[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Page 3687]
[FR Doc No: 2015-01068]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74082; File No. SR-ICC-2014-19]

Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of
Designation of Longer Period for Commission Action on Proposed Rule
Change To Formalize the ICC Operational Risk Management Framework

January 16, 2015.
    On November 18, 2014, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change SR-ICC-2014-19 pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder.\2\ The
proposed rule change was published for comment in the Federal Register
on December 2, 2014.\3\ The Commission did not receive comments on the
proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-73684 (Nov. 25,
2014), 79 FR 71495 (Dec. 2, 2014) (SR-ICC-2014-19).
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    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day from the publication of notice of filing of this proposed rule
change is January 16, 2015. The Commission is extending this 45-day
time period.
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    \4\ 15 U.S.C. 78s(b)(2).
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    ICC is proposing to update and formalize ICC's Operational Risk
Management Framework. In light of the fact that the proper management
and documentation of the systems to be maintained in order to formalize
the processes for assessing operational risk can be detailed and
require specific knowledge of the risks involved, the Commission finds
it appropriate to designate a longer period within which to take action
on the proposed rule change so that it has sufficient time to consider
this proposed rule change.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates March 2, 2015, as the date by which the Commission
should either approve or disapprove, or institute proceedings to
determine whether to disapprove, the proposed rule change (File No. SR-
ICC-2014-19).
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    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(31).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-01068 Filed 1-22-15; 8:45 am]
BILLING CODE 8011-01-P


and August 1, 2007 to Colorado's 5 CCR 1001-5 Regulation Number 3, Part
D. The October 25, 2005 submittal included a renumbering of Regulation
Number 3. The incorporation by reference in paragraph (c)(120)(i)(A) on
this section reflects the renumbered sections as of the October 25,
2005 submittal. Sections were removed from Part D between the October
25, 2005 and August 1, 2007 submittal. The incorporation by reference
in paragraph (c)(120)(i)(B) of this section reflects the numbering of
the sections as of the August 1, 2007 submittal.
    (i) Incorporation by reference.
    (A) 5 CCR 1001-5, Regulation 3, Stationary Source Permitting and
Air Pollutant Emission Notice Requirements, Part D, Concerning Major
Stationary Source New Source Review and Prevention of Significant
Deterioration, adopted April 16, 2004 and effective June 30, 2004:
    (1) Section I, Applicability, Sections I.A., General Applicability;
I.A.1;
    (2) Section II, Definitions,
    (i) II.A;
    (ii) II.A.1, Actual Emissions; II.A.1.a (only the language that
appears in plain or underlined text and not the language that appears
as italicized text); II.A.1.b; II.A.1.c; II.A.1.e;
    (iii) II.A.3, Air Quality Related Value;
    (iv) II.A.5, Baseline Area;
    (v) II.A.6, Baseline Concentration;
    (vi) II.A.8, Best Available Control Technology (BACT) (the language
that appears in plain or underlined text but not language that appears
as italicized text, with the following exception--EPA is incorporating
italicized text and is not incorporating underlined text when the
combined effect of that action is to replace the phrase ``air pollutant
regulated under the Federal Act'' (or an equivalent phrase) with the
term ``regulated NSR pollutant'');
    (vii) II.A.12, Complete;
    (viii) II.A.16, Federal Land Manager (FLM);
    (ix) II.A.19, Innovative Control Technology;
    (x) II.A.21, Lowest Achievable Emission Rate (LAER); II.A.21.a;
II.A.21.b (only the language that appears in plain or underlined text
and not the language that appears as italicized text);
    (xi) II.A.23, Major Modification (the language that appears in
plain or underlined text but not language that appears as italicized
text, with the following exception--EPA is incorporating italicized
text and is not incorporating underlined text when the combined effect
of that action is to replace the phrase ``air pollutant regulated under
the Federal Act'' (or an equivalent phrase) with the term ``regulated
NSR pollutant''); II.A.23.b; II.A.23.c; II.A.23.d; II.A.23.d(i);
II.A.23.d(ii); II.A.23.d(iv); II.A.23.d.(v);

II.A.23.d.(vi); II.A.23.d.(vii); II.A.23.d.(ix); II.A.23.f;
    (xii) II.A.24, Major Source Baseline Date;
    (xiii) II.A.25, Major Stationary Source; II.A.25.a; II.A.25.c;
II.A.25.e; II.A.25.f;
    (xiv) II.A.26, Minor Source Baseline Date;
    (xv) II.A.27, Net Emissions Increase; II.A.27.a; (the language that
appears in plain or underlined text and the addition of the italicized
phrase ``With respect to any regulated NSR pollutant emitted by any
major stationary source''); II.A.27.a.(i) (only the language that
appears in plain or underlined text and not the language that appears
as italicized text); II.A.27.a.(ii) (only the language that appears in
plain or underlined text and not the language that appears as
italicized text); II.A.27.b (only the language that appears in plain or
underlined text and not the language that appears as italicized text);
II.A.27.c; II.A.27.c.(i); II.A.27.c(ii); II.A.27.c(iii); II.A.27.d;
II.A.27.e; II.A.27.f; II.A.27.g; II.A.27.g.(i); II.A.27.g.(ii);
II.A.27.g.(iii) (only the language that appears in plain or underlined
text and not the language that appears as italicized text);
II.A.27.g.(iv); II.A.27.h; II.A.27.j; II.A.27.k, Creditable Decreases
for Fuel Switching;
    (xvi) II.A.40, Regulated NSR Pollutant; II.A.40.a; II.A.40.b;
II.A.40.d; II.A.40.e;
    (xvii) II.A.43, Secondary Emissions (only the language that appears
in plain or underlined text and not the language that appears as
italicized text);
    (xviii) II.A.44, Significant; II.A.44.b; II.A.44.c;
    (xix) II.A.45, Significant Emissions Increase;
    (3) Section III, Permit Review Procedures;
    (4) Section IV, Public Comment Requirements;
    (5) Section V, Requirements Applicable to Nonattainment Areas,
Sections V.A, Major Stationary Sources; V.A.1; V.A.2; V.A.3; V.A.3.d;
V.A.4; V.A.5; V.A.6; V.A.7, Applicability of Certain Nonattainment Area
Requirements; V.A.7.a; V.A.7.b; V.A.8, Exemptions from certain
nonattainment area requirements;
    (6) Section VI, Requirements applicable to attainment and
unclassifiable areas and pollutants implemented under section 110 of
the Federal Act (Prevention of Significant Deterioration Program),
Sections VI.A, Major Stationary Sources and Major Modifications;
VI.A.1, Control Technology Review; VI.A.1.a; VI.A.1.b; VI.A.1.c (only
the language that appears in plain or underlined text and not the
language that appears as italicized text); VI.A.2, Source Impact
Analysis; VI.A.3, Pre-construction Monitoring and Analysis; VI.A.4,
Post-Construction Monitoring; VI.A.5, Operation of Monitoring Stations;
VI.A.6, Additional Impact Analysis (only the language that appears in
plain or underlined text and not the language that appears as
italicized text); VI.B, Applicability of Certain PSD Requirements;
VI.B.1 through VI.B.4; VI.B.7; VI.C, Notice to the U.S. EPA; VI.D,
Major Stationary Sources in attainment areas affecting nonattainment
areas;
    (7) Section VII, Negligibly Reactive Volatile Organic Compounds
(NRVOCs);
    (8) Section VIII, Area Classifications, Sections VIII.A; VIII.C;
VIII.D;
    (9) Section IX, Redesignation;
    (10) Section X, Air Quality Limitations, Sections X.A, Ambient Air
Increments; X.A.1, X.A.2; X.A.3; X.A.4, Periodic Review;
    (11) Section XI, Exclusions From Increment Consumption;
    (12) Section XII, Innovative Control Technology;
    (13) Section XIII, Federal Class I Areas; adopted April 16, 2004
and effective June 30, 2004.
    (B) Regulation 3, Stationary Source Permitting and Air Pollutant
Emission Notice Requirements, Part D, Concerning Major Stationary
Source New Source Review and Prevention of Significant Deterioration,
Section II, Definitions; Sections II.A; II.A.22.a; II.A.24.d;
II.A.38.c; II.A.42.a; adopted August 17, 2006 and effective October 30,
2006.

