[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11634-11635]
[FR Doc No: 2013-03646]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC13-72-000.
    Applicants: Alcoa Power Generating Inc.
    Description: Application for Authorization under Section 203 of the
Federal Power Act and Request for Waivers of Alcoa Power Generating
Inc.
    Filed Date: 2/7/13.
    Accession Number: 20130207-5142.
    Comments Due: 5 p.m. ET 2/28/13.

    Docket Numbers: EC13-73-000.
    Applicants: Twin Cities Power, LLC.
    Description: Application for Authorization under Section 203 of
Twin Cities Power, LLC.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5080.
    Comments Due: 5 p.m. ET 3/1/13.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER13-301-002.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc. submits tariff filing per
35.17(b): Errata Filing--Docket ER13-301-001--MKEC Formula Rate
Revisions to be effective 1/1/2013.
    Filed Date: 2/7/13.
    Accession Number: 20130207-5115.
    Comments Due: 5 p.m. ET 2/28/13.

    Docket Numbers: ER13-323-001.
    Applicants: ISO New England Inc.
    Description: ISO New England Inc. submits tariff filing per 35:
Correct Defined Term in Generator Audit Revisions to be effective 12/
31/9998.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5040.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-629-001.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado submits tariff
filing per 35.17(b): 2013--02--07--BNGR Amnd T-L Agrmt-542 to be
effective 1/1/2013.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5002.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-663-001.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado submits tariff
filing per 35.17(b): 2013--02--07--MDEU Amnd T-L Agrmt-541 to be
effective 1/1/2013.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5001.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-666-001.
    Applicants: Public Service Company of Colorado.
    Description: Public Service Company of Colorado submits tariff
filing per 35.17(b): 2013--02--07--SPNR Amnd T-L Agrmt-548 to be
effective 1/1/2013.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5003.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-898-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits tariff filing
per 35.13(a)(2)(iii: Amendment to BART NITSA (Richmond Garage) to be
effective 4/9/2013.
    Filed Date: 2/7/13.
    Accession Number: 20130207-5120.
    Comments Due: 5 p.m. ET 2/28/13.

    Docket Numbers: ER13-899-000.
    Applicants: Abest Power & Gas, LLC.
    Description: Abest Power & Gas, LLC submits tariff filing per
35.12: Application for Market-Based Rate Authority to be effective 3/8/
2013.
    Filed Date: 2/7/13.
    Accession Number: 20130207-5121.
    Comments Due: 5 p.m. ET 2/28/13.

    Docket Numbers: ER13-901-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits tariff
filing per 35.15: Notices of Cancellation of SGIA & DSA Randolph Roof
Top Solar Project with ASIT to be effective 10/22/2012.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5000.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-902-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: 2013-02-08 Schedule 31
Annual Update to be effective 4/9/2013.
    Date: 2/8/13.
    Accession Number: 20130208-5016.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-903-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits tariff filing per 35.13(a)(2)(iii: 2013-02-08 UDS-SCADA Filing
40.2.14 to be effective 4/9/2013.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5017.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-904-000.
    Applicants: Wabash Valley Power Association, Inc.
    Description: Wabash Valley Power Association, Inc. submits tariff
filing per 35.13(a)(2)(iii: Amendments to Rate Schedules to be
effective 4/9/2013.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5031.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-905-000.
    Applicants: Green Mountain Power Corporation, ISO New England Inc.
    Description: Green Mountain Power Corporation submits tariff filing
per 35.13(a)(2)(iii: Green Mtn. Power, ISO-NE and Woodsvie LSA to be
effective 4/26/2011.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5038.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-906-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits tariff
filing per 35.15: Notice of Cancellation to Mojave Solar Letter
Agreement to be effective 12/10/2012.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5041.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-907-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison Company submits tariff
filing per 35.13(a)(2)(iii: Letter Agreement Mojave Solar 4 Project to
be effective 1/11/2013.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5042.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-908-000.
    Applicants: Alabama Power Company.
    Description: Alabama Power Company submits tariff filing per 35:
OATT Order No. 1000 Compliance Filing--FILING SUBMITTED UNDER PROTEST
to be effective 12/31/9998.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5087.
    Comments Due: 5 p.m. ET 3/25/13.

    Docket Numbers: ER13-909-000.

    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. submits
tariff filing per 35.13(a)(2)(iii: NYISO tariff amendments to revise
energy price calculations in scarcity periods to be effective 12/31/
9998.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5113.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-910-000.
    Applicants: American Transmission Systems Incorporated, PJM
Interconnection, L.L.C.
    Description: American Transmission Systems, Incorporated submits
tariff filing per 35.13(a)(2)(iii: CEI (ATSI) submits SA Nos. 3501 &
3502-IA & CA among CEI and WM Renewable Energy to be effective 1/9/
2013.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5117.
    Comments Due: 5 p.m. ET 3/1/13.

    Docket Numbers: ER13-911-000.
    Applicants: Smoky Mountain Transmission LLC.
    Description: Smoky Mountain Transmission LLC submits Request for
Waiver of Order No. 1000 Transmission Planning Requirements.
    Filed Date: 2/8/13.
    Accession Number: 20130208-5121.
    Comments Due: 5 p.m. ET 3/1/13.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 08, 2013.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2013-03646 Filed 2-15-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 155 (Thursday, August 11, 2011)]
[Rules and Regulations]
[Page 49649]
[FR Doc No: 2011-20404]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

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

Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 /
Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]

Oral Dosage Form New Animal Drugs; Change of Sponsor;
Chlortetracycline; Sulfamethazine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for five new animal
drug applications (NADAs) from Fort Dodge Animal Health, Division of
Wyeth Holdings Corp., a wholly owned subsidiary of Pfizer, Inc., to
Boehringer Ingelheim Vetmedica, Inc.

