[Federal Register: February 24, 2009 (Volume 74, Number 35)]
[Notices]
[Page 8265-8266]
[DOCID:fr24fe09-82]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Clinical Trial Design for Hospital-Acquired Pneumonia and
Ventilator-Associated Pneumonia; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop, cosponsored with the Infectious Diseases Society of America
(IDSA), the American College of Chest Physicians (ACCP), the Society of
Critical Care Medicine (SCCM), and the American Thoracic Society (ATS)
regarding scientific issues in clinical trial design for hospital-
acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP).
This public workshop is intended to provide information about, and gain
perspective from, health care providers, academia, and industry on
various aspects of antimicrobial drug development for HAP and VAP,
including diagnosis of HAP and VAP, effect of antimicrobial treatment
for HAP and VAP, endpoints for trials of HAP and VAP, and statistical
issues in analysis of results of trials in HAP and VAP. The input from
this public workshop will help in developing topics for further
discussion.
    Date and Time: The public workshop will be held on March 31, 2009,
from 8 a.m. to 6 p.m. and on April 1, 2009, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Crowne Plaza
Hotel, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD 20910.
Seating is limited and available only on a first-come, first-served
basis.
    Contact: Chris Moser or Lori Benner, Center for Drug Evaluation and
Research, Food and Drug Administration, Office of Antimicrobial
Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, Silver Spring,
MD 20993- 0002,<PHONE_NUMBER>.
    Registration: To register electronically, e-mail registration
information (including name, title, firm name, address, telephone, and
fax numbers) to<EMAIL_ADDRESS>by March 23, 2009. Persons without
access to the Internet can call<PHONE_NUMBER> to register. Registration
is free for the public workshop. Interested parties are encouraged to
register early because space is limited. Seating will be available on a
first-come, first-served basis. Persons needing a sign language
interpreter or other special accommodations should notify Chris Moser
or Lori Benner (see Contact) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop,
cosponsored with IDSA, ACCP, SCCM, and ATS, regarding antimicrobial
drug

development for HAP and VAP. This public workshop will focus on
scientific considerations in designing clinical trials for HAP and VAP.
Topics for discussion include the following: (1) Approaches to the
diagnosis of HAP and VAP, (2) the effect of antimicrobial treatment for
HAP and VAP, (3) various endpoints that might be considered as
endpoints for trials of HAP and VAP, and (4) statistical issues in
analysis of results from trials in HAP and VAP. The input from this
public workshop will help in developing topics for further discussion.
    The agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop.
    Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 20 working days after the public workshop at a cost of 10
cents per page. Transcripts will also be available on the Internet at
http://www.fda.gov/cder/meeting/hap_vap.htm approximately 45 days
after the workshop.

    Dated: February 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3832 Filed 2-23-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 129 (Thursday, July 7, 2022)]
[Notices]
[Pages 40530-40531]
[FR Doc No: 2022-14460]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2021-0115; FRL-9996-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Paint Stripping and Miscellaneous
Surface Coating at Area Sources (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NESHAP for Paint Stripping and
Miscellaneous Surface Coating at Area Sources (EPA ICR Number 2268.06,
OMB Control Number 2060-0607), to the Office of Management and Budget
(OMB) for review and approval in accordance with the Paperwork
Reduction Act. This is a proposed extension of the ICR, which is
currently approved through June 30, 2022. Public comments were
previously requested, via the Federal Register, on April 13, 2021
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. An agency
may neither conduct nor sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.

DATES: Additional comments may be submitted on or before August 8,
2022.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2021-0115, online using www.regulations.gov (our preferred method)
or by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 2821T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. EPA's
policy is that all comments received will be included in the public
docket without change including any personal information provided,
unless the comment includes profanity, threats, information claimed to
be Confidential Business Information (CBI), or other information whose
disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Muntasir Ali, Sector Policies and
Program Division (D243-05), Office of Air Quality Planning and
Standards, U.S. Environmental Protection Agency, Research Triangle
Park, North Carolina, 27711; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
https://www.regulations.gov, or in person at the EPA Docket Center, WJC
West Building, Room 3334, 1301 Constitution Ave. NW, Washington, DC.
The telephone number for the Docket Center is<PHONE_NUMBER>. For
additional information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Paint Stripping and

Miscellaneous Surface Coating at Area Sources (40 CFR part 63, subpart
HHHHHH) are part of the EPA Integrated Urban Strategy to reduce cancer
risk from area sources under Section 112(k)(3)(C) of the Clean Air Act
(CAA). These standards apply to existing facilities and new facilities
that conduct paint stripping operations using methylene chloride-
containing paint strippers, motor vehicle and mobile equipment surface
coating operations, and miscellaneous surface coating operations
located at area sources. In general, all NESHAP standards require
initial notifications, performance tests, and periodic reports by the
owners/operators of the affected facilities. They are also required to
maintain records of the occurrence and duration of any startup,
shutdown, or malfunction in the operation of an affected facility, or
any period during which the monitoring system is inoperative. These
notifications, reports, and records are used by the EPA to determine
compliance with the standards.
    Form Numbers: None.
    Respondents/affected entities: Paint stripping and miscellaneous
surface coating operations.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart HHHHHH).
    Estimated number of respondents: 39,812 (total).
    Frequency of response: Initially and occasionally.
    Total estimated burden: 102,000 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $12,100,000 (per year), which includes
$27,100 in annualized capital/startup and/or operation & maintenance
costs.
    Changes in the Estimates: There is an adjustment decrease in the
total estimated burden as currently identified in the OMB Inventory of
Approved Burdens. This decrease is not due to any program changes. The
reason for the change in burden is related to an error in the prior ICR
which was corrected in this renewal package. The prior ICR assumed that
all sources would submit an annual notification of changes report, but
this rule does not require sources to submit an annual report unless a
change has occurred in information previously submitted in either the
initial notification required by Sec.  63.11175(a), Notification of
Compliance, or a previous annual notification of changes report. We
have adjusted this assumption, and based on OAQPS discussions with
industry, we have assumed that 20 percent of existing sources will
submit a notification of changes report each year; this includes
submittal of a methylene chloride minimization plan for paint stripping
sources using more than one ton of methylene chloride in the calendar
year.
    The prior ICR also assumed that no government-owned miscellaneous
surface coating operations at area sources would need to update records
of painter certification or records of filter efficiency each year. We
have revised this assumption and estimate that the proportions of
government-owned surface coating sources and commercial surface coating
sources that must record this information each year will be the same.
Therefore, in line with our assumptions for commercial surface coating
sources, we have assumed that 20 percent of painters at government-
owned surface coating sources will need to have their records updated
each year, and that one percent of government-owned surface coating
sources will opt to use filters which will require them to test and
record the filter efficiency. This adjustment in the burden estimate
for government-owned surface coating sources results in an increase in
recordkeeping burden for those sources. However, the overall burden
estimate for all types of sources, including government-owned surface
coating sources, has still decreased due to our corrected assumption
regarding annual notification of changes reports. Therefore, the number
of sources predicted by this ICR to submit reports has been greatly
reduced, and the associated labor and operation and maintenance costs
have seen a corresponding reduction. However, the individual cost per
respondent of submitting a notification or report has not changed.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-14460 Filed 7-6-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44062-44064]
[FR Doc No: 2011-18495]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64903; File No. SR-EDGA-2011-20]

Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of
Filing and Immediate Effectiveness of Amendment to EDGA Rule 11.9

 July 18, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on July 13, 2011, EDGA Exchange, Inc. (the ``Exchange'' or
``EDGA'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 11.9 to make certain changes
consistent with the upcoming implementation of the adoption of Rule
15c3-5 under the Act (the ``Market Access Rule'').\3\ The text of the
proposed rule change is available on the Exchange's Web site at http://www.directedge.com, at the Exchange's principal office, and at the
Public Reference Room of the Commission.
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    \3\ 17 CFR 15c3-5.
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The self-regulatory organization has prepared summaries,
set forth in Sections A, B and C below, of the most significant aspects
of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

Purpose
    On November 3, 2010, the Commission adopted the Market Access

Rule,\4\ pursuant to which, among other things, broker-dealers
providing market access are required to implement certain pre-order
entry checks in order to manage the financial, regulatory, and other
risks associated with providing its customers with market access. In
anticipation of the upcoming July 14, 2011 compliance date for the
Market Access Rule, the Exchange is proposing to amend EDGA Rule 11.9
to describe the manner in which the Exchange's affiliated routing
broker-dealer, Direct Edge ECN, LLC d/b/a DE Route (``DE Route'') will
handle routable orders consistent with the Market Access Rule.
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    \4\ See Securities Exchange Act Release No. 63241 (November 3,
2010), 75 FR 69792 (November 15, 2010).
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    In order to comply with the Market Access Rule, DE Route proposes
to implement, as part of the procedures of DE Route, certain tests, on
both an order-by-order basis and over a short period of time, that are
designed to limit the financial exposure that could arise as a result
of market access and to ensure compliance with all regulatory
requirements that are applicable in connection with market access.
Consistent with the requirements of the Market Access Rule, these tests
are designed to reject orders that DE Route deems to be erroneous or
duplicative, would cause the entering Member's credit exposure to
exceed a preset credit threshold, or are non-compliant with applicable
pre-trade regulatory requirements (as defined in the Market Access
Rule). To the extent DE Route determines, based on its procedures, that
an order should be rejected, DE Route may also seek to cancel orders
that have already been routed away.
Basis
    The Exchange believes that its proposal is consistent with the
requirements of the Act and the rules and regulations thereunder that
are applicable to a national securities exchange, and, in particular,
with the requirements of Section 6(b) of the Act.\5\ In particular, the
proposed change is consistent with Section 6(b)(5) of the Act,\6\
because it would promote just and equitable principles of trade, and,
in general, protect investors and the public interest. The proposed
rule is consistent with the requirements of the Act because the change
is necessary for the Exchange's affiliated broker-dealer, DE Route, to
comply with the Market Access Rule. The Exchange also believes that the
proposed changes will benefit Members of the Exchange because it
provides clarity on the procedures employed by DE Route consistent with
the Market Access Rule.
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    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \7\ and Rule 19b-
4(f)(6)(iii) thereunder.\8\
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    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6)(iii).
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    A proposed rule change filed under 19b-4(f)(6) normally may not
become operative prior to 30 days after the date of filing.\9\ However,
Rule 19b-4(f)(6)(iii) \10\ permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The Exchange has asked the
Commission to waive the 30-day operative delay so that the proposal may
become operative immediately upon filing. The Exchange notes that
waiving the 30-day operative delay will allow DE Route to comply with
Rule 15c3-5 under the Act by July 14, 2011; \11\ the compliance date
for Rule 15c3-5. For this reason, the Commission believes that waiving
the 30-day operative delay is consistent with the protection of
investors and the public interest, and designates the proposed rule
change to be operative upon filing with the Commission.\12\
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    \9\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires that a self-regulatory organization submit to
the Commission written notice of its intent to file the proposed
rule change, along with a brief description and text of the proposed
rule change, at least five business days prior to the date of filing
of the proposed rule change, or such shorter time as designated by
the Commission. The Exchange has satisfied this requirement.
    \10\ Id.
    \11\ 17 CFR 240.15c3-5.
    \12\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form http://www.sec.gov/rules/sro.shtml); or
     Send an E-mail to<EMAIL_ADDRESS>Please include
File No. SR-EDGA-2011-20 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-EDGA-2011-20. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the Exchange. All comments received will be posted
without change; the

Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
EDGA-2011-20 and should be submitted by August 12, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-18495 Filed 7-21-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 181 (Tuesday, September 18, 2012)]
[Notices]
[Page 57574]
[FR Doc No: 2012-22981]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3347-EM; Docket ID FEMA-2012-0002]

Louisiana; Amendment No. 2 to Notice of an Emergency Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of an emergency declaration for
the State of Louisiana (FEMA-3347-EM), dated August 27, 2012, and
related determinations.

DATES: Effective Date: September 10, 2012.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this emergency is closed effective September 10, 2012.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-22981 Filed 9-17-12; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: March 30, 2010 (Volume 75, Number 60)]
[Proposed Rules]
[Page 15645-15648]
[DOCID:fr30mr10-26]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2010-0147; FRL-9130-4]

Approval and Promulgation of Air Quality Implementation Plans;
Texas; Revisions to the Emission Credit Banking and Trading Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve severable portions of two
revisions to the Texas State Implementation Plan (SIP) submitted by the
State of Texas on October 24, 2006, and August 16, 2007. These
revisions amend existing sections and create a new section in Title 30
of the Texas Administrative Code (TAC), Chapter 101--General Air
Quality Rules, Subchapter H--Emissions Banking and Trading, Division
1--Emission Credit Banking and Trading, referred to elsewhere in this
notice as the Emission Reduction Credit (ERC) Program. The October 24,
2006, submittal creates a new section for international emission
reduction provisions and amends existing sections to further clarify
procedures for using emission protocols and to update the approved list
of emission credit uses. The August 16, 2007, submittal amends two
sections of the ERC program to update cross-references to recently
recodified 30 TAC Chapter 117 provisions. EPA has determined that these
SIP revisions comply with the Clean Air Act and EPA regulations, are
consistent with EPA policies, and will improve air quality. This action
is being taken under section 110 and parts C and D of the Federal Clean
Air Act (the Act or CAA).

