[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Rules and Regulations]
[Pages 47060-47061]
[FR Doc No: 2011-19170]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0012; Airspace Docket No. 10-ASO-44]

Amendment of Class D and Class E Airspace; Columbus Lawson AAF,
GA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies Class D and Class E airspace at Lawson
Army Airfield (AAF), Columbus, GA, by removing the reference to the
Columbus Metropolitan Airport Class C airspace area from the
description. Controlled airspace at Columbus Metropolitan Airport is
being downgraded due to decreased air traffic volume. This action is
necessary for the safety and management of air traffic within the
National Airspace System. This action also updates the geographic
coordinates of Columbus Lawson AAF.

DATES: Effective 0901 UTC, October 20, 2011. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On May 24, 2011, the FAA published in the Federal Register a notice
of proposed rulemaking (NPRM) to modify Class D and E airspace at
Lawson Army Airfield (AAF), Columbus, GA by removing the reference to
the Columbus Metropolitan Airport Class C airspace area from the
description, and modifying the geographic coordinates of Lawson AAF (76
FR 30045) Docket No. FAA-2011-0012. Interested parties were invited to
participate in this rulemaking effort by submitting written comments on
the proposal to the FAA. No comments were received. Class D and E
airspace designations are published in paragraph 5000 and 6002,
respectively, of FAA Order 7400.9U dated August 18, 2010, and effective
September 15, 2010, which is incorporated by reference in 14 CFR 71.1.
The Class D and E airspace

designations listed in this document will be published subsequently in
the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends the Class D airspace and Class E airspace designated as
surface area at Columbus Lawson AAF, Columbus, GA by removing the
reference to the Columbus Metropolitan Airport Class C airspace from
the description. The volume of air traffic has decreased at Columbus
Metropolitan Airport, therefore, Class C airspace has been removed. The
geographic coordinates for the Lawson AAF are being adjusted to
coincide with the FAAs aeronautical database. This action is necessary
for the safety and management of IFR operations at the airports.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore, (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
subtitle VII, part A, subpart I, section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Columbus Lawson AAF, Columbus, GA.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9U, Airspace Designations and Reporting
Points, dated August 18, 2010, effective September 15, 2010, is amended
as follows:

Paragraph 5000 Class D Airspace

* * * * *

ASO GA D Columbus Lawson AAF, GA [Amended]

Columbus Lawson AAF, GA
    (Lat. 32[deg]19'55'' N., long 84[deg]59'14'' W.)

    That airspace extending upward from the surface to and including
2,700 feet MSL within a 5.2-mile radius of Lawson Army Airfield.
This Class D airspace area is effective during the specific dates
and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.

Paragraph 6002 Class E Airspace Designated as Surface Areas

* * * * *

ASO GA E2 Columbus Lawson AAF, GA [Amended]

Columbus Lawson AAF, GA
    (Lat. 32[deg]19'55'' N., long. 84[deg]59'14'' W.)

    Within a 5.2-mile radius of Lawson Army Airfield. This Class E
airspace area is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Airport/
Facility Directory.

    Issued in College Park, Georgia, on July 19, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-19170 Filed 8-3-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 62 (Friday, April 2, 2021)]
[Proposed Rules]
[Pages 17322-17324]
[FR Doc No: 2021-06778]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 86, No. 62 / Friday, April 2, 2021 / Proposed
Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0256; Project Identifier MCAI-2020-00480-R]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters Deutschland GmbH
(AHD) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus Helicopters Deutschland GmbH (AHD) Model MBB-BK 117 D-2
helicopters. This proposed AD was prompted by a failed electrical test
during production. This proposed AD would require replacing certain
wire harness trim connector backshells (backshells), as specified in a
European Union Aviation Safety Agency (EASA) AD, which is proposed for
incorporation by reference (IBR). This proposed AD would also prohibit
installing the affected backshells. The FAA is proposing this AD to
address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by May 17,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that is proposed for IBR in this AD, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999
000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You may
find this material on the EASA website at https://ad.easa.europa.eu.
You may view this material at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available in the AD docket on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2021-0256.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0256; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Katherine Venegas, Aviation Safety
Engineer, Los Angeles ACO Branch, Compliance & Airworthiness Division,
FAA, 3960 Paramount Blvd., Lakewood, California 90712; telephone (562)
627-5353; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0256; Project Identifier
MCAI-2020-00480-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposal.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Katherine Venegas, Aviation Safety Engineer, Los Angeles ACO Branch,
Compliance & Airworthiness Division, FAA, 3960 Paramount Blvd.,
Lakewood, California 90712; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Any commentary that the FAA receives that is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2019-0198, dated August 15, 2019
(EASA AD 2019-0198), to correct an unsafe condition for all Airbus
Helicopters Deutschland GmbH (AHD), formerly Eurocopter Deutschland
GmbH, Model MBB-BK117 D-2 helicopters.
    This proposed AD was prompted by a short circuit in a yaw trim
actuator connector that occurred during production electrical tests.
Subsequent investigations determined that a sharp edge in the backshell
damaged the wiring insulation. The FAA is issuing this proposed AD to
address an unsafe condition that could result in yaw or pitch trim
runaway and subsequent loss of control of the helicopter. See the

EASA AD for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2019-0198 specifies replacing backshells part number (P/N)
M85049/90-13W02 if manufactured by AMPHENOL or if the manufacturer is
unknown (affected part) with backshells P/N M85049/90-13W02 not
manufactured by AMPHENOL (serviceable part). EASA AD 2019-0198 also
prohibits the (re-)installation of an affected part.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    These products have been approved by the aviation authority of
another country, and are approved for operation in the United States.
Pursuant to the bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the EASA
AD referenced above. The FAA is proposing this AD after evaluating all
the relevant information and determining the unsafe condition described
previously is likely to exist or develop in other products of the same
type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2019-0198, described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this proposed AD and except as discussed under
``Differences Between this Proposed AD and the EASA AD.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2019-0198
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2019-0198 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2019-0198 that is required for compliance with EASA AD 2019-
0198 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2021-0256 after the FAA
final rule is published.

