[Federal Register Volume 87, Number 231 (Friday, December 2, 2022)]
[Rules and Regulations]
[Pages 73935-73936]
[FR Doc No: 2022-26171]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0245; Airspace Docket No. 21-AAL-8]
RIN 2120-AA66

Amendment to VOR Federal Airway V-436 and Jet Route J-125, and
Establishment of United States Area Navigation Route T-399 in the
Vicinity of Clear, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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

SUMMARY: This action corrects a final rule published by the FAA in the
Federal Register on November 1, 2022, that amends Alaskan VHF
Omnidirectional Range (VOR) Federal airway V-436 and Jet Route J-125,
and establishes United States Area Navigation (RNAV) route T-399 in the
vicinity of Clear, AK. In the final rule, the amendments to V-436
addressed in the preamble were incomplete and did not address all of
the airway segment amendments being made. Additionally, the final rule
referenced the AILEE, AK, route point as a waypoint (WP), in error, in
the V-436 and T-399 amendment discussions in the preamble and in the T-
399 route description in the regulatory text. The correct
characterization of the AILEE, AK, route point is as a Fix. This action
corrects the oversight of not including all of the V-436 amendments
addressed in the preamble to match the V-436 description in the
regulatory text and changes all references of the AILEE, AK, WP to the
AILEE, AK, Fix to match the FAA's National Airspace System Resource
(NASR) database information.

DATES: Effective date 0901 UTC, December 29, 2022. 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 7400.11 and
publication of conforming amendments.

ADDRESSES: FAA Order 7400.11G, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule in the Federal Register (87 FR
65675; November 1, 2022), amending Alaskan VOR Federal airway V-436 and
Jet Route J-125, and establishing RNAV route T-399 in the vicinity of
Clear, AK. Subsequent to publication, the FAA determined that the
amendments to V-436 addressed in the preamble were incomplete and did
not address all of the airway segment amendments being made.
Additionally, the FAA determined that the AILEE, AK, route point was
incorrectly identified as a WP. As such, the preamble discussion of the
V-436 amendments appear inconsistent with the amended V-436 description
listed in the regulatory text and all references of the AILEE, AK, WP
do not match the FAA's NASR database information.
    This rule corrects the preamble discussion of the V-436 amendments
to include all of the airway segment amendments being made and changes
all references of the AILEE, AK, WP to the AILEE, AK, Fix. This action
does not alter the alignment of the amended V-436 airway or the
established T-399 route listed in the final rule.
    Alaskan VOR Federal airways are published in paragraph 6010(b) and
United States Area Navigation Routes are published in paragraph 6011 of
FAA Order JO 7400.11G, dated August 19, 2022, and effective September
15, 2022, which is incorporated by reference in 14 CFR 71.1. The
Alaskan VOR Federal airway and RNAV T-route listed in this document
will be published subsequently in FAA Order JO 7400.11.

Correction to Final Rule

    Accordingly, pursuant to the authority delegated to me, the V-436
amendment discussion contained in the preamble and all references of
the AILEE, AK, WP in Docket No. FAA-2021-0245, as published in the
Federal Register of November 1, 2022 (87 FR 65675), FR Doc. 2022-23369,
are corrected as follows:

0
1. In FR Doc. 2022-23369, appearing on page 65676, in the first and
second columns, replace the V-436 amendment discussion to read,
    ``V-436: V-436 extends between the Anchorage, AK (ANC), VHF
Omnidirectional Range/Distance Measuring Equipment (VOR/DME) and the
Deadhorse, AK (SCC), VOR/DME. This action removes the airway segment

between the Talkeetna, AK (TKA), VOR/DME and the Nenana, AK (ENN), VHF
Omnidirectional Range/Tactical Air Navigation (VORTAC) and replaces the
removed airway segment with an airway segment that extends between the
Talkeetna, AK (TKA), VOR/DME; the AILEE, AK, Fix; and the Fairbanks, AK
(FAI), VORTAC. Additionally, the airway segment north of the Nenana,
AK, VORTAC to the Deadhorse, AK, VOR/DME is removed as discussed in the
NPRM. As amended, V-436 will extend between the Anchorage, AK, VOR/DME
and the Fairbanks, AK, VORTAC.''
0
2. In FR Doc. 2022-23369, appearing on page 65676, in the second
column, replace the T-399 establishment discussion to read,
    ``T-399: T-399 is a new RNAV route that extends between the
Talkeetna, AK (TKA), VOR/DME and the Nenana, AK (ENN), VORTAC over the
AILEE, AK, Fix; the PAWWW, AK, WP; and the SEAHK, AK, WP.''

0
3. In FR Doc. 2022-23369, appearing on page 65677, correct the table
for T-399 Talkeetna, AK (TKA) to Nenana, AK (ENN) [New] to read:

T-399 Talkeetna, AK (TKA) to Nenana, AK (ENN) [New]

Talkeetna, AK (TKA)                             VOR/DME                        (Lat. 62[deg]17'54.16'' N, long. 150[deg]06'18.90'' W)
AILEE, AK                                       FIX                            (Lat. 63[deg]36'00.04'' N, long. 149[deg]32'23.46'' W)
PAWWW, AK                                       WP                             (Lat. 63[deg]58'06.62'' N, long. 149[deg]35'19.10'' W)
SEAHK, AK                                       WP                             (Lat. 64[deg]22'38.93'' N, long. 149[deg]32'37.92'' W)
Nenana, AK (ENN)                                VORTAC                         (Lat. 64[deg]35'24.04'' N, long. 149[deg]04'22.34'' W)

* * * * *

    Issued in Washington, DC, on November 28, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-26171 Filed 12-1-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Notices]
[Pages 74210-74211]
[FR Doc No: 2015-29955]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Application for Modification of
Special Permit

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of Application for Modification of Special Permits

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the applications described herein. This
notice is abbreviated to expedite docketing and public notice. Because
the sections affected, modes of transportation, and the nature of
application have been shown in earlier Federal Register publications,
they are not repeated here. Requests for modification of special
permits (e.g. to provide for additional hazardous materials, packaging
design changes, additional mode of transportation, etc.) are described
in footnotes to the application number. Application numbers with the
suffix ``M'' denote a modification request. These applications have
been separated from the new application for special permits to
facilitate processing.

