Rule2026-11940

Pydiflumetofen; Pesticide Tolerances

Primary source

Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.

Published
June 15, 2026
Effective
June 15, 2026

Issuing agencies

Environmental Protection Agency

Abstract

This regulation establishes tolerances for residues of pydiflumetofen (CASRN 1228284-64-7) in or on the food and feed commodities of sugarcane, cane. Under the Federal Food, Drug, and Cosmetic Act (FFDCA), Syngenta Crop Protection, LLC, submitted a petition to EPA requesting that EPA establish a maximum permissible level for residues of this pesticide in or on the identified commodities.

Full Text

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<title>Federal Register, Volume 91 Issue 114 (Monday, June 15, 2026)</title>
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[Federal Register Volume 91, Number 114 (Monday, June 15, 2026)]
[Rules and Regulations]
[Pages 35888-35892]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11940]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2025-0183; FRL-13308-01-OCSPP]


Pydiflumetofen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pydiflumetofen (CASRN 1228284-64-7) in or on the food and feed 
commodities of sugarcane, cane. Under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), Syngenta Crop Protection, LLC, submitted a 
petition to EPA requesting that EPA establish a maximum permissible 
level for residues of this pesticide in or on the identified 
commodities.

DATES: This regulation is effective on June 15, 2026. Objections and 
requests for hearings must be received on or before August 14, 2026 and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of this document).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2025-0183, is available at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Additional information about dockets generally, 
along with instructions for visiting the docket in person, is available 
at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Registration Division 
(7505T), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 566-1030; email address: <a href="/cdn-cgi/l/email-protection#5e0c1a180c10312a373d3b2d1e3b2e3f70393128"><span class="__cf_email__" data-cfemail="cb998f8d9985a4bfa2a8aeb88baebbaae5aca4bd">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    If you have any questions regarding the applicability of this 
action to a particular entity, consult the person listed under FOR 
FURTHER INFORMATION CONTACT.

B. What is EPA's authority for taking this action?

    EPA is issuing this rulemaking under section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section 
408(b)(2)(A)(i) 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.'' FFDCA section 
408(b)(2)(A)(ii) 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. FFDCA section 408(b)(2)(C) 
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. . .''

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. If you fail to file an objection to the 
final rule within the time period specified in the final rule, you will 
have waived the right to raise any issues resolved in the final rule. 
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 the docket ID number EPA-HQ-
OPP-2025-0183 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 August 14, 2026.
    The EPA's Office of Administrative Law Judges (OALJ), in which the 
Hearing Clerk is housed, urges parties to file and serve documents by 
electronic means only, notwithstanding any other particular 
requirements set forth in

[[Page 35889]]

other procedural rules governing those proceedings. See ``Order Urging 
Electronic Filing and Service,'' dated December 3, 2025, which can be 
found at <a href="https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf">https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf</a>. Although the EPA's 
regulations require submission via U.S. Mail or hand delivery, the EPA 
intends to treat submissions filed via electronic means as properly 
filed submissions; therefore, the EPA believes the preference for 
submission via electronic means will not be prejudicial. When 
submitting documents to the OALJ electronically, a person should 
utilize the OALJ e-filing system at <a href="https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf">https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf</a>.
    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 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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. If you wish to 
include CBI in your request, please follow the applicable instructions 
at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly 
mark the information that you claim to be CBI. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice.

II. Petitioned-For Tolerance

    In the Federal Register of September 5, 2025 (90 FR 42896) (FRL-
12474-06-OCSPP), 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 4F9138) by Syngenta Crop Protection, LLC, P.O. Box 18300, 
Greensboro, NC 27419. The petition requested that 40 CFR part 180 be 
amended by establishing tolerances for residues of the fungicide 
pydiflumetofen, (3-(difluoromethyl)-Nmethoxy-1-methyl-N-[1-methyl-2-
(2,4,6-trichlorophenyl)ethyl]-1H-pyrazole-4-carboxamide), in or on 
sugarcane at 0.05 ppm. That document referenced a summary of the 
petition prepared by Syngenta Crop Protection, LLC, the registrant, 
which is available in the docket, <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Three 
comments were received on the notice of filing. EPA's response to these 
comments is discussed in Unit IV.D. EPA has modified the commodity 
definition from sugarcane to sugarcane, cane.