0
3. Section 52.352 is revised to read as follows:

Sec.  52.352  Interstate transport.

    (a) Addition to the Colorado State Implementation Plan of the
Colorado Interstate Transport regarding the 1997 8-Hour Ozone Standard
for the ``significant contribution,'' the ``interference with
maintenance'' requirements, and the addition of ``interference with
visibility protection'' requirements regarding the 1997 8-Hour Ozone
and PM2.5 Standards, submitted by the Governor's designee on
June 18, 2009 and March 31, 2010.
    (b) Addition to the Colorado State Implementation Plan of the
Colorado Interstate Transport SIP regarding the 1997 8-Hour Ozone and
1997 PM2.5 Standards for the ``interference with prevention
of significant deterioration'' requirement, and the addition of the
``significant contribution'' and ``interference with maintenance''
requirements regarding the 1997 PM2.5 Standards, submitted
by the Governor's designee on March 31, 2010.

[FR Doc. 2012-70 Filed 1-6-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 28, 2005 (Volume 70, Number 187)]
[Notices]
[Page 56657-56658]
[DOCID:fr28se05-68]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP05-657-000]

Midwestern Gas Transmission Company; Notice of Proposed Changes
in FERC Gas Tariff

September 21, 2005.
    Take notice that on September 2, 2005, Midwestern Gas Transmission
Company (Midwestern) tendered for filing to become part of Midwestern's
FERC Gas Tariff, Third Revised Volume No. 1, Second Revised Sheet No.
241, to become effective October 2, 2005.
    Midwestern states that the filing is being made to amend subsection
8.9.2 of the General Terms and Conditions of Midwestern's Tariff to
change Midwestern's Operational Flow Order charge from a fixed price to
a formula based on a daily index price to more appropriately reflect
today's volatile and

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

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

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

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-5276 Filed 9-27-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Rules and Regulations]
[Pages 71033-71044]
[FR Doc No: 2010-29405]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 81

[EPA-HQ-OAR-2009-0443; FRL-9230-4]
RIN-2060-AP78

Air Quality Designations for the 2008 Lead (Pb) National Ambient
Air Quality Standards

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule establishes air quality designations for certain
areas in the United States for the 2008 lead (Pb) National Ambient Air
Quality Standards (NAAQS). Based on air quality monitoring data, EPA is
issuing this rule to identify areas that do not meet the 2008 Pb NAAQS
and areas that contribute to Pb air pollution in a nearby area that
does not meet the Pb NAAQS. EPA is deferring designation for all other
areas of the United States, including Indian country, pending
collection and review of additional data from recently deployed Pb
monitors. The Clean Air Act (CAA) requires areas designated
nonattainment by this rule to undertake certain planning and pollution
control activities to attain the standards as quickly as reasonably
possible.

DATES: Effective Date: The effective date of this rule is December 31,
2010.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-HQ-OAR-2009-0443. All documents in the docket are
listed in the index at http://www.regulations.gov. Although listed in
the index, some information is not publicly available, i.e.,
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in the docket or in hard
copy at the Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The Public Reading Room is open from 8:30
a.m. to 4:30 p.m. Monday through Friday, excluding legal holidays. The
telephone number for the Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the Office of Air and Radiation Docket and
Information Center is<PHONE_NUMBER>.
    In addition, EPA has established a Web site for this rulemaking at:
http://www.epa.gov/leaddesignations/2008standards/index.html. The Web
site includes EPA's final state and tribal designations, as well as
state initial recommendation letters, EPA modification letters,
technical support documents, responses to comments and other related
technical information.

FOR FURTHER INFORMATION CONTACT: Rhonda Wright, Office of Air Quality
Planning and Standards, U.S. Environmental Protection Agency, Mail Code
C539-04, Research Triangle Park, NC 27711, phone number<PHONE_NUMBER>
or by e-mail at<EMAIL_ADDRESS>or Tom Rosendahl, Office of Air
Quality Planning and Standards, U.S. Environmental Protection Agency,
Mail Code C539-04, Research Triangle Park, NC 27711, phone number (919)
541-5314 or by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Regional Office Contacts

    Region I--Robert McConnell<PHONE_NUMBER>,
    Region II--Mazeeda Khan<PHONE_NUMBER>,
    Region III--Melissa Linden<PHONE_NUMBER>,
    Region IV--Lynorae Benjamin<PHONE_NUMBER>,
    Region V--Andy Chang<PHONE_NUMBER>,
    Region VI--Emad Shahin<PHONE_NUMBER>,
    Region VII--Stephanie Doolan<PHONE_NUMBER>,
    Region VIII--Kevin Leone<PHONE_NUMBER>,
    Region IX--Ginger Vagenas<PHONE_NUMBER>,
    Region X--Steve Body<PHONE_NUMBER>.
    The public may inspect the rule and state-specific technical
support information at the following locations:

------------------------------------------------------------------------
            Regional offices                          States
------------------------------------------------------------------------
Dave Conroy, Chief, Air Programs         Connecticut, Maine,
 Branch, EPA New England, 1 Congress      Massachusetts, New Hampshire,
 Street, Suite 1100, Boston, MA 02114-    Rhode Island, and Vermont.
 2023,<PHONE_NUMBER>.
Raymond Werner, Chief, Air Programs      New Jersey, New York, Puerto
 Branch, EPA Region II, 290 Broadway,     Rico, and Virgin Islands.
 25th Floor, New York, NY 10007-1866,
<PHONE_NUMBER>.
Cristina Fernandez, Branch Chief, Air    Delaware, District of Columbia,
 Quality Planning Branch, EPA Region      Maryland, Pennsylvania,
 III, 1650 Arch Street, Philadelphia,     Virginia, and West Virginia.
 PA 19103-2187,<PHONE_NUMBER>.
Richard A. Schutt, Chief, Air Planning   Alabama, Florida, Georgia,
 Branch, EPA Region IV, Sam Nunn          Kentucky, Mississippi, North
 Atlanta Federal Center, 61 Forsyth       Carolina, South Carolina, and
 Street, SW., 12th Floor, Atlanta, GA     Tennessee.
 30303,<PHONE_NUMBER>.
Jay Bortzer, Chief, Air Programs         Illinois, Indiana, Michigan,
 Branch, EPA Region V, 77 West Jackson    Minnesota, Ohio, and
 Street, Chicago, IL 60604, (312) 886-    Wisconsin.
 1430.
Guy Donaldson, Chief, Air Planning       Arkansas, Louisiana, New
 Section, EPA Region VI, 1445 Ross        Mexico, Oklahoma, and Texas.
 Avenue, Dallas, TX 75202, (214) 665-
 7242.
Joshua A. Tapp, Chief, Air Programs      Iowa, Kansas, Missouri, and
 Branch, EPA Region VII, 901 North 5th    Nebraska.
 Street, Kansas City, KS 66101-2907,
<PHONE_NUMBER>.
Monica Morales, Leader, Air Quality      Colorado, Montana, North
 Planning Unit, EPA Region VIII, U.S.     Dakota, South Dakota, Utah,
 EPA Region VIII, 1595 Wynkoop Street,    and Wyoming.
 Denver, CO 80202-1129,<PHONE_NUMBER>.
Lisa Hanf, Air Planning Office, EPA      American Samoa, Arizona,
 Region IX, 75 Hawthorne Street, San      California, Guam, Hawaii,
 Francisco, CA 94105,<PHONE_NUMBER>.     Nevada, and Northern Mariana
                                          Islands.
Mahbubul Islam, Manager, State and       Alaska, Idaho, Oregon, and
 Tribal Air Programs, EPA Region X,       Washington.
 Office of Air, Waste, and Toxics, Mail
 Code OAQ-107, 1200 Sixth Avenue,
 Seattle, WA 98101,<PHONE_NUMBER>.
------------------------------------------------------------------------

Table of Contents

    The following is an outline of the Preamble.

