related to the
interstate transport of pollution:

 7011.0500-0553 Indirect Heating Fossil Fuel Burning Equipment
 7011.0600-0625 Direct Heating Fossil Fuel Burning Equipment
 7011.1400-1430 Petroleum Refineries
 7011.1600-1605 Sulfuric Acid Plants
 7011.0150 Preventing Particulate Matter from Becoming Airborne
 7011.0710-0735 Industrial Process Equipment
 7011.0850-0859 Concrete Manufacturing Plant Standards of
Performance
 7011.0900-0922 Hot Mix Asphalt Plants
 7011.1000-1015 Bulk Agricultural Commodity Facilities
 7011.1100-1125 Coal Handling Facilities
 7011.1300-1325 Incinerators
 7011.1700-1705 Nitric Acid Plants
 Title I/Title V operating permits and administrative orders
for facilities in the state as defined in the January 23, 2017
submittal.

    Minnesota's submittal also contains a technical analysis of its
interstate transport of pollution relative to the 2012 annual
PM2.5 NAAQS. The technical analysis studies Minnesota
sources' contribution to monitored PM2.5 air quality values
in other states and whether Minnesota would need to take further steps
to decrease its emissions to (and therefore impacts on) those areas.
Minnesota's technical analysis considers CSAPR rule implementation, EPA
guidance and memoranda, and other factors such as meteorology and
state-wide emissions inventories. Minnesota did not focus on its
potential contribution to areas EPA identified as not attaining the
2012 annual PM2.5 NAAQS based on monitor data in Alaska,
California, Idaho, Nevada, or Hawaii. The distance between Minnesota
and these areas, coupled with the prevailing wind directions, leads EPA
to propose to find that Minnesota will not contribute significantly to
any of the potential receptors in those states.\1\
---------------------------------------------------------------------------

    \1\ It should be noted that EPA has projected that receptors in
California and Idaho will be in nonattainment in 2021 but, as just
noted, Minnesota's distance from those receptors, as well as the
fact that the wind generally blows from west to east over the
continental U.S., means that Minnesota will not contribute to them.
---------------------------------------------------------------------------

    Additionally, EPA's 2016 memorandum found Allegheny County,
Pennsylvania, the Liberty monitor, to be a potential receptor, however,
EPA proposes to find that Minnesota will not contribute significantly
to the receptor. Minnesota's impacts on that potential receptor is
relatively small. CSAPR contained a determination that for the 1997 and
2006 PM2.5 NAAQS, any state whose impacts on a specific
receptor in a downwind state meet or exceed a threshold of 1% of the
NAAQS are considered linked to that receptor (76 FR 48236). In other
words, EPA determined that any state whose impacts are below that
threshold will not significantly contribute to nonattainment or
interfere with maintenance of the relevant NAAQS. EPA has not
determined a comparable threshold for the 2012 annual PM2.5
NAAQS. EPA believes that a proper and well-supported weight of evidence
approach can provide sufficient information for purposes of evaluating
the impact of Minnesota on the Liberty monitor. In addition, in its
review, Minnesota determined that its impact on air quality monitors in
Pennsylvania is less than 1% of the 2012 annual PM2.5 NAAQS.
Minnesota's determination is based on EPA's source apportionment
modeling predicting state contributions to downwind monitors in 2012
under the base case scenario in our original CSAPR analysis. For these
reasons, we propose to find that Minnesota's emissions will not
contribute significantly to the Liberty monitor.
    With respect to Illinois, EPA's source apportionment modeling in
our original CSAPR analysis predicts that

Minnesota's emissions impact Illinois's monitors. The PM2.5
monitoring data for Illinois for the period from January 2011 to July
2014 suffered from data quality/completion issues, and no current
annual PM2.5 design values existed for Illinois at the time
of the modeling for the 2016 memorandum. Illinois has since resolved
these quality control issues.
    EPA considered available data from monitors in Illinois for its
analysis of Minnesota's submittal. As shown in Table 1, Illinois is now
meeting the standard throughout the state.