DATES: Comments must be received on or before April 29, 2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R06-
OAR-2010-0147, by one of the following methods:
    (1) http://www.regulations.gov: Follow the on-line instructions for
submitting comments.
    (2) E-mail: Mr. Jeff Robinson at<EMAIL_ADDRESS>Please
also cc the person listed in the FOR FURTHER INFORMATION CONTACT
paragraph below.
    (3) U.S. EPA Region 6 ``Contact Us'' Web site: http://epa.gov/
region6/r6coment.htm. Please click on ``6PD'' (Multimedia) and select
``Air'' before submitting comments.
    (4) Fax: Mr. Jeff Robinson, Chief, Air Permits Section (6PD-R), at
fax number<PHONE_NUMBER>.
    (5) Mail: Mr. Jeff Robinson, Chief, Air Permits Section (6PD-R),
Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas,
Texas 75202-2733.
    (6) Hand or Courier Delivery: Mr. Jeff Robinson, Chief, Air Permits
Section (6PD-R), Environmental Protection Agency, 1445 Ross Avenue,
Suite 1200, Dallas, Texas 75202-2733. Such deliveries are accepted only
between the hours of 8:30 a.m. and 4:30 p.m. weekdays except for legal
holidays. Special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-R06-OAR-
2010-0147. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information the
disclosure of which is restricted by statute. Do not submit information
through http://www.regulations.gov or e-mail, if you believe that it is
CBI or otherwise protected from disclosure. The http://
www.regulations.gov Web site is an ``anonymous access'' system, which
means that EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://
www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment along with any disk or CD-ROM
submitted. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters and any form of encryption and should be free of any
defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
the disclosure of which is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at the Air
Permits Section (6PD-R), Environmental Protection Agency, 1445 Ross
Avenue, Suite 700, Dallas, Texas 75202-2733. The file will be made
available by appointment for public inspection in the Region 6 FOIA
Review Room between the hours of 8:30 a.m. and 4:30 p.m. weekdays
except for legal holidays. Contact the person listed in the FOR FURTHER
INFORMATION CONTACT paragraph below to make an appointment. If
possible, please make the appointment at least two working days in
advance of your visit. A 15 cent per page fee will be charged for
making photocopies of documents. On the day of the visit, please check
in at the EPA Region 6 reception area on the seventh floor at 1445 Ross
Avenue, Suite 700, Dallas, Texas.
    The State submittal related to this SIP revision, and which is part
of the EPA docket, is also available for public inspection at the State
Air Agency listed below during official business hours by appointment:
    Texas Commission on Environmental Quality, Office of Air Quality,
12124 Park 35 Circle, Austin, Texas 78753.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning
today's proposed rule, please contact Ms. Adina Wiley (6PD-R), Air
Permits Section, Environmental Protection Agency, Region 6, 1445 Ross
Avenue (6PD-R), Suite 1200, Dallas, TX 75202-2733. The telephone number
is<PHONE_NUMBER>. Ms. Wiley can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document wherever, any
reference to ``we,'' ``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. What Action Is EPA Taking?
II. What Did Texas Submit?
III. What Is EPA's Evaluation of These SIP Revisions?
IV. Final Action
V. Statutory and Executive Order Reviews

I. What Action Is EPA Taking?

    We are proposing to approve severable portions of two revisions to
the Texas SIP submitted by the Texas Commission on Environmental
Quality (TCEQ) on October 24, 2006, and August 16, 2007, specific to
the ERC Program. The ERC Program, SIP-approved by EPA on September 6,
2006, establishes a market-based trading program for the generation and
use of emission credits (generated and used at a specified emission
rate, tons per year) to provide flexibility for sources in complying
with certain State and Federal requirements. The revisions we are
proposing to approve amend existing sections and create a new section
in the ERC Program at Title 30 of the Texas Administrative Code (TAC),
Chapter 101--General Air Quality Rules, Subchapter H--Emissions Banking
and Trading, Division 1--Emission Credit Banking and Trading. The
October 24, 2006, submittal creates a new section for international
emission reduction provisions and amends existing sections to further
clarify procedures for using emission protocols and to update the
approved list of emission credit uses. The severable portions of the
August 16, 2007 submittal that we are proposing to approve non-
substantively revise the ERC Program to correctly update the cross-
references to the stationary source nitrogen oxide (NOX)
rules found in the Texas SIP at 30 TAC Chapter 117 as a result of the
non-substantive recodification of Chapter 117 approved by EPA as part
of the Texas SIP on December 3, 2008 (see 73 FR 73562). Consequently,
we are proposing to approve the revisions to the Texas SIP at 30 TAC
sections 101.302(a), 101.302(d)(1)(C)(vi), 101.302(f), and
101.306(a)(5) and the creation of new section 101.305 submitted on
October 24, 2006. Additionally, we are proposing to approve revisions
to the Texas SIP at 30 TAC sections 101.302(d)(1)(A) and 101.306(b)(3)
submitted on August 16, 2007 by the TCEQ.

II. What Did Texas Submit?

    We are proposing to approve severable portions of two revisions to
the Texas SIP specific to the ERC Program. The first revision we are
proposing action on was adopted by the TCEQ on October 4, 2006 and
submitted to EPA on October 24, 2006. At the same time that TCEQ
adopted and submitted revisions to the ERC Program, revisions were also
adopted and submitted for the Discrete Emission Credit Banking and
Trading Program (referred to elsewhere in this notice as the Discrete
Emission Reduction Credit (DERC) Program) and the Emissions Banking and
Trading of Allowances (EBTA) Program. The revisions to the DERC and
EBTA Programs are specific to separate, distinct trading programs and,
as such, are severable from the ERC Program revisions. We are not
proposing to act upon the severable revisions to the DERC Program at 30
TAC Chapter 101, Subchapter H, Division 4, sections 101.372, 101.373,
101.375, 101.376 and 101.378. EPA is processing a separate rulemaking
to address the 2006 and 2007 DERC Program revisions (see EPA-R06-OAR-
2010-0418). EPA has not yet taken action on the EBTA Program at 30 TAC
Chapter 101, Subchapter H, Division 2 and therefore is not proposing
action today on the repeal and replacement of section 101.338 and the
revisions to section 101.339. The second revision upon which we are
proposing action was adopted by the TCEQ on July 25, 2007, and
submitted to EPA on August 16, 2007. Also at this time TCEQ adopted and
submitted revisions to the general air quality definitions, the DERC
Program, and the System Cap Trading (SCT) Program. We are not acting
today upon revisions to the general air quality definitions at 30 TAC
Chapter 101, Subchapter A, section 101.1 because the ERC Program does
not rely upon them (therefore the revisions are severable from the ERC
Program) and previous revisions to section 101.1 are still pending for
review by EPA. We are also not acting today upon the revisions to the
DERC Program at 30 TAC Chapter 101, Subchapter H, Division 4, sections
101.372 and 101.376 because these revisions are severable from the ERC
program and the October 24, 2006, SIP revision is still under EPA
review. EPA intends to take a separate rulemaking action to address the
2006 and 2007 DERC Program revisions (see EPA-R06-OAR-2010-0418). EPA
has not yet taken action on the System Cap Trading Program at 30 TAC
Chapter 101, Subchapter H, Division 5 and therefore is not acting today
upon the severable revisions to sections 101.383 and 101.385.
    A copy of the October 24, 2006, and August 16, 2007, SIP submittals
as well as our Technical Support Document (TSD) can be obtained from
the Docket, as discussed in the ``Docket'' section above. A discussion
of the specific Texas rule changes that we are approving is included in
the TSD and summarized below.