Differences Between This Proposed AD and the EASA AD

    The EASA AD applies to all Model MBB-BK117 D-2 helicopters, whereas
this proposed AD applies to that model helicopter with an affected part
installed instead. The EASA AD requires replacing each affected part
with a serviceable part within 9 months, whereas this proposed AD would
require that replacement within 30 hours time-in-service instead.

Costs of Compliance

    The FAA estimates that this proposed AD affects 30 helicopters of
U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates that operators may incur the following
costs in order to comply with this proposed AD.
    Replacing each backshell would take about 8 work-hours and parts
would cost $220, for an estimated cost of $900 per backshell.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

Airbus Helicopters Deutschland GmbH (AHD): Docket No. FAA-2021-0256;
Project Identifier MCAI-2020-00480-R.

(a) Comments Due Date

    The FAA must receive comments by May 17, 2021.

(b) Affected Airworthiness Directives (ADs)

    None.

(c) Applicability

    This AD applies to Airbus Helicopters Deutschland GmbH Model
MBB-BK 117 D-2 helicopters, certificated in any category, having an
affected part as defined in European Union Aviation Safety Agency
(EASA) AD 2019-0198, dated August 15, 2019 (EASA AD 2019-0198).

(d) Subject

    Joint Aircraft System Component (JASC) Code 2700, Flight Control
System.

(e) Reason

    This AD was prompted by a short circuit in a yaw trim actuator
connector that occurred during production electrical tests.
Subsequent investigations determined that a sharp edge in the wire
harness trim connector backshell damaged the wiring insulation. The
FAA is issuing this AD to address an unsafe condition that could
result in yaw or pitch trim runaway and subsequent loss of control
of the helicopter.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with EASA AD 2019-0198.

(h) Exceptions to EASA AD 2019-0198

    (1) Where EASA AD 2019-0198 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where paragraph (1) of EASA AD 2019-0198 specifies to
replace each affected part with a serviceable part within 9 months,
this AD requires replacing each affected part with a serviceable
part within 30 hours time-in-service after the effective date of
this AD.
    (3) Although the service information referenced in EASA AD 2019-
0198 specifies to discard certain parts, this AD requires removing
those parts from service.
    (4) Where the service information referenced in EASA AD 2019-
0198 specifies to use tooling, equivalent tooling may be used.
    (5) Paragraph (2) of EASA AD 2019-0198 does not apply to this
AD; this AD requires compliance with paragraph (i) of this AD.
    (6) The ``Remarks'' section of EASA AD 2019-0198 does not apply
to this AD.

(i) Parts Installation Prohibition

    As of the effective date of this AD, do not install a wire
harness trim connector backshell identified in paragraph (c) of this
AD on any helicopter.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Strategic Policy Rotorcraft Section, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the Strategic Policy Rotorcraft Section,
send it to: Manager, Strategic Policy Rotorcraft Section, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    (1) For EASA AD 2019-0198 contact the EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu. You may
view this material at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. This material may be found in the AD
docket on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2021-0256.
    (2) For more information about this AD, contact Katherine
Venegas, Aviation Safety Engineer, Los Angeles ACO Branch,
Compliance & Airworthiness Division, FAA, 3960 Paramount Blvd.,
Lakewood, California 90712; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
    Issued on March 25, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-06778 Filed 4-1-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 67 (Friday, April 7, 2023)]
[Notices]
[Pages 20882-20883]
[FR Doc No: 2023-07100]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2017-0751; FRL-10860-01-OCSPP]

Pesticide Registration Review; Decisions and Case Closures for
Several Pesticides; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's the closure of
the registration review cases for irgarol, oregano oil, and tagetes
oils (formerly flower oils case), because the last U.S. registrations
for these pesticides have been canceled.

ADDRESSES: The docket for this action, identified under docket
identification (ID) number EPA-HQ-OPP-2017-0751, is available online at
https://www.regulations.gov. Additional instructions on visiting the
docket, along with more information about dockets generally, is
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For pesticide specific information, contact: The Chemical Review
Manager for the pesticide of interest identified in Table 1 in Unit IV.
    For general information on the registration review program,
contact: Melanie Biscoe, Pesticide Re-evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; email address:
[email protected]; phone,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. General Information

Does this action apply to me?

    This action is directed to the public in general and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the pesticide specific contact person listed under FOR FURTHER
INFORMATION CONTACT: For pesticide specific information, contact: The
Chemical Review Manager for the pesticide of interest identified in
Table 1 in Unit IV.