I. Preamble Glossary of Terms and Acronyms
II. What is the purpose of this document?
III. What is lead?
IV. What are the health and welfare concerns addressed by the Pb
standards?
V. What are the CAA requirements for air quality designations and
what action has EPA taken to meet these requirements?
VI. What guidance did EPA issue and how did EPA apply the statutory
requirements and applicable guidance to determine area designations
and boundaries?
VII. What air quality data has EPA used?
VIII. How do designations affect Indian country?
IX. Where can I find information forming the basis for this rule and
exchanges between EPA, states, and tribes related to this rule?
X. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act (NTTAA)
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    K. Congressional Review Act

    L. Judicial Review

I. Preamble Glossary of Terms and Acronyms

    The following are abbreviations of terms used in the preamble.

APA Administrative Procedure Act
AQS Air Quality System
CAA Clean Air Act
CBI Confidential Business Information
CFR Code of Federal Regulations
D.C. District of Columbia
EO Executive Order
EPA Environmental Protection Agency
FR Federal Register
FRM Federal Reference Method
IQ Intelligence Quotient
NAAQS National Ambient Air Quality Standards
NTTAA National Technology Transfer and Advancement Act
OMB Office of Management and Budget
Pb Lead
PM Particulate Matter
RFA Regulatory Flexibility Act
RIA Regulatory Impact Analysis
SBA Small Business Administration
SIP State Implementation Plan
UMRA Unfunded Mandate Reform Act of 1995
TAR Tribal Authority Rule
TSD Technical Support Document
TSP Total Suspended Particulate
TPY Tons Per Year
U.S. United States
VCS Voluntary Consensus Standards

II. What is the purpose of this document?

    The purpose of this action is to announce and promulgate
designations and boundaries for areas of the country not meeting the
2008 Pb NAAQS based on available information, in accordance with the
requirements of the CAA. The list of areas being designated
nonattainment in each state, and the boundaries of each area, appear in
the table at the end of this final rule. EPA has been working closely
with the states involved in these designations and several steps have
been taken to announce that this rule is available. EPA has posted the
notice on several EPA Web sites and provided a copy of the rule to
those states with nonattainment areas.
    This notice identifies the 16 areas being designated as
nonattainment areas for the 2008 Pb NAAQS. The basis for designating
these areas as ``nonattainment'' is monitored air quality data from
calendar years 2007-2009 indicating a violation of the NAAQS. For these
areas being designated nonattainment, states must develop a State
Implementation Plan (SIP) that meets the requirements of section 172(c)
and 191 of the CAA and provides for attainment of the NAAQS as
expeditiously as practicable, but no later than December 31, 2015.
These SIPs must be submitted to EPA within eighteen months of the
effective date of these designations, i.e., by June 30, 2012.\1\
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    \1\ In addition, as discussed in the proposed and final Pb NAAQS
rules, all states are required to submit SIPs pursuant to section
110(a)(1) (``infrastructure SIPs'') within 3 years of promulgation
of the new standard.
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III. What is lead?

    Lead (Pb) is a metal found naturally in the environment and present
in some manufactured products. The major sources of Pb air emissions
were historically motor vehicles (such as cars and trucks) and
industrial sources. Motor vehicle emissions of Pb have been
dramatically reduced with the phase-out of leaded gasoline, but Pb is
still used as an additive in general aviation gasoline used in piston-
engine aircraft and remains a trace contaminant in other fuels. Larger
industrial sources of Pb emissions currently include metals processing,
particularly primary and secondary Pb smelters. Lead is also emitted
from sources such as: Iron and steel foundries; primary and secondary
copper smelters; industrial, commercial, and institutional boilers;
waste incinerators; glass manufacturing; and cement manufacturing.

IV. What are the health and welfare concerns addressed by the Pb
standards?

    Lead is generally emitted in the form of particles, which can end
up being deposited in water, soil and dust. People may be exposed to Pb
by inhaling it, or by ingesting lead-contaminated food, water, soil, or
dust. Once in the body, Pb is quickly absorbed into the bloodstream and
can result in a broad range of adverse health effects. These include
damage to the central nervous system, cardiovascular function, kidneys,
immune system, and red blood cells. Children are particularly
vulnerable to Pb exposure, in part because they are more likely to
ingest Pb and in part because their still-developing bodies are more
sensitive to the effects of Pb. Urban children are also of particular
risk if the mother is exposed to lead. The harmful effects to
children's developing nervous systems (including their brains) arising
from Pb exposure may include IQ loss, poor academic achievement, long-
term learning disabilities, and an increased risk of delinquent
behavior.
    Lead is persistent in the environment and accumulates in soils and
sediments through deposition from air sources, direct discharge of
waste streams to water bodies, mining, and erosion. Ecosystems near
some longstanding point sources of Pb demonstrate a wide range of
adverse effects including losses in biodiversity, changes in community
composition, decreased growth and reproductive rates in plants and
animals, and neurological effects in vertebrates.

 V. What are the CAA requirements for air quality designations and what
action has EPA taken to meet these requirements?

    After the promulgation of a new or revised NAAQS, EPA is required
to designate areas as nonattainment, attainment, or unclassifiable,
pursuant to section 107(d)(1) of the CAA. The Administrator signed a
final rule revising the Pb NAAQS on October 15, 2008, which was
published in the Federal Register on November 12, 2008, and became
effective January 12, 2009. Based on the Administrator's review of the
scientific evidence, including numerous studies published since the
last review of the Pb NAAQS, and taking into consideration the comments
expressed by the Clean Air Scientific Advisory Committee and the
public, the Administrator revised the standard from a level of 1.5
[micro]g/m\3\ to a level of 0.15 [micro]g/m\3\. In addition, the
Administrator changed the averaging time and form to a rolling 3-month
average evaluated over a 3-year period. The rule also established new
requirements for Pb monitoring networks, including the requirement that
new Pb monitors be located in close proximity to the largest Pb
emissions sources by January 1, 2010.
    The process for designating areas following promulgation of a new
or revised NAAQS is contained in section 107(d) of the CAA. The CAA
requires EPA to complete the initial area designation process within 2
years of promulgating a new or revised NAAQS. However, if the
Administrator has insufficient information to make these designations
within that time frame, EPA has the authority to extend the designation
process by up to one additional year. In light of the new monitoring
network which is generating additional information that could be used
to support additional designations in the upcoming year, EPA intends to
complete the initial area designations for Pb in two rounds. In this
rule, EPA is completing the first round by designating as
``nonattainment'' any area that is violating the 2008 Pb NAAQS based on
2007-2009 air quality data from the pre-2010 monitoring network. For
all other areas, EPA is extending the deadline for designations by up
to 1 year so that data from the newly deployed monitors can be
considered in