A. October 24, 2006 SIP Submittal

1. 30 TAC Chapter 101, Subchapter H, Division 1, Section 101.302--
General Provisions
    The existing SIP-approved version of section 101.302 was adopted by
the TCEQ on December 13, 2002, and approved by EPA on September 6, 2006
(see 71 FR 52698). The revisions to sections 101.302(a) and (f) adopted
by the TCEQ on October 4, 2006, delete the information pertaining to
international emission reductions and move these provisions to new
section 101.305. Additionally, section 101.302(d)(1)(C)(vi) is revised
to clarify EPA's approval process of the quantification protocols for
the ERC Program.
2. 30 TAC Chapter 101, Subchapter H, Division 1, Section 101.305--
Emission Reductions Achieved Outside the United States
    On October 4, 2006, TCEQ adopted new section 101.305. This new
section contains the previously SIP-approved international emission
reduction provisions from sections 101.302(a) and (f) and updates the
international provisions consistent with the requirements of Texas
Senate Bill 784.
3. 30 TAC Chapter 101, Subchapter H, Division 1, Section 101.306--
Emission Credit Use
    The existing SIP-approved version of section 101.306 was adopted by
the TCEQ on December 13, 2002, and approved by EPA on September 6, 2006
(see 71 FR 52698). The proposed SIP revision adopted by the TCEQ on
October 4, 2006, amends section 101.306(a)(5) to update the list of
approved uses of emission credits to include the use of emission
credits as allowances in the Highly-Reactive Volatile Organic Compound
Emission Cap and Trade (HECT) Program at 30 TAC Chapter 101, Subchapter
H, Division 6.

B. August 16, 2007 SIP Submittal

1. 30 TAC Chapter 101, Subchapter H, Division 1, Section 101.302--
General Provisions
    The revisions to section 101.302 adopted by the TCEQ on July 25,
2007, further revise the revisions adopted by the TCEQ on October 4,
2002. The 2007 revisions non-substantively amend section
101.302(d)(1)(A) to correctly cross-reference the recodified stationary
source nitrogen oxide (NOX) rules to the Texas SIP at 30 TAC
Chapter 117.

2. 30 TAC Chapter 101, Subchapter H, Division 1, Section 101.306--
Emission Credit Use
    The revisions to section 101.306 adopted by the TCEQ on July 25,
2007, further revise the revisions adopted by the TCEQ on October 4,
2002. The 2007 revisions non-substantively amend section 101.306(b)(3)
to correctly cross-reference the recodified stationary source
NOX rules to the Texas SIP at 30 TAC Chapter 117.

III. What Is EPA's Evaluation of These SIP Revisions?

A. October 24, 2006 SIP Submittal

1. 30 TAC Chapter 101, Subchapter H, Division 1, Section 101.302--
General Provisions
    The October 4, 2006, revisions to sections 101.302(a),
101.302(d)(1)(C)(vi) and 101.302(f) are approvable. Sections 101.302(a)
and 101.302(f) were revised to delete the information pertaining to
international emission reductions and relocate these provisions to new
section 101.305. This consolidation of the international emission
reduction provisions improves the clarity of the ERC Program by
creating a new section specific to international emission reductions.
Section 101.302(d)(1)(C)(vi) was revised to clarify EPA's role in the
approval of emission quantification protocols. While the previous SIP-
approved provisions were accurate and consistent with EPA's Economic
Incentive Program (EIP) Guidance (``Improving Air Quality with Economic
Incentive Programs'' (EPA-452/R-01-001, January 2001)), the revised
language has been restructured to more closely follow the provisions
for approving emission quantification protocols at section 5.2(c) of
the EIP Guidance.
    The revisions to section 101.302 described above were made pursuant
to TCEQ's September 8, 2005, commitment letter for the DERC Program
(included in the docket for this action). In this commitment letter,
TCEQ committed to revising, among others things, section 101.302 to
more clearly require EPA approval for international emission reduction
transactions and to clarify the EPA's role in approving emission
quantification protocols. Because EPA granted full approval to the ERC
Program on September 6, 2006, the ERC-specific elements in the DERC
commitment letter can be decoupled from EPA's analysis of the DERC-
specific elements submitted by TCEQ in response to our conditional
approval of the DERC Program. Therefore, EPA can propose approval of
the revisions to section 101.302 without analyzing the remainder of the
DERC conditional approval commitments.
2. 30 TAC Chapter 101, Subchapter H, Division 1, Section 101.305--
Emission Reductions Achieved Outside the United States
    New section 101.305 adopted on October 4, 2006, is approvable. EPA
finds that in addition to relocating the SIP-approved international
emission reduction language from section 101.302, new section 101.305
has expanded the scope of our original ERC Program approval to allow
the use of international reductions in lieu of ERCs to occur in
attainment areas within 100-km of the Texas-Mexico border, consistent
with the requirements of Texas Senate Bill 784. However, the continued
requirement at section 101.305 for EPA approval before any such use is
consistent with the intent of our ERC Program approval on September 6,
2006. EPA approval continues to be through a case-specific SIP revision
that must clearly demonstrate through a detailed CAA section 110(l)
analysis that the use of such international reductions will not
jeopardize attainment or maintenance of the National Ambient Air
Quality Standards or any other applicable standards. As noted in our
September 6, 2006, final approval of the ERC Program ``* * *
international trades present an especially difficult case. For
instance, currently there is no approvable mechanism for demonstrating
that reductions made in another country are surplus or enforceable.
Nonetheless, emission reductions in other countries could potentially
offer substantial air quality benefits in the United States.'' See 71
FR 52698, 52699. In approving this revision to the ERC program, EPA is
continuing to recognize ``the concept of international trading and
describing a framework (i.e., the submission of a SIP revision
demonstrating among other things the validity and enforceability of
foreign reductions) for such trading, in the event that a suitable and
approvable mechanism is ever developed for resolving concerns including
enforceability and surplus. Until such a mechanism is developed and
approved by EPA, however, EPA will not approve international trades
under the ERC rule.'' See 71 FR 52698, 52699. Further, it is important
to note, that even though we are approving the use of international
reductions in lieu of ERCs along the Texas-Mexico border, the use of
these reductions must still meet the requirements of the CAA.
Therefore, the international reductions are not available for use as
Federal NSR offsets since section 173(c)(1) of the CAA requires that
offset reductions come from the same nonattainment area as the proposed
source or modification or another nonattainment area with an equal or
higher nonattainment classification.
3. 30 TAC Chapter 101, Subchapter H, Division 1, Section 101.306--
Emission Credit Use
    The October 4, 2006, revision to section 101.306(a)(5) is
approvable. TCEQ correctly updated the list of approved uses of
emission credits to include the use of emission credits as allowances
in the HECT. EPA approved the use of emission credits as HECT
allowances in our September 6, 2006, approval of the HECT (see 71 FR
52659).
    The revision to section 101.306 described above was also made
pursuant to TCEQ's September 8, 2005, commitment letter for the DERC
Program (included in the docket for this action). In this commitment
letter, TCEQ committed to revising, among others things, section
101.306 to identify that emission credits could be used as HECT
allowances. Because EPA granted full approval to the ERC Program on
September 6, 2006, the ERC-specific elements in the DERC commitment
letter can be decoupled from EPA's analysis of the DERC-specific
elements submitted by TCEQ in response to our conditional approval of
the DERC Program. Therefore, EPA can propose approval of the revisions
to section 101.306 without analyzing the remainder of the DERC
conditional approval commitments.