DATES: Comments must be received on or before December 14, 2015.
    Address Comments To: Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Ryan Paquet, Director, Office of
Hazardous Materials Approvals and Permits Division, Pipeline and
Hazardous Materials Safety Administration, U.S. Department of
Transportation, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.
    Copies of the applications are available for inspection in the
Records Center, East Building, PHH-30, 1200 New Jersey Avenue
Southeast, Washington, DC or at http://regulations.gov.
    This notice of receipt of applications for modification of special
permit is published in accordance with Part 107 of the Federal
hazardous materials transportation law (49 U.S.C. 5117(6); 49 CFR I
.53(b)).

    Issued in Washington, DC, November 4, 2015.
Don Burger,
Chief, General Approvals and Permits.

----------------------------------------------------------------------------------------------------------------
                                                                      Regulation(s)
   Application No.          Docket No.             Applicant             affected       Nature of permit thereof
----------------------------------------------------------------------------------------------------------------
                                          MODIFICATION SPECIAL PERMITS
----------------------------------------------------------------------------------------------------------------
7765-M..............  ......................  Carleton             49 CFR               To modify the special
                                               Technologies,        173.302(a)(4);       permit to authorize a
                                               Inc., Orchard        175.3.               competent internal
                                               Park, NY.                                 Carleton inspector to
                                                                                perform the required
                                                                                duties outlined in Sec.
                                                                                178.35(c).
12399-M.............  ......................  Linde Gas, North     49 CFR 180.209.....  To modify the special
                                               America LLC.,                             permit to authorize DOT
                                               Murray Hill, NJ.                          Speciafication 3AL
                                                                                cylinders made of 6351-
                                                                                T6 aluminum to be
                                                                                requalified by
                                                                                ultrasonic examination
                                                                                and eddy current
                                                                                examination in
                                                                                accordance with 49 CFR
                                                                                Appendix C to Part 180.
12562-M.............  ......................  Taeyang              49 CFR               To modify the special
                                               Corporation, Chung   173.304(d)(3)(ii).   permit to authorize
                                               Nam.                                      additional Division 2.1
                                                                                hazardous materials,
                                                                                add an additional
                                                                                inside container
                                                                                design, mark each
                                                                                container ``DOT-SP
                                                                                12562'' instead of
                                                                                ``DOTE-12562'' and
                                                                                company name change.
13192-M.............  ......................  Thomas Gray &        49 CFR 173.12(b)...  To modify the special
                                               Associates, Inc.,                         permit to authorize
                                               Orange, CA.                               transportation of
                                                                                radioactive materials.
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                                     Regulation(s)
    Application No.        Docket No.           Applicant              affected         Nature of permit thereof
----------------------------------------------------------------------------------------------------------------
                                          MODIFICATION SPECIAL PERMITS
----------------------------------------------------------------------------------------------------------------
14206-M...............  ................  Digital Wave           49 CFR 172.203(a),    To modify the special
                                           Corporation,           172.301(c), and       permit to add DOT
                                           Centennial, CO.        180.205.              Specification 3AX, 3AAX
                                                                                cylinders and 3T tubes
                                                                                which exceed 125 lbs
                                                                                water capacity for
                                                                                requalification by
                                                                                ultrasonic examination
                                                                                once every ten years.
14625-M...............  ................  KIK Piedmont LLC,      49 CFR                To modify the special
                                           Gainesville, GA.       173.306(a)(3)(v).     permit to allow an
                                                                                additional DOT
                                                                                Specification 2Q
                                                                                aluminum non-refillable
                                                                                inside container.
16361-M...............  ................  The University of      49 CFR 173.196......  To modify the special
                                           Cincinnati,                                  permit to eliminate the
                                           Cincinati, OH.                               requirement for the
                                                                                transport vehicle to be
                                                                                equipped with an
                                                                                environmental control
                                                                                backup system capable of
                                                                                turning on power to
                                                                                maintain a temperature
                                                                                of at -30 degrees
                                                                                Celsius or below.
16490-M...............  ................  William T. Poe &       49 CFR 176.63;        To modify the special
                                           Associates Inc. d/b/   176.83; 176.116(e);   permit originally issued
                                           a Explosive Service    176.116(e);           on an emergency basis to
                                           International, Baton   176.120;              authorize an additional
                                           Rouge, LA.             176.137(a)(7);        two years.
                                                                  176.138(b);
                                                                  176.144(e);
                                                                  176.145(b);
                                                                  176.164(e);
                                                                  176.178(b).
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
   Application No.        Docket No.          Applicant        Regulation(s) affected   Nature of permit thereof
----------------------------------------------------------------------------------------------------------------
                                          MODIFICATION SPECIAL PERMITS
----------------------------------------------------------------------------------------------------------------
16492-M..............  ................  Construction         49 CFR 172.101 Hazardous  To modify the special
                                          Helicopters, Inc.,   Materials Table Column    permit to remove the
                                          Howell, MI.          (9B), Subpart C of Part   provision ``training or
                                                               172, 172.301(c),          qualification of a new
                                                               172.302(c),               crew member will not
                                                               173.27(b)(2), 175.30,     take place during the
                                                               Part 178.                 execution of this
                                                                                special permit.''
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2015-29955 Filed 11-25-15; 8:45 am]
 BILLING CODE 4909-60-M


