[Federal Register Volume 78, Number 79 (Wednesday, April 24, 2013)]
[Notices]
[Pages 24197-24199]
[FR Doc No: 2013-09553]

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ENVIRONMENTAL PROTECTION AGENCY

EPA-HQ-OPP-2010-0014; FRL-9384-6]

Product Cancellation Order for Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's order for the cancellations,
voluntarily requested by the registrants and accepted by the Agency, of
the products listed in Table 1 of Unit II., pursuant to the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). This cancellation
order follows a September 19, 2012 Federal Register notice of receipt
of requests from the registrants listed in Table 2 of Unit II. to
voluntarily cancel these product registrations. In the September 19,
2012 notice, EPA indicated that it would issue an order implementing
the cancellations, unless the Agency received substantive comments
within the 180-day comment period that would merit its further review
of these requests, or unless the registrants withdrew their requests.
The Agency did not receive any comments on the notice. Further, the
registrants did not withdraw their requests. Accordingly, EPA hereby
issues in this notice a cancellation order granting the requested
cancellations. Any distribution, sale, or use of the products subject
to this cancellation order is permitted only in accordance with the
terms of this order, including any existing stocks provisions.

DATES: The cancellations are effective April 24, 2013.

FOR FURTHER INFORMATION CONTACT: John W. Pates, Jr., Pesticide Re-
Evaluation Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    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.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0014, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. What action is the agency taking?

    This notice announces the cancellation, as requested by
registrants, of 50 products registered under FIFRA section 3. These
registrations are listed in sequence by registration number in Table 1
of this unit.

                     Table 1--Product Cancellations
------------------------------------------------------------------------
    EPA Registration No.          Product name          Chemical name
------------------------------------------------------------------------
00100-00990.................  Demon WP Insecticide  Cypermethrin.
000264-00778................  Stratego............  Propiconazole;
                                                     trifloxystrobin.
000432-00867................  Delta GC Insecticide  Deltamethrin.
                               Granule.
000432-01240................  DeltaGard GC          Deltamethrin.
                               Granular
                               Insecticide..
000432-01241................  DeltaGard T & O       Deltamethrin.
                               Granular
                               Insecticide.
000432-01242................  DeltaGard GC          Deltamethrin.
                               Granular
                               Insecticide.
000432-01243................  DeltaGard T & O       Deltamethrin.
                               Granular
                               Insecticide.
000432-01307................  Tempo 20 WP T & O     Cyfluthrin.
                               Insecticide in
                               Water Soluble
                               Packets (120G).
000432-01325................  Tempo 0.02            Cyfluthrin.
                               Ornamental
                               Insecticide.
000432-01337................  Tempo 2 Golf Course   Cyfluthrin.
                               Insecticide.
000432-01359................  Tempo 2 Greenhouse    Cyfluthrin.
                               and Nursery
                               Insecticide.
000675-00019................  Bulk Amphyl Brand     2-Benzyl-4-
                               Disinfectant.         chlorophenol; o-
                                                     phenylphenol.
001043-00115................  Process Vesphene II   4-Tert amylphenol; o-
                               ST.                   phenylphenol.
001448-00092................  Busan 1024..........  3,5,7-Triaza-1-
                                                     azoniatricyclo(3.3.
                                                     1.1 (superscript
                                                     3,7)) decane, 1-
                                                     methyl-, chloride.
002829-00090................  Durotex 7603........  10,10'-
                                                     Oxybisphenoxarsine.
002829-00096................  Vinyzene BP 5-2.....  10,10'-
                                                     Oxybisphenoxarsine.

002829-00105................  Vinyzene BP-5 SIL3..  10,10'-
                                                     Oxybisphenoxarsine.
002829-00109................  Vinyzene BP-5-2MS...  10,10'-
                                                     Oxybisphenoxarsine.
002829-00110................  Vinyzene BP 5-2 MEK.  10,10'-
                                                     Oxybisphenoxarsine.
002829-00115................  Vinyzene SB-1.......  10,10'-
                                                     Oxybisphenoxarsine.
002829-00120................  OBPA................  10,10'-
                                                     Oxybisphenoxarsine.
002829-00125................  Vinyzene BP-5-5 DIDP  10,10'-
                                                     Oxybisphenoxarsine.
002829-00132................  Vinyzene SB-2.......  10,10'-
                                                     Oxybisphenoxarsine.
002829-00144................  Vinyzene IT 4081      10,10'-
                               DIDP.                 Oxybisphenoxarsine.
003377-00020................  Bromine Chloride      Bromine chloride.
                               Disinfectant.
009688-00134................  Chemico Insect Bait   Sulfluramid.
                               A.
009688-00199................  Chemico Insect Bait   Sulfluramid.
                               SS.
009688-00209................  Chemico Insect Bait   Sulfluramid.
                               REP.
010292-00020................  Unitab..............  Phosphoric acid 1-
                                                     decanaminium, N-
                                                     decyl-N,N-dimethyl-
                                                     , chloride.
010772-00005................  Sno Bol Toilet Bowl   Hydrochloric acid; 1-
                               Cleaner.              decanaminium, N,N-
                                                     dimethyl-N-octyl-,
                                                     chloride;
                                                     alkyl*dimethyl
                                                     benzyl ammonium
                                                     chloride *(50%C14,
                                                     40%C12, 10%C16); 1-
                                                     decanaminium, N-
                                                     decyl-N,N-dimethyl-
                                                     , chloride; 1-
                                                     octanaminium, N,N-
                                                     dimethyl-N-octyl-,
                                                     chloride.
048520-00016................  Poly-50 Algaecide...  Poly(oxy-1,2-
                                                     ethanediyl(dimethyl
                                                     imino)-1,2-
                                                     ethanediyl(dimethyl
                                                     imino)-1,2-
                                                     ethanediyl
                                                     dichloride).
062719-00418................  RH-0611.............  Mancozeb;
                                                     myclobutanil.
062719-00584................  GF 1948.............  Propiconazole.
066330-00337................  Micro Flo Permethrin  Permethrin.
                               3.2 AG.
066330-00376................  Thifensulfuron-       Thifensulfuron.
                               methyl Technical.
074655-00027................  Olin 3204...........  Poly(oxy-1,2-
                                                     ethanediyl(dimethyl
                                                     imino)-1,2-
                                                     ethanediyl(dimethyl
                                                     imino)-1,2-
                                                     ethanediyl
                                                     dichloride).
AL020006....................  Propiconazole EC....  Propiconazole.
AR020003....................  Propiconazole EC....  Propiconazole.
CA090003....................  Agri-Mek 0.15 EC      Abamectin.
                               Miticide/
                               Insecticide.
FL100007....................  Gramoxone Inteon....  Paraquat dichloride.
KY050001....................  Propimax EC.........  Propiconazole.
ME090004....................  Ethrel Brand          Ethephon.
                               Ethephon Plant
                               Regulator.
MI040003....................  Propiconazole EC....  Propiconazole.
MI110003....................  Gramoxone Inteon....  Paraquat dichloride.
MN030003....................  Propiconazole EC....  Propiconazole.
MS030003....................  Propiconazole EC....  Propiconazole.
ND020003....................  Propiconazole EC....  Propiconazole.
NV000005....................  WIN-FLO 4F..........  Pentachloronitrobenz
                                                     ene.
NY050002....................  Propimax EC.........  Propiconazole.
OH030003....................  Propiconazole EC....  Propiconazole.
------------------------------------------------------------------------
* Note: The voluntary cancellation request published on September 19,
  2012, included SLN: WA000014. However, since the product registration
  was cancelled in the Federal Register issue of February 6, 2013 (78 FR
  8513) (FRL-9377-1), it is not included in the list shown in this Unit.