B. August 16, 2007 SIP Submittal

1. 30 TAC Chapter 101, Subchapter H, Division 1, Section 101.302--
General Provisions
    The July 25, 2007, revisions to section 101.302(d)(1)(A) are
approvable. As demonstrated further in our TSD, these non-substantive
revisions correctly cross-reference the recodified stationary source
NOX rules in the Texas SIP at 30 TAC Chapter 117. These non-
substantive revisions do not affect the approved emission
quantification protocols established for the ERC Program.
2. 30 TAC Chapter 101, Subchapter H, Division 1, Section 101.306--
Emission Credit Use
    The July 25, 2007, revisions to section 101.306(b)(3) are
approvable. As demonstrated further in our TSD, these non-substantive
revisions correctly cross-reference the recodified stationary source
NOX rules in the Texas SIP at 30

TAC Chapter 117. These non-substantive revisions do not affect the
emission use calculations established for the ERC Program.

IV. Final Action

    EPA is proposing to approve severable revisions to the Texas SIP
submitted on October 24, 2006, and August 16, 2007. Specifically from
the October 24, 2006 submittal, EPA is approving the amendments to
section 101.302(a) and (f) that move the international emission
reduction requirements to a new section, the amendments to section
101.302(d)(1)(C)(vi) that clarify EPA's role in approving emission
quantification protocols, and the amendment to section 101.306(a)(5)
that updates the approved uses for ERCs to include the HECT. EPA is
also proposing to approve provisions for international emission
reductions at new section 101.305 submitted on October 24, 2006.
Additionally, we are proposing to approve the following nonsubstantive
revisions to the Texas SIP submitted on August 16, 2007: revisions to
sections 101.302(d)(1)(A) and 101.306(b)(3) to update the cross-
references to recently recodified provisions in 30 TAC Chapter 117.
    In a separate rulemaking, EPA is proposing action on the severable
DERC Program revisions at 30 TAC sections 101.372, 101.373, 101.375,
101.376, and 101.378 submitted on October 24, 2006, and 30 TAC sections
101.372 and 101.376 submitted on August 16, 2007 (see EPA-R06-OAR-2010-
0418).
    At this time, EPA is not taking action on the revisions to the
Emissions Banking and Trading of Allowances Program at 30 TAC sections
101.338 and 101.339 submitted on October 24, 2006. EPA is also not
taking action at this time on the revisions to the general air quality
definitions at 30 TAC Section 101.1 or the revisions to the System Cap
Trading Program at 30 TAC sections 101.383, and 101.385 submitted on
August 16, 2007. These severable revisions remain under review by EPA
and will be addressed in separate actions.

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
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 Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have Tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on Tribal governments or preempt Tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Nitrogen oxides, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

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

    Dated: March 18, 2010.
Lawrence E. Starfied,
Acting Regional Administrator, Region 6.
[FR Doc. 2010-6800 Filed 3-29-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 9, 2010 (Volume 75, Number 152)]
[Rules and Regulations]
[Page 47709-47710]
[DOCID:fr09au10-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0709; Airspace Docket No. 09-AGL-28]
RIN 2120-AA66

Amendment of VOR Federal Airways V-8, V-14, V-38, V-47, V-279,
and V-422 in the Vicinity of Findlay, OH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the legal description of the VHF
Omnidirectional Range (VOR) Federal Airways V-8, V-14, V-38, V-47, V-
279, and V-422 in the vicinity of Findlay, OH. The FAA is taking this
action because the Findlay VHF Omnidirectional Range/Tactical Air
Navigation (VORTAC), included as part of the V-8, V-14, V-38, V-47, V-
279, and V-422 route structure, is being renamed the Flag City VORTAC.

DATES: Effective Date: 0901 UTC, November 18, 2010. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace and Rules
Group, Office of System Operations Airspace and AIM, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by amending the legal description of six VOR Federal Airways in
the vicinity of Findlay, OH. Currently, V-8, V-14, V-38, V-47, V-279,
and V-422 have Findlay, OH, [VORTAC] included as part of their route
structure. The Findlay VORTAC and the Findlay Airport share the same
name and facility identifier (FDY), but are not co-located and are
greater than 5 nautical miles apart. To eliminate the possibility of
confusion, and a potential flight safety issue, the Findlay VORTAC will
be renamed the Flag City VORTAC and assigned a new facility identifier
(FBC). All VOR Federal Airways with Findlay, OH, [VORTAC] included in
their legal description will be amended to reflect the Flag City, OH,
[VORTAC] name change. The name change of the VORTAC will coincide with
the effective date of this rulemaking action.
    Additionally, this action makes administrative corrections to the
V-8 and V-14 legal descriptions. Specifically, the V-8 description is
amended to reflect the termination point ``DC'' as ``Washington, DC'',
and the V-14 description is amended to reflect the navigation aid
``DRYER'' as ``Dryer''. These administrative corrections have no
operational impact to the existing airways.
    Since this action merely involves editorial changes in the legal
descriptions of VOR Federal Airways, and does not involve a change in
the dimensions or operating requirements of that airspace, notice and
public procedures under 5 U.S.C. 553(b) are unnecessary.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the legal description of six VOR Federal Airways in the
vicinity of Findlay, OH.
    Domestic VOR Federal Airways are published in paragraph 6010(a) of
FAA Order 7400.9T, signed August 27, 2009, and effective September 15,
2009, which is incorporated by reference in 14 CFR 71.1. The domestic
VOR Federal Airways listed in this document will be published
subsequently in the Order.