II. Background

    Registration review is EPA's periodic review of pesticide
registrations to ensure that each pesticide continues to satisfy the
statutory standard for registration, that is, the pesticide can perform
its intended function without unreasonable adverse effects on human
health or the environment. As part of the registration review process,
the Agency has completed case closures for

all pesticides listed in Table 1 in Unit IV. Through this program, EPA
is ensuring that each pesticide's registration is based on current
scientific and other knowledge, including its effects on human health
and the environment.

III. Authority

    EPA is conducting its registration review of the chemicals listed
in Table 1 in Unit IV pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural
Regulations for Registration Review at 40 CFR part 155, subpart C.
Section 3(g) of FIFRA provides, among other things, that the
registrations of pesticides are to be reviewed every 15 years. Under
FIFRA, a pesticide product may be registered or remain registered only
if it meets the statutory standard for registration given in FIFRA
section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with
widespread and commonly recognized practice, the pesticide product must
perform its intended function without unreasonable adverse effects on
the environment; that is, without any unreasonable risk to man or the
environment, or a human dietary risk from residues that result from the
use of a pesticide in or on food.

IV. What action is the Agency taking?

    Pursuant to 40 CFR 155.58, this notice announces the availability
of case closures for the pesticides shown in Table 1. The registration
review decisions are supported by rationales included in the docket
established for each chemical.

         Table 1--Registration Review Case Closures Being Issued
------------------------------------------------------------------------
                                                      Chemical review
 Registration review case name    Docket ID No.     manager and contact
          and number                                    information
------------------------------------------------------------------------
Irgarol, Case Number 5031.....  EPA-HQ-OPP-2010-0  Megan Snyderman,
                                 003.               [email protected],<PHONE_NUMBER>.
Oregano Oil, Case Number 6342.  EPA-HQ-OPP-2022-0  Hannah Dean,
                                 641.               [email protected],
<PHONE_NUMBER>.
Tagetes Oils (formerly Flower   EPA-HQ-OPP-2011-0  Daniel Schoeff,
 Oils Case), Case Number 8202.   628.               [email protected],<PHONE_NUMBER>.
------------------------------------------------------------------------

    The decisions for the chemicals in the table above were posted to
the docket and the public was invited to submit comments or new
information. Pursuant to 40 CFR 155.58(c), the registration review case
docket for the chemicals listed in Table 1 will remain open until all
actions required in the decision have been completed.
    Background on the registration review program is provided at:
https://www.epa.gov/pesticide-reevaluation.
    Authority: 7 U.S.C. 136 et seq.

    Dated: March 31, 2023.
Mary Elissa Reaves,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2023-07100 Filed 4-6-23; 8:45 am]
BILLING CODE 6560-50-P


<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">

<META name="generator" content="PDFCreactiveX HTML Export">
<META name="creation-date" content="25/04/2008 07:12:56 ">
<TITLE></TITLE>


[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Rules and Regulations]
[Pages 62454-62455]
[FR Doc No: 2018-26335]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

17 CFR Parts 239 and 274

[Release Nos. 33-10577, IC-33308; File Nos. S7-08-15; S7-04-18]

Form N-1A; Correction

AGENCY: Securities and Exchange Commission.

ACTION: Final rule; technical correction.

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

SUMMARY: This document makes technical corrections to several
amendments to Form N-1A, which the Commission adopted as part of three
rulemakings: Investment Company Reporting Modernization, which was
published in the Federal Register on November 18, 2016; Optional
Internet Availability of Investment Company Shareholder Reports, which
was published in the Federal Register on June 22, 2018; and Investment
Company Liquidity Disclosure, which was published in the Federal
Register on July 10, 2018. This document is being published to correct
the paragraph designations that appeared in the amendatory instructions
preceding certain of the form amendments that the Commission adopted as
part of each of these rulemakings. This document makes technical
corrections only to the paragraph designations that appear in the
amendatory instructions preceding these form amendments. This document
does not make any substantive changes (i.e., changes except corrections
to typographical errors) to the text of the form amendments themselves.

DATES: Effective December 4, 2018, except:
     The revisions to Item 27(d)(3) of Form N-1A are effective
May 1, 2020;
     Item 27(d)(7) of Form N-1A (referenced in 17 CFR 239.15A
and 274.11A) is effective January 1, 2019, through December 31, 2021;
and
     Item 27(d)(7) is removed effective January 1, 2022.

FOR FURTHER INFORMATION CONTACT: James Maclean, Senior Counsel, or
Amanda Hollander Wagner, Branch Chief, Investment Company Regulation
Office, at<PHONE_NUMBER>, Division of Investment Management,
Securities and Exchange Commission, 100 F Street NE, Washington, DC
20549-8549.

SUPPLEMENTARY INFORMATION: We are making a technical amendment to Item
27 of Form N-1A under 17 CFR 239.15A and 274.11A.

List of Subjects

17 CFR Part 239

    Reporting and recordkeeping requirements, Securities.

17 CFR Part 274

    Investment companies, Reporting and recordkeeping requirements,
Securities.

