[Federal Register: August 16, 2006 (Volume 71, Number 158)]
[Notices]
[Page 47218-47220]
[DOCID:fr16au06-85]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0598; FRL-8081-5]

Notice of Filing of a Pesticide Petition for Establishment of
Regulations for Residues of Salicylic Acid in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of an exemption from the
requirement of a tolerance for residues of the biochemical bactericide
and fungicide salicylic acid in or on various commodities.

DATES: Comments must be received on or before September 15, 2006.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0598 and pesticide petition number (PP)
6E7054, by one of the following methods:
     Federal eRulemaking Portal:  http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0598. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The Federal regulations.gov Web site is an anonymous
access system, which means EPA will not know your identity
or contact information unless you provide it in the body of your
comment. If you send an e-mail comment directly to EPA without going
through regulations.gov, your e-mail address will be automatically
captured and included as part of the comment that is placed in the
docket and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The 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 telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Chris Pfeifer, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave, NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 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. 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. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
     2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    EPA is printing a summary of a pesticide petition received under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, proposing the establishment or amendment of regulations in
40 CFR part 180 for residues of pesticide chemicals in or on various
food commodities. EPA has determined that this pesticide petition
contains data or information regarding the elements set forth in FFDCA
section 408(d)(2); however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data support granting
of the pesticide petition. Additional data may be needed before EPA
rules on this pesticide petition.

    Pursuant to 40 CFR 180.7(f), a summary of the petition included in
this notice, prepared by the petitioner is available on EPA's
Electronic Docket at http://www.regulations.gov. To locate this

information on the home page of EPA's Electronic Docket, select ``Quick
Search'' and type the OPP docket ID number. Once the search has located
the docket, clicking on the ``Docket ID'' will bring up a list of all
documents in the docket for the pesticide including the petition
summary.

New Exemption from Tolerance

     PP 6E7054. Morse Enterprises Limited, Inc., Brickell East, Floor
10, 151 S.E. 15 Road, Miami, Florida 33129, proposes to establish an
exemption from the requirement of a tolerance for residues of the
biochemical bactericide and fungicide, salicylic acid, in or on all
food commodities. Because this petition is a request for an exemption
from the requirement of a tolerance without numerical limitations, no
analytical method is required.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: July 26, 2006.
Phillip Hutton,
Acting Director, Biopesticides and Pollution Prevention Division,
Office of Pesticide Programs.

[FR Doc. E6-13488 Filed 8-15-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 88, Number 90 (Wednesday, May 10, 2023)]
[Notices]
[Pages 30125-30126]
[FR Doc No: 2023-09942]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-101-005]

Transcontinental Gas Pipe Line Company, LLC; Notice of Request
for Extension of Time

    Take notice that on April 27, 2023, Transcontinental Gas Pipe Line
Company, LLC (Transco) requested that the Federal Energy Regulatory
Commission (Commission) grant an extension of time, until May 3, 2025,
to construct and place into service, its Northeast Supply Enhancement
(NESE) Project located in Pennsylvania, onshore and offshore New
Jersey, and offshore New York as authorized in the Order

Issuing Certificate (Order).\1\ Ordering Paragraph (B)(1) of the Order
required Transco to complete the construction of the NESE Project
facilities and make them available for service within two years of the
date of the Order, or by May 3, 2021.
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    \1\ Transcontinental Gas Pipe Line Company, LLC, 167 FERC ]
61,110 (2019).
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    On May 20, 2021, the Commission granted Transco an extension of
time, until May 3, 2023, to complete construction of the NESE Project
and make it available for service.\2\ Construction on the NESE Project
has not begun. Transco states that it continues to review the scope of
work for the NESE Project to not only meet Brooklyn Union Gas Company
and KeySpan Gas East Corporation's (collectively, National Grid) firm
transportation capacity needs but also to address water quality
concerns raised by New York and New Jersey in their respective denials
of water quality certification for the project under section 401 of the
Clean Water Act. Transco asserts that the continuing need for the NESE
Project is demonstrated by the 15-year term precedent agreements with
National Grid for the entirety of the NESE Project's capacity, which
remain in full force and effect. As a result, Transco now requests an
additional two years, or until May 3, 2025, to complete construction of
the NESE Project and make it available for service.
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    \2\ Transcontinental Gas Pipe Line Company, LLC, 175 FERC ]
61,148 (2021).
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    This notice establishes a 15-calendar day intervention and comment
period deadline. Any person wishing to comment on Transco's request for
an extension of time may do so. No reply comments or answers will be
considered. If you wish to obtain legal status by becoming a party to
the proceedings for this request, you should, on or before the comment
date stated below, file a motion to intervene in accordance with the
requirements of the Commission's Rules of Practice and Procedure (18
CFR 385.214 or 385.211) and the Regulations under the Natural Gas Act
(NGA) (18 CFR 157.10).
    As a matter of practice, the Commission itself generally acts on
requests for extensions of time to complete construction for NGA
facilities when such requests are contested before order issuance. For
those extension requests that are contested,\3\ the Commission will aim
to issue an order acting on the request within 45 days.\4\ The
Commission will address all arguments relating to whether the applicant
has demonstrated there is good cause to grant the extension.\5\ The
Commission will not consider arguments that re-litigate the issuance of
the certificate order, including whether the Commission properly found
the project to be in the public convenience and necessity and whether
the Commission's environmental analysis for the certificate complied
with the National Environmental Policy Act.\6\ At the time a pipeline
requests an extension of time, orders on certificates of public
convenience and necessity are final and the Commission will not re-
litigate their issuance.\7\ The OEP Director, or his or her designee,
will act on all of those extension requests that are uncontested.
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    \3\ Contested proceedings are those where an intervenor disputes
any material issue of the filing. 18 CFR 385.2201(c)(1) (2022).
    \4\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
    \5\ Id. at P 40.
    \6\ Similarly, the Commission will not re-litigate the issuance
of an NGA section 3 authorization, including whether a proposed
project is not inconsistent with the public interest and whether the
Commission's environmental analysis for the permit order complied
with National Environmental Policy Act.
    \7\ Algonquin Gas Transmission, LLC, 170 FERC ] 61,144, at P 40
(2020).
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    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to Commission's Public Reference
Room. For assistance, contact FERC at [email protected] or
call toll-free,<PHONE_NUMBER> or TTY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFile'' link at
http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Federal Energy Regulatory
Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on May 19, 2023.