Page 1 of 4 May 14, 2003 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING JUNE 17 20, 2003 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2003 0024 Crown Plaza Washington  National Airport 1489 Jefferson Davis Highway Arlington VA 22202 703 310 8980 Effects of Atrazine on Amphibians: A Consultation List of Panel Members FIFRA SAP Session Chair Stephen M. Roberts, Ph. D. Professor and Program Director University of Florida Center for Environmental & Human Toxicology Building 471 Mowry Road Gainesville, FL 32611 Designated Federal Official Mr. Paul Lewis FIFRA Scientific Advisory Panel Office of Science Coordination and Policy Environmental Protection Agency 1200 Pennsylvania Avenue, N. W. ( 7201M) Washington, DC 20460 FIFRA Scientific Advisory Panel Members Steven Heeringa, Ph. D. Director, Division of Surveys & Technology Institute for Social Research University of Michigan PO Box 1248 Ann Arbor, MI 48106 Page 2 of 4 Gary E. Isom, Ph. D. Professor of Toxicology School of Pharmacy and Pharmacal Sciences Purdue University 575 Stadium Mall Drive West Lafayette, IN 47907 2091 Fumio Matsumura, Ph. D. Professor Institute of Toxicology and Environmental Health University of California at Davis UC Davis ITEH Building 3791 Davis, CA 95616 Mary Anna Thrall, DVM, MS Diplomate, ACVP Department of Microbiology, Immunology and Pathology Colorado State University Fort Collins CO 80523, USA FQPA Science Review Board Members Joel Coats, Ph. D. Professor and Chair Department of Entomology Iowa State University 116 Insectary Building Ames, Iowa 50011 Peter Delorme, Ph. D. Senior Evaluation Officer Environmental Assessment Division PMRA, Health Canada 2720 Riverside Drive Ottawa, Ontario, Canada K1A oK9 Robert J. Denver, Ph. D. Associate Professor and Associate Chair for Undergraduate Studies Department of Molecular, Cellular and Developmental Biology Associate Professor Department of Ecology and Evolutionary Biology Page 3 of 4 3065C Natural Science Building The University of Michigan Ann Arbor, MI 48109 1048 James Gibbs, Ph. D. Associate Professor Faculty of Environmental and Forest Biology SUNY ESF One Forestry Drive 350 Illick Hall Syracuse, NY 13210 Sherril L. Green, DVM, PhD Associate Professor Department of Comparative Medicine Stanford University School of Medicine RAF 1, Quad 7, Bldg. 330 Stanford, CA 94305 5410 Werner Kloas, Ph. D. Department of Inland Fisheries Leibniz Institute of Freshwater Ecology and Inland Fisheries Müggelseedamm 310 12587 Berlin Germany Darcy B. Kelley, Ph. D. Professor Biological Sciences 911 Fairchild Center, MC. 2432 1212 Amsterdam Avenue Columbia University New York, NY 10027 Gerald A. LeBlanc, Ph. D. Professor of Toxicology Department of Environmental & Molecular Toxicology North Carolina State University Suite 1104, 850 Main Campus Dr. Raleigh, NC 27606 7633 Carl Richards, Ph. D. Director and Professor Page 4 of 4 MN Sea Grant College Program University of Minnesota Duluth 2305 East Fifth Street Duluth, MN 55812 1445 David Skelly, Ph. D. Associate Professor of Ecology Yale School of Forestry and Environmental Studies 370 Prospect Street Greeley Laboratory # 119 New Haven, CT 06511 Richard Wassersug, Ph. D. Professor Department of Anatomy & Neurobiology Sir Charles Tupper Medical Building 5850 College Street Dalhousie University Halifax, Nova Scotia B3H 1X5 CANADA


[Federal Register Volume 82, Number 140 (Monday, July 24, 2017)]
[Notices]
[Page 34309]
[FR Doc No: 2017-15429]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR17-15-000]

Western Refining Conan Gathering, LLC; Notice of Petition for
Declaratory Order

    Take notice that on July 12, 2017, pursuant to Rule 207(a)(2) of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207(a)(2) (2016), Western Refining
Conan Gathering, LLC (Western), filed a petition for a declaratory
order seeking approval of the tariff rate structure and terms of
service for phase I of its proposed Conan Crude Oil Gathering Pipeline
System, as more fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for review in the Commission's Public
Reference Room in Washington, DC. There is an eSubscription link on the
Web site that enables subscribers to receive email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on August 11, 2017.

    Dated: July 17, 2017.
 Kimberly D. Bose,
Secretary.
[FR Doc. 2017-15429 Filed 7-21-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 144 (Monday, July 27, 2020)]
[Notices]
[Pages 45275-45276]
[FR Doc No: 2020-16155]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-89358; File No. SR-NASDAQ-2020-027]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Designation of a Longer Period for Commission Action on a
Proposed Rule Change To Apply Additional Initial Listing Criteria for
Companies Primarily Operating in Restrictive Markets

July 21, 2020

    On May 29, 2020, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to apply additional initial listing criteria for
companies primarily operating in a jurisdiction that has secrecy laws,
blocking statues, national security laws or other laws or regulations
restricting access to information by regulators of U.S.-listed
companies in such jurisdiction. The proposed rule change was published
for

comment in the Federal Register on June 12, 2020.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 89027 (June 8,
2020), 85 FR 35962. Comments on the proposed rule change can be
found at: https://www.sec.gov/comments/sr-nasdaq-2020-027/srnasdaq2020027.htm.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding, or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the notice for this proposed rule change
is July 27, 2020. The Commission is extending this 45-day time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to take action on the proposed rule change so that it has
sufficient time to consider the proposed rule change and the comments
received. Accordingly, the Commission, pursuant to Section 19(b)(2) of
the Act,\5\ designates September 10, 2020 as the date by which the
Commission shall either approve or disapprove, or institute proceedings
to determine whether to disapprove, the proposed rule change (File No.
SR-NASDAQ-2020-027).
---------------------------------------------------------------------------

    \5\ Id.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-16155 Filed 7-24-20; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: January 18, 2011 (Volume 76, Number 11)]
[Notices]
[Page 2931]
[DOCID:fr18ja11-98]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday, January
20, 2011 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matters at the Closed Meeting.
    Commissioner Paredes, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Thursday,
January 20, 2011 will be:

Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings; and
Other matters relating to enforcement proceedings.

    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: January 13, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-1074 Filed 1-13-11; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Notices]
[Pages 16409-16410]
[FR Doc No: 2011-6658]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0038; FRL-8868-3]

Summitec Corporation; Transfer of Data

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces that pesticide related information
submitted to EPA's Office of Pesticide Programs (OPP) pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (FFDCA), including information
that may have been claimed as Confidential Business Information (CBI)
by the submitter, will be transferred to Summitec Corporation in

accordance with 40 CFR 2.307(h)(3) and 2.308(i)(2). Summitec
Corporation has been awarded a contract to perform work for OPP, and
access to this information will enable Summitec Corporation to fulfill
the obligations of the contract.

DATES: Summitec Corporation will be given access to this information on
or before March 28, 2011.

FOR FURTHER INFORMATION CONTACT: Mario Steadman, Information Technology
and Resources Management Division (7502P), 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?