Statutory Authority and Text of Amendments

    For the reasons set out above, title 17, chapter II of the Code of
Federal Regulations is amended as follows:

PART 239--FORMS PRESCRIBED UNDER THE SECURITIES ACT OF 1933

0
1. The authority citation for part 239 continues to read in part as
follows:

    Authority: 15 U.S.C. 77c, 77f, 77g, 77h, 77j, 77s, 77z-2, 77z-3,
77sss, 78c, 78l, 78m,78n, 78o(d), 78o-7 note, 78u-5, 78w(a), 78ll,
78mm, 80a-2(a), 80a-3, 80a-8, 80a-9, 80a-10, 80a-13, 80a-24, 80a-26,
80a-29, 80a-30, and 80a-37; and sec. 107, Pub. L. 112-106, 126 Stat.
312, unless otherwise noted.
* * * * *

PART 274--FORMS PRESCRIBED UNDER THE INVESTMENT COMPANY ACT OF 1940

0
2. The authority citation for part 274 continues to read in part as
follows:

    Authority: 15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78l, 78m,
78n, 78o(d), 80a-8, 80a-24, 80a-26, 80a-29, and Pub. L. 111-203,
sec. 939A, 124 Stat. 1376 (2010), unless otherwise noted.
* * * * *

0
3. Form N-1A (referenced in Sec. Sec.  239.15A and 274.11A), Item 27,
is amended by:
0
a. Revising paragraph (d)(3);
0
b. Redesignating paragraph (d)(6) as (d)(6)(i);
0
c. Adding new paragraph (d)(6)(ii);
0
d. Adding paragraph (d)(7); and
0
e. Removing paragraph (d)(7).
    The revisions and additions read as follows:

    Note: The text of Form N-1A does not, and this amendment will
not, appear in the Code of Federal Regulations.

Form N-1A

* * * * *

Item 27. Financial Statements

* * * * *
    (d) * * *
    (3) Statement Regarding Availability of Quarterly Portfolio
Schedule. A statement that: (i) The Fund files its complete schedule of
portfolio holdings with the Commission for the first and third quarters
of each fiscal year as an exhibit to its reports on Form N-PORT; (ii)
the Fund's Form N-PORT reports are available on the Commission's
website at http://www.sec.gov; and (iii) if the Fund makes the
information on Form N-PORT available to shareholders on its website or
upon request, a description of how the information may be obtained from
the Fund.
* * * * *
    (6) Board Approvals and Liquidity Reviews.
    (i) Statement Regarding Basis for Approval of Investment Advisory
Contract. * * *
    (ii) Statement Regarding Liquidity Risk Management Program. If the
board of directors reviewed the Fund's liquidity risk management
program pursuant to rule 22e-4(b)(2)(iii) of the Act [17 CFR 270.22e-
4(b)(2)(iii)] during the Fund's most recent fiscal half-year, briefly
discuss the operation and effectiveness of the Fund's liquidity risk
management program over the past year.

Instruction

    If the board reviews the liquidity risk management program more
frequently than annually, a fund may choose to include the discussion
of the program's operation and effectiveness over the past year in one
of either the fund's annual or semi-annual reports, but does not need
to include it in both reports.
    (7) Front Cover Page or Beginning of Annual and Semi-Annual Report.
Include on the front cover page or at the beginning of the annual or
semi-annual report a statement to the following effect, if applicable:
    Beginning on [date], as permitted by regulations adopted by the
Securities and Exchange Commission, paper copies of the Fund's
shareholder reports like this one will no longer be sent by mail,
unless you specifically request paper copies of the reports from the
Fund [or from your financial intermediary, such as a broker-dealer or
bank]. Instead, the reports will be made available on a website, and
you will be notified by mail each time a report is posted and provided
with a website link to access the report.
    If you already elected to receive shareholder reports
electronically, you will not be affected by this change and you need
not take any action. You may elect to receive shareholder reports and
other communications from the Fund [or your financial intermediary]
electronically by [insert instructions].
    You may elect to receive all future reports in paper free of
charge. You can inform the Fund [or your financial intermediary] that
you wish to continue receiving paper copies of your shareholder reports
by [insert instructions]. Your election to receive reports in paper
will apply to all funds held with [the fund complex/your financial
intermediary].
* * * * *

    Dated: November 29, 2018.
Brent J. Fields,
Secretary.
[FR Doc. 2018-26335 Filed 12-3-18; 8:45 am]
BILLING CODE 8011-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. EPA, Office of Water, Office of Ground Water and Drinking Water 2. OMB control number b. None a 2040 0042 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title Underground Injection Control Program ( Renewal)

8. Agency form number( s) ( If applicable) EPA ICR Number: 0370.19; EPA Form Numbers: 7520 1; 7520 2A; 7520 2B; 7520 3; 7520 4; 7520 6; 7520 7; 7520 8; 7520 9; 7520 10; 7520 11; 7520 12; 7520 14; 7520 16 9. Keywords Environmental protection, Water pollution control, Underground injection 10. Abstract This ICR estimates the burden and cost to owners and operators of Class I  V injection wells to submit information to demonstrate compliance with Underground Injection Control regulations. Respondents submit permit applications, wastewater monitoring data, mechanical integrity testing reports, and well closure reports. Primacy states submit information to EPA on permits, compliance and enforcement, inspections, and inventory for all well classes.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. X Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 41,141 b. Total annual responses 478,189 1. Percentage of these responses collected electronically 0 % c. Total hours requested 1,334,054 d. Current OMB inventory 1,091,945 e. Difference 242,109 f. Explanation of difference 1. Program Change 0 2. Adjustment 242,109 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 381 b. Total annual costs ( O& M) $ 89,034 c. Total annualized cost requested $ 89,415 d. Current OMB inventory $ 31,828 e. Difference $ 57,587 f. Explanation of difference 1. Program change $ 0 2. Adjustment $ 57,587 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X")

a. __ Application for benefits e. X Program planning or management b. X Program evaluation f. __ Research c. __ General purpose statistics g. P_ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. X Quarterly 5. X Semi annually 6. X Annually 7. Q Biannually 8. Q Other ( describe) 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Robert E. Smith Phone: ( 202) 564 3895 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Cynthia C. Dougherty, Director Office of Ground Water and Drinking Water Office of Water Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95


