Document ID: EPA-HQ-OPP-2020-0065-0037
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fluazaindolizine
Posted Date: 2023-09-12T04:00Z

[Federal Register Volume 88, Number 175 (Tuesday, September 12, 2023)]
[Rules and Regulations]
[Pages 62464-62471]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19607]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2020-0065; FRL-8786-01-OCSPP]

Fluazaindolizine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fluazaindolizine in or on multiple commodities that are identified and 
discussed later in this document. E.I. du Pont de Nemours & Company 
(``DuPont'', now Corteva) requested these tolerances under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective September 12, 2023. Objections and 
requests for hearings must be received on or before November 13, 2023, 
and must be filed in accordance with the instructions provided in 40 
CFR part

[[Page 62465]]

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-2020-0065, is available online at 
http://www.regulations.gov or in-person 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 and the OPP Docket is (202) 566-
1744. For the latest status information on EPA/DC services and docket 
access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; 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 Office of the 
Federal Register's e-CFR site at https://www.ecfr.gov/current/title40.

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-2020-0065 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 
November 13, 2023. 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-2020-0065, 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.
    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 April 15, 2020 (85 FR 20910) (FRL-10006-
54), 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 
9F8795) by E.I. du Pont de Nemours & Company (``DuPont''), Chestnut Run 
Plaza, 974 Centre Road, Wilmington, DE 19805. The petition requested to 
establish tolerances in the 40 CFR part 180 for residues of the 
nematicide, fluazaindolizine, by measuring the sum of post-hydrolysis 
residues IN-A5760, IN-F4106, IN-QEK31, IN-QZY47, IN-TMQ01, IN-UJV12, 
and IN-UNS90 (expressed in parent equivalents) in or on Carrots at 15 
parts per million (ppm); Cucurbit Vegetables (Crop Group 9) at 3 ppm; 
Fruiting Vegetables (Crop Group 8-10) at 3 ppm; Sun dried tomatoes at 
30 ppm; Tomato paste at 15 ppm; Tomato puree at 6 ppm; Tomato wet 
pomace at 6 ppm; Tuberous and Corm Vegetables (Crop Subgroup 1C) at 9 
ppm; Dried potato at 30 ppm; Potato process waste at 40 ppm; and 
establishing tolerances for residues of fluazaindolizine plus its 
metabolites IN-QEK and IN-F4106 (expressed in parent equivalents), in 
the animal commodities: Cattle, whole milk at 0.5 ppm; Cattle, fat at 
0.09 ppm; Cattle, muscle at 0.02 ppm; Cattle, liver at 0.2 ppm; Cattle, 
kidney at 0.5 ppm; Goat, whole milk at 0.5 ppm; Goat, fat at 0.09 ppm; 
Goat, muscle at 0.02 ppm; Goat, liver at 0.2 ppm; Goat, kidney at 0.5 
ppm; Hog, whole milk at 0.5 ppm; Hog, fat at 0.09 ppm; Hog, muscle at 
0.02 ppm; Hog, liver at 0.2 ppm; Hog, kidney at 0.5 ppm; Horse, whole 
milk at 0.5 ppm; Horse, fat at 0.09 ppm; Horse, muscle at 0.02 ppm; 
Horse, liver at 0.2 ppm; Horse, kidney at 0.5 ppm; Sheep, whole milk at 
0.5 ppm; Sheep, fat at 0.09 ppm; Sheep, muscle at 0.02 ppm; Sheep, 
liver at 0.2 ppm; Sheep, kidney at 0.5 ppm. In addition, DuPont 
proposed pursuant to section 408(d) of the Federal Food, Drug and 
Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish 
indirect or inadvertent tolerances for residues of fluazaindolizine, by 
measuring the sum of post-hydrolysis residues IN-A5760, IN-F4106, IN-
QEK31, IN-QZY47, IN-TMQ01, IN-UJV12, and IN-UNS90 (expressed in parent 
equivalents) in or on the following commodities: Brassica Head and Stem 
Vegetables (Crop Group 5-16) at 0.5 ppm; Bulb Vegetables (Crop Group 3-
07) at 3 ppm; Cereal Grains (Crop Group 15) at 3 ppm; Corn milled by-
products at 6 ppm; Foliage of Legume Vegetables (Crop Group 7), Vines 
at 8 ppm; Foliage of Legume Vegetables (Crop Group 7), Forage and Straw 
at 5 ppm; Foliage of Legume Vegetables (Crop Group 7), Hay at 40 ppm; 
Forage, Fodder and Straw of Cereal Grains (Crop Group 16), Fodder at 4 
ppm; Forage, Fodder and Straw of Cereal Grains (Crop Group 16), Forage 
at 8 ppm; Forage, Fodder and Straw of Cereal Grains (Crop Group 16), 
Hay at 15 ppm; Forage, Fodder and Straw of Cereal Grains (Crop Group 
16), Straw at 10 ppm; Fruiting Vegetables (Crop Group 8-10) at 1 ppm; 
Grain, Aspirated Fractions at 0.5 ppm; Grass, Forage, Fodder and Hay 
(Crop Group 17), Forage at 8 ppm; Grass, Forage, Fodder and Hay (Crop 
Group 17), Hay at 15