    Table 2 of this unit includes the names and addresses of record for
all registrants of the products in Table 1 of this unit, in sequence by
EPA company number. This number corresponds to the first part of the
EPA registration numbers of the products listed in Table 1 of this
unit.

               Table 2--Registrants of Cancelled Products
------------------------------------------------------------------------
           EPA Company number                Company name and address
------------------------------------------------------------------------
100 (CA090003; FL100007; MI110003).....  Syngenta Crop Protection, LLC,
                                          410 Swing Rd., P.O. Box 18300,
                                          Greensboro, NC 27419-8300.
264 (ME090004).........................  Bayer CropScience LP, 2 T.W.
                                          Alexander Dr., P.O. Box 12014,
                                          Research Triangle Park, NC
                                          27709.
432....................................  Bayer Environmental Science, 2
                                          T.W. Alexander Dr., P.O. Box
                                          12014, Research Triangle Park,
                                          NC 27709.
675....................................  Reckitt Benckiser, LLC, 399
                                          Interpace Parkway, Parsippany,
                                          NJ 07054-0225.
1043...................................  Steris Corporation, P.O. Box
                                          147, St. Louis, MO 63166-0147.
1448...................................  Buckman Laboratories, Inc.,
                                          1256 North McLean Blvd.,
                                          Memphis, TN 38108.
2829...................................  Rohm and Haas Company, 100
                                          Independence Mall West, Suite
                                          1A, Philadelphia, PA 19106-
                                          2399.
3377...................................  Albemarle Corporation, 451
                                          Florida St., Baton Rouge, LA
                                          70801-1765.
9688...................................  Chemisco, P.O. Box 142642, St.
                                          Louis, MO 63114-0642.
10292..................................  Venus Laboratories, Inc., 111
                                          South Rohlwing Rd., Addison,
                                          IL 60101.
10772..................................  Church & Dwight Co., Inc., 469
                                          North Harrison St., Princeton,
                                          NJ 08543-5297.

48520..................................  Phoenix Products Company, 5
                                          Roger Ave., Milford, CT 06460-
                                          6436.
62719 (AL020006; AR020003; KY050001;     Dow AgroSciences, LLC, 9330
 MI040003; MN030003; MS030003;            Zionsville Rd., Indianapolis,
 ND020003; NY050002; OH030003).           IN 46268-1054.
66330..................................  Arysta Life Science North
                                          America, LLC, 15401 Weston
                                          Parkway, Suite 150, Cary, NC
                                          27513.
74655..................................  Hercules Incorporated, A Wholly
                                          Owned Subsidiary of Ashland,
                                          Inc., 7910 Baymeadows Way,
                                          Suite 100, Jacksonville, FL
                                          32256.
NV000005...............................  AMVAC Chemical Corporation,
                                          4695 MacArthur Ct., Suite
                                          1200, Newport Beach, CA 92660-
                                          1706.
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    During the public comment period provided, EPA received no comments
in response to the September 19, 2012 Federal Register notice
announcing the Agency's receipt of the requests for voluntary
cancellations of products listed in Table 1 of Unit II.

IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
cancellations of the registrations identified in Table 1 of Unit II.
Accordingly, the Agency hereby orders that the product registrations
identified in Table 1 of Unit II. are canceled. The effective date of
the cancellations that are the subject of this notice is April 24,
2013. Any distribution, sale, or use of existing stocks of the products
identified in Table 1 of Unit II. in a manner inconsistent with any of
the provisions for disposition of existing stocks set forth in Unit VI.
will be a violation of FIFRA.

V. What is the agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the EPA Administrator may approve
such a request. The notice of receipt for this action was published for
comment in the Federal Register issue of September 19, 2012 (77 FR
58136) (FRL-9361-2). The comment period closed on March 18, 2013.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. The existing stocks provisions for the products
subject to this order are as follows.
    The registrants may continue to sell and distribute existing stocks
of products listed in Table 1 of Unit II. until April 24, 2014, which
is 1 year after the publication of the Cancellation Order in the
Federal Register. Thereafter, the registrants are prohibited from
selling or distributing products listed in Table 1 of Unit II., except
for export in accordance with FIFRA section 17, or proper disposal.
Persons other than the registrants may sell, distribute, or use
existing stocks of products listed in Table 1 of Unit II. until
existing stocks are exhausted, provided that such sale, distribution,
or use is consistent with the terms of the previously approved labeling
on, or that accompanied, the canceled products.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: April 9, 2013.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2013-09553 Filed 4-23-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 141 (Tuesday, July 25, 2017)]
[Rules and Regulations]
[Page 34402]
[FR Doc No: 2017-15532]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 17

[Docket No. FDA-2017-N-0011]

Civil Money Penalty Definitions; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending a
civil money penalty regulation to correct a statutory reference to
align the regulations with the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) and to ensure accuracy and clarity in the Agency's
regulations.

DATES: This rule is effective July 25, 2017.

FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4248,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA is amending its regulation at 21 CFR
17.3 to correct a statutory reference to reflect the current citation.
FDA is revising Sec.  17.3(a)(1) through (4) by replacing section
``333(g)'' with section ``333(f).'' On July 27, 1995, FDA published a
final rule establishing hearing procedures for use when FDA proposes
the imposition of administrative civil money penalties (60 FR 38612 at
38626). The document was published with a citation to 21 U.S.C. 333(g)
(303(g) of the FD&C Act) that subsequently was changed to 21 U.S.C.
333(f) (303(f) of the FD&C Act) by section 226(b)(1) of the Food and
Drug Administration Amendments Act of 2007 (Pub. L. 110-85).
    Publication of this document constitutes final action on the change
under the Administrative Procedure Act (5 U.S.C. 553). This technical
amendment is nonsubstantive and merely updates and corrects a statutory
reference in the Code of Federal Regulations (CFR) that is no longer
current. FDA therefore, for good cause, has determined that notice and
public comment are unnecessary under 5 U.S.C. 553(b)(3)(B). Further,
this rule places no burden on affected parties for which such parties
would need a reasonable time to prepare for the effective date of the
rule. Accordingly, FDA, for good cause, has determined this technical
amendment to be exempt under 5 U.S.C. 553(d)(3) and that the rule can
become effective upon publication.
    FDA has determined under 21 CFR 25.30(i) that this final rule is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required. In
addition, FDA has determined that this final rule contains no
collections of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-20) is not required.

List of Subjects in 21 CFR Part 17

    Administrative practice and procedure, Penalties.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
17 is amended as follows:

PART 17--CIVIL MONEY PENALTIES HEARINGS

0
1. The authority citation for part 17 continues to read as follows:

    Authority: 21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c,
360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa-28; 5 U.S.C. 554,
555, 556, 557.

0
2. In Sec.  17.3, paragraph (a) is revised to read as follows:

Sec.  17.3  Definitions.

* * * * *
    (a) For specific acts giving rise to civil money penalty actions
brought under 21 U.S.C. 333(f)(1):
    (1) Significant departure, for the purpose of interpreting 21
U.S.C. 333(f)(1)(B)(i), means a departure from requirements that is
either a single major incident or a series of incidents that
collectively are consequential.
    (2) Knowing departure, for the purposes of interpreting 21 U.S.C.
333(f)(1)(B)(i), means a departure from a requirement taken:
    (i) With actual knowledge that the action is such a departure; or
    (ii) In deliberate ignorance of a requirement; or
    (ii) In reckless disregard of a requirement.
    (3) Minor violations, for the purposes of interpreting 21 U.S.C.
333(f)(1)(B)(ii), means departures from requirements that do not rise
to a level of a single major incident or a series of incidents that are
collectively consequential.
    (4) Defective, for the purposes of interpreting 21 U.S.C.
333(f)(1)(B)(iii), includes any defect in performance, manufacture,
construction, components, materials, specifications, design,
installation, maintenance, or service of a device, or any defect in
mechanical, physical, or chemical properties of a device.
* * * * *

    Dated: July 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-15532 Filed 7-24-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Notices]
[Pages 73121-73122]
[FR Doc No: 2016-25589]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4284-DR; Docket ID FEMA-2016-0001]

Georgia; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Georgia (FEMA-4284-DR), dated October 8,
2016, and related determinations.

DATES: Effective Date: October 8, 2016.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated

October 8, 2016, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the State
of Georgia resulting from Hurricane Matthew beginning on October 4,
2016, and continuing, is of sufficient severity and magnitude to
warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of Georgia.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide assistance for debris removal and
emergency protective measures (Categories A and B) under the Public
Assistance program in the designated areas, Hazard Mitigation
throughout the State, and any other forms of assistance under the
Stafford Act that you deem appropriate subject to completion of
Preliminary Damage Assessments (PDAs). Direct Federal assistance is
authorized.
    Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Hazard Mitigation will be limited to 75 percent of the total
eligible costs. Federal funds provided under the Stafford Act for
Public Assistance also will be limited to 75 percent of the total
eligible costs, with the exception of projects that meet the
eligibility criteria for a higher Federal cost-sharing percentage
under the Public Assistance Alternative Procedures Pilot Program for
Debris Removal implemented pursuant to section 428 of the Stafford
Act.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Warren J. Riley, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the State of Georgia have been designated as
adversely affected by this major disaster:

    Bryan, Camden, Chatham, Glynn, Liberty, and McIntosh Counties
for debris removal and emergency protective measures (Categories A
and B), including direct federal assistance, under the Public
Assistance program.
    All areas within the State of Georgia are eligible for
assistance under the Hazard Mitigation Grant Program.
    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-25589 Filed 10-21-16; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 81, Number 91 (Wednesday, May 11, 2016)]
[Notices]
[Pages 29259-29260]
[FR Doc No: 2016-11013]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2768-010]

The City of Holyoke Gas & Electric Department; Notice of Intent
To File License Application, Filing of Pre-Application Document, and
Approving Use of the Traditional Licensing Process

    a. Type of Filing: Notice of Intent To File License Application and
Request To Use the Traditional Licensing Process.
    b. Project No.: 2768-010.
    c. Date Filed: February 29, 2016.
    d. Submitted By: City of Holyoke Gas & Electric Department.
    e. Name of Project: Albion Mill (A Wheel) Hydroelectric Project.
    f. Location: Between the first and second level canals on the
Holyoke Canal System adjacent to the Connecticut River, in the city of
Holyoke in Hampden County, Massachusetts. The project does not occupy
federal land.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Paul Ducheney, Superintendent,
Holyoke Gas & Electric, 99 Suffolk Street, Holyoke, MA 01040; (413)
536-9340<EMAIL_ADDRESS>    i. FERC Contact: Matt Buhyoff at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Holyoke Gas and Electric filed its request to use the
Traditional Licensing Process on February 29, 2016. Holyoke Gas and
Electric provided public notice of its request on February 26, 2016. In
a letter dated April 29, 2016, the Director of the Division of
Hydropower Licensing approved Holyoke Gas and Electric's request to use
the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and/or NOAA Fisheries under section
7 of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the Massachusetts State Historic Preservation
Officer, as required by section 106, National Historical Preservation
Act, and the implementing regulations of the Advisory Council on
Historic Preservation at 36 CFR 800.2.

    l. With this notice, we are designating Holyoke Gas and Electric as
the Commission's non-federal representative for carrying out informal
consultation pursuant to section 7 of the Endangered Species Act and
section 106 of the National Historic Preservation Act.
    m. Holyoke Gas & Electric filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
(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. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). A copy is also available for inspection and reproduction at
the address in paragraph h.
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 2768. Pursuant to 18 CFR
16.8, 16.9, and 16.10, each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by February 28,
2019.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

    Dated: April 29, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-11013 Filed 5-10-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: August 7, 2008 (Volume 73, Number 153)]
[Proposed Rules]
[Page 45900-45902]
[DOCID:fr07au08-19]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0854; Directorate Identifier 2008-CE-050-AD]
RIN 2120-AA64

Airworthiness Directives; Allied Ag Cat Productions, Inc. G-164
Series Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 78-08-09,
which applies to certain Allied Ag Cat Productions, Inc. (formerly
Grumman-American) Models G-164, G-164A, and G-164B airplanes. AD 78-08-
09 currently requires repetitively inspecting the interior and the
exterior of the main tubular spar of the rudder assembly for corrosion,
taking necessary corrective action if corrosion is found, and applying
corrosion protection. Since we issued AD 78-08-09, the rudder main
tubular spar failed on a later production airplane. Consequently, this
proposed AD would retain the actions required in AD 78-08-09 and expand
the applicability to include all G-164 series airplanes. We are
proposing this AD to detect and correct corrosion in the rudder main
tubular spar, which could result in failure of the weld to the main
spar tube. This failure could lead to loss of directional control.

