[Federal Register Volume 78, Number 176 (Wednesday, September 11, 2013)]
[Notices]
[Pages 55695-55696]
[FR Doc No: 2013-22081]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0025; FRL-9397-9]

Notice of Receipt of Pesticide Products; Registration
Applications To Register New Uses

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of applications to register new
uses for pesticide products containing currently registered active
ingredients pursuant to the provisions of section 3(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. This
notice provides the public with an opportunity to comment on the
applications.

DATES: Comments must be received on or before October 11, 2013.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the EPA Registration Number or EPA File Symbol of
interest as shown in the body of this document, by one of the following
methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(RD), (7505P), 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?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions

or organize comments by referencing a Code of Federal Regulations (CFR)
part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA has received applications to register new uses for pesticide
products containing currently registered active ingredients. Pursuant
to the provisions of FIFRA section 3(c)(4), EPA is hereby providing
notice of receipt and opportunity to comment on these applications.
Notice of receipt of these applications does not imply a decision by
the Agency on these applications. For actions being evaluated under the
Agency's public participation process for registration actions, there
will be an additional opportunity for a 30-day public comment period on
the proposed decision. Please see the Agency's public participation Web
site for additional information on this process http://www.epa.gov/pesticides/regulating/registration-public-involvement.html. EPA
received the following applications to register new uses for pesticide
products containing currently registered active ingredients:
    1. EPA Registration File Symbols: 100-RLNO and 100-RLRN. Docket ID
Number: EPA-HQ-OPP-2013-0536. Applicant: Syngenta Crop Protection, LLC,
P.O. Box 18300, Greensboro, NC 27419. Active ingredient: Avermectin
(Abamectin). Product Type: Insecticide. Proposed Use: Turf.
    2. EPA Registration Numbers: 100-895, 100-898, 100-1154, and 100-
1259. Docket ID Number: EPA-HQ-OPP-2013-0536. Applicant: Syngenta Crop
Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. Active
ingredient: Avermectin (Abamectin). Product Type: Insecticide. Proposed
Use: Caneberries (Group 13-07A).
    3. EPA Registration Numbers: 100-895, 100-1259, 100-1350, 100-1351,
100-1408, and 100-1439. Docket ID Number: EPA-HQ-OPP-2013-0536.
Applicant: Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419. Active ingredient: Avermectin (Abamectin). Product Type:
Insecticide. Proposed Uses: Corn and soybeans.
    4. EPA Registration Numbers: 100-921 and 100-1363. Docket ID
Number: EPA-HQ-OPP-2013-0550. Applicant: Syngenta Crop Protection, LLC,
P.O. Box 18300, Greensboro, NC 27419. Active ingredient: Acibenzolar-s-
methyl. Product Type: Fungicide. Proposed Use: Sorghum.
    5. EPA Registration File Symbols: 352-IIE and 352-ITI. Docket ID
Number: EPA-HQ-OPP-2013-0528. Applicant: DuPont Crop Protection, Stine-
Haskell Research Center, P.O. Box 30, Newark, DE 19714. Active
ingredient: Penthiopyrad. Product Type: Fungicide. Proposed Uses:
Potato seed pieces, canola, corn and soybeans.
    6. EPA Registration Numbers: 352-728 and 352-730. Docket ID Number:
EPA-HQ-OPP-2013-0235. Applicant: DuPont Crop Protection, Stine-Haskell
Research Center, P.O. Box 30, Newark, DE 19714. Active ingredient:
Chlorantraniliprole. Product Type: Insecticide. Proposed Uses: Tree Nut
Group 14-12, and Stone Fruit Group 12-12 (except cherry, chickasaw,
plum, and damson plum).
    7. EPA Registration Numbers: 62719-363 and 62719-341. Docket ID
Number: EPA-HQ-OPP-2013-0496. Applicant: Dow Agrosciences, LLC, 9330
Zionsville Rd, Indianapolis, IN 46268-1054. Active ingredient: 1,3-
Dichloropropene. Product Type: Fumigant (Fungicide). Proposed Use:
Pineapple.
    8. EPA Registration File Symbol/Registration Number: 86203-EA and
86203-1. Docket ID Number: EPA-HQ-OPP-2013-0528. Applicant: Landis
International, Inc., P.O. Box 5126, Valdosta, GA 31603-5126, agent on
behalf of Mitsui Chemicals Agro, Inc., 1-5-2, Higashi-Shimbashi,
Minato-Ku Tokyo, 105-7117, Japan. Active ingredient: Penthiopyrad.
Product Type: Fungicide. Proposed Use: Sugarbeets.

List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: August 30, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2013-22081 Filed 9-10-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Rules and Regulations]
[Pages 53665-53668]
[FR Doc No: 2022-18883]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0740]
RIN 1625-AA00

Safety Zone; Kanawha River Mile Marker 58 to Mile Marker 59,
Charleston, WV

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a safety zone for all
navigable waters of the Kanawha River between mile markers 58 and 59.
The safety zone is needed to protect personnel, vessels, and the marine
environment from the potential hazards created by a fireworks display.
Entry of vessels or persons into this zone is prohibited unless
specifically authorized by Captain of the Port Sector Ohio Valley or a
designated representative.

DATES: This rule is effective from 9 p.m. through 10 p.m. on September
2, 2022.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0740 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST2 Justin Selan, Marine Safety Unit Huntington, U.S.
Coast Guard;<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because we must establish the safety zone by
September 2, 2022 and lack sufficient time to request public comments
and respond to these comments before the safety zone must be
established.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to the public interest because immediate
action is needed to respond to the potential safety hazards associated
with the Charleston Live on the Levee Fireworks Display taking place on
the Kanawha River between mile marker 58 and mile marker 59.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Ohio Valley (COTP) has determined that
potential hazards associated with Charleston Live on the Levee
Fireworks Display starting September 2, 2022, will be a safety concern
for anyone on the Kanawha River from mile marker 58 to mile marker 59.
This rule is needed to protect personnel, vessels, and the marine
environment from potential hazards associated with a fireworks display.

IV. Discussion of the Rule

    This rule establishes a safety zone from 9:00 p.m. through 10:00
p.m. on September 2, 2022. The safety zone will cover all navigable
waters between mile markers 58 and 59 on the Kanawha River. The
duration of the safety zone is intended to protect personnel, vessels,
and the marine environment from potential hazards created by a
fireworks display.
    No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard (USCG) assigned to units under
the operational control of the COTP. To seek permission to enter,
contact the COTP or a designated representative via VHF-FM channel 16,
or through Marine Safety Unit Huntington at<PHONE_NUMBER>. Persons and
vessels permitted to enter the safety zone must comply with all lawful
orders or directions issued by the COTP or designated representative.
The COTP or a designated representative will inform the public of the
effective period for the safety zone as well as any changes in the
dates and times of enforcement through Local Notice to Mariners (LNMs),
Broadcast Notices to Mariners (BNMs), and/or Marine Safety Information
Bulletins (MSIBs), as appropriate.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, and duration of the safety zone. This safety zone impacts a
1-mile stretch of the Kanawha River for a limited duration of less than
2 hours. Vessel traffic will be informed about the safety zone through
local notices to mariners. Moreover, the Coast Guard will issue
Broadcast Notices to Mariners via VHF-FM marine channel 16 about the
zone and the rule allows vessels to seek permission to transit the
zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to

the Small Business and Agriculture Regulatory Enforcement Ombudsman and
the Regional Small Business Regulatory Fairness Boards. The Ombudsman
evaluates these actions annually and rates each agency's responsiveness
to small business. If you wish to comment on actions by employees of
the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard
will not retaliate against small entities that question or complain
about this rule or any policy or action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting from 9 p.m. through 10 p.m. on September 2, 2022,
that will limit access of the Kanawha River from mile marker 58 to mile
marker 59. It is categorically excluded from further review under
paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-
01-001-01, Rev. 1. A Record of Environmental Consideration supporting
this determination is available in the docket. For instructions on
locating the docket, see the ADDRESSES section of this preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T08-0740 to read as follows:

Sec.  165.T08-0740  Safety Zone; Kanawha River, Charleston, WV.