making appropriate designation decisions. EPA intends to complete the
second round of area designations for the Pb NAAQS no later than
October 15, 2011.
    By not later than 1 year after the promulgation of a new or revised
NAAQS, each state Governor is required to recommend air quality
designations, including the appropriate boundaries for areas, to EPA.
EPA reviews those state recommendations and is authorized to make any
modifications the Administrator deems necessary. The statute does not
define the term ``necessary,'' but EPA interprets this to authorize the
Administrator to modify designations that did not meet the statutory
requirements or were otherwise inconsistent with the facts or analysis
deemed appropriate by EPA. If EPA is considering modifications to a
state's initial recommendation, EPA is required to notify the state of
any such intended modifications to its recommendation not less than 120
days prior to EPA's promulgation of the final designation. If the state
does not agree with EPA's modification, it then has an opportunity to
respond to EPA and to demonstrate why it believes the modification
proposed by EPA is inappropriate, as contemplated by section
107(d)(1)(B)(ii). Even if a state fails to provide any recommendation
for an area, in whole or in part, EPA still must promulgate a
designation that the Administrator deems appropriate, pursuant to
section 107(d)(1)(B)(ii).
    Section 107(d)(1)(A)(i) of the CAA defines a nonattainment area as
any area that does not meet an ambient air quality standard or that is
contributing to ambient air quality in a nearby area that does not meet
the standard. If an area meets either prong of this definition, then
EPA is obligated to designate the area as ``nonattainment.'' Section
107(d)(1)(A)(iii) provides that any area that EPA cannot designate on
the basis of available information as meeting or not meeting the
standards should be designated as ``unclassifiable.''
    EPA believes that section 107(d) provides the Agency with
discretion to determine how best to interpret the terms in the
definition of a nonattainment area (e.g., ``contributes to'' and
``nearby'') for a new or revised NAAQS, given considerations such as
the nature of a specific pollutant, the types of sources that may
contribute to violations, the form of the standards for the pollutant,
and other relevant information. In particular, EPA believes that the
statute does not require the Agency to establish bright line tests or
thresholds for what constitutes contribution or nearby for purposes of
designations.\2\
---------------------------------------------------------------------------

    \2\ This view was confirmed in Catawba County v. EPA, 571 F.3d
20 (D.C. Cir. 2009).
---------------------------------------------------------------------------

    Similarly, EPA believes that the statute permits EPA to evaluate
the appropriate application of the term ``area'' to include geographic
areas based upon full or partial county boundaries, and contiguous or
non-contiguous areas, as may be appropriate for a particular NAAQS. For
example, section 107(d)(1)(B)(ii) explicitly provides that EPA can make
modifications to designation recommendations for an area ``or portions
thereof,'' and under section 107(d)(1)(B)(iv), a designation remains in
effect for an area ``or portion thereof'' until EPA redesignates it.
    Designation activities for federally-recognized tribes are covered
under the authority of section 301(d) of the CAA. This provision of the
CAA authorizes EPA to treat eligible tribes in a similar manner as
states. Pursuant to section 301(d)(2), we promulgated regulations,
known as the Tribal Authority Rule (TAR), on February 12, 1999. 63 FR
7254, codified at 40 CFR 49 (1999). That rule specifies those
provisions of the CAA for which it is appropriate to treat tribes in a
similar manner as states. Under the TAR, tribes may choose to develop
and implement their own CAA programs, but are not required to do so.
The TAR also establishes procedures and criteria by which tribes may
request from EPA a determination of eligibility for such treatment. The
designations process contained in section 107(d) of the CAA is included
among those provisions determined to be appropriate by EPA for
treatment of tribes in the same manner as states. Under the TAR, tribes
generally are not subject to the same submission schedules imposed by
the CAA on states. As authorized by the TAR, tribes may seek
eligibility to submit designation recommendations to EPA. In addition,
CAA section 301(d)(4) gives EPA discretionary authority, in cases where
it determines that treatment of tribes as identical to states is
``inappropriate or administratively infeasible,'' to provide for direct
administration by regulation to achieve the appropriate purpose.
    To date, one tribe has applied under the TAR for eligibility to
submit its own recommendations under section 107(d). Nonetheless, EPA
invited all tribes to submit recommendations concerning designations
for the 2008 Pb NAAQS. EPA worked with the tribes that requested an
opportunity to submit designation recommendations. Tribes were provided
an opportunity to submit their own recommendations and supporting
documentation and could also comment on state recommendations and EPA
modifications.
    Designation recommendations and supporting documentation were
submitted by most states and a few tribes to EPA by October 15, 2009.
After receiving recommendations from states and tribes, and after
reviewing and evaluating each recommendation, EPA provided a response
to the states and tribes on June 15, 2010. In these letter responses,
we indicated whether EPA intended to make modifications to the initial
state or tribal recommendations and explained EPA's reasons for making
any such modifications. EPA requested that states and tribes respond to
any proposed EPA modifications by August 16, 2010. We received comments
from some states suggesting changes to EPA's proposed modifications and
providing additional information. EPA evaluated these comments, and all
of the timely supporting technical information provided. As a result,
some of the final designations reflect further modifications to the
initial state and tribal recommendations. The state and tribal letters,
including the initial recommendations, and EPA's June 2010 responses to
those letters, including any modifications, and the subsequent state
and tribal comment letters are in the docket for this action.
    Although not required by section 107(d) of the CAA, EPA also
provided an opportunity for members of the public to comment on EPA's
June 2010 response letters. In order to gather additional information
for EPA to consider before making final designations, EPA published a
notice on July 8, 2010 (75 FR 39254) which invited the public to
comment on EPA's intended designations. In that notice, EPA provided
the opportunity to all interested parties other than states and tribes
to submit comments by August 16, 2010. State and tribal initial
recommendations and EPA's responses, including modifications, were
posted on a publically accessible Web Site (http://www.epa.gov/leaddesignations/2008standards/index.html). Timely comments from the
public and EPA's responses to significant comments are in the docket
for this action.

VI. What guidance did EPA issue and how did EPA apply the statutory
requirements and applicable guidance to determine area designations and
boundaries?

    In the notice of proposed rulemaking for the revised Pb NAAQS (73
FR 29184), EPA issued proposed guidance on its approach to implementing
the

standard, including its approach to initial area designations. EPA
solicited comment on that guidance and, in the notice of final
rulemaking (73 FR 66964), adopted guidance concerning how to determine
the boundaries for nonattainment areas for the Pb NAAQS.\3\ In that
guidance EPA recommended that monitoring data from the three most
recent calendar years be used to identify a violation of the Pb NAAQS.
This is appropriate because the form of the Pb NAAQS is calculated over
36 consecutive valid 3-month site means (specifically for a 3 calendar
year period and the 2 previous months).\4\ EPA is basing these final
designations on monitored Pb concentrations from Federal Reference
Method (FRM) monitors from calendar years 2007-2009. EPA notes that
data from 2006-2008 were the most recent data available to states when
states made their recommendations to EPA. Accordingly, although the
determination of whether an area violates the standard was based on
2007-2009 data, EPA considered state recommendations and data from
2006-2008 as appropriate in determining boundaries for nonattainment
areas.
---------------------------------------------------------------------------

    \3\ See also, ``Area Designations for the Revised Lead National
Ambient Air Quality Standards,'' memorandum to Regional
Administrators, Regions I-X, from William Harnett, dated August 21,
2009.
    \4\ For convenience, this notice refers to the period of 3
calendar years and the 2 previous months simply as 3 calendar years.
Thus, monitoring for ``calendar years 2007-2009'' includes data from
November 2006 through December 2009.
---------------------------------------------------------------------------

