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

Fluoxapiprolin; 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 might apply to them:

• 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-2022-0980 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 31, 2026.

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 EPA's regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, 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/HomePage?ReadForm.

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. Summary of Petitioned-For Tolerance

In the Federal Register of July 5, 2023 (88 FR 42935) (FRL-10579-05-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 2F9005) by Bayer CropScience, 800 N Lindbergh Blvd., St. Louis, MO 63167. The petition requested that EPA establish tolerances in 40 CFR part 180 for residues of the fungicide fluoxapiprolin in or on tuberous and corm vegetables subgroup 1C at 0.01 parts per million (ppm); onion, bulb subgroup 3-07A at 0.03 ppm; onion, green subgroup 3-07B at 2.0 ppm; lettuce, head at 0.8 ppm; leafy vegetable group 4-16, except head lettuce at 5.0 ppm; brassica head and stem vegetable group 5-16 at 0.8 ppm; fruiting vegetable group 8-10 at 0.06 ppm; cucurbit vegetable group 9 at 0.06 ppm; small fruit vine climbing subgroup 13-07F, except fuzzy kiwifruit at 0.2 ppm; grape, raisin at 0.4 ppm; leafy petiole vegetable subgroup 22B at 1.5 ppm as primary crops; and in or on low growing berry subgroup 13-07G at 0.01 ppm as rotational crops. That document referenced a summary of the petition that was prepared by the petitioner, which is available in the docket at https://www.regulations.gov, docket ID number EPA-HQ-OPP-2022-0980. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is establishing tolerances for onion, green subgroup 3-07B; vegetable, cucurbit, group 9; vegetable, leafy, group 4-16; and grape, raisin that vary from what the petition requested based on the data. In addition, EPA is not establishing a tolerance for low growing berry subgroup 13-07G for the indirect rotational crop usage. The reasons for these changes are explained in Unit IV.C.

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 therein, 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 fluoxapiprolin, including exposure resulting from the tolerances established by this action. EPA's assessment of hazards, exposures, and risks associated with fluoxapiprolin follows.

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.

Fluoxapiprolin is a piperidinyl-thiazole-isoxazoline fungicide used to control oomycete diseases in a variety of vegetable and vine crops. Fluoxapiprolin has an oxysterol binding protein inhibitor pesticidal mode of action, but a mammalian mode of action has not been determined. Across the fluoxapiprolin database, there were no adverse effects seen in guideline studies. No developmental or maternal toxicity was observed up to the limit dose in developmental toxicity studies in rats and rabbits. In a rat two-generation reproduction toxicity study, no toxicity was observed up to the highest doses tested (262/302 mg/kg/day (M/F)), which were selected based on toxicokinetic data. In the developmental and reproduction toxicity studies, there was no indication that fluoxapiprolin had an adverse effect on fetal or offspring development, fertility, or reproductive performance. In the carcinogenicity studies, fluoxapiprolin was not found to be carcinogenic in rats or mice and was not mutagenic. Based on the lack of toxicity in the available fluoxapiprolin toxicity database, no toxicological points of departure (POD) have been established to evaluate incidental oral, dermal, or inhalation exposure scenarios for fluoxapiprolin human health risk assessment.

In the toxicological database for fluoxapiprolin, a 28-day oral toxicity study in rats examining an aerobic soil degradate of fluoxapiprolin, BCS-BP32808, is available. Decreased total motor activity and piloerection in males and females was observed at 12 mg/kg/day (no observed adverse effect level (NOAEL) was 5 mg/kg/day), indicating that the degradate BCS-BP32808 is more toxic than the parent. Additionally, BCS-BP32808 was positive for mutagenicity in a bacterial reverse mutation assay but did not induce gene mutations in an in vitro mammalian cell gene mutation test. BCS-BP32808 showed a positive response in the in vitro chromosomal aberration assay. However, when BCS-BP32808 was tested in vivo, it did not induce micronuclei in the mouse micronucleus test up to non-cytotoxic doses. Lastly, BCS-BP32808 was negative for the induction of mutations in vivo in the liver and glandular stomach of transgenic mice. Therefore, there is low concern for mutagenicity for BCS-BP32808 in vivo.

The toxicological database for fluoxapiprolin is considered complete and adequate for hazard identification, characterization, and risk assessment. Fluoxapiprolin was categorized as having low acute toxicity via the oral (Toxicity Category III), dermal (Toxicity Category III), and inhalation routes (Toxicity Category IV) of exposure. It produces minimal but reversible eye irritation (Toxicity Category IV). It is not a dermal irritant but is a dermal sensitizer.

C. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA identifies toxicological PODs 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 the NOAELs are observed and the lowest dose at which adverse effects of concern (the LOAEL) are identified. 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/science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

Based on the lack of toxicity in the available fluoxapiprolin toxicity database, no toxicological PODs have been established for fluoxapiprolin. More detailed information on the toxicological endpoints for the degradate of fluoxapiprolin, BCS-BP32808, used for human health risk assessment can be found in the document "Fluoxapiprolin: Human Health Risk Assessment to Support the Registration of a New Active Ingredient for Proposed Uses on Brassica Head and Stem Vegetables; Bulb Vegetables; Cucurbit Vegetables; Fruiting Vegetables; Leafy Vegetables; Leaf Petiole Vegetables; Small Fruit Vine Climbing, Except Fuzzy Kiwifruit; and Tuberous and Corm Vegetables" (hereafter, the Fluoxapiprolin Human Health Risk Assessment) in docket ID number EPA-HQ-OPP-2022-0980 at https://www.regulations.gov.

D. Exposure Assessment

1. Dietary Exposure From Food and Feed Uses

In evaluating dietary exposure to fluoxapiprolin, EPA considered exposure under the petitioned-for tolerances. EPA assessed dietary exposures from fluoxapiprolin as follows:

i. Acute and chronic 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 acute or chronic effects were identified in the toxicological studies for fluoxapiprolin; however, such effects were identified for the degradate of fluoxapiprolin, BCS-BP32808. In estimating the acute and chronic dietary exposure, EPA used the Dietary Exposure Evaluation Model software with the Food and Commodity Intake Database (v 4.02). This software uses the food consumption information from the United States Department of Agriculture's 2005-2010 National Health and Nutrition Examination Survey, What We Eat in America. As to residue levels in food, EPA conducted unrefined acute and chronic dietary exposure assessments based on the recommended tolerance for fluoxapiprolin for onion, green subgroup 3-07B, which are high enough to cover residues for the degradate, BCS-BP32808. BCS-BP32808 was only identified and quantifiable in green onion samples, and the tolerance level for onion, green subgroup 3-07B is higher than the BCS-BP32808 residue levels of the individual green onion samples. Both the acute and chronic assessments assume 100 percent crop treated (PCT), default processing factors, and incorporate conservatively modeled estimated drinking water concentrations (EDWC) of BCS-BP32808.

ii. Cancer. Based on its review of available data, EPA has concluded that fluoxapiprolin is not likely to be carcinogenic. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iii. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the acute or chronic dietary exposure assessment for BCS-BP32808. Tolerance level residues and/or 100 PCT were assumed.

The Agency addressed exposures from the three major routes (oral, dermal, and inhalation) and determined whether the individual exposures from these routes can be combined. If two or more exposures have endpoints based on the same target organ or system, they can be combined. Toxicity was seen only for the degradate BCS-BP32808. Therefore, BCS-BP32808 was used for establishing residues of concern (ROC) in primary crops, rotational crops, and drinking water for risk assessment purposes. For livestock commodities, no residues are included in the ROCs for risk assessment purposes. No endpoints were selected for fluoxapiprolin, thus there is no need to consider combining routes of exposures to that compound. As identified earlier, the BCS-BP32808 degradate has been identified for toxicological effects. No endpoints were selected for dermal and inhalation exposures for BCS-BP32808, thus these routes cannot be combined.

For fluoxapiprolin, the nature of the residue is adequately understood based on plant and livestock metabolism studies. In the metabolic profile in plants, the parent compound represented the most prominent residue in above-ground parts of crops (grapes and lettuce), whereas metabolites that have been formed in soil were mainly detected in potato tuber. The predominant residues observed in primary crops were also observed in rats. The metabolic pathway of fluoxapiprolin in rats, poultry (laying hens), and ruminants (goats) was similar.

Field trial studies are of an adequate number and geographic representation. The magnitude of the residue data show that when following the proposed use patterns, parent fluoxapiprolin is the most widely observed compound and comprises most of the residues. Due to its hazard, BCS-BP32808, has been identified as the ROC for risk assessment in primary crop plants. While it was not observed in the lettuce, grape, or potato metabolism studies, it was observed at quantified levels in the green onion residue trials. The unrefined acute and chronic dietary exposure analyses are based on the recommended tolerance for fluoxapiprolin for onion, green subgroup 3-07B, which are high enough to cover residues for BCS-BP32808. Additionally, both assessments assume 100 PCT and incorporate conservatively modeled EDWCs of BCS-BP32808.

2. Dietary Exposure From Drinking Water

The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for fluoxapiprolin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluoxapiprolin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.