    This action applies to the public in general. As such, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. 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 get copies of this document and other related information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0038. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. Contractor Requirements

    Under these contract numbers, the contractor will perform the
following: Support OPP and Agency position documents, review the
scientific technical assessments of potential hazards, exposures, and
risks of pesticides and their components to human health and the
environment. In addition, the contractor shall create Data Evaluation
Records including converting information such as the materials and
methods of a study into a format specified by the Program Office
including secondary and Quality Assurance (QA) contractor reviews, as
specified. The contractor may be tasked to draft risk assessments,
final rules for tolerances or tolerance exemptions, and regulatory
documents such as Biopesticide Regulatory Action Documents. This
contract involves no subcontractors.
    OPP has determined that the contracts described in this document
involve work that is being conducted in connection with FIFRA.
Pesticide chemicals will be the subject of certain evaluations to be
made under this contract. These evaluations may be used in subsequent
regulatory decisions under FIFRA. Some of this information may be
entitled to confidential treatment. The information has been submitted
to EPA under sections 3, 4, 6, and 7 of FIFRA and under sections 408
and 409 of FFDCA.
    In accordance with the requirements of 40 CFR 2.307(h)(3), the
contracts with Summitec Corporation prohibits use of the information
for any purpose not specified in these contracts; prohibits disclosure
of the information to a third party without prior written approval from
the Agency; and requires that each official and employee of the
contractor sign an agreement to protect the information from
unauthorized release and to handle it in accordance with the FIFRA
Information Security Manual. In addition, Summitec Corporation is
required to submit for EPA approval a security plan under which any CBI
will be secured and protected against unauthorized release or
compromise. No information will be provided to Summitec Corporation
until the requirements in this document have been fully satisfied.
Records of information provided to Summitec Corporation will be
maintained by EPA Project Officers for these contracts. All information
supplied to Summitec Corporation by EPA for use in connection with
these contracts will be returned to EPA when Summitec Corporation has
completed its work.

List of Subjects

    Environmental protection, Business and industry, Government
contracts, Government property, Security measures.

    Dated: March 15, 2011.
Oscar Morales,
Director, Information Technology and Resources Management Division,
Office of Pesticide Programs.
[FR Doc. 2011-6658 Filed 3-22-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Notices]
[Page 71608]
[FR Doc No: 2022-25559]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14867-003]

Scott's Mill Hydro, LLC; Notice of Technical Conference

    On Thursday, December 1, 2022, Commission staff will hold a
technical conference to provide clarification to Scott's Mill Hydro,
LLC regarding deficiencies in the final license application and
additional information needs identified by Commission staff for the
proposed Scott's Mill Hydroelectric Project No. 14867.\1\
---------------------------------------------------------------------------

    \1\ Commission staff's letter identifying deficiencies and
requesting additional information is available at: https://elibrary.ferc.gov/eLibrary/docinfo?accession_number=20221020-3051.
---------------------------------------------------------------------------

    The technical conference will begin at 9:30 a.m. Eastern Standard
Time. The conference will be held at the Federal Energy Regulatory
Commission headquarters building located at 888 1st Street NE,
Washington, DC, and will include teleconference capabilities.
Discussion topics for the technical conference are included in Appendix
A.
    All local, state, and federal agencies, Indian tribes, and other
interested parties are invited to participate. There will be no
transcript of the conference, but a summary of the meeting will be
prepared for the project record. If you are interested in participating
in the meeting you must contact Jody Callihan at<PHONE_NUMBER> or
[email protected] by November 28, 2022 to receive specific
instructions on how to participate.

    Dated: November 15, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-25559 Filed 11-22-22; 8:45 am]
BILLING CODE 6717-01-P


54818 Federal Register / Vol. 68, No. 182 / Friday, September 19, 2003 / Rules and Regulations * * * * * [ FR Doc. 03   23854 Filed 9   18   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0282; FRL   7324   6]

Butafenacil; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a tolerance for residues of butafenacil ( 1,1 dimethyl 2 oxo 2( 2 propenyloxy) ethyl 2 chloro 5[ 3,6 dihydro 3 methyl 2,6 dioxo 4 ( trifluoromethyl) 1( 2H) pyrimidinyl] benzoate) in or on cotton and livestock commodities. Syngenta Crop Protection, Inc. requested this tolerance 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 September 19, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0282, must be received on or before November 18, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   5697; e mail address: Tompkins. Jim@ epa. gov.

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)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) 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. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit II. 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 Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0282. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of February 26, 2003 ( 68 FR 8896) ( FRL   7293   9), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of a pesticide petition ( PP 1F6309) by Syngenta Crop Protection, Inc., P. O. Box 18300, Greensboro, NC 27419   8300. That notice included a summary of the petition prepared by Syngenta Crop Protection, Inc., the registrant. There were no comments received in response to the notice of filing. The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the herbicide butafenacil, the [ 2+ 2] cycloaddition dimer of butafenacil, and CGA 293731 in or on cotton, undelinted seed at 0.5 parts per million ( ppm); and in or on cotton, gin byproducts at 13.0 ppm. Section 408( b)( 2)( A)( i) of the 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 the 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 the 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 the final rule on Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997) ( FRL   5754   7).

III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the VerDate jul< 14> 2003 15: 30 Sep 18, 2003 Jkt 200001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19SER1. SGM 19SER1 54819 Federal Register / Vol. 68, No. 182 / Friday, September 19, 2003 / Rules and Regulations 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 the FFDCA, for a tolerance for residues of butafenacil and CGA 293731 on cattle, kidney; goat, kidney; hog, kidney; horse, kidney; and sheep, kidney at 0.05 parts per million ( ppm); in or on cattle, liver; goat, liver; hog, liver; horse, liver; and sheep, liver at 0.50 ppm; and tolerances for residues of butafenacil in or on cotton, undelinted seed at 0.50 ppm; and in or on cotton, gin byproducts at 10 ppm. EPA's assessment of exposures and risks associated with establishing these tolerances follows.

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. The nature of the toxic effects caused by butafenacil are discussed in Table 1 of this unit as well as the no observed adverse effect level ( NOAEL) and the lowest observed adverse effect level ( LOAEL) from the toxicity studies reviewed.