    (a) Regulated area. The regulations in this section apply to the
following area: all navigable waters of the Kanawha River from mile
marker 58 to mile marker 59 near Haddad Riverfront Park, Charleston,
WV.
    (b) Definitions. Designated representative means a Coast Guard
Patrol Commander (PATCOM), including a Coast Guard coxswain, petty
officer, or other officer operating a Coast Guard vessel and a Federal,
State, and local officer designated by or assisting the Captain of the
Port Ohio Valley (COTP) in the enforcement of the regulations in this
section.
    Participant means all persons and vessels registered with the event
sponsor as a participants in the race.
    (c) Regulations. The Coast Guard may patrol the event area under
the direction of a designated Coast Guard Patrol Commander. The Patrol
Commander may be contacted on Channel 16 VHF-FM (156.8 MHz) by the call
sign ``PATCOM.''
    (2) All persons and vessels not registered with the sponsor as
participants or official patrol vessels are considered spectators. The
``official patrol vessels'' consist of any Coast Guard, State or local
law enforcement and sponsor provided vessels assigned or approved by
the Commander, Eighth Coast Guard District, to patrol the event
    (3) Spectator vessels desiring to transit the regulated area may do
so only with prior approval of the Patrol Commander and when so
directed by that officer and will be operated at a no wake speed in a
manner which will not endanger participants in the event or any other
craft.
    (4) No spectator shall anchor, block, loiter, or impede the through
transit of participants or official patrol vessels in the regulated
area during the effective dates and times, unless cleared for entry by
or through an official patrol vessel.
    (5) The Patrol Commander may forbid and control the movement of all
vessels in the regulated area. When hailed or signaled by an official
patrol vessel, a vessel shall come to an immediate stop and comply with
the directions given. Failure to do so may result in expulsion from the
area, citation for failure to comply, or both
    (6) Any spectator vessel may anchor outside the regulated area
specified above, but may not anchor in, block, or loiter in a navigable
channel.
    (7) The Patrol Commander may terminate the event or the operation
of any vessel at any time it is deemed necessary for the protection of
life or property.
    (8) To seek permission to enter, contact the COTP or the COTP's
representative by VHF-FM marine radio channel 16 or phone at 1-800-253-
7465. Those in the regulated area must comply with all lawful orders or
directions given to them by the COTP or the designated representative.
    (9) The COTP will provide notice of the regulated area through
advanced notice via local notice to mariners and broadcast notice to
mariners and by on-scene designated representatives.

    (d) Enforcement periods. This safety zone will be enforced from 9
p.m. to 10 p.m. on September 2, 2022.

    Dated: August 25, 2022.
H.R. Mattern,
Captain, U.S. Coast Guard, Captain of the Port Ohio Valley.
[FR Doc. 2022-18883 Filed 8-31-22; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: October 3, 2005 (Volume 70, Number 190)]
[Notices]
[Page 57573-57574]
[DOCID:fr03oc05-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Filing

September 27, 2005.
    In the matter of: ER00-3562-003, ER03-341-002, ER03-342-002,
ER03-838-003, ER04-1081-001, ER04-1080-001, ER03-209-002, ER03-36-
004, ER99-2858-008, ER05-48-001, ER05-1266-001, ER05-817-001, ER05-
818-001, ER05-819-001, ER05-820-001, ER02-1319-004, ER04-831-002,
ER04-832-002, ER00-1115-003, ER03-446-002, ER02-1959-003, ER04-1099-
001, ER04-1100-001, ER01-2688-008, ER02-2227-004, ER02-600-006,
ER02-2229-003, ER03-24-003, ER05-67-001, ER05-68-001, ER99-1983-003,
ER03-290-002; Calpine Energy Services, L.P., Calpine PowerAmerica-
OR, LLC, Calpine PowerAmerica-CA, LLC, Power Contract Financing,
L.L.C., PCF, LLC, Calpine Energy Management, L.P., CES Marketing V,
L.P., Calpine Northbrook Energy Marketing, LLC, MEP Pleasant Hill,
LLC, Calpine Bethpage 3, LLC, Ontelaunee Power Operating Company,
LLC, Calpine Merchant Services Company, Inc., CES Marketing VIII,
LLC, CES Marketing IX, LLC, CES Marketing X, LLC, Zion Energy,

LLC, Calpine Newark, LLC, Calpine Parline, LLC, Calpine Construction
Finance Company, L.P., Calpine Philadelphia, Inc., CPN Bethpage 3rd
Turbine, Inc., Bethpage Energy center 3, LLC, TBG Cogen Partners,
Gilroy Energy Center, LLC, Creed Energy Center, LLC, Delta Energy
Center, LLC, Goose Haven Energy Center, LLC, Los Esteros Critical
Energy Facility, LLC, Metcalf Energy Center, LLC, Pastoria Energy
Facility L.L.C., Geysers Power Company, LLC, Calpine California
Equipment Finance Company, LLC.

    Take notice that on September 9, 2005, Calpine Energy Services,
L.P. (CES) and each of its above referenced affiliated public utilities
(collectively, Filing Entities), files a change in status in compliance
with Commission Order No. 652 issued February 10, 2005, 111 FERC ]
61,413 (2005).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

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

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on October 11, 2005.

Magalie R. Salas,
Secretary.
[FR Doc. E5-5397 Filed 9-30-05; 8:45 am]

BILLING CODE 6717-01-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [insert name and telephone number
with area code]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

TEMPLATE:

[Bayer CropScience],]

[Insert petition number]

	EPA has requested a notice of filing (identified as a deficiency in the
submitted petition) to support the 30 day plant back interval for
soybeans planted after a potato seed piece treatment with clothianidin
at a rate of 420 g ai/ha. Soybean rotational residue data showed no
residues greater than the LOQ of 0.01 ppm for soybeans planted 30 days
after  treatment of bare soil with Poncho 600 FS at a rate of 420 g
ai/ha. This supports a 30 day plant back interval for soybeans after
potato seed piece treatment at the above rate. No rotational crop
tolerances are required. Therefore, no further data is required in this
NOF.

 PAGE

 PAGE   6


[Federal Register: July 9, 2007 (Volume 72, Number 130)]
[Rules and Regulations]
[Page 37109-37115]
[DOCID:fr09jy07-4]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[EPA-HQ-OW-2007-0467; FRL-8337-2]
RIN NA2040

Withdrawal of Federal Marine Aquatic Life Water Quality Criteria
for Toxic Pollutants Applicable to Washington State

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is proposing to amend the Federal regulations to withdraw
its 1992 federally promulgated marine copper and cyanide chronic
aquatic life water quality criteria for Washington State, thereby
enabling Washington to implement its current EPA-approved chronic
numeric criteria for copper and cyanide that cover all marine waters of
the State.
    In 1992, EPA promulgated Federal regulations establishing water
quality criteria for priority toxic pollutants for 12 States, including
Washington, and two Territories that had not fully complied with the
Clean Water Act (CWA). These regulations are known as the ``National
Toxics Rule'' or ``NTR.'' On November 18, 1997, Washington adopted
revised chronic marine aquatic life criteria for copper and cyanide,
the only two marine aquatic life priority toxic pollutants in the NTR
applicable to Washington. These revisions included a chronic marine
aquatic life water quality criterion for copper for all marine waters
and a chronic site-specific cyanide criterion for the Puget Sound. EPA
approved these criteria on February 6, 1998. On August 1, 2003,
Washington adopted revisions to its water quality standards, including
a chronic marine criterion for cyanide for all marine waters except the
Puget Sound. EPA approved this criterion on May 23, 2007. Since
Washington now has marine copper and cyanide chronic aquatic life
criteria effective under the CWA that EPA has approved as protective of
Washington's designated uses, EPA is proposing to amend the NTR to
withdraw the federally promulgated criteria.

DATES: This rule is effective on September 7, 2007 without further
notice, unless EPA receives adverse comment by August 8, 2007. If EPA
receives such comment, EPA will publish a timely withdrawal in the
Federal Register informing the public that this rule, or the relevant
provisions of this rule, will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2007-0467, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail<EMAIL_ADDRESS>     Mail to either: Water Docket, USEPA, Mailcode: 2822T, 1200
Pennsylvania Ave., NW., Washington, DC 20460 or Becky Lindgren,
Washington Marine Aquatic Life NTR Removal, U.S. EPA, Region 10, OWW-
131, 1200 Sixth Avenue, Seattle, WA 98101, Attention Docket ID No. EPA-
HQ-OW-2007-0467.