    Dated: May 4, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-09942 Filed 5-9-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Proposed Rules]
[Pages 13438-13440]
[FR Doc No: 2018-06246]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0137; Airspace Docket No. 18-ACE-2]

Proposed Amendment and Establishment of Class E Airspace;
Columbus, NE

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace designated as a
surface area and remove the Notice to Airmen (NOTAM) part-time status,
amend Class E airspace extending upward from 700 feet above the
surface, and establish Class E airspace designated as an extension to
the Class E surface area at Columbus Municipal Airport, Columbus, NE.
The FAA is proposing this action at the request of Minneapolis Air
Route Traffic Control Center (ARTCC) and as the result of an FAA
airspace review. Additionally, the geographic coordinates of the
airport would be updated to coincide with the FAA's aeronautical
database. This action is necessary for the safety and management of
instrument flight rules (IFR) operations at the airport.

DATES: Comments must be received on or before May 14, 2018.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2018-0137; Airspace Docket No. 18-ACE-2 at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records

Administration (NARA). For information on the availability of FAA Order
7400.11B at NARA, call<PHONE_NUMBER>, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend Class E airspace to support IFR operations at
Columbus Municipal Airport, Columbus, NE.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2018-0137;
Airspace Docket No. 18-ACE-2.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 that would:
    Amend the Class E airspace designated as a surface area within a
4.2-mile radius (reduced from a 4.7-mile radius) at Columbus Municipal
Airport, Columbus, NE; remove the Columbus VOR/DME and the extensions
to the southeast and northwest of the airport as they are no longer
needed to define this boundary; remove the NOTAM part-time language
from the airspace description; and update the geographic coordinates of
the airport to coincide with the FAA's aeronautical database;
    Establish Class E airspace designated as an extension to the Class
E surface area at Columbus Municipal Airport within 2.4 miles each side
of the Columbus VOR/DME 150[deg] radial from the 4.2-mile radius of the
airport to 7.0 miles southeast of the airport, and within 2.4 miles
each side of the Columbus VOR/DME 309[deg] radial from the 4.2-mile
radius of the airport to 7.7 miles northwest of the airport; and
    Amend Class E airspace extending upward from 700 feet above the
surface to within a 6.7-mile radius (reduced from a 7.7-mile radius) of
Columbus Municipal Airport; remove the Columbus Municipal ILS
Localizer, Platte Center NDB, and the associated northwest extension;
amend the extension to the southeast to within 2.4 miles (increased
from 1.6 miles) each side of the Columbus VOR/DME 150[deg] (previously
157[deg]) radial from the 6.7-mile radius to 7.0 miles (decreased from
11 miles) southeast of the airport; add an extension 2.4 miles each
side of the Columbus VOR/DME 309[deg] radial extending from the 6.7-
mile radius to 7.7 miles northeast of the airport; and update the
geographic coordinates of the airport to coincide with the FAA's
aeronautical database.
    Airspace reconfiguration is necessary due to a request from
Minneapolis ARTCC, to bring the airspace into compliance with FAA Order
7400.2L, Procedures for Handling Airspace, and to support the safety
and management of IFR operations at this airport.
    Class E airspace designations are published in paragraphs 6002,
6004, and 6005, respectively, of FAA Order 7400.11B, dated August 3,
2017, and effective September 15, 2017, which is incorporated by
reference in 14 CFR 71.1. The Class E airspace designations listed in
this document will be published subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small

entities under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017, and
effective September 15, 2017, is amended as follows:

Paragraph 6002 Class E Airspace Areas Designated as Surface Areas.

* * * * *

ACE NE E2 Columbus, NE [Amended]

Columbus Municipal Airport, NE
    (Lat. 41[deg]26'55'' N, long. 97[deg]20'34'' W)

Within a 4.7 mile radius of Columbus Municipal Airport.
    Paragraph 6004. Class E Airspace Areas Designated as an
Extension to a Class D or Class E Surface Area.
* * * * *

ACE MO E4 Columbus, NE [New]

Columbus Municipal Airport, NE
    (Lat. 41[deg]26'55'' N, long. 97[deg]20'34'' W)
Columbus VOR/DME
    (Lat. 41[deg]27'00'' N, long. 97[deg]20'27'' W)

That airspace extending upward from the surface within 2.4 miles
each side of the Columbus VOR/DME 150[deg] radial extending from the
4.2-mile radius of Columbus Municipal Airport to 7.0 miles southeast
of the airport, and within 2.4 miles each side of the Columbus VOR/
DME 309[deg] radial extending from the 4.2-mile radius of Columbus
Municipal Airport to 7.7 miles northwest of the airport.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ACE NE E5 Columbus, NE [Amended]

Columbus Municipal Airport, NE
    (Lat. 41[deg]26'55'' N, long. 97[deg]20'34'' W)
Columbus VOR/DME
    (Lat. 41[deg]27'00'' N, long. 97[deg]20'27'' W)

That airspace extending upward from 700 feet above the surface
within a 6.7-mile radius of Columbus Municipal Airport and within
2.4 miles each side of the Columbus VOR/DME 150[deg] radial
extending from the 6.7-mile radius to 7.0 miles southeast of the
airport and within 2.4 miles each side of the Columbus VOR/DME
309[deg]radial extending from the 6.7-mile radius to 7.7 miles
northwest of the airport.