[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Notices]
[Page 13592]
[FR Doc No: 2012-5468]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10482-107]

AER NY-Gen, LLC; Eagle Creek Hydro Power, LLC, Eagle Creek Water
Resources, LLC, Eagle Creek Land Resources, LLC; Notice of Application
for Transfer of License, and Soliciting Comments and Motions To
Intervene

    On February 24, 2012, AER NY-Gen, LLC (transferor), Eagle Creek
Hydro Power, LLC, Eagle Creek Water Resources, LLC, and Eagle Creek
Land Resources, LLC (transferees) filed an application for the transfer
of license for the Swinging Bridge Hydroelectric Project No. 10482,
located on the Mongaup River in Sullivan County, New York.
    Applicants seek Commission approval to transfer the license for the
Swinging Bridge Hydroelectric Project from the transferor to the
transferees.
    Applicants' Contact: Transferor: Mr. Joseph Klimaszewski, AER NY-
Gen, LLC, P.O. Box 876, East Aurora, NY 14052,<PHONE_NUMBER>.
Transferees: Mr. Bernard H. Cherry, Eagle Creek Hydro Power, LLC, Eagle
Creek Water Resources, LLC, and Eagle Creek Land Resources, LLC, 65
Madison Avenue, Morristown, NJ 07960,<PHONE_NUMBER>.
    FERC Contact: Patricia W. Gillis<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments and motions to intervene: 15 days from
the issuance date of this notice. Comments and motions to intervene may
be filed electronically via the Internet. See 18 CFR 385.2001(a)(1) and
the instructions on the Commission's Web site under http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. If unable to be filed electronically, documents may be paper-
filed. To paper-file, an original plus seven copies should be mailed
to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
888 First Street NE., Washington, DC 20426. More information about this
project can be viewed or printed on the eLibrary link of Commission's
Web site at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the
docket number (P-10482) in the docket number field to access the
document. For assistance, call toll-free 1-866-208-3372.

    Dated: February 29, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-5468 Filed 3-6-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 20 (Thursday, January 30, 2014)]
[Notices]
[Pages 4947-4948]
[FR Doc No: 2014-01787]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2013-0002]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final Notice.

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

SUMMARY: New or modified Base (1% annual-chance) Flood Elevations
(BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries
or zone designations, and/or the regulatory floodway (hereinafter
referred to as flood hazard determinations) as shown on the indicated
Letter of Map Revision (LOMR) for each of the communities listed in the
table below are finalized. Each LOMR revises the Flood Insurance Rate
Maps (FIRMs), and in some cases the Flood Insurance Study (FIS)
reports, currently in effect for the listed communities. The flood
hazard determinations modified by each LOMR will be used to calculate
flood insurance premium rates for new buildings and their contents.

DATES: The effective date for each LOMR is indicated in the table
below.