Table 1--Illinois Annual PM2.5 Design Values for 2015-2017 Design Period
------------------------------------------------------------------------
                                                             2015-2017
             Local site name                Monitoring     design value
                                               site        ([mu]g/m\3\)
------------------------------------------------------------------------
Alsip...................................     17-031-0001             9.5
Washington High School..................     17-031-0022             9.3
Mayfair Pump Station....................     17-031-0052             9.1
Springfield Pump Station................     17-031-0057            10.2
Com Ed..................................     17-031-0076             9.5
Schiller Park...........................     17-031-3103            10.5
Summit..................................     17-031-3301             9.7
Des Plaines.............................     17-031-4007             9.4
Northbrook..............................     17-031-4201             8.4
Cicero..................................     17-031-6005            10.0
Naperville..............................     17-043-4002             8.3
Elgin...................................     17-089-0003             8.3
Aurora..................................     17-089-0007             8.3
Cary....................................     17-111-0001         \+\ 8.2
Joliet..................................     17-197-1002             7.9
Braidwood...............................     17-197-1011             7.9
Jerseyville.............................     17-083-0117         \+\ 8.8
Granite City............................     17-119-1007             9.7
Alton...................................     17-119-2009             8.8
Wood River..............................     17-119-3007             8.7
Houston.................................     17-157-0001             8.5
East St. Louis..........................     17-163-0010             9.8
Champaign...............................     17-019-0006             7.9
Bondville...............................     17-019-1001             7.8
Knight Prairie..........................     17-065-0002             8.2
Normal..................................     17-113-2003             8.0
Decatur.................................     17-115-0013             8.4
Peoria..................................     17-143-0037             8.2
Rock Island.............................     17-161-3002             8.1
Springfield.............................     17-167-0012             8.2
Rockford................................     17-201-0013             8.3
------------------------------------------------------------------------
+ Data incomplete.

    Illinois' air quality trends reflect what is shown across the
nation: A general downward trend in ambient air concentrations,
including sites that Minnesota analyzed in its submittal. During the
last valid design period, only three Illinois counties reported 2008-
2010 annual PM2.5 design values above the NAAQS: Cook,
Madison, and Saint Clair counties. In Cook County, the 2008-2010 annual
design value was 13.0 micrograms per cubic meter ([micro]g/m\3\), and
the annual mean values have trended downward. As shown in the table
above, these areas are now meeting the NAAQS for the 2015 to 2017
design period. Therefore, EPA expects that all counties in Illinois
will attain and maintain the PM2.5 NAAQS without the need
for additional PM2.5 reductions in Minnesota, and for this
reason, we propose to find that Minnesota will not contribute
significantly to nonattainment or maintenance problems in Illinois.
    Minnesota found, and our review confirmed, that despite the fact
that Minnesota emissions potentially contribute to monitored
PM2.5 air quality in areas in other states, all of those
areas were attaining the 2012 annual PM2.5 NAAQS based on
2014-2016 data. Despite Minnesota not significantly contributing to the
monitored PM2.5 air quality in Pennsylvania, our review
evaluated PM2.5 air quality issues in Pennsylvania. All but
two areas in Pennsylvania (Allegheny and Delaware counties) were
attaining the 2012 annual PM2.5 NAAQS based on 2012-2014
data. A review of 2013-2015 design values shows that all areas except
for Allegheny County have attained the NAAQS. Our review also considers
2014-2016 design values, which show only Allegheny and Lancaster
counties not meeting the NAAQS. In Delaware and Lebanon counties, not
only do the most recent PM2.5 monitor data show these
counties are attaining the PM2.5 NAAQS, EPA's
PM2.5 modeling data for 2017 and 2025 do not indicate any
nonattainment or maintenance issues in these counties. There is a clear
downward trend in PM2.5 values in these counties. For
Lancaster County, despite having a 2014-2016 design value that exceeds
the NAAQS, there is a clear downward trend in the monitored
PM2.5 air quality data that supports EPA's PM2.5
modeling that shows no nonattainment or maintenance problems for this
county by 2021.
    The modeling information contained in EPA's 2016 memorandum shows
that one monitor in Allegheny County, PA (the Liberty monitor,
420030064) may have a maintenance issue in 2017, but is projected to
both attain and maintain the NAAQS by 2025. A linear interpolation of
the modeled design values to 2021 shows that the monitor is likely to
both attain and maintain the standard by 2021. Emissions and air
quality data trends help to corroborate this interpolation.