[[Page 62466]]

ppm; Leafy Vegetables (Crop Group 4-16) at 9 ppm; Leaves of Root and 
Tuber (Crop Group 2) at 15 ppm; Legume Vegetables (Crop Group 6), 
Mature Seed at 9 ppm; Legume Vegetables (Crop Group 6), Immature Seed 
and Pod at 3 ppm; Low Growing Berry (Crop Subgroup 13-07G) at 0.6 ppm; 
Nongrass Animal Feeds (Forage, Fodder, Straw and Hay) (Crop Group 18), 
Fodder at 5 ppm; Nongrass Animal Feeds (Forage, Fodder, Straw and Hay) 
(Crop Group 18), Forage at 8 ppm; Nongrass Animal Feeds (Forage, 
Fodder, Straw and Hay) (Crop Group 18), Hay at 15 ppm; Nongrass Animal 
Feeds (Forage, Fodder, Straw and Hay) (Crop Group 18), Straw at 10 ppm; 
Oilseed (Crop Group 20) at 9 ppm; Oilseed Crop Group 20), Forage and 
Straw at 5 ppm; Root Vegetables (Crop Subgroup 1A) at 7 ppm; Root 
Vegetables Except Sugar Beet (Crop Subgroup 1B) at 7 ppm; Soybean Hulls 
at 20 ppm; Soybean Meal at 20 ppm; Stalk, Stem and Leaf Petiole 
Vegetables (Crop Group 22) at 3 ppm; Strawberry, Dehydrated at 3 ppm; 
and Wheat Milled By-Products at 6 ppm. That document referenced a 
summary of the petition prepared by DuPont (now Corteva), the 
registrant, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing. 
EPA's response to this comment is discussed in Unit IV.C.
    In the Federal Register of June 28, 2021 (86 FR 33922) (FRL-10025-
08), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), amending the previous NOF dated April 15, 2020 by 
announcing commodities that were not included in the previous NOF. E.I. 
du Pont de Nemours & Company (``DuPont''), Chestnut Run Plaza, 974 
Centre Road, Wilmington, DE 19805, requests to establish a tolerance in 
40 CFR part 180 for residues of the nematicide, fluazaindolizine in or 
on Poultry, fat at 0.01 ppm; Poultry, meat at 0.01 ppm; Poultry, meat 
byproducts at 0.01 ppm; and Eggs at 0.01 ppm. In addition, DuPont is 
proposing pursuant to section 408(d) of the Federal Food, Drug and 
Cosmetic Act, 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish 
indirect or inadvertent tolerances for residues of fluazaindolizine, 
including its metabolites and their conjugates, expressed as the 
stoichiometric equivalent of fluazaindolizine, in or on the following 
commodity: Grass, forage, fodder and hay, group 17, straw at 0.15 ppm.
    Based upon review of the data supporting the petition, EPA is 
establishing tolerances at different levels than petitioned-for and has 
determined that tolerances for certain petitioned-for commodities are 
not necessary. The Agency has also modified all of the commodity 
definitions used and updated certain crop groups. The reasons for these 
changes are explained in Unit IV.D.