TABLE 1.   ACUTE TOXICITY OF BUTAFENACIL Guideline number Study Type Results Toxicity Category 870.1100 Acute oral Lethal dose ( LD) 50 > 5,000 milligrams/ kilogram ( mg/ kg) male and female ( M/ F) IV 870.1200 Acute dermal LD50 > 2,000 mg/ kg M/ F III 870.1300 Acute inhalation Lethal concentration ( LC) 50 > 5.10 milligrams per Liter ( mg/ L) IV 870.2400 Primary eye irritation Ocular irritation resolved within 96 hours III 870.2500 Primary skin irritation Not an irritant IV 870.2600 Dermal sensitization Not a sensitizer Not Applicable ( NA)

TABLE 2.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline number Study Type Results 870.3100 90   Day oral ( dietary) toxicity rodents ( rat) NOAEL = 300 ppm ( 18.8/ 20.6 mg/ kg/ day M/ F) LOAEL = 1,000 ppm ( 62.3/ 69.3 mg/ kg/ day M/ F), based on decreased body weight gains, decreased hemoglobin, hematocrit mean corpuscular hemoglobin ( MCH), mean corpuscular volume ( MCV), increased red cell volume, increased bone marrow hypercellularity; increased bilirubin and urobilinogen; increased alanine aminotransferase; hepatocyte necrosis; inflammatory liver cell infiltration 870.3100 90   Day oral ( dietary) toxicity in rodents ( mouse) NOAEL = 30 ppm ( 4.11/ 5.67 mg/ kg/ day M/ F) LOAEL = 100 ppm ( 13.8/ 20.1 mg/ kg/ day M/ F), based on hepatic histopathology: fatty change, glycogen deposition, and hypertrophy in both sexes 870.3150 90   Day oral ( capsule) toxicity in non rodents ( dog) NOAEL = 200 mg/ kg/ day M/ F LOAEL = 1,000 mg/ kg/ day M/ F, based on decreases in MCV and MCH in males; increases in RDW, HDW, platelets and triglycerides in males; and hemosiderosis in spleen and liver and extramedullary hematopoiesis the spleen in males 870.3200 28   Day dermal toxicity ( rat) NOAEL = 1,000 mg/ kg/ day LOAEL = not determined 870.3700 Prenatal developmental toxicity in rodents ( rat) Maternal NOAEL = 1,000 mg/ kg/ day Maternal LOAEL = not determined Developmental NOAEL = 1,000 mg/ kg/ day Developmental LOAEL = not determined 870.3700 Prenatal developmental toxicity in non rodents ( rabbit Maternal NOAEL = 100 mg/ kg/ day Maternal LOAEL = 1,000 mg/ kg/ day based on decreased body weight gains and food consumption during the treatment period and on blood stained vaginal discharge ( related to total litter loss) in two doses Developmental NOAEL = 100 mg/ kg/ day Developmental LOAEL = 1,000 mg/ kg/ day based on increased early resorptions and post implantation loss VerDate jul< 14> 2003 15: 30 Sep 18, 2003 Jkt 200001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19SER1. SGM 19SER1 54820 Federal Register / Vol. 68, No. 182 / Friday, September 19, 2003 / Rules and Regulations TABLE 2.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline number Study Type Results 870.3800 2   Generation reproduction and fertility effects Parental/ systemic NOAEL = 30 ppm ( 2.4/ 2.5 mg/ kg/ day M/ F) Parental/ systemic LOAEL = 300 ppm ( 23.8/ 25.2 mg/ kg/ day M/ F), based on decreased body weights and food consumption and on increased incidences of bile duct hyperplasia and liver necrosis in males and females of both generations Offspring NOAEL = 300 ppm ( 23.8/ 25.2 mg/ kg/ day M/ F) Offspring LOAEL = 1,000 ppm ( 79.6/ 83.8 M/ F), based on decreased pup body weight and body weight gain in both generations Reproductive NOAEL = 30 ppm ( 2.4/ 2.5 mg/ kg/ day M/ F) Reproductive LOAEL = 300 ppm ( 23.8/ 25.2 mg/ kg/ day M/ F) based on an increase in the number of days to mating in both generations 870.4100 1   Year chronic oral ( capsule toxicity ( dog) NOAEL = 500 mg/ kg/ day M/ F LOAEL = 1,000 mg/ kg/ day M/ F, based on decreased body weight gain in males, decreased MCV, MCH, and mean corpuscular hemoglobin concentration ( MCHC); increased thrombocytes and red cell volume distribution width; hepatic histopathology: glycogen disposition, inclusion bodies in cytoplasm, and pigment disposition in both sexes, and focal vaculolation in females 870.4200 18   Month carcinogenicity dietary study ( mouse) NOAEL = 10 ppm ( 1.17/ 1.20 mg/ kg/ day M/ F) LOAEL = 60 ppm ( 6.96/ 6.59 mg/ kg/ day M/ F), based on enlarged livers with increased weights, and hepatic microscopic lesions including Kupffer cell hyperplasia, inflammatory cell infiltration and single cell necrosis in both sexes and on deposits of lipofuscin in males No evidence of carcinogenicity 870.4300 Combined 2   Year chronic/ carcinogenicity dietary study ( rat) NOAEL = 100 ppm ( 3.76/ 4.43 mg/ kg/ day M/ F) LOAEL = 300 ppm ( 11.4/ 13.0 mg/ kg/ day M/ F), based on minimal hepatic abnormalities in the females, including a fatty change and increased mitotic activity No evidence of carcinogenicity 870.5100 In vitro bacterial gene mutation Negative in a reverse gene mutation assay in strains TA98, TA100, TA102, TA1535, TA1537 of S. typhimurium and strain WP2( uvrA) of E. coli in the presence and absence of mammalian metabolic activation 870.5300 In vitro mammalian cells in culture Evidence of borderline induction of mutant colonies in presence of S9 in a mammalian cell gene mutation assay at the hypoxanthine guanine phophoribosyl transferase ( HGPRT) locus of Chinese hamster V79 cells 870.5375 In vitro mammalian cytogenetics Negative. No evidence of increase in chromosome aberrations over background 870.5395 In vivo mammalian cytogenetics  micronucleus assay ( mouse) Negative. No increase in frequency of micronucleated polychromatic erythrocytes 870.5550 Other genotoxicity  unscheduled DNA synthesis ( UDS) in vivo/ in vitro Negative. No evidence of induction of UDS; no indications of induction of DNA damage 870.5550 Other genotoxicity  UDS  in vitro Negative. No evidence of induction of UDS; no indications of induction of DNA damage in primary rat hepatocytes in culture 870.6200 Acute neurotoxicity screening battery ( rat) NOAEL = 2,000 mg/ kg LOAEL = Not determined No evidence of neurotoxicity 870.6200 Subchronic neurotoxicity screening battery ( rat) NOAEL = 300 ppm 21/ 24 mg/ kg/ day M/ F LOAEL = 1,000 ppm 72/ 76 mg/ kg/ day M/ F, based on liver histopathology and decreased motor activity at week 13 in the males No evidence of neurotoxicity VerDate jul< 14> 2003 15: 30 Sep 18, 2003 Jkt 200001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19SER1. SGM 19SER1 54821 Federal Register / Vol. 68, No. 182 / Friday, September 19, 2003 / Rules and Regulations TABLE 2.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline number Study Type Results 870.7485 Metabolism and pharmacokinetics ( rat) Overall recovery of administered radioactivity exceeded 95%, most ( 74   93%) of which was eliminated in the feces. Approximately 4   15% of the administered radioactivity was excreted in the urine over 168 hours while tissue residues were negligible thereby implying limited absorption. No radioactivity was detected in expired air. Excretion of radioactivity was > 90% complete by 48 hours. Up to six components were detected in the urine of rats from both dose groups, the most prevalent being an hydrolysis product, CGA 293731 which represented > 90% of urinary radioactivity. Urinary elimination of metabolites was quantitatively greater in female rats than in males. Only minor amounts ( near detection limits) of parent compound were detected in the urine of high dose males. Based upon biliary elimination, ¥ 74   79% of the dose entered the hepatobiliary pathway but was eliminated via the feces. An increase in parent compound in feces of the high dose group was indicative of saturated absorption and/ or saturated metabolism, but could not be definitively resolved due to the absence of biliary elimination studies at the high dose. Biliary elimination studies revealed that approximately 60   64% of the administered low dose was detected in 0   4 hour pooled bile samples and that the majority of fecal radioactivity could be attributed to biliary metabolites 870.7485 Mechanistic studies Effects on enzymes of cultured mouse, rat, and/ or human hepatocytes involved with heme biosynthesis 870.7485 Mechanistic studies Effects on liver microsomal and plasma protox activity and its metabolic conversion 870.7485 Mechanistic studies Effects on porphyrin profile in rats; treatment induced porphyria, consisting of accumulation of selected porphyrins in the liver, spleen, and plasma and increased excretion in urine and feces 870.7485 Mechanistic studies Test substance interferes with heme biosynthesis in rats, as evidenced by dose dependent, pronounced porphyria in the liver, spleen, and plasma; increased porphyrin excretion, and decreased activity of various isoenzymes of the hepatic microsomal cytochrome P450 system 870.7485 Mechanistic studies Test substance interferes with heme biosynthesis in mice, as evidenced by dose dependent, pronounced porphyria in the liver, spleen, and plasma; increased porphyrin excretion, and decreased activity of various isoenzymes of the hepatic microsomal cytochrome P450 system 870.7485 Mechanistic studies Effects on porphyrin profile in mice; treatment induced porphyria, consisting of accumulation of selected porphyrins in the tissue and plasma, and increased excretion of heme precursors B. Toxicological Endpoints The dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the margin of exposure ( MOE). 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. A UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/ UF). Where an additional safety factors ( SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF. For non dietary risk assessments ( other than cancer) the UF is used to determine the level of concern ( LOC). For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOAEL/ exposure) is calculated and compared to the LOC. A summary of the toxicological endpoints for butafenacil used for human risk assessment is shown in Table 3 of this unit:

