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.

• 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 ( printed page 54229) 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 docket ID number EPA-HQ-OPP-2022-0455 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 October 20, 2026.

EPA's Administrative Law Judges Division (ALJD), 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 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 ALJD electronically, a person should utilize the ALJD e-filing system at 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 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 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 29, 2025 (90 FR 46544 (FRL-12474-07-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 1F8976) by UPL Delaware, Inc. and UPL NA, Inc., 630 Freedom Business Center, Suite 402, King of Prussia, PA 19406. The petition requested that 40 CFR 180.301 be amended by establishing tolerances for residues of the fungicide carboxin in or on vegetable, legume, forage and hay, except soybean, subgroup 7-22A at 2 parts per million (ppm); vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E at 0.2 ppm; and vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F at 0.2 ppm. The petition also requested that 40 CFR 180.301 be amended by removing the tolerance for residues of carboxin in or on bean, dry, seed. The document referenced a summary of the petition prepared by UPL Delaware, Inc. and UPL NA Inc., which is available in the docket at www.regulations.gov.

The September 29, 2025 notice of filing supersedes two earlier notices of filing published in the Federal Register on January 3, 2023 (88 FR 38) (FRL-9410-08-OCSPP), and September 12, 2023 (88 FR 62499) (FRL-10579-07-OCSPP), which were based on earlier versions of the same petition (PP 1F8976) requesting tolerances for crop subgroup 6-22E: dried shelled bean, except soybean at 0.2 ppm; crop subgroup 6-22F: pulses, dried shelled pea at 0.2 ppm; pea, dry, forage at 0.4 ppm; and pea, dry, hay at 2 ppm. UPL Delaware, Inc. and UPL NA, Inc. subsequently amended their petition as noticed in the September 29, 2025, Federal Register .

EPA received one comment in response to the September 29, 2025, notice of filing expressing concerns that pesticide use is linked to cancer and other chronic diseases and any “exemption” should rarely be allowed outside of uses tied to national security. EPA also received one comment in response to the September 12, 2023, notice of filing expressing concerns about pesticide residues in food and their connection to resistance and allergic reactions.

The Agency acknowledges the commenters' concerns regarding potential health effects associated with pesticide use. However, the existing legal framework provided by section 408 of the FFDCA authorizes EPA to establish a tolerance when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the available data, as well as other factors the FFDCA requires EPA to consider, EPA has determined that the carboxin tolerances established in this action are safe. The commenters provided no information supporting the conclusion that these tolerances are not safe.

III. Final Tolerance Action

A. Aggregate Risk Assessment and Determination of Safety

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

The toxicity database for carboxin is adequate, with the exception of a subchronic inhalation toxicity study. In subchronic and chronic feeding studies in rats with carboxin, the kidney was the primary target organ with effects including chronic progressive nephropathy and histopathological changes showing increased incidence and severity with time. For dogs and mice, the primary target organ appeared to be the liver. The developmental toxicity studies in rats and rabbits and the reproduction study in rats with carboxin indicated no increased quantitative or qualitative susceptibility of the fetuses or pups, as compared to adults. In the carcinogenicity study in mice with carboxin, dose-related increases in the incidence of liver centrilobular hypertrophy were observed; however, this is considered to be an adaptive rather than an adverse response. Carboxin is classified as “Not Likely to Be Carcinogenic to Humans” based on the lack of evidence of ( printed page 54230) carcinogenicity in male and female rats and mice in acceptable carcinogenicity studies. Carboxin exhibits low acute toxicity via oral (Toxicity Category III), inhalation (Toxicity Category IV), and dermal (Toxicity Category III) routes of exposure. It is a slight eye irritant (Toxicity Category III). It is not a skin irritant (Toxicity Category IV) and is negative for dermal sensitization. The developmental toxicity studies in rats and rabbits and the reproduction study in rats with carboxin indicated no increased quantitative or qualitative susceptibility of the fetuses or pups, as compared to adults. In the developmental toxicity studies in rats for carboxin, no adverse effects were observed in either the dams or the fetuses. In a developmental toxicity study in rabbits, abortions were observed at 750 mg/kg/day on GDs 27-28. The abortions are considered to be both maternal and developmental adverse effects. In a two-generation reproduction study with carboxin in rats, the reproductive effects (decreased fertility indices in F2b parents) and offspring effects (decreased pup weight) occurred at higher doses than the parental effects (gross and histopathological changes in the kidneys, e.g., chronic nephritis).