DATES: This rule is effective August 11, 2011.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth
Holdings Corp., a wholly owned subsidiary of Pfizer, Inc., 235 East 42d
St., New York, NY 10017 has informed FDA that it has transferred
ownership of, and all rights and interest in, five approved NADAs
(NADAs 055-012, 055-018, 055-039, 065-071, and 065-440) to Boehringer
Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO
64506-2002. Accordingly, the Agency is amending the regulations in 21
CFR part 520 to reflect the transfer of ownership.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. Revise Sec.  520.445 to read as follows:

Sec.  520.445  Chlortetracycline and sulfamethazine powder.

    (a) Specifications. Each pound of soluble powder contains
chlortetracycline bisulfate equivalent to 102.4 grams (g) of
chlortetracycline hydrochloride and sulfamethazine bisulfate equivalent
to 102.4 g of sulfamethazine.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  556.150 and 556.670 of this
chapter.
    (d) Conditions of use in swine. Administer in drinking water as
follows:
    (1) Amount. 250 milligrams (mg) of chlortetracycline and 250 mg of
sulfamethazine per gallon.
    (2) Indications for use. For the prevention and treatment of
bacterial enteritis; as an aid in the reduction of the incidence of
cervical abscesses; and as an aid in the maintenance of weight gains in
the presence of bacterial enteritis and atrophic rhinitis.
    (3) Limitations. Use as the sole source of chlortetracycline and
sulfonamide. Not to be used for more than 28 consecutive days. Withdraw
15 days before slaughter.

Sec.  520.445a  [Removed]

0
3. Remove Sec.  520.445a.

Sec.  520.445b  [Redesignated as Sec.  520.441]

0
4. Redesignate Sec.  520.445b as Sec.  520.441.

0
5. Amend newly redesignated Sec.  520.441 by revising paragraphs
(b)(2), (b)(3), and the last sentence of paragraph (d)(4)(iii)(C) to
read as follows:

Sec.  520.441  Chlortetracycline powder.

* * * * *
    (b) * * *
    (2) Nos. 046573 and 000010 for use as in paragraph (d) of this
section.
    (3) No. 000010 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B),
and (d)(4)(ii) through (d)(4)(iv) of this section.
* * * * *
    (d) * * *
    (4) * * *
    (iii) * * *
    (C) * * * For Nos. 000010 and 021930, do not slaughter animals for
food within 5 days of treatment. For No. 000010, do not slaughter
animals for food within 24 hours of treatment.
* * * * *

Sec.  520.445c  [Redesignated as Sec.  520.443]

0
6. Redesignate Sec.  520.445c as Sec.  520.443.
0
7. Amend newly redesignated Sec.  520.443 as follows:
0
a. Revise paragraphs (a) and (b);
0
b. Remove paragraph (d);
0
c. Redesignate paragraph (e) as paragraph (d); and
0
d. Revise the heading for newly redesignated paragraph (d) introductory
text.
    The revisions read as follows:

Sec.  520.443  Chlortetracycline tablets and boluses.

    (a) Specifications. Each tablet/bolus contains 25, 250, or 500
milligrams (mg) chlortetracycline hydrochloride.
    (b) Sponsor. See No. 000010 in Sec.  510.600(c) of this chapter.
* * * * *
    (d) Conditions of use in calves--* * *
* * * * *

    Dated: August 4, 2011.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2011-20404 Filed 8-10-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Rules and Regulations]
[Pages 54510-54516]
[FR Doc No: 2019-21715]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0561; FRL-9999-70]

Indaziflam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
indaziflam in or on the tropical and subtropical fruit (edible peel)
group 23 and tropical and subtropical fruit (inedible peel) group 24.
Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 10, 2019. Objections and
requests for hearings must be received on or before December 9, 2019,
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-2018-0561, 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_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. 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 Publishing 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-2018-0561 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
December 9, 2019. 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-2018-0561, 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 December 21, 2018 (83 FR 65660) (FRL-
9985-67), 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
8E8686) by IR-4, IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of indaziflam, N-
[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-yl]-6-(1-fluoroethyl)-
1,3,5-triazine-2,4-diamine, including its metabolites and degradates,
in or on the raw agricultural commodities Fruit, tropical and
subtropical, edible peel, group 23 at 0.01 ppm and Fruit, tropical and
subtropical, inedible peel, group 24 at 0.01 ppm. The petition also
requested to amend 40 CFR 180.653 by removing the established tolerance
for residues of indaziflam in or on the raw agricultural commodity
Fruit, tropical and subtropical, small fruit, edible peel, subgroup 23A
at 0.01 ppm. That document referenced a summary of the petition
prepared by Bayer CropScience, the registrant, which is available in
the docket, http://www.regulations.gov. There were no comments received
in response to the notice of filing.
    Although not requested, EPA is removing the tolerance for
``banana'' since it is covered by the new group 24 tolerance. Also, the
tolerance expression is being modified as well. The reasons for these
changes are explained in Unit IV.C.