VerDate jul< 14> 2003 15: 30 Sep 18, 2003 Jkt 200001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19SER1. SGM 19SER1 54822 Federal Register / Vol. 68, No. 182 / Friday, September 19, 2003 / Rules and Regulations TABLE 3.   TOXICOLOGICAL DOSE AND ENDPOINTS FOR BUTAFENACIL Exposure Scenario Dose Used in Risk Assessment UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute dietary ( General population including infants and children) None NA An endpoint attributable to a single dose is not available in the data base Chronic dietary ( All populations NOAEL= 1.2 mg/ kg/ day UF = 100 Chronic RfD = 0.012 mg/ kg/ day Special FQPA SF = 1 cPAD = chronic RfD Special FQPA SF = 0.012 mg/ kg/ day Mouse oncogenicity study The LOAEL is 6.96 mg/ kg/ day, based on enlarged livers with increased weights, and hepatic microscopic lesions including Kupffer cell hyperplasia, inflammatory cell infiltration, and single cell necrosis in both sexes and on deposits of lipofuscin in males Short term inhalation ( 1 to 30 days) Oral NOAEL = 18.8 mg/ kg/ day Residential LOC for MOE = 100 Occupational = 100 90   day rat feeding study The LOAEL for this study is 62.3 mg/ kg/ day based on decreased hemoglobin, hematocrit, mean corpuscular hemoglobin mean corpuscular volume, increased red cell volume distribution width, and increased incidence of bone marrow hypercellularity Short term incidental oral ( 1 to 30 days) NOAEL = 18.8 mg/ kg/ day Residential LOC for MOE = 100 Occupational = NA 90   day rat feeding study The LOAEL for this study is 62.3 mg/ kg/ day, based on decreased hemoglobin, hematocrit, mean corpuscular hemoglobin mean corpuscular volume, increased red cell volume distribution width, and increased incidence of bone marrow hypercellularity Intermediate term incidental oral ( 1   6 months) NOAEL = 18.8 mg/ kg/ day Residential LOC for MOE = 100 Occupational = NA 90   day rat feeding study The LOAEL for this study is 62.3 mg/ kg/ day, based on decreased hemoglobin, hematocrit, mean corpuscular hemoglobin mean corpuscular volume, increased red cell volume distribution width, and increased incidence of bone marrow hypercellularity Dermal ( All durations) NA NA Quantification of dermal risk assessment is not required due to lack of concern for dermal, systemic or developmental toxicity Short term inhalation ( 1 to 30 days) Oral NOAEL = 18.8 mg/ kg/ day Residential LOC for MOE = 100 Occupational = 100 90   day rat feeding study The LOAEL for this study is 62.3 mg/ kg/ day based on decreased hemoglobin, hematocrit, mean corpuscular hemoglobin mean corpuscular volume, increased red cell volume distribution width, and increased incidence of bone marrow hypercellularity Intermediate term inhalation ( 1 to 6 months) Oral NOAEL = 18.8 mg/ kg/ day Residential LOC for MOE = 100 Occupational = 100 90   day rat feeding study The LOAEL for this study is 62.3 mg/ kg/ day, based on decreased hemoglobin, hematocrit, mean corpuscular hemoglobin mean corpuscular volume, increased red cell volume distribution width, and increased incidence of bone marrow hypercellularity VerDate jul< 14> 2003 15: 30 Sep 18, 2003 Jkt 200001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19SER1. SGM 19SER1 54823 Federal Register / Vol. 68, No. 182 / Friday, September 19, 2003 / Rules and Regulations TABLE 3.   TOXICOLOGICAL DOSE AND ENDPOINTS FOR BUTAFENACIL   Continued Exposure Scenario Dose Used in Risk Assessment UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Long term inhalation (> 6 months) Oral NOAEL = 1.2 mg/ kg/ day Residential LOC for MOE = 100 Occupational = 100 Mouse oncogenicity study The LOAEL is 6.96 mg/ kg/ day, based on enlarged livers with increased weights, and hepatic microscopic lesions including Kupffer cell hyperplasia, inflammatory cell infiltration, and single cell necrosis in both sexes and on deposits of lipofuscin in males Cancer ( oral, dermal, inhalation NA NA Classified as `` not likely to be carcinogenic to humans''