    Over the last decade, local and regional emissions reductions of
primary PM2.5, sulfur dioxide (SO2), and nitrogen
oxide (NOX), have led to large reductions in annual
PM2.5 design values in Allegheny County, Pennsylvania. In
2007, all of Allegheny County's PM2.5 monitors exceeded the
level of the 2012 annual PM2.5 NAAQS (the 2005-2007 annual
average design values ranged from 12.9-19.8 [mu]g/m\3\, as shown in
Table 2). The 2014-2016 annual average PM2.5 design values
now show that only one monitor (Liberty, at 12.8 [mu]g/m\3\) exceeds
the health-based annual PM2.5 NAAQS of 12.0 [mu]g/m\3\.

                                                   Table 2--PM2.5 Annual Design Values in [mu]g/m \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  Monitor                   2005-2007  2006-2008  2007-2009  2008-2010  2009-2011  2010-2012  2011-2013  2012-2014  2013-2015  2014-2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
Avalon....................................  .........  .........  .........     * 16.3     * 14.7       13.4       11.4       10.6       10.6     * 10.4
Lawrenceville.............................       15.0       14.0       13.1       12.2       11.6       11.1       10.3       10.0        9.7        9.5
Liberty...................................       19.8       18.3       17.0       16.0       15.0       14.8       13.4       13.0       12.6       12.8
South Fayette.............................       12.9     * 11.8       11.7       11.1       11.0       10.5        9.6        9.0        8.8      * 8.5
North Park................................     * 13.0     * 12.3     * 11.3     * 10.1        9.7        9.4        8.8        8.5        8.5      * 8.2
Harrison..................................       15.0       14.2       13.7       13.0       12.4     * 11.7       10.6       10.0        9.8        9.8
North Braddock............................       16.2       15.2       14.3       13.3       12.7       12.5     * 11.7       11.4       11.2       11.0
Parkway East Near-Road....................  .........  .........  .........  .........  .........  .........  .........  .........  .........     * 10.6
Clairton..................................       15.3       14.3       13.2       12.4     * 11.5     * 10.9      * 9.8        9.5        9.8      * 9.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Value does not contain a complete year's worth of data.