III. Final Tolerance Action

A. 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 pydiflumetofen including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with pydiflumetofen 
follows.
    In an effort to streamline its publications in the Federal 
Register, EPA is not reprinting sections that repeat what has been 
previously published for tolerance rulemakings of the same pesticide 
chemical. Where scientific information concerning a particular chemical 
remains unchanged, the content of those sections would not vary between 
tolerance rulemaking, and EPA considers referral back to those sections 
as sufficient to provide an explanation of the information EPA 
considered in making its safety determination for the new rulemaking.
    EPA has previously published several tolerance rulemakings for 
pydiflumetofen in which EPA concluded, based on the available 
information, that there is a reasonable certainty that no harm would 
result from aggregate exposure to pydiflumetofen and established 
tolerances for residues of that chemical. EPA is incorporating 
previously published sections from these rulemakings as described 
further in this rulemaking, as they remain unchanged. These sections 
include toxicological profile, toxicological points of departure/levels 
of concern, exposure assessment, cancer, dietary exposure of drinking 
water, safety factor for infants and children, aggregate risk and 
determination of safety, chronic risk and analytical enforcement 
methodology. The risk assessment published in support of this 
rulemaking is ``Pydiflumetofen. Human Health Risk Assessment to Support 
a Tolerance for Indirect or Inadvertent Residues in/on Sugarcane and a 
Label Amendment to Add a Soil Use for Cottonseed subgroup 20C, Leafy 
greens subgroup 4-16A, and Vegetable, fruiting, group 8-10'' which is 
available in the docket for this action at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

B. 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. Specific information on the studies received and the nature 
of the adverse effects caused by pydiflumetofen as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in the 
final rule published in the Federal Register of August 19, 2019 (84 FR 
155) (FRL-9997-09). The Hazard and Science Policy Council (HASPOC) 
recommended a waiver for the requirement for the subchronic 
neurotoxicity (SCN) and immunotoxicity studies. (HASPOC, M. Lewis, TXR 
0057659, 12/22/2017). Based on a weight of evidence approach 
considering all the available hazard and exposure information, the 
HASPOC later also recommended a subchronic inhalation study be waived 
(HASPOC, Z. Staley, TXR 0058378, 10/05/2022).

C. 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

[[Page 35890]]

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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides</a>.
    A summary of the toxicological endpoints for pydiflumetofen used 
for human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of May 24, 2018 (83 FR 101) (FRL-
9976-66). All endpoints remain unchanged from the referenced Federal 
Register except for the reduction of the dermal absorption factor (DAF) 
from 17% to 5% which is applied to the dermal endpoint. For more 
information on this change see the risk assessment supporting that 
rulemaking ``Pydiflumetofen. Human Health Risk Assessment to Support 
Tolerance without U.S. Registrations for Coffee, Green Bean, and Dragon 
Fruit'' which is available in docket EPA-HQ-OPP-2024-0502 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