    Issued in Fort Worth, Texas, on March 21, 2018.
Christopher L. Southerland,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2018-06246 Filed 3-28-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 187 (Friday, September 25, 2020)]
[Notices]
[Pages 60474-60476]
[FR Doc No: 2020-21186]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1816]

Lavipharm Laboratories, Inc., et al.; Proposal To Withdraw
Approval of Five Abbreviated New Drug Applications; Opportunity for a
Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is proposing to withdraw approval
of five abbreviated new drug applications (ANDAs) and is announcing an
opportunity for the ANDA holders to request a hearing on this proposal.
The basis for the proposal is that the ANDA holders have repeatedly
failed to file required annual reports for those ANDAs and have failed
to satisfy the requirement to have an approved risk evaluation and
mitigation strategy (REMS).

DATES: The ANDA holders may submit a request for a hearing by October
26, 2020. Submit all data, information, and analyses upon which the
request for a hearing relies November 24, 2020. Submit electronic or
written comments by November 24, 2020.

ADDRESSES: The request for a hearing may be submitted by the ANDA
holders by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments to submit your request
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a
hearing, will be posted to the docket unchanged.

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     Because your request for a hearing will be made public,
you are solely responsible for ensuring that your request does not
include any confidential information that you or a third party may not
wish to be posted, such as medical information, your or anyone else's
Social Security number, or confidential business information, such as a
manufacturing process. The request for a hearing must include the
Docket No. FDA-2020-N-1816 ``Lavipharm Laboratories, Inc., et al.;
Proposal To Withdraw Approval of Five Abbreviated New Drug
Applications; Opportunity for a Hearing.'' The request for a hearing
will be placed in the docket and publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
    The ANDA holders may submit all data and analyses upon which the
request for a hearing relies in the same manner as the request for a
hearing except as follows:
     Confidential Submissions--To submit any data analyses with
confidential information that you do not wish to be made publicly
available, submit your data and analyses only as a written/paper
submission. You should submit two copies total of all data and
analyses. One copy will include the information you claim to be
confidential with a heading or cover note that states ``THIS DOCUMENT
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy,
including the claimed confidential information, in its consideration of
any decisions on this matter. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov
or available at the Dockets Management Staff between 9 a.m. and 4 p.m.,
Monday through Friday,<PHONE_NUMBER>. Submit both copies to the Dockets
Management Staff. Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law.
    Comments Submitted by Other Interested Parties: For all comments
submitted by other interested parties, submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.

     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1816 for ``Lavipharm Laboratories, Inc., et al.; Proposal To
Withdraw Approval of Five Abbreviated New Drug Applications;
Opportunity for a Hearing.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 and other applicable
disclosure law. For more information about FDA's posting of comments to
public dockets, see 80 FR 56469, September 18, 2015, or access the
information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

SUPPLEMENTARY INFORMATION: The holder of an approved ANDA to market a
new drug for human use is required to submit annual reports to FDA
concerning its approved ANDA under Sec. Sec.  314.81 and 314.98 (21 CFR
314.81 and 314.98). The holders of the approved ANDAs listed in table 1
have repeatedly failed to submit the required annual reports and have
not responded to the Agency's request for submission of the reports.
    Additionally, in accordance with section 505-1 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1), the Agency
determined that a REMS is necessary for all the applicable listed drugs
that the ANDAs in table 1 reference to ensure the benefits of the
listed drugs outweigh the risks. In accordance with section 505-1(i) of
the FD&C Act, an ANDA is required to have a REMS if the applicable
listed drug has an approved REMS. We notified the holders of approved
ANDAs in table 1 of the REMS requirement on September 28, 2017. The
holders of the approved ANDAs listed in table 1 have failed to receive
approval of a REMS for their products.

    Table 1--Approved ANDAs for Which Required Reports Have Not Been
               Submitted and a REMS Has Not Been Approved
------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 077051.................  Fentanyl transdermal  Lavipharm
                               system film,          Laboratories, Inc.,
                               extended-release,     69 Princeton-
                               25 micrograms (mcg)/  Hightstown Rd.,
                               hour (hr), 50 mcg/    East Windsor, NJ
                               hr, 75 mcg/hr, and    08520.
                               100 mcg/hr.
ANDA 085217.................  Acetaminophen and     Everylife, 2021 15th
                               Codeine Phosphate     Avenue West,
                               Tablet, 325           Seattle, WA 98119.
                               milligrams (mg)/30
                               mg.
ANDA 085638.................  Acetaminophen,        Scherer
                               Aspirin, and          Laboratories, Inc.,
                               Codeine Phosphate     2301 Ohio Dr.,
                               Capsule, 150 mg/180   Suite 234, Plano,
                               mg/60 mg.             TX 75093.
ANDA 085639.................  Acetaminophen,        Do.
                               Aspirin, and
                               Codeine Phosphate
                               Capsule, 150 mg/180
                               mg/30 mg.
ANDA 085640.................  Acetaminophen,        Do.
                               Aspirin, and
                               Codeine Phosphate
                               Capsule, 150 mg/180
                               mg/15 mg.
------------------------------------------------------------------------

    Therefore, notice is given to the holders of the approved ANDAs
listed in table 1 and to all other interested persons that the Director
of CDER proposes to issue an order, under section 505(e)(2) of the FD&C
Act (21 U.S.C. 355(e)(2)), withdrawing approval of the ANDAs and all
amendments and supplements thereto on the grounds that the ANDA holders
have failed to submit reports required under Sec. Sec.  314.81 and
314.98 and section 505(k) of the FD&C Act, and have failed to receive
approval of a REMS for their products in accordance with section 505-1
of the FD&C Act.
    In accordance with section 505(e) of the FD&C Act and 21 CFR
314.150(a) and (b)(1) and 21 CFR 314.200, the ANDA holders are hereby
provided an opportunity for a hearing to show why the approval of the
ANDAs identified above should not be withdrawn and an opportunity to
raise, for administrative determination, all issues relating to the
legal status of the drug products covered by these ANDAs.