     Hand Delivery: EPA Docket Center, EPA West Room 3334, 1301
Constitution Ave., NW., Washington, DC, 20004 or Becky Lindgren,
Washington Marine Aquatic Life NTR Removal, 1200 Sixth Avenue, Seattle,
WA 98101, Attention Docket ID No. EPA-HQ-OW-2007-0467. Such deliveries
are only accepted during the Docket's normal hours of operation, and
special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2007-
0467. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://www.regulations.gov Web site is an ``anonymous access'' system,

which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through http://www.regulations.gov

your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at two Docket Facilities. The OW

Docket Center is open from 8:30 a.m. until 4:30 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (202)
566-2426 and the Docket address is OW Docket, EPA West, Room 3334, 1301
Constitution Avenue, NW., Washington, DC, 20004. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>. Publicly available docket materials are also
available in hard copy at U.S. EPA, 1200 Sixth Avenue, Seattle, WA
98101. Docket materials can be accessed from 9 a.m. until 3 p.m.,
Monday through Friday, excluding legal holidays. The telephone number
is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Becky Lindgren, U.S. EPA, Region 10,
1200 Sixth Avenue, Seattle, WA 98101 (telephone:<PHONE_NUMBER> or e-
mail<EMAIL_ADDRESS>or Claudia Fabiano, U.S. EPA
Headquarters, Office of Science and Technology, 1200 Pennsylvania
Avenue, NW., Mail Code 4305T, Washington, DC 20460 (telephone: 202-566-
0446 or e-mail: fabiano.claudia@epa.gov).

SUPPLEMENTARY INFORMATION: This section is organized as follows:

Table of Contents

I. Why Is EPA Using a Direct Final Rule?
II. General Information
    A. What Entities May be Affected by this Action?
    B. What Should I Consider as I Prepare My Comments for EPA?
III. Background
    A. What Are the Applicable Federal Statutory and Regulatory
Requirements?
    B. Why Is EPA Withdrawing Federal Marine Aquatic Life Water
Quality Criteria for Toxic Pollutants Applicable to Washington?
    C. What are the Federal Marine Aquatic Life Water Quality
Criteria for Toxic Pollutants Applicable to Washington that EPA is
Withdrawing?
IV. Statutory and Executive Order Reviews
    A. Executive Order 12866 (Regulatory Planning and Review)
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132 (Federalism)
    F. Executive Order 13175 (Consultation and Coordination with
Indian Tribal Governments)
    G. Executive Order 13045 (Protection of Children from
Environmental Health Risks and Safety Risks)
    H. Executive Order 13211 (Actions that Significantly Affect
Energy Supply, Distribution or Use)
    I. National Technology Transfer and Advancement Act of 1995
    J. Executive Order 12898 (Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations)
    K. Congressional Review Act

I. Why Is EPA Using a Direct Final Rule?

    EPA is publishing this rule without a prior proposed rule because
the Agency views this action as noncontroversial and anticipates no
adverse comment. Because the public had the opportunity to comment on
Washington State's adoption of marine copper and cyanide aquatic life
criteria, EPA does not anticipate any adverse comments on the
withdrawal of Washington from the NTR, located at 40 CFR 131.36 (57 FR
60848), for those criteria. For this reason, EPA is taking this action
in a direct final rule. However, in the ``Proposed Rules'' section of
the Federal Register, EPA is publishing a separate notice that will
serve as a parallel proposed rule to withdraw the same Federal marine
aquatic life water quality criteria for toxic pollutants applicable to
Washington in the event that adverse comments are received on all or
distinct provisions of this direct final rule.
    If EPA receives any adverse comment regarding any or all provisions
of this direct final rule, the Agency will publish a timely withdrawal
in the Federal Register informing the public that this direct final
rule, or the relevant provisions of this direct final rule, will not
take effect. In that event, EPA would address all public comments in
any subsequent final rule based on the parallel proposed rule. Any
provisions of this direct final rule that are not timely withdrawn by
EPA will become effective on September 7, 2007, notwithstanding adverse
comment on any other provision. EPA will not institute a second comment
period on this direct final rule. Any parties interested in commenting
must do so at this time. For further information about commenting on
this rule, see the ADDRESSES section of this document.

II. General Information

A. What Entities May Be Affected by This Action?

    This direct final rule, if made final, will withdraw federally
promulgated marine copper and cyanide aquatic life water quality
criteria for waters in Washington State. Entities discharging copper or
cyanide pollutants to the marine surface waters of Washington could be
affected by this rulemaking since water quality standards are used in
determining National Pollutant Discharge Elimination System (NPDES)
permit limits, CWA section 404 dredge and fill permits, and other
activities requiring CWA section 401 certification.

Categories and entities that may ultimately be affected include:

------------------------------------------------------------------------
           Category            Examples of potentially affected entities
------------------------------------------------------------------------
Industry.....................  Industries discharging pollutants to
                                surface waters in Washington State.
Municipalities...............  Discharges from publicly-owned facilities
                                such as publicly-owned treatment works
                                and water filtration facilities.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding NPDES-regulated entities likely to be
affected by this action. This table lists the types of entities that
EPA is now aware could potentially be affected by this action. Other
types of entities not listed in the table could also be affected. To
determine whether your facility may be affected by this action, you
should carefully examine today's proposed rule. If you have questions
regarding the applicability of this action to the particular entity,
consult the person listed in the preceding FOR FURTHER INFORMATION
CONTACT section.

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

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the

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

III. Background

A. What Are the Applicable Federal Statutory and Regulatory
Requirements?

    In 1992, EPA promulgated a final rule (known as the ``National
Toxics Rule'', or ``NTR'') to establish numeric water quality criteria
for toxic pollutants for 12 States and two Territories (hereinafter
referred to as ``States'') that had failed to comply fully with section
303(c)(2)(B) of the Clean Water Act (``CWA'') (57 FR 60848, 60910,
December 22, 1992). Section 303(c)(2)(B) required States to adopt
numeric water quality criteria for those priority toxic pollutants for
which EPA had published recommended water quality criteria pursuant to
Section 304(a) of the Act. The criteria that EPA promulgated in the NTR
were based on EPA's then current Section 304(a) recommended water
quality criteria. The NTR criteria are codified at 40 CFR 131.36 and
became the applicable water quality criteria in those 14 States for CWA
purposes on February 5, 1993.
    As described in the preamble to the final NTR, when a State adopts,
and EPA approves, numeric water quality criteria, thus meeting the
requirements of section 303(c)(2)(B) of the CWA, EPA will issue a rule
amending the NTR to withdraw the Federal criteria for that State. See
57 FR 60860. If the State's criteria are no less stringent than the
promulgated Federal criteria, EPA will withdraw its criteria without
notice and comment because additional comment on the criteria is
unnecessary. However, if a State adopts criteria that are less
stringent than the federally promulgated criteria, but that in the
Agency's judgment fully meet the requirements of the Act, EPA will
provide an opportunity for public comment before withdrawing the
federally promulgated criteria. See 57 FR 60860.

B. Why Is EPA Withdrawing Federal Marine Aquatic Life Water Quality
Criteria for Toxic Pollutants Applicable to Washington?

    On November 18, 1997, Washington adopted revisions to its surface
water quality standards. Washington adopted a chronic marine aquatic
life water quality criterion for copper for all marine waters and a
chronic site-specific cyanide criterion for the Puget Sound. EPA Region
10 approved these criteria on February 6, 1998, finding that they were
consistent with the CWA and EPA's implementing regulations at 40 CFR
part 131. On August 1, 2003, Washington adopted revisions to its water
quality standards, including a revised chronic cyanide criterion for
all marine waters except the Puget Sound. EPA Region 10 approved this
revised criterion on May 23, 2007, finding that it was consistent with
the CWA and EPA's implementing regulations at 40 CFR part 131. By
adopting chronic numeric criteria for copper and cyanide that are
applicable to all marine waters of the State, Washington has complied
with the requirements of section 303(c)(2)(B) of the CWA, which
requires that states adopt numeric criteria for toxic pollutants for
which EPA has published recommended water quality criteria and the
discharge or presence of which in the affected waters could reasonably
be expected to interfere with those designated uses adopted by the
State, as necessary to support such designated uses. This fact, plus
EPA's approval of Washington's numeric criteria as protective of
designated uses, makes the federally promulgated criteria no longer
necessary for compliance with the CWA. Therefore, EPA has determined
that the federally promulgated criteria are no longer needed and is
proposing to withdraw the federally promulgated criteria for
Washington.