Although no high temperature hydrolysis data is available for carboxin, the chemical structure of carboxin suggests that the release of aniline may occur following the processing of carboxin-treated crop commodities. Aniline may be a potential degradation product of carboxin in cooked food, but it is toxicologically different from carboxin. EPA has classified aniline as a B2-probable human carcinogen with an oral cancer slope factor of 5.7 × 10⁻³ (mg/kg/day)⁻¹, which is considered very conservative for cancer assessment of aniline. The Agency did not identify any other oral endpoint for aniline.

Specific information on the risk assessment conducted in support of this action, including on the studies received and the nature of the adverse effects caused by carboxin and aniline, can be found in the document titled “Carboxin: Human Health Risk Assessment for the Use of Liquid Formulations on Dried Shelled Peas; to Establish a Tolerance for Residues in/on Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F and Vegetable, Legume, Forage and Hay, Except Soybean, Subgroup 7-22A; to Convert the Existing Tolerance for Residues in/on Bean, Dry, Seed Tolerance to Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E; and to Allow a 0-Day Plantback Interval for Vegetable, Legume, Pulse, Pea, Dried Shelled, Subgroup 6-22F in Conjunction with a Tolerance on this Crop Subgroup” (hereinafter “Carboxin Human Health Risk Assessment”) which is available in the docket for this action.

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, 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 www.epa.gov/​science-and-assessing-pesticide-risks/​assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for carboxin and aniline used for human health risk assessment can be found in the Carboxin Human Health Risk Assessment, which is available in the docket for this action.

D. Exposure Assessment

1. Dietary Exposure From Food and Feed Uses

In evaluating dietary exposure to carboxin and aniline, EPA considered exposure under the petitioned-for tolerances as well as all existing carboxin tolerances in 40 CFR 180.301. EPA assessed dietary exposures from carboxin and aniline in food as follows:

i. Acute exposure. Carboxin. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for carboxin; therefore, a quantitative acute dietary exposure and risk assessment is not necessary.

Aniline. There are no data to determine an acute endpoint for aniline at this time; therefore, a quantitative acute dietary exposure and risk assessment for carboxin-derived aniline residues was not conducted.

ii. Chronic exposure. Carboxin. In conducting the chronic dietary exposure assessment for carboxin, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database Version 4.02, which uses 2005-2010 food consumption data from the United States Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America. As to residue levels in food, EPA assumed tolerance-level residues, default processing factors, and 100 percent crop treated (PCT) for all crops.

Aniline. Aniline is a high temperature hydrolysis degradate for another registered pesticide, buprofezin. The highly refined estimated dietary exposure of the most highly exposed adult population (adults 50-99 years old) to buprofezin-derived aniline in cooked foods is 0.000052 mg/kg/day. Estimated chronic exposures to buprofezin-derived aniline residues are orders of magnitude below any potential chronic non-cancer reference dose for aniline. Any chronic exposures to carboxin-derived aniline residues are expected to be significantly lower than to buprofezin-derived aniline residues based on carboxin's limited use patterns and lower tolerance-level residues in food commodities. Therefore, a quantitative chronic non-cancer dietary exposure and risk assessment for carboxin-derived aniline residues is not necessary.

iii. Cancer. Carboxin. Based on the data discussed in Unit III.A., EPA has concluded that carboxin is not likely to be carcinogenic to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is not necessary.

Aniline. Due to the absence of high temperature hydrolysis data for carboxin, a quantitative cancer dietary exposure and risk assessment for carboxin-derived aniline residues was not conducted. However, cancer dietary exposure and risk assessments for buprofezin-derived aniline residues are currently available. See “Buprofezin: Acute, Chronic (Food and Drinking Water) and Cancer (Aniline; Cooked Food Only) Aggregate Dietary Exposure ( printed page 54231) and Risk Assessments for the New Use on Bushberry Crop Subgroup 13-07B and Proposed Amendment to Expand the Use on Succulent Beans to All Members of Proposed Edible Podded Bean Legume Vegetable Subgroup 6-22A” and “Buprofezin. Human Health Risk Assessment for Proposed New Use on Bushberry Crop Subgroup 13-07B and Proposed Amendments to Expand Use on Succulent Beans to All Members of Proposed Edible Podded Bean Legume Vegetable Subgroup 6-22A and Use on Greenhouse-Grown Tomatoes and Peppers to All Members of Fruiting Vegetable Crop Group 8-10” in docket ID number EPA-HQ-OPP-2020-0235. EPA conducted a qualitative assessment of cancer dietary exposure and risk for carboxin-derived aniline residues based on the assessments for buprofezin-derived aniline residues.