ADDRESSES: Each LOMR is available for inspection at both the respective
Community Map Repository address listed in the table below and online
through the FEMA Map Service Center at www.msc.fema.gov.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final flood hazard determinations as shown in the
LOMRs for each community listed in the table below. Notice of these
modified flood hazard determinations has been published in newspapers
of local circulation and ninety (90) days have elapsed since that
publication. The Deputy Associate Administrator for Mitigation has
resolved any appeals resulting from this notification.
    The modified flood hazard determinations are made pursuant to
section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4105, and are in accordance with the National Flood Insurance Act of
1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The new or modified flood hazard determinations are the basis for
the floodplain management measures that the community is required
either to adopt or to show evidence of being already in effect in order
to remain qualified for participation in the National Flood Insurance
Program (NFIP).
    These new or modified flood hazard determinations, together with
the floodplain management criteria required by 44 CFR 60.3, are the
minimum that are required. They should not be construed to mean that
the community must change any existing ordinances that are more
stringent in their floodplain management requirements. The community
may at any time enact stricter requirements of its own or pursuant to
policies established by other Federal, State, or regional entities.
    These new or modified flood hazard determinations are used to meet
the floodplain management requirements of the NFIP and also are used to
calculate the appropriate flood insurance premium rates for new
buildings, and for the contents in those buildings. The changes in
flood hazard determinations are in accordance with 44 CFR 65.4.
    Interested lessees and owners of real property are encouraged to
review the final flood hazard information available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Location and case    Chief executive officer       Community map                                        Community
         State and county                    No.                of  community              repository       Effective date of  modification      No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Texas:
    Collin (FEMA Docket No.: B-     City of Plano (12-06- The Honorable Harry        City Hall, 1520        September 20, 2013.............       480140
     1338).                          4168P).               LaRosiliere, Mayor, City   Avenue K, Plano, TX
                                                           of Plano, P.O. Box         75074.
                                                           860358, Plano, TX 75086.
    Dallas (FEMA Docket No.: B-     City of Coppell (13-  The Honorable Karen Hunt,  Department of          November 4, 2013...............       480170
     1349).                          06-1839P).            Mayor, City of Coppell,    Engineering, 265
                                                           P.O. Box 9478, Coppell,    Parkway Boulevard,
                                                           TX 75019.                  Coppell, TX 75019.
    Dallas (FEMA Docket No.: B-     City of Dallas (13-   The Honorable Mike         Department of Public   November 4, 2013...............       480171
     1349).                          06-1839P).            Rawlings, Mayor, City of   Works, 320 East
                                                           Dallas, 1500 Marilla       Jefferson Boulevard,
                                                           Street, Room 5EN,          Room 307, Dallas, TX
                                                           Dallas, TX 75201.          75203.
    Dallas (FEMA Docket No.: B-     City of Grand         The Honorable Ron Jensen,  City Development       September 9, 2013..............       485472
     1338).                          Prairie (13-06-       Mayor, City of Grand       Center, 206 West
                                     1633P).               Prairie, P.O. Box          Church Street, Grand
                                                           534045, Grand Prairie,     Prairie, TX 75050.
                                                           TX 75053.
    Dallas (FEMA Docket No.: B-     City of Irving (13-   The Honorable Beth Van     Department of Public   November 4, 2013...............       480180
     1349).                          06-1839P).            Duyne, Mayor, City of      Works, 825 West
                                                           Irving, 825 West Irving    Irving Boulevard,
                                                           Boulevard, Irving, TX      Irving, TX 75060.
                                                           75060.
    Fort Bend (FEMA Docket No.: B-  City of Katy (12-06-  The Honorable Fabol R.     Public Works           August 2, 2013.................       480301
     1324).                          1798P).               Hughes, Mayor, City of     Department, 910
                                                           Katy, P.O. Box 617,        Avenue C, Katy, TX
                                                           Katy, TX 77493.            77493.
    Gillespie (FEMA Docket No.: B-  Unincorporated areas  The Honorable Mark         Gillespie County, 101  October 31, 2013...............       480696
     1349).                          of Gillespie County   Stroeher, Gillespie        West Main Street,
                                     (13-06-0803P).        County Judge, 101 West     Fredericksburg, TX
                                                           Main Street, Room 101,     78624.
                                                           Fredericksburg, TX 78624.
    Tarrant (FEMA Docket No.: B-    City of Fort Worth    The Honorable Betsy        Department of          October 31, 2013...............       480596
     1355).                          (12-06-1456P).        Price, Mayor, City of      Transportation and
                                                           Fort Worth, 1000           Public Works, 1000
                                                           Throckmorton Street,       Throckmorton Street,
                                                           Fort Worth, TX 76102.      Fort Worth, TX 76102.
    Tarrant (FEMA Docket No.: B-    City of Saginaw (12-  The Honorable Gary         City Hall, 333 West    October 31, 2013...............       480610
     1355).                          06-1456P).            Brinkley, Mayor, City of   McLeroy Boulevard,
                                                           Saginaw, 333 West          Saginaw, TX 76179.
                                                           McLeroy Boulevard,
                                                           Saginaw, TX 76179.

Virginia: Fairfax (FEMA Docket      Unincorporated areas  The Honorable Sharon       Fairfax County         October 31, 2013...............       515525
 No.: B-1355).                       of Fairfax County     Bulova, Chairman-at-       Department of Public
                                     (12-03-2453P).        Large, Fairfax County      Works and
                                                           Board of Supervisors,      Environmental
                                                           12000 Government Center    Services, 12000
                                                           Parkway, Suite 530,        Government Center
                                                           Fairfax, VA 22035.         Parkway, Suite 449,
                                                                                Fairfax, VA 22035.
--------------------------------------------------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: December 18, 2013.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2014-01787 Filed 1-29-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Rules and Regulations]
[Pages 38976-38981]
[FR Doc No: 2018-16989]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0352; FRL-9978-83]

Spinetoram; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
spinetoram in or on tea, dried and tea, instant. Dow AgroSciences,
LLC., requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective August 8, 2018. Objections and
requests for hearings must be received on or before October 9, 2018,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0352, 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.

FOR FURTHER INFORMATION CONTACT: Michael Goodis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW, Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address: [email protected].

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. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0352 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
October 9, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0352, 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 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.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 23, 2017 (82 FR 49020) (FRL-
9967-37), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
7E8554) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis,
Indiana 46268-1054. The petition requested that 40 CFR 180.635 be
amended by establishing tolerances for residues of the insecticide
spinetoram, in or on tea, dried at 70 parts per million (ppm) and tea,
instant at 70 ppm. That document referenced a summary of the petition
prepared by Dow AgroSciences, the registrant, which is available in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for spinetoram including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with spinetoram follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Spinetoram and spinosad are considered by EPA to be
toxicologically identical for human health risk assessment based on
their very similar chemical structures and similarity of the
toxicological databases for currently available studies, therefore, the
Agency has assessed and summarized the toxicological profile for both
together. The primary toxic effect observed from exposure to spinetoram
and spinosad was histopathological changes in multiple organs (specific
target organs were not identified). Vacuolization of cells and/or
macrophages was the most common histopathological finding noted across
the toxicological database with the dog being the most sensitive
species. In addition to the numerous organs observed with
histopathological changes, anemia was noted in several studies. There
was no evidence of increased quantitative or qualitative susceptibility
from spinetoram or spinosad exposure. In developmental studies, no
maternal or developmental effects were seen in rats or rabbits. In the
rat reproduction toxicity studies, offspring toxicity (decreased litter
size,