C. What Are the Federal Marine Aquatic Life Water Quality Criteria for
Toxic Pollutants Applicable to Washington That EPA Is Withdrawing?

    In this action, EPA is withdrawing Washington from the NTR for
those

marine cyanide and copper chronic criteria that the State has adopted
and EPA has approved. Table 1 provides a summary of the marine copper
and cyanide chronic aquatic life values under the NTR, Washington's
1997 criteria, and EPA's current recommended 304(a) criteria.
1. Chronic Marine Aquatic Life Criterion for Cyanide Applicable to All
Waters Except Puget Sound
    Washington has adopted, and EPA has approved, a marine aquatic life
criterion for cyanide of 1 microgram per liter ([mu]g/l) chronic
applicable to all marine waters except the Puget Sound. This criterion
is identical to the federally promulgated cyanide criterion in the NTR,
which is 1 [mu]g/l for the chronic value. This criterion is also
identical to EPA's Section 304(a) recommended water quality criterion.
Because Washington's criterion is identical to, i.e., no less stringent
than, the federally promulgated criterion in the NTR, the Federal
criterion is no longer necessary for compliance with the CWA, and EPA
is withdrawing it with this action. See 57 FR 60860.
2. Chronic Marine Aquatic Life Criterion for Cyanide Applicable to
Puget Sound
    Washington has adopted and EPA has approved a chronic site-specific
marine aquatic life criterion for cyanide. The chronic site-specific
cyanide criterion is 2.8 [mu]g/l and is only applicable to the waters
within the borders of Puget Sound (the waters east of a line from Point
Roberts to Lawrence Point to Green Point to Deception Pass, and south
from Deception Pass and of a line from Partridge Point to Point
Wilson). This value is less stringent than the cyanide value
promulgated in the NTR and less stringent than the value listed as part
of EPA's current recommended CWA section 304(a) criteria. Despite this
fact, EPA worked closely with Washington in developing the chronic
site-specific cyanide criterion, reviewing the test methodology and
resulting data, and approved the criterion on February 6, 1998. See EPA
Region 10 approval of Washington State's site-specific criteria for the
Puget Sound, February 6, 1998.
    The Federal water quality standards regulation at 40 CFR 131.11
requires states to adopt water quality criteria protective of
applicable designated uses. Section 131.11(b)(1) states that states
should, in adopting criteria, establish numerical values based on
Section 304(a) Guidance, Section 304(a) Guidance modified to reflect
site-specific conditions, or other scientifically defensible methods.
Regarding cyanide, Washington established site-specific chronic numeric
criterion based on EPA's CWA section 304(a) Guidance modified to
reflect site-specific conditions in the Puget Sound, which EPA approved
on February 6, 1998.
    Site-specific criteria, as with all water quality criteria, must be
based on a sound scientific rationale and ensure protection of the
applicable designated use. Washington's site-specific marine cyanide
criterion for Puget Sound was based on modifying EPA's methodology for
deriving aquatic life criteria by using species found in Puget Sound.
In developing the site-specific criteria for Puget Sound, Washington
substituted toxicity information from all species in the Cancer genus
found within Puget Sound for the toxicity data representing an
exclusively east coast species of crab (Cancer irroratus). In reviewing
the methodology utilized by Washington in performing this substitution,
EPA found that it was scientifically defensible because it used the
same scientific methodology followed in the development of EPA's own
section 304(a) recommended chronic criteria for cyanide, and because
the methodology Washington used in developing the site-specific
criterion used all the same genus that were recommended in EPA's
Guidelines for Deriving Numerical National Water Quality Criteria for
the Protection of Aquatic Organisms and Their Uses (EPA, 1985, PB85-
227049). Therefore, as described in EPA's February 6, 1998 approval
letter, EPA approved the State's site-specific criterion based on EPA's
conclusion that these criterion were scientifically defensible, as well
as protective of aquatic life in the Puget Sound.
    Consequently, Washington now has a chronic marine aquatic life
water quality criterion for cyanide that meets the requirements of the
statute and federal regulation. As such, the deficiencies leading to
EPA's promulgation of this criterion in the NTR for the State have been
remedied and the federal regulatory provisions applying this criterion
to the Puget Sound in Washington is no longer needed for compliance
with the CWA.
3. Chronic Marine Aquatic Life Criterion for Copper Applicable to All
Waters
    Washington has adopted, and EPA has approved, marine aquatic life
criterion for copper of 3.1 [mu]g/l chronic. The value promulgated in
the NTR for the copper chronic criterion is 2.4 [mu]g/l. The Washington
State criterion for copper is, therefore, less stringent than the value
promulgated in the NTR. However, Washington's criterion for copper is
equal to EPA's most recent CWA section 304(a) recommended criterion for
the protection of aquatic life for copper, which EPA updated in 1995.
    EPA derived the section 304(a) recommended chronic criterion for
the protection of aquatic life for copper using up-to-date scientific
information. Under CWA section 304(a), EPA periodically publishes
updated ambient water quality criteria recommendations to reflect the
latest data and scientific information about the relationship between
pollutant concentrations and environmental and human health effects.
EPA's national recommended water quality criteria serve as guidance to
states and authorized tribes in adopting water quality standards under
the CWA. After December 1992, when EPA promulgated a copper criterion
for Washington as part of the NTR using the Agency's then current
section 304(a) criteria recommendations, new data on the toxicity of
copper to aquatic organisms in marine waters became available. Thus,
EPA updated its national CWA section 304(a) recommended chronic marine
aquatic life criterion for copper in 1995 to reflect this new
scientific data. On November 18, 1997, Washington State adopted a
marine copper aquatic life criterion equivalent to EPA's revised CWA
section 304(a) recommended marine copper chronic aquatic life criteria.
Washington did this in order to incorporate the latest scientific
knowledge into its State water quality standards.
    EPA also relies on its section 304(a) recommended water quality
criteria when EPA promulgates water quality standards for a State. EPA
did this in 2000 when it promulgated acute and chronic criteria for
copper in California. Those water quality standards were based on EPA's
updated 1995 recommended water quality criteria for copper. See 40 CFR
131.38.
    As described in EPA's February 6, 1998 approval, Washington State's
chronic marine aquatic life criterion for copper met the requirements
of 40 CFR 131.11, which provides that states may adopt criteria based
on EPA's CWA section 304(a) recommended criteria. Based on the science
supporting EPA's recommended water quality criteria, EPA concluded that
Washington's chronic marine aquatic life criterion for copper is
protective of the applicable aquatic life designated uses. While
Washington's chronic marine aquatic life criterion for copper is less
stringent than the corresponding value in the NTR, in its February 6,
1998 approval, EPA concluded that Washington's

chronic marine aquatic life water quality criterion for copper is
protective of Washington's designated uses and meets the requirements
of the CWA and federal regulation. As such, the deficiencies leading to
EPA's promulgation of this criterion in the NTR for the State have been
remedied and the federal regulatory provisions applying this criterion
to the Puget Sound in Washington is no longer needed. Therefore, EPA is
removing Washington from the NTR for chronic marine copper aquatic life
criterion with this action.

                  Table 1.--Summary of Marine Chronic Copper and Cyanide Aquatic Life Criteria
----------------------------------------------------------------------------------------------------------------
                                                                                EPA's current
                                                   1992 NTR values        1997 Revised       recommended 304(a)
                   Chemical                      (Chronic ([mu]g/L))    Washington values     criteria (Chronic
                                                                       (Chronic ([mu]g/L))       ([mu]g/L))
----------------------------------------------------------------------------------------------------------------
Copper........................................                   2.4                   3.1                   3.1
Cyanide.......................................                     1                    1*                    1
----------------------------------------------------------------------------------------------------------------
* The Puget Sound site-specific criterion is 2.8 [mu]g/L chronic and is applicable only to waters which are east
  of a line from Point Roberts to Lawrence Point to Green Point to Deception Pass and south from Deception Pass
  and of a line from Partridge Point to Point Wilson (these are the borders of Puget Sound).