DATES: We must receive comments on this proposed AD by October 6, 2008.

ADDRESSES: Use one of the following addresses to comment on this
proposed AD:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Grumman American Aviation Corporation, P.O. Box 2206, Savannah, Georgia
31402; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Andy McAnaul, Aerospace Engineer, ASW-
150, FAA San Antonio MIDO-43, 10100 Reunion Place, Suite 650, San
Antonio, Texas 78216, phone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments regarding this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include the docket number, ``FAA-
2008-0854; Directorate Identifier 2008-CE-050-AD'' at the beginning of
your comments. We specifically invite comments on the overall
regulatory, economic, environmental, and energy aspects of the proposed
AD. We will consider all comments received by the closing date and may
amend the proposed AD in light of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive concerning this proposed AD.

Discussion

    Excessive corrosion on the main tubular spar, part number A1203-11,
of the rudder assembly resulting from moisture accumulating in the
lower internal cavity on Allied Ag Cat Productions, Inc. (formerly
Grumman-American) Models G-164, G-164A, and G-164B airplanes caused us
to issue AD 78-08-09, Amendment 39-3191. AD 78-08-09 currently requires
the following on certain Models G-164, G-164A, and G-164B airplanes:
     Repetitively inspecting the rudder main tubular spar for
corrosion;
     Repairing any corrosion found; and
     Applying corrosion protection.
    AD 78-08-09 applies only to early production Allied Ag Cat
airplanes. In March 2008, the rudder main tubular spar failed on a
Model G164B airplane, serial number 586B (not affected by AD 78-08-09).
The spar failed where the lower fitting is welded to the main tube.
Investigation revealed that the failure was a result of severe internal
corrosion caused by moisture trapped in the lower internal cavity of
the spar tube.
    AD 78-08-09 does not establish a way to identify affected rudders.
It is a common practice to repair agricultural airplanes with repaired
or used serviceable parts from other sources, or using removed parts
from other airplanes. Based on the lack of traceability, rudders
affected by AD 78-08-09 are potentially being installed on

Allied Ag Cat model airplanes not affected by AD 78-08-09. Also, many
rudders have been modified to ``tall'' rudders by supplemental type
certificate (STC), or replaced with aftermarket rudders, which all have
the same corrosion susceptible design as the original earlier
production rudders.
    This condition, if not detected and corrected, could result in
failure of the rudder main spar tubular spar. This failure could lead
to loss of directional control.

Relevant Service Information

    We have reviewed Grumman American Aviation Corporation Ag-Cat
Service Bulletin No. 61, dated June 6, 1977.
    The service information specifies:
     Repetitively inspecting the main tubular spar for
corrosion;
     Repairing any corrosion found; and
     Applying corrosion protection.

FAA's Determination and Requirements of the Proposed AD

    We are proposing this AD because we evaluated all information and
determined the unsafe condition described previously is likely to exist
or develop on other products of the same type design. This proposed AD
would supersede AD 78-08-09 with a new AD that would retain the actions
required in AD 78-08-09 and expand the applicability to include all G-
164 series airplanes. This proposed AD would require you to use the
service information described previously to perform these actions.

Costs of Compliance

    We estimate that this proposed AD would affect 2,700 airplanes in
the U.S. registry.
    We estimate the following costs to do the proposed inspections:

----------------------------------------------------------------------------------------------------------------
                                                                                Total cost per   Total cost on
                  Labor cost                              Parts cost                airplane      U.S. operators
----------------------------------------------------------------------------------------------------------------
4 work-hours x $80 per hour = $320...........  Not applicable.................            $320         $864,000
----------------------------------------------------------------------------------------------------------------

    We have no way of determining the cost of repairs or parts
replacement or the number of airplanes that may require repair or part
replacement based on the result of the proposed inspections.

Authority for this Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket that contains the proposed AD, the
regulatory evaluation, any comments received, and other information on
the Internet at http://www.regulations.gov; or in person at the Docket
Management Facility between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The Docket Office (telephone<PHONE_NUMBER>)
is located at the street address stated in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by removing Airworthiness Directive
(AD)
    78-08-09, Amendment 39-3191, and adding the following new AD:

Allied Ag Cat Productions, Inc.: Docket No. FAA-2008-0854;
Directorate Identifier 2008-CE-050-AD.

Comments Due Date

    (a) We must receive comments on this airworthiness directive
(AD) action by October 6, 2008.

Affected ADs

    (b) This AD supersedes AD 78-08-09, Amendment 39-3191.

Applicability

    (c) This AD applies to the following airplane models, all serial
numbers, that are certificated in any category:

------------------------------------------------------------------------
                                 Models
-------------------------------------------------------------------------
G-164, G-164A, G-164B, G-164B with 73'', G-164B-15T, G-164B-34T, G-164B-
 20T, G-164C, G-164D, and G-164D with 73'' wing gap.
------------------------------------------------------------------------

Unsafe Condition

    (d) This AD results from a report of the rudder main tubular
spar failing on a later production airplane. We are issuing this AD
to detect and correct corrosion in the rudder main tubular spar,
which could result in failure of the weld to the main spar tube.
This failure could lead to loss of directional control.