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 indaziflam including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with indaziflam 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.
    Metabolism studies with rats indicate that indaziflam is rapidly
and completely (>90%) absorbed by the oral route, although absorption
may become saturated at higher doses. Following absorption, indaziflam
is distributed to multiple tissues, with the highest levels found in
the liver, skin, and thyroid. Metabolism of indaziflam was extensive
and occurred primarily via oxidation to form carboxylic acid and
hydroxylated metabolites. Based on in vivo dermal absorption data from
rats and comparative in vitro absorption data from rat and human skin,
dermal absorption for humans is estimated to be 7.3%.
    The nervous system is the major target for toxicity in rats and
dogs. Evidence of neurotoxicity (e.g., decreased motor activity,
clinical signs, and/or neuropathology) was observed in both species
throughout the database, which included the dog subchronic and chronic
toxicity studies; the rat acute, subchronic, and developmental
neurotoxicity (DNT) studies; the rat two-generation reproduction study;
the rat chronic toxicity study; and the rat combined carcinogenicity/
chronic toxicity study. In repeated-dose studies, the dog was the more
sensitive species, showing the lowest no observed adverse effects
levels (NOAELs) and lowest observed adverse effects levels (LOAELs)
among all available studies, based on neuropathology (degenerative
nerve fibers in the brain, spinal cord, and sciatic nerve). At higher
doses, three dogs in the subchronic study were prematurely terminated
due to excessive clinical signs including ataxia, tremors, decreased
pupil response, seizures, and other findings.
    In the rat, a marginal decrease in motor/locomotor activity was
observed in females in the acute neurotoxicity study. Decreases in
motor/locomotor

activity were also seen in the subchronic neurotoxicity study in
females and in the DNT study in male offspring at post-natal day (PND)
21. Clinical signs of neurotoxicity were observed in the acute,
subchronic, and developmental neurotoxicity studies and consisted
primarily of tremors, changes in activity and reactivity, repetitive
chewing, dilated pupils, and oral, perianal, and nasal staining.
Similar clinical signs of neurotoxicity were observed in the 2-
generation reproduction study, the rat chronic toxicity study, and the
combined rat carcinogenicity/chronic toxicity study. Neuropathology
findings were also observed in the rat manifested as focal/multifocal
vacuolation of the median eminence of the brain and the pituitary pars
nervosa and degenerative nerve fibers in the Gasserian ganglion,
sciatic nerve, and tibial nerve. Evidence of neurotoxicity was not seen
in the mouse following subchronic or chronic exposure.
    Other organs affected by indaziflam in mice and rats included the
kidney, liver, thyroid, stomach, seminal vesicles, and ovaries. Effects
on the kidney were observed following chronic exposure in rats and mice
while effects on the liver were observed following chronic exposure in
the rat. Effects on the thyroid were only observed in multiple dose rat
studies and usually in the male only. Increased thyroid stimulating
hormone (TSH) measured at 3 and 14 weeks in the 90-day and 1-year
studies showed an increase in males at week 3. Histopathological
alterations (thyroid follicular cell hypertrophy at 90 days and 1 year,
as well as colloid alterations at chronic exposure times) were
observed, but no increases in thyroid weight were noted. Thyroid
histopathology was observed at a lower dose in the two-year study,
compared to the 90-day and 1-year studies. Chronic exposures also led
to atrophied or small seminal vesicles in male rats and glandular
erosion/necrosis in the stomach and blood-filled ovarian cysts/
follicles in female mice. In rats, effects observed on the liver,
thyroid, kidney, and seminal vesicles occurred at doses that were
similar to or higher than those that produced neurotoxicity. However,
these effects in the rat occurred at higher doses than those at which
neurotoxicity was observed in the dog. Decreased body weight was also
observed in most subchronic and chronic studies following oral exposure
to indaziflam. There was no evidence of immunotoxicity in the available
studies, which included a guideline immunotoxicity study in the rat. No
systemic effects were observed in the rat following a 28-day dermal
exposure period.
    Since the previous assessment, the maternal findings in the rat
developmental toxicity study have been revised because the decreases in
maternal weight gain and food consumption did not result in reduced
mean maternal body weight at any dose tested and no other maternal
findings were reported. Decreased mean fetal weight was observed at the
highest dose tested, indicating increased quantitative susceptibility.
However, no evidence of increased quantitative or qualitative
susceptibility was seen in developmental toxicity studies in rabbits, a
developmental neurotoxicity study in rats, or in a 2-generation
reproduction study in rats. No developmental effects were observed in
rabbits up to maternally toxic dose levels. Decreased pup weight and
delays in sexual maturation (preputial separation in males and vaginal
patency in females) were observed in the rat two-generation
reproductive toxicity study, along with clinical signs of toxicity, at
a dose causing parental toxicity that included coarse tremors, renal
toxicity, and decreased weight gain. In the developmental neurotoxicity
study, transiently decreased motor activity (PND 21 only) in male
offspring was observed and was considered a potential neurotoxic
effect. It was observed at a dose that also caused clinical signs of
neurotoxicity along with decreased body weight in maternal animals.
    Indaziflam showed no evidence of carcinogenicity in the two-year
dietary rat and mouse bioassays. All genotoxicity studies that were
conducted on indaziflam were negative.
    Specific information on the studies received and the nature of the
adverse effects caused by indaziflam as well as the NOAEL and the LOAEL
from the toxicity studies can be found at http://www.regulations.gov in
the document titled ``Indaziflam--Aggregate Human Health Risk
Assessment of the Proposed New Use on Lowbush Blueberry, and Crop Group
Expansions to Tropical and Subtropical Fruit, Edible Peel, Group 23 and
Tropical and Subtropical Fruit, Inedible Peel, Group 24'' on pages 29-
39 in docket ID number EPA-HQ-OPP-2018-0561.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.
    A summary of the toxicological endpoints for indaziflam used for
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Indaziflam 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 (General population  NOAEL = 7.5 mg/kg/    Acute RfD = 0.075    Subchronic Gavage Toxicity Study
 including infants and children     day.                  mg/kg/day aPAD =     in Dogs.
 and females 13 to 49 years old).  UFA = 10x...........   0.075 mg/kg/day.    LOAEL = 15 mg/kg/day, based on
                                   UFH = 10x...........                        axonal degenerative microscopic
                                   FQPA SF = 1x........                        findings in the brain, spinal
                                                                               cord, and sciatic nerve.
Chronic dietary (All populations)  NOAEL= 2 mg/kg/day..  Chronic RfD = 0.02   Chronic Dietary Toxicity Study in
                                   UFA = 10x...........   mg/kg/day cPAD =     Dogs.
                                   UFH = 10x...........   0.02 mg/kg/day.     LOAEL = \6/7\ mg/kg/day M/F, based
                                   FQPA SF = 1x........                        on nerve fiber degenerative
                                                                               lesions in the brain, spinal
                                                                               cord, and sciatic nerve.
Incidental oral short-term (1 to   NOAEL= 7.5 mg/kg/day  LOC for MOE = 100..  Subchronic Gavage Toxicity Study
 30 days).                         UFA = 10x...........                        in Dogs.
                                   UFH = 10x...........                       LOAEL = 15 mg/kg/day, based on
                                   FQPA SF = 1x........                        axonal degenerative microscopic
                                                                               findings in the brain, spinal
                                                                               cord, and sciatic nerve.
Dermal short-term (1 to 30 days).  Oral study NOAEL =    LOC for MOE = 100..  Subchronic Gavage Toxicity Study
                                    7.5 mg/kg/day                              in Dogs.
                                    (dermal absorption                        LOAEL = 15 mg/kg/day, based on
                                    rate = 7.3%).                              axonal degenerative microscopic
                                   UFA = 10x...........                        findings in the brain, spinal
                                   UFH = 10x...........                        cord, and sciatic nerve.
                                   FQPA SF = 1x........
Inhalation short-term (1 to 30     Oral study NOAEL=     LOC for MOE = 100..  Subchronic Gavage Toxicity Study
 days).                             7.5 mg/kg/day                              in Dogs.
                                    (inhalation                               LOAEL = 15 mg/kg/day, based on
                                    absorption rate =                          axonal degenerative microscopic
                                    100%).                                     findings in the brain, spinal
                                   UFA = 10x...........                        cord, and sciatic nerve.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  No Evidence of Carcinogenicity. 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). 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 indaziflam, EPA considered exposure under the petitioned-
for tolerances as well as all existing indaziflam tolerances in 40 CFR
180.653. EPA assessed dietary exposures from indaziflam 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.
    Such effects were identified for indaziflam. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption information from
the U.S. Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA).
As to residue levels in food, the acute assessment was based on
tolerance-level residues and 100 percent crop treated (PCT).
    ii. Chronic exposure. In estimating chronic dietary exposure, EPA
used 2003-2008 food consumption information from the USDA's NHANES/
WWEIA. As to residue levels in food, the chronic assessment was based
on tolerance-level residues and 100 PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that indaziflam 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 PCT information. EPA did not use
anticipated residue estimates or PCT information in the dietary
assessment for indaziflam. Tolerance level residues and 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for indaziflam in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of indaziflam. Further information regarding EPA
drinking water models used in pesticide exposure assessments can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Residues of concern in drinking water are indaziflam, triazine
indanone, indaziflam-carboxylic acid, indaziflam-olefin, indaziflam-
hydroxyethyl, and fluoroethyl diaminotriazine (FDAT). With the
exception of FDAT, all of the metabolites are assumed to have
comparable toxicity to the parent due to structural similarity (i.e.,
both rings intact). However, FDAT, a single-ring metabolite, is not
expected to be more toxic than the parent indaziflam based on FDAT's
non-neurotoxic mode of action. The Agency calculated total indaziflam
estimated drinking water