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 fluazaindolizine including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with 
fluazaindolizine 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.
    The main target organs of fluazaindolizine are the urinary tract 
(rat and mouse), liver and/or gallbladder (mouse and dog), and 
hematopoietic system (dog). In the mouse carcinogenicity study, the 
incidence and severity of amyloidosis in specific tissues was increased 
in both sexes. There was no evidence of increased in utero 
susceptibility in the rat or rabbit developmental studies; however, 
increased quantitative susceptibility was observed in the rat 
reproductive toxicity study, based on urinary tract histopathological 
lesions in F2 generation weanlings at a lower dose than 
doses resulting in toxicity in parental animals. Fluazaindolizine is 
classified as ``Not likely to be carcinogenic to humans'' based on lack 
of evidence of treatment-related increases in tumors in adequately 
conducted carcinogenicity studies in rats and mice.
    Specific information on the studies received and the nature of the 
adverse effects caused by fluazaindolizine 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 the document titled ``Fluazaindolizine: Human 
Health Risk Assessment for the New Active Ingredient'' (hereinafter 
``Fluazaindolizine Human Health Risk Assessment'') on pages 54-82 in 
docket ID number EPA-HQ-OPP-2020-0065.

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/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological endpoints for fluazaindolizine used 
for

[[Page 62467]]

human risk assessment can be found in the Fluazaindolizine Human Health 
Risk Assessment.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluazaindolizine, EPA considered exposure under the 
petitioned-for tolerances. EPA assessed dietary exposures from 
fluazaindolizine 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 
fluazaindolizine; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the 2003-2008 food consumption data from the U.S. 
Department of Agriculture's National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, EPA used field-trial based anticipated residue calculations for 
all crops and assumed 100 percent crop treated (PCT) for all crops.
    iii. Cancer. Based on the data summarized in the Fluazaindolizine 
Human Health Risk Assessment, EPA has concluded that fluazaindolizine 
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. 
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 fluazaindolizine in drinking water. Further information 
regarding EPA drinking water models used in pesticide exposure 
assessment can be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.
    Separate estimated drinking water concentrations (EDWCs) were 
calculated for the metabolite IN-VM862 and a combination of 
fluazaindolizine and the other metabolites IN-QEK31, IN-REG72, IN-
F4106, and IN-A5760, due to greater toxicological potency of IN-VM862. 
This combination is referred to as the Fluazaindolizine Drinking Water 
Total Residue Fraction (FDWTRF). Based on the Pesticide Water 
Calculator (PWC), EPA used an EDWC of 990 ppb for FDWTRF and 1,300 ppb 
for IN-VM862 in the chronic dietary risk assessment.
    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). Fluazaindolizine is 
not registered for any specific use patterns that would result in 
residential exposure.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to fluazaindolizine and any 
other substances and fluazaindolizine does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that fluazaindolizine 
has 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 https://www.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. Increased quantitative 
susceptibility was observed for fluazaindolizine in the rat 2-
generation reproductive study. An increased incidence and severity of 
urinary tract histopathology was observed in male and female 
F2 weanlings at a lower dose than in P and F1 
adult animals. No susceptibility was observed in the rat or rabbit 
developmental toxicity studies. The metabolite IN-F4106 showed 
increased prenatal susceptibility (decreased fetal body weight) in the 
rat developmental toxicity study. However, concern for prenatal 
susceptibility is low for both parent and metabolite because clear 
NOAELs and LOAELs were identified for fetal toxicity and endpoints 
selected for risk assessment are protective of these findings.
    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 fluazaindolizine is complete.
    ii. There is no indication that fluazaindolizine is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors to account for neurotoxicity.
    iii. Increased quantitative susceptibility was observed for 
fluazaindolizine in the rat two-generation reproductive study. However, 
as noted above, concern for prenatal susceptibility is low for both 
parent and metabolite because clear NOAELs and LOAELs were identified 
for fetal toxicity and endpoints selected for risk assessment are 
protective of these findings.
    iv. There are no residual uncertainties with regard to the exposure 
assessment

[[Page 62468]]

for fluazaindolizine. An acute dietary endpoint was not identified for 
any population and therefore an assessment of acute dietary risk was 
not performed. For chronic dietary exposure, risk estimates were 
partially refined by using average field trial residues and empirical 
processing factors. Conservative, upper bound estimates were used to 
assess exposure to fluazaindolizine and its residues of concern through 
drinking water. Based on these considerations, exposure from food and 
drinking water will not be underestimated. No residential use patterns 
are proposed at this time.