    In the guidance, EPA stated that the perimeter of a county
containing a violating monitor would be the initial presumptive
boundary for nonattainment areas, but also stated that the state, tribe
and/or EPA could conduct additional area specific analyses that could
justify establishing either a larger or smaller area. EPA indicated
that the following factors should be considered in an analysis of
whether to exclude portions of a county and whether to include
additional nearby areas outside the county as part of the designated
nonattainment area: (1) Emissions in areas potentially included versus
excluded from the nonattainment area; (2) Air quality in potentially
included versus excluded areas; (3) Population density and degree of
urbanization including commercial development in included versus
excluded areas; (4) Expected growth (including extent, pattern and rate
of growth); (5) Meteorology (weather/transport patterns); (6)
Geography/topography (mountain ranges or other air basin boundaries);
(7) Jurisdictional boundaries (e.g., counties, air districts,
reservations, etc.); and (8) Level of control of emission sources. EPA
further indicated that we would consider information provided by the
state resulting from one or more of the following techniques: (1)
Qualitative analysis; (2) spatial interpolation of air quality
monitoring data; or (3) air quality simulation by dispersion modeling.
    EPA received comments on the proposed guidance suggesting that
violations of the Pb NAAQS were likely to occur in close proximity to
stationary sources of Pb. In response, EPA indicated that it agreed
that Pb emissions do not generally transport over long distances (e.g.,
as compared to fine particulate matter), and that in situations where a
single source, rather than multiple sources, is causing a NAAQS
violation, EPA believes that a state may well be able to use area-
specific analyses to determine whether a nonattainment area that is
smaller than the county boundary is appropriate.
    EPA found that states did use the factors and the variety of
techniques identified by EPA in making recommendations for
nonattainment areas smaller than the county. In recommending
boundaries, EPA and states began with monitors that recorded a
violation of the 2008 Pb NAAQS. As provided in Appendix R to 40 CFR
part 50, all valid Pb-TSP data and all valid Pb-PM10 data
measured by a FRM or equivalent method submitted to EPA's Air Quality
System (AQS), or otherwise available to EPA, and meeting the
requirements of 40 CFR part 58, including Appendices A, C, and E are
used in design value calculations.\5\ In some cases, states requested
unclassifiable designations for areas around monitors with a design
value exceeding the standard. EPA does not believe such a designation
would be consistent with the requirements of the CAA when we have valid
data supporting a designation of nonattainment.
---------------------------------------------------------------------------

    \5\ A design value is the air quality value that is compared to
the NAAQS to determine compliance. For the Pb NAAQS, the design
value is the highest 3-month site mean of daily Pb concentrations
over 36 consecutive 3-month means for 3 calendar years.
---------------------------------------------------------------------------

    For areas with a violating monitor, the designated nonattainment
area must encompass the entire area that does not meet, and any nearby
area that contributes to ambient air quality in the area that does not
meet, the 2008 Pb NAAQS. Given the sources and characteristics of Pb
emissions, states and EPA generally found factors such as emissions,
air quality and meteorology to be particularly relevant in determining
appropriate boundaries, while factors such as population density and
expected growth were not as relevant for the 2008 Pb NAAQS, and thus
did not play a significant role in determining boundaries. In some
cases, states made a judgment that it was important to follow
jurisdictional boundaries, particularly where jurisdictional boundaries
smaller than a county exist. In other cases, states chose to rely
primarily on air dispersion modeling to determine the recommended
boundaries for nonattainment areas. In each case, EPA reviewed the
state recommendations and, for the most part, EPA has accepted the
state's recommendations; however, where EPA felt that changes were
necessary to a state's initial recommendation, we conveyed those issues
to the state and have worked with the state to revise the boundaries.

VII. What air quality data has EPA used?

    The final Pb designations contained in this action are based upon
air quality monitoring data from calendar years 2007-2009. Some
stakeholders have requested that EPA delay designations, or designate
areas unclassifiable, by not considering all relevant data (e.g.,
excluding 2007 or 2008 data) in making designation decisions. As
discussed previously, the form of the standard requires comparison of
monitoring values from 36 three-month rolling averages (i.e., 3 years,
plus 2 preceding months). Thus, a violation will have generally
occurred if any of the 36 three-month average concentrations of either
Pb-TSP or Pb-PM10 exceeds the level of the NAAQS, and a
finding of compliance will require that all 36 three-month averages of
Pb-TSP be at or below the level of the NAAQS.\6\ Moreover, pursuant to
the CAA, EPA is making designations as expeditiously as practicable.
Accordingly, where sufficient data from 2007-2009 are available to
support a nonattainment designation, EPA does not have discretion to
postpone designations or to exclude certain years from consideration in
considering whether monitored data results in a violation of the Pb
NAAQS pursuant to 40 CFR 50.16. Section 107(d) requires EPA to
designate areas as nonattainment if sufficient data exist to support
such a designation. EPA can only delay designations for up to one extra
year if we do not have sufficient data to make

a designation within the prescribed 2-year period.
---------------------------------------------------------------------------

    \6\ For additional details on how to determine when the 2008 Pb
NAAQS have been met, see 40 CFR part 50, Appendix R.
---------------------------------------------------------------------------

VIII. How do designations affect Indian country?

    All counties, partial counties or Air Quality Control Regions
listed in the table at the end of this document are designated as
indicated. For the first round of Pb designations, EPA is only
designating nonattainment areas. There are no areas in Indian country
being designated nonattainment at this time.

IX. Where can I find information forming the basis for this rule and
exchanges between EPA, states, and tribes related to this rule?

    Information providing the basis for this action and related
decisions are provided in the technical support documents (TSDs),
response to comments document, and other information in the docket. The
TSDs, applicable EPA guidance memoranda, copies of correspondence
regarding this process between EPA and the states, tribes, and other
parties, and EPA's responses to comments, are available for review at
the EPA Docket Center listed above in the addresses section of this
document and on our designation Web site at http://www.epa.gov/leaddesignations/2008standards/index.html. State specific information
is available from the EPA Regional Offices.

X. Statutory and Executive Order Reviews

    Upon promulgation of a new or revised NAAQS, the CAA requires EPA
to designate areas as attaining or not attaining the NAAQS. The CAA
then specifies requirements for areas based on whether such areas are
attaining or not attaining the NAAQS. In this final rule, EPA assigns
designations to areas as required.

A. Executive Order 12866: Regulatory Planning and Review

    This action is not a ``significant regulatory action'' under the
terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and
is therefore not subject to review under the EO.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b). This rule responds to the
requirement to promulgate air quality designations after promulgation
of a NAAQS. This requirement is prescribed in the CAA section 107 of
title 1. The present final rule does not establish any new information
collection.

C. Regulatory Flexibility Act

    This final rule is not subject to the Regulatory Flexibility Act
(RFA), which generally requires an agency to prepare a regulatory
flexibility analysis for any rule that will have a significant economic
impact on a substantial number of small entities. The RFA applies only
to rules subject to notice-and-comment rulemaking requirements under
the Administrative Procedure Act (APA) or any other statute. This rule
is not subject to notice-and-comment requirements under the APA or any
other statute because the rule is not subject to the APA and is subject
to CAA section 107(d)(2)(B), which does not require that the Agency
issue a notice of proposed rulemaking before issuing this rule.

D. Unfunded Mandates Reform Act

    This action contains no federal mandate under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for state, local, or tribal governments or the private
sector. The action imposes no enforceable duty on any state, local or
tribal governments or the private sector. Therefore, this action is not
subject to the requirements of sections 202 and 205 of the UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. It does not create
any additional requirements beyond those of the CAA and Pb NAAQS (40
CFR 50.16); therefore, no UMRA analysis is needed. This rule
establishes nonattainment designations for certain areas of the country
for the Pb NAAQS. The CAA requires states to develop plans, including
control measures, based on the designations for areas within the state.
    One mandate that may apply as a consequence of this action to all
designated nonattainment areas is the requirement under CAA section
176(c) and associated regulations to demonstrate general conformity of
federal actions to SIPs. These rules apply to federal agencies making
conformity determinations. The EPA concludes that such conformity
determinations will not cost $100 million or more in the aggregate.
    The EPA believes that any new controls imposed as a result of this
action will not cost in the aggregate $100 million or more annually.
Thus, this federal action will not impose mandates that will require
expenditures of $100 million or more in the aggregate in any one year.
    Nonetheless, EPA carried out consultation with government entities
affected by this rule, including states, tribal governments, and local
air pollution control agencies.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
meaningful and timely input by state and local officials in the
development of regulatory policies that have federalism implications.
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the states, or the relationship between the national
government and the states, or on the distribution of power and
responsibilities among the various levels of government.''
    This final rule does not have federalism implications. It will not
have substantial direct effects 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,
as specified in Executive Order 13132. The CAA establishes the process
whereby states take primary responsibility in developing plans to meet
the Pb NAAQS. This rule will not modify the relationship of the states
and EPA for purposes of developing programs to implement the Pb NAAQS.
Thus, Executive Order 13132 does not apply to this rule.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 2, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have Tribal implications.'' This action does not have
tribal implications, as specified in Executive Order 13175 (65 FR
67249, November 9, 2000). This rule concerns the designation of areas
as attainment and nonattainment for the Pb NAAQS. The CAA provides for
states and eligible tribes to develop plans to regulate emissions of
air pollutants within their areas based on their designations. The TAR
provides tribes the opportunity to apply for eligibility to develop and
implement CAA programs such as

