Pesticide Tolerance; Exemptions, Petitions, Revocations, etc.: Pydiflumetofen

Pydiflumetofen; Pesticide Tolerances

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:

• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• 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 other procedural rules governing those proceedings. See "Order Urging Electronic Filing and Service," dated December 3, 2025, which can be found at https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf. 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 https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.

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 https://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. If you wish to include CBI in your request, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules 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, http://www.regulations.gov. 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 https://www.regulations.gov.

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 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

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 https://www.regulations.gov.

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 https://www.regulations.gov.

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.

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 (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 https://www.regulations.gov 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.

VI. Statutory and Executive Order Reviews

Additional information about these statutes and Executive orders can be found at https://www.epa.gov/regulations/and-executive-orders.

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).

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

[FR Doc. 2026-11940 Filed 6-12-26; 8:45 am]

BILLING CODE 6560-50-P