concentrations (EDWCs) for residues of concern that are structurally
similar to indaziflam (i.e., indaziflam, triazine-indanone, indaziflam-
carboxylic acid, indaziflam-hydroxyethyl, and indaziflam-olefin), and
separate EDWCs for total FDAT, including its fluoroethyl-
triazinanedione (ROI1) degradate. The Agency combined the total
indaziflam and total FDAT EDWCs for use in the dietary assessments.
    Based on the Pesticide in Water Calculator (PWC), the EDWCs of
combined residues of indaziflam for acute exposures are estimated to be
84 parts per billion (ppb) for surface water and 3.7 ppb for ground
water, and for chronic exposures are estimated to be 26 ppb for surface
water and 3.7 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For the acute dietary risk
assessment, the water concentration value of 84 ppb was used to assess
the contribution to drinking water. For the chronic dietary risk
assessment, the water concentration value of 26 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).
    Indaziflam is currently registered for the following uses that
could result in residential exposures: Turf, gardens, and trees. EPA
assessed residential exposure using the following assumptions: Short-
term dermal and inhalation handler exposure is expected for adults as a
result of applying products containing indaziflam to lawns/turf and
gardens/trees using a variety of application equipment. Short-term
post-application dermal exposure is expected for adults, children 11 to
less than 16 years old, and children 6 to less than 11 years old as a
result of playing, mowing, and/or golfing on treated turf. Short-term
dermal and incidental oral exposure (hand to mouth, object to mouth,
incidental soil ingestion) is expected for children 1 to less than 2
years old as a result from playing on treated turf/lawns. Lastly,
short-term post-application dermal exposure is expected for adults and
children 6 to less than 11 years old as result of application to
gardens and trees.
    The Agency selected only the most conservative, or worst case,
residential adult and child scenarios to be included in the aggregate
estimates, based on the lowest overall MOE (i.e., highest risk
estimates). The worst-case residential exposure scenario for both
adults and children resulted from short-term dermal and incidental oral
(for children only) post-application exposure to treated turf. 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 indaziflam to share a common mechanism of
toxicity with any other substances, and indaziflam does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
indaziflam 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. Since the previous
assessment, the maternal findings in the rat developmental toxicity
study have been revised because the decreases in maternal weight gain
and food consumption did not result in reduced mean maternal body
weight at any dose tested and no other maternal findings were reported.
Decreased mean fetal weight was observed at the highest dose tested,
indicating increased quantitative susceptibility. However, no evidence
of increased quantitative or qualitative susceptibility was seen in
developmental toxicity studies in rabbits, a developmental
neurotoxicity study in rats, or in a 2-generation reproduction study in
rats. No developmental effects were observed in rabbits up to
maternally toxic dose levels. Decreased pup weight and delays in sexual
maturation (preputial separation in males and vaginal patency in
females) were observed in the rat two-generation reproductive toxicity
study, along with clinical signs of toxicity, at a dose causing
parental toxicity that included coarse tremors, renal toxicity and
decreased weight gain. In the developmental neurotoxicity study,
transiently decreased motor activity (PND 21 only) in male offspring
was observed and was considered a potential neurotoxic effect. It was
observed at a dose that also caused clinical signs of neurotoxicity
along with decreased body weight in maternal animals.
    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 indaziflam is complete.
    ii. Evidence of neurotoxicity was observed in dogs and rats
throughout the database, which included the dog subchronic toxicity
study; the rat subchronic toxicity; the rat acute, subchronic, and
developmental neurotoxicity screening batteries; the rat two-generation
reproduction study; the rat chronic toxicity study; and the rat
combined carcinogenicity/chronic toxicity study. Evidence of
neurotoxicity was manifested as neuropathology in dogs and as decreased
motor activity and clinical signs (e.g., tremors) in rats. Evidence of
neurotoxicity was the most consistent effect (seen in dogs and rats),
the most sensitive toxicological finding (based on neuropathology in
dogs) and is being used as the basis for the risk assessment.
    iii. No developmental effects were observed in rabbits up to
maternally toxic dose levels. Offspring effects in the DNT study in
rats and multi-generation toxicity studies only occurred in the
presence of maternal toxicity and were not considered more severe than
the parental effects. However, decreased