Environmental Review

    There are no changes to the lateral limits. Therefore, the FAA has
determined that this action is not subject to environmental assessments
and procedures in accordance with FAA Order 1050.1E, Policies and
Procedures for Considering Environmental Impacts, and the National
Environmental Policy Act.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of the Federal
Aviation Administration Order 7400.9T, Airspace Designations and
Reporting Points, signed August 27, 2009, and effective September 15,
2009, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-8 [Amended]

    From INT Seal Beach, CA, 266[deg] and Ventura, CA, 144[deg]
radials; Seal Beach; Paradise, CA; 35 miles, 7 miles wide (3 miles
SE and 4 miles NW of centerline) Hector, CA; Goffs, CA; INT Goffs
033[deg] and Morman Mesa, NV, 196[deg] radials; Morman Mesa; Bryce
Canyon, UT; Hanksville, UT; Grand Junction, CO; Kremmling, CO; Mile
High, CO; Akron, CO; Hayes Center, NE; Grand Island, NE; Omaha, NE;
Des Moines, IA; Iowa City, IA; Moline, IL; Joliet, IL; Chicago
Heights, IL; Goshen, IN; Flag City, OH; Mansfield, OH; Briggs, OH;
Bellaire, OH; INT Bellaire 107[deg] and Grantsville, MD, 285[deg]
radials; Grantsville; Martinsburg, WV; to Washington, DC. The
portion outside the United States has no upper limit.
* * * * *

V-14 [Amended]

    From Chisum, NM; Lubbock, TX; Childress, TX; Hobart, OK; Will
Rogers, OK; INT Will Rogers 052[deg] and Tulsa, OK 246[deg] radials;
Tulsa; Neosho, MO; Springfield, MO; Vichy, MO; INT Vichy 067[deg]
and St. Louis, MO, 225[deg] radials; Vandalia, IL; Terre Haute, IN;
Brickyard, IN; Muncie, IN; Flag City, OH; INT Flag City 079[deg] and
Dryer, OH, 240[deg] radials; Dryer; Jefferson, OH; Erie, PA;
Dunkirk, NY; Buffalo, NY; Geneseo, NY; Georgetown, NY; INT
Georgetown 093[deg] and Albany, NY, 270[deg] radials; Albany; INT
Albany 084[deg] and Gardner, MA, 284[deg] radials; Gardner; to
Norwich, CT.
* * * * *

V-38 [Amended]

    From Moline, IL; INT Moline 082[deg] and Peotone, IL, 281[deg]
radials; Peotone; Fort Wayne, IN; Flag City, OH; INT Flag City
131[deg] and Appleton, OH, 312[deg] radials; Appleton; Zanesville,
OH; Parkersburg, WV; Elkins, WV; Gordonsville, VA; Richmond, VA;
Harcum, VA; Cape Charles, VA.
* * * * *

V-47 [Amended]

    From Pine Bluff, AR; Gilmore, AR; Dyersburg, TN; Cunningham, KY;
Pocket City, IN; Nabb, IN; Cincinnati, OH; Rosewood, OH; Flag City,
OH; to Waterville, OH.
* * * * *

V-279 [Amended]

    From INT Flag City, OH, 146[deg] and Rosewood, OH, 083[deg]
radials; to Flag City; 7 miles wide (4 miles northeast and 3 miles
southwest of the centerline) to Flag City.
* * * * *

V-422 [Amended]

    From INT Chicago O'Hare, IL, 127[deg] and Chicago Heights, IL,
358[deg] radials; Chicago Heights; INT Chicago Heights 117[deg] and
Knox, IN, 276[deg] radials; Knox; Webster Lake, IN; INT Webster Lake
097[deg] and Flag City, OH, 289[deg] radials; to Flag City.
* * * * *

    Issued in Washington, DC, on July 27, 2010.
Edith V. Parish,
Manager, Airspace and Rules Group.
[FR Doc. 2010-19271 Filed 8-6-10; 8:45 am]
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[Federal Register: August 30, 2006 (Volume 71, Number 168)]
[Rules and Regulations]
[Page 51500-51505]
[DOCID:fr30au06-18]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0327; FRL-8090-1]

Bifenazate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues
of bifenazate in or on pea, garden; pea, edible podded; vegetable,
tuberous and corm, subgroup 1C; fruit, stone, group 12, except plum;
plum; cattle fat; goat fat; hog fat; horse fat; and sheep fat.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective August 30, 2006. Objections and
requests for hearings must be received on or before October 30, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0327. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., 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 in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail 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.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines

referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0327 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 30, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0327, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of May 3, 2006 (71 FR 26087) (FRL-8058-6),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petitions (PP 3E6762
and 5E6992) by IR-4, 681 U.S. Highway 1 South, North
Brunswick, NJ 08902. The petition requested that 40 CFR 180.572 be
amended by establishing tolerances for combined residues of the
insecticide, bifenazate, (1 methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-
yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-