Buprofezin is applied as a broadcast foliar application on a variety of food crops with the maximum seasonal application rates ranging from 0.7 to 4.0 pounds of active ingredient per acre per growing season. Tolerances established for residues of buprofezin in or on various food commodities range from 0.02 to 80 ppm, with most tolerances greater than 0.2 ppm. Buprofezin residue data indicate that there is a proportion of buprofezin residues in or on food crops that is available for conversion to aniline during food processing that is subjected to high temperature cooking conditions. A highly refined cancer dietary exposure and risk assessment for buprofezin-derived aniline residues was conducted for cooked food only using an oral cancer slope factor (Q₁ * of 5.7 × 10⁻³ (mg/kg/day)⁻¹) for aniline. This assessment was conducted using a maximum conversion factor of buprofezin to aniline of 18.9%, which was the highest found in a high temperature hydrolysis study of buprofezin-derived aniline and was applied to estimate residues of buprofezin-derived aniline which may form in food as a result of cooking. The highly refined estimated dietary exposure of the most highly exposed adult population (adults 50-99 years old) to buprofezin-derived aniline in cooked foods is 0.000052 mg/kg/day.

Any dietary exposure to carboxin-derived aniline residues in cooked foods are expected to be significantly lower than buprofezin-derived aniline residues based on carboxin's limited use patterns and lower tolerance-level residues. Carboxin is used for pre-planting seed treatment, with low maximum application rates ranging from 0.005 to 0.825 pounds of active ingredient per acre per year. Carboxin residues in or on certain food crops were non-detectable or below the limit of quantitation (LOQ) based on field trials conducted at exaggerated use rates. Residue data for other food crops indicate that there was not much carboxin residue, at the most less than 0.025 to less than 0.2 ppm, available for conversion to aniline during food processing that is subjected to high temperature cooking conditions. Tolerances established for residues of carboxin in or on various food commodities, including the tolerances established in this action, range from 0.03 to 0.2 ppm, with several tolerances at 0.2 ppm. The LOQ of the residue data collection method was 0.025 ppm, whereas the LOQ of the enforcement analytical methods was 0.2 ppm, indicating that many of the tolerances at 0.2 ppm would be much lower if not for the limitation of the enforcement analytical methods. These low residue levels can be attributed to carboxin's limited used patterns.

2. Dietary Exposure From Drinking Water

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

For surface water, estimated drinking water concentrations (EDWC) were modeled using Pesticide in Water Calculator (PWC) (version 1.52) for seed treatment of all labeled crops except rice. EDWCs for rice seed treatment use were modeled by Pesticide in Flooded Applications Model Version 2. For groundwater, EDWCs were modeled using PWC and the six standard groundwater scenarios at the maximum application rate of 0.825 lb a.i./A/yr for registered crops. The highest post breakthrough average EDWC for carboxin residues of concern ( i.e., carboxin and its sulfoxide metabolite) was 81.7 µg/L or parts per billion (ppb) in groundwater. The EDWC of carboxin residues of concern in surface water from chronic exposure was minimal (6.2 µg/L). EDWCs were directly entered into the dietary exposure model. For the chronic dietary risk assessment, the ground water concentration value of 81.7 ppb was used to assess the contribution to drinking water.

For aniline, the Agency has determined that there is no expectation of carboxin-derived aniline residues in drinking water.

3. From Non-Dietary Exposure

The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., from lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Carboxin is not registered for any specific use patterns that would result in residential exposure to carboxin or carboxin-derived aniline.

4. Cumulative Effects From Substances With a Common Mechanism of Toxicity

Section 408(b)(2)(D)(v) of the 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 carboxin and any other substances. For the purposes of this action, therefore, EPA has not assumed that carboxin has a common mechanism of toxicity with other substances.

For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at www.epa.gov/​pesticide-science-and-assessing-pesticide-risks/​cumulative-assessment-risk-pesticides.

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 Food Quality Protection Act (FQPA) safety factor. 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. ( printed page 54232)

2. Prenatal and Postnatal Sensitivity

The developmental toxicity studies in rats and rabbits and the reproduction study in rats with carboxin indicated no increased quantitative or qualitative susceptibility of the fetuses or pups, as compared to adults. In the developmental toxicity studies in rats for carboxin, no adverse effects were observed in either the dams or the fetuses. In a developmental toxicity study in rabbits, abortions were observed at 750 mg/kg/day on GDs 27-28. The abortions are considered to be both maternal and developmental adverse effects. In a two-generation reproduction study with carboxin in rats, the reproductive effects (decreased fertility indices in F_2b parents) and offspring effects (decreased pup weight) occurred at higher doses than the parental effects (gross and histopathological changes in the kidneys, e.g., chronic nephritis).