Determination of the ROCs for human health in drinking water included consideration of fluoxapiprolin and the degradate BCS-BP32808. The drinking water ROC is limited only to the granddaughter degradate BCS-BP32808 and does not include the parent fluoxapiprolin. Fluoxapiprolin is classified as hardly mobile, while the degradate BCS-BP32808 is classified as highly mobile. For the drinking water ROC for BCS-BP32808, the aerobic soil metabolism half-lives range from 3.8 to 28.7 days (non-persistent to slightly persistent). Aerobic and anaerobic aquatic metabolism half-lives range from 14 to 56.2 days and 85.5 to 108 days in the total system, respectively.

Based on the Pesticides in Water Calculator (PWC; version 2.001), the EDWCs of degradate BCS-BP32808 for acute dietary exposures are estimated to be 1.0 µg/L for surface water and 1.2 µg/L for groundwater. EDWCs for chronic dietary exposures are estimated to be 0.2 µg/L for surface water and 1.0 ug/L for groundwater. The modeled maximum EDWCs were incorporated into the dietary exposure model.

3. From Non-Dietary Exposure

The term "residential exposure" is used in this document to refer to non-occupational, non-dietary exposure ( e.g., from lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Fluoxapiprolin is not registered for any use patterns that are expected to 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."

In 2016, EPA's Office of Pesticide Programs released a guidance document, "Pesticide Cumulative Risk Assessment: Framework for Screening Analysis". The Agency has utilized this framework for fluoxapiprolin and determined that although fluoxapiprolin shares some chemical and/or toxicological characteristics ( e.g., chemical structure or apical endpoint) with other pesticides, the toxicological database does not support a testable hypothesis for a common mechanism of action. No further data are required to determine that no common mechanism of toxicity exists for fluoxapiprolin and other pesticides and no further cumulative evaluation is necessary for fluoxapiprolin. 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/pesticide-cumulative-risk-assessment-framework.

E. Safety Factor for Infants and Children

1. In General

FFDCA section 408(b)(2)(C) 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 Food Quality Protection Act (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

The available toxicity database for fluoxapiprolin does not show any evidence of neurotoxicity, including in the acute neurotoxicity study. A developmental neurotoxicity study was not required.

Evidence of potential neurotoxicity was observed in the 28-day oral toxicity study conducted on the degradate of fluoxapiprolin, BCS-BP32808. However, there is a low degree of concern for the potential neurotoxic effects since (1) clear NOAELs were identified for the neurotoxic effects; and (2) the endpoints chosen for risk assessment are protective of any potential neurotoxicity.

3. Conclusion

For fluoxapiprolin, EPA has not identified any toxicological endpoints of concern associated with any threshold effects and has conducted a qualitative assessment. As part of that assessment, the Agency did not use SFs for assessing risk, and no additional SF is needed for assessing risk to infants and children. EPA has also evaluated the available data for fluoxapiprolin and concluded that there are no residual uncertainties concerning the potential risks to infants and children that would impact its conclusions about threshold effects.

For BCS-BP32808, EPA is retaining the 10X FQPA SF for protection of infants and children to address hazard uncertainties, including incompleteness of the database, prenatal and postnatal toxicity, and subchronic to chronic uncertainty. The Agency concludes that this safety factor will be protective of potential toxicity to infants and children given the conservative exposure estimates and overall low expected exposure.

E. Aggregate Risk and Determination of Safety

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population adjusted dose (aPAD) and the chronic population adjusted dose (cPAD). Short-, intermediate-, and chronic term aggregate risks are evaluated by comparing the estimated total food, water, and residential exposure to the appropriate points of departure to ensure that an adequate MOE exists.

No adverse effects were observed in the submitted toxicological studies for fluoxapiprolin regardless of the route of exposure. Therefore, a quantitative aggregate exposure assessment was not conducted for fluoxapiprolin.

For the degradate of fluoxapiprolin, BCS-BP32808, the Agency characterized the risk of BCS-BP32808 based upon the results observed in the 28-day oral toxicity study and conservative exposure assumptions as a protective screening measure. Residential exposures to BCS-BP32808 are not anticipated based on the proposed uses, and no dermal, incidental oral, and inhalation endpoints or PODs have been established for BCS-BP32808. Therefore, the quantitative dietary assessment of BCS-BP32808 is considered as a screening-level aggregate exposure assessment for BCS-BP32808.

1. Acute Risk

Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to fluoxapiprolin (BCS-BP32808) will occupy 3.8% of the aPAD for all infants, 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 fluoxapiprolin (BCS-BP32808) from food and water will utilize less than 1% of the cPAD for the general U.S. population, and 1.6% for all infants, the population group receiving the greatest exposure. There are no residential uses for fluoxapiprolin.

3. Short- and Intermediate-Term Risk

Short- and intermediate-term aggregate exposure 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, fluoxapiprolin is not being proposed to be registered for any use patterns that would result in either short- or intermediate-term residential exposure. Therefore, the short-term and intermediate-term aggregate risks are equivalent to the chronic dietary risk estimates, which are not of concern.