[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate),
in or on fruit, stone, group 12 at 2.0 parts per million (ppm); pea,
garden at 0.2 ppm; pea, edible podded at 4.0 ppm; and vegetable,
tuberous and corm at 0.01 ppm.
    PP 3E6762 proposed to amend 40 CFR 180.572 by deleting existing
peach and nectarine tolerances, and establish a tolerance for fruit,
stone (Group 12) at 2.0 ppm. Following review of the residue chemistry
data, EPA determined that the commodity terms and tolerances levels
should be revised to the following: Pea, garden, succulent at 0.20 ppm;
vegetable, tuberous and corm, subgroup 1C at 0.10 ppm; and fruit,
stone, group 12, except plum at 2.5 ppm. Additionally, EPA determined
subsequent revisions for existing tolerances for plum at 0.20 ppm, and
fat of cattle, goat, hog, horse, and sheep at 0.10 ppm (previously
established at 0.3 ppm (plum) and 0.1 ppm (animal fat commodities).
    EPA is also deleting established tolerances in Sec. 180.572(a) for
peach and nectarine since they will be replaced by the establishment of
the tolerance for residues of bifenazate on fruit, stone, group 12,
except plum. Additionally, EPA is deleting the time-limited tolerance
for tomato under Sec. 180.572(b) since that tolerance has expired.
    The notices referenced above included a summary of the petitions
prepared by Crompton Uniroyal Chemical, the registrant. There were no
comments received in response to the notice of filing.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for combined of bifenazate on pea,
garden, succulent at 0.20 ppm; pea, edible podded, succulent at 4.0
ppm; vegetable, tuberous and corm, subgroup 1C at 0.10 ppm; fruit,
stone, group 12, except plum at 2.5 ppm; plum at 0.20 ppm; and fat of
cattle, goat, hog, horse, and sheep at 0.10 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerances follow.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the toxic effects caused by bifenazate as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at
http://www.regulations.gov (Docket ID EPA-HQ-OPP-2006-0327-0002, pages 10-12).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which the NOAEL from the toxicology study
identified as appropriate for use in risk assessment is used to
estimate the toxicological level of concern (LOC). However, the lowest
dose at which the LOAEL of concern is identified is sometimes used for
risk assessment if no NOAEL was achieved in the toxicology study
selected. An uncertainty factor (UF) is applied to reflect
uncertainties inherent in the extrapolation from laboratory animal data
to humans and in the variations in sensitivity among members of the
human population as well as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk
characterization at http://www.epa.gov/pesticides/health/human.htm.

     A summary of the toxicological endpoints for bifenazate used for
human risk assessment can be found at http://www.regulations.gov (Docket ID

EPA-HQ-OPP-2006-0327-0002, page 15).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.572) for the combined residues of bifenazate,
in or on a variety of raw agricultural and livestock commodities. A
tolerance is also established for milk. Risk assessments were conducted
by EPA to assess dietary exposures from bifenazate in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for bifenazate, therefore a
quantitative acute dietary exposure assessment is not performed.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates
food consumption data as reported by respondents in the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII), and accumulated exposure to the chemical for each commodity.
The following assumptions were made for the chronic exposure
assessments: The chronic analyses incorporated tolerance-level residues
for all commodities excluding squash, peach, tomato, and soybean
(anticipated residues based on average field-trial residues were
assumed) and milk (anticipated residue was assumed). The chronic
analyses incorporated average percent crop treated (PCT) information.
DEEM (ver. 7.81) default processing factors were assumed for all
commodities excluding apple juice, grape juice, wine/sherry, tomato
paste, and tomato puree. The processing factors for these commodities

were reduced to 0.23, 0.17, 0.17, 5.0, and 5.0, respectively, based on
data from processing studies.
    iii. Cancer. Bifenazate has been classified as ``not likely'' to be
a human carcinogen. Therefore, a cancer dietary exposure assessment was
not performed.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E)
of the FFDCA authorizes EPA to use available data and information on
the anticipated residue levels of pesticide residues in food and the
actual levels of pesticide chemicals that have been measured in food.
If EPA relies on such information, EPA must pursuant to section
408(f)(1) require that data be provided 5 years after the tolerance is
established, modified, or left in effect, demonstrating that the levels
in food are not above the levels anticipated. Following the initial
data submission, EPA is authorized to require similar data on a time
frame it deems appropriate. For the present action, EPA will issue such
Data Call-Ins for information relating to anticipated residues as are
required by FFDCA section 408(b)(2)(E) and authorized under FFDCA
section 408(f)(1). Such Data Call-Ins will be required to be submitted
no later than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition 1,
that the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
    The Agency used PCT information as follows: 1% for almonds, apples,
apricots, cucumbers, pecans, peppers, walnuts, and watermelons; 5% for
grapes, nectarines, prunes, plums, and tomatoes; 10% for peaches and
pears, and 25% for strawberries.
    EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available federal, state, and private market survey data for that use,
averaging by year, averaging across all years, and rounding up to the
nearest multiple of five percent except for those situations in which
the average PCT is less than one. In those cases < 1% is used as the
average and < 2.5% is used as the maximum. EPA uses a maximum PCT for
acute dietary risk analysis. The maximum PCT figure is the single
maximum value reported overall from available federal, state, and
private market survey data on the existing use, across all years, and
rounded up to the nearest multiple of five percent. In most cases, EPA
uses available data from United States Department of Agriculture/
National Agricultural Statistics Service (USDA/NASS), Proprietary
Market Surveys, and the National Center for Food and Agriculture Policy
(NCFAP) for the most recent 6 years.
    The Agency believes that the three conditions listed have been met.
With respect to Condition 1, PCT estimates are derived from Federal and
private market survey data, which are reliable and have a valid basis.
The Agency is reasonably certain that the percentage of the food
treated is not likely to be an underestimation. As to Conditions 2 and
3, regional consumption information and consumption information for
significant subpopulations is taken into account through EPA's
computer-based model for evaluating the exposure of significant
subpopulations including several regional groups. Use of this
consumption information in EPA's risk assessment process ensures that
EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which bifenazate may
be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for bifenazate in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of bifenazate. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.

    Parent bifenazate degrades rapidly in aerobic soil conditions with
a half-life of approximately 30 minutes. The first degradate formed
(D3598; half-life of 7 hours) was reported in a concentration of 95% of
the applied radioactivity. D3598 degrades to D1989 (reported at a
maximum of 26% of the applied radioactivity), which is moderately
persistent with an EFED-calculated half-life of approximately 96 days.
Photodegradation and other routes of dissipation of parent bifenazate
do not appear to be significant.
    EPA concluded that the residue of concern in drinking water is
D1989. Parent and D3598 were not included as a residue of concern in
drinking water due to the short half-lives of these compounds and the
lack of an acute dietary endpoint (toxicity of D3598 is assumed to be
equivalent to bifenazate). Since ground water or surface water
monitoring data are not available, a Tier I screening concentration in
ground water (SCI-GROW) and surface water first index sceening tool
reservoir (FIRST) were provided for the EECs of D1989. Both models were
conducted using the strawberry application scenario (2 x 0.50 lbs ai/
acre; 21-day RTI; highest registered/proposed application rate).
    Based on the SCI-GROW and FIRST models, the estimated environmental
concentrations (EECs) of bifenazate are estimated to be 6.38 parts per
billion (ppb) for chronic surface water and < 0.001 ppb for ground
water. Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID\TM\). For chronic
dietary risk assessment, the annual average concentration of 6.38 ppb
was used to access the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Bifenazate is currently registered for use on the following
residential non-dietary site: Ornamentals. The risk assessment was
conducted using the following residential exposure assumptions: EPA
anticipated only short-term dermal and inhalation exposure for
residential handlers. The proposed formulation was appropriate for
application via pump up sprayers, garden hose-end sprayers, or similar
``homeowner'' pesticide devices. A