fetal weight was observed in the rat developmental toxicity study in
the absence of adverse maternal effects. Therefore, the Agency
concluded that there is evidence of increased quantitative
susceptibility to rat fetuses exposed in utero to indaziflam. In all
studies, clear NOAELs/LOAELs were identified for maternal/parental and
fetal/offspring effects.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to indaziflam in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
indaziflam.

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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to indaziflam will occupy 19% of the aPAD for all infants less than 1
year old, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
indaziflam from food and water will utilize 7.8% of the cPAD for all
infants less than 1 year 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
indaziflam is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Indaziflam is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to indaziflam. 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 1,400 for adults and 580 for
children 1 to less than 2 years old. Because EPA's level of concern for
indaziflam is an MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    An intermediate-term adverse effect was identified; however,
indaziflam is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
indaziflam.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, indaziflam is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to indaziflam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem
mass spectrometry detection (LC/MS/MS) method (DH-003-P07-02) for fruit
and nut tree matrices for indaziflam and FDAT) is available to enforce
the tolerance expression. The method 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_ADDRESS>
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 any MRLs for indaziflam.

C. Revisions to Petitioned-For Tolerances

    Although not requested, EPA is also removing the existing tolerance
for ``banana'' because it is superseded by the new crop group 24
tolerance. Also, EPA is amending the tolerance expression for
indaziflam to correct the residues that should be measured in
determining compliance with the established tolerance levels. The
Agency has determined that residues of the FDAT metabolite should be
aggregated with residues of indaziflam when evaluating compliance with
established tolerance levels. This revision does not require any
changes in tolerance levels because those tolerance levels were
established based on aggregated residues of FDAT and indaziflam. In
accordance with its policy to improve the consistency and clarity of
its tolerance expressions, EPA is revising the tolerance expression in
this rulemaking.

V. Conclusion

    Therefore, tolerances are established for residues of indaziflam in
or on Fruit, tropical and subtropical, edible peel, group 23 at 0.01
ppm and Fruit, tropical and subtropical, inedible peel, group 24 at
0.01 ppm.
    Additionally, the existing tolerances for both the tropical and
subtropical, small fruit, edible peel, subgroup 23A and banana are
removed as unnecessary due to the establishment of the above
tolerances.

    Lastly, the tolerance expression in paragraph (a) is modified to
read as follows: ``General. Tolerances are established for residues of
the herbicide indaziflam, N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-
1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine, including its
metabolites and degradates, in or on the commodities in the following
table. Compliance with the tolerance levels specified in the table
below is to be determined by measuring only indaziflam and FDAT, 6-
[(1R)-1-fluoroethyl]-1,3,5-triazine-2,4-diamine, calculated as the
stoichiometric equivalent of indaziflam, in or on the commodity.''