IV. Statutory and Executive Order Reviews

A. Executive Order 12866 (Regulatory Planning and Review)

    This action withdraws Federal requirements applicable to Washington
and imposes no regulatory requirements or costs on any person or
entity, does not interfere with the action or planned action of another
agency, and does not have any budgetary impacts or raise novel legal or
policy issues. Thus, it has been determined that this rule is not a
``significant regulatory action'' under the terms of Executive Order
12866 (58 FR 51735, October 4, 1993) and is therefore not subject to
OMB review.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden
because it is administratively withdrawing Federal requirements that
are no longer needed in Washington. It does not include any information
collection, reporting or recordkeeping requirements. However, the
Office of Management and Budget (OMB) has previously approved the
information collection requirements contained in the existing
regulations 40 CFR part 131 under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control
number 2040-0049, EPA ICR number 1530.12. A copy of the OMB approved
Information Collection Request (ICR) may be obtained from Susan Auby,
Collection Strategies Division; U.S. Environmental Protection Agency
(2822T); 1200 Pennsylvania Ave., NW., Washington, DC 20460 or by
calling<PHONE_NUMBER>.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have significant economic impact on a substantial number
of small entities. Small entities include small businesses, small
organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of this action on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's (SBA) regulations at 13 CFR
121.201; (2) a small governmental jurisdiction that is a government of
a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field.
    This rule imposes no regulatory requirements or costs on any small
entity. Therefore, I certify that this action will not have a
significant economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of the UMRA generally requires EPA to identify
and consider a reasonable number of regulatory alternatives and adopt
the least costly, most cost-effective or least burdensome alternative
that achieves the objectives of the rule. The provisions of section 205
do not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in

the development of EPA regulatory proposals with significant Federal
intergovernmental mandates, and informing, educating, and advising
small governments on compliance with the regulatory requirements.
    This rule contains no Federal mandates (under the regulatory
provisions of Title II of the UMRA) for State, Tribal, or local
governments or the private sector because it imposes no enforceable
duty on any of these entities. Thus, this rule is not subject to the
requirements of UMRA sections 202 and 205 for a written statement and
small government agency plan. Similarly, EPA has determined that this
rule contains no regulatory requirements that might significantly or
uniquely affect small governments and is therefore not subject to UMRA
section 203.

E. Executive Order 13132 (Federalism)

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
    This rule imposes no regulatory requirements or costs on any State
or local governments, therefore, it does not have federalism
implications under Executive Order 13132.

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

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This rule imposes no
regulatory requirements or costs on any Tribal government. It does not
have substantial direct effects on Tribal governments, the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes, as specified in Executive Order 13175.

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

    Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
    This rule is not subject to Executive Order 13045 because it is not
economically significant and EPA has no reason to believe the
environmental health or safety risks addressed by this action present a
disproportionate risk to children.

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

    This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001), because it is not a
significant regulatory action under Executive Order 12866.

I. National Technology Transfer Advancement Act

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

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

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this rule will not have disproportionately
high and adverse human health or environmental effects on minority or
low-income populations because (1) since Washington's criteria apply to
all marine waters in the State, EPA does not believe that this action
would disproportionately affect any one group over another, and (2) EPA
has previously determined, based on the most current science and EPA's
CWA section 304(a) recommended criteria, that Washington's State-
adopted and EPA-approved criteria are protective of human health and
aquatic life.

K. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2) and will be effective on September 7, 2007.

List of Subjects in 40 CFR Part 131

    Environmental protection, Indians--lands, Intergovernmental
relations, Reporting and recordkeeping requirements, Water pollution
control.

    Dated: July 2, 2007.
Stephen L. Johnson,
Administrator.

0
For the reasons set forth in the preamble, 40 CFR part 131 is amended
as follows:

PART 131--WATER QUALITY STANDARDS

0
1. The authority citation for part 131 continues to read as follows:

    Authority: 33 U.S.C. 1251 et seq.

Sec.  131.36  [Amended]

0
2. Section 131.36 is amended by revising the table in paragraph
(d)(14)(ii) to read as follows:

Sec.  131.36  Toxic criteria for those states not complying with Clean
Water Act Section 303(c)(2)(B).

* * * * *
    (d) * * *
    (14) * * *
    (ii) * * *

------------------------------------------------------------------------
          Use  classification                  Applicable criteria
------------------------------------------------------------------------
Fish and Shellfish; Fish...............  These classifications are
                                          assigned the criteria in:
                                          Column D2--all.
Water Supply (domestic)................  These classifications are
                                          assigned the criteria in:
                                          Column D1--all.
Recreation.............................  This classification is assigned
                                          the criteria in: Column D2--
                                          Marine waters and freshwaters
                                          not protected for domestic
                                          water supply.
------------------------------------------------------------------------

* * * * *
[FR Doc. E7-13207 Filed 7-6-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 78 (Thursday, April 23, 2015)]
[Notices]
[Pages 22733-22734]
[FR Doc No: 2015-09478]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0277; FRL-9926-63]

Pesticide Program Dialogue Committee; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act, the
Environmental Protection Agency's (EPA's) Office of Pesticide Programs
is announcing a public meeting of the Pesticide Program Dialogue
Committee (PPDC) on May 14-15, 2015. In addition, EPA is announcing
meetings

on May 13, 2015, of the following PPDC Workgroups: Integrated Pest
Management, Comparative Safety Statements, 21st Century Toxicology/New
Integrated Testing Strategies, and Public Health. These meetings
provide advice and recommendations to the EPA Administrator on issues
associated with pesticide regulatory development and reform
initiatives, evolving public policy and program implementation issues,
and science issues associated with evaluating and reducing risks from
use of pesticides.

DATES: Meeting: The PPDC meeting will be held on Thursday, May 14,
2015, from 9 a.m. to 5 p.m., and Friday, May 15, 2015, from 9 a.m. to
12 p.m.
    Work Group Meetings: On Wednesday, May 13, 2015, PPDC Work Group
meetings are scheduled as follows: Integrated Pest Management Work
Group, 9:30 a.m. to 11:30 a.m., Comparative Safety Statements Work
Group, 2:00 p.m. to 3:30 p.m., 21st Century Toxicology/New Integrated
Testing Strategies Work Group, 1 p.m. to 3 p.m., and Public Health Work
Group, 2:00 p.m. to 5:00 p.m.
    Agenda: A draft agenda will be posted on or before April 30, 2015.
    Accommodations requests: To request accommodation of a disability,
please contact the person listed under FOR FURTHER INFORMATON CONTACT,
preferably at least 10 days prior to the meeting, to give EPA as much
time as possible to process your request.

ADDRESSES: The PPDC Meeting and PPDC Work Group meetings will be held
at 1 Potomac Yard South, 2777 S. Crystal Drive, Arlington, VA. The PPDC
meeting will be held in the lobby-level Conference Center. The PPDC
Work Group meetings will be held as follows: Integrated Pest Management
Work Group and the Comparative Safety Statements Work Group in the
lobby-level Conference Center; 21st Century Toxicology/New Integrated
Testing Strategies Work Group in the fourth floor conference room
number N4850-70; and Public Health Work Group in the seventh floor
conference room number PYS7100.
    EPA's Potomac Yard South Bldg. is approximately 1 mile from the
Crystal City Metro Station.

FOR FURTHER INFORMATION CONTACT: Dea Zimmerman, Office of Pesticide
Programs (LC-8J), Environmental Protection Agency, 77 W. Jackson
Boulevard, Chicago, IL 60604; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you work in an
agricultural settings or if you are concerned about implementation of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the
Federal Food, Drug, and Cosmetic Act (FFDCA); and the amendments to
both of these major pesticide laws by the Food Quality Protection Act
(FQPA) of 1996; the Pesticide Registration Improvement Act, and the
Endangered Species Act. Potentially affected entities may include, but
are not limited to: Agricultural workers and farmers; pesticide
industry and trade associations; environmental, consumer, and farm
worker groups; pesticide users and growers; animal rights groups; pest
consultants; State, local, and tribal governments; academia; public
health organizations; and the public. If you have 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?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2015-0277, 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), West William Jefferson Clinton 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

II. Background

    The PPDC is a federal advisory committee chartered under the
Federal Advisory Committee Act (FACA), Public Law 92-463. EPA
established the PPDC in September 1995 to provide advice and
recommendations to the EPA Administrator on issues associated with
pesticide regulatory development and reform initiatives, evolving
public policy and program implementation issues, and science issues
associated with evaluating and reducing risks from use of pesticides.
The following sectors are represented on the current PPDC:
Environmental/public interest and animal rights groups; farm worker
organizations; pesticide industry and trade associations; pesticide
user, grower, and commodity groups; Federal and state/local/tribal
governments; the general public; academia; and public health
organizations.