Compliance

    (e) To address this problem, you must do the following, unless
already done:

------------------------------------------------------------------------
             Actions                  Compliance          Procedures
------------------------------------------------------------------------
(1) Drill an access hole and do   (i) For airplanes   Following Steps 1
 a borescope visual inspection     previously          through 3 of
 of the lower end internal         affected by AD 78-  Grumman American
 cavity of the rudder main spar    08-09: Initially    Aviation
 tube for corrosion and do a       inspect within      Corporation Ag-
 visual inspection of the          the next 60         Cat Service
 exterior of the rudder main       months after the    Bulletin No. 61,
 spar tube for corrosion.          last inspection     dated June 6,
                                   required in AD 78-  1977.
                                   08-09 or within
                                   the next 30 days
                                   after the
                                   effective date of
                                   this AD,
                                   whichever occurs
                                   later.
                                   Repetitively
                                   inspect
                                   thereafter at
                                   intervals not to
                                   exceed 60
                                   calendar months.
                                  (ii) For airplanes
                                   not previously
                                   affected by AD 78-
                                   08-09: Initially
                                   inspect within
                                   the next 30 days
                                   after the
                                   effective date of
                                   this AD.
                                   Repetitively
                                   inspect
                                   thereafter at
                                   intervals not to
                                   exceed 60
                                   calendar months.
(2) If corrosion is found during  Before further      As specified in
 any inspection required in        flight after any    Steps 5 and 6 of
 paragraph (e)(1) of this AD,      inspection in       Grumman American
 repair in accordance with         which corrosion     Aviation
 Advisory Circular 43.13-1B or     is found.           Corporation Ag-
 equivalent, or replace the                            Cat Service
 damaged part(s).                                      Bulletin No. 61,
                                                       dated June 6,
                                                       1977. Following
                                                       Advisory Circular
                                                       43.13-1B or
                                                       equivalent, and
                                                       an FAA-approved
                                                       procedure. The
                                                       appropriate
                                                       maintenance
                                                       manual contains
                                                       these procedures.
(3) After each inspection and     Before further      As specified in
 repair or replacement required    flight after any    Step 4 of Grumman
 in this AD, corrosion protect     inspection          American Aviation
 the spar tube internal cavity     required in         Corporation Ag-
 by filling with warm, raw         paragraph (e)(1)    Cat Service
 linseed oil, Paralketone, or      of this AD and      Bulletin No. 61,
 CRC3 (LPS Heavy Duty Rust         after any repair    dated June 6,
 Inhibitor Type 3), or suitable    or replacement      1977.
 equivalent protector for alloy    required in
 steel, and allow to drain. Seal   paragraph (e)(2)
 access hole with Scotch           of this AD.
 caulking compound, or suitable
 silicone based sealant, or
 equivalent.
(4) Verify rigging check of the   Before further      Following an FAA-
 rudder.                           flight after any    approved
                                   inspection          procedure. The
                                   required in         appropriate
                                   paragraph (e)(1)    maintenance
                                   of this AD and      manual contains
                                   after any repair    these procedures.
                                   or replacement
                                   required in
                                   paragraph (e)(2)
                                   of this AD.
(5) Only install a rudder that    As of the next 30   Not applicable.
 has been inspected as specified   days after the
 in paragraph (e)(1) of this AD,   effective date of
 is free of corrosion, and has     this AD.
 had the corrosion protection
 applied and sealed as specified
 in paragraph (e)(3) of this AD.
------------------------------------------------------------------------

Alternative Methods of Compliance (AMOCs)

    (f) The Manager, Fort Worth Airplane Certification Office, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. Send information to ATTN: Andy
McAnaul, Aerospace Engineer, ASW-150, FAA San Antonio MIDO-43, 10100
Reunion Place, Suite 650, San Antonio, Texas 78216, phone: (210)
308-3365; fax:<PHONE_NUMBER>. Before using any approved AMOC on any
airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (g) AMOCs approved for AD 78-08-09 are not approved for this AD.

Related Information

    (h) To get copies of the service information referenced in this
AD, contact Grumman American Aviation Corporation, P.O. Box 2206,
Savannah, Georgia 31402. To view the AD docket, go to U.S.
Department of Transportation, Docket Operations, M-30, West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington,
DC 20590, or on the Internet at http://www.regulations.gov.

    Issued in Kansas City, Missouri, on August 1, 2008.
James E. Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-18228 Filed 8-6-08; 8:45 am]

BILLING CODE 4910-13-P


\* MERGEFORMAT
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460
                                                                      OFFICE OF
                                                            CHEMICAL SAFETY AND
                                                           POLLUTION PREVENTION

MEMORANDUM

Date:	March 25, 2011

SUBJECT:	Tetrachlorvinphos.  Response to Comment on Storage Stability Residue Data Deficiencies.

PC Code:  083701/083702
DP Barcodes:  D385359 & D386954
Decision No.:  359967
Registration No.:  Not Applicable
Petition No.: Not Applicable
Regulatory Action: Reregistration Follow-up
Risk Assessment Type: Not Applicable
Case No.: 0321
TXR No.: Not Applicable
CAS No.: 22248-79-9
MRID Nos.: 486378101 48319001
40 CFR: 180.252

FROM:	Christine L. Olinger, Chemist
		Risk Assessment Branch VII
		Health Effects Division (7509P)
		Office of Pesticide Programs

THRU:	Donna S. Davis, Chemist
		Michael S. Metzger, Chief,
		Risk Assessment Branch VII
		Health Effects Division (7509P)
		Office of Pesticide Programs

TO:	James Parker, CRM
		Risk Management and Implementation Branch II
		Pesticide Re-evaluation Division (7508P)
		Office of Pesticide Programs

In response to deficiencies noted in a review of livestock magnitude of residue studies (C. Olinger; 10/7/10; D320848, D320858, D320859, and D381350) SRA International, on behalf of KMG Bernuth, has submitted data relating to the storage stability of tetrachlorvinphos residues in livestock tissues, eggs, and milk.  The Pesticide Re-evaluation Division (PRD) has requested HED review of this information to satisfy the outstanding data deficiencies.

CONCLUSIONS

No additional storage stability data are needed to support the use of tetrachlorvinphos on poultry.  The magnitude of residue study on poultry is adequate and there are no outstanding deficiencies with this study.  The magnitude of residue requirement is considered satisfied for poultry.

No storage stability data are available for livestock commodities.  The samples from the ruminant magnitude of residue study that reflect the maximum current use pattern were stored less than thirty days, so storage stability data are not needed.  Provided the registrant does not make changes to the current use pattern/application rates, no additional storage stability data are needed and the requirement for a magnitude of residue study for ruminants is satisfied.  Should the registrant wish to revise the existing use patterns such that the magnitude of residue data from other treatment groups would be used for tolerance and/or risk assessment, additional storage stability data demonstrating stability of tetrachlorvinphos and its metabolites for at least two months would be required.

DETAILED CONSIDERATIONS

HED identified the following deficiencies regarding the storage stability data as well as detailed information on storage intervals in the review of poultry and ruminant magnitude of residue studies (C. Olinger; 10/7/10; D320848, D320858, D320859, and D381350).