larger area per day may be treated with a hose-end sprayer than with a
``pump-up'' compressed-air sprayer, which in turn results in possibly
greater contact with the active ingredient per day. Therefore, exposure
from a hose-end sprayer was assessed rather than that of a compressed-
air sprayer. With respect to post-application residential exposures, no
significant post-application exposure is anticipated from landscape
ornamentals, either by residents or professional applicators;
therefore, no residential post-application assessment was conducted.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to bifenazate and any other
substances and bifenazate does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that bifenazate has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1.  In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. The developmental studies in
rats and rabbits did not demonstrate any qualitative or quantitative in
utero extra sensitivity of fetuses to bifenazate. Similarly, increased
qualitative or quantitativesusceptibility to offspring was not observed
from bifenazate during prenatal or postnatal development in the
reproduction study.
    3. Conclusion. The Agency evaluated the bifenazate toxicological
database in reference to the potential for enhanced sensitivity to
infants and children. Acceptable developmental toxicity studies in the
rat and rabbit are available, as is an acceptable 2-generation
reproduction study in the rat. EPA concluded that a bifenazate
developmental neurotoxicity study is not required. EPA also concluded
the 10X FQPA safety factor could be reduced to 1X for bifenazate for
the following reasons:
    i. There is no indication of quantitative or qualitative increased
susceptibility of rats and rabbits to in utero or postnatal exposure.
    ii. A bifenazate developmental neurotoxicity study is not required.
    iii. The toxicological database, the residue chemistry database and
the environmental fate database, are complete for FQPA assessment.
    iv. The dietary drinking water assessment utilizes water
concentration values generated by model and associated modeling
parameters which are designed to provide conservative, health
protective, high-end estimates of water concentrations which will not
likely be exceeded.
    v. The residential handler assessment is based upon the residential
standard operating procedures (SOPs). The residential SOPs are based
upon reasonable worst-case assumptions and are not expected to
underestimate risk. These assessments of exposure are not likely to
underestimate the resulting estimates of risk from exposure to
bifenazate.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. No acute risk is expected from exposure to
bifenazate since no acute endpoints were identified for the general
U.S. population (including infants and children) or the females 13-50
years old population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
bifenazate from food and water will utilize 38% of the chronic
population adjusted dose (cPAD) for the U.S. population, 79% of the
cPAD for all infants (< 1 year old), and 94% of the cPAD for children 1-
2 years old. There are no residential uses for bifenazate that result
in chronic residential exposure to bifenazate. Therefore, EPA does not
expect the aggregate exposure to exceed 100% of the cPAD.
    3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Bifenazate is currently
registered for use that could result in short-term residential exposure
and the Agency has determined that it is appropriate to aggregate
chronic food and water and short-term exposures for bifenazate.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential
exposures aggregated result in aggregate margin of exposures (MOEs) of
1,600 for the U.S. population, 1,900 for females 13-49 years old, and
2,000 for adults 50 years and older. These aggregate MOEs do not exceed
the Agency's level of concern for aggregate exposure to food, water,
and residential uses. Therefore, EPA does not expect short-term
aggregate exposure to exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. Bifenazate has been
classified as ``not likely'' to be a human carcinogen by any relevant
route of exposure. Therefore, bifenazate is expected to pose at most a
negligible cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, and to infants and children from aggregate
exposure to bifenazate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A method (UCC-D2341) is available for enforcement of the currently
established plant tolerances. The methods used in the field trial and
processing studies were similar to the current enforcement method.
Since the

procedures are similar and adequate method validation and concurrent
recoveries were attained in the field trial and processing studies, EPA
concludes that the current enforcement method is appropriate for
enforcement of the tolerances associated with this petition.
    Adequate enforcement methodology is available to enforce the
tolerance expression. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
B. International Residue Limits

    Canada, Codex, and Mexico do not have maximum residue limits (MRLs)
for residues of bifenazate in/on tuberous and corm vegetables or
succulent pea; therefore, harmonization is not an issue for these
crops. However, Codex MRLs are established in/on peach, nectarines,
plum, and prunes (no Canadian or Mexican stone fruit MRLs) at 2.0 ppm.
The Codex MRL residue definition is for bifenazate per se. The U.S. and
Codex tolerances/MRLs are not compatible with regard to tolerance
expression and therefore, the levels can not be harmonized.

V. Conclusion

    Therefore, the tolerance is established for combined residues of
bifenazate, (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-
yl)hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-
[1,1'-biphenyl]-3-yl), 1-methylethyl ester, in or on pea, garden,
succulent at 0.20 ppm; pea, edible podded, succulent at 4.0 ppm;
vegetable, tuberous and corm, subgroup 1C at 0.10 ppm; fruit, stone,
group 12, except plum at 2.5 ppm; plum at 0.20 ppm; and fat of cattle,
goat, hog, horse, and sheep at 0.10 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-). Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on 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, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 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, on 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 directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, 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.''
``Policies that have tribal implications'' is defined in the Executive
Order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, 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, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VII. 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
United States. 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 United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: August 23, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.572 is amended by:
    i. In paragraph (a)(1), in the table, by removing the commodities
``peach'' and ``nectarine''; revising the tolerance levels for the
commodities ``cattle, fat''; ``goat, fat''; ``hog, fat''; ``horse,
fat''; and ``sheep, fat'' and by alphabetically adding commodities
``fruit, stone, group 12, except 12''; ``pea, garden, succulent'';
``pea, edible podded, succulent''; and ``vegetable, tuberous and
corm''; and
    ii. In paragraph (b), in the table, by removing the commodity
tomato.
    The amendments read as follows.

Sec.  180.572  Bifenazate; tolerances for residues.

    (a)(1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Cattle, fat................................................         0.10
                                * * * * *
Fruit, stone, group 12, except plum........................          2.5
Goat, fat..................................................         0.10
                                * * * * *
Hog, fat...................................................         0.10
                                * * * * *
Horse, fat.................................................         0.10
                                * * * * *
Pea, garden, succulent.....................................         0.20
Pea, edible podded, succulent..............................          4.0
                                * * * * *
Plum.......................................................         0.20
Sheep, fat.................................................         0.10
                                * * * * *
Vegetable, tuberous and corm, subgroup 1C..................         0.10
------------------------------------------------------------------------

* * * * *

[FR Doc. E6-14427 Filed 8-29-06; 8:45 am]

BILLING CODE 6560-50-S