III. How can I request to participate in this meeting?

    PPDC meetings are free, open to the public, and no advance
registration is required. Public comments may be made during the public
comment session of each meeting or in writing to the person listed
under FOR FURTHER INFORMATION CONTACT.

    Authority: 7 U.S.C. 136 et seq.

    Dated: April 16, 2015.
Jack Housenger,
Director, Office of Pesticide Programs.
[FR Doc. 2015-09478 Filed 4-22-15; 8:45 am]
 BILLING CODE 6560-50-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division Contact:  RD

Interregional Research Project No. 4

PP# 6E8450

The U.S. Environmental Protection Agency (EPA) has received a pesticide
petition (PP# 6E8450) from Interregional Research Project Number 4
(IR-4), Rutgers, The State University of New Jersey, 500 College Road
East, Suite 201W, Princeton, NJ  08540, proposing, pursuant to Section
408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. §
346a(d), to amend 40 CFR. § 180.614 by establishing tolerances for the
residues of Kasugamycin,
(3-O-[2-amino-4-[(carboxyimino-methyl)amino]-2,3,4,6-tetradeoxy-α-D-ara
bino-hexopyranosyl]-D-chiro-inositol), in or on the following raw
agricultural commodities:  Fruit, stone, subgroup 12-12A at 0.6 ppm and
Walnut at 0.04 ppm.  EPA has determined that the petition contains data
or information regarding the elements set forth in FFDCA Section
408(d)(2), however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data support granting of the
petition. Additional data may be needed before EPA rules on the
petition.

A. 	Residue Chemistry

1.   Metabolism in plants. The metabolism of kasugamycin in tomatoes has
been investigated and is well understood as published in the Federal
Register of April 8, 2005 (67 Fed. Reg. 17997). The nature of residues
of kasugamycin in tomatoes was investigated using 14C radiolabeled
kasugamycin. Parent kasugamycin was the primary component in both fruit
and foliage. The main metabolite in fruit, present at a maximum level of
0.01 part per million (ppm), was identified as kasugamycinic acid,
resulting from the conversion of the iminomethyl function to a
carboxylic acid; conjugates of kasugamycin and kasugamycinic acid were
also found in fruit at very low levels.  Investigation of extracts from
foliage indicated the presence of 2-N-acetyl kasugamycin,
kasuganobiosamine, and conjugates of kasugamycin and kasugamycinic acid.

2.  Metabolism in livestock.  The metabolism of kasugamycin in the
lactating goat has been investigated using 14C radiolabeled kasugamycin
and is well understood; 14C-kasugamycin was fed at an exaggerated level
(14.4X) of 12.6 mg/kg (dry feed basis) to a goat for 5 days.

The majority of the label was excreted as unchanged kasugamycin in the
urine and feces.  Residues ranged from 0.003 ppm in skim milk to 0.024
ppm in milk fat. Residues in other tissues ranged from 0.002 ppm
(omental fat) to 0.013 ppm (liver). The kidney contained 0.262 ppm
kasugamycin. Of the residues found in kidney, 92.9% was identified as
unchanged kasugamycin.

The goat study indicated that kasugamycin is poorly absorbed and those
residues that are retained comprise only parent compound.

3.  Analytical method.  A practical analytical method for detecting and
measuring levels of kasugamycin has been developed and validated in all
appropriate agricultural commodities. This analytical method is suitable
for monitoring of food with residues at the levels proposed for the
tolerances. The limit of quantitation (LOQ) for this method is 0.04 ppm.
An independent laboratory validation of the residue analytical method
was successful.

	4.  Magnitude of residue.  Eight trials (four tart and four sweet) were
conducted for this study, one in New York (tart cherry, EPA Region 1),
four in Michigan (two tart and two sweet cherry, EPA Region 5), one in
Colorado (tart cherry, EPA Region 9), and two in California (both sweet
cherry, EPA Region 10).  The number of trials and geographic
representation (when combined with trials conducted for study
AAFC07-073R) are adequate for obtaining a tolerance in cherry.

At all trials, four foliar (directed) applications of Kasumin 2L at a
rate of approximately 0.084 lb ai/A each were applied, for a total
application of approximately 0.34 lb ai/A.  A spreader/sticker type
adjuvant was added to the spray tank mix during each application.  The
applications were made at 7 (+/- 1) day intervals starting at
approximately 51 days before harvest.  The applications were timed so
that commercially mature sweet and tart cherries could be collected 30
(+/- 3) days after the final application.

Control samples were fortified and analyzed both prior to and
concurrently with field-treated samples.  Fortification levels ranged
from 0.04 to 4.0 ppm.  Method validation recoveries ranged from
94 to 101% at the lowest level of method validation (LLMV), and from
82 to 101% overall.  The average recovery of all kasugamycin
fortifications at 0.04 ppm was 98 ± 4% (n = 9).  The average recovery
of all kasugamycin method validation and concurrent fortifications at
0.4 ppm was 83 ± 8% (n = 10).  The limit of detection (LOD) and LOQ
were statistically calculated as 0.0045 ppm and 0.0137 ppm,
respectively, for kasugamycin.  A five-point standard curve was
generated each time an analysis set was run; the correlation coefficient
was always (0.95.  Note: Matrix in trial CA 112 had a significant
interference; for control sample A and treated sample C, the peak of
interest was partially resolved and quantitation was possible. For
sample D, however, the resolution of kasugamycin could not be achieved
and quantitation was impossible.

The maximum storage interval for field-treated samples in this study was
303 days.  Storage stability testing was performed after 307 days of
frozen storage; results demonstrated stability.

The results from the trials show that the maximum residues in cherry
fruit following a total application of approximately 0.34 lb ai/A and a
PHI of 30 (+-3) days were 0.358 ppm (29 PHI) (NY18 trial, tart cherry).
The mean residue in all eight trials was 0.172 ppm. The decline study
(MI04) did not show significant residue loss from 7 to 30 days after
treatment.  The highest residue detected was 0.365 ppm for the 0 day
sample in the MI04 trial (tart cherry).

Three field trials (6 samples) were conducted in walnuts according to
the proposed use pattern (i.e., 4 foliar directed applications at 0.083
lb ai/A with 7 day retreatment interval). Walnuts were harvested
approximately 100 days after the last application. Quantifiable residues
were observed in one sample (0.0400 ppm from 07-CA60). All other
residues were below the LLMV of 0.04 ppm.  The tolerance for walnuts is
proposed at the limit of quantitation (0.04 ppm).

B. 	Toxicological Profile

1.  Acute toxicity.  Kasugamycin has a low order of acute toxicity.  The
acute oral and dermal LD50 values for kasugamycin are greater than 5,000
milligrams per kilogram (mg/kg) for rats regardless of gender. In acute
inhalation testing in the rat, kasugamycin’s LC50 is greater than 2.05
milligram/liter (mg/L). Further, kasugamycin was mildly irritating to
the eyes, non-irritating to the skin of rabbits, and non-sensitizing to
the skin of the guinea pig.  This technical label will carry the EPA
signal word “CAUTION.”

2.  Genotoxicity.  A battery of mutagenicity studies yielded negative
results in bacteria and mammalian cells; kasugamycin was negative in the
following assays:  bacterial reverse mutation, Chinese hamster ovary
(CHO), chromosomal aberration (in vitro), mammalian erythrocyte
micronucleus, unscheduled DNA synthesis, and in vitro mammalian cell
gene mutation.  Overall, it is unlikely that kasugamycin presents a
genetic hazard

3.  Reproductive and developmental toxicity.

i.  Rat developmental.  In the developmental toxicity study conducted
with rats, for maternal toxicity, the no observed adverse effect level
(NOAEL) is 200 mg/kg/day and the lowest observed adverse effect level
(LOAEL) is 1000 mg/kg/day based on decreased body weights, body weight
gains, and food consumption; increased incidence of loose stool; and
distention of the large intestine with stool in the cecum.

For developmental toxicity, the NOAEL is 1000 mg/kg/day and the LOAEL is
≥1000 mg/kg/day.

ii. Rabbit developmental.  In the developmental toxicity study conducted
with rabbits, the maternal NOAEL is 10 mg/kg/day and the LOAEL is = 30
mg/kg/day based on the range-finding study results of maternal weight
loss, decreased food consumption during treatment and abortion (three or
four females).