4. Aggregate Cancer Risk for U.S. Population

Based on the evidence of low carcinogenicity in two adequate rodent carcinogenicity studies, fluoxapiprolin is not expected to pose a cancer risk to humans.

5. Determination of Safety

Based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to fluoxapiprolin residues. More detailed information on this action can be found in the Fluoxapiprolin Human Health Risk Assessment in docket ID number EPA-HQ-OPP-2022-0980.

IV. Other Considerations

A. Analytical Enforcement Methodology

For analysis of fluoxapiprolin for purposes of regulatory enforcement, the petitioner has proposed method 01624 for assessing residues on plants and method 01628 for assessing residues on livestock products and biproducts. Extracted residue levels are determined by a high-performance liquid chromatography/triple-stage quadrupole mass spectrometry method. The method limit of quantitation is 0.01 mg/kg (ppm). Furthermore, the method is considered acceptable for enforcement purposes.

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). Codex 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 proposed MRLs for fluoxapiprolin on grapes; grapes, dried; onion bulb; tomato; and potato. The U.S. tolerances and proposed Codex MRLs for the following commodities are harmonized: grape, raisin and grapes, dried at 0.5 ppm; onion, bulb, subgroup 3-07A and onion bulb at 0.03 ppm; and vegetable, tuberous and corm, subgroup 1C and potato at 0.01 ppm. The U.S. tolerance and Codex MRL are not harmonized for grapes or vegetable, fruiting, group 8-10 and tomato. EPA is establishing a tolerance for fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.2 ppm, which is higher than the proposed individual Codex MRL for grapes at 0.15 ppm. The U.S. tolerance is based on available residue data and use by U.S. growers consistent with approved label instructions could result in residues that exceed the Codex MRL. Harmonizing with the proposed Codex MRL could put U.S. growers at risk of violative residues despite legal use. EPA is establishing a tolerance for vegetable, fruiting, group 8-10 at 0.06 ppm, which is lower than the proposed individual Codex MRL for tomato at 0.07 ppm. Fluoxapiprolin is being jointly reviewed in the U.S. and Canada. For this joint review, the U.S. tolerances and Canadian MRLs and associated tolerance expressions are harmonized between the U.S. and Canada. While Codex has proposed an MRL for tomato, the MRL is not yet established. Mexico has not established any fluoxapiprolin MRLs.

C. Revisions to Petitioned-For Tolerances

The petitioned-for tolerance on onion, green subgroup 3-07B has been revised from 2.0 ppm to 2 ppm to remove trailing zeros in accordance with Organization for Economic Cooperation and Development (OECD) rounding class practice. The Agency is establishing a higher tolerance level than the petition requested for vegetable, cucurbit, group 9 (0.07 ppm instead of 0.06 ppm) and vegetable, leafy, group 4-16 (6 ppm instead of 5 ppm) based on OECD tolerance calculation procedures. The Agency is establishing a tolerance for vegetable, fruiting, group 8-10 of 0.06 ppm to harmonize with Canada at that level. The Agency is establishing a higher tolerance level than the petition requested for grape, raisin (0.5 ppm instead of 0.4 ppm), based on the grape highest average field trial data and the raisin processing factor. Additionally, EPA is not establishing a tolerance for inadvertent residues on berry, low growing, subgroup 13-07G for the indirect rotational crop usage since fluoxapiprolin residues in strawberry fruit were less than the limit of quantitation (0.010 ppm) in a limited field rotational crop study.

V. Conclusion

Therefore, a tolerance is established for residues of fluoxapiprolin in or on the food and feed commodities of: Fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 0.2 ppm; Grape, raisin at 0.5 ppm; Leaf petiole vegetable subgroup 22B at 1.5 ppm; Lettuce, head at 0.8 ppm; Onion, bulb, subgroup 3-07A at 0.03 ppm; Onion, green, subgroup 3-07B at 2 ppm; Vegetable, brassica, head and stem, group 5-16 at 0.8 ppm; Vegetable, cucurbit, group 9 at 0.07 ppm; Vegetable, fruiting, group 8-10 at 0.06 ppm; Vegetable, leafy, group 4-16, except lettuce, head at 6 ppm; and Vegetable, tuberous and corm, subgroup 1C at 0.01 ppm.

VI. Statutory and Executive Order Reviews

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 has exempted these types of actions from review under Executive Order 12866.

A. 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.

B. Regulatory Flexibility Act (RFA)

Since tolerance actions 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 RFA, 5 U.S.C. 601 et seq., do not apply to this action.

C. 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.

D. 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.

E. 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.

F. 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 2026 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.

G. 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.

H. 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.

I. 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. 2026-13198 Filed 6-29-26; 8:45 am]

BILLING CODE 6560-50-P