    An ANDA holder who decides to seek a hearing must file the
following: (1) a written notice of participation and request for a
hearing (see DATES and ADDRESSES) and (2) the data, information, and
analyses relied on to demonstrate that there is a genuine and
substantial issue of fact that requires a hearing (see DATES and
ADDRESSES). Any other interested person may also submit comments on
this notice. The procedures and requirements governing this notice of
opportunity for a hearing, notice of participation and request for a
hearing, the information and analyses to justify a hearing, other
comments, and a grant or denial of a hearing are contained in Sec.
314.200 (21 CFR 314.200) and in 21 CFR part 12.
    The failure of an ANDA holder to file a timely written notice of
participation and request for a hearing, as required by Sec.  314.200,
constitutes an election by that ANDA holder not to avail itself of the
opportunity for a hearing concerning CDER's proposal to withdraw
approval of the ANDAs and constitutes a waiver of any contentions
concerning the legal status of the drug products. FDA will then
withdraw approval of the ANDAs, and the drug products may not
thereafter be lawfully marketed or delivered for introduction into
interstate commerce. Any new drug product introduced or delivered for
introduction into interstate commerce without an approved ANDA is
subject to regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or
denials but must present specific facts showing that there is a genuine
and substantial issue of fact that requires a hearing (Sec.
314.200(g)). If a request for a hearing is not complete or is not
supported, the Commissioner of Food and Drugs will enter summary
judgment against the person who requests the hearing, making findings
and conclusions, and denying a hearing (Sec.  314.200(g)(1)).
    All submissions under this notice of opportunity for a hearing must
be filed in two copies. Except for data and information prohibited from
public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the
submissions may be seen at the Dockets Management Staff (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to
the docket at https://www.regulations.gov.
    This notice is issued under section 505(e)(2) of the FD&C Act and
under authority delegated to the Director of CDER by the Commissioner
of Food and Drugs.

    Dated: September 16, 2020.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 2020-21186 Filed 9-24-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 14, 2005 (Volume 70, Number 239)]
[Notices]
[Page 74003-74005]
[DOCID:fr14de05-58]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0298; FRL-7747-4]

Notice of Filing of a Pesticide Petition for the Establishment of
Regulations for Residues of the Insecticide Clothianidin in or on Food
Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of the
insecticide clothianidin in or on cotton, undelinted seed and cotton,
gin byproducts.

DATES: Comments must be received on or before January 13, 2006.

ADDRESSES: Comments, identified by docket identification (ID) number
EPA-HQ-OPP-2005-0298 and pesticide petition (PP) number 5F6908, may be
submitted electronically, by mail, or through hand delivery or courier.
Follow the detailed instructions as provided in Unit I. of the
SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:  Kable Davis, Registration Division
(7505C), Office of Pesticide Programs, U. S. Environmental Protection
Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001; phone
number:<PHONE_NUMBER>, e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 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. 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. EPA has established an official public docket for this action
under docket ID number EPA-HQ-OPP-2005-0298. 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, 1801 S. Bell St., 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. You may access this document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/
.

    Agency Web site. EDOCKET, EPA's electronic public docket and
comment system was replaced on November 25, 2005, by an enhanced
federal-wide electronic docket management and comment system located at
http://www.regulations.gov. Follow the online instructions.

    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, to 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.
    Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
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. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
    1. If you submit an electronic comment as prescribed in this unit,
EPA recommends that you include your name, mailing address, and an e-
mail address or other contact information in the body of your comment.
Also include this contact information on the outside of any disk or CD
ROM you submit, and in any cover letter accompanying the disk or CD
ROM. This ensures that you can be identified as the submitter of the
comment and allows EPA to contact you in case EPA cannot read your
comment due to technical difficulties or needs further information on
the substance of your comment. EPA's policy is that EPA will not edit
your comment, and any identifying or contact information provided in
the body of a comment will be included as part of the comment that is
placed in the official public docket, and made available in EPA's
electronic public docket. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment.
    i. Your use of EPA's electronic public docket to submit comments to
EPA electronically is EPA's preferred method for receiving comments. Go
directly to EPA Dockets at http://www.epa.gov/edocket/, and follow the

online instructions for submitting comments. Once in the system, select
``search,'' and then key in docket ID number EPA-HQ-OPP-2005-0298. The
system is an ``anonymous access'' system, which means EPA will not know
your identity, e-mail address, or other contact information unless you
provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to<EMAIL_ADDRESS>
Attention: Docket ID Number EPA-HQ-OPP-2005-0298. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number EPA-HQ-OPP-2005-
0298.
    3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
Number EPA-HQ-OPP-2005-0298. Such deliveries are only accepted during
the docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action and the pesticide petition number of
the summary in the subject line on the first page of your response. It
would also be helpful if you provided the name, date, and Federal
Register citation related to your comment.