    The Liberty monitor is already close to attaining the NAAQS, and
expected emissions reductions in the next four years will lead to
additional reductions in measured PM2.5 concentrations.
There are both local and regional components to the measured
PM2.5 levels in Allegheny County and the greater Pittsburgh
area. Previous CSAPR modeling showed that regional emissions from
upwind states, particularly SO2 and NOX
emissions, contribute to PM2.5 nonattainment at the Liberty
monitor. In recent years, large SO2 and NOX
reductions from power plants have occurred in Pennsylvania and states
upwind from the Greater Pittsburgh region. Based on existing CSAPR
budgets, Pennsylvania's energy sector emissions of SO2 will
have decreased 166,000 tons between 2015-2017 as a result of CSAPR
implementation. This is due to both the installation of emissions
controls and retirements of electric generating units (EGUs) (see the
TSD for more details). Projected power plant closures and additional
emissions controls in Pennsylvania and upwind states will help further
reduce both direct PM2.5 and PM2.5 precursors.
Regional emission reductions will continue to occur from current on-
the-books Federal and state regulations such as the Federal on-road and
non-road vehicle programs, and various rules for major stationary
emissions sources.
    In addition to regional emissions reductions and plant closures,
additional local reductions of both direct PM2.5 and
SO2 emissions are expected to occur and should also
contribute to further declines in Allegheny County's PM2.5
monitor concentrations. For example, significant SO2
reductions have recently occurred at US Steel's integrated steel mill
facilities in southern Allegheny County as part of a 1-hr
SO2 NAAQS SIP.\2\ Reductions are largely due to declining
sulfur content in the Clairton Coke Work's coke oven gas (COG). Because
this COG is burned at US Steel's Clairton Coke Works, Irvin Mill, and
Edgar Thompson Steel Mill, these reductions in sulfur content should
contribute to much lower PM2.5 precursor emissions in the
immediate future. The Allegheny SO2 SIP also projects lower
SO2 emissions resulting from vehicle fuel standards,
reductions in general emissions due to declining population in the
Greater Pittsburgh region and several shutdowns of significant sources
of emissions in Allegheny County.
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    \2\ http://www.achd.net/air/publichearing2017/SO2_2010_NAAQS_SIP_5-1-2017.pdf.
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    EPA modeling projections, the recent downward trend in local and
upwind emissions reductions, the expected continued downward trend in
emissions between 2017 and 2021, and the downward trend in monitored
PM2.5 concentrations, all indicate that the Liberty monitor
will attain and be able to maintain the 2012 annual PM2.5
NAAQS by 2021.
    With respect to Florida, in the CSAPR modeling analysis for the
1997 PM2.5 NAAQS, Florida did not have any potential
nonattainment or maintenance receptors identified for the 1997 or 2006
PM2.5 NAAQS. At this time, it is anticipated that this trend
will continue, however, as there are ambient monitoring data gaps in
the 2009-2013 data that could have been used to identify potential
PM2.5 nonattainment and maintenance receptors for Miami/
Dade, Gilchrist, Broward and Alachua counties in Florida, the modeling
analysis of potential receptors was not complete for these counties.
However, the most recent ambient data (2015-2017) for these counties
has been preliminarily deemed complete and indicates design values well
below the level of the 2012 annual PM2.5 NAAQS. In addition,
the highest preliminary value for these observed monitors is 7.5 [mu]g/
m\3\ at the Miami-Dade County monitor (12-086-1016), which is well
below the NAAQS. This is also consistent with historical data: complete
and valid design values in the 2006-2008, 2007-2009 and/or 2008-2010
periods for these counties were all well below the 2012 annual
PM2.5 NAAQS. This is also consistent with historical data:
complete and valid design values in the 2006-2008 and/or 2007-2009
periods for these counties were well below the 2012 annual
PM2.5 NAAQS. For these reasons, we find that none of the
counties in Florida with monitoring gaps between 2009-2013 should be
considered either nonattainment or maintenance receptors for the 2012
annual PM2.5 NAAQS. For these reasons, we propose to find
that emissions from Minnesota will not significantly contribute to
nonattainment or interfere with maintenance of the 2012 annual
PM2.5 NAAQS in Florida. We find further support in the fact
that EPA's source apportionment modeling predicted state impacts on
downwind monitors in 2012 under the base case scenario in our original
CSAPR analysis, showing little impact from Minnesota to any of
Florida's counties.

    The conclusions of Minnesota's analysis are consistent with EPA's
expanded review of its January 23, 2017 submittal. All areas that
Minnesota sources potentially contribute to attain and maintain the
2012 annual PM2.5 NAAQS, and as demonstrated in its
submittal, Minnesota will not contribute to projected nonattainment or
maintenance issues at any sites in 2021. Minnesota's analysis shows
that through permanent and enforceable measures currently contained in
its SIP, and other emissions reductions occurring in Minnesota and in
other states, monitored PM2.5 air quality in all identified
areas that Minnesota sources may impact will continue to improve, and
that no further measures are necessary to satisfy Minnesota's
responsibilities under CAA section 110(a)(2)(D)(i)(I). Therefore, EPA
is proposing that prongs one and two of the interstate pollution
transport element of Minnesota's infrastructure SIP are approvable.

IV. What action is EPA taking?

    EPA is proposing to approve a portion of Minnesota's January 23,
2017 submittal certifying that the current Minnesota SIP is sufficient
to meet the required infrastructure requirements under CAA section
110(a)(2)(D)(i)(I), specifically prongs one and two, as set forth
above. EPA is requesting comments on the proposed approval.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
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 action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because this rulemaking does not involve technical standards; 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).
    In addition, 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 and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

    Dated: July 30, 2018.
Cathy Stepp,
Regional Administrator, Region 5.
[FR Doc. 2018-17362 Filed 8-10-18; 8:45 am]
 BILLING CODE 6560-50-P