D. Exposure Assessment

    In evaluating dietary exposure to pydiflumetofen, EPA considered 
exposure under the petitioned-for tolerances as well as all existing 
pydiflumetofen tolerances in 40 CFR 180.699. EPA assessed dietary 
exposures from pydiflumetofen in food as follows:
    1. 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. The exposure assessment 
remains the same; for a description of the EPA approach to and 
assumptions for the exposure assessment, please reference Unit III.C of 
the August 12, 2019, rulemaking.
    2. Dietary exposure from food and feed uses. EPA's dietary exposure 
assessments have been updated to include the additional exposure from 
the new use on sugarcane. The chronic and acute dietary (food and 
drinking water) exposure and risk assessment were conducted using the 
Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database (DEEM-FCID) Version 4.02, which uses the 2005-2010 food 
consumption data from the U.S. Department of Agriculture's (USDA's) 
National Health and Nutrition Examination Survey, What We Eat in 
America (NHANES/WWEIA). The chronic and acute dietary risk assessments 
were partially refined, assuming tolerance-level residue values, 100% 
crop treated (100 PCT) for all commodities, and default processing 
factors, when empirical processing factors were not available. The 
assessment is considered partially refined due to the use of empirical 
processing factors.
    3. Cancer. EPA determines whether quantitative cancer exposure and 
risk assessments are appropriate for a food-use pesticide based on the 
weight of the evidence from cancer studies and other relevant data. If 
quantitative cancer risk assessment is appropriate, Cancer risk may be 
quantified using a linear or nonlinear approach. If sufficient 
information on the carcinogenic mode of action is available, a 
threshold or nonlinear approach is used and a cancer RfD is calculated 
based on an earlier noncancer key event. If carcinogenic mode of action 
data are not available, or if the mode of action data determines a 
mutagenic mode of action, a default linear cancer slope factor approach 
is utilized. As discussed in Unit III.A. of the 2019 Final Rule, EPA 
has concluded that pydiflumetofen should be classified as ``Not Likely 
to be Carcinogenic to Humans'' at doses that do not induce a 
proliferative response in the liver. This determination has remained 
unchanged.
    4. Dietary exposure from drinking water. The new use on sugarcane 
does not result in an increase in the estimated residue levels in 
drinking water, so EPA used the same estimated drinking water 
concentrations identified in Unit IV. C of the 2019 rulemaking.
    5. 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). For this action there 
are no residential exposures anticipated. As such, there is no 
quantitative residential post-application exposure assessment 
associated specifically with this action. For further discussion 
regarding non-dietary exposure see the risk assessment 
``Pydiflumetofen. Human Health Risk Assessment to Support Tolerance 
without U.S. Registrations for Coffee, Green Bean, and Dragon Fruit'' 
which is available in docket EPA-HQ-OPP-2024-0502 at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at <a href="http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide">http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide</a>.
    6. 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 pydiflumetofen and any other substances. For the purposes 
of this action, therefore, EPA has not assumed that pydiflumetofen has 
a common mechanism of toxicity with other substances.

E. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
fetal sensitivity or toxicity in rat and rabbit developmental studies; 
however, quantitative offspring sensitivity was noted in the 2-
generation reproduction study. Pup body-weight depression starting on 
day 4 of lactation and persisting into adulthood was observed at doses 
that did not elicit an adverse response in the parental rats. Although 
body weight was depressed in these animals after maturity and during 
the mating and post-mating period

[[Page 35891]]

(specifically in males), it was considered evidence of offspring 
susceptibility because the lower body weight was a result of impaired 
growth in the pups. Reduced pup weight, reduced litter size, and 
increased liver and spleen weight in offspring was also noted following 
prenatal and perinatal exposure to the pydiflumetofen metabolite, 
2,4,6-trichlorophenol. PODs were selected for each exposure scenario to 
be protective of the parent and metabolite offspring toxicity and 
offspring susceptibility in the risk evaluation.
    3. Conclusion. EPA continues to conclude that there are reliable 
data to support the reduction of the FQPA safety factor from 10X to 1X. 
See Unit III.D. of August 12, 2019, rulemaking for a discussion on the 
Agency's rationale for that determination.

F. 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 Unit 
III.C. for acute exposure, the acute dietary exposure from food and 
water to pydiflumetofen will occupy 9.0% of the aPAD for children 3-5 
years 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 
pydiflumetofen from food and water will utilize 29% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
pydiflumetofen is not expected.
    3. Short-term risk- and intermediate. 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). Pydiflumetofen 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 pydiflumetofen.
    Using the exposure assumptions described in Unit III.C. for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 800 for adults, 
1200 for children 6 to less than 11 years old, and 2600 for children 11 
to less than 16 years old. Because EPA's level of concern for 
pydiflumetofen is a 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). Because no intermediate-term adverse effect was identified, 
pydiflumetofen is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on its cancer 
classification, a cancer aggregate assessment is not required for 
pydiflumetofen. The chronic reference dose is protective of all chronic 
toxicity, including carcinogenicity, resulting from exposure to 
pydiflumetofen and its metabolite 2,4,6-trichlorphenol.
    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 pydiflumetofen residues, including its metabolites and 
degradates More detailed information about the Agency's analysis can be 
found at <a href="https://www.regulations.gov">https://www.regulations.gov</a> in the document titled 
``Pydiflumetofen. Human Health Risk Assessment to Support a Tolerance 
for Indirect or Inadvertent Residues in/on Sugarcane and a Label 
Amendment to Add a Soil Use for Cottonseed subgroup 20C, Leafy greens 
subgroup 4-16A, and Vegetable, fruiting, group 8-10.'' in docket ID 
number EPA-HQ-OPP-2025-0183.