For developmental toxicity, the NOAEL is 10 mg/kg/day and the LOAEL is =
30 mg/kg/day based on the decrease in fetal body weight in the
range-finding study.

iii.  Reproduction.  In the rat reproduction study the parental/systemic
NOAEL is 70.3/82.9 mg/kg/day (M/F) and the LOAEL is 425.3/503.4
mg/kg/day (M/F) based on decreased body weights and body weight gains in
P males, and red and swollen skin around the anal opening (M&F)(P and F1
animals).

For reproductive toxicity, the NOAEL is 70.3/82.9 mg/kg/day (M/F) and
the LOAEL is 425.3/503.4 mg/kg/day (M/F) based on testicular
atrophy/degeneration in F1 males, decreased fertility and fecundity in
the F1 parents for both litters, and increased pre-coital interval
during the mating period for the F2 litter.

For offspring toxicity, the NOAEL is 425.3/503.4 mg/kg/day (M/F) and the
LOAEL is >425.3/503.4 mg/kg/day (M/F).

4.  Subchronic toxicity.

≥1,000 ppm male but were not considered adverse.

ii.  Rat 21-day dermal toxicity.  A 21-day dermal toxicity study was
conducted in the rate.  For systemic effects, NOAEL is >500 mg/kg/day
for male and ≥500/200 mg/kg/day for female.  The LOAEL was not
determined as no effects were noted at the highest dose tested.

For dermal effects, the NOAEL is 250 mg/kg/day for males and 250/100
mg/kg/day for females.  The LOAEL was 500 mg/kg/day for males and
500/200 mg/kg/day for females based on erytherma, edema, eschar,
ulceration, scabbing, microscopic findings of acanthosis, inflammation,
and ulceration.

iii.  Rat 90-day dietary neurotoxicity.  A 90-day acute neural screen
battery was conducted in the rat.  For systemic effects, the NOAEL was
210/238 mg/kg/day (M/F). The LOAEL was 439/486 mg/kg/day (M/F) based on
decreased body weight and body weight gain.

For neurotoxicity, the NOAEL was ≥439/486 mg/kg/day (M/F). The LOAEL
was not determined as no neurotoxic effects were observed at the highest
dose tested.

iv.  Mouse 90-day oral toxicity.  A 13-week subchronic feeding study was
conducted in the mouse.  The NOAEL is 135.4/170.9 mg/kg/day (M/F) and
the LOAEL is 408.5/565.6 mg/kg/day (M/F) based on increased mortality
and anal lesions (M/F), and kidney lesions (F). At 1,559/1,834 mg/kg/day
(M/F), decreased body weights and body weight gains (M/F), testicular
tubular dilatation and degeneration, perianal/perigenital staining (F),
and extramedullary hematopoiesis of the spleen (M) were seen.

v.  Dog 90-day oral toxicity.  A 13-week subchronic feeding study was
conducted in the dog. The NOAEL is 99.6/103.6 mg/kg/day (M/F) and the
LOAEL is 99.6/103.6 mg/kg/day (M/F) based on tongue lesions, few feces,
swollen mouth, excessive salivation, and thickened skin at the
commissure of the mouth. At 182/170 mg/kg/day (M/F), decreased body
weights, body weight gains, and food consumption were seen.

           5.  Chronic toxicity.  Kasugamycin has been tested in chronic
studies with dogs, rats, and mice.

                      i.  Rat combined chronic toxicity/carcinogenicity.
 A 24-month combined chronic/oncogenicity study was conducted in rats.
The NOAEL was 11.3/140 mg/kg/day (M/F).  The LOAEL was 116/≥140
mg/kg/day (M/F) based on increased testicular softening and atrophy in
males.  No evidence of carcinogenicity was observed.

                   ii.  Carcinogenicity mouse.  A 78-week chronic
feeding study was conducted in mice. The NOAEL was 186.3/215.2 mg/kg/day
and the LOAEL was >186.3/215.2 mg/kg/day with no evidence of
carcinogenicity.

           6.  Dog chronic toxicity.  A 52-week chronic toxicity study
was carried out in dogs.  The NOAEL was 99.6/103.6 mg/kg/day (M/F) and
the LOAEL was >99.6/103.6 mg/kg/day with no evidence of carcinogenicity.

           7.  Immunotoxicity.  An immunotoxicity study was carried out
in female mice.  The systemic NOAEL is 755/691 mg/kg/day (AFC group/NK
group).  The LOAEL is 2,468/2,531 mg/kg/day (AFC group/NK group) based
on clinical observations, decreased mean body weights, and decreased
hematological parameter.

The immunotoxicity NOAEL is ≥2,468/2,531 mg/kg/day and the LOAEL was
not determined.  A significant decrease (p≤0.05) in Total Spleen
Activity (AFC/spleen) was only observed at a dose causing excessive
toxicity (HDT) and that exceeded the limit dose.

	8.  Carcinogenicity.  Kasugamycin did not produce carcinogenicity in
adequately designed chronic studies with rats or mice; additionally, no
mutagenic potential was noted in any of the five mutagenicity studies.
Classification of kasugamycin is “not likely to be carcinogenic to
humans.”

	9.  Animal metabolism.  A metabolism and pharmacokinetics study was
carried out in the rats.  The mean radioactivity recovery 168 hours
after exposure ranged between 90.6-96.7%, with the majority of the dose
recovered within 48 hours in the feces (81.9-93.9%) and urine
(1.26-3.07%).  The maximum concentration found in the plasma of both
males and females occurred approximately one hour after the
administration of a single low or high dose.  More kasugamycin
accumulated in the kidneys, urinary bladder, and lymph nodes than in the
blood, but after 168 hours, little or no kasugamycin was found in these
tissues.  The absorption and metabolism of kasugamycin in rats was
limited (<5% dose) and was not affected by sex, dose level, or duration
of dosing.  Parent compound was the major component identified in the
urine, feces, liver, kidney, and plasma.  Minor amounts (<1% dose) of
the metabolite kasuganobiosamine were identified in urine, liver,
kidney, and plasma but none detected in the feces.  Elimination occurred
primarily in the feces (87.7-94.5%, however, kasugamycin was not
excreted in the bile (enterohepatic circulation did not occur).

	10.  Metabolite toxicology.  No metabolites of significant expected
toxicity were identified in the animal metabolism study.

11.  Endocrine disruption.  Beyond testicular softening seen in the rat
combined chronic toxicity/carcinogenicity study, there is no evidence
that kasugamycin has any effect on endocrine function.

C. 	Aggregate Exposure

1.   Dietary exposure.  Tier I chronic dietary exposure evaluations were
conducted for the active ingredient fungicide/bactericide, kasugamycin,
using EPA’s DEEM-FCID/Calendex v.4.02/10.00.  Default processing
factors were used in these assessments.  All food consumption data were
from the 2005-06, 2007-08, and 2009-10 cycles of the National Health and
Nutrition Examination Survey/“What We Eat in America” (NHANES/WWEIA)
dietary survey.  These exposure assessments included tolerance values as
proposed for current uses on pome fruits and the maximum residue levels
(MRL) as established in Canada for fruiting vegetables and walnuts, in
addition to the proposed use on cherries and assumed 100% of the crops
were treated.  Secondary residues in animal commodities were not
considered as anticipated residues and transfer information from
metabolism studies indicate that tolerances for kasugamycin in animal
commodities are not required.  Drinking water estimates were
incorporated directly into the dietary exposure assessment using the
value of 1.1781 ppb derived for the surface water estimated drinking
water concentrations (EDWC) previously by EPA.  This value was chosen
for the risk assessment as it exceeds the 0.116 ppb value obtained for
groundwater.

For acute dietary exposures, no appropriate dose and endpoint could be
identified from the submitted studies for females ages 13-49 or the
general population. Consequently, an acute dietary exposure assessment
was not conducted.

For chronic dietary exposures, the reference dose (RfD) is 0.113
mg/kg/day, based on the NOAEL for males (11.3 mg/kg/d) in the combined
chronic toxicity/oncogenicity study in rats and an uncertainty factor of
100. No additional Food Quality Protection Act (FQPA) safety factor was
applied.  The toxic effect of concern is increased testicular softening
observed in males at 116 mg/kg/d. No effects were observed in females at
the maximum dose (140 mg/kg/d).