* The reference to the Special FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment 1. Dietary exposure from food and feed uses. No tolerances have previously been established for butafenacil. Risk assessments were conducted by EPA to assess dietary exposures from butafenacil in food as follows: i. Acute exposure. Quantitative acute dietary 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 appropriate endpoint attributable to a single exposure was identified for butafenacil in either the general population or to the subpopulation of females 13   50 years old, therefore no acute exposure assessment was performed. ii. Chronic exposure. In conducting this chronic dietary risk assessment, the Dietary Exposure Evaluation Model Food Commodity Intake Database ( DEEM FCID   ) analysis evaluated the individual food consumption 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 dietary exposure analysis assumed 100% crop treated and tolerance level residues or maximum field trial residues. Based on total food exposure for butafenacil, all population subgroups are below 1% cPAD. iii. Cancer. Butafenacil showed no evidence of carcinogenicity in animal tests in two different species, and therefore, a quantitative cancer risk assessment was not performed. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for butafenacil 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 butafenacil. The Agency uses the First Index Reservoir Screening Tool ( FIRST) or the Pesticide Root Zone/ Exposure Analysis Modeling System ( PRZM/ EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The screening concentration in ground water ( SCI GROW) model is used to predict pesticide concentrations in shallow ground water. For a screeninglevel assessment for surface water EPA will use FIRST ( a Tier I model) before using PRZM/ EXAMS ( a Tier II model). The FIRST model is a subset of the PRZM/ EXAMS model that uses a specific high end runoff scenario for pesticides. While both FIRST and PRZM/ EXAMS incorporate an index reservoir environment, the PRZM/ EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health LOC. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a % RfD or % PAD. Instead drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to butafenacil they are further discussed in Unit III. E. Based on the FIRST and SCI GROW models, the EECs of butafenacil for chronic exposures are estimated to be 0.049 parts per billion ( ppb) for surface water and 0.00095 ppb for ground water. 3. From non dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Butafenacil is not proposed for registration for use on any sites that would result in residential exposure. 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.'' EPA does not have, at this time, available data to determine whether butafenacil has a common mechanism of toxicity with other substances. 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 butafenacil and any other substances VerDate jul< 14> 2003 15: 30 Sep 18, 2003 Jkt 200001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19SER1. SGM 19SER1 54824 Federal Register / Vol. 68, No. 182 / Friday, September 19, 2003 / Rules and Regulations and butafenacil 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 butafenacil 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 the 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 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. 2. Prenatal and postnatal sensitivity. There are no residual concerns regarding prenatal or postnatal toxicity or completeness of the toxicity or exposure data base. 3. Conclusion. There is a complete toxicity data base for butafenacil and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X SF to protect infants and children could be reduced to 1X. The FQPA factor was reduced because:   There is no quantitative or qualitative evidence of increased susceptibility of rat and rabbit fetuses to in utero exposure in developmental studies or to in utero and postnatal exposure to rats in the 2   generation reproduction study.   There are no residential uncertainties for prenatal or postnatal toxicity.   The toxicological data base is complete for the assessment of toxicity and susceptibility following prenatal and/ or postnatal exposures. No clinical signs of neurotoxicity or neuropathology were observed in the data base, and the developmental neurotoxicity study was not required.   There are no residual concerns regarding prenatal or postnatal toxicity or completeness of the toxicity or exposure data base.   The dietary food exposure assessment is Tier I, screening level, which is based on tolerance level residues or maximum field trial residues and assumes 100% of all crops will be treated with chemical. By using these screening level assessments, actual exposures/ risks will not be underestimated.   The dietary drinking water assessment utilizes water concentration values generated by health protective, high end estimates of water concentrations which will not likely be exceeded.   There are currently no registered residential uses of butafenacil.   These assessments will not underestimate the exposure/ risks posed by current or proposed uses of butafenacil.

E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water ( EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water ( e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD  ( average food + residential exposure)). This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by EPA's Office of Water are used to calculate DWLOCs: 2 L/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short term, intermediate term, chronic, and cancer. When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Acute risk. No acute risk from exposure to butafenacil is expected because there were no toxic effects of concern attributable to a single dose identified in available data. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to butafenacil from food will utilize < 1% of the cPAD for the U. S. population, < 1% of the cPAD for infants ages 1   2, and < 1% of the cPAD for children ages 3   5. There are no proposed residential uses for butafenacil that result in chronic residential exposure to butafenacil. In addition, there is potential for chronic dietary exposure to butafenacil in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 4 of this unit:

VerDate jul< 14> 2003 15: 30 Sep 18, 2003 Jkt 200001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19SER1. SGM 19SER1 54825 Federal Register / Vol. 68, No. 182 / Friday, September 19, 2003 / Rules and Regulations TABLE 4.   AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON CANCER) EXPOSURE TO BUTAFENACIL Population cPAD ( mg/ kg/ day) % cPAD ( mg/ kg/ day) Chronic Food Exposure1 ( mg/ kg/ day) Ground Water EEC2 ( ppb) Surface Water EEC2 ( ppb) Chronic DWLOC3 ( ppb)