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, 
fluazaindolizine 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 
fluazaindolizine from food and water will utilize 82% of the cPAD for 
all infants less than one year old, the population group receiving the 
greatest exposure. There are no residential uses for fluazaindolizine.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate risk takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, 
fluazaindolizine is not registered for any use patterns that would 
result in either short- or intermediate-term residential exposure. 
Because there is no short- or 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 short- or intermediate-term risk), no further 
assessment of short- or intermediate-term risk is necessary, and EPA 
relies on the chronic dietary risk assessment for evaluating short- and 
intermediate-term risk for fluazaindolizine.
    4. Aggregate cancer risk for U.S. population. Fluazaindolizine 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 fluazaindolizine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Crops: The petitioner submitted method validation, supplemental 
method validation, and radiovalidation data for Method No. DuPont-33861 
(Rev. 3). This method successfully quantitates two ion transitions for 
fluazaindolizine via liquid chromatography with tandem mass 
spectrometry (LC-MS/MS). Method No. DuPont-33861 (Rev. 3) meets HED's 
criteria for enforcement analytical methods.
    Livestock: The petitioner submitted method validation and an 
independent laboratory validation (ILV) for Method No. DuPont-39226 
(Rev. 1). This method successfully quantitates two ion transitions for 
fluazaindolizine via LC-MS/MS. Method No. DuPont-39226 (Rev. 1) meets 
HED's criteria for enforcement analytical methods.
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; 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 has not established any MRLs for fluazaindolizine.

C. Response to Comments

    One comment was received on the April 15, 2020, notice of filing 
that stated in part ``this application should be denied. stop using 
this chemical.'' Although the Agency recognizes that some individuals 
believe that pesticides should be banned on agricultural crops, the 
existing legal framework provided by section 408 of the FFDCA 
authorizes EPA to establish tolerances when it determines that the 
tolerance is safe. Upon consideration of the validity, completeness, 
and reliability of the available data as well as other factors the 
FFDCA requires EPA to consider, EPA has determined that the 
fluazaindolizine tolerances are safe. The commenter has provided no 
information indicating that a safety determination cannot be supported.

D. Revisions to Petitioned-For Tolerances

    All tolerance values being established in this rulemaking vary 
slightly from what the petitioner requested. This is primarily because 
the petitioner proposed various metabolites as residues of concern for 
crop and livestock commodities, whereas EPA has concluded that the only 
residue needed to measure compliance with the tolerance is 
fluazaindolizine. All raw agricultural commodity (RAC) crop tolerances 
were calculated according to the Organization for Economic Cooperation 
and Development (OECD) tolerance calculation procedure. Tolerances in/
on processed commodities were calculated by multiplying average 
processing factors by the mean or highest average field trial (HAFT) 
value for blended and non-blended commodities, respectively. Commodity 
definitions are used in accordance with EPA's correct commodity 
definition guideline.
    EPA is not establishing the requested primary crop tolerances for 
dried potato, potato process waste, tomato paste, and tomato puree, or 
the requested rotational crop tolerances for aspirated grain fractions 
(AGF), corn milled byproducts, soybean hulls, soybean meal, dehydrated 
strawberries, and wheat milled byproducts. Residues of parent 
fluazaindolizine in these processed commodities are not expected to 
concentrate to levels above the associated tolerances for the raw 
agricultural commodities, so processed commodity tolerances are not 
necessary. The Agency is not establishing the requested primary crop 
tolerance on tomato wet pomace, as this processed fraction is not 
considered a significant feed item and a tolerance is not necessary.
    The Agency is not establishing the requested rotational crop 
tolerance for fruiting vegetable crop group 8-10, as residues of parent 
fluazaindolizine are