survival, and body weights with spinosad; increased incidence of late
resorptions and post-implantation loss with spinetoram) was seen in the
presence of parental toxicity (increased organ weights, mortality, and
histopathological findings) at approximately the same dose for both
chemicals. Dystocia and/or other parturition abnormalities were
observed with both spinetoram and spinosad in the reproduction toxicity
studies. There was no evidence of neurotoxicity, immunotoxicity, or
carcinogenicity from spinetoram exposure.
    Specific information on the studies received and the nature of the
adverse effects caused by spinetoram as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Spinosad/Spinetoram. Human Health
Risk Assessment in Support of Proposed Spinetoram Tolerance for
Residues in/on Imported Tea'' at page 8 in docket ID number EPA-HQ-OPP-
2017-0352 and in document ``Spinosad/Spinetoram. Draft Human Health
Risk Assessment for Registration Review,'' at pages 12-17 in docket ID
number EPA-HQ-OPP-2011-0666.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    Spinetoram and spinosad should be considered toxicologically
identical in the same manner that metabolites are generally considered
toxicologically identical to the parent. As a result, studies from both
toxicological databases were considered for endpoint selection.
    A summary of the toxicological endpoints for spinetoram used for
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Spinetoram/Spinosad for Use in Human Health Risk
                                                   Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations)..       A dose and endpoint of concern attributable to a single dose was not
                                                                      observed.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 2.49 mg/kg/   Chronic RfD =        Chronic Toxicity--Dog
                                    day.                  0.0249 mg/kg/day.    (Spinetoram).
                                   UFA = 10x...........  cPAD = 0.0249 mg/kg/ LOAEL = 5.36/5.83 mg/kg/day (males/
                                   UFH = 10x...........   day.                 females) based on arteritis and
                                   FQPA SF = 1x........                        necrosis of the arterial walls of
                                                                               the epididymides in males and of
                                                                               the thymus, thyroid, larynx, and
                                                                               urinary bladder in females.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to   NOAEL = 4.9 mg/kg/    Residential LOC for  Subchronic Oral Toxicity--Dog
 30 days) and intermediate-term     day.                  MOE <100.            Study (with spinosad).
 (1 to 6 months).                  UFA = 10x...........                       LOAEL = 9.73 mg/kg/day based on
                                   UFH = 10x...........                        microscopic changes in multiple
                                   FQPA SF = 1x........                        organs, clinical signs of
                                                                               toxicity, decreases in body
                                                                               weights and food consumption, and
                                                                               biochemical evidence of anemia
                                                                               and liver damage.
----------------------------------------------------------------------------------------------------------------
Dermal (All durations)...........     No hazard was identified for dermal exposure; therefore, a quantitative
                                                          dermal assessment is not needed.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation (or oral)  Residential LOC for  Subchronic Oral Toxicity--Dog
 days) and Intermediate-Term (1-6   study NOAEL = 4.9     MOE <100.            Study (with spinosad).
 months).                           mg/kg/day                                 LOAEL = 9.73 mg/kg/day based on
                                    (inhalation assumed                        microscopic changes in multiple
                                    equivalent to oral).                       organs, clinical signs of
                                   UFA = 10x...........                        toxicity, decreases in body
                                   UFH = 10x...........                        weights and food consumption, and
                                   FQPA SF = 1x........                        biochemical evidence of anemia
                                                                               and liver damage.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)            Classified as ``not likely to be carcinogenic to humans.''
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population-adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spinetoram and spinosad, EPA considered exposure under the
petitioned-for tolerances as well as all existing spinetoram tolerances
in 40 CFR 180.635 as well as existing spinosad tolerances. With the
exception