General U. S. population 0.012 < 1% 0.000041 0.00095 0.049 420 All infants (< 1 year old) 0.012 < 1% 0.000014 0.00095 0.049 120 Children ( 1   2 years old) 0.012 < 1% 0.000097 0.00095 0.049 120 Children ( 3   5 years old) 0.012 < 1% 0.000104 0.00095 0.049 120 Children ( 6   12 years old) 0.012 < 1% 0.000069 0.00095 0.049 120 Youth ( 13   19 years old) 0.012 < 1% 0.000036 0.00095 0.049 360 Adults ( 20   49 years old) 0.012 < 1% 0.000033 0.00095 0.049 420 Females ( 13   49 years old) 0.012 < 1% 0.000030 0.00095 0.049 360 Adults ( 50+ years old) 0.012 < 1% 0.000031 0.00095 0.049 420 1 Maximum chronic water exposure ( mg/ kg/ day) = cPAD ( mg/ kg/ day)  chronic food exposure from DEEM ( mg/ kg/ day); no res. exp. 2 Parent plus CGA 293731; cotton application scenario  1 x 0.141 lb ai/ acre; maximum proposed rate 3DWLOC( µ g/ L) = ( allowable water exposure ( mg/ kg/ day) x body weight ( kg) x 1,000 µ g/ mg) ÷ ( water consumption ( liters)) Consumption = 1 L/ day for populations < 13 years old and 2 L/ day for populations   13 years old. Default body weights = 70 kg for general U. S. population and adult males, 60 kg for youth and females   13 years old, and 10 kg for all others.

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). Butafenacil is not proposed for registrations for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 4. Intermediate term risk. Intermediate term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Butafenacil is not proposed for registrations for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 5. Aggregate cancer risk for U. S. population. Butafenacil is not expected to pose a cancer risk because no evidence of carcinogenicity was found in adequate animal tests in two different species, therefore no aggregate cancer risk assessment was performed. 6. 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 butafenacil residues. IV. Other Considerations A. Analytical Enforcement Methodology Syngenta Crop Protection, Inc. proposed Syngenta Method 131   99 for enforcement of the proposed cotton tolerances ( adequate validation, independent laboratory validation ( ILV), and radiovalidation data have been submitted). The petitioner did not propose ruminant liver and kidney tolerances and therefore did not propose a method for enforcement of the recommended ruminant liver and kidney tolerances. The petitioner has and will submit an enforcement method, adequate validation, ILV, and radiovalidation for enforcement of the ruminant liver and kidney tolerances as a condition of registration.

B. International Residue Limits Canada, Codex, and Mexico do not have maximum residue limits for residues of butafenacil in/ on cotton. Therefore, harmonization is not an issue.

C. Conditions As a condition of registration, the petitioner must submit: 1. A ruminant liver and kidney enforcement method and submit adequate validation, ILV, and radiovalidation data. 2. Submit confirmatory data on the frozen storage stability of residues of butafenacil in or on cottonseed, cotton gin byproduct, cotton hull, cotton meal, and cotton oil. 3. Submit a ruminant feeding study to confirm the Agency's estimate of maximum residues of butafenacil from the goat metabolism study.

V. Conclusion Therefore, the tolerance is established for residues of butafenacil, in or on cattle, kidney; goat, kidney; hog, kidney; horse, kidney; and sheep, kidney at 0.05 ppm; in or on cattle, liver; goat, liver; hog, liver; horse, liver; and sheep, liver at 0.50 ppm; in or on cotton, undelinted seed at 0.50 ppm; and in or on cotton, gin byproducts at 10 ppm.

VI. Objections and Hearing Requests 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. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

VerDate jul< 14> 2003 15: 30 Sep 18, 2003 Jkt 200001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19SER1. SGM 19SER1 54826 Federal Register / Vol. 68, No. 182 / Friday, September 19, 2003 / Rules and Regulations A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2003   0282 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 November 18, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2003   0282, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32).

VII. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408( d) of the 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   4). 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 the 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 VerDate jul< 14> 2003 15: 30 Sep 18, 2003 Jkt 200001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19SER1. SGM 19SER1 54827 Federal Register / Vol. 68, No. 182 / Friday, September 19, 2003 / Rules and Regulations 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 the 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.

VIII. 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: September 10, 2003. James Jones, Director, Office of Pesticide Programs.

 Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

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

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

 2. Section 180.592 is added to read as follows:

§ 180.592 Butafenacil; tolerances for residues.

( a) General. ( 1) Tolerances are established for residues of the herbicide butafenacil, ( 1,1 dimethyl 2 oxo 2( 2 propenyloxy) ethyl 2 chloro 5[ 3,6 dihydro 3 methyl 2,6 dioxo 4 ( trifluoromethyl) 1( 2H) pyrimidinyl] benzoate) in or on the following raw agricultural commodities:

Commodity Parts per million Cotton, gin byproducts ... 10 Cotton, undelinted seed 0.50 ( 2) Tolerances are established for residues of the herbicide butafenacil, ( 1,1 dimethyl 2 oxo 2( 2 propenyloxy) ethyl 2 chloro 5[ 3,6 dihydro 3 methyl 2,6 dioxo 4 ( trifluoromethyl) 1( 2H) pyrimidinyl] benzoate) and its metabolite CGA 293731 ( 1 carboxy 1 methylethyl 2 chloro 5[ 3,6 dihydro 3 methyl 2,6 dioxo 4( trifluoromethyl) 1( 2H) pyrimidinyl] benzoate), in or on the following livestock commodities:

Commodity Parts per million Cattle, kidney .................. 0.05 Cattle, liver ...................... 0.50 Goats, kidney .................. 0.05 Goats, liver ..................... 0.50 Hog, kidney ..................... 0.05 Hog, liver ........................ 0.50 Horse, kidney .................. 0.05 Horse, liver ..................... 0.50 Sheep, kidney ................. 0.05 Sheep, liver ..................... 0.50 ( b) Section 18 emergency exemptions. [ Reserved] ( c) Tolerances with regional registrations. [ Reserved] ( d) Indirect and inadvertant residues. [ Reserved] [ FR Doc. 03   23853 Filed 9   18   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0300; FRL   7324   9]

S Metolachlor; Pesticide Tolerances AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for combined residues of the herbicide S metolachlor and its metabolites in or on asparagus; carrot, roots; horseradish; onion, green; rhubarb; and swiss chard. The 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 ( FQPA) of 1996. DATES: This regulation is effective September 19, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0300, must be received on or before November 18, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Hoyt Jamerson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   9368; e mail address: jamerson. hoyt@ epa. gov.

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)   Animal production ( NAICS 112)   Food manufacturer ( NAICS 311)   Pesticide manufacturer ( NAICS 32532) 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 VerDate jul< 14> 2003 15: 30 Sep 18, 2003 Jkt 200001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19SER1. SGM 19SER1