3. Conclusion

EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA safety factor were reduced to 1X for dietary exposure scenarios. The current action does not have residential uses; if any future actions have residential uses, then the FQPA safety factor would also be 1X for all residential/non-occupational exposure scenarios, with the exception of inhalation scenarios due to the lack of a subchronic inhalation toxicity study. That decision is based on the following findings:

i. With the exception of a subchronic inhalation toxicity study, the toxicity database for carboxin is adequate for FQPA evaluation. Developmental toxicity studies in rats and rabbits and a two-generation reproduction toxicity study in rats with carboxin are available for FQPA consideration.

ii. There is no evidence of neurotoxicity in the existing toxicity database. No guideline acute or subchronic neurotoxicity studies were submitted; however, no indications of neurotoxic effects were observed in any of the subchronic or chronic studies in dogs, mice, or rats. Based on a Weight-of-Evidence approach, EPA determined that the acute and subchronic neurotoxicity studies are not required at this time.

iii. There was no evidence of increased quantitative or qualitative susceptibility in the developmental toxicity studies in rabbits or rats with carboxin.

iv. There is no residual uncertainty with respect to the dietary exposure database. A conservative chronic dietary (food and water) risk assessment was conducted for carboxin incorporating tolerance-level residues, EPA's default processing factors, 100 PCT, and the highest EDWCs. There are no residential uses for carboxin. These assessments will not underestimate the exposure and risks posed by carboxin.

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. Carboxin: Acute Risk

An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, carboxin is not expected to pose an acute risk, and an acute aggregate risk assessment is not required.

2. Carboxin: Chronic Risk

Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to carboxin from food and drinking water will utilize 87% of the cPAD for all infants less than 1 year old, the population group receiving the greatest exposure. There are no residential uses for carboxin. Therefore, chronic aggregate exposures and risk estimates are equivalent to the chronic dietary (food and drinking water) exposure and risk estimates. These risks are not of concern.

3. Carboxin: 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). Carboxin is not registered for any specific use patterns that would result in residential exposure. Therefore, short- and intermediate-term risk is equal to chronic dietary risk, which is not of concern.

4. Carboxin: Aggregate Cancer Risk for U.S. Population

Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, carboxin is classified as “Not Likely to be Carcinogenic to Humans,” and quantification of cancer risk is not required.

5. Aniline

There are no data to determine an acute endpoint for aniline at this time; hence, an acute dietary risk assessment was not conducted for carboxin-derived aniline residues. The highly refined estimated chronic exposure of the most highly exposed adult subpopulation (adults 50 to 99 years old) to buprofezin-derived aniline residues is 0.000052 mg/kg/day. Estimated chronic exposures to buprofezin-derived aniline residues are orders of magnitude below any potential chronic non-cancer reference dose for aniline. Any chronic exposures to carboxin-derived aniline residues are expected to be significantly lower than to buprofezin-derived aniline residues based on carboxin's limited use patterns and lower tolerance-level residues. Therefore, a quantitative chronic non-cancer dietary risk assessment for carboxin-derived aniline residues is not necessary to conclude with reasonable certainty that chronic exposures from carboxin-derived aniline residues do not pose a non-cancer dietary risk. The highly refined estimated chronic exposure of the most highly exposed adult subpopulation to buprofezin-derived aniline results in an upper bound cancer risk estimate of 3 × 10⁻⁷. Based again on carboxin's limited use patterns and lower tolerance-level residues, the Agency concludes that the cancer risk estimate for buprofezin-derived aniline residues indicates that there should not be any cancer risk from carboxin-derived aniline residues.

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 carboxin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology is available to enforce the tolerance expression. The Pesticide Analytical Manual, Vol. II lists three methods for determining the combined residues of carboxin and its metabolites, ( printed page 54233) determined as the common moiety, aniline, and expressed as carboxin. These methods include a colorimetric method, which in principle is based on the alkaline hydrolysis of carboxin and its sulfoxide metabolite to produce aniline; and gas-liquid chromatography (GLC) methods. A GLC/Mass Selective Detector data-collection method is also available to enforce tolerances for carboxin.

B. International Residue Limits

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex has not established MRLs for carboxin in or on any commodities.

V. Conclusion

Therefore, tolerances are established for residues of carboxin, 5,6-dihydro-2-methyl- N -phenyl-1,4-oxathiin-3-carboxanilide, including its metabolites and degradates, in or on Vegetable, legume, forage and hay, except soybean, subgroup 7-22A at 2 ppm; Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E at 0.2 ppm; and Vegetable, legume, pulse, pea, dried shelled, subgroup 6-22F at 0.2 ppm. The existing tolerance for bean, dry, seed at 0.2 ppm is removed as unnecessary, because this commodity is covered by the new tolerance for Vegetable, legume, pulse, bean, dried shelled, except soybean, subgroup 6-22E at the same level.

VI. Statutory and Executive Order Reviews

Additional information about these statutes and executive orders can be found at 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 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.

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, 40 CFR chapter I is amended as follows:

91 FR 54228