of tea, spinosad is registered for application to all of the same crops
as spinetoram, with similar pre-harvest and retreatment intervals, and
application rates greater than or equal to spinetoram. Further, both
active ingredients control the same pest species. For this reason, EPA
has concluded it would overstate exposure to assume that residues of
both spinosad and spinetoram would appear on the same food. The risk
assessment included commodities that have tolerances for both spinosad
and spinetoram as well as commodities where only spinosad tolerances
are established. EPA aggregated exposure by assuming that all
commodities, with the exception of tea, contain spinosad (because side-
by-side spinetoram and spinosad residue data indicated that spinetoram
residues were less than or equal to spinosad residues); for tea, EPA
assumed spinetoram residues were present. EPA assessed dietary
exposures from spinetoram in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for spinetoram or spinosad;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA (2003-2008). As to residue levels in food, EPA assumed 100
percent crop treated (PCT), average field-trial residues or tolerance-
level residues for crop commodities, average residues from the
livestock feeding studies, spinosad residue estimates for fish/
shellfish (residues of spinetoram in fish/shellfish are expected to be
insignificant), and experimental or default processing factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that spinetoram does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use PCT information in the dietary assessment for
spinetoram. Section 408(b)(2)(E) of FFDCA authorizes EPA to use
available data and information on the anticipated residue levels of
pesticide residues in food and the actual levels of pesticide residues
that have been measured in food. If EPA relies on such information, EPA
must require pursuant to FFDCA section 408(f)(1) that data be provided
5 years after the tolerance is established, modified, or left in
effect, demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such Data Call-Ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for spinetoram and spinosad in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of spinetoram and spinosad. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the surface water concentration calculator (SWCC) and
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of spinetoram for acute exposures
are estimated to be 25.9 parts per billion (ppb) for surface water and
below the levels of detection for ground water. For chronic exposures
for non-cancer assessments, the spinetoram EDWCs are estimated to be
19.3 ppb for surface water and well below the levels of detection for
ground water. EDWCs of spinosad for acute exposures are estimated to be
30.6 ppb for surface water and below the levels of detection for ground
water. For chronic exposures for noncancer assessments, the spinetoram
EDWCs are estimated to be 22.8 ppb for surface water and below the
levels of detection for ground water.
    Modeled estimates of drinking water concentration were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 22.8 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    EPA assessed residential exposure using the following assumptions:
The use on tea will not result in residential exposure; however,
spinetoram and spinosad are currently registered for uses that could
result in residential exposures including home lawns and pet (cats/
kittens) spot-on applications; therefore, there is potential for
residential handler and post-application exposures to both spinetoram
and spinosad. Since spinosad and spinetoram control the same pests, EPA
concludes that these products will not be used for the same uses in
combination with each other and thus combining spinosad and spinetoram
residential exposures would overstate exposure. EPA assessed
residential exposure for both spinosad and spinetoram using the most
conservative residential exposure scenarios for either chemical.
    EPA assessed the following ``worst-case'' residential exposure
scenarios as: (1) Adult residential handler (inhalation exposure from
applications to lawns and turf) and (2) child (1-<2 years) (hand-to-
mouth exposures from post-application exposure to turf). Because EPA's
level of concern for spinetoram is a MOE below 100, the MOEs for both
of these residential exposure scenarios are not of concern. In
addition, the short-term assessment is protective of intermediate-term
exposure as the short- and intermediate-term PODs are identical.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found spinetoram to share a common mechanism of
toxicity with any other substances, and spinetoram does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
spinetoram does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of
increased prenatal or postnatal susceptibility.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for spinetoram is adequate for FQPA SF
consideration.
    ii. There is no evidence of neurotoxicity from spinetoram exposure.
    iii. There is no evidence that spinetoram results in increased pre-
or post-natal susceptibility in rats or rabbits.
    iv. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions in assessing
exposures and these assessments will not underestimate the exposure and
risks posed by spinetoram.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
spinetoram is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
spinetoram from food and water will utilize 72% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
spinetoram is not expected; therefore, the chronic dietary estimate
represents the chronic aggregate estimate.
    3. Short- and Intermediate-term risk. Short- and Intermediate-term
aggregate exposures takes into account short-term and intermediated-
term residential exposures plus chronic exposure to food and water
(considered to be a background exposure level). Spinetoram is currently
registered for uses that could result in short- and intermediate-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short- and intermediate-term residential exposures to spinetoram.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 780 for adults
(handler) and 200 for children (post-application). Because EPA's level
of concern for spinetoram is a MOE below 100, these MOEs are not of
concern. In addition, the short-term assessment is protective of
intermediate-term exposure as the short- and intermediate-term PODs are
identical.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, spinetoram is not expected to pose a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to spinetoram residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available for both plant and
livestock commodities. Method GRM 05.03 (HPLC/MS/MS) is an acceptable
method for the determination of spinetoram residues in a variety of
crops. Methods GRM 05.15 and GRM 06.08 (HPLC/MS) are acceptable methods
for determination of spinetoram residues in bovine and poultry tissues,
milk, cream, and eggs. Both methods are available to enforce the
tolerance expression.
    The methods may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for spinetoram.

V. Conclusion

    Therefore, tolerances are established for residues of spinetoram,
expressed as the combined residues of XDE-175-J: 1-H-as-indaceno[3,2-
d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-
[alpha]-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl] oxy]-9-ethyl-
2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro 14-methyl-,
(2R,3aR,5aR,5bS,9S,13S, 14R,16aS,16bR); XDE-175-L: 1H-as-indaceno[3,2-
d]oxacyclododecin-7,15-dione, 2-[(6-deoxy-3-O-ethyl-2,4-di-O-methyl-
[alpha]-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-
(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-
2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS); ND-J:
(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-9-ethyl-14-methyl-13
[[(2S,5S,6R)-6-methyl-5-(methylamino)tetrahydro-2H-pyran-2-yl]oxy]-
7,15-dioxo-2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-
octadecahydro-1H-as-indaceno[3,2-

d]oxacyclododecin-2-yl 6-deoxy-3-O-ethyl-2,4-di-O-methyl-[alpha]-L-
mannopyranoside; and NF-J: (2R,3S,6S)-6-
([(2R,3aR,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-3-O-ethyl-2,4-di-O-
methyl-[alpha]-L-mannopyranosyl) oxy]-9-ethyl-14-methyl-7,15-dioxo-
2,3,3a,4,5,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-octadecahydro-1H-as-
indaceno[3,2-d]oxacyclododecin-13-yl]oxy)-2-methyltetrahydro-2H-pyran-
3-yl(methyl)formamide, in or on tea, dried at 70 parts per million
(ppm) and tea, instant at 70 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: July 24, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.635 add alphabetically the entries for ``Tea, dried'';
and ``Tea, instant''; and footnote 1 to the table in paragraph (a) to
read as follows:

Sec.  180.635   Spinetoram; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Tea, dried \1\..........................................              70
Tea, instant \1\........................................              70

                                * * * * *
------------------------------------------------------------------------
\1\ There are no U.S. registrations as of August 8, 2018 for use on tea.

* * * * *
[FR Doc. 2018-16989 Filed 8-7-18; 8:45 am]
 BILLING CODE 6560-50-P