Chronic exposure to the most exposed subpopulation (children 1-2 years)
resulted in exposure equivalent to 3.0% of the chronic RfD of 0.113
mg/kg-bw/day.  EPA generally has no concern for exposures below 100% of
the RfD; there is a reasonable certainty that no harm will result from
dietary (food) exposure to residues arising from the proposed uses for
kasugamycin

Cancer:  EPA classified kasugamycin as “not likely to be a human
carcinogen.”  Due to the classification, no quantitative cancer
exposure assessment was performed.

2.  Non-dietary exposure.

          i.  Occupational handler (mixer/loader/applicator) exposure.
Products containing kasugamycin will be registered for agricultural uses
only and will not be available for any residential or public uses.
Kasumin 2L will be applied only by professionals; assessment of
occupational handler exposures potential post-application exposure is
required. These exposures are anticipated to be of short-term or
intermediate-term duration. The exposure related hazards are:

For dermal exposure of any duration, EPA determined there was no need to
conduct an occupational risk assessment in 2012.  Based on this
determination and the similarity of use pattern between pome fruit and
cherries, no dermal assessments were conducted.

For inhalation exposures (short- and intermediate-term), the dog
subchronic (NOAEL = 10.6/11.4 mg/kg/day (M/F); LOAEL = 106.0/107.9
mg/kg/day) and the rabbit developmental studies (NOAEL = 10 mg/kg/day;
LOAEL = 30 mg/kg/day) were selected as co-critical studies.  The NOAELs
were comparable and believed to be protective of both portal of entry
effects to the lung from irritation as well as systemic effects.  For
the assessment, a NOAEL of 11 mg/kg/day with LOAELs of 106 mg/kg/day was
utilized.  Complete absorption of inhaled exposures is assumed.

Applications of Kasumin 2L to cherries will be made with airblast
equipment.

The highest rate, maximum number of applications, shortest intervals,
and shortest PHI on the proposed label were modeled individually for
handlers making applications to cherries.

EPA default assumptions for the maximum daily area treated were also
employed in the assessment (40 acres/day for airblast applications; EPA,
2001). Inhalation unit exposures were obtained from EPA’s
“Occupational Pesticide Handler Unit Exposure Surrogate Reference
Table” (EPA, 2013). Handler exposure estimates assume a 70 kg body
weight. Complete (100%) absorption of inhaled exposures is assumed.

Short-/intermediate-term inhalation exposures and margins of exposure
(MOE) calculated for occupational handlers mixing/loading and applying
kasugamycin range from 58,000 to 1,300,000.  MOEs greater than 100
indicate that occupational handler exposures associated with
applications of kasugamycin to cherries are not of concern.

Walnuts: Maximum spray concentration of 0.00083 lb ai/gal sprayed at a
rate of 100gal/A (i.e., 0.083 lb ai/A). No more than 4 applications can
be made per season with a minimum interval between applications of 7
days. The PHI on walnuts is 100 days.

Applications of Kasumin 2L to walnuts will be made with airblast
equipment. The highest rates, maximum number of applications, shortest
intervals and shortest PHI on the proposed label were modeled
individually for handlers making applications to walnuts.

EPA default assumptions for the maximum daily area treated were also
employed in the assessment; these being, 40 acres/day for airblast
applications (EPA, 2001).  Dermal and inhalation unit exposures were
obtained from the PHED Surrogate Exposure Guide (EPA, 1997). Handler
exposure estimates assume a 60 kg body weight. Complete (100%)
absorption of inhaled exposures is assumed. A dermal absorption fraction
was not applied in the calculation because the endpoint of concern is
from a dermal toxicity study.

Short-/intermediate-term dermal and inhalation exposures and margins of
exposure (MOEs) calculated for occupational handlers applying
kasugamycin range from 78,600 to 1,510,000.  Short-/intermediate-term
dermal, and short-/intermediate-term inhalation MOEs range from 7,530 to
402,000.

MOEs greater than 100 indicate that occupational handler exposures
associated with applications of kasugamycin to walnuts are not of
concern.

D. 	Cumulative effects.  FFDCA Section 408(b)(2)(D)(v) requires that,
when considering whether to establish, modify, or revoke a tolerance,
EPA consider “available information” concerning the cumulative
effects of a particular pesticide’s residues and other substances that
have a “common mechanism of toxicity.”   EPA does not have, at this
time, available data to determine whether kasugamycin has a common
mechanism of toxicity with other substances or how to include this
pesticide in a cumulative risk assessment.  For the purposes of this
tolerance action, EPA has not assumed that kasugamycin has a common
mechanism of toxicity with other substances.

E. 	Safety determination.

1.   U.S. population.  The chronic dietary exposure analysis (food plus
water) showed that exposure from all proposed uses of kasugamycin would
result in an exposure equal to 0.000564 mg/kg body wt/day (0.5% of the
chronic RfD of 0.113 mg/kg/day) for the general U.S. population.  A
chronic cancer exposure analysis was not performed, since there is no
evidence of human carcinogenic potential for kasugamycin.  Short-term
aggregate and intermediate-term aggregate risk was not assessed because
there are no current, pending, or proposed residential uses for
kasugamycin.  Based on the completeness and reliability of the toxicity
data supporting these petitions, there is a reasonable certainty that no
harm will result from aggregate exposure to residues arising from the
proposed kasugamycin tolerances, including anticipated dietary exposure
from food and water exposures.

2.   Infants and children.  The chronic dietary exposure analysis (food
plus water) showed that exposure from all established and proposed uses
of kasugamycin would result in an exposure equal to 0.00338 mg/kg body
wt/day (3.0% of the chronic RfD of 0.113 mg/kg/day) for the most
sensitive subpopulation, children (1-2 years old). A chronic cancer
exposure analysis was not performed since there is no evidence of human
carcinogenic potential for kasugamycin.  Short-term aggregate and
intermediate-term aggregate risk was not assessed because there are no
current, pending, or proposed residential uses for kasugamycin.  Based
on the completeness and reliability of the toxicity data supporting
these petitions, there is a reasonable certainty that no harm will
result from aggregate exposure to residues arising from all proposed
kasugamycin tolerances, including anticipated dietary exposure from food
and water exposures.  Considering the potential aggregate exposure from
food and water exposure routes, aggregate exposure is not expected to
exceed 100% of the chronic RfD and there is a reasonable certainty that
no harm will result to infants and children from the aggregate exposure
to kasugamycin.

F. 	International tolerances.  There are no Codex MRLs established for
kasugamycin.  Kasugamycin is currently not included on Annex 1 and has a
default MRL of 0.01 within the European Union.

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& peas, broad beans, dried peanuts, other legumes/pulses, potatoes,
Japanese radish, roots (including radish), Japanese radish, leaves
(including radish), Chinese cabbage, cabbage, broccoli, other
cruciferous vegetables, burdock, lettuce (including cos lettuce and leaf
lettuce), onions, welsh (including leek), garlic, carrots, celery,
pimento (sweet pepper), melons, Japanese pears, pears, loquat, peaches,
mume plum, kiwifruit, and tea at 0.04 ppm; sugar beets, turnips, roots
(including rutabaga), turnip, leaves (including rutabaga), watercress,
brussels sprouts, kyona, cauliflower, shungiku, other composite
vegetables, mitsuba, other umbelliferous vegetables, other solanaceous
vegetables, cucumbers (including gherkin), pumpkins (including squash),
watermelon, other cucurbitaceous vegetables, okra, ginger, other
vegetables, unshu orange, pulp, citrus natsudaidai, whole lemons,
oranges (including navel oranges), grapefruits, limes, other citrus
fruits, other fruits, other spices, and other herbs at 0.05 ppm.

Canada has established MRLs as follows: black walnuts and English
walnuts at 0.04 ppm; African eggplants, scarlet eggplants, bell peppers,
currant tomatoes, eggplants, bush tomatoes, goji berries, tomatoes,
naranjullas, non-bell peppers, garden huckleberrires, martynias,
sunberries, tree tomatoes, pepinos, okras, coconas, broundcherries
roselles, tomatillos, and  pea eggplants at 0.1 ppm; and Loquats,
Chinese quinces, apples, medlars, Japanese quinces, Asian pears,
tejocotes quinces, azaroles, mayhaw, crabapples, and pears at 0.2 ppm.

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