   * New storage stability studies should be conducted with quantifiable (i.e., fortified) residues of all analytes in all cattle and poultry matrices.  In addition, the registrant needs to submit information pertaining to dates of treatment, collection, extraction, and analysis to verify the maximum storage intervals of all samples collected from both the cattle and poultry studies.
   * Although a companion storage stability study was included in support of the cattle study, the submitted data were deemed inadequate because of the study design.  Selected samples of various matrices were re-assayed after the initial analysis.  Considerable degradation may have occurred prior to the initial analysis of storage stability samples.  Many of the matrices did not have quantifiable residues of one or more of the analytes at the time of initial analysis, so potential degradation upon storage cannot be accurately assessed.

SRA International, on behalf of KMG Bernuth, has submitted additional information on the storage intervals for these studies, which is discussed below.

Data Submitted to Support MRID 47589301 Poultry Magnitude of Residue Study
The registrant has provided information on the storage intervals for samples from the original poultry study.  SRA submitted storage interval information in two volumes, MRID Nos. 486378101 and 48319001.  A summary of the storage intervals is presented in Table 1 below.

Table 1.  Storage Intervals for Samples from Tetrachlorvinphos Poultry Magnitude of Residue Study [1]
                                    Matrix
                                  Group(s) 2
                               Time Interval [3]
                               No. Days Storage
                                    Matrix
                                  Group(s) 2
                               Time Interval [3]
                               No. Days Storage
                                     Eggs
                                      1-4
                                      -7
                                      1-3
                                     Eggs
                                      1-4
                                      78
                                      11
                                     Eggs
                                      1-4
                                      -1
                                      1-2
                                     Eggs
                                      1-4
                                      82
                                       9
                                     Eggs
                                      1-4
                                       1
                                      2-3
                                     Eggs
                                      1-4
                                      84
                                     12-20
                                     Eggs
                                      1-4
                                       3
                                      2-3
                                     Eggs
                                      1-4
                                      86
                                      18
                                     Eggs
                                      1-4
                                       5
                                      2-3
                                     Eggs
                                      1-4
                                      88
                                      16
                                     Eggs
                                      1-4
                                       8
                                      1-3
                                     Eggs
                                      1-4
                                      91
                                      13
                                     Eggs
                                      1-4
                                      12
                                       2
                                     Eggs
                                      1-4
                                      95
                                      15
                                     Eggs
                                      1-4
                                      15
                                      2-4
                                     Eggs
                                      1-4
                                      98
                                      12
                                     Eggs
                                      1-4
                                      17
                                      2-4
                                     Eggs
                                      1-4
                                      101
                                       9
                                     Eggs
                                      1-4
                                      19
                                      2-4
                                     Eggs
                                      1-4
                                      105
                                       5
                                     Eggs
                                      1-4
                                      22
                                      1-4
                                    Muscle
                                      1-4
                                       0
                                      14
                                     Eggs
                                      1-4
                                      26
                                       2
                                    Muscle
                                      3R
                                       7
                                      22
                                     Eggs
                                      1-4
                                      29
                                      2-4
                                    Muscle
                                      3R
                                      14
                                      15
                                     Eggs
                                      1-4
                                      31
                                      3-4
                                    Muscle
                                      3R
                                      21
                                       8
                                     Eggs
                                      1-4
                                      33
                                      3-4
                                     Liver
                                      1-4
                                       0
                                      18
                                     Eggs
                                      1-4
                                      36
                                      1-4
                                     Liver
                                      3R
                                       7
                                      22
                                     Eggs
                                      1-4
                                      40
                                       2
                                     Liver
                                      3R
                                      14
                                      15
                                     Eggs
                                      1-4
                                      43
                                      2-6
                                     Liver
                                      3R
                                      21
                                       8
                                     Eggs
                                      1-4
                                      45
                                     3-10
                                    Kidney
                                      1-4
                                       0
                                      27
                                     Eggs
                                      1-4
                                      47
                                     3-10
                                    Kidney
                                      3R
                                       7
                                      22
                                     Eggs
                                      1-4
                                      50
                                     1-19
                                    Kidney
                                      3R
                                      14
                                      15
                                     Eggs
                                      1-4
                                      54
                                     2-17
                                    Kidney
                                      3R
                                      21
                                       8
                                     Eggs
                                      1-4
                                      57
                                      4-6
                                   Skin/Fat
                                      1-4
                                       0
                                      20
                                     Eggs
                                      1-4
                                      59
                                     4-10
                                   Skin/Fat
                                      3R
                                       7
                                      26
                                     Eggs
                                      1-4
                                      61
                                     6-10
                                   Skin/Fat
                                      3R
                                      14
                                      19
                                     Eggs
                                      1-4
                                      64
                                     11-19
                                   Skin/Fat
                                      3R
                                      21
                                      12
                                     Eggs
                                      1-4
                                      68
                                     9-17
                                 Abdominal Fat
                                      1-4
                                       0
                                      25
                                     Eggs
                                      1-4
                                      70
                                      12
                                 Abdominal Fat
                                      3R
                                       7
                                      26
                                     Eggs
                                      1-4
                                      71
                                     4-11
                                 Abdominal Fat
                                      3R
                                      14
                                      19
                                     Eggs
                                      1-4
                                      73
                                       4
                                 Abdominal Fat
                                      3R
                                      21
                                      12
                                     Eggs
                                      1-4
                                      75
                                       6

[1] MRID No. for poultry magnitude of residue study is MRID 47589301; storage intervals are reported in MRID Nos. 48378101 48319001.
2 Groups are described in MRID 47589301.
3 Time intervals for eggs are days after study initiation.  Negative numbers refer to number of days prior to first application.  Time intervals for tissues refer to days after sacrifice.

The Agency generally requires storage stability data when samples from magnitude of residue studies are stored for more than 30 days.  Since all samples were stored for less than 30 days, no storage stability data are needed to support the poultry magnitude of residue study.  There are no outstanding deficiencies for the poultry magnitude of residue study and the magnitude of residue requirement for poultry has been satisfied.

Data Submitted to Support MRID 47193001 Ruminant Magnitude of Residue Study
The registrant provided storage intervals for the samples from the original ruminant study.  In addition, the registrant submitted an inadequate storage stability study to support the ruminant magnitude of residue study.  In response to the deficiencies identified in the October 2010 review the registrant submitted detailed information on storage intervals from the magnitude of residue study (MRID Number pending).

The magnitude of residue study included five different treatment groups, which are described in Table 2 below.  Treatment group 4 represents the current maximum label rate for both the feed-through and dermal treatment uses.  A summary of the storage intervals from treatment group 4 is presented in Table 3 below.