II. What Action Is the Agency Taking?

    EPA is printing the summary of the pesticide petition received
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, proposing the establishment of regulations in 40 CFR
part 180 for residues of the insecticide clothianidin in or on cotton,
undelinted seed and cotton, gin byproducts. EPA has determined that
this pesticide petition contains data or information regarding the
elements set forth in FFDCA section 408(d)(2); however, EPA has not
fully evaluated the sufficiency of the submitted data at this time or
whether the data support granting of the pesticide petition. Additional
data may be needed before EPA rules on this pesticide petition.
    Pursuant to 40 CFR 180.7(f), a summary of the petition, prepared by
the petitioner along with a description of the analytical methods
available for the detection and measurement of the pesticide chemical
residues is available on EPA's Electronic Docket at http://www.epa.gov/edocket.
 To locate this information, on the home page of EPA's

Electronic Docket select ``Quick Search'' and type the OPP docket ID
number for the pesticide petition (as specified in Unit I.B.1.) in the
search field. Once the search has located the docket, clicking on the
``Docket ID'' will bring up a list of all documents in the docket for
the pesticide including the petition summary.

New Tolerance

    PP 5F6908. Bayer CropScience, 2 T.W. Alexander Drive, Research
Triangle Park, NC 27709, proposes to establish a tolerance for residues
of the insecticide clothianidin in or on raw agricultural commodities
cotton, undelinted seed at 0.01 parts per million (ppm); and cotton,
gin byproducts at 0.01 ppm. In plants and plant products, the residue
of concern, parent clothianidin, can be determined using High
Performance Liquid Chromatography (HPLC) with Electrospray Mass
Spectrometry/Mass Spectrometry Detection (MS/MS detection). In an
extraction efficiency testing, the plant residues method has also
demonstrated the ability to extract aged clothianidin residue. Although
the plant residues Liquid Chromatography (LC)-MS/MS method is highly
suitable for enforcement method, an LC-Ultraviolet (UV) method has also
been developed which is suitable for enforcement (monitoring) purposes
in all relevant matrices.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: December 1, 2005.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 05-23975 Filed 12-13-05; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: October 29, 2008 (Volume 73, Number 210)]
[Notices]
[Page 64317-64318]
[DOCID:fr29oc08-53]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0941; FRL-8389-2]

Carbaryl RED Amendment and Response to Petition to Cancel
Registrations; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of an amendment to
EPA's Reregistration Eligibility Decision (RED) for Carbaryl, and EPA's
response to a petition from the Natural Resources Defense Council
(NRDC), insofar as the petition seeks to have EPA cancel all
registrations for carbaryl. In the carbaryl RED amendment, EPA is
modifying certain worker risk mitigation measures that were imposed as
a result of the 2004 Interim RED for the pesticide carbaryl. EPA is
amending the carbaryl RED to incorporate the revised occupational
exposure and risk assessment for carbaryl. EPA reevaluated the carbaryl
risk assessments and regulatory decision in response to public comments
received from numerous parties, new data submitted by the technical
registrant, Bayer CropSciences, and new science and new methodologies
developed in the time between the completion of the Interim RED for
carbaryl and the completion of the cumulative risk assessment for the
N-methyl carbamate group of pesticides. This notice also announces the
availability of EPA's response to a petition from NRDC insofar as it
seeks to have EPA cancel all uses of carbaryl under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). Elsewhere in
today's Federal Register, EPA is publishing its response to NRDC's
petition insofar as it seeks to have EPA revoke all tolerances for
carbaryl under the Federal Food, Drug, and Cosmetic Act (FFDCA).

FOR FURTHER INFORMATION CONTACT: Christina Scheltema, Special Review
and Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, 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?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0941. 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>.
    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.

II. Background

A. What Action is the Agency Taking?

    This notice announces the availability of an amendment to EPA's
Reregistration Eligibility Decision (RED) for Carbaryl. EPA is amending
the carbaryl RED to incorporate the revised occupational exposure and
risk assessment for carbaryl, which was not included in the September
2007 carbaryl RED. As a result, EPA is modifying certain worker risk
mitigation measures that were imposed in the 2004 Interim RED for the
pesticide carbaryl.
    Under section 4 of FIFRA, EPA is reevaluating existing pesticides
to ensure that they meet current scientific and regulatory standards.
In 2007, EPA issued a RED for carbaryl under section 4(g)(2)(A) of
FIFRA. In 2004, EPA issued an interim RED for carbaryl. In response to
a notice of availability published in the Federal Register of October
27, 2004 (69 FR 62663) (FRL-7679-9), the Agency received comments from
the carbaryl registrant and others, including NRDC.
    This notice also announces the availability of EPA's response to a
petition submitted by NRDC insofar as the petition seeks to have EPA
cancel all registrations for carbaryl. (EPA's response to this petition
is available in the carbaryl RED docket, EPA-HQ-OPP-2007-0941.)
Elsewhere in today's Federal Register, EPA is publishing its response
to NRDC's petition insofar as it seeks to have EPA revoke all
tolerances for carbaryl under FFDCA. (See docket EPA-HQ-OPP-2008-0347.)

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2) of FIFRA, as amended, directs that, after
submission of all data concerning a pesticide active ingredient, ``the
Administrator shall determine whether pesticides containing such active
ingredient are eligible for reregistration,'' before calling in
product-specific data on individual end-use products and either
reregistering products or taking other ``appropriate regulatory
action.''

List of Subjects

    Environmental protection, Carbaryl, Pesticides.

    Dated: October 21, 2008.
Steven Bradbury,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E8-25664 Filed 10-28-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 76, Number 21 (Tuesday, February 1, 2011)]
[Notices]
[Pages 5586-5589]
[FR Doc No: 2011-2082]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9260-5]

California State Motor Vehicle and Nonroad Engine Pollution
Control Standards; Mobile Cargo Handling Equipment Regulation at Ports
and Intermodal Rail Yards; Opportunity for Public Hearing and Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of opportunity for public hearing and comment.