VI. Statutory and Executive Order Reviews

    This action establishes and modifies 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), nor is it considered a
regulatory action under 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 tolerances 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: September 18, 2019.
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. Section 180.653(a) is amended as follows:
0
a. Revise the introductory text; and
0
b. In the table:
0
i. Add a heading for the table;
0
ii. Remove the entry for ``Banana'';
0
iii. Add alphabetically the entries ``Fruit, tropical and subtropical,
edible peel, group 23'' and ``Fruit, tropical and subtropical, inedible
peel, group 24'';
0
iv. Remove the entry for ``Fruit, tropical and subtropical, small
fruit, edible peel, subgroup 23A''; and
0
v. Remove footnote 2 to the table.
    The revision and additions read as follows:

Sec.  180.653  Indaziflam; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide indaziflam, N-[(1R,2S)-2,3-dihydro-2,6-dimethyl-1H-inden-1-
yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine, including its
metabolites and degradates, in or on the commodities in the following
table. Compliance with the tolerance levels specified in the following
table is to be determined by measuring only indaziflam and FDAT, 6-
[(1R)-1-fluoroethyl]-1,3,5-triazine-2,4-diamine, calculated as the
stoichiometric equivalent of indaziflam, in or on the commodity.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Fruit, tropical and subtropical, edible peel, group 23......        0.01
Fruit, tropical and subtropical, inedible peel, group 24....        0.01

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-21715 Filed 10-9-19; 8:45 am]
 BILLING CODE 6560-50-P


manipulation of the gold, silver, platinum, or palladium markets.
---------------------------------------------------------------------------

    \200\ See supra notes 182-184 and accompanying text.
    \201\ See supra Section III.A. Similarly, the Commission has
recently stated that it does not believe that the listing and
trading of shares of the JPM Copper Trust is likely to disrupt the
supply of copper available for immediate delivery. See JPM Order,
supra note 6, 77 FR 75468, 75474.
    \202\ See supra notes 80-82 and accompanying text.
---------------------------------------------------------------------------

    For the reasons discussed above, the Commission does not believe
that the proposed listing and trading of the Shares is likely to render
the copper market or the price of the Shares more susceptible to
manipulation. Correspondingly, the Commission does not believe that
approval of the proposed rule change will impose any burden on
competition between participants in the market for copper as it will
not provide market participants a greater opportunity to achieve an
unfair competitive advantage.

E. Surveillance

    The commenter questions whether NYSE Arca's surveillance procedures
are adequate to prevent fraudulent and manipulative trading in the
Shares. According to the commenter, NYSE Arca's surveillance procedures
are not adequate because they are the kind of ``garden-variety
measures'' that are always in place to prevent collusion and other
forms of manipulation by traders.\203\
---------------------------------------------------------------------------

    \203\ See V&F May 9 Letter, supra note 6, at 10.
---------------------------------------------------------------------------

    NYSE Arca states that its surveillance procedures will be adequate
to properly monitor Exchange trading of the Shares in all trading
sessions and to deter and detect violations of Exchange rules and
applicable federal securities laws.\204\ In particular, the Exchange
represents the following:
---------------------------------------------------------------------------

    \204\ See Notice, supra note 3, 77 FR at 38360. The Exchange
also states that its existing surveillances will be augmented with a
product-specific review designed to identify potential manipulative
trading activity through the use of the creation and redemption
process. See Amendment No. 1, supra note 7.
---------------------------------------------------------------------------

     Pursuant to NYSE Arca Equities Rule 8.201(g), an ETP
Holder acting as a registered Market Maker in Commodity-Based Trust
Shares must file with the Exchange and keep current a list identifying
all accounts for trading in an underlying commodity, related commodity
futures or options on commodity futures, or any other related commodity
derivatives, which the

Market Maker may have or over which it may exercise investment
discretion. No Market Maker shall trade in an underlying commodity,
related commodity futures or options on commodity futures, or any other
related commodity derivatives, in an account in which a Market Maker,
directly or indirectly, controls trading activities, or has a direct
interest in the profits or losses thereof, which has not been reported
to the Exchange as required by NYSE Arca Equities Rule 8.201.
     In addition, pursuant to NYSE Arca Equities Rule 8.201(g),
the Exchange is able to obtain information regarding trading in the
Shares and the underlying copper, copper futures contracts, options on
copper futures, or any other copper derivative, through ETP Holders
acting as registered Market Makers, in connection with their
proprietary or customer trades that they effect on any relevant
market.\205\
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    \205\ See Notice, supra note 3, 77 FR at 38360. See also Arca
September 14 Letter, supra note 6, at 2-3.
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     NYSE Arca has regulatory jurisdiction over its ETP Holders
and their associated persons, which include any person or entity
controlling an ETP Holder, as well as a subsidiary or affiliate of an
ETP Holder that is in the securities business.\206\
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    \206\ See Amendment No. 1, supra note 7.
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     With respect to a subsidiary or affiliate of an ETP Holder
that does business only in commodities or futures contracts, the
Exchange can obtain information regarding the activities of such
subsidiary or affiliate through surveillance sharing agreements with
regulatory organizations of which such subsidiary or affiliate is a
member.\207\
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    \207\ See id.
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     Commentary .04 of NYSE Arca Equities Rule 6.3 requires an
ETP Holder acting as a registered Market Maker in the Shares, and its
affiliates, to establish, maintain, and enforce written policies and
procedures reasonably designed to prevent the misuse of any material
nonpublic information with respect to such products, any components of
the related products, any physical asset or commodity underlying the
product, applicable currencies, underlying indexes, related futures or
options on futures, and any related derivative instruments (including
the Shares).\208\
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    \208\ See Notice, supra note 3, 77 FR at 38360. See also Arca
September 14 Letter, supra note 6, at 3.
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     NYSE Arca may obtain trading information via ISG from
other exchanges that are members of the ISG, including the COMEX.\209\
The Exchange also states that it has entered into a comprehensive
surveillance sharing agreement with LME that applies to trading in
copper and copper derivatives.\210\
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    \209\ See Notice, supra note 3, 77 FR at 38360.
    \210\ See id.