programs to attain and maintain the Pb NAAQS, but it leaves to the
discretion of the tribe the decision of whether to apply to develop
these programs and which programs, or appropriate elements of a
program, the tribe will seek to adopt. This rule does not have a
substantial direct effect on one or more Indian tribes. It does not
create any additional requirements beyond those of the Pb NAAQS (40 CFR
section 50.16). This rule establishes the designation for certain areas
of the country for the Pb NAAQS but no areas in Indian country are
being designated under this rule. Additionally, no tribe has
implemented a CAA program to attain the Pb NAAQS at this time.
Furthermore, this rule does not affect the relationship or distribution
of power and responsibilities between the federal government and Indian
tribes. The CAA and the TAR establish the relationship of the federal
government and tribes in developing plans to attain the NAAQS, and this
rule does nothing to modify that relationship. Because this rule does
not have tribal implications, Executive Order 13175 does not apply.
    Although Executive Order 13175 does not apply to this rule, EPA
communicated with tribal leaders and environmental staff regarding the
designations process. EPA also sent individualized letters to all
federally recognized tribes to explain the designation process for the
2008 Pb NAAQS, to provide the EPA designations guidance, and to offer
consultation with EPA. EPA provided further information to tribes
through presentations at the National Tribal Forum and through
participation in National Tribal Air Association conference calls. EPA
also sent individualized letters to all federally recognized tribes
that submitted recommendations to EPA about EPA's intended designations
for the Pb standards and offered tribal leaders the opportunity for
consultation. These communications provided opportunities for tribes to
voice concerns to EPA about the general designations process for the Pb
NAAQS, as well as concerns specific to a tribe, and informed EPA about
key tribal concerns regarding designations as the rule was under
development.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    The action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it is not economically significant as defined
in Executive Order 12866. However, the protection offered by the Pb
NAAQS may be especially important for children because neurological
effects in children are among if not the most sensitive health
endpoints for Pb exposure. Because children are considered a sensitive
population, in setting the Pb NAAQS we carefully evaluated the
environmental health effects of exposure to Pb pollution among
children. These effects and the size of the population affected are
summarized in the EPA's 2006 Air Quality Criteria Document for Pb and
in the proposed and final Pb NAAQS rules. (http://www.epa.gov/airquality/lead/fr/20081112.pdf)

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355
(May 22, 2001)), because it is not a significant regulatory action
under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    Section 12(d) of the NTTAA of 1995, Public Law 104-113, section
12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus
standards (VCS) in its regulatory activities unless to do so would be
inconsistent with applicable law or otherwise impracticable. Voluntary
consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, and business
practices) that are developed or adopted by VCS bodies. The NTTAA
directs EPA to provide Congress, through OMB, explanations when the
Agency decides not to use available and applicable VCS.
    This action does not involve technical standards. Therefore, EPA
did not consider the use of any VCS.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations.

    Executive Order 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the U.S.
    The EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on any population, including minority or low-income
populations.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
U.S. The EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the U.S. prior to
publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2). This rule will be effective December 31, 2010.

L. Judicial Review

    Section 307(b)(1) of the CAA indicates which Federal Courts of
Appeal have venue for petitions of review of final actions by EPA. This
section provides, in part, that petitions for review must be filed in
the Court of Appeals for the District of Columbia Circuit: (i) When the
agency action consists of ``nationally applicable regulations
promulgated, or final actions taken, by the Administrator,'' or (ii)
when such action is locally or regionally applicable, if ``such action
is based on a determination of nationwide scope or effect and if in
taking such action the Administrator finds and publishes that such
action is based on such a determination.''
    This rule designating areas for the 2008 Pb NAAQS is ``nationally
applicable'' within the meaning of section 307(b)(1). This rule
establishes designations for areas across the U.S. for the 2008 Pb
NAAQS. At the core of this rulemaking is EPA's interpretation of the
definition of nonattainment under section 107(d)(1) of the CAA, and its
application of that interpretation to areas across the country.
    For the same reasons, the Administrator also is determining that
the final designations are of nationwide scope and effect for the
purposes of section 307(b)(1). This is particularly appropriate
because, in the report on the 1977 Amendments that revised section
307(b)(1) of the CAA, Congress noted that the Administrator's
determination that an action is of ``nationwide scope or effect'' would
be appropriate for any action that has a scope or effect beyond a
single judicial circuit. H.R. Rep. No. 95-294 at 323, 324, reprinted in
1977

U.S.C.C.A.N. 1402-03. Here, the scope and effect of this rulemaking
extends to numerous judicial circuits since the designations apply to
areas across the country. In these circumstances, section 307(b)(1) and
its legislative history calls for the Administrator to find the rule to
be of ``nationwide scope or effect'' and for venue to be in the DC
Circuit.
    Thus, any petitions for review of final designations must be filed
in the Court of Appeals for the District of Columbia Circuit within 60
days from the date final action is published in the Federal Register.

List of Subjects in 40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: November 16, 2010.
Lisa P. Jackson,
Administrator.

0
For the reasons set forth in the preamble, 40 CFR Part 81, is amended
as follows:

PART 81--DESIGNATIONS OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
1. The authority citation for part 81 continues to read as follows:

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

Subpart C--Section 107 Attainment Status Designations

0
2. Section 81.301 is amended by revising the table for ``Alabama--
Lead'' to read as follows:

Sec.  81.301  Alabama.

* * * * *

                                                  Alabama--Lead
----------------------------------------------------------------------------------------------------------------
                                      Designation for the 1978 NAAQS \a\       Designation for the 2008 NAAQS
          Designated area          -----------------------------------------------------------------------------
                                       Date \1\              Type             Date \2\              Type
----------------------------------------------------------------------------------------------------------------
Troy, AL:
    Pike County (part)............  ..............  Attainment...........  ..............  Nonattainment.
    Area is bounded by a 0.8 mile
     radius from a center point at
     latitude 31.78627106 North
     and longitude 85.97862228
     West, which fully includes
     the Sanders Lead Facility.
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after March 7, 1995, unless otherwise noted.
\2\ This date is December 31, 2010, unless otherwise noted.

* * * * *

0
3. Section 81.305 is amended by adding the table for ``California--
Lead'' at the end of the section to read as follows:

Sec.  81.305  California.