[[Page 62469]]

expected to be below the limit of quantitation (LOQ) in fruiting 
vegetables planted as rotational crops and therefore the primary crop 
tolerance is adequate.
    The Agency is not establishing the requested rotational crop 
tolerances for the straw of commodities in crop groups 7 and 20, as 
these are not identified as significant feed items and tolerances are 
not needed. Similarly, EPA is not establishing the requested rotational 
crop tolerance for the fodder of crop group 18, as this is not a 
recognized commodity for the crop group.
    Finally, EPA is establishing rotational crop tolerances for crop 
groups 6-22, 7-22, 15-22 and 16-22 rather than the requested rotational 
crop tolerances on crop groups 6, 7, 15 and 16. EPA proposed changes to 
these four crop groups on January 10, 2022 (87 FR 1091) (FRL-5031-12-
OCSPP) and finalized the revised crop groups as 6-22, 7-22, 15-22 and 
16-22 on September 21, 2022 (87 FR 57627) (FRL-5031-13-OCSPP). EPA 
regulations state ``Once a revised crop group is established, EPA will 
no longer establish tolerances under the pre-existing crop group.'' 40 
CFR 180.40(j)(4). EPA has determined that the residue data support 
rotational crop tolerances for crop groups 6-22, 7-22, 15-22 and 16-22 
based on EPA's practice for evaluating residue data for rotational crop 
tolerances and because there were no changes to major crops in groups 
6-22, 7-22, 15-22 and 16-22. No food commodities are included in the 
revised crop groups that were not already accounted for in the initial 
dietary exposure assessment. Therefore, an updated dietary assessment 
is not needed, and the exposure and risk assessments do not change as a 
result of the crop group updates.

V. Conclusion

    Therefore, tolerances are established for residues of 
fluazaindolizine, including its metabolites and degradates in or on 
carrot at 0.05 ppm; cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm; 
cattle, meat byproducts at 0.01 ppm; egg at 0.01 ppm; goat, fat at 0.01 
ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; hog, 
fat at 0.01 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.01 
ppm; horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat 
byproducts at 0.01 ppm; milk at 0.01 ppm; poultry, fat at 0.01 ppm; 
poultry meat at 0.01 ppm; poultry, meat byproducts at 0.01 ppm; sheep, 
fat at 0.01 ppm; sheep, meat at 0.01 ppm; sheep, meat byproducts at 
0.01 ppm; tomato, dried at 0.4 ppm; vegetable, cucurbit, group 9 at 
0.15 ppm; vegetable, fruiting, group 8-10 at 0.07 ppm; and vegetable, 
tuberous and corm, subgroup 1C at 0.2 ppm.
    Additionally, tolerances are established for inadvertent residues 
of fluazaindolizine, including its metabolites and degradates in or on 
animal feed, nongrass, group 18, forage at 0.01 ppm; animal feed, 
nongrass, group 18, hay at 0.015 ppm; animal feed, nongrass, group 18, 
straw at 0.15 ppm; berry, low growing, subgroup 13-07G at 0.01 ppm; 
grain, cereal, forage, hay, stover, and straw group 16-22, forage at 
0.01 ppm; grain, cereal, forage, hay, stover, and straw group 16-22, 
hay at 0.015 ppm; grain, cereal, forage, hay, stover, and straw group 
16-22, stover at 0.15 ppm; grain, cereal, forage, hay, stover, and 
straw group 16-22, straw at 0.15 ppm; grain, cereal, group 15-22 at 
0.01 ppm; grass, forage, fodder and hay, group 17, forage at 0.01 ppm; 
grass, forage, fodder, and hay, group 17, hay at 0.015 ppm; grass, 
forage, fodder and hay, group 17, straw at 0.15 ppm; oilseed group 20 
at 0.8 ppm; rapeseed, forage at 0.09 ppm; stalk, stem, and leaf petiole 
vegetable group 22 at 0.03 ppm; vegetable, Brassica, head and stem, 
group 5-16 at 0.015 ppm; vegetable, bulb, group 3-07 at 0.03 ppm; 
vegetable, legume, forage and hay, group 7-22, forage at 0.09 ppm; 
vegetable, legume, forage and hay, group 7-22, hay at 0.4 ppm; 
vegetable, leafy, group 4-16 at 0.015 ppm; vegetable, leaves of root 
and tuber, group 2 at 0.015 ppm; vegetable, legume, group 6-22 at 0.8 
ppm; and vegetable, root, subgroup 1B at 0.02 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). 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

[[Page 62470]]

and pests, Reporting and recordkeeping requirements.