    Further, in the context of preventing fraudulent and manipulative
acts, the Exchange discusses its authority to halt trading in the
Shares in the interest of promoting a fair and orderly market and
protecting the interests of investors.\211\
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    \211\ See Arca September 14 Letter, supra note 6, at 3 (``As
stated in the Notice, the Exchange may consider all relevant factors
in exercising its discretion to halt or suspend trading in the
Shares, and trading on the Exchange in the Shares may be halted
because of market conditions or for reasons that, in the view of the
Exchange, make trading in the Shares inadvisable.'').
---------------------------------------------------------------------------

    In addition, NYSE Arca has obtained a representation from the
Sponsor that it will: (1) Implement a firewall with respect to its
affiliates regarding access to material non-public information of the
Trust concerning the Trust and the Shares; and (2) will be subject to
procedures designed to prevent the use and dissemination of material
non-public information of the Trust regarding the Trust and the
Shares.\212\ The Commission believes the firewall that the Exchange
will require the Sponsor to erect is a reasonable measure to help
prevent the flow of non-public information to the Sponsor's
affiliates.\213\
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    \212\ See Amendment No. 1, supra note 7.
    \213\ Further, NYSE Arca represents that it can obtain
information about the activities of the Sponsor and its affiliates
under the Exchange's listing rules. See Amendment No. 1, supra note
7.
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    More generally, based on the Exchange's representations, the
Commission believes that the Exchange's surveillance procedures appear
to be reasonably designed to permit the Exchange to monitor for,
detect, and deter violations of Exchange rules and applicable federal
securities laws and rules.\214\ In addition to all of the same
surveillance procedures employed with respect to the trading of all
other Commodity-Based Trust Shares, NYSE Arca states that a new
product-specific review will be employed to monitor trading in the
Shares to identify potential manipulative trading activity through the
use of the creation and redemption process.\215\ The commenters have
not identified any specific deficiency in the proposed procedures or
provided any evidence that the Exchange's surveillance program has been
ineffective with respect to trading in other Commodity-Based Trust
Shares.
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    \214\ The Commission has discussed above in Section III.D other
reasons why it believes that the listing and trading of the Shares
as proposed is unlikely to increase the likelihood of manipulation
of the copper market and, correspondingly, of the price of the
Shares.
    \215\ See Amendment No. 1, supra note 7.
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F. Dissemination of Information About the Shares and Copper

    The Commission believes the proposal is reasonably designed to
promote sufficient disclosure of information that may be necessary to
price the Shares appropriately. Specifically, the Commission believes
that dissemination of the NAV, IIV, and copper holdings information, as
discussed above, will facilitate transparency with respect to the
Shares and diminish the risk of manipulation or unfair informational
advantage.\216\
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    \216\ See supra notes 193-198 and accompanying text. The
commenter asserts that, because the Trust will be valued using the
LME Bid Price without taking into account locational premia, under
certain circumstances, the NAV of the Trust may not be accurate. See
V&F September 12 Letter, supra note 6, at 7-8. The commenter asserts
that the values of LME-traded industrial metals are determined by
their location, and that the LME Bid Price is the value of copper at
the cheapest-to-deliver location. See id. The commenter predicts
that, if the Trust accumulates all of the metal from LME warehouses
in the cheapest-to-deliver location, then the cheapest-to-deliver
location will change, and correspondingly the LME Bid Price will be
based on a new location. See id. In that circumstance, the commenter
argues, there may be a significant divergence between the NAV of the
Trust and the actual value of the Trust's copper. See id. at 7-8.
    The Sponsor states that the Trust does not assign locational
premia because any warrant, regardless of location, can be delivered
at the LME Bid Price, and further asserts that this valuation method
will allow an authorized participant to effectively reconcile its
position in copper. See BlackRock Letter, supra note 6, at 9.
    The Commission believes that the use of the LME Bid Price to
value the Trust's copper may lead to a divergence between the NAV of
the Trust and the market value of the Trust's copper because the LME
Bid Price is used to value the Trust's copper and the Trust's copper
may not be in the cheapest-to-deliver location. The Commission does
not expect any possible divergence to cause any problems with
respect to trading in the Shares, and notes that the commenter did
not assert it would. The Commission believes that the degree of
divergence will be limited to the difference in the price of copper
held by the Trust and the price of copper at the cheapest-to-deliver
location. The Commission notes that the Trust will disclose on its
Web site the location, warehouse identification number, lot number,
net weight of the lot, and brand of each lot of copper it holds, as
well as the order in which all lots will be delivered to redeeming
authorized participants. See Amendment No. 2, supra note 9.
---------------------------------------------------------------------------

    Further, as noted above, quotation and last-sale information for
the Shares will be available via the Consolidated Tape Association, and
the Exchange will make available via the Consolidated Tape trading
volume, closing prices, and NAV for the Shares from the previous
day.\217\ Additionally, as discussed above, the Exchange has identified
numerous sources of copper price information unconnected with the
Exchange that are readily available to

investors.\218\ The Commission therefore believes that sufficient
venues for obtaining reliable copper pricing information exist to allow
investors in the Shares to adequately monitor the price of copper and
compare it to the NAV of the Shares.
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    \217\ See supra text accompanying notes 31-32.
    \218\ See Notice, supra note 3, 77 FR at 38358-59.
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G. Listing and Trading of the Shares