Table 2.  Summary of Treatment Groups from Ruminant Magnitude of Residue Study
                                     Group
                             Treatment Description
                                       1
Control
                                       2
Nominal 1x rate Oral Only
                                       3
Nominal 1x rate Oral; Nominal 0.5x rate Dermal
                                       4
Nominal 1x rate Oral; Nominal 1x rate Dermal
                                       5
Nominal 3x rate Oral; Nominal 0.5x rate Dermal

Table 3.  Storage Intervals for Samples from Tetrachlorvinphos Ruminant Magnitude of Residue Study (Group 4 Only)[1]
                                    Matrix
                                   Cow No.2
                             Time Interval (Days)3
                               No. Days Storage
                                     Milk
                                     8-10
                                      -7
                                       9
                                     Milk
                                     8-10
                                      -1
                                       3
                                     Milk
                                     8-10
                                       1
                                       6
                                     Milk
                                     8-10
                                       2
                                       7
                                     Milk
                                     8-10
                                       4
                                      16
                                     Milk
                                     8-10
                                       7
                                      26
                                     Milk
                                     8-10
                                      10
                                      20
                                     Milk
                                     8-10
                                      14
                                       9
                                     Milk
                                     8-10
                                      17
                                       8
                                     Milk
                                     8-10
                                      21
                                       7
                                     Milk
                                     8-10
                                      24
                                      11
                                     Milk
                                     8-10
                                      28
                                      14
                                   Skim Milk
                                     8-10
                                      14
                                      25
                                   Skim Milk
                                     8-10
                                      29
                                      15
                                     Cream
                                     8-10
                                      14
                                      23
                                     Cream
                                     8-10
                                      29
                                      22
                                    Muscle
                                       8
                                       0
                                   23 (63)4
                                    Muscle
                                       9
                                       0
                                    22 (62)
                                    Muscle
                                      10
                                       0
                                    21 (61)
                                Peritoneal Fat
                                       8
                                       0
                                      28
                                Peritoneal Fat
                                       9
                                       0
                                      27
                                Peritoneal Fat
                                      10
                                       0
                                      26
                               Subcutaneous Fat
                                       8
                                       0
                                    23 (63)
                               Subcutaneous Fat
                                       9
                                       0
                                    22 (62)
                               Subcutaneous Fat
                                      10
                                       0
                                    21 (61)
                                    Kidney
                                       8
                                       0
                                      31
                                    Kidney
                                       9
                                       0
                                      30
                                    Kidney
                                      10
                                       0
                                      29
                                     Liver
                                       8
                                       0
                                      34
                                     Liver
                                       9
                                       0
                                      33
                                     Liver
                                      10
                                       0
                                      32
[1] MRID No. for ruminant magnitude of residue study is MRID 47193001; storage intervals are reported in email sent 3/23/11; MRID number pending.
2 Cow identification numbers are described in MRID 47193001.
3 Time intervals for milk are days after study initiation.  Negative numbers refer to number of days prior to first application.  Time interval for tissues refers to days after sacrifice.
4 Number of days storage prior to TCPEdiol analysis (where different from other analytes) is shown in parentheses

The samples from treatment group 4 represent the application rates and retreatment intervals that represent current product labels.  Almost all samples were analyzed within 30 days; all were analyzed within 34 days with the exception of the analyses for one metabolite, TCPEdiol, in muscle and subcutaneous fat.  HED does not need additional storage stability data to support this treatment group since samples were analyzed within 30 days or slightly later.  Although some samples were analyzed for one metabolite after two months of storage, most samples were analyzed within an appropriate interval for this metabolite and residues were non-detectable.  Since significant exposure is not expected, a storage stability study for this metabolite will not be required to support treatment group 4.

However, samples from other treatment groups were stored up to two months.  The data from these groups have not been used directly in tolerance and/or risk assessment, but have only been used for risk characterization.  Should the registrant amend use directions such that these data would be needed for tolerance assessment, storage stability data would be required.


[Federal Register Volume 86, Number 163 (Thursday, August 26, 2021)]
[Notices]
[Pages 47648-47649]
[FR Doc No: 2021-18403]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0008]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Circulatory System
Devices Panel of the Medical Devices Advisory Committee. The general
function of the committee is to provide advice and recommendations to
the Agency on FDA's regulatory issues. The meeting will be open to the
public.

DATES: The meeting will take place virtually on November 2 and 3, 2021,
from 9 a.m. to 6 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions including information regarding special
accommodations due to a disability may be accessed at: https://www.fda.gov/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings.

FOR FURTHER INFORMATION CONTACT: Akinola Awojope, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002,
<EMAIL_ADDRESS>301-636-0512, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On November
2, 2021, the committee will discuss and make recommendations on
information about the benefit-risk profile of the Endologix AFX
endovascular graft system with regards to the risk of Type III
endoleaks. FDA requests panel input regarding the totality of data
collected on AFX devices and whether further actions are necessary.
    On November 3, 2021, the committee will discuss and make
recommendations on the continued safety and effectiveness of
endovascular stent grafts and how to strengthen real-world data
collection on long-term performance of the devices, both for currently
marketed devices and for future technologies. FDA intends to request
panel input on the clinical outcomes that are most relevant to capture
in the real world, along with their frequency and duration.
Additionally, FDA intends to seek input on data collection platforms,
and how to incentivize and optimize real world data collection.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting, and the background material
will be posted on FDA's website after the meeting. Background material
and the link to the online teleconference meeting room will be
available at https://www.fda.gov/advisory-committees/circulatory-
system-devices-panel/2021-meeting-materials-

circulatory-system-devices-panel. Select the link for the 2021 Meeting
Materials. The meeting will include slide presentations with audio
components to allow the presentation of materials in a manner that most
closely resembles an in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 21, 2021. Oral presentations from the public will be scheduled
on November 2 and November 3, 2021, between approximately 1 p.m. and 2
p.m. Eastern Time. Those individuals interested in making formal oral
presentations should notify the contact person (see FOR FURTHER
INFORMATION CONTACT). The notification should include a brief statement
of the general nature of the evidence or arguments they wish to
present, the names and addresses of proposed participants, the date
which they want to present, and an indication of the approximate time
requested to make their presentation on or before October 13, 2021.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by October 14, 2021.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Artair Mallett at<EMAIL_ADDRESS>or<PHONE_NUMBER> at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings for procedures on public conduct during
advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: August 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18403 Filed 8-25-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 16, 2009 (Volume 74, Number 240)]
[Notices]
[Page 66642-66644]
[DOCID:fr16de09-68]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0347; FRL-8803-9]

Carbaryl; Product Cancellation Order

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This Notice announces EPA's order for the cancellations,
voluntarily

requested by the registrant and accepted by the Agency, of products
containing the pesticide, carbaryl, pursuant to section 6(f)(1) of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as
amended. This cancellation order follows an October 21, 2009 Federal
Register Notice of Receipt of Request from the carbaryl registrant to
voluntarily cancel their carbaryl pet collar product registrations.
These are not the last carbaryl products registered for use in the
United States; however, they are the last carbaryl products registered
for use on pets. In the October 21, 2009 Notice, EPA indicated that it
would issue an order implementing the cancellations, unless the Agency
received substantive comments within the 30-day comment period that
would merit its further review of these requests, or unless the
registrant withdrew its request within this period. The Agency received
one comment on the Notice, but it did not merit further review of the
request. Further, the registrant did not withdraw its request.
Accordingly, EPA hereby issues in this Notice a cancellation order
granting the requested cancellations. Any distribution, sale, or use of
the carbaryl products subject to this cancellation order is permitted
only in accordance with the terms of this order, including any existing
stocks provisions.