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

SUMMARY: The California Air Resources Board (CARB) has notified EPA
that it has adopted regulations for mobile cargo handling equipment at
ports and intermodal rail yards (Mobile Cargo

Handling Equipment). CARB's Mobile Cargo Handling Equipment
requirements are designed to use best available control technologies to
reduce public exposure to emissions of diesel particulate matter and
nitrogen oxides. The requirements apply to any motorized vehicle used
to handle cargo, including yard trucks, top handlers, side handlers,
rubber-tired gantry cranes, forklifts, dozers, and loaders. By letter
dated January 29, 2007, CARB has requested that EPA confirm that
certain requirements are within-the-scope of previously granted EPA
waivers and authorizations under the Clean Air Act, and grant a new
full authorization pursuant to the Clean Air Act for other requirements
that are applicable to nonroad engines. This notice announces that EPA
has tentatively scheduled a public hearing to consider California's
Mobile Cargo Handling Equipment request and that EPA is now accepting
written comment on the request.

DATES: EPA has tentatively scheduled a public hearing concerning CARB's
request on Thursday, February 17, 2011, at 1 p.m. EPA will hold a
hearing only if any party notifies EPA by February 7, 2011, expressing
its interest in presenting oral testimony. By February 11, 2011, any
person who plans to attend the hearing may call David Alexander at
(202) 343-9540, to learn if a hearing will be held or may check the
following webpage for an update: http://www.epa.gov/otaq/cafr.htm.
    Parties wishing to present oral testimony at the public hearing
should provide written notice to David Alexander at the e-mail address
noted below. If EPA receives a request for a public hearing, that
hearing will be held in Room 1332A of the Ariel Rios North Building,
which is located at 1200 Pennsylvania Avenue, NW., Washington, DC
20004.
    If EPA does not receive a request for a public hearing, then EPA
will not hold a hearing, and instead consider CARB's request based on
written submissions to the docket. Any party may submit written
comments until March 17, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2010-0862, by one of the following methods:
     On-Line at http://www.regulations.gov: Follow the On-Line
Instructions for Submitting Comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Air and Radiation Docket, Docket ID No. EPA-HQ-OAR-
2010-0862, U.S. Environmental Protection Agency, Mailcode: 6102T, 1200
Pennsylvania Avenue, NW., Washington, DC 20460. Please include a total
of two copies.
     Hand Delivery: EPA Docket Center, Public Reading Room, EPA
West Building, Room 3334, 1301 Constitution Avenue, NW., Washington, DC
20460. Such deliveries are only accepted during the Docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
    On-Line Instructions for Submitting Comments: Direct your comments
to Docket ID No. EPA-HQ-OAR-2010-0862. EPA's policy is that all
comments we receive will be included in the public docket without
change and may be made available online at http://www.regulations.gov,
including any personal information provided, unless the comment
includes information claimed to be Confidential Business Information
(CBI) or other information whose disclosure is restricted by statute.
Do not submit information that you consider to be CBI or otherwise
protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an e-mail comment
directly to EPA without going through http://www.regulations.gov, your
e-mail address will automatically be captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    EPA will make available for public inspection materials submitted
by CARB, written comments received from any interested parties, and any
testimony given at the public hearing. Materials relevant to this
proceeding are contained in the Air and Radiation Docket and
Information Center, maintained in Docket ID No. EPA-HQ-OAR-2010-0862.
Publicly available docket materials are available either electronically
through http://www.regulations.gov or in hard copy at the Air and
Radiation Docket in the EPA Headquarters Library, EPA West Building,
Room 3334, located at 1301 Constitution Avenue, NW., Washington, DC.
The Public Reading Room is open to the public on all federal government
work days from 8:30 a.m. to 4:30 p.m.; generally, it is open Monday
through Friday, excluding holidays. The telephone number for the
Reading Room is<PHONE_NUMBER>. The Air and Radiation Docket and
Information Center's Web site is http://www.epa.gov/oar/docket.html.
The electronic mail (e-mail) address for the Air and Radiation Docket
is<EMAIL_ADDRESS>the telephone number is<PHONE_NUMBER>, and
the fax number is<PHONE_NUMBER>. An electronic version of the public
docket is available through the federal government's electronic public
docket and comment system. You may access EPA dockets at http://www.regulations.gov. After opening the http://www.regulations.gov Web
site, enter EPA-HQ-OAR-2010-0862, in the ``Enter Keyword or ID'' fill-
in box to view documents in the record. 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.
    EPA's Office of Transportation and Air Quality also maintains a
webpage that contains general information on its review of California
waiver requests. Included on that page are links to prior waiver and
authorization Federal Register notices; the page can be accessed at
http://www.epa.gov/otaq/cafr.htm.

FOR FURTHER INFORMATION CONTACT: David Alexander, Compliance and
Innovative Strategies Division, U.S. Environmental Protection Agency,
1200 Pennsylvania Avenue (6405J), NW., Washington, DC 20460. Telephone:
(202) 343-9540. Fax:<PHONE_NUMBER>. E-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. California's Mobile Cargo Handling Requirements for Equipment at
Ports and Intermodal Rail Yards