* * * * *

                                                California--Lead
----------------------------------------------------------------------------------------------------------------
                                      Designation for the 1978 NAAQS \a\       Designation for the 2008 NAAQS
         Designation area          -----------------------------------------------------------------------------
                                       Date \1\              Type             Date \2\              Type
----------------------------------------------------------------------------------------------------------------
Los Angeles County--South Coast
 Air Basin, CA:
    Los Angeles County (part).....  ..............  Unclassifiable/        ..............  Nonattainment.
                                                     Attainment.
        That portion of Los
         Angeles County which lies
         south and west of line
         described as follows:
        Beginning at the Los
         Angeles-San Bernardino
         County boundary and
         running west along the
         Township line common to
         Township 3 North and
         Township 2 North, San
         Bernardino Base and
         Meridian;
        then North along the range
         line common to Range 8
         West and Range 9 West;
        then west along the
         Township line common to
         Township 4 North and
         Township 3 North;.
        then north along the range
         line common to Range 12
         West and Range 13 West to
         the southeast corner of
         Section 12, Township 5
         North and Range 13 West;
        then west along the south
         boundaries of Sections
         12, 11, 10, 9, 8, and 7,
         Township 5 North and
         Range 13 West to the
         boundary of the Angeles
         National Forest which is
         collinear with the range
         line common to Range 13
         West and Range 14 West;

        then north and west along
         the Angeles National
         Forest boundary to the
         point of intersection
         with the Township line
         common to Township 7
         North and Township 6
         North (point is at the
         northwest corner of
         Section 4 in Township 6
         North and Range 14 West);
        then west along the
         Township line common to
         Township 7 North and
         Township 6 North;
        then north along the range
         line common to Range 15
         West and Range 16 West to
         the southeast corner of
         Section 13, Township 7
         North and Range 16 West;
        then along the south
         boundaries of Sections
         13, 14, 15, 16, 17 and
         18, Township 7 North and
         Range 16 West;
        then north along the range
         line common to Range 16
         West and Range 17 West to
         the north boundary of the
         Angeles National Forest
         (collinear with the
         Township line common to
         Township 8 North and
         Township 7 North);
        then west and north along
         the Angeles National
         Forest boundary to the
         point of intersection
         with the south boundary
         of the Rancho La Liebre
         Land Grant;
        then west and north along
         this land grant boundary
         to the Los Angeles-Kern
         County boundary.
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after November 6, 1991, unless otherwise noted.
\2\ This date is December 31, 2010, unless otherwise noted.

0
4. Section 81.310 is amended by revising the table for ``Florida--
Lead'' to read as follows:

Sec.  81.310  Florida.

* * * * *

                                                  Florida--Lead
----------------------------------------------------------------------------------------------------------------
                                       Designation for the 1978 NAAQS a        Designation for the 2008 NAAQS
          Designated area          -----------------------------------------------------------------------------
                                       Date \1\              Type             Date \2\              Type
----------------------------------------------------------------------------------------------------------------
Tampa, FL:
    Hillsborough County (part)....  ..............  Unclassifiable/Not     ..............  Nonattainment.
                                                     Designated.
        Area is bounded by a 1.5
         km radius centered at UTM
         coordinates 364104
         meters, 3093830 meters N,
         Zone 17, which surrounds
         the EnviroFocus
         Technologies Facility .
----------------------------------------------------------------------------------------------------------------
a Includes Indian country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after November 6, 1991, unless otherwise noted.
\2\ This date is December 31, 2010, unless otherwise noted.

* * * * *

0
5. Section 81.314 is amended by adding the table for ``Illinois--Lead''
to the end of the section to read as follows:

Sec.  81.314  Illinois.

* * * * *

                                                 Illinois--Lead
----------------------------------------------------------------------------------------------------------------
                                      Designation for the 1978 NAAQS \a\       Designation for the 2008 NAAQS
          Designated area          -----------------------------------------------------------------------------
                                       Date \1\              Type             Date \2\              Type
----------------------------------------------------------------------------------------------------------------
Granite City, IL:
    Madison County (part).........  ..............  Unclassifiable/        ..............  Nonattain ment.
                                                     Attainment.
        Area is bounded by Granite
         City Township and Venice
         Township.
----------------------------------------------------------------------------------------------------------------
a Includes Indian country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after November 6, 1991, unless otherwise noted.
\2\ This date is December 31, 2010, unless otherwise noted.

0
6. Section 81.315 is amended by revising the table for ``Indiana--
Lead'' to read as follows:

Sec.  81.315  Indiana.

* * * * *

                                                  Indiana--Lead
----------------------------------------------------------------------------------------------------------------
                                       Designation for the 1978 NAAQS a        Designation for the 2008 NAAQS
          Designated area          -----------------------------------------------------------------------------
                                       Date \1\              Type             Date \2\              Type
----------------------------------------------------------------------------------------------------------------
Muncie, IN:
    Delaware County (part)........
        A portion of the City of    ..............  Not Designated.......  ..............  Nonattain ment.
         Muncie, Indiana bounded
         to the North by West 26th
         Street/Hines Road, to the
         east by Cowan Road, to
         the south by West Fuson
         Road, and to West by a
         line running south from
         the eastern edge of
         Victory Temple's driveway
         to South Hoyt Avenue and
         then along South Hoyt
         Avenue.
----------------------------------------------------------------------------------------------------------------
a Includes Indian country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after November 6, 1991, unless otherwise noted.
\2\ This date is December 31, 2010, unless otherwise noted.

* * * * *

0
7. Section 81.324 is amended by revising the table for ``Minnesota--
Lead'' to read as follows:

Sec.  81.324  Minnesota.

* * * * *

                                                 Minnesota--Lead
----------------------------------------------------------------------------------------------------------------
                                      Designation for the 1978 NAAQS \a\       Designation for the 2008 NAAQS
         Designation area          -----------------------------------------------------------------------------
                                       Date \1\              Type             Date \2\              Type
----------------------------------------------------------------------------------------------------------------
Eagan, MN:
    Dakota County (part)..........  ..............  Attainment...........  ..............  Nonattainment.
Portions of Dakotacounty that are
 bounded by: Lone Oak Rd. (County
 Rd. 26) to the north, County Rd.
 63 to the east, Wescott Rd. to
 the south, and Lexington Ave.
 (County Rd. 43) to the west
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after December 19, 1994, unless otherwise noted.
\2\ This date is December 31, 2010, unless otherwise noted.

* * * * *

0
8. Section 81.326 is amended by revising the table for ``Missouri--
Lead'' to read as follows:

Sec.  81.326  Missouri.

* * * * *

                                                 Missouri--Lead
----------------------------------------------------------------------------------------------------------------
                                      Designation for the 1978 NAAQS \a\       Designation for the 2008 NAAQS
         Designation area          -----------------------------------------------------------------------------
                                       Date \1\              Type             Date \2\              Type
----------------------------------------------------------------------------------------------------------------
Iron, MO:
    Dent County (part)............  ..............  Unclassifiable/        ..............  Nonattainment.
                                                     Attainment.

        Sections 4, 9, 16, 21, 28,  ..............  .....................  ..............  .....................
         33 of T34N, R2W..
    Iron County (part)............  ..............  Unclassifiable/        ..............  Nonattainment.
                                                     Attainment.
        Sections 6-7, 18-19, 30-32  ..............  .....................  ..............  Nonattainment.
         of T34N, R1W and Sections
         1-3, 10-15, 22-27, 34-36
         of T34N, R2W.
    Reynolds County (part)........  ..............  Unclassifiable/        ..............  Nonattainment.
                                                     Attainment.
        Sections 5-7 of T33N, R1W   ..............  .....................  ..............  .....................
         and Sections 1-3, 10-12
         of T33N, R2W.
Jefferson County, MO:
    Jefferson County (part) Within          1/6/92  Nonattainment........  ..............  Nonattainment.
     city limits of Herculaneum.
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after November 6, 1991, unless otherwise noted.
\2\ This date is December 31, 2010, unless otherwise noted.

* * * * *

0
9. Section 81.336 is amended by revising the table for ``Ohio--Lead''
to read as follows:

Sec.  81.336  Ohio.