DATES: The cancellations of the products listed in Table 1 of Unit II.
are effective September 30, 2010.

FOR FURTHER INFORMATION CONTACT: Jacqueline Guerry, Pesticide Re-
Evaluation Division, 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?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2008-0347. 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. What Action is the Agency Taking?

    This Notice announces, effective September 30, 2010, the
cancellation, as requested by the registrant Wellmark International of
certain end-use carbaryl products registered under section 3 of FIFRA.
These registrations are listed in sequence by registration number in
Table 1 of this unit.

                Table 1.--Carbaryl Product Cancellations
------------------------------------------------------------------------
           Registration Number                      Product Name
------------------------------------------------------------------------
2724-272                                   Flea Collar RF-76 for Cats
------------------------------------------------------------------------
2724-273                                   Flea Collar RF-75 for Dogs
------------------------------------------------------------------------

    Table 2 of this unit includes the name and address of record of the
registrant of the products in Table 1 of this unit.

          Table 2.--Registrants of Cancelled Carbaryl Products
------------------------------------------------------------------------
            EPA Company Number                Company Name and Address
------------------------------------------------------------------------
2724                                        Wellmark International
                                            1501 E. Woodfield Road,
                                             Suite 200
                                            WestSchaumburg, Illinois
                                             60173
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

     The Agency received one comment in response to the October 21,
2009, Carbaryl; Notice of Receipt of a Request to Voluntarily Cancel
Pesticide Registrations to Terminate Use of Certain Products, from
BioSpotVictims.org (BioSpot), a non-profit organization. BioSpot
supports the decision by the registrant to cancel their carbaryl pet
collar products; however, BioSpot objects to EPA's proposal to allow
persons other than the registrant to continue to sell existing stocks
of canceled products until such stocks are exhausted. BioSpot raises
the concern that children will be exposed to carbaryl pet collars well
beyond December 30, 2010, and therefore, urges EPA to consider
prohibiting all persons from selling existing stocks of carbaryl pet
collar products after December 30, 2010. BioSpot did not provide any
information to support or substantiate this concern.
    Based on its use pattern, the Agency understands that the shelf-
life for treated pet collars, in general, is short. Further, based on
conversations with the registrant, the Agency understands that a 3
month shelf-life for the registrant's pet collar products is typical,
and therefore, the EPA expects that any existing stocks of carbaryl pet
collars will move through the channels of trade quickly. This is
reflected in the existing stocks provision which only allows the
registrant to sell or distribute existing stocks for 3 months after the
effective date of this order. Additionally, these products are labeled
for up to 4 months of effective flea protection; direct the user to
replace the collar after 4 months, if necessary; and instruct the user
not to reuse the collar. The Agency believes if the collars are used in
the manner consistent with the labeling, and the law, and discarded
properly as directed, the existing stocks will, again, move through the
channels of trade quickly. Thus, EPA disagrees with BioSpot's claim
that the existing stock provision in this Notice will allow exposure to
carbaryl pet collars to extend ``well beyond'' December 30, 2010.
    In addition, the Agency's Existing Stocks Policy (56 FR 29362)
June, 26, 1991, generally provides that if the Agency has not
identified a particular risk concern, registrants will generally be
permitted to sell or distribute existing stocks for 1 year after the
cancellation request was received and that persons other than the
registrant will generally be allowed to sell, distribute, or use
existing stocks until such stocks are exhausted. The policy also
explains that where EPA has identified a particular risk issue, the
Agency will generally weigh the risk against the benefits of allowing
any continued sale, distribution, or use on a case-by-case basis. In
doing so, one of the factors that the Agency may take into
consideration is the degree to which the registrant's actions
accelerated the removal of the pesticide from the market, and whether
the

cancellation would have occurred at all without the existing stocks
provision. (56 FR 29365).
    The registrant's voluntary cancellation request is conditioned upon
the inclusion of the proposed existing stocks provision. Thus, one of
the things EPA has considered in deciding whether to allow any
continued sale, distribution, or use of existing stocks is the exposure
that might result absent the voluntary cancellation--even if EPA
otherwise would have initiated cancellation proceedings. EPA has
determined that granting this request with the proposed existing stocks
provision will result in the removal of carbaryl pet collar products
from the market sooner (and certainly with the expenditure of far fewer
resources) than if EPA were to initiate cancellation proceedings. For
these reasons, the Agency does not believe that the comments submitted
during the comment period merit further review or a denial of the
requests for voluntary cancellation.

IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
cancellations of the carbaryl registrations identified in Table 1 of
Unit II. Accordingly, effective September 30, 2010, the Agency orders
that the carbaryl product registrations identified in Table 1 of Unit
II are canceled. After September 30, 2010, any distribution, sale, or
use of existing stocks of the products identified in Table 1 of Unit II
in a manner inconsistent with any of the Provisions for Disposition of
Existing Stocks set forth in Unit VI. will be considered a violation of
FIFRA.

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

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a Notice
of Receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the Administrator may approve such
a request.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. The cancellation order issued in this Notice
includes the following existing stocks provisions.
    The registrant may sell or distribute existing stocks of the
products identified in Table 1 of Unit II until December 30, 2010. All
sale or distribution of existing stocks by the registrant is prohibited
after December 30, 2010, unless that sale or distribution is solely for
the purpose of facilitating disposal or export of the product. The
Agency will allow persons other than the registrant to continue to sell
and/or use existing stocks of canceled products until such stocks are
exhausted, provided that such use is consistent with the terms of the
previously approved labeling on, or that accompanied, the canceled
product.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: December 9, 2009.
 Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.

[FR Doc. E9-29894 Filed 12-15-09; 8:45 am]

BILLING CODE 6560-50-S