    In a letter dated January 29, 2007, CARB submitted to EPA its
request pursuant to section 209 of the Clean Air Act (``CAA'' or ``the
Act''), regarding its regulations for Mobile Cargo Handling Equipment
at Ports and Intermodal Rail Yards (``Mobile Cargo Handling Equipment''
or ``CHE''). CARB's Mobile Cargo Handling Equipment regulations were
adopted at CARB's December 8, 2005 public hearing (by Resolution 05-62)
and were subsequently modified

after making the regulation available for supplemental public comment
by CARB's Executive Officer in Executive Order R-06-007 on June 2,
2006. The Mobile Cargo Handling Equipment regulations are codified at
title 12, California Code of Regulations section 2479.
    CARB's Mobile Cargo Handling Equipment regulations establish best
available control technology (BACT) requirements that affect the
sellers, renters, lessors, owners, and operators of mobile cargo
handling equipment that are used at California's ports or intermodal
rail yards. For newly purchased, leased, or rented equipment, certified
on-road engines would be required if available for the specific
equipment type and application. Otherwise, the highest level certified
off-road engine would be required, along with installation of the
highest level verified diesel emission control strategy (VDECS) within
one year of purchase, lease, or rent, or within six months of becoming
available, if after a year. The regulations require in-use yard trucks
to meet BACT performance standards primarily through accelerated
turnover of older yard trucks to those equipped with cleaner, on-road
engines (2007 model year or later). Owners or operators who have
installed VDECS prior to the end of 2006, or who are already using
certified on-road engines, are given additional time to comply. In
addition, compliance is phased in for owners or operators who have more
than three yard trucks in their fleet.
    Equipment other than yard trucks (non-yard trucks) would also be
required to meet BACT, constituting replacement by cleaner on-road or
off-road engines and/or the use of retrofits. When retrofits are used,
replacement with Tier 4 off-road engines or installation of a Level 3
VDECS (which achieves an eighty-five percent reduction of emissions of
diesel particulate matter) is required for some equipment. The Mobile
Cargo Handling Equipment regulations also include recordkeeping and
reporting requirements for owners and operators of mobile cargo
handling equipment.

II. Clean Air Act New Motor Vehicle and Engine Waivers of Preemption

    Section 209(a) of the Clean Air Act preempts states and local
governments from setting emission standards for new motor vehicles and
engines; it provides:

    No State or any political subdivision thereof shall adopt or
attempt to enforce any standard relating to the control of emissions
from new motor vehicles or new motor vehicle engines subject to this
part. No state shall require certification, inspection or any other
approval relating to the control of emissions from any new motor
vehicle or new motor vehicle engine as condition precedent to the
initial retail sale, titling (if any), or registration of such motor
vehicle, motor vehicle engine, or equipment.

    Through operation of section 209(b) of the Act, California is able
to seek and receive a waiver of section 209(a)'s preemption. If certain
criteria are met, section 209(b)(1) of the Act requires the
Administrator, after notice and opportunity for public hearing, to
waive application of the prohibitions of section 209(a). Section
209(b)(1) only allows a waiver to be granted for any State that had
adopted standards (other than crankcase emission standards) for the
control of emissions from new motor vehicles or new motor vehicle
engines prior to March 30, 1966, if the State determines that its
standards will be, in the aggregate, at least as protective of public
health and welfare as applicable Federal standards (i.e., if such State
makes a ``protectiveness determination''). Because California was the
only state to have adopted standards prior to 1966, it is the only
state that is qualified to seek and receive a waiver.\1\ The
Administrator must grant a waiver unless she finds that: (A)
California's above-noted ``protectiveness determination'' is arbitrary
and capricious; \2\ (B) California does not need such State standards
to meet compelling and extraordinary conditions; \3\ or (C)
California's standards and accompanying enforcement procedures are not
consistent with section 202(a) of the Act.\4\ EPA has previously stated
that consistency with section 202(a) requires that California's
standards must be technologically feasible within the lead time
provided, giving due consideration of costs, and that California and
applicable Federal test procedures be consistent.\5\
---------------------------------------------------------------------------

    \1\ See S.Rep. No. 90-403 at 632 (1967).
    \2\ Clean Air Act (CAA) section 209(b)(1)(A).
    \3\ CAA section 209(b)(1)(B).
    \4\ CAA section 209(b)(1)(C).
    \5\ See, e.g., 74 FR 32767 (July 8, 2009); see also Motor and
Equipment Manufacturers Association v. EPA (MEMA I), 627 F.2d 1095,
1126 (D.C.Cir. 1979).
---------------------------------------------------------------------------

III. Clean Air Act Nonroad Engine and Vehicle Authorizations

    Section 209(e)(1) of the Act permanently preempts any State, or
political subdivision thereof, from adopting or attempting to enforce
any standard or other requirement relating to the control of emissions
for certain new nonroad engines or vehicles.
    Section 209(e)(2) requires the Administrator, after notice and
opportunity for public hearing, to authorize California to enforce
standards and other requirements relating to the control of emissions
from new engines not listed under section 209(e)(1), if certain
criteria are met. EPA has promulgated regulations implementing these
provisions at 40 CFR part 1074. These regulations set forth the
criteria that EPA must consider before granting California
authorization to enforce its new nonroad emission standards. Title 40
of the Code of Federal Regulations, part 1074.105 provides:

    (a) The Administrator will grant the authorization if California
determines that its standards will be, in the aggregate, at least as
protective of public health and welfare as otherwise applicable
federal standards.
    (b) The authorization will not be granted if the Administrator
finds that any of the following are true:
    (1) California's determination is arbitrary and capricious.
    (2) California does not need such standards to meet compelling
and extraordinary conditions.
    (3) The California standards and accompanying enforcement
procedures are not consistent with section 209 of the Act.
    (c) In considering any request from California to authorize the
state to adopt or enforce standards or other requirements relating
to the control of emissions from new nonroad spark-ignition engines
smaller than 50 horsepower, the Administrator will give appropriate
consideration to safety factors (including the potential increased
risk of burn or fire) associated with compliance with the California
standard.