    Dated: September 5, 2023.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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. Add Sec.  180.720 to subpart C to read as follows:

Sec.  180.720  Fluazaindolizine; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
nematicide fluazaindolizine, including its metabolites and degradates, 
in or on the commodities to Table 1 of this section. Compliance with 
the tolerance levels specified in Table 1 is to be determined by 
measuring only fluazaindolizine, 8-chloro-N-[(2-chloro-5-
methoxyphenyl)sulfonyl]-6-(trifluoromethyl)imidazo[1,2-a]pyridine-2-
carboxamide, in or on the commodity.

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Carrot..................................................            0.05
Cattle, fat.............................................            0.01
Cattle, meat............................................            0.01
Cattle, meat byproducts.................................            0.01
Egg.....................................................            0.01
Goat, fat...............................................            0.01
Goat, meat..............................................            0.01
Goat, meat byproducts...................................            0.01
Hog, fat................................................            0.01
Hog, meat...............................................            0.01
Hog, meat byproducts....................................            0.01
Horse, fat..............................................            0.01
Horse, meat.............................................            0.01
Horse, meat byproducts..................................            0.01
Milk....................................................            0.01
Poultry, fat............................................            0.01
Poultry, meat...........................................            0.01
Poultry, meat byproducts................................            0.01
Sheep, fat..............................................            0.01
Sheep, meat.............................................            0.01
Sheep, meat byproducts..................................            0.01
Tomato, dried...........................................             0.4
Vegetable, cucurbit, group 9............................            0.15
Vegetable, fruiting, group 8-10.........................            0.07
Vegetable, tuberous and corm, subgroup 1C...............             0.2
------------------------------------------------------------------------

    (b)-(c) [Reserved]
    (d) Indirect or inadvertent residues. Tolerances are established 
for residues of the nematicide fluazaindolizine, including its 
metabolites and degradates, in or on the commodities to Table 2 of this 
section. Compliance with the tolerance levels specified in Table 2 is 
to be determined by measuring only fluazaindolizine, 8-chloro-N-[(2-
chloro-5-methoxyphenyl)sulfonyl]-6-(trifluoromethyl)imidazo[1,2-
a]pyridine-2-carboxamide, in or on the commodity.

                        Table 2 to Paragraph (d)
------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Animal feed, nongrass, group 18, forage.................            0.01
Animal feed, nongrass, group 18, hay....................           0.015
Animal feed, nongrass, group 18, straw..................            0.15
Berry, low growing, subgroup 13-07G.....................            0.01
Grain, cereal, forage, hay, stover, and straw group 16-             0.01
 22, forage.............................................
Grain, cereal, forage, hay, stover, and straw group 16-            0.015
 22, hay................................................
Grain, cereal, forage, hay, stover, and straw group 16-             0.15
 22, stover.............................................
Grain, cereal, forage, hay, stover, and straw group 16-             0.15
 22, straw..............................................
Grain, cereal, group 15-22..............................            0.01
Grass, forage, fodder and hay, group 17, forage.........            0.01
Grass, forage, fodder and hay, group 17, hay............           0.015
Grass, forage, fodder and hay, group 17, straw..........            0.15
Oilseed group 20........................................             0.8
Rapeseed, forage........................................            0.09
Stalk, stem and leaf petiole vegetable group 22.........            0.03

[[Page 62471]]

 
Vegetable, Brassica, head and stem, group 5-16..........           0.015
Vegetable, bulb, group 3-07.............................            0.03
Vegetable, legume, forage and hay, group 7-22, forage...            0.09
Vegetable, legume, forage and hay, group 7-22, hay......             0.4
Vegetable, leafy, group 4-16............................           0.015
Vegetable, leaves of root and tuber, group 2............           0.015
Vegetable, legume, group 6-22...........................             0.8
Vegetable, root, subgroup 1B............................            0.02
------------------------------------------------------------------------

[FR Doc. 2023-19607 Filed 9-11-23; 8:45 am]
BILLING CODE 6560-50-P