    The Commission believes that the Exchange's proposed rules and
procedures for the listing and trading of the Shares are consistent
with the Act. For example, the Commission believes that the proposal is
reasonably designed to prevent trading when a reasonable degree of
transparency cannot be assured. As detailed above, NYSE Arca Equities
Rules 7.34(a)(5) and 8.201(e)(2) respectively provide that: (1) If the
Exchange becomes aware that the NAV is not being disseminated to all
market participants at the same time, it will halt trading on the NYSE
Marketplace until such time as the NAV is available to all market
participants; \219\ and (2) the Exchange will consider suspension of
trading if, after the initial 12-month period following commencement of
trading: (a) the value of copper is no longer calculated or available
on at least a 15-second delayed basis from a source unaffiliated with
the Sponsor, Trust, or Custodian, or the Exchange stops providing a
hyperlink on its Web site to any such unaffiliated source providing
that value; or (b) if the IIV is no longer made available on at least a
15-second delayed basis.\220\ In addition, the Exchange's general
authority to halt trading because of market conditions or for reasons
that, in the view of the Exchange, make trading in the Shares
inadvisable, also will advance this objective. Further, trading in the
Shares will be subject to NYSE Arca Equities Rule 7.12, the Exchange's
circuit breaker rule, which governs trading halts caused by
extraordinary market volatility.
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    \219\ See id. at 38359.
    \220\ Additionally, the Exchange represents that it may halt
trading during the day in which an interruption to the dissemination
of the IIV occurs. If the interruption persists past the trading day
in which it occurred, the Exchange will halt trading no later than
the beginning of the of the trading day following the interruption.
See id.
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    Further, the Shares will be subject to Exchange rules governing the
responsibilities of market makers and customer suitability
requirements. In addition, the Shares will be subject to Exchange Rule
8.201 for initial and continued listing of Shares.\221\ As discussed
above,\222\ the Commission believes that the listing and delisting
criteria for the Shares are expected to maintain a minimum level of
liquidity and therefore minimize the potential for manipulation of the
Shares. The Commission also believes that the Information Bulletin will
adequately inform members and member organizations about the terms,
characteristics, and risks of trading the Shares.
---------------------------------------------------------------------------

    \221\ See id.
    \222\ See supra note 199 and accompanying text.
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H. Commission Findings

    After careful review, and for the reasons discussed in Sections
III.A-G above, the Commission finds that the proposed rule change is
consistent with the requirements of the Act, including Section 6 of the
Act,\223\ and the rules and regulations thereunder applicable to a
national securities exchange.\224\ In particular, the Commission finds
that the proposed rule change is consistent with Section 6(b)(5) of the
Act,\225\ which requires, among other things, that the rules of a
national securities exchange be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general, to protect
investors and the public interest; with Section 6(b)(8) of the
Act,\226\ which requires that the rules of a national securities
exchange not impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act; and with Section
11A(a)(1)(C)(iii) of the Act,\227\ which sets forth Congress's finding
that it is in the public interest and appropriate for the protection of
investors to assure the availability to brokers, dealers, and investors
of information with respect to quotations for and transactions in
securities.\228\
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    \223\ 15 U.S.C. 78f.
    \224\ This approval order is based on all of the Exchange's
representations.
    \225\ 15 U.S.C. 78f(b)(5).
    \226\ 15 U.S.C. 78f(b)(8).
    \227\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
    \228\ As noted above, quotation and last-sale information for
the Shares will be available via the Consolidated Tape Association,
and the Exchange will make available via the Consolidated Tape
trading volume, closing prices, and NAV for the Shares from the
previous day. See supra text accompanying notes 31-32.
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether Amendments No.1
and No. 2 to the proposed rule change are consistent with the Act.
Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2012-66 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEArca-2012-66. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submissions, all subsequent amendments, all
written statements with respect to the proposed rule changes that are
filed with the Commission, and all written communications relating to
the proposed rule changes between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filings also will be available
for inspection and copying at the principal offices of the Exchanges.
All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-NYSEArca-2012-
66 and should be submitted on or before March 21, 2013.

V. Accelerated Approval of Proposed Rule Change as Modified by
Amendments No. 1 and No. 2

    As discussed above, the Exchange submitted Amendment No. 1 to make
additional representations regarding the Exchange's surveillance
program,\229\ and

submitted Amendment No. 2 to supplement representations regarding Web
site disclosure of the Trust's copper holdings.\230\ The Commission
believes these additional representations are, among other things,
useful to help assure adequate information is available to the Exchange
to support its monitoring of Exchange trading of the Shares in all
trading sessions; to help the Exchange deter and detect violations of
NYSE Arca rules and applicable federal securities laws; and to help
assure adequate availability of information to support the arbitrage
mechanism. Accordingly, the Commission finds good cause, pursuant to
Section 19(b)(2) of the Act,\231\ for approving the proposed rule
change, as modified by Amendments No. 1 and No. 2, prior to the 30th
day after the date of publication of notice in the Federal Register.
---------------------------------------------------------------------------

    \229\ See supra note 7.
    \230\ See supra note 9.
    \231\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

VI. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\232\ that the proposed rule change (SR-NYSEArca-2012-66), as
modified by Amendments No. 1 and No. 2, be, and hereby is, approved on
an accelerated basis.
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    \232\ 15 U.S.C. 78s(b)(2).

    By the Commission.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-04623 Filed 2-27-13; 8:45 am]
BILLING CODE 8011-01-P