* * * * *

                                                   Ohio--Lead
----------------------------------------------------------------------------------------------------------------
                                      Designation for the 1978 NAAQS \a\       Designation for the 2008 NAAQS
         Designation area          -----------------------------------------------------------------------------
                                       Date \1\              Type             Date \2\              Type
----------------------------------------------------------------------------------------------------------------
Bellefontaine, OH:
    Logan County (part) The         ..............  Not Designated.......  ..............  Nonattainment.
     portions of Logan County that
     are bounded by: sections 27,
     28, 33, and 34 of Lake
     Township.
Cleveland, OH:
    Cuyahoga County (part) The      ..............  Not Designated.......  ..............  Nonattainment.
     portions of Cuyahoga County
     that are bounded on the west
     by Washington Park Blvd./
     Crete Ave./East 49th St., on
     the east by East 71st St., on
     the north by Fleet Ave., and
     on the south by Grant Ave.
Delta, OH:
    Fulton County (part) The        ..............  Not Designated.......  ..............  Nonattainment.
     portions of Fulton County
     that are bounded by: sections
     12 and 13 of York Township
     and sections 7 and 18 of Swan
     Creek Township.
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after November 6, 1991, unless otherwise noted.
\2\ This date is December 31, 2010, unless otherwise noted.

* * * * *

0
10. Section 81.339 is amended by adding the table for ``Pennsylvania--
Lead'' to the end of the section to read as follows:

Sec.  81.339  Pennsylvania.

* * * * *

                                               Pennsylvania--Lead
----------------------------------------------------------------------------------------------------------------
                                      Designation for the 1978 NAAQS \a\       Designation for the 2008 NAAQS
          Designated area          -----------------------------------------------------------------------------
                                       Date \1\              Type             Date \2\              Type
----------------------------------------------------------------------------------------------------------------
Lower Beaver Valley, PA:
    Beaver County (part)..........  ..............  Unclassifiable/        ..............  Nonattainment
                                                     Attainment.
        Area is bounded by Potter   ..............  .....................  ..............  .....................
         Township and Vanport
         Township.
Lyons, PA:
    Berks County (part)...........  ..............  Unclassifiable/        ..............  Nonattainment.
                                                     Attainment.
        Area is bounded by          ..............  .....................  ..............  .....................
         Kutztown Borough, Lyons
         Borough, Maxatawny
         Township and Richmond
         Township.
North Reading, PA:
    Berks County (part)...........  ..............  Unclassifiable/        ..............  Nonattainment.
                                                     Attainment.

        Area is bounded by Alsace   ..............  .....................  ..............  .....................
         Township, Laureldale
         Borough, and Muhlenberg
         Township.
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after November 6, 1991, unless otherwise noted.
\2\ This date is December 31, 2010, unless otherwise noted.

0
11. Section 81.343 is amended by revising the table for ``Tennessee--
Lead'' to read as follows:

Sec.  81.343  Tennessee.

* * * * *

                                                 Tennessee--Lead
----------------------------------------------------------------------------------------------------------------
                                      Designation for the 1978 NAAQS \a\       Designation for the 2008 NAAQS
          Designated area          -----------------------------------------------------------------------------
                                       Date \1\              Type             Date \2\              Type
----------------------------------------------------------------------------------------------------------------
Bristol, TN:
    Sullivan County (part) Area is  ..............  Not Designated.......  ..............  Nonattainment.
     bounded by a 1.25 km radius
     surrounding the UTM
     coordinates 4042923 meters E,
     386267 meters N, Zone 17,
     which surrounds the Exide
     Technologies Facility.
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after November 6, 1991, unless otherwise noted.
\2\ This date is December 31, 2010, unless otherwise noted.

* * * * *

0
12. Section 81.344 is amended by revising the table for ``Texas--Lead''
to read as follows:

Sec.  81.344  Texas.

* * * * *

                                                   Texas--Lead
----------------------------------------------------------------------------------------------------------------
                                      Designation for the 1978 NAAQS \a\       Designation for the 2008 NAAQS
          Designated area          -----------------------------------------------------------------------------
                                       Date \1\              Type             Date \2\              Type
----------------------------------------------------------------------------------------------------------------
Frisco, TX:
    Collin County (part) The area         12/13/99  Attainment...........  ..............  Nonattainment.
     immediately surrounding the
     Exide Technologies battery
     recycling plant in Frisco,
     bounded to the north by
     latitude 33.153 North, to the
     east by longitude 96.822
     West, to the south by
     latitude 33.131 North, and to
     the west by longitude 96.837
     West.
----------------------------------------------------------------------------------------------------------------
\a\ Includes Indian country located in each county or area, except as otherwise specified.
\1\ This date is 90 days after November 6, 1991, unless otherwise noted.
\2\ This date is December 31, 2010, unless otherwise noted.

[FR Doc. 2010-29405 Filed 11-19-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33523-33524]
[FR Doc No: 2015-14359]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0793]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device Recall
Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

DATES: Fax written comments on the collection of information by July
13, 2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0432.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Medical Device Recall Authority--21 CFR 810 (OMB Control Number 0910-
0432)--Extension

    This collection of information implements section 518(e) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and
part 810 (21 CFR part 810), medical device recall authority provisions.
Section 518(e) of the FD&C Act provides FDA with the authority to issue
an order requiring an appropriate person, including manufacturers,
importers, distributors, and retailers of a device, if FDA finds that
there is reasonable probability that the device intended for human use
would cause serious adverse health consequences or death, to: (1)
Immediately cease distribution of such device; (2) immediately notify
health professionals and device-user facilities of the order; and (3)
instruct such professionals and facilities to cease use of such device.
    Further, the provisions under section 518(e) of the FD&C Act set
out the following three-step procedure for issuance of a mandatory
device recall order:
     If there is a reasonable probability that a device
intended for human use would cause serious, adverse health consequences
or death, FDA may issue a cease distribution and notification order
requiring the appropriate person to immediately:
    [cir] Cease distribution of the device,
    [cir] notify health professionals and device user facilities of the
order, and
    [cir] instruct those professionals and facilities to cease use of
the device;
     FDA will provide the person named in the cease
distribution and notification order with the opportunity for an
informal hearing on whether the order should be modified, vacated, or
amended to require a mandatory recall of the device; and
     After providing the opportunity for an informal hearing,
FDA may issue a mandatory recall order if the Agency determines that
such an order is necessary.
    The information collected under the recall authority provisions
will be used by FDA to do the following: (1) Ensure that all devices
entering the market are safe and effective; (2) accurately and
immediately detect serious problems with medical devices; and (3)
remove dangerous and defective devices from the market.
    In the Federal Register of March 11, 2015 (80 FR 13586), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
   Collection activity--21 CFR       Number of     responses per   Total annual     burden per      Total hours
             Section                respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Collections Specified in the                   2               1               2               8              16
 Order--810.10(d)...............
Request for Regulatory Hearing--               1               1               1               8               8
 810.11(a)......................
Written Request for Review--                   1               1               1               8               8
 810.12(a-b)....................
Mandatory Recall Strategy--                    2               1               2              16              32
 810.14.........................
Periodic Status Reports--                      2              12              24              40             960
 810.16(a-b)....................
Termination Request--810.17(a)..               2               1               2               8              16
    Total Hours.................  ..............  ..............  ..............  ..............           1,040
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
   Collection activity--21 CFR       Number of      records per    Total annual     burden per      Total hours
             Section               recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Documentation of Notifications                 2               1               1               8               8
 to Recipients--810.15(b).......
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                         Average
  Collection Activity--21 CFR      Number of    disclosures  per   Total annual     burden per      Total hours
            Section               respondents      respondent       disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
Notification to Recipients--                 2                 1               2              12              24
 810.15(a)-(c)................
Notification to Recipients;                  2                 1               2               4               8
 Followup--810.15(d)..........
Notification of Consignees by               10                 1              10               1              10
 Recipients--810.15(e)........
    Total.....................  ..............  ................  ..............  ..............              42
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: June 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14359 Filed 6-11-15; 8:45 am]
 BILLING CODE 4164-01-P