    As stated in the preamble to the section 209(e) rule, EPA has
historically interpreted the section 209(e)(2)(iii) ``consistency''
inquiry to require, at minimum, that California standards and
enforcement procedures be consistent with section 209(a), section
209(e)(1), and section 209(b)(1)(C) (as EPA has interpreted that
subsection in the context of section 209(b) motor vehicle waivers).\6\
---------------------------------------------------------------------------

    \6\ See 59 FR 36969 (July 20, 1994).
---------------------------------------------------------------------------

    In order to be consistent with section 209(a), California's nonroad
standards and enforcement procedures must not apply to new motor
vehicles or new motor vehicle engines. To be consistent with section
209(e)(1), California's nonroad standards and enforcement procedures
must not attempt to regulate engine categories that are permanently
preempted from state regulation. To determine consistency with section
209(b)(1)(C), EPA typically reviews nonroad authorization requests
under the same ``consistency'' criteria that are applied to motor
vehicle waiver requests. Pursuant to section 209(b)(1)(C), the
Administrator shall not grant California a motor vehicle waiver

if she finds that California ``standards and accompanying enforcement
procedures are not consistent with section 202(a)'' of the Act.
Previous decisions granting waivers and authorizations have noted that
state standards and enforcement procedures are inconsistent with
section 202(a) if: (1) There is inadequate lead time to permit the
development of the necessary technology giving appropriate
consideration to the cost of compliance within that time, or (2) the
federal and state testing procedures impose inconsistent certification
requirements.

IV. Within-the-Scope Determinations

    If California amends regulations that were previously granted a
waiver of preemption or authorization, EPA can confirm that the amended
regulations are within-the-scope of the previously granted waiver or
authorization. Such within-the-scope amendments are permissible without
a full waiver review if three conditions are met. First, the amended
regulations must not undermine California's determination that its
standards, in the aggregate, are as protective of public health and
welfare as applicable federal standards. Second, the amended
regulations must not affect consistency with section 202(a) of the Act.
Third, the amended regulations must not raise any ``new issues''
affecting EPA's prior waivers or authorizations.

V. EPA's Request for Public Comment

    When EPA receives a new waiver or authorization request from CARB,
EPA traditionally publishes a notice of opportunity for public hearing
and comment, and then publishes a decision in the Federal Register
following the conclusion of the comment period. In contrast, when EPA
receives a request from CARB for a within-the-scope confirmation, EPA
may publish a decision in the Federal Register and concurrently invite
public comment if an interested party is opposed to EPA's decision.
    Because CARB's request regarding its Mobile Cargo Handling
Equipment regulations includes both within-the-scope confirmation
requests and a request for a full authorization, EPA is inviting
comment on several issues. First, we request comment on which criteria
we should apply to the various provisions included within CARB's Mobile
Cargo Handling Equipment regulations. More specifically, we are
requesting comment on whether any of the particular regulatory
provisions included in CARB's request should be considered as within-
the-scope of previous EPA waivers or authorizations, and which
particular regulatory provisions should be so considered, or whether
EPA should consider all of the regulatory provisions as requiring a
full waiver or authorization. Next, we seek comment on application of
the appropriate criteria. To the extent that a commenter believes a
regulatory provision is within-the-scope, they should also comment on
how EPA should apply its within-the-scope criteria; alternatively,
should a commenter believe that a particular regulatory provision
requires a full waiver or authorization, we request comment on whether
California has met the criteria for receipt of a full waiver or
authorization.
    Within the context of a within-the-scope analysis, EPA invites
comment on whether California's Mobile Cargo Handling Equipment
requirements: (1) Undermine California's previous determination that
its standards, in the aggregate, are at least as protective of public
health and welfare as comparable Federal standards, (2) affect the
consistency of California's requirements with section 202(a) of the
Act, and (3) raise any other new issues affecting EPA's previous waiver
or authorization determinations.
    As stated above, EPA is also requesting comment on issues relevant
to a full waiver and authorization analyses, in the event that EPA
determines that any of California's standards should not be considered
within-the-scope of CARB's previous waivers and authorizations, and
instead require a full waiver or authorization analysis. Specifically,
we request comment on: (a) Whether CARB's determination that its
standards, in the aggregate, are at least as protective of public
health and welfare as applicable federal standards is arbitrary and
capricious, (b) whether California needs such standards to meet
compelling and extraordinary conditions, and (c) whether California's
standards and accompanying enforcement procedures are consistent with
section 209 of the Act.

VI. Procedures for Public Participation

    If a hearing is held, the Agency will make a verbatim record of the
proceedings. Interested parties may arrange with the reporter at the
hearing to obtain a copy of the transcript at their own expense.
Regardless of whether a public hearing is held, EPA will keep the
record open until March 17, 2011. Upon expiration of the comment
period, the Administrator will render a decision on CARB's request
based on the record from the public hearing, if any, all relevant
written submissions, and other information that she deems pertinent.
All information will be available for inspection at the EPA Air Docket
No. EPA-HQ-OAR-2010-0862.
    Persons with comments containing proprietary information must
distinguish such information from other comments to the greatest extent
possible and label it as ``Confidential Business Information'' (CBI).
If a person making comments wants EPA to base its decision on a
submission labeled as CBI, then a non-confidential version of the
document that summarizes the key data or information should be
submitted to the public docket. To ensure that proprietary information
is not inadvertently placed in the public docket, submissions
containing such information should be sent directly to the contact
person listed above and not to the public docket. Information covered
by a claim of confidentiality will be disclosed by EPA only to the
extent allowed, and according to the procedures set forth in 40 CFR
Part 2. If no claim of confidentiality accompanies the submission when
EPA receives it, EPA will make it available to the public without
further notice to the person making comments.

    Dated: January 25, 2011.
Margo T. Oge,
Director, Office of Transportation and Air Quality, Office of Air and
Radiation.
[FR Doc. 2011-2082 Filed 1-31-11; 8:45 am]
BILLING CODE 6560-50-P