IV. Other Considerations

A. Analytical Enforcement Methodology

    For a discussion of the available analytical enforcement method, 
see Unit IV.A. of the August 12, 2019, rulemaking.

B. International Residue Limits

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

C. Effective and Expiration Date(s)

    In general, a tolerance action is effective on the date of 
publication of the final rule in the Federal Register. For actions in 
the final rule that lower or revoke existing tolerances, EPA will set 
an expiration date for the existing tolerance of six months after the 
date of publication of the final rule in the Federal Register, in order 
to allow a reasonable interval for producers in exporting members of 
the World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS) 
Measures Agreement to adapt to the requirements.

D. Response to Comments

    EPA received three comments in response to the September 5, 2025, 
Notice of Filing, which summarized the agency's tolerance petition 
process. Two comments were identical, where the second comment was a 
duplicate of the original comment. The original comment raised 
questions about the residue level on food but was not accompanied by 
any substantiation nor data supporting a conclusion that the tolerances 
established in this action do not meet the FFDCA safety standard. 
Although EPA recognizes that some individuals would oppose any use of 
pesticides on food, section 408 of the FFDCA authorizes EPA to set 
tolerances for residues of pesticide chemicals in or on food when it 
determines that the tolerance meets the safety standard imposed by that 
statute. Upon review of the available information, EPA concludes that 
these tolerances would be safe. A third comment was received but was 
irrelevant to the current petition.

V. Conclusion

    Therefore, tolerances are established for residues of 
pydiflumetofen, in or on sugarcane, cane at 0.05 ppm.

[[Page 35892]]

VI. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive orders 
can be found at <a href="https://www.epa.gov/regulations/and-executive-orders">https://www.epa.gov/regulations/and-executive-orders</a>.

A. Executive Order 12866: Regulatory Planning and Review

    This action is exempt from review under Executive Order 12866 (58 
FR 51735, October 4, 1993), because it establishes or modifies a 
pesticide tolerance or a tolerance exemption under FFDCA section 408 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.

B. Executive Order 14192: Unleashing Prosperity Through Deregulation

    Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply 
because actions that establish a tolerance under FFDCA section 408 are 
exempted from review under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under 
the PRA 44 U.S.C. 3501 et seq., because it does not contain any 
information collection activities.

D. Regulatory Flexibility Act (RFA)

    Since tolerance actions that are established on the basis of a 
petition under FFDCA section 408(d), such as the tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the RFA, 5 U.S.C. 601 et seq., do not apply to this 
action.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more (in 1995 dollars and adjusted annually for inflation) as described 
in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely 
affect small governments. The action imposes no enforceable duty on any 
state, local or tribal governments or on the private sector.

F. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will 
not have substantial direct effects on the states, on the relationship 
between the national government and the states, or on the distribution 
of power and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will 
not have substantial direct effects on tribal governments, on the 
relationship between the Federal government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
government and Indian tribes.

H. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997) because tolerance actions like this one are exempt from 
review under Executive Order 12866.
    However, EPA's 2021 Policy on Children's Health applies to this 
action. This rule finalizes tolerance actions under the FFDCA, which 
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 . . .'' (FFDCA 408(b)(2)(C)). The Agency's 
consideration is summarized in Unit III.E.

I. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211 (66 FR 28355) 
(May 22, 2001) because it is not a significant regulatory action under 
Executive Order 12866.

J. National Technology Transfer Advancement Act (NTTAA)

    This action does not involve technical standards that would require 
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA 
will submit a rule report to each House of the Congress and to the 
Comptroller General of the United States. 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: June 9, 2026.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    For the reasons set forth 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. In Sec.  180.699 amend Table 2 to paragraph (d) by adding the entry 
for ``sugarcane, cane'' in alphabetical order to read as follows:


Sec.  180.699   Pydiflumetofen; tolerances for residues.

* * * * *
    (d) * * *

                        Table 2 to Paragraph (d)
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Sugarcane, cane............................................        0.05
------------------------------------------------------------------------

[FR Doc. 2026-11940 Filed 6-12-26; 8:45 am]
BILLING CODE 6560-50-P


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Indexed from Federal Register on June 15, 2026.

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